Forwards final draft radiation emitting equipment rules, Title IV ...

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HON. TERRY E. BRANSTADccwm.

HEALTH MXnXH XXXXXXXXXXXXDEPARTMENT fTXWYHYYXXXXHXXXX

| Paul F. Carlsoni Acting Commissioner

of Public Health

June 5, 1985

Joel 0. LubenauSenior Project ManagerState Agreements ProgramOffice of State ProgramsU.S. Nuclear Regulatory Commission -

Washington, D.C. 20555

Dear Mr uoenau:

Reference is made to the May 15, 1985, letter from John A. Eure. Enclosed is thefinsi draft of our Radiation Emitting Equipment Rules, Title IV which were publishedin the Iowa Administrative Code on June 5,1985. We will be getting published copiesaf ter July 1,1985. When these copies are available I will send one to you.

If you have any questions, please do not hesitate to contact me.

Sincerely,l /

/91Donalc A. Flater, Coordinator

' Radiological Health ProgranEnvironmental Health Section515/281-3478

DAF/bf

Enclosure

8507260122 850717PDR STPRO ESGI

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JR 5 'iS35 En:rgy Cbenission has ent red into an effectivo'.

agreement under edeoction 274b. of the Atomic EnergyAct of 1954, as amended (73 Stat. 689).

KJE.TM IEPARWENT (470) " Airborne radioactive motorial" means any radio-active material dispersed in the air in the form of

*Pursuant to the authority of section 136C.3, The dusta, fumes, niets, vapore, or gases.Code, the State Department of Health amende chaptere " Airborne radioactivity area" means my roan,

38 to 41 to establish minimum standards for the regu. enclosure, or operating sees in thich airborne radio-lation of radiation emitting equipment. active meterial exists in concentrations in excese of

the anotsste specified in 40.16(1MC), Table I, ColumnTitle IV 1 of those ruleep or any roan, enclosure, or operet-

RADIATIENI DtITTIls EINIFIENT ing area in sich airborne ruficactive materialOglPTER 2 existe in concentratione sich, areraged over the

EIElut. PROVISIIBS number of hours in any week during thich individuelsna in the area, exceed 25 percent of the anomte

470-38.1(136C) Seaps. specified in 40.17(136C), Table I, Cblumn 1 of theseiIExcept as otherwise specifically provided, these rules.

rules apply to all persons who possess, use, or " Byproduct etterial" messa any radioactive mater-trenefer rm11ation machines and to all persons tho isl (except special nuclear material) yielded in oruse, manufacture, produce, distribute, sell, trans- made radioactive by exposure to the radiation inci-port, tr ans fer, install, repair, receive, acquire, dent to the process of producing or utilizing specialom, or possese radioactive material; provided, how- nuc1(at meterial. |over, that nothing in these rulee shall apply to any " Calender quarter" neans not less than 12 consecu-person to the extent such person is e4 ject to regu- tive weeks nor more than 14 consecutive weeks. Thelation by the U.S. 96sclear Reguletory Commission. first calender quarter of each year shall begin Jn

Regulation by the state of source meterial, byproduct .lanuary and edeequent calender cuarters shall be aometerial and special nuclear material in quantities arranged etch thit no day is included in are thannot sufficient to form a critical case is sejact to one calendar quarter and no day in any one year is-

the provisions of the agressant between the state end omitted from inclusion within a calendar quarter. Nb . -

the U.S. heleur Regulatory Commission and to 10 CFR licensee or registrant shall change the methodPert 150 of the Commission's regulations. observed by him of determining enlender quarters for

Reference to CFRs in this chapter are those in purposes of thoes regulatione except at the beginningeffect on .lenuary 1,1986. of a calender year.

"Calibretion" means the determination efj (1) the470-38.2(136C) Definitisme. As uend in this chapter response or reading of an instrument relative tn aand chapters 39 to 41, these terms have the defini- series of lesom radiation values over ths range oftions set forth below. Additional definitione used the instrument, or (2) the attength of e source ofonly in a certain chapter will be found in that radiation relative to a standard.chcpter. " Carrier" mearts a person engaged in the trans-

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"Ag" usene the maximus activity of special form portation of passengere or property by land or interriadioactive material permitted in a Type A package. as e aammon, contract, or private carrier, or by

( "A " means the maxista activity of radioactive meter. civil aircraft. -2i ial, other than special form radioactive material, ''CFR" meena Code of federal Regulations.

permitted in a Type A package. These values are " Curie'' seens e tr:it of measurement of radio-listc<f in 470-38.14(136C) or may be derived in accor- activity. Qie curie (C1) is that quantity of radio-dance idth the procedure prescribed in NOTE 4 and 5 active material thich doesys et the rate of 3.7 x

fomd at the end of 33.14(136C). 1010 diair tt,grations per second (dpe). Commonly used" Accelerator-produced meterial" moons any meterial esmultiples of the curie are the millicurie and the

cade radioactive by a particle accelerator. nicrocurie. the millicurie (mC1)=0.OO1 ewie a 3.7 x" Art" means 1984 fous Act , H. F. 2110 entitled 107 dps. 0)e microcurie (uci n 0.000001 eurie 3.7,

Regulation of Radiation Machines and Radioactive x 104 dpe.'

Materiale. (Chapter 136C, The Code.) ." Depleted uranite" means the' swrco enterial

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" Agency" means lose State Department of Health. uraniun in which the isotope uranitas-235 is less then

: " Agreement state' meene any state with thich the 0.711 weight percent of the total uranium present.| U.S. Nuclear Rogulatory Cowsission or the U.S. Atorsic Depleted uranius dwo ret include special ntelest| en terial .|

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"Deee" as used in these rules shell means Individual packages may hevo e trenoport index not -

c. Coorbed does le the energy imported to mett:r less then 01 and not mors than 10.by lonizing radiation por mit mass of irradiated "Former U.S. Atomic Energy (bemission (AEC) ormeterial at the piece of interest. The mit of U. S. helear Regulatory Commisolon (MC) licensedabsorbed does is the red (see " Red"). facilities" means nuclear reactore, nuclear fuel

b. Does equivalent is a quantity that expreseos reprocessing, p1 mite, wania enrichesit plante, oron a common acele for all radiation a meamwe of the critical mese experimental facilities there AEC or

peetulated effect on a given organ. It is defined as WC Liconese have been terminated.the absorbed does in rede times certain modifying " Healing arte" means the fielde of diagnosing andfactors. The mit of does egaivelant is the tem (see treating dieseos, providing health care and improving" Ram"). health by the practice of medicine, osteopetF ,

"!bes commitment" means the total radiation does chiropractic, podistry, dentistry, nursing, veterin-

to e part of the body that d11 result from retention ary medicine, and supporting professions, such asin the body of radioactive meterial. For purposes of physician assistants, nurse practitioners, radiologiccetimating the does commitment, it is soeused that technologists and dental hygienists.from the time of intele the period of exposure to "High radiation arear' means any area, accessibleretained meterial dll not exceed fifty years. to individuale, in shich there existe radiation et

" Exclusive use" (also referred to in other regula- auch levelo shot a egjor portion of the body couldtions as " solo use" or " full load") means the sole receive in. any one hour a dose in excese of oneuse of a conveyance by a single consignor and for htsidred millireme.thich all initial, intermediate, and final loading "Maan use" means the internal or external admini-and mloading are corried out in accordance with the stration of radiation or radioactive material todirection of the consignor or consignes, hteen beings.

" Exposure" speans the quotient of dQ by de where "Individuel" scene any husen being. *

'dQ" is the absolute value of the total charge of the "Inspectiore seene en official erasination or! lone of one sign produced in air den all the elec - observation including but not limited to, teste,

trone (negatrono and positrons) liberated by photone surveys, and monitoring to determine compliance dth4

|in a voltmo element of air having ease "6" are rules, ordere, requirements and conditions of the

completely stopped in air. (The mit of expostee is egency. .

the roentgen (R).) Wien not underlined as above .(or "Intevlock" meste a device arranged or connactedindiceted, as. 'exposwe'(X)), the term 'expoewe' has such that the occurrence of an event or condition isa more general meaning in these rulee. f required before a second event or condition can occur

"Exposwa rate" means the supoews por mit of or continue to occur.time, such as R por minute and mR por how. " License" means a license iset,ad by the Agency in

l " Fissile meterial" means any special nuclear accordance dth the regulatials a$ opted by the

meterial consisting of or containing one or more Agency.

flesile radionuclidee. Fissile radionuclides are " Licensee" means any person so is licensed by theplutonitan-238, plutonius-239, 'plutonius-241, Agency in accordarme with these rules and the Act.uranium-233, and ur anium-235. Neither netwal or " Licensing state" mamme any state - d th rules

| depleted uranius is fissile material. Agency juris- equivalent to the " Suggested State Regulations fordiction extends only to special nuclear meterial if Omtrol of Radiation" relating to, and an effective

| quantities not sufficient to form a critical mass as progen for, the regulatory control of N4104 throtqhdefined in this Dianter. licensing.

.a. Fissile Claes I A package sich may be " Low specific activity meterial" mesis any of the

I trenoported in m11mited numbers and in any arrange- fbilodng

ment, and sich requires no nuclear criticality a. Uranius or thorium ores and physical or chemi-

) cafety controle during trenoportation. A transport cal concentrates of those oreeg

itu*eu la not seeigned foe purposes of nuclear criti- b. thirradiated netwal or depleted uranius or'

celity oefety but may be required because of external mirradiated natural thoriung

radiation levels. c. Tritius oxide in aqueous solutions providedb. Fleeile Class II: A package inich may be the concentration does not exceed 5.0 mil 11 curies per

traiegerted together with other packages in any milliliterscrrervjenent but, for criticality control, in numbers d. Material in sich the triioactivity le essen-

i dich do not exceed an aggregate transport index of tielly miformly distributed and in sich the esti-,

| 50. lhese shipmente require no other ruclear meted everage concentration per gra of contents does! criticality safety control during transportation. not exceed:

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1. 010001 tillicuri3 (f radionuclides far thich 'Pzrsonnel sonit: ring equipment * means devices.

the A2 qusntity in 38.14(136C) is not more than 0.05 (e.g., film badges, pocket dosimeters, and thermolun-curie; inescent dosisoters) assigned to be torn or carried )

2. 0.005 millicurie of radionuclides for which by an individual for the purpose of estimiting thethe A2 quantity in 38.14(136C) is sore than 0.05 dose received by the individual.curie, but not more than 1 curie or " Pharmacist" means an individual licensed by the

3. 0 3 millicurie of radionuclides for which the state of Iowa to compound and dispense drugs, pre-A2 quantity in 38.14(136C) is more than 1 curie. scriptions, and poisons.

(bjects af nonradioattive meterial externally " Physician" means a person sho is currentlye.contaminated with radioactive materisl, provided that licensed in love to practice medicir.J and surgery,tha radioactive material is not readily dispersible osteopathic medicins and strgery, or osteopathy.and the surface contamination, den averaged over an " Rad" memie the special (nit of absorbed dose.area of 1 square meter, does not exceed 0.0001 milli- the red equals one hmdredth of a joule per kilograncurie (220,000 disintegrations per minute) per square of materialg for example, if tissue is the naturialcentimeter of radionuclides for inich the A2 quantity of interest, then one rad equals one hmdred erge perin 38.14(136C) is not more than 0.05 curie, or 0.001 gram of tissue.

millicurie (2,200,000 disintegrations per minute) per " Radiation" (ionizing) means any electrmagneticcquare centimeter for other radionuclides. or particulate radiation capable of producing icne

"NAIN" neans any naturally occurring or accel- directly or indirectly by interaction with matter.crator-produced radioactive material except bypro- This includes alpha particles, beta particles, gamnsduct, fource, or special nuclear material. -

rays, x-rays, neutrone, gotons, and other atomic" Natural radioactivity" mehns radoactivity of particles, but does not include sound waves, radio,

naturally occurring nuclides. waves, microwaves or visible, infrared or ultraviolet"Marmal form radioactive material" means radio- light.

active material ehich has not been demonstrated to " Radiation area" mans any ares, accessible toqualify as "special form radioactive material." individuals, in which there exista radiation et ets:b

" Occupational dose" means exposura of an indivi- levels that major portions of the body could receivedual to redistien (1) in a restricted area; or (2) in in any one hour a dose in excess of fivo milliremo-

the course of employment in thich the individual's or in any five consecutive days a dose in excess ofduties involve expcaure to radiation; provided, that one hundred milliress,

occupational dose shall not be deemed to include any " Radiation unittiruj equipment" means radictioncxposure of an individual to radiation for the pur- machines or radioactive material.pose of diagncais or therapy of sich individual. " Radiation facility" means a facility (e.g.)

" Package" means the packaging together with its hospitals, laboratories, physician's offices, indus-radioactive contrints as presented for transport. trial plants, etc.) there aither a radiation machine

" Pac kaging" means the assembly of components or radioactive material is used.nocessary to ensure compliance with the packaging " Radiation machine" neens any device capable ofrequirements of this part. It may consist of one or producing radiation except those which produce radi-more receptacles, absorbent esterials, spacing struc- ation only from radioactive materisi.tures, thermal insul ation, radiation shielding, and " Radiation safety officer" means one vio has thedevices for cooling or absorbing mechanical shocks. kiowledge ard respansibility to sply appropriateThe vehicle, tie-dom system, and auxiliary equipment radiation protection regulations.may be designated as part of the packaging. " Radioactive meterial" means any material (sclid,

" Particle accelerator" mears any mechine capable liquid, or gas) which emits radiation apor.taneously.af sa:celerating electrons, gotone, neutrona, or " Radioactivity" caans the disintegration or ctherother charged particles in a vacuus and of discharg- nuclear transfor9ation of tnstable atomic nuclei bying the resultant particulate or other radiation into the emission of radiation.O medium at energies usually in excess of one MeV. " Registrant" means any person who is registered

" Person" meana any individual, corporation, part- and is legally obligated to register with the m;encynorship, firm, association, trust, estate, public or purcuant to thece rules and the Act.priv ate institution, grcup, a2ency, political s@- " Registration" means registration with the agencydivision of this state, any other state or political in accordance with Se tales adopted by the agency.,

ctbdivision or agency thereof, and sny legal stcces- " Regulations of the U.S. Departrent of Transports-cor, representative, agent or agency of the fo re- tion" means the regulations in 49 CFR Parts 100.-189.

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rRegulations of the U,$. 'NLclear Regulttsry models, devices, equipment, mettriclo, and process ~Commission" means the regulations in 10 CFR Parts es. Research and development does not include the0-199. Internal or external administration of radiation or

" Rem" means a measure of the dose of any radiation radioactive materials to human beings.to body tissue in terms of its estimated biological " Restricted area" (controlled area) means any areacf fect relative to e dose received from an exposure access to dich is controlled by the registrant orto one roentgen (R) of x-rays. (One millires (arem) licensee for purposes of protection of individuals

s 0.001 rom.) For the purpose of these rules, any of from exposure to radiation and radioactive material.

the following is considered to be equivalent to a " Restricted area" shall not include any areas useddone of one rams for residential quarters, although a separate room or

a. An exposure of one R of x, or genes radiation. roans in a residential building may be set apart as ab. An absorbed dose of one red due to x, gamma, restricted area.

er beta radiation. " Roentgen" (R) means the special mit of expo-10-4 coulombs /c. An absorbed dose of 0.05 red due to particles sure. One roentgen equals 2.58 x

heavier than protons and with sufficient energy to kilogran of air (see " Exposure").reach the lens of the eye. " Sealed source" means radioactive material that is

d. An absorbed dose of 0.1 rad due to neutrons or permanently bonded or fixed in a capsule or matrix

high energy protons. designed to prevent release and dispersal of the

e. A neutron flux of 14 million neutrons per radioactive material mder the most severe conditionscquare centimeter incident upon the body; or, if sich are likely to be encomtered in normal use andthern exists sufficient information to estimate with handling.reasonable accuracy the approximate distribution in "SI" International Systaa of Units Conversion

energy of the neutrons, the . incident number of neu- Tables'

trons per square centimeter equivalent to one tem maybe estimated from the following table:

Expression in terms ofNeutron Flux Dose Equivalents

Other SI base*

Number of (bantity Nmne Symbol mits mitsneutrons per Average fluxsquare centi- density to activity bequerel Bq 1 dps S-1

meter for a deliver 100 mill'i- (curie) Ci 3.7 xNeutron dose equivalent rems in 40 hours 1010Bq

energy of 1 rem (neutroas/cm2 per I

(MeV) (neutrons /cm2) second) absorbed gray By J kg 1 m2s-2

dose (rad) rad 10-2cy

Thennel 970 x 106 6700.0001 720 x 106 500 dose equi- sievert Sv J kg-2 m2s-2

0.005 820 x 106 570 valent (rem) rem 10-2sy

0.02 400 x 106 280

0.1 120 x 106 80 expo :ure coulomb R C b-1 s A kg-1

| 0.5 43 x 106 30 per 2.58 x1.0 26 x 106 18 kilogram 10 4

2.5 29 x 106 20 (roentgen) C kg-1

5.0 26 x 106 jg7.5 24 x 106 17

10.0 24 x 106 17 " Source material" means:10 to 30 14 x 106 10 a. Uranium or thoria, or any combination thereof,

in any physical or chemical form; or"Research and development" means theoretical b. Ores which contain by weight one-tentieth of

analysis, exploration, or experimentation; or the one percent (0.05 percent) or more of:cxtension of investigative findings and theuries of a 1. Uranium,scientific or technical nature into practical appli- 2. Thorium, orcation for experimental and demonstration purposes, 3. Any combination thereof.including the experimental production and testing of Source material does not include special nuclear

material.

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"Sourso cf radictiorf means my redisectivo mater- measuremento of levelo cf radictio'n er concentrction,

tal, or any device or equipment emitting or capable of radioactive material present.of producing radiation. "Teste" means the procese of verifying compliance

"Special fons radioactive material" mems radio- with an applicable rule.active motorial sich satisfies the fb11owing condi- "These rules" mean all chapters of 470 Title IVtienes Radiation Enitting Equipment.

(1) It is either a single solid piece or is " Transport index" means the dimensionless numbercontained in a sealed capsule that can be opened only (rounded up to the first decimal place) placed on the

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by destroying the capsules label of a package to designate the degree of control(2) The piece or capsule has at least one dison- to be exercised by the carrier dwirq transporte-

clon not less than 5 millimeters (0.197 inch); and tion. The transport index is the neber expressing(3) It satisfies the test requirements specified the maximum radiation level in milliran per hour at 1

by the U.S. MtC. A special fone encopoulation meter from the external swface of the package.designed in accordance with the WIC requirements in " Type A quantity" means a quantity of radioactiveoffect on lune 30, 1983, and constructed prior to meterial, the aggregate ruficactivity of sich does.luly 1,1985 may continue to be used. A special form not exceed A3 for special fons radioactive material,encapsulation either designed or constructed after or a A2 for normal form radioactive materini, dere. lune 30, 1985 must meet requirements of this defini- A3 and A2 are given in 38.14(1360) of this part ortion applicable at the time of its design or con- may be determined by procedures described inctruction. 38.14(136C) of this part.

"Special nuclear material in quantities not suffi- " Type B package" means a Type B packaging togethercient to form a critical mass" means uranium enriched with its radioactive coritents. A Type B packagein the isotope U-235 in quantities not exceeding 350 design le designated as B(U) or B(K). B(U) refers tograms of contained U-2353 uranium-233 in quantities the need for milateral approval of internationsi

~~, ' not exceeding 200 grene: plutonium in quantities not shipments; B(M) refers to the need for multi-lateralexceeding 200 grams; or any combination of than in approval. There is no distinction made in hoe pack-accordance with the following fbanula: for each of ages with these designations may be used in domesticthat special nuclear material, determine the ratio transportation. To deteraire their distinction forbetween the quantity of that special nelear meterial international transportation, see 00T regulations in.and the quantity specified above for the same kind of 49 CFR Part 173. A Type B package approved prior to

' cpecial nucleae material. The sum of stch ratios for September 6. 1983 was designated only as Type 9.c11 of the kinds of special nuclear material in Limitations on its use are specified in T.9.combination shall not exceed "1" (i.e., mity). For " Type B packaging" asans a packaging designed toex ample , the following qumtities in combination retain the integrity of containment and phieldingwould not exceed the limitation and are within the required by U. S. MtC regulations when stjected toformula r the normal conditions of trasport and hypothetical

accident test conditions set forth in 10 CTR Part 71.175 (arame contained U-2351 + 50 (arans U-233) " Type B quantity" means a quantity of radioactive

350 200 material greater than a Type A quantity.+ 50 (grane Pu) = 1 "U.S. Department of Energy" means the Department

200 of Energy established by Pelic Law 95-91, .haguet 4,1977, 91 Stat. 565, 42 U.S.C. M <e', seq. , to the

"Specifi: activity" of a radionuclide means the extent that the Department ex peises rectioncradioactivity of the radionuclide per mit mass of formerly vested in the U.S. Atomic Energy Commission,that nuclide. The specific activity of a meterial in its Chairman, members, officers and components andwhich the radionuclide is essentially triiformly transferred to the U.S. Energy Research and Develop-distributsd is the tedioactivity per mit mass of the ment Administration and to the Achinistrator thereofmeterial. pursumt to sectione 104(b) , (c) and (d) of the

" Survey" means e evaluation of the production, Energy Reorganization Act of 1974 (P@lic Law 93-438,use, release, disposal, or presence of sources of October 11,1974 , 88 Stat.1233 at 1237, effectiveradiation mder a specific set of conditions to .1mnuary 19, 1975) and retransferred to the Secretarydeterstne actual or potential radiation ha rtrds. of Energy pursumt to section 301(a) of the Depart-men appropriate, seh evaluation includes, but is sent of Energy Organization Act (P*1ic Law 95-91,

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not limited to tests, nhysic t.1 examination and August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C.7151, effective October 1,1977.)

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"thr: fined and mprocessed cre" mesis cre in its 38.3(3) U.S. Department cf F.nergy Q>ntractars and'natural fann prior to any processing, etch as grind- U.S. Nuclear Regulatory Comunission Contractors. Anying, roseting, beneficiating, or refining. U.S. Department of Energy contractor or s4 contractor

"threstricted area" (mcontrolled area) means any and any U.S. Nuclear Regulatory Commission contractorarea access to sich is not controlled by the regis- or s4 contractor of the following categories operat-trent for purposes of protection of individuals from ing within this State is exempt from these regula-expoews to radiation and radioactive material, and tions to the extent that such contractor or escon-any aree used for residential quartera. tractor under his contract receives, posaeeses, uses,- -

"Maste handling licensees" means persons licensed transfers or acquires sources of radiationsto receive and store radioactive moetes prior to a. Primo contractors performing work for the

disposal and/or persons licensed to dispose of radio- U.S. Department of Energy at U.S. government-omed oractive unste. controlled sites, including the transportation of

"trher" means an individual engaged in verk mder sources of radiation to or from sich sites and the

o licones or registration issued Sy the Agency and per formance of contract services duriruj temporarycontrolled by a licensee or registrant, but does not interruptions of such transportation;include the licensee or registrant. b. Prime contractors of the U.S. Department of

Energy performinq research in, or development of,470-38.3(136C) Exemptions. manufacturing, storage, testing or transportation of,

38.3(1) General provision. The agency map upon atomic seapons or components thereof;application there for or upon its om initiative, c. Primo contractors of the U.S. Department ofgrant such exemptions or exceptions from the require- Energy using or operating nuclear reactors or othermenta of these rules as it determines are authorized nuclear devices in a U.S. government-omed vehicle orby law and will not result in mdue hazard to p411e vessel; andhealth and safety or property. d. Any other prime contractor or s4 contractor o'f

38.3(2) Transportation Examption the U.S. Department of Energy or of the U.S. NJeleers. fh=an and contra:t carriers, freight forward- Regulatory Comunission son the State and the Nuclear

crs, and warehousemen so are s4 ject to the require- Regulatory (benission jointly determinements of the U.S. Dspartment of Transportation in 49 (1) That the exemption of the prime contractor or'

CFR 170 through 189, the U.S. Postal Service in the s4 contractor is authorized by law; andPostal Service Manual. (Domestic Mail Manual), Section , (2) That mder the terse of the contract or,

124.3 incorporated by reference, 39 CFR 111.11 (1974) 'secontract, there la adequate assurance that the

or the Ious Departmeni. of Transportationi are exempt / mark thereunder can be accomplished without unduefrom these regulations to the extent that they trans- risk to the p411c health and safety.port or score radioactive material in the regular 38.3(4) Manufacturer exemption. Any manufacturer

j - course of their carriage for another or storage inci- of radiation machines thich are covered mder thedont thereto. Consson and contract carriers who are Federal Radiation Control for Health and Safety Act'

not e4 ject to the requirements of the U.S. Depart- (42 LEC263 b to n) are exempt from these rules withment of Transportation, U.S. Postal Service or the regard to the provisions of this federal law.Iowa Department of Transportatinn are adject to

cpplicable sections of these rules. 470-38.4(136C) Records. Each registrent or licenseeb.- Any licensee is exempt from the requirements shall meintain records showing the receipt, transfer,

of this Diapter to the extent that he delivers to a and disposal of all sources of radiation. Additianalcarrier for transport a package containing radio- record requirenents are specified elsedere in theseactive material having a specific activity not rules.greater than 0.002 microcurie per gram.

c. A licensee is exempt from all requirements of 478-38.5(136C) Inspections.this chapter, other than 29.78(136C) and 39.92(136C), 38.5(1) Each registrant or licensee shall affordwith roepect to shipment or carriage of the follow- the agency at ,all reasonable times opportmity to

~ ings inspect sources of radiation and the premises andi

| (1) Packages containing no more than Type A facilities serein such sources of radiation are usedquantities of radioactive materAal; or or stored.

(2) Packages transported between locations within 38.5(2) Each registrant or licensee shall makethe thited States sich contain only americitme or available to the agency for inspection, upon reason-plutonium in special fcts with an aggregate radio- able notice, records maintained pu suant to theseactivity not to exceed 20 curies. rules.

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4 & 38.6(13 8) Teste. Each registrant er licensee o remoto ar indirect rel tionship to the health Cnd.

j ehall perform teon instructione from the agency, or eefety of an individual.shall permit the agency to perfone, such reasonable b. Failure to mitigate or eliminate health risk,teste es-the agency desse appropriate or necessary andincluding, but not limited to, teste of: The relative deterent effect of the penalty inc.

38.6(1) Sources of radiations view of the' violator's ability to pay the penalty.38.6(2) facilitiae serein sources of radiation

are used or stored; 4h38.9(138C) Enfisecament. ''LDon determination by38.6(3) 8tadiation detection - and monitoring the Agency that the kt or these rulee here been

instrueente and violated or that a pelic health risk exists, the,

18.6(4) Rher equipment and devices used in Agency d1l tales one or more of the follodng stepe:connection with utilization or -storage of registered 38.9(1) thder an actual or potential conditionsources of radiation. posing a risk to any individual camparable to a Class

'.. I violation issue an order under Section 136C.13, lhe4 & 30.7(136C) Additional Requirements. 1he agency Code, or Sseection 2, Section 136C.5, lhe Code,say, by rule, or order, impose upon any registrar:t or 38.9(2) Send a letter of notification to thelicensee - auch requirmeents in addition to those non-complim t facility se soon se possible afteresteliehed in these rules as it desse appropriate or' violations are noted sich acceplishes the follow-neceesery to minicias danger to p411c health and ingssafety or property. a. Cites each esetion of the Iowa (bde or rulesL ~

violated.475-38.S(136C) Penetties. b. Specifies the manner in sich the registrant

38.8(1) It le mlawful to operate or utilize or licenses failed to comply.radiation emitting equipment or radioactive materiale c. Specifies the steps required for eliminatingin violation of the provisions of the Act or of any or eitigating mnacessary or excesolve heen eupa- a

. . rule adopted pursuant to the Act. persona convicted stre,

of violating the svovisions of the Act or the rules d. Ibqtmots a timely and comprehensive carrective2 adoptad pursuant to the Act shall be guilty of a a: tion plan, including a time achedule for completion

simple alsdeseener (136C.4, lhe Code). of the plan.38.8(2) In ' addition to - criminal penalties, the 38.9(3) Stipulata s firm time schedule within

department may impose a civil penalty not to exesed sich_a corrective action plan needs to be s@mittedone ttmusand do11ers on . a person do violates a, and approve the time schedule for its completion if

,1 proviolon of the Act, rules or nedere issued uvier the plan is adequate.the chapter or a ters, condition, or limitation of a 38.9(4) In cases dere the registrant or; licensee

__ licones or registration certificate issued mder the fails to coply dth the conditions of the noticechapter or who comelte violation for sich a licenas letter sent, a regulatory letter will be sont ordur-cr registrant certificate may be revoked mder rules ing compliance and advising appropriate persone that1seued pursuant to the chapter. Each day of contirw mieen corrective action is initiated utthin fiveued violation constitutes a esperate offense in days, the Agency will seek approprieto penalties aidcomputing the civil penalty. airect remedini relief. '

38.9(3) The severity of penaltise levied against 38.9(5) In esses sero voluntary action by thuany person will. be based on the following three regiattent or licensee is not forthcoming the Agercyfa: tore s dll take one or a cambination of the fbliowing

The magnitude on' pelic health risk impoaod by stape*a.

-the violation. hose include the fbilowing violation a. lepomd or order the impomding of radioactiveclasseet material in accordance witn Se section 2, Section

(1) Class I Violations: Ccnditione sich present 136C.5, the (bde.immediate danger or edetential probability of doeth b. Impose si appropriate civil penalty.ce physical harm to an individual. c. Arvoke a radion:tive material liconee.

(2) Class II Violations: Conditions sich h-sve a d. Esqtmet the comty attorney or the Attorneydirect and immediate relationship to tie health and General to seek court action to enjoin vicistions andsafsty of an individual, but sich do not prssent m (seek r< r ricticn for a simple siademeanor. Orimminent danger or e@stantial probability of doesh ,

Teke enforce =cnt action that the Agency realse.cr physical harm to an individual. oppropriatt am necessary and is authori:ed by law.

(3) Close III Violations: Conditiona $1ch have i

<

. -7-,

_ _ _ _ _ _ _ _ _

.

4 .j

f ' 4&34.10(13dC) Preh hited Hees. 38.13(2) Redigactivo . %t:r1-1 Liconeing and38.10(1) Hand-held fluoroscopic screene shall not Inspection Fees,

be used. a. Licensing Fees. These fees are required to bej 38.10(2) Shoe-fitting fluoroscopic devices shall eseitted 4th a facility's application fbr a new

not be used. license, licones amendeert or license renewal.(1) Fees for the license, amendeont of liconee

4h38.11(13dC) hpon ding. Sources of radiation and renewal of licones of byproduc t, enurce andshall be e4 ject to impomding pursuant to-136C.For-- -epocial nuclear meterial d1l bar -the seos as-thosethe Act. outlined in the U. S. Nuclear Regulatory Commission

fee schedules fomd in 10 CFR part 170 entitled " Fees|. 4&38.12(13dC) t h - M i===. All comomicetions For Facilities and hterial Licensees Md Other Regu-j and reporte concerning these rules, and applications lation Services thder The Atomic Energy Act of 1954

, flied thereunder, should be addressed to the agency as Amended".Et its office located at the Luc as Rate Office (2) fees for the license, amendment of license andBuilding, Des hines, Ioaa 50319. renewal of license for NAM will be the same as those

,

specified in 38.13(2)a(1) for byproduct meterial.4h38.13(13dC) Fee Schedde. b. Inspection Fees: 1hese fees dll be assessed

38.13(1) Radiation 4 chines. Each registrant on the facility after completion of the inspection.

shall, at the time of . registration and each . year (1) Fees for the inopoetion of a fs=ility licensed; thereafter, remit to the agency a fee in m anomt to possess and use byproduct , source and special| sufficient to defray the cost of registering and nuclear materials in this state will be based on thej inspecting the registrent's radiation machine. All criteria set forth in the " schedule of fees for

' fees shall bJ made payable to the treasurer of the health and eefety, and safeguards inspections for|| State of Ion ed shall be in the asomt camputed by meterials liconees" of to CFR 170.

the following schedules_

(2) Fees for the inspection of a facility liconeed;

| a. Pbseessors of radiation machines used in the to poseees and use NAM dll be determined in thel practice of medicine, _ osteopathy, chiroprsatic and same manner as those for byproduct material in

surgery shall pay a fee of $35.00 per year for one 38.13(2)b(1).,

x-ray tee and $15.00 per year for each additional 38.13(3) Omer assessed expenses. In cases eern''

x-ray tse up to a maxima of $250.00 per year. the agency determines that the cost of regulating andb.. Pbesessors of radiation nachines used in the -inspecting registered ' radiation eachines or NARM

| practice of dentistry,' podiatry and veterinary medi- significantly exceeds the fee paid, it may assess thecine shall pay a fee of $25.00 per year for one x-ray omer or user of theos radiation sources for thetee .md $10.00 per year for each additional x-ray stuel expenses incurred by the agency. I

tse up to e maximum of $200.00 por year. 38.13(4) Environmental Surveillance Fee. A fee

-c. Passessors of other radiation machines shall may be levied against any licensee for environmentalpay annual fees in accordance with the type and use surveillance activities sich are necessary to assessof equipment as described below: the radiological impact of activities condteted by

- that licanase. This fee shall be sufficient to

Each defroy actual costs incurred by the Agency includingInitial Additional Maximum but not limited to salary, per dian, trevel andUnit thit Fee laboratory analysis. This fee shall cover the ccat

,

for leak testing of any source of radioactive mater-1. Radiographic $ 20.00 $ 10.00 $150.00 ial to assoso the extent of leakage or containment.

I 2.' Analytic $ 20.00 $ 10.00 $150.00

|. 3. Serilization $ 50.00 $ 10.00| Radioactive

hterial4. Prodestion $200.00 $200.lX)

Accelerator5. Other

Accelerator $ 40.00 $ 15.00 $250.006. Other equipment fees will be determined on a case

by case basis.

*

-8-

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- 470-38.14(136C) A AS A VALES FUt RADIGIEELIES. 475-38.14(136C) A1 Am A2 VALES FWI RADI0ptELIES.t 2(that.)

Element Element ;Symbol of and Specific Symbol of and Specific

;radio- atomic Activity radio- . atomic Activitynuclide number A (C1) A (C1) (C1/g) nuclide number Aj(C1) Ag(C1) (Ci/g)1 2

227Ae Actinium (89) 1000 0.003 7.2 x 10 778r Bromine (35) 70 25 7.1 x 105228Ac 10 4 2.2 x 106 38C1 10 10 1.3 x 108

Ag silver (47) 40 40 3.1 x 104 242Ce Curium (96) 200 0.2 3.3 x 103105

110"Ag 7 7 4.7 x 103 243 9 0.009 4.2 x 10C100 20 1.6 x 105111 244g 10 0.01 8.2 x 10Ag

241 , Americium (95) 8 0.008 3.2 245Ce 6 0.006 1.0 x 10-1A

243 , 8 0.008 1.9 x 10-1 246 , 6 0.006 3.6 x 10-1A C

37Ar. Argon (18) 1000 1000 1.0 x 105 56Co (bbelt (27) 5 5 3.0 x 104

41Ar.. 20 20 4.3 x 107 57Co 90 90 8.5 x 103

58"Co 1000 1000 5.9 x 10641Ar. .. 1 1 4.3 x 10773 , Arsenic (33) 1000 400 2.4 x 104 58Co 20 20 3.1 x 104A

74 , 20 20 1.0 x 105 60Co 7 7 1.1 x 103A

76 , 10 10 1.6 x106 SICr 01romium (24) 600 600 9.2 x 104A

A j;9Ce Cesium (55) 40 40 7.6 x 10577 , 300 20 1.1 x 106

828r 6 6 1.1 x 106 131Cs 1000 1000 1.0 x 105

134*Cs 1000 10 7.4 x 10611C Carbon (6) 20 20 8.4 x 108

14C 1000 60 4.6 134Ca 10 10 1.2 x 103

135 s 1000 25 8.8 x 10445Ca Calcium (20) 1000 25 1.9 x 104 C

47Ca 20 20 5.9 x 105 136Cs 7 7 7.4 x 104

1 09Cd Cadmium (48) 1000 70 2.6 x 103 137 s 30 10 9.8 x 10C

115"Cd 30 30 2.6 x 104 64Cu (Dpper (29) 80 25 3.8 x 106

67 u 200 25 7.9 x 105115Cd 80 20 5.1 x 105 C

Dy . Dysprosium (66) 100 20 8.2 x 106139Ce Osrium (58) 100 100 6.5 x 103 165

166cy 1000 200 2.3 x 105141Ce 300 25 2.8 x 104

C 169Er Erbiun (68) 1000 25 8.2. x 104, 143 e 60 20 6.6 x 105171Er 50 20 2.4 x 106

144Ce 10 1 3.2 x 103 j

249Cf Californium (98) 2 0.002 3.1 152mEu Europian (63) 30 30 2.2 x 106

250Cf 7 0.007 1.3 x 102 152Eu 20 10 1.9 x 102

252 r 2 0.009 6.5 x 102 154Eu 10 5 1.5 x 102C

36C1 011orine (17) 300 10 3.2 x 10-2 153 u 400 60 1.4 x 103E

211At Astatine (85) 200 7 2.1 x 106 18r Fluorine (9) 20 20 9.3 x 107

193Au (Did (79) 200 200 9. 3 x 105 52Fe Iron (26) 5 5 7.3 x 10630 .30 1.2 x 105 55Fe m M 2.2 x 103

196Au10 10 4.9 x 10440 20 2.5 x 105 59Fe198Au

199Au 200 25 2.1 x 105 67c, Gnilium (31) 100 100 6.0 x 105

68 e 20 20 4.0 x 1071318e 8mriun (56) 40 40 8.7 x 104 C

40 10 4.0 x 102 72c, 7 7 3.1 x 106133Be14%, 20 20 7.3 x 104 153Cd Cadolinium (64) 200 100 3.6 x 103

7g, anryllium (4) 300 300 3.5 x 105 159Cd 300 20 1.1 x 106

6a , Germanium (32) 20 10 7.0 x 103206st Bismuth (C3) 5 5 9.9 x 104 c

10 25 2.2x 6 71c, m M 1.6 x d20781

100 4 1.2 x 105 3H Hydrogen (1) see T-Tritiun210Bi(ReE)212gg 6 6 1.5 x 107 181Hf Hafniun (72) 30 25 1.6 x 104

1978Hg Hereury (80) 200 200 6.6 x 105249Bk Beakellus (97) 1000 1 1.8 x 1G3

200 200 2.5 x 1051974

80 25 1.4 x 104, compressed or ur:anpressed **u1 compressed 203Hg*

* **compr essed 106Ho mLniun (67) 30 30 6.9 x 105

-9-

-,

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|

|, .

415-38.14(138t) Ag Ale A2 UALES FM WWIW8ELIES. 475-38.14(138C) Aq Als A2 VALES FWt 8ADIW8E11ES. - |(Omst.) (Gsnt.)

1

Element- ElementSymbol of and Specific Spubol of and Specificradio-. stamic Activity radio- . etomic Activity

-nelide neber Aj(C1) A (Ci) -(Ci/g) nuclide number A (C1) (Ci/g)A (C1)2 q 2

1231 Iodine (53) 50 50 1.9 x 106 237Np Neptmia (93) 5 0.005 6.9 x 1041251 1000 70 1.7 x 104 239Np 200 25 2.3 x 1051261 40 10 7.8 x 104 1850s Onmium (76) 20 20 7.3 x 1031291 1000 2 1.6 x 104 1910s 600 200 4.6 x 1041311 40 10 1.2 x 105 $91mos 200 200 1.2 x 1061321 7 7 1.1 x 107 1930s 100 20 5.3 x 105133 = 30 10 1.1 x 106 32 Phosphorus (15) 30 30 2.9 x 1051 p

1 23 5 Protactinium (91) 20 0.8 3.2 x 104134 - 8 8 2.7 x 1071 231p, 2 0.002 4.5 x 10-2135 - 10 10 3.5 x 106

233p, 100 100 2.1 x 1041111n Indlun (49)- 30 25 4.2 x 105

113"In 60 60 1.6 x 107 201Pb Lead (82) 20 20 1.7 x 106

'114 min 30 '. 20 2.3 x 104 210Pb 100 0.2 8.8 x 10'

115 min. 100 20 6.1 x 106 21 2Pb 6 5 1.4 x 106~

190Ir - Iridium (77) 10 10 6.2 x 100 103Pd Pe11adium (46) 1000 .700 7.5 x 104

; 192 , 20 10 9.1 x 103 109Pd 100 20 2.1 x 1061

$47p, Promethium (61) 1000 25 9.4 x 102'

194It 10 10 8.5 x 105jg9p. 100 20 4.2 x 105'42g Potassium (19) 10 10 6.0 x 106210p, Peleiium (84) 200 0.2 4.5 x 10343g 20 10 3.3 x 10614*p, Prenoodymium(59) 10 10 1.2 x 104

,

85mKr* Krypton (36) 100 100 8.4 x 106'

143p, 300 20 6.6 x 104; 85mKr** 3 3 8.4 x 106'

^85Kr* 1000 1000 4.0 x .102 1 91Pt . Platinum (78) 100 100 2.3 x 105 ,,

193mpe 200 200 2.0 x 1055 5 4.0 x 102, 85g,**- -

19?mPt. 300 20 1.2 x 10787g,* 20 20 2.8 x 107197pg 300 20 8.8 x 105- ' 87g,** 0.6 0.6 2.8 x 107 ,

14 4 . Lanthanum (57) 30 30 5.6 x 105 238 u Plutonium (94) . 3 0.003 1.7 x 10P2 0.002 6.2 x 10-2

177Lu Lutetium (71) 300 25 1.1 x 105 239Pu fNFP NLxed fission 24%u 2 0.002 2.3 x 10-1

241Pu 1000 0.1 1.1 x 102products 10 0.4 ---

28g - Nagnesi a (12) 6 6 5.2 x 106 242 u 3 0.003 3.9 x 10-3P

| 524 Nanganese (25), 5 5 4.4 x 105 223Ra Radium (88) 50 0.2 5.0 x 104

224n. 6 0.5 1.6 x 10554g 20 20 8.3 x 103.

5 5 2.2 x 107 226g. 10. 0.05 1.0- 56,g ,

228g, 10 0.05 2.3 x 102! 99g Mal %>denue (42) 100 20 4.7 x 105; 13N Nitrogen (7) 20 10 1.5 x 109 81Rb meidium (37) 30 25 8.2 x 106

30 30 8.1 x .104l 22g, - Sodium (11) .8 8 6.3 x 103 86fb

5 5 8.7 x 106 87Rb .

4*g x 19 8! 24Ne-

*** ***

1.8 x 10-8(- 93 met,i Niobium (41) 1000 200 1 1 x 103 lb(Naturel)*** ***'

.

186R. Imenium -(75) 100 20 1.9 x 105!- 95,q, 20 20 3.9 x 1043.8 x 10-8

97,q, 20 20 2.6 t 107 187 r *** ***R

188p, 10 10 1.0 x 106'147Nd Neodymim -(60) 100 20 8.0 x 104

2.4 x '10-8149g 30 20 1.1 x 107 h(Naturel)*** ***

59Mi Nickel (28) 1000 900 8.1 x 10-2 103mgg thodium (45) 1000 1000 3.2 x 107

1000 100 4.6 x 10 105 n 200 25 8.2 x 105'

63Ni R

10 13 1.9 x 107 222Rn Redon (86) 10 2 1.5 x' 10565Ni

97Ru lbthenium (44) 80 80 5.5 x 10530 25 3.2 x 104*uncampressed Mempressed - ***thlimited 103Ru ,

20 20 6.6 x 106105Ru

- 10 -

,

. -.

470-38.14(136C) Aj Als A2 VALES FUt RflDIGIGELIES. 470 38.14(136Cf A1 AIS A2 VALES R/010lGELIES.-

(O'*4 *) (Omt.)

Elseent ElementSymbol of and Specific Symbol of and Srecificradio- stonic Activity radio- . stomic Activity

A (C1) (Ci/g) nuclide number Ag(C1) Af,C1) (C1/g)4 (C1)ntc11de number 21

1 06Au 10 7 3.4 x 103 2320 30 0.03 2.1 x 10

35s Sulphtar (16) 1000 60 4.3 x 104 233U 100 0.1 9.5 x 10-3

96mic Technet1un 1000 1000 3.8 x 107122Sb Antimony (51) 30 30 3.9 x 105

124Sb 5 5 1.8 x 104 96Tc 6 6 3.2 x 105

97mic 1000 200 1.5 x 104125Sb 40 25 1.4 x 1C3

46se Scandium (21) 8 8 3.4 x 104 97Tc 1000 400 1.4 x 104998Tc 100 100 5.2 x 10647se 200 20 8.2 x 105

48se 5 5 1.5 x 106 99Tc 10!1C 25 1.7 x 10 2125my. Telluriun (52) 1000 100 1.B x 10475s, Selenlun (34) 40 40 1.4 x 104

3151 Silicon (14) 100 20 3.9 x 107 127mie 300 20 4.0 x 1042.0 x 10-8 127 , 300 20 2.6 x 106147s, $.anarius (62) * *

t

1 51s, 1000 90 2.6 x 10 129my, 30 10 2.5 x 104129 , 100 20 2.0 x 107300 20 4.4 x'105153Se 7

131my, 10 10 8.0 x 105113Sn Tin (50) 60 60 1.0 x 104

132Ts 7 7 3.1 x 105119mSn 100 100 4.4 x 103

125sn 10 10 1.1 x 105 227Th Thorium (90) 200 0.2 3.2 x 104 .

6 0.008 9.3 x 10285es, strontium (38) CO 80 3.2 x 107 228Th

85 , 30 30 2.4 x 104 2340 Uraniun (92) 100 0.1 6.2 x 10-35

87ms, 50 50 1.2 x 107 235u 100 0.2 2.1 x 10-6200 0.2 6.3 x 10-5100 10 2.9 x 104 2360

*

89Sr ,3.3 x 10 7 .

9%r 10 0.4 1.5 x 102 238U* *

(see 38.1710 10 3.6 x 106 U(natural)* *

91Sr10 '10 1.3 x 107 (136C))

92Sr (see 38.17y** 7ritium (1) 1000 1000 9.7 x 103 U(enriched) < 20E* *

- y(campressed) 1000 1000 9.7 x 103 (136C))

y++* 1000 1000 9.7 x 103 U(enriched) > 205 12 0.1 (sep 38.17

y* m 1000 1000 9.7 x 103 (136C))(ooe 38.17y(tritiated water) 1000 1000 9.7 x 103 U(depleted) * *

T(other forse) 20 20 9.7 x 103 (136C))

182 Tantalun (73) 20 20 6.2 x 103 U(irrafisted) - - -

748y Yanadium (23) 6 6 1.7 x 105

160Tb Terbiu (65) 20 10 1.1 x104

230Th Thorium (90) 3 0.003 1.9 x 10-2 181w Tungsten (74) 200 100 5.0 x 103

1000 25 5.3 x 105 185w 1000 25 9.7 x 10-3231Th

1.1 x 10-7 187w 40 20 7.0 x 105* *232Th234y- 10 10 2.3 x 104 127g** Xenon (54) 70 70 2.8 x 104

2.2 x 10 7 127Xe(compressed) 5 5 2.8 x 104n* *

Th(natural)131*h(compressed) 10 10 1.0 x 105

Th(irrefisted) - - -

20071 thallium (81) 20 20 5.8 x 105 69Zn Zine (30) 300 20 5.3 x 107

200 200 2.2 x 1@ 93 r Zirconium (40) 1000 200 3.5 x 10 3220171 , 20 20 2.1 x 104

202T1 1 40 40 5.4 x 104 952r20 20 2.0 x 1 @

204y3 300 10 4.3 x 102 97 r*

Z

170 Thulius (69) 300 10 6.0 x 1037

171 , 1000 100 1.1 x 103 NOTE it for the ptspose of 470-38.14(136C) , can .7

230g Uranium (92) 1G0 0.1 2.7 x 104 pressed gas means a gas at a pressure michexceeds the anbient atmospheric pressure at

'thlimited **t.re cepressed *** activated luminous the locatiui dets the containment system

paint **" absorbed on oolid carrier eso closed.

- 11 -

_. . . - . .- __ _. -. _ _ _ _ -- . _ _ _ _ _ _. _-

, .

NOTE 2: The value3 cf At and A2 must be calculst'd sero Z in the atomic number cf the mc11d2.*

e

in accordance with the procedure specified 3. For beta emitters, Aj is determined by thein Appendix A, paragraph II(3), taking into maximum bets energy (E,,,) according to 38.15(136C);accomt the activity of the fiselon products 4. For alphe emitters, Aj is determined by theand of the wanium-23) in addition to that expressionsof the thorium. -

A1 1000 A3NOTE 3: The valuse of Aj and A2 must be calculated

in a:cordance dth the procedure specified sore A3 is the value listed in 38.16(136C);4

in Appendix A, paragraph II (3), taking into (2) A2 is the more restrictive of the followingaccount the activity of the fission prodsets te valusesand plutonism lootopos in addition to that 1 The corresponding Aj; andof the uranius. 2. 1he value A3 obtained fram 38.15(136C)

c. For any single radionuclide does identity leg and A2 for a single radio- mknown, the value of At is taken to be 2 Ci and theNOTE 4: Determine A

nuclide se follows: value of A2 is taken to be 0.002 Ci. % wever, if the(A) atomic number of the radionuclide is leiom to be less

then 82, the value of Aj is taken to be 10 Ci and the-

- Determination of ' At and A2 for a Single Radio- valtu of A2 is taken to be 0.4 C1..nuclide

a. For a single rafionuclide of known identity, NOTE 5: Determine At and A2 for a mixtwo of radio-the values of 49 armi A2 are taken from 470-38.14- nuclide including the radioactive decay'

(136C) if listed there. The valuse At and A2 in chains as follotes470-38.14(136C) are also applicable for radionuclide ( 8) .contained in alpha or gamme neutron sources.

7 or a Mixture of Radio-Fb. For any single radionuclide does identity is ' Determination of As and A' knom but sich'is not listed in 470-38.14(136C),the nuclides, Including Radioactive Decay Chaine.

a. For mixed fission products the following'

values of Aj and A2 are determined according to thefollowing procedures activity limite may be assumed if a detailed analysis' *

(1) If. the radionuclide melts only one type of of the sixture is not carried out:radiation, Aj is determined according to the rules in -'A1 10 Ci?

peregraphs 1, 2, 3, and 4 of this pere;roph. For .- A2 = 0.4 CiJradionuclides amitting different kinds of radiation, b. A single radioactive decay chain is considered

At is the most restrictive value of those determined to be a single radionuclide den the radi$nuclides- for each kind of radiation. % wever, in both cases, are present in their netwally occurring proportions

Aj is restricted to a menista of.1000 C1. If a and no daughter nuclide has a half-life either longerperent nuclide decays into a shorter lived daughter than 10 days or longer then .that of the parent

1 with a half-life not greater than 10 days, At is nuclide. The activity to be taken into accomt andcalculated for both the peront and the daughter, and the Aj or A2 value from 38.14(136C) to be applied arethe more limiting of the te values is assigned to thoes corresponding to the perant nuclide of that'

the perent nuclide. chain. then calculating Aj or A2 values, radiation1. For genes emitters, Aj is determined by the emitted by daughters must be considered. % wever, in

expreselons the case of radioactive decay chains in sich anydaughter nuclide hee a half-life either longer then

'

Aj s 9 curies 10 days or greater then that of the parent nuclide,the perant and daughter nuclides are considered to bex ,

mixtures of different nuclides.uhere x is the gamma-roy constant, corresponding to c. In the case of a mixture of different rufio-the does in Iq/h at 1 a per Ci; the number 9 results nuclides, sere the identity and activity of eachfram the choice of 1 Pen /h at a distance of 3 e se radionuclide are knoist, the permissible activity ofthe reference dose-equivalent rate. each radionuclide Rj, R2...Pn is such that F14

2. For X-ray emitters, At is determined by the F2 * * * In is greater then unity, unere(tomic mmber of the nuclide

Total Activity of stjF,1 :

for Z< 55---At = 1000 Ci Ai (Rj)

; for Z) 55--A1 s 200 Ci

'. 12 -

s

, _ - _ _ . _ _ . , _ . . , _ _ , _ _ _

- -.

.

.,

' - F m T=trl Activity er R , 470-38.17(136C) ACTIVITY-MASS REl.ATICI6 HIPS FIEt3

g (R ) 1RAflIt3(/TlgtitMA 2i

f Total Activity of %F a

Ai (R ) Thorius and Specific ActivitynUranium Enrich-

2 . . . R ) is the value of Aj or A2 as ne it* wt 5 C1/g g/CiAg (Rg, R n235t 0 presentappropriate for the nuclide R , R2 * * * Rn .

d. den the identity of each radionuclide is -

6knom but the individual activities of some of the 0.45 5.0 x 10-7 2.0 x 10radiantelides are not inom , the formula given in 0.72 (natural) 7.06 x 10-7 1.42 x 106paragraph c. is applied to establish the values of At 1.0 7.6 x 10-7 1.3 x 106cr A2 es appropriate. 1.5 1.0 x 10 6 1.0 x 106

5All the radionuclides whose individual activities 5.0 2.7 x 10-6 3,7 x 10

cre not loown (their total m:tivity, will, however, 10.0 4.8 x 10-6 2.1 x 1055be known) are classed in a single group and the most 20.0 1.0 x 10-5 1.0 x 10

restrictive value of At and A2 applictie to any one 35.0 2.0 x 10 5 5.0 x 1044cf them is used as the valtan of At or Ag in the 50.0 2.5 x 10-5 4.0 x 10

denominator of the fraction. 90.0 5.8 x 10-5 1.7 x 1@4e. Where the identity of each radionuclide is 93.0 7.0 x 10-5 1.4 x 10

knam but the individual activity of none T)f the 95.0 9.1 x 10-5 1.1 x 104radionuclides is knom, the most restrictive value of Nutural Thorim 2.2 x 10-7 4.6 x 106Aj or A2 applicable to my one of the radionuclidespresent is adopted as the applicable value. *The figures for uranium include representative

f. Sen the identity of none of the nuclides is values for the activity of the trenium-234 which iskna m, the value of Aj is taken to bu 2 Ci and the concentrated during the enrichment process. The

value of A2 is taken to be 0.002 C1. H) wever, if activity for Thorium includes the equilibritan con-cipha emitters are knom to be absent, the value of centration of Thorium-228.A2 is taken to be 0.4 C1.

* *

4h38.18(136C) Effisetive date. During the s*cond

470-38.15(136C) RELATICI6 HIP BETWEEN Aj APC E.,, session of the 70th General Assembly (1984) existirqf Gt EMITTERS 01 apter 136C, lhe Q)de, as amended by H. F. 2110

authorizing the Governor to enter into an agreementfisax (M'Y) A1 (C1) with the U. S. Nuclear Regulatory Commission (MIC)

thereby endling the Iowa State Department of thalth<0.5 1000 to license and further esgulate byproduct, source and

0.5-<1.0 300 ana11 quantitites of special nuclear ruficactive'

1.0-<1.5 100 materials. The signiswj of such an agreement in1.5-<2.0 30 authorized in Federal logislation mder Subsection

>2.0 10 274b of the Atemic Energy Act of 1954, es amended.Diapter 38 es anended M11 become effective on the.date the Governor and MtC sign the subject agreement.

4 h 38.16(136C) RELATIOf6 HIP BE1 WEEN A3 Als TIE These rules are intended to implement Io m Q:de

ATEMIC IESEER IF T)E RADIONE1.!!E Otapter 136C.

A3

Atonic Half-life less Half-life 1000 hel f-life

Phanber then 1000 days days to 106 greateryears then 106

years

.

1 to 81 '3 C1 .05 C1 3 Ci82 and save .002 C1 .002 C1 3 Ci

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. . . _ ~. . . - . - . .. _ .-- .- . _ . - - - _ - _ _ _ _ - _ . _. .-.

.

. e

. (3) Welding rods.(4) Electric lamps for illusinating purposes pro-

vided that each lamp does not contain are than 50

CMPTER 39 milligrams of thorium.(5) Cetnicidal lamps, smlamps, and lanps for

REIIISTRATION F RJWIATISI MDlIE NW outdaar or . industrial lighting provided that och

LICDEinstE F RmIO4CTIVE ETERIAL lamp does not contain more than two grens of thotius.(6) Rare earth metals and compounds, mixtures,

479--39.1(136C) Ptarpose ed scope. All persons and products containing not more than 0.25 percent bypossessing radiation machines within the state shall weight t5orium, wanium, or any combination of thesebe togistered in accordance with this chapter except oras specifically exempted. % person shall receive, (7) Personnel neutron &simeters, provided that

possess, use, transfer, own or acquire radioactive each dosimeter does not contain spore than 50 milli-

material except as authorized in a specific or gener- grens of thorium.t1 license issued pursuant to chapter 39 or as other- b. Source material contained in the following

wise provided in these rules. products:References to CFRs in this chapter are those in (1) Glazed ceranic tableware, provided that the

ofrect on January 1,1986. glaze contains not note than 20 percent by wight

source material, or470-39.2(136C) Definitions. For pwposes of chap- (2) Piezoelectric ceranic containing tot nore

ter 39 of these rules, " facility" means the location than two percent by weight source material.at which one or more radiation machines or radio- c. Photographic film, negatives, and prints con-active material sources are installed or located taining wanlun or thorium.tithin one building, vehicle, or under one roof end d. Any finished prodtet or part fabricated of, crtre under the same administrative control. cont aining , tmgsten-thorium or sognesium-thoriva

alloys, provided that the thoriun content of the

470-39.3(136C) Exemptions. alloy does not exceed four percent by =eight and thsc39.3(1) Electronic equipment that produces radi- this exemption shall not be deemed to authorize tha

ation incidental to its operation for other purposes chsmic al, physic al, or metallurgical treatment o r.is exempt from the requirements of chapter 39. processing of any s ch product or part.

39.3(2) Radiation ancnines sile in transit or ,e. , Uranium contained in comterweights installedstorage incident thereto are exempt from the require- in aircrafts, rockets, projectiles, and missiles, or

ments of chapter 39. stored or handled in connection with installation or39.3(3) Any person possessirg source material is renoval of sich counterweights, provided tha,t

exempt fran the requirements of chapter 39 to the (1) The comterweights are manufactured in accor-extent that sich person receiv es, possesses, uses, dance with a specific license issued by the U.S.

sms, or transfers source asterial in any chemical Nuclear Regulatory Commission, authorizing distribu-mixture, conpound, solution, or alloy in sich the tion by the licensee pwsuant to 10 CFR Part 40.oource material is by weight less than 1/20 of 1 per- (2) Each comterweight has been impressed withcent (0.05 percent) of the mixture, compound, solu.- the following legend clearly legible through any

tion or alloy. plating or other covering: " DEPLETED URANItN."39.3(4) Any person possessin) source material is (This requirenent need not be met by counterweights

exempt from the requiraments of chapter 39 to the manufactured prior to December 31, 1969; provided ,

extent that sunh person receives, passesses , uses, that such counterweights are bepressed with the

or transfers mrefined and mprocessed ore contain- legend, "CAUTIOi RADIDACTIVE MATERIAL-URANIUM," as

ing source materialt provided that, except as author- previously required by the rules.)ized in a specific license, such person shall not (3) Each counterweight is durably and legibly

refine or process such ore. labeled or marked wLth the identification of the37.3(5) Any person oossessing source material is manufacturer end the statement: " UNAUTHORIZED ALTERA-

exempt from the requirements of chapter 39 to the T10NS PROHIBITED." (This requiranent need not be metextent thkt such person receives, possesses, uses, by comterweights me 4factured prior to December 31,or tranfers: 1969; provided, that otch counterweights are in-

e. Any quantities of thorius contained int pressed with the legend, "CAUT ICN--RADIDACTIVE

(1) Incandascent gas mantles. MATERI AL--UR ANItJ4," as greviously required by the(2) Vacuun tthes. rules.) and

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.- _ . - . - _. _ - . - - . - - - - - _ - - _ - - - _ ~ ._ ,

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i

(4) This exemption sh:11 not be deemed tz author- c. Except as providad in 39.3(8)*c" and *d," any

i ime the chemical, physical, or metallurgical treet- person is exempt from these rules to the extent thatment or processing of any such counterweights other och person receives, possesses, uses, trans fers ,4

then repair or restoration of any plating or other owne, or acquires radioactive meterial in individualcovering. quantities each of thich does not exceed the appli-,

f. Uranius used en shielding constituting part of cable quantity set forth in 39.34(136C).'

any shipping container mich is conspicuously and t' . Any person iho possesses radioactive meteriallegibly impressed with the legend " CAUTION-RADIO- rNeived or acquired under the general liconee form-ACTIVE SHIELDIfC--lftANItM" and sich meets the speci- erly provided in 39.18(136C) is exempt from the,

fications for containers for radioactive material requirements for a license set forth in chapter 39 toprescribed in 49 CFR Part 173 of U.S. Department of the extent that such norson possesses, uses, trans-

iTransportation regulations. fere, or one such radioactive meteriel. Such exemp-

; g. Thorium contained in finished optical lenses, tion does not apply for radium-226.provided that each lens does not contain more than c. This estule 39.3(8) does not authorias the'

thirty percent by neight of thorium, and that this production, packaging or repackaging of radioactiveexemption shall not be deemed to authorias either material for purposes of commercial distribution, or4

(1) The shaping, grinding, or polishing of seh the incorporation of radioactive material into pro- ,

;

lens or manufacturing processes other then the sesen- ducts intended for commercial distribution.i

bly of . och lens into optical systone and devices d. No person may, for purposes of commercial dis-without any alteration of the lene, or tribution, trenefer radioactive meterial in the indi-

_,

i (2) The receipt, possession, use, or transfer of vidual quantities set forth in 39.73(136C), leiowing

ithorium contained in. contact lenses, or in specto- or having reason to believe that such quantities ofcles, or in eyepieces in binoculars or other optical radioactive material d1l be transferred to persons,

, instruments.- exempt under 39.3(8) or equivalent regulations of the,

h. Uranius contained in detector heads for use in U.S. hclear Regulatory Ommelesion , any agreementfire detection unite, provided that each detector state or licensing state, except in accordance with e

_ head contains.not more then 0.005 microcurie of uren- specific license issued by tM U.S. % clear Regule-ij

ius, or tory Commission pursuant to ~4ction 32.18 of 10 CFR,

; ,i.. Thorius contained in any finished aircraft Port 32 or. by the egency prouent to 39.32(2) which,,

.

} engine part containing nicleel-thoria elloy, provided licones states that the radioactive meterial may bethat s. transferred by the licenses to persons exempt mder#

.;

.' 3?.1(8) or the equivalent regulations of the U.S.(1). The thorius le dispersed in the nicles1-thoriaclloy in the form .of finely divided thoria (thorium heleer Regulatory Onesiselon, en agreement state, or

, ,

dioxide),and licensing state. Authority to trmnefer poseEssion or| (2) The thorium content in the nickel-thoria elloy control by the manufacturer, processor, or producer '

does not exceed four percent by usight. of any equipment, device, commodity, or other prodet39.3(6) .The exemptiore in 39.3(5) do not author- containing byproduct materiet ihose essequent pos-j

_ inn the manufacture of any of the products described. eession, use, trenefer and disposal by all other pSr.); 39.3(7) Radioactive material other than source sons are exempted fran regulatory requirements may be

j meterial exempt concentrations. obtained only fram the U.S. Nuclear Regulatory Com-e. Except as provided in 39.3(7)"S," any person mission, behington, D.C. 20555.'

| is exempt from the requiremente of chapter 39 to the 39.3(9) Radioactive meterial other then sowceI cxtent that och peroon receives, possesses, uses, materiel-- certain itano containing asterial. Ex-

4trenefore, oms or acquires products containing cept for persone iho apply radioactive meterial to,

j - radioactive motoriet introduced in concentratione not or persais iho incorporate radioactive material into

1 in excess of.those listed in 39.64(136C). the following products, any person is exempt fromj b. Na person may introdJce radioactive material these rulee to the extent that such person receives,

into e product or meterial leioning or having reason possesses, uses, trenefore, ouns, or acquires the4

to believe that it d11 be transferred to persons following products: ( Authority to transfer posses-

) exempt under 39.3(7)"e" or equivalent regulations of slan or control by the manufacturer, processor, orthe U.S. heleet Regulatory Omunisolon, any agreenent producer of any equipment, device , cassedity , orctate or licensing state, except in accordance with a other product containing byproduct meterial ehose'

sesequent possession, use, trensfer, and disposal bycpecific . license issued pwouent to 39.33(136C) orthe general licones provided in 39.57(136C). all other persons are exempted from requietory re-

} 39.3(8) Radioactive material other than source quiremente may be obtained only from the U.S. % clearmaterial exempt quantities. Regulatory Commission, Washington, D.C. 20555.)

;

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e e

. o.' Timepieces er hands er diclo contcining not (2) 1 cicrocuris cf cob 11t-60.more, than the following specified quantities of (3) 5 microcuries of nickel-63.radianctive materials (4) 30 microcuries of krypton-85.

(1) 25 millicuries of tritium per timepiece. (5) 5 microcuries of cesium-137.(2) 5 millicuries of tritium per hand. (6) 30 microcuries of promethium-147, and(3) 15 mil 11 curies of tritium per dial (bezels (7) Provided further, that the radiation done

when used shall be considered as part of the dial). rate from each electron t@e containing radioactive(4) 100 microcuries of promethita-147 per watch material will not exceed one millired per hour at one

or 200 microcuries of promethium-147 per any other centimeter fran any sur face sen measured throughtimepiece. seven milligrams per square centimeter of absorber.

(5) 20 microcuries of promethium-147 per ietch For pwposes of 39.3(9)'*h," " electron tses" includehand or 40 microcuries of promethita-147 per other spark gap t ees, power tubes, gas tubes includingtimepiece hand. glow lamps, receiving tses, microweve tses, irei-

(6) 60 microcuries of promethium-147 per watch cator tees, pick-up tsee, radiation detectiondial or 120 microcuries of promethium-147 per other tees, and any other completely sealed tses that aretimepiece dial (bezels den used shall be considered designed to conduct or control electrical currenta.as part of the dial). i. Ionizing radiation measuring instruments con-

(7) 1 microcurie of radian-226 per timepiece in taining, for purposes of internal calibration ortimepieces acquired pior to the effective date of standardization, one or more sources of radioactivethis rule. material, provided thats

b. The radiation dose rate from hands and dialb (1) Each source contains no more than one exemptcontaining promethium-147 will not exceed, when meas- quantity set forth in 39.65(136C),andured through 50 milligrams per square centimeter of (2) Each instrument contains no more than tenabsorbers exempt quantities. For purposes of this requirement',

(1) For veristwatches, 0.1 millirad per hour at an instrument's source (s) may contain either one N10 centimeters from any surface. more different types of radionuclides and an indivi-

(2) For pocket watchen, 0.1 millired per hour at dual exempt quantity may bc composed of fractional1 centimeter from any d,c e . parts of one or more of the exempt quantities H

(3) For any e .epiece, 0.2 millitad per 39.65(136C), provided that the sum of sah fractions -

hour at 10 centimete. any surface, shall not exceed is11ty.c. Lock illuminators containing not snre than 15 j._ Spark gop irrafiators containing not more theo

, cil11 curies of tritium or not more than 2 millicur- one microcurie of cobalt-60 per spark gap irradiate,

les of panothium-147 installed in automobile locks. for use in electrically ignited fuel oil burnersThe radiation does rate from each lock illtaninator having a firing rate of at least three gallons percontaining promethium-147 sill not exceed 1 mil 11 rad hour.per hour at 1 centimeter from any surface den meas- 39.3(10) Radioactive material other than sourceured thraugh 50 milligrans per square centimeter of material-- self-luminous Foducts containing radio-absorber. active material,

d. Precision balances containing not more than 1 a. Tritium, C ypton-85, or Promethium-147.c1111 curie of tritium per balance or not more than Except for persons idio manufacture, process, or pro-0.5 millicurie of tritium per balance part. duce self-luninous products esotalning tritium, kryp-

e. Automobile shift quadrants containing not ton-85, or promethium-147, any person is etesept frommore than 25 mil 11 curies of tritium. these rules to the extent that smh person receives,

f. Marine compasses containing not more than 750 possesses, uses, transfers, owns, or acquires tri-millicuries of tritium gas and cther marine naviga- tius, krypton-85, or promethium-147 in self-luminoustional instruments containing not more than 250 prodtets manufactured, processed, produced, imported,villicuries of tritium gas. or transferred in recordance with a specific license

g. Thermostat dials and pointers containing not issued by the U.S. Nuclear Regulatory Cawnissionmore tFan 25 millicuries of tritium per thennostat. pursuant to Section 32.22 o f 10 CFR Part 32, which

h. Electron tubes; provided, that each 14e does license authorizes the transfer of the product tonot contain more than one of the following cpecified persons to sre extm t ft::ra regulatory requirtsnents.quantities of radioactive noterial: The exenption in 39.3(10) does not apply to tritita,

(1) 150 millicuries of tritium per microwave krypton-85, or pomethium-147 used in products forreceiver protector t4e or 10 ail 11 curies of tritim frivolous purpows or in tove or adorreents.per s'1y other electron ttbe. b. Rodiut-226. Any Wrson is exempt from these

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rules to thei extent th:t such person recsivoo, po2- licens) iccued by the U.S. %cloce Regulttary Cosmic 'eessee, uses, transfer s, or oma articles containing alon, or shall have been manufactured in accordanceless then 0.1 microcurie of radium-226 dich mee with the specificatiore contained in a specific li-acquired prior to the effectise date of this rule. conee issued by the agency or any agreement state to

39.3(11) Radioactive esterial other then source the manufacturer of such resino pursuant to licensingges and aerosol detectore containing requiremente, equivalent to those in Sectione 32.16meterial -

radioactive meterial. and 32.17 of 10 CFR Port 32 of the regulations of thee. Except for persons amo manufacture, process, U.S. Nuclear Regulatory Commission. This exemption

ce produce ges ed aercool detectors containing does not authorize the manufacture of any resino con-radioactive meterial, any person is exempt from these taining scandius-46.rules to the extent that each person receives, pos-

seeses, uses, trenerere, owns, or acquires radio- 478-39.4(136C) Application for registration of redi-active meterial in gas and aerosol detectors designed atten sesines. Each person possessing a radiationto protect life or property from fires and airborne machine shellshazarde provided that detectors containing radio- 39.4(1) Apply for registration with the agencyactive meterial shall have been manufactured, impor- within ninety days following the effective date ofted, or transferred in accordance with a specific these rules or thereafter prior to the operation oflicense issued by the U.S. % clear Regulatory Commis- a radiation facility. Application for registration

,

tion ( Authority to transfer possession or control by shall be completed on forms furnished by the agencythe manufacturer, processor or producer of any_ equip- and shall contain all the infonnation required by

ment, device, enamodity, or other product containing the form and accompanying instructions. The agency

byproduct meterial dose sibeequent possession, use, requires that at least the following information betransfer, and disposal by all other persons are provided: ,

exempted from regulatory requiremente may be obtained e. Name, address and telephone number of theonly from the U.S. Nuclear Regulatory Commission, following:Washington, DC 20555.) pwouent to Section 32.26 of (1) The facility.

10 CFR Part 323 or a licensing state pursuant to (2) The owner of the facility.' ~ trenefer of the (3) The individuel responsible for the use of39.35(136C) , diich authorizes ' the

~

detectors to persons who are exempt from regulatory the facility.

requirements. (4) The individuel designated mder 39.4(2).t b.~ Gee and acrosol detectors previously manufac- b. - The manufacturer, model number, and type of

tured and distributed to general licensees in accord- each radiation machine located 4 thin the facility.

ance with a specific License issued by an agreement c. If the facility le mobile, the geographicctate shall be considered exempt mder 39.3(11)"a," areas within the state to be covered. /provided that the device is labeled in accordance d. The signature of the individual designated -with the specific license authorizing distribution of mder 39.4(2).the generally licensed device, and provided further o. Name of the radiation machine supplier,

that they meet the requiremente of 39.35(136C). installer and service agent.c. Gee and aerosol detectr.,rs containing NARM pre- f. The date of application and signature of the

viously manufactured ed distributed in accordance individual responsible for the use of the facility.. with a specific license issued' by a licensing state 39.4(2) Designate on the application form an'

shall be considered except mder 39.3(11)"a," pro- individual to be responsible for radiation protec-vided that the device is labeled in accordance with tion.

the specific license matherizing distribution, and'

provided further that they meet- the requiremente of 47539.5(136C) leemnos of nottee of registration.39. 35(136C) . 39.5(1) Upon s determination that an applicent

39.3(12) Radioactive motorial other than source meets the requirements of the rules, the agencynoterial-- resino containirq scandium-46 and de- ehall issue a notice of registration.signed for sand consolidetion in oil wolle. Any per- 39.5(2) The egency may incorporate in the noticeson is exempt from these rules to the extent that of registration at the time of issuance or there-such person receives, possesses, uses, transfers, after by appropriate rule, or order, such additionalowns or acquires synthetic pleetic resine containing requiremente and conditione 4th respect to thescandium-46 dich are designed for sand consolidation registrant's receipt, posseenion, use and tronafer ofin oil elle. Such resine shell have been menu- radiation machines as it deems appropriate or neces-factured cr imported in accordance with a specific sery.

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. .

. 470-E6(1MC) Empiration of notice of registrak shall include stion. Except as provided by 39.8(2), cuch notico cf (1) The type of radiation machine.registration shall expire within twelve sonths of (2) The nature, duration, and scope of use, andissuance or at the end of the day on the date stated (3) The exact location (s) diere the radiationtherein, W11chever is later. machine is to be used.

b. If, .for a specific case, the (te working

470-39.7(IMC) Renamel of notice of registration. days) period muld impose an mdue hardship on the39.7(1) Application for renewal of registration person, up)n application to the mjency, permission

shall be filed in accordance with 39.4(136C). to proceed sooner may be granted.39.7(2) In any case in W11ch a registrant has 39.11(2) The person referred to in 39.11(1)

properly filed an application for renewal of current shallregistration within ninety days prior to the expira- a. Comply with all applicable rules of the

tion of the existing registration, such registration agency.shall not expire testil the agency has made its final b. Supply the agency with such other infomationdetermination un the acceptability of the applica- as the agency may reasonably request, andt ion. c. Pest operate within the state on a temporarv

basis in excess of one hundred eighty calendar days470-39.8(136C) Report of changes. The registrant per year.

thall notify the ajency in writing before making anychange W11ch muld render the information contained 470-39.12(136C) General license. General licensesin the application for registration or the notice of provided in this chapter are effective without the

registration no longer accurate. filing of applications with the agency or the issu-

ance of licenairuj documents to the particular per-

470-39.9(1MC) Approval not implied. Pts person, in sons, although the filing of a certificate with the

Cny advertisanent, in referring to the fact that the agency may be required by the particular generMperson is registered with the agency pursuant to the license. The general licensee is subject to all

provisions of 39.4(136C), shall state or imply that other applicable partions of these rules and any

any activity under such registration has been ap- limitations of the general license.proved by the agency.

470-39.13(136C) General license ditch alleen per-470-39.10(136C) Sale or transfer obligation. sons to une or transfer 15 pomde of esucce material

39.10(1) Any person dio sells, leases, transfers, at any one time. A general license is hereby issuedlends, disposes, assembles, or installs radiation authorizing caramercial and industrial firms, re-machines in this state shall notify the agency with- search, educational and medical institutions, and

in fifteen days of s state and local government agencies to use and trans-e. The name and address of persons who have for not more than 15 pounds of source meterial et any

received the eachines or material. one time for research, development, educational, cum-b. The saanufacture r, model number and serial mercial, or operational purposes. A person author-

nianber of each radiation machine transferred, and ized to use or transfer source material, pursuant to

c. The date of transfer of each radiation mach- this general license, may not receive more than s

ine. total of one hmdred fifty pomda of source material

39.10(2) In the case of diagnostic X-ray systems in any one calender year.| which contain certified components, a copy of the

; r ssembler 's report prepared in compliance 21 CFR 479-39.14(136C) General license issued mder 39.13'

1020.30(d) of the federal diagnostic X-ray standard (IMC) exemption rrovision. Persona so receive,

chall suffice in lieu of any other report by the poosess, use, or transfer source material pursuant tcassembler. the general license issued in 39.13(136C) are exempt

from the provisions of 470-chapter 40 of these rules470-39.11(1MC) Out-of-state radiation machines. to the extent that stch receipt, passession, use, or

39.11(1) Written notice. trans fer is within the terms of sich general 11 -

a. 16enever any radiation pochine is to be cence. Provided however, that this exemptico shall

brought into the state, for any temporary use, the not be deemed to apply to any sich perann diu tra alsoperson proposing to posse =s such machine in the in possession of source material mder a specific

ttate shall give written notice to the agency (at licence issued putst. ant to this chapter.least tm working days) be fore such machino orcaterial is to be used in the state. The notice

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! 470-39.15(136C) A general 11conne is horsby 'isemd thd1 be sW itted within thirty days aftcr the'authorizing the receipt of title to source material effective date of a ch change.without regard to spanntity. This pneral license 39.16(4) A person so receives, acquires, posses-does not aJthorize any person to receive, posess, see, or uses depleted uranium pesuant to the generaluse, or transfer source material. license established by 39.16(1):

a. Shall. not introduce seh depleted wanium, inC70-39.16(136C) Duplete,e wenium in industrial pro- any form , into a chemical, physical, or metallurgi-ducts and devices. col treatment or process, except a treatment or pro-

39.16(1) A general license is hereby issued to cess for repair or restoration of eny plating or

receive, acquire, possess, use or transfer, in accor- other covering of the depleted uranium,dance with the provisions of 39.16(2), to 39.16(5), b. mall not abandon seh depleted uranium.depleted uraniun contained in industrial products or c. Shall transfer or dispose of such depleted

devices for the purpose of providing a concentrated uranium only by transfer in accordance with themass in a small volume of the product or devir.e. provisions of 39.55(136C). In the case dere the

39.16(2) The general license in 39.16(1) applies. transferee receives the depleted uranlurr pursuant toonly to industrial products or devices which have the general license established by 39.16(1), thebeen manufactured either in accordance with a speci- trans feror shall furnish the transferee a copy of

fic license issued to the manufacturer of the pro- this rule and a copy of Agency Form SHD-2.0-791. Inducts or devices pursuant to 39.45(136C) or in accor- the case dere the transferee receives the depleted

dance with a specific license issued to the manufac- uraniun pursuant to a general license contained in~

turer by the U.S. MJclear Regulatory Demission or en the U.S. NJclear Regulatory Commission's or agree-agreement state which authorizes manufacture of the ment state's rule equivalent to 39.16(1), the trans-products or devices for distribution to persons feror shall furnish the trans feree a copy of this

generally licenced by the U.S. Nu: lear Regulatory rule and a copy of the Agency Form SHD-2.0-791 accom-Commission or an agreement state. panied by a note explaining that use of the product

39.16(3) Persons who receive, acquire, possess, or device is regulated by the U.S. Nuclear Regulatorycr une depleted ur anium pursuant to the general Commission or agreenent state mder requirements stb-license established by 39.16(1) shall file Agency stantially the sane as those in this rule.Form SID-2.0-791 " Registration Certificate - Use of d. Within thirty days of any trans fer, shall ' -

Depleted Uraniurn thder General Lic ense ," with the report in writing to the Agency the name and addressagency. The form shall be stbeitted within thirty of -the person receiving the depleted tranium pw-days after the first receipt or acquisitien of such suant to such transfer, and

depleted tr enium. The licensee shall furnish on e. %all not export seh depleted uranium exceptAgency Form SHD-2.0-791 the following information in accordam s with a licenae issued by the U.S.

and seh other information as may be required by Nuclear Regulatory @maission ptrsuant to 10 CFRthat forms Part 110.

a. Name and address of the registrant. 39.16(5) Arrf person receiving, acquiring, posses-b. A statement that the registrant has developed sing, using, or transferring depleted uranium pur-

and will maintain procedures designed to establish suant to the general license established by 39.16(1)physical control over the depleted uranium described is exempt from the requirements of 470--chapter 40in 39.16(1) and designed to prevent transfer of sich with respect to the depleted uranium covered by thatdepleted uranius in any form, including metal scrap, general license.to persons ret authorized to receive the &pleteduranium. 470-39.17(136C) Qsneral license immed for manufac-

c. Nune or title, address, and telephone number two of devices and erpsipment mder special 1.icenseof the individual duly auttorized to act for and on from NRC. A general license is hereby issted tobehalf or the registrant in supervising the proce- trans fer , receive , acquire, own, possess, and usedures identified in 39.16(3)"b," and radioactive material incorporated in the following

d. The 11ccreee pasessirq or using depleted devices or equipment which have been manufactured,uraniun under the general license established by tested and laboled by the manufacturer in accordance39.16(1) shall report in icitity to the agency any with a specific license issued to the manufacturer bychanges in in formation furnished in Agency form the U.S. Nuclear Regulatory Commission for use pur-$10-2.0-791 " Registration Certificate--Use of suant to Section 31.3 of 10 CFR Part 31.Deoleted Uranlun thder General License." The report

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_ 1hia general license is e4 ject to the provisions devico et the ' tim) cf roccipt, and be: ring o etets-cf 38.4(136C) to 38.9(136C), 38.11(136C), 39.3(7)"b," ment that removal of the label is prohibited, are39.48(1 %C) , 39.55(1 %C) , 39.56(1 %C) , 39.59(1 %C) maintained thereon and shall comply with all instruc-and 470-chapter 40. tions and precautions provided by sah labels. )

39.17(1) Static elimination devic e. Devices b. Shall assure that the device is tweted for

designed for use as static eliminators 21ch contain, leakage of radioactive material and proper cperationas a sealed source or sources, radioactive material of the "on-of f" sechenian and indicator, if any, at

consisting of a total of not more than 500 micro- no longer than six-month intervals or at such othercuries of polonium-210 per device. intervals as are specified in the label. Ibwever s

39.17(2) Ion generating tee. Devices designed (1) Devices containing only krypton need not befor ionization of air thich contain, as a sealed tested for leakage of radioactive motorial, andsource or sources, radioactive material consisting of (2) Devices containing only tritium or not moreo total of not more than 500 microcuries of polonium- than 100 microcuries of other beta- or genma-e91ttiry;210 per device or a total of not more than 50 milli- material or 10 microcuries of alpha-emitting materialcuries of hydrogen-3 (tritium) per device. and devices held in storage in the original shippirg

container prior to initial installation need not be

470-39.18 Reserved. tested for any pwpose.470-39.19 Reserved. c. 9 all asswa that other testing, installation,

servicing , and renoval from installation irwolving

475-39.20(136C) Certain mesowirug, gauging or con- the radioactive material, its shielding or contain-

trolling devices. ment, are perforred:-

39.20(1) A general license (radioactive material (1) In accordance with the instructione providedcther than source material) is hereby issued to com- by the labels, or

mercial and industrial firms and to research, educe- (2) By a person holding an applicable specific

_

tional and medical institutions, individuale in the license from the agency, the U.S. Nuclear Regulatoryconduct of their business, and state or local govern- Commission, en agreement state or a licensing statemeet egencies to om, receive, acquire, possess, use to perform such activities.

[ cr transfer in accordance wLth the provisions of d. * 9 tall maintain records simwing conpliance39.20(2) to 39.20(5), radioactive meterial, excluding with the requirements of 39.20(3)"b" and *c." Thespecial nuclear material, contained in devices de- records shall einw the results of tests. The

cigned and manufactured for the purpose of detecting, records also shall show the dates of performance, ofmeasuring, gauging or controlling thickness, density, and the names of persone performing, testing, instal-

,

level, interface location, radiation, leakage, or ' lation, servicing, and removal from installation con-qualitative or quantitative chemical composition, or corning the ruficactive material, its ship 1 ding or

, for producing light or an ionized atmosphere. containment. Records of tests for leakage of radio-'

39.20(2) The general license in 39.20(1) applies active material required by 39.18(3)"b" shall be

only to radioactive material contained in devices maintained for one year after the next required leakwhich have been manufactured and leeled in accord- tast is performed or mtil the sealed source isance with the specifications contained in a specific transferred or disposed of. Records of tento of thelicense issued by tte agency pwsuant to 39.M(1MC) "on-of f" mechanism and irdicator requirof b)cr in accordance with the specifications contained in 39.20(3)"b" shall be maintained for ene year aftera specific license issued by the U.S. % clear Regula- the next required test of the "on-of f" mechanien andtory Commission, an agreement state or a licensing indicator is performed or until the sealed source io

state, ihich authorizes distribution of oevices to trans ferred or disposed of. Records thich stopersone generally licensed by the U.S. Nelear Regu- required by 39.20(3)"c" shall be maintained for alatory Commission, an agreement state or a licensing period of two years fran the date of the recorded

state. Regulations under the Federal Food, Drug, and event or until the device le transferred of disposed

Cosmetic Act autterizing the use of radioactive con- of.trol devices in food production require certain addi- e. Upon the occurrence of a failure of or damagetional labeling thereon which is found in 21 CFR to , or any irdication of a possible failure of of

179.21. damage to, the shielding of the radioactive netsrial39.20(3) Any person iho om s , receives, ac- or the " ore-of f" mechanima or indicator or u;mn the

quires, possesses, uses or transfers radioactive detection of 0.005 microc uele or more renovablematerial in a device pursuant to the general license radioactive material, shall immediately suspend oper.in 39.20(1): ation of the device mtil it has been repuited by the

a. Stall assure that all labels affixed to the manufacturer er other persoq leiding an @pliccble

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specific license' from the agency, the U.S. %cic r h. Sall transf;r the devico to another gener 1'Regulatory Comunission, an agreement state or a licen- licensee only dere the device remains in use et a

cing state to perform etch activities. particular location. In su:h cases the transferord. Shall maintain records showing compliance with shall give the transferee a copy of this rule and any

the requirments of 39.20(3)"b" and "c." The records safety documents identified in the label on the

shell show the results of tests. The records also device and within thirty days of the transfer, reportshall show the dates of perfonnance, of and the nones to the ajency, the nanufacturer's none and nodelcf persons performing, testing, installation, servic- number of device transferred, the name end address ofing, and renovel from installation concerning the the transferee, and the none or position of an indi-radioactive material, its shielding or containment. vidual do may constitute a point of contact betweenRoccrds of tests for leakage of radioactive material the Agency and the trenofereeg or sere the device isrequired by 39.18(3)"o" chall be maintained for one held in storage in the original shipping container atyear after the next required leak test is performed its intended location of use prior to initial use by

cr until the sealed source is transferred or disposed a general licensee, andc f. Records of tests of the "on-of f" mechanism and i. mall comply with the provisions of 40.15(2)indicator required by 39.20(3)"b" shall be maintained and 40.15(3) for reporting radiation incidents,

far one ) ear after the next required test of the theft, or loss of licerJed material but shall be

'on-o f f" mechanism and indicator is per formed or exempt from the other requirements of 470--chapteruntil the sealed source is transferred or disposed 40.

- c f. Records which are required by 39.20(3)"c"_ shall 39.20(4) The general license in 39.20(3) does-be maintained for a period of te years from the date not authorize the manufacture of devices containing

cf the recorded event or mtil the device is trans- radioactive material.fcreed or disposed F 39.20(5) The general license provided in 39.18(3)

e. Upon the ot 4 of a failure of or damage is stbject to the provisions of 38.4(136C) tota, or any indicat. ,f a possible failure of or 38.9(1 %C) , 38.11(1 %C) , 35.48(1 %C) , 39.55(1%C) ,damage to, the shieldirw; of the radioactive material 39.56(136C) and 39.59(1%C).er the Nn-off" sechanian or indicator or upon the

d tection of' O.005 ' microcurie or more removable 470-39.21(136C) Laminous amfety devices Ihr air-radioactive material, shall immediately suspend oper- craft.

ction of the device mtil it has been repaired by the 39.21(1) A general license (radioactive materialmanufacturer or other person holding an applicable other than source material) is hereby issued to own,cpecific license fran the agency, the U.S. % clear receive, acquire, possess, and use tritius or prane.Regulatory Conunission, en agreement state or a licen- thium-147 contained in luminous safety devices for

.

Cing state to repair such devices, or dispcsed of by use in aircraft, provided: /transfer to a person authorized by an applicable a. Each device contains not more than 10 curies ~cpecific license to receive the ruficactive material of tritita or 300 millicuries of promethium-147, andcontained in the device and, within thirty days, b. Each device has been manufactured, assembled

furnish to the agency a report containing a brief or imported in a cordance wLth a specific licensedescription of the event and the remedial action issued by the U.S. Nuclear Regulatory Consnission, ortaken. each dervice has been manufactured or assembled in

f. Shall not abandon the device containing radio- accordance with the specifications contained in eactive material. specific license issued by the agency or any agree-

g. Except as provided in 39.20(3)"h ," shall sent state to the manufacturer or assembler of suchtransfer or dispose of the device containing radio- device ptrauent to licensing requirements equivalentactive meterial only by transfer to a specific liceo- to those in Section 32.53 of 10 ER Part 32.see of the agency, the U.S. % clear Regulatory 39.21(2) Persons so om, receive, acquire, pos-Cossaission, en agreement state or a licensing state sesa, or use luminous safety devices pursuant to thedose specific license authorizes the licensee to general license in 39.21(1) are mempt from thereceive the device. Within thirty days after trans- requirements of 470--chapter 40 except that theyf;r of a device to a specific licensee, the trans- shall comply with the grovisions of 40.15(2) andfcror shall furnish to the agency a report contsining 40.15(3).identification of the device by manufacturer's name 39.21(3) This general license does not authorizeard model number and the none arti address of the the manufacture, asnombly, or repair of luminousperson receiving the device. N) report is required safety devices containirq tritium or pranethiun-147.if the device is transferred to the specific licensee 39.21(4) This general license does not authorirein order to obtain a replacement device. the omership, receipt, acquisition, passession or

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use of promethium-147 contained in instrument dials. licensing state pwsusnt to licensing requitanents

39.21(5) This general license is subject to the equivalent to those contained in Section 32.57 of 10

provisions of rules 38.4(1%C) to 38.9(136C), 38.11 CFR Part 32 or Section 70.39 of 10 CFR Part 70.(136C), 39.48(1%C), 39.55(1%C), 39.56(136C), and 39.23(5) The general licenses provided in39.59(1MC) . 39.23(1), 39.23(2), and 39.23(3) are s@ ject to the

provisione of 38.4(1%C) to 38.9(136C), 38.11(136C),475-M.22(136C) Omership of radioactive meterial. 39.48(1 %C) , 39.55(1 %C) , 39.56(1 %C) , 39.59(1%C)A girneral license is hereby issued to own radio- and 470--chapter 40. In addition, persons so owi,

active material without regard to quantity. Notwith- receive, acquire, possess, use, or transfer one or

Ctanding any other provisiors of 470--enapter 39, more calibration or reference sources pursuant to

this general license does not authorize the manufac- these general licenses:two, production, trans fer, receipt, possession or a. 91 ell not possess at any one time, at any oneuse of radioactive material. location of storage or use, more than 5 microcuries

of americium-241, 5 microcuries of plutonium, or 5

470-M.23(1MC) Calibration and reference sources. microcuries of radium-226 in such sources.39.23(1) A general license is hereby issued to b. 91all not receive, possess, use, or transfer

those persons listed below to owt, receive, acquire, such sources unless the source, or the storage con-possess, use and tram fer , in accordance with the tainer, bears a label thich includes one of the

provisions of 39.23(4) and 39.23(5) americium-241 in following statements, as appropriate, or a substan-~

the form of calibration or reference sources tially similar statenent idiich contains tne infonna-a. Any person who holds a specific license tion called for in one of the following statements,

issued by the agency idiich authorizes that person to as appropriates. receive, possess, use and transfer radioactive mater- '

tal, and The receipt, posession, use and transferb. Any person who holds a specific license of this source, M) del , Serial %).

issued by the U.S. 4 clear Regulatory Commission , are a@ ject to a general licensewhich authorizes that parsen to receive, possess, and the regulations of the U.S. Nuclearuse and transfer special nuclear material. Regulatory Camsission or of o State with

39.23(2) A general license is hereby issued to idiich the Commission has entered inte enoei, receive, possess, use and transfer plutonium in - agreement for the exercise of regulatorythe forin of calibration or reference sources in authority. Q ry)t remove this inbel.accordance with the provisions of 39.23(4) and CAUTION RADI0 ACTIVE MATERIAL THIS- -

39.23(5) to any person who holds a specific license SOURCE CONTAINS ( AMERICILH-241) (PLUT0NhN)issued by the agency idiich authorizes that person to (showing cnly the name of the appropriatereceive, possess, use, and transfer radioactive material.) 00 NOT TCUCH RAD 10ACT1YE PORTION

material . (F THIS 50liRCE.

39.23(3) A general license is hereby it. sued tocwn, receive, poseess, use, ard transfer radium-226in the form of calibration or reference sources in Neae of manufacturer or impirteraccoraance with tr.e grovisione of 39.23(4) and

39.23(5) to any person who holds a specific license (OR)

issuea by tne agency elch authorizes that person toreceive, possess, uso and transfer radioactive mater- The receipt, possession, use and transfer'

ial, of this source, % del Serial,

39.23(4) The general licenses in 39.23(1) to No. _, are subject to a general39.23(3) apply only to calibration or refererce licones and the rules of a Licenstrq

aources ediich have been manufactured in accordance State. Do not remove this leoel.THISt:ith the specifiestione cont eined in a specific CAUTION RADICACTIYC MATERIAL- -

license issued to the esnufacturer or importer of SOURCE CDNTAINS RADIlN 226. 00 NOT TOUCH

the sources by the U.S. Wclear Regulatory Smals. RAD 10ACTIVC PCR110N OF THIS SOURCE.

clon pursuant to Sectiun 32.57 of 10 CFR Part 32 orSection 70.39 of 10 CrR Part 70 or editch have beensanufactured in accordance with the specifications Nare of manufacturer or imprtar

contair ed in e specific licerso issued to the manu-

facturer by the agency, cny ~ agreemmit at.te or

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c. Sr.11. not trenefer, abandon, cr diepose cf ' g. Irdine-131 ce iodin:ted heen eerum c1btanirtsuch source except by transfer to a person authorized (1HSA) for determinations of blood and blood pleeneby a license from the Agency, the U.S. % clear Regu- voltane.1 story Commiselon, an agreement state or a licensing 39.24(2) % physician shall receive, possese,

' ctate to receive the source. use or transfer radioactive motorial prouent to,the

d. Shell store such source, except den the general license establiehod by 39.24(136C) tritilsource is being used, in a closed contait.or adequate- Agency Form SIC-2.0-789, " Certificate - Medical Use

; . ly designed and constructed to contain americium-241, of Radioactive Material thder General License" hasplutonium, or radium-226 which might otherwise escape been filed dth the agency and a validated copy of

; during storage, and the Agency Form S60-2.0-789 has been received from !

: e. Sell not .use such source for siy pwpose the agency dth certification ntamber sosigned. The! Ether than the calibration of radiation detectore or generally liconeed physician ohell furnish on Agency

the standardization of other sources. Form 560-2.0-789 the following information and such; 39.23(6) , These general licenses do not authorias other information se may be required by that form:, the manufacture of calibration or reference sources a. None and address of the generally licensedj containing americium-241, plutonium, or raditan-226. physician.

b. A statement that the generally licensed physi-' -

470-39.24(136C) lendical diagnostle uses. Ale clan le a daly licensed physician authorized to39.39(136C) requires manufacturere of radiopherne- dispense drugs in the practice of medicine in thisceuticale sich are under the general liconee in this state, and

~

rule to .effix a certain identifying !abel to the c. A statenent that the generally licensed physi-container or in the leaflet or bruchure sich accom- cien hem appropriate radiation measuring instrtamentepanies the radiopharmaceutical. The New Drug Provi- to carry out the diagnostic procedures for sich theclone of the Federal Food, Drug, and Cosmetic Act use of radioactive material is proposed under the

cleo yvern the availability and use of any specific general licevue of 39.24(136C) and that the physiciaadiagnostic drugs in interstate comunerce. is competent in the use of such instrtaments.,

'39.24(1) A general license is hereby issued to 39.24(3) A physician so receives, possesses or' eny physician to receive, possess, transfer or use uses a pharmaceutical containing radioactive meter -

radioactive meterial est forth below for the stated ial pursuant to . the general . license established by',

diagnostic uses, provided, however, that the use le ,39.24(1):in accordence dth the provisions of 39.24(2), to e. - 9 all not possess et any one time, prouent

to the general license in 39.24(1) more thant39.24(4), the radioactive meterial is in the form of ,

capsulee, disposable syringes, .or other propeckaged (1) 200 microcuries of iodine-131,individual doses and the radioactive meterial hee (2) 200 microcuries of iodine-125, /been manufactured in accordance dth a specific (3) 5 microcuries of cabelt-57, -

,11 cones lesund by the agency pursuant to 39.39(136C), (4) 5 microcuries of cobalt-58,ce by the U.S. % clear. Regulatory Commiselon, any (5) 5 microcuries of cobalt-60, andagreement state or a licensing state - pursuant to (6) 200 microcuries of chromium-51.cquivalent rulee asthorizing distribution to persons b. 91all store the pherseceutical until admini-generally licensed pursuant to 39.24(1) or its equiv- stored in the original shipping contsiner, or a

container providing equivalent radiation protection.olents -

a. 01romitan-51 as modita radiochromets for deter- c. Shell use the pherseceutical only for the

aination of red blood cell volumes and studies of red uses authorized by 39.24(1).blood cell survivel time. d. Shell not administer the pharmaceutical to a

b.. Cobalt-57 for the meeswesent of intestine 1 woman dth confirmed pregnancy or ta e person underabsorption of cyanocobalamin. eighteen years of age. And

c. Cbbelt-58 for the sensurement of intestinel e. Siell not transfer the radioactive motorialabsorption of cyanocobalanin. to e person so is not authorized to receive it pur-

d.. Cobalt-40 for the aseswoment of intestinel suent to a license lesund by the agency, the U.S.' absorption of cyanocobalamin. Nuclear Reguletary Commission, an agreeeent state or

e. Iodine-125 es lodinated hunen eorum albtanin a licensing state, or-in any menner other then in the(IHSA) for determinations of blood and blood plasse triopened, labeled shipping container se received fromvolume. the supplier, except by afsinistering it to a

.f. lodine-131 es sodium iodide for measurement patient.cf thyroid uptake. and .39.24(4) The generally licensed physician posses-

sing or using radioactive esterial under the general

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license of 32.24(1) shall report in duplicate to the 39. 31( 3)'c' to use radioactive material mder the ',agency, any changes in the information furnished by general license in 39.25(136C). The physician, )him on Agency fone 52-2.0-798, " Certificate Medical veterinarian, clinical laboratory or tospital shall ;

Use of Radioactive Material thder General License." furnish on Agency Fonn SHD-2.0-790 the followingThe report shall be stbeitted within thirty days infoneation and etch other infonnation as may . becfter the ef fective date of sta:5 change. required by that forms

39.24(5) Any person using radioactive material a. None and address of the physician, veterinar-pursuant to the general license of 39.24(1) is exempt inn, clinical laboratory or hoepital.

from the requirements of 470--chapter 40 with respect b. The location of use, andto the radioactive material covered by the general c. A statenent that the physician, veterinarian,license. clinical laboratory or hospital has appropriate radi--

ation measuring instruments to carry out in vitro

470-79.25(136C) General licerme fler une of radio- clinical or laboratory tests with radioactive mater-active material fbe certain in vitro clinicei or ial as authorized mder the general license inlaborotary testing. The New Drug provisions of the 39.25(1) and that stch tests will be performed onlyFederal Food, Drug, and Cosmetic Act also govern the by personnel competent in the use of such instrumentsavailability and use of any specific diagnostic drugs and in the handling of the radioactive material.in interstate commerce. 39.25(3) A person to receives, acquires, posses-

39.25(1) A general license is hereby issued to ses or uses radioactive material pursuant to the

any physician, veterinarian, clinical laborofory or general license established by 39.25(1) shall coeplyhospital to receive, acquire, possess, transfer or with the followingsuse, for any of the following stated tests, in accor- a. The general licensee shall not possess at anydance with the provisions of 39.25(2), to 39.25(6), one time, pursuant to the general license inthe following radioactive materials in prepackaged 39.25(1), at any one location of storage or use, a

_ units for use in in vitro clinical or laboratory total amount of iodine-125, iodine-131, selenium-75,tests not involving internal or external administra- iron-59 and cobalt-57 in excess of 200 microcuries.,

r tion of radioactive material, or the radiation there- b. The general licensee shall store ths radio-

fran, to human beirqs or animals: active material, mtil used, in the original shippirq-

a. Carbon-14, in units ret exceeding 10 micro- container or in a container providing equivalentcuries each. radiation protsetion.

b. Cobalt-57, in units not exceeding 10 micro- c. The general licensee shall use the radioact-curies each. ive seterial only for the uses authorized by

c. Hydrogren-3 (tritium), in units not exceeding 39.25(1). /50 microcuries each. d. The general licensee shall not transfer the

d. lodine-125, in unita not exceeding 10 micro- radioactive material to a person who is not esthor-t,uries each. ized to receive it ptesuant to a license issued by

e. Nck todine-125 re ference or calibration the agency, the U.S. Nuclear Regulatory Commission,sources, in mits not exceeding 0.05 microcurie of any agressent state or licensing stato, nor trarafer

ladine-129 and 0.005 microcurie of americium-241 the radioactive material in any mar'nce other than incach. the mopened, labeled shippirq container as received

f. Iodine-131, in mits not exceeding 10 micro- from the oupplier.curies each. e. The cyeneral licensee shall dispose of the

g. Iron-59, in unita not exceeding 20 micro- Nck lodine-125 reference or calibration sourevecuries each. described in 39.25(1)e as required by 40.14(1).

h. Selenium-75, in units not exceeding to micro- 39.25(4) The general licensee shall not receive,curies each. acquire, possess, or use railosct ive material pw-

39.25(2) Pu person shall receive, acquire, pos- euant to 39.25(1):sess, use or transfur radioactise material pwsuant a. Except es prepackaged mits. *ich areto the generst license established by 39.25(1) until labeled in accordance with the provisions of an

Agency form SHD-2.0-790, " Certificate--In Vitro Test- applicable specific license, issued pur suant toing with Radioactive Material thdor General License,,' 39.40(136C) or in accordarce with the provisions ofbaa been filed with the agency and a validated copy a specific license isstard by tas U.S. %cluer Pegula-cf Agency form SHD-2.0-790 with certification number lory Comaisalon, any agreement st ate or licensingassigned has been reesived from the agency, or, mtil state sich aJthorirves the e,anufacture end distribu-

the authorization has been granted pursuant to tion of iodine-125, iodine-131, carbon-14, hydrogen-3(trit itrn) , iron-59, selenitrn-75, cobalt-57, or %ck

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lodine-125 to persone generally licensed mder exempt from the requirenrnto of'470--chaptcr 40 with"j39.25(136C) or its equivalent, and respect to radioactive material covered by that"

general license, except that sich persons usirq theb. thless one of the following statements, as

appropriate, or a substantially similar statement Hock lodine-125 described in 39.25(1)e shall comply

thich contains the information called for in one of with the provisions of 40.14(1) to 40.15(3).Jthe following statements, appears on a label affixed .

ito each prepackaged mit or appears in a leaflet orbrochure thich accompanies the package: 470-39.26(136C) Ice detection devices. |

39.26(1) A general license (radioactive materialThis radioactive material shall be re- other than source material) is hereby issued to own, |

ceived, acquired, possessed, and used only receive, acquire, possess, use and transfer stron- :

by physicians, veterinarians, clinical tium-90 contained in ice detection devices, providedlaboratories or hospitals and only for in eact device contains not more than 50 microcuries of

-

vitro clinical or laboratory testa not stror tita-90 and each device has been manufactured or--

involving internal or external administre- importad in accordance with a specific license issued Ytion of the material, or the radiation by the U.S. Nuclear Regulatory Commission or eachtherefrom, to human beings or animals. Its device has been manufactured in accordance with thereceipt, acquisition, possession, use and specifications contained in a specific license issuedtransfer are stbject to the regulations and by the agency or en agreenent state to the manufac-a general license of the U.S. Nuclear Regu- turer of etch device pursuant to licensing require-latory Commission or of a state with whicli mente equivalant to those in Section 32.61 of 10 CFRthe Commission has entered into an agree- Part 32.ment for the exercise of regulatory author- 39.26(2) Persons who uwi, receive , acquire,

ity. possess, use or transfer strontius-90 contained inice detection oevices pursuant to the <pnerA

license in 39.26(1):Name of manufacturer a. 91all, upon occurrence of visually observable

damage, such as a bend or crack or discoloration*

OR fran overheating to the device, discontinue use of'the device until it has been inspected, tested for _-leakage and repaired by a person holding a specific jThis radioactive asterial shall be re-

ceived, acquired, possessed, and used only license from the U.S. Nuclear Regulatory Commission -1,

by physiciano, veterinarians, clinical or en agressent state to manufacture or service such ]laboratories or hospitals and only for in devices or shall dispose cf the device pursuant to 3vitro clinical or laboratory tests not the provisions of 40.14(1) of t*ie radiation rules. jinvolving internal or external administra- b. Shall assure that all labels affixed to the af

]tion of the seterial, or the radiation device et the time of receipt, and thich bear s

therefrom, to htsssi beings or animals. Its statement which prohibits removal of the labels, are ]receipt, acquisition, possession, use and maintained thereon, and Jtrans fer are stbject to the rules and a c. Are exempt from the requirements of 470-- 4general license of a licensing state. 01epter 40, except that etch persons shall comply g.

with the provisions of 40.14(1), to 40.15(3).39.26(3) This general license does nct authorize J

Name of manufacturer the manufacture, assembly, disassembly or repair ofstrontium-90 in ice detection devices. . L

39.25(5) The physician, veterinarian, clinical 39.26(4) This general license is stbject to thelaborstnry or hospital possessing or using radioact- provisions of 38.4(1%C) to 38.9(1%C), 38.11(1%C), ;

i

ive material under the genersi license of 39.25(1) 39.48(136C), 39.55(136C), 39.56(136C) and 39.59 j

shall report in writing to the agency, any changes in (1 %C) .

the information furnished on Agency form SHD-2.0-790, 39.27 Reserved." Certificate--In Vitto Testing with Radioactive IHaterial Under General License." The report shall be 470-39.28(1L") Specific licenses. Specific licen- j

Ifurnished within thirty days after the effective date aos require the ethmission of an application to theof such change. agency and issuance of a licensirg doctament by the h

"

39.25(6) Any person ustrq rafloactive material agency. The licensee is sibject to all applicablepursuant to the general license of 39.25(1) is

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' portJnne of these rulee se nell es siy limitations forth in 39.30(1%C) a specific license for honen usecpecified in the licensing document. of radioactive meterial in institutions will be

issued ifs47439.29(1MC) Filing application fist specific a. The applicant has appointed a medical iso-licenses. topes committee of at least three members to evaluate

39.29(1) Applications for specific licenses all proposals for research, diagnostic, and therapeu-shall be filed in triplicate on Agency form SHD-2.0- tic use of radioactive meterial within that institu-795. tion. Membership nf the committee should include

39.29(2) The egency may at any time after the physiciane expert in s.ternal medicine, hematology,filing of the original application, and before the therapeutic radi31cgy, and a person experienced inCupiration of the licones, require further stats- assay of radioactive material and protection againstments in order to enable the agency to detemine radiation.whether the application should be granted or denied b. The applicant possesses adequate facilitieser eether a license should be modified or revoked. for the clinical care of patients.

39.29(3) Each application shall be signed by the c. The physicini designated on the applicationapplicant or licensee or a person duly authorized to es the individual user has esotential experisnce inact for and on the applicant's behalf, the handling and administration of radioactive mater-

39.29(4) An application for a license may in- iol and =tiere applicable, the clinical managen:ent ofclude a request for a license authorizing one or more radioactive patiente, and

~

activities. d. If the application le for a license to use

39.29(5) In the application, the applicant may utspecified quantities or multiple types of radio-incorporate by reference information contained in active meterial, the applicant's staff has stbetan-previous applicatione, statemente, or reports filed tial experience in the use of a variety of radioact-with the agency provided such references are clear ive materials for a variety of hunen uses.and specific. 39.31(2) Specific licenses to individual physi-

- 39.29(6) Applicatione and documente esmitted to cians for husen use of radioactive material.the agency may be made available for pelic inspec- e. An application by an individual physician ortion except that the agency may withhold any document group of pnyeicians for a specific license for humaner part thereof from p411c inspection if disclosure use of radioactive material will be approved if t *

cf its content is not required in the p411c interest (1b The applicant setiefied the general require-,

. and would adversely affect the interest of the person ments specified in 39.30(1%C).,

concerned. (2) The application is for use in the appli-cant's practice ir. en office outside a medicel insti-

47439.30(1XC) General requirements fler the leeu- tution.ence of specific licerees. A license application (3) The applicant has a: cess to a hospital poe-rill be approved if the agency determines thats seesing adequate facilities to hospitalize and soni-

39.30(1) The applicant le qualified by reason of tor the applicant's radioactive patients whenever ittraining and experience to use the meterial in ques- is advisable, andtion for the purpose requested in accordence with (4) The applicant has extensive experience inthese rules in such a manner as to minimize danger to the proposed use, the handling and achninistration ofp411c health and safety or property. radionuclideo, and eere applic able, the clinicial

39.30(2) The applicant 's troposed equipment, management of radioactive patiente.facilities, and procedures are adequate to minimize b. The agency will not opprove an application bydanger to p411c health and eefety or property. en individual physician or group of phyelcians for a

39.30(3) The issuance of the license will not be specific license to receive, possess, or use radio-inimical to the health and safety of the p411c. active material on the pranises cf a medical institu-

39.30(4) The applicant satisfies any applicable tion uileserspecial requiremente in 39.31(1%C), to 39.38(1%C) (1) The use of radioactive meterial is limitedand 39.40(1%C) to 39.45(1%C). tot

1. The celainistration of ria11opharmaceutic als470-39.31(1MC) Special requiremente for imeumnce for diagnostic or therapeutic purposes.cf coetain specific 11cornes for renJiesclive mater. 2. The performance of diagnostic studies onial . patiente to sose a rajiopharmaceutic41 has been

39.31(1) Himen use of radioactive matertal in eeninistered.institutione. In addititui to the requiremente set 3. Tho por formance of in vitro diagnoittle

studies, or

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4 The eclibrcti:n and quality control check 3 of (2) Fct Group Ill, no licensee shdl reccivo,'radioactive assay instrunentation, radiation safety possess, or use generators or reagent kits contain-instrumentation and diagnostic instrumentation. ing radioactive material or shall use reagent kits

(2) The physician brings the radioactive mater- that do not contain radioactive material to prepare

ial and removes the radioactive material den depart- radiopharmaceuticals containing radioactive material,ing. The institution cannot receive, possess, or except

ctore radioactive material other L5an the enount of 1. Reagent kits not containing radicactive mater-material remaining in the patient, and lal that are approved by the agency, the U.S. Nu: lear

(3) The medical institution does not hold a Regulatory Commission, an agreenent state, or aradioactive material license under 39.31(1). licensing state for use by persons licensed pursuant

39.31(3) Specific licenses for certain groups of to 39.31(3) and 39.66(136C) or equivalent rules, ormedical uses of radioactive meterial. 2. Generators or reagent kits containing radio-

e. SWject to the provisions of 39.31(3) pars- active material that are manufactured, labeled, pack-

graphe "b," "c," and "d," an application for a speci- aged, and distributed in accordance with a specificfic license pursuant to 39.31(1), 39.31(2) , and license issued by the agency pursuant to 39.43(136C) ,'9.31(4), for any medical use or uses of radioactive a specific license issued by the U.S. Nuclear Reguls-,

material specified in one or more of Groups I to VI, tory Commission pursuant to Section 32.73 of 10 CFRinclusive, of 39.66(136C) will be approved for all of Part 32, or a specific license issued by an agreementthe uses within the group or groupe Alch include the state or a licensing state pursuant to equiv alentuse or uses specified in the application if t rules.

_

(1) The applicant satisfies the requirenents of (3) For Group VI, no licensee shall receive ,39.31(1), 39.31(2), or 39.31(4). possess, or use radioactive material except as con-

(2) The applicant, or the physician designated tained in a source or device that has been manufac,-in the application as the individual user, has ade- tured, labeled, packaged, and distributed in accord-quate clinical experience in the types of uses once with a specific license issued by the agencyincluded in the group or groups. pursuant to 39.44(136C), a specific license issued by

( 3) The applicant, or the physicians and all the U.S. Ptselear Regulatory Commission pursuant toother personnel who will be invohed in the prepara- Section 32.74 of 10 CFR Part 32, or a specific

tion and use of the radioactive material, have ade- license issued to the manufacturer by an agreenent'quate training and experience in the handling of state or a licensing state pursuant to equivalentradioactive meterial appropriate to their participa- rules.-tion in the uses included in the group or groups. (4) For Group III, any licensee using gennators

(4) The applicant's radiation detection and or reagent kits shalltmeasuring instrunentation la adequate for conducting 1. Elute the generator, or process radioactivethe peccedures involved in the uses included in the material with the reagent kit, in accordance withgroup or groups, and instructions approved by the U.S. Nuclear Regulatory

(5) The applicant's radiation safety operatiry Commission, en agreanent state, or licensing stateprocedures are adequate for handling and disposal of and furnished by the manufacturer on the labelthe radioactive material involved in the uses attached to or in the leaflet or brochure that accom-included in the group or groups. panies the generator or reagent kit.

b. Any licensee to is authorized to use radio- 2. Before administration to patients, cause eachactive material pursuant to one or more groups in elution or extraction cf technetiun-99m from a moly-39.31(3)"a" and 39.66(136C) is sWject to the follow- bdenum-99/ technetium-99m p nerator to be tested toing conditions determine either the total molybdenua-99 activity or

(1) For Groups I, II, IV, and V, no licenses the concentration of nolybdenum-99. This testingshall receive, possess or use radioactive material shall be conducted according to written proceduresexcept as a radiopharmaceutical manufactu.ed in the and by personnel to have been specifically trainedform to be adminiatored to the patient, labeled, to perform the test.packaged , and distributed in a:cordance with a 3. Prohibit the administration to patients of

specific license issued by the agency pursuant to technetiun-99m containing more than one microcurie of39.44(136C) , a specific license issued by the U.S. molybdenum-99 per millicurie of technetium-99m, crWclear Regulatory Commission pursuant to Section more than five microcuries of mol)bdenua-99 per

32.72 of 10 CfR Part 32, or a specific license issued administered dose, et the time of ad,einistration, andby an agreement state or a licensing state pursuant 4. Maintain for three years for agency inspec-to equivalent rules. tion records of the molybdenum-99 test conducted on

each elution from the generator.

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(5) Fct Groups I, II, and III, any 'lic;nsee using 2. Wien the sealed source is stored and is notradioactive meterial for clinical procedures other being used; such sources shall, however, be tnstedthan those specified in the product labeling (package for leakage prior to any use or transfer mless theyinsert) shall comply with the product labeling . have been leak tested within six months prior to theregarding chemical and physical form, route of admin- date of use or transfer.istration, and dosage range. (2) The . leek test shall be capable of detecting

c. Any licensee dio is licensed pw suant to the gresence of 0.005 microcurie of radioactive39.31(3)s for one or more of the medical use groups material on the test samplo. The test sample shall

f in 39.66(136C) also is authorized to use radioactive be taken from the sealed source or from the surfaces! material under the general license in 39.31(136C) for of the device in which the sealed source is momted

the specified in vitro uses without filing Agency or stored on Wiich contaninetion might be expected toForm SHD-2.0-790 as required by 39.25(2); provided, accumulate. Records of leak test resulta shall bethat the licensee is s@ ject to the other provisions kept in mits of microcuries and maintained for

of 39.25(136C). inspection by the agency,d. Any licensee dio is licensed pursuant to (3) If the leak test reveals the presence of

39.31(3)"a" for one or more of the medical use groups 0.005 microcurie or more of removable contamination,in 39.66(136C) also is aJthorized, ssject to the the licensee shall immediately withdraw the sealed

. provisions of 39.31(3), paragraphs "d" and "s," to source from use and shall cause it to be decontamin-receive, possess, and use for calibration and refer- ated and repaired or to be disposed of in accordance

'

ence standards ~

with this chapter and 470--chapter 40. A report(1) Any radioactive material listed in Group I, shall be filed within five days of the test with the

Group II, or Group III of 39.66(136C) with a half- agency describing the equipment involved, the testlife not longer than 100 days, in amounts not to results and the corrective action taken. >

cxceed 15 millicuries total. f. Any licensee who possesses and uses calibra-(2) Any radioactive material listed in Group I, tion and reference sources pursuant to 39.31(1)d(4)

| Croup II, or Croup III of 39.66(136C) with a half- shall

,. life greater than one hmdred days in anomts not to (1) Follow the rafiation safety , mid handlingExceed 200 microcuries total. instructions spproved by the agency, the U.S. Nuclear-

(3) Technetium-99m in amounts not to exceed 30 Regulatory Com nission, an agreement state er a licen-| c1111 curies. And sing state and furnished by tne manufacturer on the

j

| (4) Any radioactive material, in amounts not to label attached to the source, or permanent container !

| Exceed 3 mil 11 curies per source, contained in cali- thereof, or in the leaflet or brochure that accompan- !

I bretion or reference sources that have been manufac- les the source, and maintain such instruct, ion in a

tured, labeled, packaged, and distributed in accord- legible and conveniently available form, and I

ence with a specific license issued by the agency (2) Conduct a quarterly physical inventory topursuant to 39.44(136C), a specific license issued by accomt for all sources received and possessed.the U.S. Mr lear Regulatory Cbemission pwsuant to Records of the inventories shall be maintained for

| Section 32.74 of 10 CFR Part 32, or a specific inspection by the agency and shall include thelicense issued to the manufacturer by an agreement quantities and kinds of radioactive material, loca-

ttste or a licensing state pursuant to equivalent tion of sources, and the date of the inventory.rules. 39.31(4) Haan use of sealed ocurces. In addi-

e. Any licensee who possesses sealed sources as tion to the requirements set forth in 39.30(136C) a

calibration or reference sources pursuant to specific license for human use of sealed sources will

39.31(3)"d" shall cause each sealed source containing be issued only if the applicant or, if the applicw

radioactive material, other then hydrogen-3, with a tion is made by an institution, the individaal usershalf-life greater than thirty days in any form other a. Has specialized training in the diagnostic orthan gas to be tested for leakags or contanination or therapeutic usa of the sealed source considered, orboth at ictervals not to esce6d six months. has experience equivalent to such training, and

(1) In the absence of a certificate from s trans- b. Is a physician,foror indicating that a test has been made within six 39.31(5) the of sealed sources in industrialmonths prior to the trans fer, the saaled tources tr.diography. In additicn to the requirenects set

f should not be used until tested, provided, however, forth in 39.30(136C) a specific license for use of|

( that no leak tests are required diens sealed sources in industrial radiography will be1. The source contains 100 nicrocuries er less of issued ift

beta-emitting or gamma-emitting material, or both, oc s. Tne applicant w!11 have en adequate progran10 microcuries or lesa of alpha-emitting material, nr for training radiographers and radiographer's

Il

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aseittents and eUMaits ta the agency a schedule cr trenefsr and dirpocal by all cther persons tro cxemp-'description of such progrun inich specifies ther tod from regulatory requirements may be obtained only

(1) Initial training. from the U.S. % clear Regulatory Commission, Wething-(2) Periodic training. ton, D.C. 20555.(3) - (b-the-job training. 39.32(1) The different types of broad scope

(4) Means to be used by the liconeee to determine licenses are.oot forth belowsthe radiographer's knowledge and mderstanding of and a. A " Type A specific license of broad scope" isability to comply with agency rules and licensing a specific license authorizing receipt, acquisition,requirements, and the operating and emergency proco- ownership, possession, use and transfer of any chemi-dures of the applicant. And cal or physical form of the rtdioactive meterial

(5) Means to be used by the licensee to determine specified in the license, but not exceeding quanti-the radiographer's assistants knowledge and under- ties specified in the license, for any authorized

standing of and ability to comply with the operating purpose. 1he quantities specified are usually in theand emergency procedures of the applicant. multicurie range.

b. The applicant hee established and semits to b. A " Type B specific license of broad scope" isthe agency satisfactory written operating and emer- a specific license authorizing receipt, acquisition,gency procedures described in 41.4(14) of the radi- ownership, possession, use and trenefer of any chemi-ttion rules. cal or physical form of radioactive material speci-

c.- The applicant will have an internal inspection fled in 39.67(136C), for any authorized purpose.system adequate to assure that these rules, license (1) The possession limit for a Type B license ofprovisione, and the applicant's operatirq and emer- broad scope, if only one radionuclide is possessedgency procedures are followed by radiographers and thereunder, is the quantity specified for that radio-radiographers' sesistants; the inspection systen nuclide in 39.67(136C), Column I.-

.

shall' include the performance of internal inspections (2) If te or more radionuclides are possessedet intervals not to exceed three sonths and the theremder the possession limit for each is deter-

- retention of records of such inspections for te mined as follows: For each radionuclide, determineyears.. the ratio of the quantity possessed to the applicable

d. The' applicant semits to the agency a descrip- quantity specified in 39.67(136C), Column I, for thattion of the overall organizational structure pertain- radionuclide, the sun of the ratios for all radio *

- ing to the industrial radiography program, including nuclides possessed eder the license shall not exceedtpecified delegations of authority and responsibility mity.~

c. A " Type C specific licones of broad scope" isfor operation of the progress. '

e. Applicants 40 desire to conduct their own a specific license authorizing receipt, acquisition,leek tests have established adequate procedures to be ownership, possession, use and transfer of aby chemi-followed in testing sealed sources for possible leak- cel or physical form of radioactive meterial speci ~age and contamination and admits to the agency a find in 39.67(136C), for any authorized purpose.description of such procedures including: (1) The possession limit ~ for a Type C license of

(1) Instrumentation to be used. broad scope, if only 'one radionuclide is possessed(2) . Method of performing tests, and thereunder, is the quantity specified for that radio-(3) - Pertinent experierce of the individual who nuclide in 39.67(136C), Column II.

will perform the test,' and (2) If two or more radionuclides are possessed

f. The licensee shall conduct a progree for theremder, the possession limit is determined forinspection ' and meintenance of radiographic expoewe each as follows: For each radionuclide, determine

devices and storage containers to aoeure proper the ratio of the pntity possessed to the applicablefmetioning of componente important to safety. quantity specified in 39.67(136C), (blumn II, for

that radionuclide. The sun of the ratlos for all'

470Jf.32(136C) Special regisirements fler specific radionuclides possessed mder the license shall not11eenose of bread scape. This rule presc ribes exceed mity.requirements for the issuance of specific licenses of 39.32(2) An application for a Type A specific-

broad scope for tedioactive meterial and certain license of broad scope will be approved 17:rules spverning holders of sich licenses. Authority e.- The applicant satisfies the general require-to transfer possession or control by the manufat.- ments specified in 39.30(136C).twer, processor, or ' graducer of any equipment, b. The applicant has engaged in a reasonabledevice, commodity, or other product containing by- number of activities involving the use of radioactive

-product meterial *os e stbsequent possession, use, meterial, and

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e .

n-

c. The applicant has established administrativo a. Tha applicent satisfies the general require-'

controls and provisione relating to organization and monts specified in 39.30(136C).: management, procedures, recordkeeping, material con. b. The applicant semits a statenent that radio-! trol and accounting, and management review that are active material will be used only by, or mder the

neccesary to esswo safe operations, including: direct supervision of, individuals do have received:1 (1) The establishment of a radiation safety (1) A college degree et the bachelor level, or

committee camposed of sich persone as a radiation equivalent training and experience, in the physical4

| safety officer, a representative of management, and or biological sciences or in engineering, and; persons trained _ and experienced in the safe use of (2) At least forty hours of training and experi-

radioactive material. ence in the safe handling of radioactive meteriel, in(2) The appointment of a radiation safety officer the characteristics of ionizing radiation, mits of

who is qualified by training and experience in radi- radiation does and quantities, radiation detection,

ation protection, and so is available for advice and instrumentation, and biological hazards of exposureassistance on radiation safety matters, and to radiation appropriate to the type and forms cf

(3) The establisheent af appeoptiste adminiatra- radioactive meterial to be used, andtive procedures to assures c. The applicant has established administrative;

1. Control of procurement and use of radioactive controls and peovisions relating to procurement of1 meterial. radioactive material, procedures, recordkeeping, |

2. Completion of safety evaluations of proposed meterial control and accounting, and management,

) uses of radioactive meterial dich tale into con- review necessary to assure safe operations.j sideration such matters as the adequecy of facilities 39.32(5) Specific licenses of broad scope are; and equipment, training and experience of the user, subject to the following conditions:'

and the operating and handling procedures, and e. thless specifically authorized, persods3. Review, approval, and recording by the radi- licensed pursuant to 39.32(136C) shall cots

..[ ction safety cannittee of safety evaluations of (1) Conduct tracer studies in the envirornientproposed uses prepared in accordance with involving direct rolesse of radioactive meterial.'

t 39.32(2)"c"(3)2. prior to use of the radioactive (2) Receive, acquito, om, pos'sess, use or trane.meterial. for devices containirig 100,000 curies or more of-

_

39.32(3) An application for a Type 8 specific radioactive material in sealed sources used for^ license of broad scope will be approved if irrealation of meterials.

a. The applicent satisfies the general require- (3) Condtet activities for sich a specifit {,

! monts specified in 39.30(136C),and license issued by the agency under 39.31(136C), |b. . The applicant hee established administrative 39.33(136C) to 39.45(136C) is required, or / |controls and provisione relating to organization and (4) Add or cause the addition of radioactive jmanagement, procedures, recordkeeping, meterial material to any food, beverage, cosmetic, drug, or

; control and accounting, and management review that other product designed for it'gestion or inhalation1 cre necessary to assise safe operations, including: by, or application to, a human being.

(1) The appointment of a radiation safety officer b. Each Type A specific license of broad scope. who is quellfied by training and experience in radi- issued mder this chapter shall be sWject to the

| ation protection, and who is available for advice and condition that radioactive material possessed under(seistance on radiation safety metters, ed the license may only be used by, or mder the direct

| (2) The establishment of appropriate administra- supervision of, individuals approved by the licon-tive procedures to assures see's radiation safety committee.

1. Control of procurement and une of radioactive c. Each Type 8 specific license of broad scopemeterial. issued u; der this chapter shall be s@ ject to the,

i 2. Completion of safety eyelustione of proposed condition that radioactive eaterial possessed under'uses of radioactive meterial sich take into con- the license may only be teed by, or mder the direct

*

cideration such setters as the adequacy of facilities supervision of, indi/iduals approved by the licen-and equipment, training and experience of the user, see's radiation safety officer.

j and the operating or handling procedures, and d. Ex5 Type C opecific license of broad scopei 3. Review, approval, and recording by the radi- issind mder this chanter chall be s4 ject to the} ction safety officer of safety evalustions of pro- condition that radioactive material possessed under+

| po. sed uses prepared in accordance ulth 39.32(3)"b" the license a:ay only be used by, er eder the directj (2)2. prior to une of the radioactive materiel. supervision of, individuals dus satisfy the reouire.| 39.32(4) An application for a Type C specific ments of 39.32(4).] license of broad scope will be approved if:

1

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47539.3)(136C) Special requirmento Ase licensisus ' sh:ll so indiccto. Th2 report 'oh:11 be filed within'the introesetion of radioactive meterial into pro- thirty days after filing the last report, or aftse

emite in exempt concentralians. application for renewal of license or after notifying

39.33(1) In addition to the requirments set forth the agency of the intention to discontinue the

in 39.30(136C), a specific license authorizing the activities authorized by the license.

introduction of radioactive material into a product

cr asterial owned by or in the possession of the 470 39.34(136C) Special rerguirmonto fler licessinglicensee or another to be transferred to persons the distribution af radioactive material in mampt

cxempt inder 39.3(7)*a" will be issued if s quantities. Authority to transfer possession or

a. The applicant osoits a description of then control by the manufacturer, processor, or producer(1) Product or material into dich the radio- of any equipment, device, commodity, or other product

active motorial will be introduced. containing byproduct meterial dose eseequent

(2) Intended use of the radioactive material and possession, use, transfer and disposal by all otherthe product or material into sich it is introduced. persons are exempted from regulatory requirements may

(3) Method of introduction. be obtained only fran the U.S. Nuclear Regulatory

(4) Initial concentration of the radioactive Commission, Washington, D.C. 20555.material in the product or material. 39.34(1) iln application for a specific license to

(5) Control methods to assure that no more than distribute NARM to persons exempted from these rulesthe specified concentration is introdtzed into the pursuant to 39.3(8) will be approved ifsproduct or material. a. The radioactive material is not contained in

_

(6) Estimated time interval between introduction any food, beverage, cosmetic, drug, or other commod-and transfer of the product or material, and ity designed for ingestion or inhalation by, or

-(7) Estimated concentration of the radioactive application to, a htsnan being.,

meterial in the product or material at the time of b. The radioactive material is in the form oftransfer, and processed chemical elements, compounds, or mixtures,

b. The applicant provides reasonable aestrances tieaue su ples, bionssay semples, counting standards,

(1) That the concentrations of radioactive mater- plated or encapoulated sources, or similar es-ial at the time of transfer will not exceed the stances, identified as radicactive and to be used forconcentrations in 39.64(136C). Its radioactive properties, but is nat incorporated

(2) That reconcentration of the radioactive into any manufactured or assembled commodity, pro-toterial in concentrations exceeding those in duct, or device intended for commercial distribution,

and39.64(136C) is not likely. '

; (3) That use of lower concentrations is not c. The applicant submits copies of-prototypereseible, and labels and brochtres and the agency appre'ves such

(4) That the product or material is not likely to labels and brochures.~

be incorporated in any food, beverage, cosmetic, drug 39.34(2) The license issued inder 39.34(1) iscc ather commodity or product designed for ingestion subject to the following comfitionser inhalation by, or application to, a human being. a. 2 more then ten exempt quantities shall be

39.33(2) Each person licensed inder 39.33(1) sold or transferred in any single transaction.

shall file an annual report with the agency dich Nwever, an exempt quantity may be composed ofshall identify ther fractional parts of one or more of the exempt

a. Type and quantity of each product or meterial quantity provided the sun of the fractions shall not

| into which radioactive material has been introduced exceed unity.

| during the reporting period. b. Each exempt quantity shall be separately and

| b. Name and address of the person who owned or individually packaged. 2 more than ten sur.hI possessed the product or meterial, into sich radio- packaged exempt cpanntities shall be contained in any

active material has been introduced, at the time of outer package for transfer to persons exempt pursuant

introduction. to 39.3(8). The outer package shall be such that the

c. Type and quantity of radionuclide introduced dose rate at the external surface of the package does

into each such product or meterial, and not exceed 0.5 milliran per hour.d. Initial concentrations of the radionuclide in c. The inanediate container of each quantity or

the product or meterial at time of transfer of the separately packaged fractional quantity of

radioactive meterial by the licensee. radioactive material shall bear a durable, legible39.33(3) If no trenefers cf radioactive material label s ieht

have been made pursuant to 39.33(1) during the (1) Identifies the radionuclide and the quantilyreporting period, the report specified in 39.33(2) of radioactivity, and

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i

..

(2) Beers the words " Radioactive Material.a e. The applicent entierise the general require- :

d. In addition to the labeling information mente of 39.30(136C).,

required by 39.34(2)"c," the label affixed to the b. The applicent osoite sufficient information

4-immediate container, or an accompanying brochure reisting to the design, manufacture, prototype test-

! shell: ing, quality control, labele, proposed uses, instal-(1) State that the contente are exempt from lation, servicing, leek testing, operating and safety

. Licensing state requirementag instructions, and potential hareeds of the device toI (2) Bear the words "Redioactive Meterial-Not for provide reasonable assurance that:I Hasan Use--Introduction into Foods, Beverages, (1) The device can be safely operated by persone

Cosmetice, Drugs or Medicinale, or into Producto not having training in radiological protection.4

Manufactured fbr Commercial Distribution le Prohib- (2) thder ordinary conditions of handling, stor-ited - Exempt thsentities Should ltat Be Combined"; and age, and use of the device, the radioactive meterial

(3) Set forth appropriate additional radiation contained in the device d1l not be rolessed or,

safety precautions and instructions relating to the inadvertently removed fram the device, and it is,

handling, use, storage and disposal of the radioact- miikely that any porean will receive in any period' ,

ive meterial. of one calender quarter e does in excess of 10 per-; 39.34(3) Each person licensed mder 39.33(2) cent of the limite specified in the t6le in; ehall maintain records identifying, by name and 40.2(1)"e,".and

address, each person to som radioactive meterial is (3) thder accident conditions sich as fire and:

transferred for use under 39.3(8) or the equivalent explosion associated with handling, storage, and use! rulee of a licensing state, and stating the kinds and of the device, it is miikely that any person euld

I quantities of radioactive meterial transferred. receive an external radiation does or does commitment'

a. An annual summary report stating the total in excess of the following orgen doses:; quantity of each radionuclide transferred under the: <- Cpecific license shall be filed dth the 41ency. 1. thole body; head and trunk;} b. Each report shell cover the year ending Jme active blood-forming orgens:

' 30, and shell be flied within thirty deye thereafter. gonads or lene of eye . . . . . . 15 rame< -

c. If no trenefere of radioactive material havebeen modo pursuant to 39.33(2) during the reportirup 2. Hende and forearms; feet and

'

- period, the report shall so indicate. - ankleet localized areas ofskin overaged over areas no: -

475-39.35(136C) Special :=mpsiremede Ibr lieansing larger than 1 square centimeter . 200 rue.

{ NAWI into yo ed moreamt deteeters. Special /requiremente for licensing the incorporation of 3. (Rher orgene . . . . . . . . . . . 50 rose4

; naturally occurring and accelerator-produced radio-i active material into goe and aerosol detectors ares c. Each device beers a durable, legible, clearly; 39.35(1) An application for a specific license visible label or labels approved by the egency, *ichi tuthorizing the incorporation of NMG4 into goe and contain in e clearly identified and separate state-

serosol detectore to be distributed to persons exempt ments

under 39.J(11)"c" will be approved if the application (1) Instructions and precautione necessary to,

catisfies requirements equivalent to thoes contained ensure safe installation, operation, and servicing of! in Section 32.26 of 10 CFR Part 32. the devices documente such as operating ord service

39.35(2) The maxime quantity of radium-226 in manuele may be identified in the label ad used toi cach device shall not exceed 0.1 microcurie. provide this information.

(2) The requirement, or Inck of requirement, for475-37.36(136C) Special requiremente fler licensing leak testing, or for testing any "on-off" sechaniani

f the manufacture ed distribution of doeiess to per- and indicator, including the mexious time intervalsens generally licensed tender 39.20(136C). for such testing, and the identification of radio-

,

39.36(1) An application for a specific license to active meterial by isotope, q; entity of radioactiv-j manufacture or dintribute devices containing radio- ity, and date of determination of the quantity, and

active meterial, excluding specist nuclear meterial, (3) The information celled for in one of the)

j to persons generally licensed under 39.20(1360) or following statsoents, es oppropriate, in the same or

| squivalent regulations of the U.S. P4 clear Regulatory esotentis11y elmilar form:i Commiselon, an agreement state, or a licensing stato} will be approved ift

li

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The rec;ipt, possesti:n, use and transfJr g. Maximum pres:uro withstrod' cisting pratstype'of this device, Model , Serial No. tests.

, are esject to a general license h. Maximun quantity of contained radioactiveor the equivalent and the regulations of material.the U.S. Nuclear Regulatory Comunission or a 1. Radiotoxicity of contained radioactive mater-

,

I state with tich the U.S. Pkselear Regula- ial, and .

tory (banission has entered into an agree- J. Operating experience with identical devices orment for the exercise of regulatory author- similarly designed and constructed devices.ity. This label shall be maintained on the 39.36(3) In the event the applicant desires thatdevice in a legible condition. Removal of the general licensee under 39.20(136C), or mderthis label is prohibited. equivalent regulations of the U.S. P&Jclear Regulatory

Commission, an agreement state, or a licensing state(CAUTION - RADIDACTIVE MATERIAL) be asthorized to install the device, collect the

sample to be analyzed by a specific licensee for

leakage of radioactive material, service the device,Name of manufacturer of distributor test the "on-off" sechanian and indicator, or remove

the device from installation.OR a. The applicant shall include in the applica-

tion:

The receipt, possession, use, and transfer (1) Written instructions to be followed by the

of this device, % del ,SerialNoi general licensee., are s4 ject to a general license (2) Estimated calendar quarter doses associated

or the equiv alent , and the rules of a with su:h activity or activities, and

licensing state. this label shall be main- (3) Bases for such estimates. '

toined on the device in a legible condi- b. The s4mitted information shall demonstratetion. Removal of this label is prohibited. that performance of such activity or activities by an

individual mtrained in radiological protection, in'

(CAUTION - RADI0 ACTIVE HATERIAL) addition to other handling, atorage and use ofdevices mder the general license, . is miikely to'-

cause that individual to receive a calendar quarter

Name of manufacturer or distributor dose in excess of ten percent of the limits specified.

in the table in 40.2(1)"a" of the radiation rules.39.36(2) In the event the applicant desires that 39.36(4) Each person licensed mder 39.35(136C)

the device be required to be tested at intervals to distribute devices to generally licensed personslonger than six months, either for proper operation shallCf the "on-off" sechanian and indicator, if any, or s. Furnish a copy of the general license con-

for -leakage of radioactive asterial or for both, the tained in 39.20(136C) to each person to som he

applicant shall include in the . application sufficient directly or throucp an intermediate person transfersinformation to demonsteste that such longer interval radioactive material in a device for use pursuant to

is justified by performance characteristics of the the general license contained in 39.20(136C).device or similar devices and by design features b. Furnish a copy of the general license con-dich have a significant bearing on the probability tained in the U.S. Nuclear Regulatory Commission's,er consequences of leakage of rafloactive material agreement state's, or licensing state's regulation

from the device or failure of the "on-off" mechanism equivalent to 39.20(136C), or alternatively, furnishand indicator. In determining the acceptable inter- a copy of the cpneral license contained in 39.20

val for the test for leakage of radioactive material, (136C) to each person to whom the licensee directlythe agency will consider information sich includes, or through an intermediate person trans fers radio-but is not limited tot active material in a device for use pursuant to the

a. Primary containment or source capsule. general license of the U.S. >&Jclear Regulatory Com-b. Protection of primary contairment. mission, the agreement state, or the licensingc. Methcd of sealing containment. state. If a copy of the general license in 39.20

d. Containment construction materials. (136C) is furnished to such a person, it shall be

e. Form of contained radioactive material. aceaepanied by a note explaining that the use of thef. Maxieue temperature withstood during prototype device is regulated by the U.S. Nuclear Regulatory

tests. Commission, Agreenent State, or Licenairq State mder

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requirements sibetantially the see as those in to the U.S. MJelear Regulatory Commission.39.20(136C). (7) If no transfers have been made to the general

c. Report to the agency all transfers of stch licensees within a particular stato during the

devices to persons for use under the general license reporting period, this information shall be reportedin 39.20(136C). Such reports shall identify to the responsible state agency upon request of that

(1) Each general licensee by name and address. agency.

(2) An individual by name or position to may f. Keep records showing the nee, address, andconstitute a point of contact between the agency and the point of contact for each general licensee to

the general licensee. *om the licensee directly or through an intermediato(3) The type and model number of device trans- person transfers radioactive material in devices for

forted, and use pw suant to the general license provided in

(4) The quantity and type of radioactive material 39.20(136C) or equivalent regulations of the U.S.

contained in the device. MJclear Regulatory Commission, en agreement state, ord. If one or more intermediate persons will a licensing state. The records shall show the date

tanporarily possess the device at the intended place of each transfer, the radionuclide and the quantity

cf use prior to its possession by the user, the of radioactivity in each device transferred, the

report identified in 39.36(4)"c" shall include identity of any intermediate person, and conplianceidentification of each intermediate person by name, with the report requiroments of 39.36(4).address, contact, and relationship to the intended

user. 470-39.37(136C) Special requirements for the manu-(1) If no transfers have been made to persons factwer, assembly, or repair of lumirusse safety

generally licensed mder 39.20(136C) during the devices for use in aircraft. ki application for a

reporting period, the report shall so indicate. specific license to manufacture, essemble, or repsir(2) The report shall cover each calendar quarter luminous safety devices containing tritiun or proaie-

and shall be filed within thirty days thereafter. thium-147 for use in aircraft, for distribution to

e. Furnish reports to other agencies persons generally licensed under 39.21(136C) =111 be,

(1) Report to the U.S. MJclear Regulatory Commis- approved if:cion all transfers of such devices to persons for use 39.37(1) The applicant satisfies the general

under the U.S. Nuclear Regulatory Casaission general requirements specified in 39.30(136C), andlicense in Section 31.5 of 10 CFR Part 31. 19.37(2) The applicant satisfies the requirements

(2) Report to the responsible state agency all of Sections 32.53 to 32.56, and 32.101 of 10 CFR Parttransfers of devices manufactured and distributed 32, or their equivalent.

i_ pursuant to 39.32(2) for use under a general licernein that state's rules equivalent to 39.20(136C) . 470-39.38(136C) Special requirements for license to

(3) Such reports shall identify: marusfactwe calibration usucces containing seeri-

1. Each general licensee by nee aid address. c14m-241, plutonium or radium-226 for distribution to2. An individual by nano or psition *o say persone generally licennad mder 39.23(136C). Ai

constitute a point of contact between the agency and application for a speci fic license to enufacture

the general licenseo. calibration and reference sources containing amer t-3. The type and model of the device transfarred, clun-241, plutonian or radium-226 to perscns genet-

and ally licensed under 39.24(136C) will be soproved ift4. The quantity and type of radioactive material 39.33(1) The applicant satisfies the epneral

contained in the device. requirernents of 39.30(136C),and(4) If one or more intermediato persons will 39.38(2) The applicant satisfies the requitarents

temporarily possess the devicte at the intended place of Sections 32.57, 32.58, 32.59, and 32.102 of 10 CFRcf use prior to its posession by the user, the Part 32 and Section 70.39 of 10 CFR Part 70 or theirreport shall include identification of each inter- equivalent.

mediate person by name, addtres, contact, and rela-tionship to the intended user. 470 39.M(136C) Manufacture eru! distributinn of

(5) Tne report shall be stemitted in within refloactive sistorial for medical tase mder generalthirty dayo after the end of aach calendat quarter in licornee. In addition to requitanente set forth in

which etch a devico is trarmferreo to the generally 39.30(136C) , a epeci fic license authorinnt) the

licensed person. distribution of radicactive mat 1 rial fer use by

rer uiciara uider the ceneesl license in 39.24(136C)(6) If no transfers hwe been made to tne U.S. r

Nuclear Regulatcry Conwnission licensees during the will he issued if treportinq period, this information shell oc reoorted

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39.39(1) The applicent C4mito evidenco that the c .. Hydrogen-3 (tritium) in mito not exceeding 5Cradioactive meterial is to be manufactured, labeled, microcuries each.and packaged in accordance dth a new drug applice- d. Iodine-125 in mite not exceeding 10 micro-tion sich the Commissioner of Food and Drugs, Food curies each.and Drug Administration, has approved, or in accord- e. hck lodine-125 in mite not exceeding 0.05ance with a license for a biologic product issued by microcurie of iodine-129 and 0.005 microcurie ofthe Secretary, U.S. thpartment of Health and Hunan americium-241 each.Services, and f. lodine-131 in units not exceeding 10 micro-

39.39(2) (he of the fb11owing statemente, as curies each.appropriate, or a edetentially similar statement g. Iron-59 in mite not exceeding 20 microcuriessich contains the infonestion called for in one of each.the follodng otstemente, appsere on the label h. Selenitmi-75 in units not aceeding 10 micro-cffixed to the container or appears in the leaflet or curies each.brochure sich accompanies the packages 39.40(3) Each propeckaged mit bears a durable,

clearly visible label

This radioactive drug may be received, s. Identifying the radioactive contente as topossessed and used only by physicians chemical fann and radionuclide, and indicating thatlicensed in the practice of medicine. Its the amount of radioactivity does not exceed:

.. receipt , posseselon, use and transfer are (1) 10 microcuries of iodine-125, lodine-131,adject to the regulations and a general carbon-14, cobalt-57, or selenium-75.license or its souivalent of the U5. (2) 50 microcuries of hydrogen-3 (tritium).Nuclear Regulatory Commission or of a state (3) 20 microcuries of iron-59, orwith dich the Cammission has entered into (4) hek Iodine-125 in mits not meeeding 0.05.

an agreement for the exercies of regulatory microcurie iodine-129 and 0.005 microcurie of,

authority. mericium-241 each, andb. Displaying the radiation caution sysbol

described in 40.9(3)"e"(1) and the aarde, " CAUTION,*

Name of manufacturer RADIO 4CTIVE HATERIAL,". and "Not for Internal or, , . External Use in haans or Animals." "

. OR 39.40(4) the of the following statements, se

appropriate, or a edetentially elmilar etetament- ., .. , ,

This radioactive drug may be received, / *ich containe -the information celled for in one ofpossessed and used .only by physicians the following stetments, appears on a label offixedlicensed to dispense droge in the practice to each propeckaged mit or appears in a leaflet orof medicine. Its receipt, posseselon, use brochure sich accampanies the packages -'

! and trenerer are s4 ject to the rules and a| general license or its equivalent of e .This radioactive meterial may be received,

licensing atste. acquired, . possessed and used only by physi-ciano, veterinarians, clinical laboratories.

i or hospitals and only for in vitro clinical

j Nune of manufacturer or laboratory tests not involving internelj or external administration of the seterial,

4539.40(1MC) huesfacture ad d etribution of or the radiation therefrom, to human beings;

| rediaasties estarial the aestein in vitse elinisei er or animale. Its receipt, acquisition, pos-

! lateratory tasting eder generet 15eamme. An appli- session, use ed trenefer are esject to

) cation fbr a specific . license to manufacture or the regulatione and a general license of

; distribute radioactive . meterial for use under 'the the U.S. belear Reguletory Commission ori general license of 39.25(136C) will be approved if t of a otete dth sich the Quamiselon hee! 39.40(1)- The applicant satisfies the general entered into an agreement for the exercise

requirments specified in 39.30(136C) . of regulatory authority.| 39.40(2) The radioactive meterial.is to be pre.[ pared for distribution in propeckaged mits of

e. Carbon-14 in unite not exceeding 10 micro- Name of manufacturer,

i curies each.| b. Cobalt-57 in unita not exceeding 10 micro- OR

j cutice each.

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' This radioactive meterial may be received, s@ ject to the Federal Food, Drug and Cosmetic Actacquired, possessed and used only by physi- and the Public Health Service Actsclans, veterinarians, clinical laboratories 39.42(3) The applicant s@mits information on theor hospitals and only for in vitro clinical radionuclide, chemical and physical fo rm , packagingor laboratory tests not involving internal including maximum activity por package, and shieldingor external administration of the material, provided by-the packaging of the radioactive materialor the radiation therefrom, to human beings sich is appropriate for safe handling and storaja ofor animals. Its receipt, acquisition, pos- radiopharriaceuticals by group licensees, andsession, use and transfer are s4 ject to 39.42(4) Labeling.the rules and a general license of a a. The label affixed to each package of thelicensing State. radiopharmaceutical contains information on the

radionuclide, quantity, and date of assay and ths:label affixed to each package, or the leaflet or bro-

None of manufacturer chure d ich accomponies each package, contair's astatement that the radiopharmaceutical is licensed by

39.40(5) The label affixed to the istit, or the the agency for distribution to peraune licensed pur-leaflet or brochure thich a companies the package, suant to 39.31(3) and 39.66(1%C) Group I, Group II,contains adequate information as to the precautions Crog IV and Group V of this chapter, as appropriate,to ba observed in handling and storing etch radio- or uide r equiv alent licenses of the U.S. Pbclearactive material. In the case of >bek Iodine-125 Regulatory Commission, en agreement state, or areference or calibration source, the info rmation licensing state.accompanying the source must also contain directions b. The labels, leaflets, or brochures required byto the licensee regarding the waste disposal require- 39.42(4)"a" are in addition to the labeling requiredments set out in 470--40.14(136C). by the Food and Drug Administration (FDA) and they

may be separate from or, with the approval of FDA,

479-39.41(136C) Licensjeup the manufacture and may be combined with the Inbeling required by FDA.dintribution of ice detection devices. An applica-

tion for a specific license to annufacture and 470-39.43(136C) Manufactwo and distribution of-distribute ice detectico devices to persons generally generators or reagent kits for greperation of radio-licensed mder 39.26(1%C) will be approved if t pharmaceuticals containirap radioactive unterial.

39.41(1) The applicant satisfies the general 39.43(1) Although the agency does rut regulat e,

requirements of 39.30(136C),and the manufacture and distribution of reagent kits that39.41(2) The criteria of Sectione 32.61, 32.62 do not contain radioactive noterial, it doesi regulate

and 32.103 of 10 CFR Part 32 are met. the use of such reagent kits for the preparation ofradiophannaceuticals containing radioective meterial

470.-39.42(136C) Enufactwo and dtstribution of as part of its licensing and regulation of the usersradiophemmeceuticale containing radioactive material of radioactive material.for medical use mder group licenses. 41 application 39.43(2) Any manufacturer of reagent kits that riofor a specific license to manufacture and distribute not contain radioactive meterial so dasites to he eradiopharmaceuticals containiraj material for use by his reagent kits approved by the agency for use bypersons licensed pursuant to 39.31(3) for the uses persons licensed pursuant to 39.31(3) and 39.66(1%C)listed in 39.66(136C) Croup I, Cro@ !!, Croup IV or Cro @ III may submit the pertinent information speci-Crcup V will be approved ifs fled in 39.43(1%C).

39.42(1) 1he applicmt satisfies the general 39.43(3) An application for a specific licmse to

requirements specified in 39.30(1%C). manufacture and distribute generaters or reagent kits39.42(2) The applicant osalta evidence that containing radioactive material for preparatiui ofa. The radiophargscoutical containirg radiorctive radiopharmaceuticals by persons licensed pwsuant to

noterial will be manufactured, labeled, and pxkaged 39.31(3) for the uses listed in 39.66(136C) Croup IIIin accordance with the Federsi rood, Drug and Cos- will be approved ifsmetic Act or the P@lic Health Service Act, such as o s. The applicant satisfies the general require.new drug application (NDA) approsed by the food and cents specified in 39.30(1%C).Drug Administration (FDA), or a "%tico of Claimed b. The applicant subtits evidence that:Investigational Cxamption for a Mew Drug" (IND) that (1) The generator or reagent kit is to be manu-has been accepted by the FDA, or factured, labeled and packagd in scardance =lth the

b. The manufacture and distribution of the radio. Federal Food, Drug and Cos,netic Act or the P211cpharmaceutical containing radioactive nterf al is not Health Service Ac t , such as New Or iq Applicatica

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(NOA) approved by the Food and Drug Adelni:tration meintcin its integrity mder stressee likely to be'(FDA), or a "Netice of Claimed Investigational Exemp- encomtered in normal use and accidente.

{ tion for a New Drug" (IND) that has been accepted by d. For devices containing radioactive meterial,the FDA, or the radiation profile of a prototype device.

(2) The manufactwo and distribution of the e. Oste 11e of quality control procedures to-

generators or reagent kits are not e4 ject to the assure that production sources and devices meet theFederal Food, Drug and Cosmetic Act and the P411c standerde of the design and prototype teste.

1 Health Service Act. f. Procedures and standards for calibratingc. The applicent osoite information on the sources and devices.

radionuclide, chemical and physical form, packaging g. Legend and methods for labeling sources andincluding moxieue activity per package, and shielding devices as to their radioactive content, and

i provided by the packaging of the radioactive meterial h. Instructione for handling and storing the' contained in the generator or reagent kit. source or device from the radiation safety etend-

d. The label . affixed to the generator or reagent point.,

1 kit contains information on the radionuclide, quanti- (1) These instructions are to be included on a*

ty, and date of assey, and durable label attached to the source or device or

: e. The label offixed to the generator or reagent attached to a permanent storage container for the i

kit, or the leaflet or brochure 41ch accoopenies the source or device.generator or reagent kit, containe s (2) Provided, that instructions sich are too'

(1) Adequate information, from a radiation _earety lengthy for such label may be summarized on the labelctandpoint, on the procedures to be followed and the and printed in detail on a brochwe chich to refer-,

equipment and enielding to be used in eluting the enced on the label.I| generator or processing radioactive meterial with the 39.44(3) The label affixed to the source or

| reagent kit, and device, or to the permanent storage container for the(2) A statement that this generator or reagent source or device, contains infonestion on the radio-

kit, as appropriste, is approved for use by persone nuclide, quantity, and date of assey, and a statementi licensed by the agency pursuant to 39.31(3) and that the none of source or device le licensed by the ,

I 39.66(136C) Group III or under equivalent licenses of agency for distribution to persono licensed pursuant*

t

| the ' U.S. Maclear Regulatory Ommoiesion an agressent to 39.31(3) and 39.66(1MC) Group VI or mder equive ' i

| ctate, or e licensing state. _ The labels, leaflete, lent 11ceness of the U.S. Nuclear Regulatory Commis-i se brochwee required by 39.43(1MC) are in addition sion, en a;teament state, or a licensing state,I to the labeling required by the Food and Drug Admini- provided that such labeling for sources which do not j

-

; etration (fDA) and they may be esperate from or, with require long term storage may be on a leaflet ori the approval of FDA, may be combined with the label- brochure which accompanies the source. I'

ing required by FDA. 39.44(4) In the event the applicant desires thet! the source or device be required to be tested for

470-39.44(136C) Neusfastwo ad distribution er leakage of radioactive meterial at intervale longer( omwees er devices containing radioactive estorial then six annthe, the applicent shall include in the

for undical use. An application for e specific application sufficient information to demonetteteIlicense to manu fact ure and distribute sources and that such longer interval is justified by performance

devices containing radioactive seterial to persone cherectoristice of the source or device or similar [licensed pursuant to 39.31(3) for use as a calibre- sources or devices and by design features that have otion or reference source or for the uses listed in significant bearing on the probability or conee- !39.66(1MC) Group VI will be approved ifs qmnces of leakage of radioactive meterial from the |

39.44(1) The applicant satisfies the general source, andrequiremente in 39.30(1%C). 39.44(5) In determining the acceptable interval l

39.44(2) The applicant osoite sufficient infor- for test of leakage of radioactive meterial, themotion regarding each type of source or device porti- agency will consider information that includes but is j

nont to en evaluation of its radiation esfety includ- not limited toings a. Primary containment or source capsuls.

,

!s. The radioactive esterial contained, its chemi- b. Protection of primary containment.col and physical form, and enount. c. Method of seeling containment.

b. Detalle of desigi and construction of the d. Containment construction meteriale. p

oource or device. e. Form of contained radioactive meterial.i

c. Procedures for, and reeutte o f, prototype f. Minimus temperature withstood during prototypeteste to demonstrate that the source or device will teste.

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g. %ximum pressure withstood & ring prototype b. tabel or merk each mit toetests. (1) Identify the manufacturer of the product or

h. Maximun quantity of contained radioactive device and the number of the license mder $1ch thematerial. product or device was manufactured, the fact that the

1. Radiotoxicity of contained radioactive mater- product or device containe depleted wenium, and theial, and quantity of . depleted uranium in each product or

J. (berating experience with identical sources or device, anddevices or similarly designed and constructed sources (2) State that the receipt, possession, me andor devices. trenefer of the product or device are seject to a

general license or the equivalent and the regulations470-39.45(136C) Requirmente for license to manufac- of the U.S. % clear Regulatory (banission or antwo ed distribute inhetriet prodmete containing agreement state.depleted uranium for asso-volumn applications. c. Auswa that the depleted uranium before being

39.45(1) An application for a specific license to installed in each pro &ct or device has been fm-manufacture industrial products and devices contain- pressed with the following legend clearly legibleing depleted uranium for use pwsuant to 39.16(1%C) through any platirq or other covering: " Depletedor equivalent regulations of the U.S. Nuclear Regula- Uranlue".tory Commission or an ajreement state will be d. Furnish a copy of the general license con-approved ift tained ins_

a. The applicant satisfies the general require- (1) Rule 39.16(1%C) and a copy of Agency formments specified in 39.30(1%C). SHD-2.0-791 to each person to whom he transfers

b. The applicant s4mits sufficient infonsation depleted uranium in a product or device for userelating to the design, manufacture, prototype test- pursuant to the general license contained in

- ing, quality control procedures, labeling or merking, 39.16(1%C), or- proposed uses, and potential hazards of the indus- (2) The U.S. Nuclear Regulatory Commission's or, trial product or device to provide reasonable assur- agreenent state's regulations equivalent to 39.16, ence that possession, use or transfer of the depleted (136C) and a copy of the U.S. . Nuclear Regulatory

urenlum in the product or device is not likely to Commission's or ajreenent state's certificate, orcause any individual to receive in any period of one alternatively, furnish a copy of the general licensecalender quarter a radiation dose in excess of ten contained in 39.16(1%C) and a copy of Agency Fonepercert of the limits specified in 40 2(1)"a," and SHD-2.0-791 to each person to whom depleted uranian

c. The applicant osoits sufficient information is transferred in a product or device for use pur-regarding the industrial product ur device and the suant to the general license of the U.S/ Nmlestpresence of depleted uranium for a mees-volume appli- Regulatory Commission or en agreement state, with acation in the product or device to provide reasonable note explaining that use of the product or device icsseurance that mique benefits wl11 accrue to the regulated by the U.S. Wclear Regulatory Commiselonpublic because of the usefulness of the product or or an agreement state under requirements subston-device. tielly the sane as those in 39.16(1%C).

39.45(2) In the case of an industrial product or o. Report to the egency all transfers of indus-device *ose miqta, benefits are g;estion21e, the trial products or devices to persons for use mderagency will approve an appliention for a specific the general license in 39.16(136C).license mder 39.45(136C) only if the produc t or (1) Such report shell identify:device is found to combine a high degree of utility 1. Each general licensee by name and address.and low grobability of econtrolled disposal and 2. An individual by name or position to anydispersal of significant quantities of depleted constitute a point of contact betiean the agency anduranitse into the environnent. the general licensee.

39.45(3) The agency may deny any application for 3. The type and model nuser of device trans-a specific license mde r 39.45(136C) if the end ferred, and the qsentity of depleted uranius con-use(s) of the industrial product or device cannot be tained in the product or device.reason 6bly foreseen. (2) The tecntt shttil be ssheitted within thirty

39.45(4) Eacn persen licensed pureuunt to days after the end of each calendar quarter in *!ch39.45(1) sh411: etch a product or device is transferred to the gener-

e. Heintain the level of quality control required ally licensed person.by the licenes in the manufacture of the industrist (3) If no transfers hee been cade to personsproduct or device, and in the installation of the generally licensed urder 39.16(136C) during thedepleted uranius intu the product or device. reportirg period, the report shall so indicate.

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f. Report'to the U.S. tct:er Regulat2ry CommiG- requiremento and conditione 4th respect to tho'sion c11 transf;ra cf industri:1 producto or devices licensee'o rec:1pt, possession, use and tran f;r of

to persone for use mder the U.S. Wclear Regulatory radioactive seterial e4 ject to this chapter as itCommission general 11 cones in Section 40.25 of 10 CFR deems appropriate or necessary in order to:Port 40. a. Mnimize danger to p411c health and safety or

g. Report to the responelble state egency all property. ,

t rans fers of devices manufactured and distributed b. Require swh repo rts and leeping of etchpursuant to 39.45(136C) for use under a general records, and to provide for such inspections oflicense in that state's rules equivalent to activities mder the license as may be appropriate or39.16(136C). necessary, and

Ih. Such report shall identify: c. Prevent Ices or theft of meterial s4 ject to(1) Each general licensee by name and address. this chapter.(2) An individual by noe or position so may

,

constitute a point of contact between the Agency and 4539.4S(136C) Specific tems ad canditions ofthe general licensee. 11 cones

(3) The type and nodel msnber of the device 39.48(1) Each license issued pw suant to thistransferred, and Diepter shall be subject to all the provisione of the

(4) The quantity of depleted uranlue contained in Act, now or hereaf ter in effect, and to all rules and

the product or device. orders of the agency.i. The report shall be semitted within thirty 39.48(2) % license issued or granted mder this,

d:ys after the end of each calendar quarter in' which chapter and no right to possees or utilian radio-

cuch product or device is tansferred to the generally active meterial granted by any license issued pw-licensed person. suant to this chapter shall be transferred, assigned,

J. If no transfers have been made to the U.S. or in any menner disposed of, either voluntarily o'r% clear Regulatory Coninission licensee during the involuntarily, directly or indirectly, through trans-reporting' period, this information shall be reported for of control of any license to arty person mlesst3 the U.S. % clear Regulatory Commission, and the agency shall, after escuring full information

k. If no transfers have been modo to the general find that the trans fer is in accordance dth thelicensees within a particular agreement stato during provisions of the Act, and shall give its consent in' -

the reporting period, this information shall be writing .reported to the responsible agreement state agency 39.48(3) Each person licensed by the agency pur-um n the request of that ajency, and suent to this chapter shall confine use md poses.

1. Keep recorde showing tNr nane, addrene and sion of the meterial licensed to the locations andpoint of contact for each general licenses to thom purposes authorized in the license. /depleted uraniun is transferred in industrial pro. 39.48(4) Each licensee shall notify the agency inducts or devices for use pw ouent to the general witing den the licenses decides to permanently dis-license provided in 39.16(136C) or equivalent regule- continue all activities involving materials author.

tions of the U.S. heleer Regulatory Commission or en irod mder the license.agreement state. The recorda shall be maintained foro period of two years and shall show the date of each 470-39.49(136C) Empiration of Licenses. Except as

t rars fe r , the quantity of depleted wenium in each prov ided in 39.50(2), each specific license shallproduct or device trarisferred, and compliance with expire at the end of the specified day in the monththe report requirements of thle rule. and year strated herein.

4 5 39.46 heorved. 475-39.50(136C) Amneum1 of licensee.39.50(1) Applications for renewal of specific

470-39.47(136C) Issuance of specific Licensee. licenses shall be flied in accordance with39.47(1) Umn a determinetton that an application 39.29(136C) .

meets the requirements of the Act and rules of the 39.50(2) In any case in inich a licenses, not

agency, the agency will leem a specific license less then thirty &ys grior to espiration of theauthorizing the proposed activity in such form and licensee's existing license, has filed an applicationcontainity sich conditions ar:1 11eitations as it in proper fo rm for renewal or for a new licensedeems appropriate or necessary. authorizing the same ac tivities, such existing

39.47(2) The ' agency may incorporate in any license shall not espite mtil final action by thelicense at the time of inuance , or thereafter by agency.appr opriat e tule, tules, or order, such afditional

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To any pers'on suompt fran the rules to the4hM.51(136C) Amenhent of Licensee at regtmet of c.

licensee. Applications for amendment of a license extent pernitted taider sich exemption.ehall be flied in accordence with 39.29(136C) and d. To any person aJthorized to receive etchshall specify the respects in W11ch the licensee material under tarse of a general license or itsdesires the license to be amended and the grounds for equiv alent , or a specific license or equiv alent

such amendment. licensing dcctament, issued by the agency, the U.S.Nuclear Regulatory Commission, any ajreement state or

4hM.52(136C) Agoney action an applications to any licensing stats or to ariy person otherwisetense and amend. In considering an application by e authorized to receive auch material by the federal

licenses to renew or snend the license, tho /gency gavernment or any agency thereof, the agency , anwill apply the criteria set forth in 39.30(136C) to agressent state or a licensing state. Or39.44(136C), or 39.45(136C) as applicable. e. As otherwise authorized by the agency in

writing.4 h 39.53(136C) Persone posseeming a license fbr 39.55(3) Before transferrirv; radioactive materialsource, trypro&ct , or speelal reeleer enterial in to a specific licensee of the agency, the U.S.quantittee runt sufficient to form a critical ases on % clear Regulatory Commission, an agreasent state orcffective date of these rules. Any person dio, on a licensing state, or to e general licensee dio is

the effective date of these rules, passesses a gener- required to register with the agency, the U.S.c1 or specific license for source, byproduc t , or Nuclear Regulatory Consission, an egreement state orspecial nuclear material in quantities not sufficient a licensing state prior to receipt of the radioactiveto form a critical mass, issued by the U.S. Nuclear material, the licensee trr.nsferring the meterialRegulatory Cammission, shall be deamed to possess a shall verify that the transferee's license authorizesline license issued under this chapter and the Act, the receipt of the type, form, and quantity of reJio-such license to expire either ninety days after active meterial to be transfstred.feceipt from the agency of a notice of expiration of 39.55(4) Any of the following methode for theetch license, or on the date of expiration specified verification required by 39.55(3) is acceptable sin the U.S. Nuclear Regulatory Comeleolon license, s. The transferer osy possess and read a currentditchever is earlier. copy of the transferse's specific license or regis-

tration certificute.

4 5 39.54(136C) FWrseno ra-isig naturally occur- b. The tronofsror euy poness a written certifi-rirug arid accolarstar-pro &ced radioective esterial on estion by the trarmferee that the tr neferee u

effective ete of these rulee. Any person dio, on authorized by licerme or registration certificate tothe effective date of these rules, possesses NAfN for receive the typo, forts, and quantity of radienctivewhich a specific licenae is required by the Act or material to be transferred, specifying the license orthis chepter shall be & amed to p)esess etc h a registration certificato ntsaber, issuing ejency, andlicense issued under the Act and this chapter. Such expiration date.

license shall espire ninety days efter the effective c. For emergency shipesnts, the transferor sm.ydate of these rules; provided, howeve r , that if accept otal certification by the trarsferes that the

cithin ninety days the person pinsessiru; sich eister- tr ans feree is authorized by licerme or registrationist files wt appliction in proper form for a license, r.ortirirate to receive the type, fctm and quantity ofcuch existing licenne shall not espire tritil the radioactivs ,mterial to be trene fer r ed , speci fyltv;applicatinn hee been finally determined by the the licenes or registration certificate numbst, issu-agency. ing w;ency, and espiration date; provided that the

oral rectification 1, confirmed in eriting within ten4h39.55(136C) Transfer of esteriet. days.

37.55(1) b licermee shall trennfer radioactive d. ihe transferer may obtain other informationmeterial except es authorized pursuont to crenplied by a reportirv; service from official records39.55(136C). of the agency, the U.S. Mclear Kegulotory Cxels-

39.55(2) Execpt as otherwise provided in the elon, an agreement state, or e licensing state! lirense and e'kyect to the provisions of 39.55(3) and tegording the identity of licenaces and the ecope and

39.55(4), any licoasse may trwisfer redlenettve empiration daten of licensen snd registration.catorial e. %n none of the aathods of wri ficat ion

4. To the oggncy. A licensee eey transfer motor- h acribed in 11.55(4), paragtnr s "a" to "d* areetal to the m;ency only after receivire; prior approval readily avalla.b l.s or then a tesc.ofsror estre9 to

fion thn againcy. veri'y that in formation receised tv one of eithh. To the U.S. r partment of Energy. wt>vich is correct or up to diete, tha transfernt nye

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- _ . _ _ _ _ _ _ _ _ _ . - , _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _

. .

ettcin and recard confissation from the agency, tao c. Th3 licensing &cument dose not limit the| U.S. Itaclear Reguletory Commiselon, or an agreement activity authorimod by such document to specified

state, or a licensing state that the transferee is installations or locatiore.,

'

} licensed to receive the radioactive meterial. b. The out-of etete liconese notifies the agency| 39.S$(S) Siipoont ed trenoport of radioactive in wikirq et least three doye prior to engaging in; esterial shall be in accordance dth the previolone such estivity.| sf . 39.59(136C) . (1) Such notification shall indicate the loco-

tion, period, sul type of proposed poseseolon and use 1

| 4&M.56(13dC) Man finetism, sesenetion, ed dthin the state, and shall be accapenied by a copy :I tennimetten of liessess. of the pertinent licensing document.i 39.56(1) The tesse and conditions of all liconese (2) If, for a epocific case, the three day period |

'

|- shell be adject to amendment, revielen er modifice- umuld lepees an undue herdship on the out-of-etatej tien er the license any be suspended or revoked by licensee, the licensee moy, upon application to the ji reeman of econdsente to the Act, or by reseen of agency, obtain permiselon to proceed sooner.

'

! rulee and ordere leeued by the egency. (3) The agency any wive the requirseent fbt '

d 39.56(2) Any license soy be revoked, - - C or filing additional written notifications during the-

modified, in sole or in part because of t emeinder of the calender yearfo11owing the receipt! e. Any meterial falso statement in the applice- of the initiet notification from a person engaging ini tion or any statment of fact required eder provi- activites eder the general license provided in| elone of the Act, or 39.57(1).4 b. Conditione revealed by such application or c. The out-of-state liconees complice dth all

! ctatement of fact or any report, record, or inspec- applicable rules of the agency and with all the terme! tion or other meets sich muld arrant the agency to and conditions of the licensing document, eucopt any| refuse to grant a licones on an original application, such torno and conditiene dich may be inceneistent

ce dth applicable rulee of the egency.'

c.. . Violation of, or failure to observe any of the d. The out-of-etate licensee supplies seah other,

tesse and conditions of the Act, or of the license, information se the agency any requeet, andor of any rule or order of the egency. e. The out of-state licensee shall not trenefer*

39.56(3) Encept in cases of 411 fulness or those or dispose of radioactive estorial posseeeed or usedin sich the pelic health, interest or eefety under the general license provided in 39.57(1) escept,

! requires othetwice, no license shell be edified, by trenefer to e person

| _ euepended, or revoked unlees, prior to the institu s (1) Speelfically licensed by the egeney or byi tien of proceedings therefor, femte or conduct sich another liceveing state to receive such seterial, or

( eey untrent such action shall have been celled to the (2) Emespt fra the requiremonte for ,p license.

| . ettention of the licermee in witing and the licensee for such esteriet isider 39 3(7). -.

! shell have been accorded an oppnetunity to demon- 39.57(2) festetthetending the provielene ofi ctrote or achieve camp 11ance with all lawful require- N.57(1), any person do holde a epocific 11 conesi sente. Leeund by the U.S. Inselear Regulatory Consiooien er"

! 39.56(4) The agency any teseinete e epocific en agressent state authorising the holder to manufac.license upon request odeitted by the liconess to the ture, transfer, install, or ' service a device de-4

apney in witing. scribed in 39.20(1) dthin areas e4 ject to the

j jurisdiction of the licensing body is hereby granted; 4&N.57(138C) Assipreset seampitlen liessess of a generel 11eenee to inntall, teonefere demonstrete e

j hygeodust, someo, and speaket seelser asterlat in or service such device in this state provided thatI; apostitime not soffielent to them e eritient same. e. Such person shall file e report dth the! 39.57(1) Seject to these rulee, eiy person so agency dthin thirty days efter the end of earh

holde e specific license free the U.S.16selear Regu- calender quarter in mich any device is treneferred1stery Osmeiselon er en agressent state, sul issued to or installed in this state. Carh eueh reportby the egency having jurisdiction dere the liconees shell identify each genere! liconese ta see siahmaintains an offlee for directing the licensed activ. device le treneferred by nose and addrese, the typeity and at sich radiation oefety recorde are note- of device treneferred, and the synntity and type ofc11y meintained, le hereby granted a generet license radioactive motorial contained in the device.to conduct the activities authorized in such 11cene- b. The device has been manufactured, leheled,

,

j . ing deciment dthin this etete fbr a period not in installed mid serviced in accordance with applieshle

! encoes of ore hundred eighty doye in any calender provisions of the opselfic license leeued to such| yees provided that person by the U.S. ecleer Regulatory Commission or

! -m-'

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en agreement stato,applicable rules of the agency and with all the ter

c. Such person ohell assure that any labels and conditione of the liconalng document, except an,required to be offixed to the device mder rules of such terme and conditions thich ney be inconsistent '

the authority dich licensed manufacture of the with applicable rulee of the egency.device t'eer a statement that " Removal of thie label d. The out-of-state licensee supplice etch otherle prohibited," and

information se the egency may request, andd. The telder of the epocific license shall e. The out-of-state licensee shall not transferfurnish to each general liconese to than such specif- or dispose of radioactive meterial possessed or used

ic licenses trenefere such device or on those pre- mder the general license provided in 39.58(1) exceptmisee the liconeee installe such device a copy of the by trenefer to a personsgeneral license contained in 39.20(136C) or in equiv- (1) Specifically licensed by the egency or bysient rules of the egency having jurisdiction over auther licensing state to receive such material, orthe manufacture and distribution of the device. (2) Exempt free the requiremente for e license

39.57(3) The agency may withdrew, limit, or for such meterial under 39.3(136C).qualify its acceptance of any specific license or 39.58(2) 4twithetending the provielone ofequivalent licensing document issued by t' a U.S. 39.58(1), any person who holde e specific license% clear Regulatory Quemiselon or en a;reasent state, issued by a licorning state authorizing the holder to

. or any product distributed pureumit to such licensing eenufacture, trenefer, install, or service e devicedocument, upon detensining that such action is_neces- desc ribed in 39.20(1) within etees etbject to theeery in order to prevent undue herard to public jurisdiction of the licensing body le hereby grantedhealth and eefety or property. a general license to install, transfer, demonstrate

or service auch a device in this state provided thet475-39.5e(136C) helpreent recopiltlan of 11cessee i

e. Such person shall file e report with theof nekurelly emeerring ad seeelerster-peedieed agency within thirty doye after the erut of eachradioactive seteriet. '

calender giarter in inich any device is transferred-

39.58(1) Stbject to these rulee, any person so to or instelled in this state. Each such repo rt'

holde a specific license from a licensing state, and shall identify:instad by the egency having jurlediction there the (1) Each general licermee to *as sich device tulicensee maintelne en office for directing the treneferred by name and address.licensed activity eruf et thich radiation safety (2)' The type of device transferred, andrecorde are normally esintained, is hereby granted e (3) The quantity and type of radioactive materint-

general license to conduct the activities authorized contained in the device.-

in such licensing document within this state for a b. The device has been manufactured, / abeled,lperiod not in encoes of one bedred eighty days in installed, and serviced in accordance with applicableany calender year provided thatt provisians of the specific licones issued to etch

e. The 11cerning document see not limit the person by a licensing state.ectivity authorized by etch document to specified c. Such person shall soeure that any leheleinstallations or locations. required to be effixed to the device mder rules of

b. The out-of-state licensee notiflee the agency the authority Alch licensed manufacture of thein writirv; et least three days prior to engaging in device beer e stetment that " Removal of thle tenetsuch activity. le prohibited," and

(1) Sur.h nutification she11 indicate the loca- d. The holder of the specific license shall furn- i

tion, period, and type of proNeed posseselon and use ich to each general 11conoce to *ue the holder i

within the state, and shell be occampenied by a copy trenerere such device or on those prestees the holdercf the pertinent licensing &ctaient. Installe such device a cooy of the general 11:enne

(2) If, for a specific case, the three day period contained in 39.20(1) or in equivalent rules of the,

)would immes en mdue herdship on the out of-etste agency having jurisdiction over the manufacture aidliceewee, the licermee soy, iguan application to the distribution of the device.

3

i egency, obtain permiselon to proceed e>oner. 39.58(3) The egency any withdrew, limit, or qual-i

l (3) The egency any waive the requitraent for ify its acceptance of any specific license or equi.fillry additional written notifications during the valent licensing document issued by a licensingremainder of the celeruler year fn11owing the receipt state, or any groduct diotributed pursuant to su:hof the initial notification from a person enge;ing in licensing document, upon deteretning that such action

r act ivities mdes the epneral license grovided in le necessary in order to grevent mdue heterd to39.56(1). public hostth and eefety or property.c. The out-of-state licensee empline with all 470-39.59 to 470-39.71 keenved.

1

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e .

475 E7t(136C) Eesmpt eensentretiano , 470-E72(136C) Esempt consentreklass (Cont.) *

Column 11 Column IIColumn Liquid Column Liquid

! and Solid I and SolidGee con. concen- Gee con- concen.,

Element (stonic centration tretion Element (stomic centration tretion

number) teotope uC1/s1 uC1/m1 number) lootope uC1/m1 uC1/m1

Copper (29) Co-64 3x10-3Antimony (51) 2-122 3:1042-124 2x10 4Sb-125 1x10-3 Oysprosium (66) Dy-165 4x10-3

Oy-166 4x10-4Argon (18) Ar 37 1 10-3

Ar-41 4=10-7 Crbium (68) Er-169 9u10-4Er-171 1x10-3

Arsenic (33) As-73 5x10-3As-74 5x10-4 Europlun (63) Eu-152 (9.2h) 6x10-4An-76 '2x10-4 Eu-155 2x10-3As-77 6:10-4

Fluorine (9) F-18 2x 10-6 8:10 3Berlus (56) Be-131 2x10-3

8s-140 h 10-4 Gadolinium (64) Cd-153 2x10-1Cd-159 8x10-4

Berylitus (4) Be-7 2x10-2

Collium (31) Co-72 4x10-4Bismuth (83) 81-206 4:10-4

Cermenius (32) Co.71 2x10-2 , ,

Oromine (35) Br-82 410-7 h10-3Gold (79) Au-196 2x10-3

Cednius(48) Cd-109 2x10-3 Au-198 5:10-4,

Cd-115e 3:10-4 Au-1?9 2x10-3Cd-115 h10 4 /

Hefnita (72) Hf 181 7x10-4Calcium (20) Co-45 9x10-3

Co-47 5:10-4 Hydrogen (1) H-3 5x10-6 3:10-2

Carbon (6) C-14 1:10-6 8x10-3 Indlue (49) In-113m 1:10-2In-tite 2x10 4

Cerium (58) Ce-141 9x10-4Co-143 4:10-4 lodine (53) 1-126 h10 9 2:10*3Co-144 1510-4 1 131 3:10-7 2:10-5

! 132 0=10-8 6104Ceetta (55) Ca 131 2x10-2 1 133 1:104 7:10-5

Co-134m 6:10-2 1-134 2 10-3 1x10-3Cs-134 9x10-5

Iridium (77) Ir-190 2x 10-3

Dilorine (17) C1-38 9:10-7 4 10-3 tr-192 4:10-4tr-194 3:10-4

| Diroielun (24) Cr-51 2:10-3tron (26) Fe-55 8410-3

Cnbelt (27) Co-57 5:10-3 Fe-59 6410-4Co-58 1:10-3Co-60 5:10-4 Krypton (36) Kr-85m 1:10-6

Kr 85 h 10-6

l

-M.

|;

. - ..~

- w -- - . . . .. .+-.n... ..

. o

N

' 475 39.7t(13dC) Emanpteeneantraliano(Cont.) 475 39.72(136C) Eseapt eeneentretiene (Cont.)

Column !! Column !IColumn Liquid Coltan Liquid

I and Solid I and SolidGee con- concen- Ces con- concen-,

Gement (stonic contration tretion Doesnt (stonic centration tretionnumber) Isotope uC1/e1 uC1/mi number) lootope uC1/e1 uti/mi

4Lenthenue (57) Le-140 2x10 Promethits (61) Pe-147 2x10-3Pm-149 4x10-4

Lead (82) Pb-203 4x10-3menism (75) Re-183 6:10-3

Lutetius (71) Lu-177 1 10-3 Re-186 9:10-4Re-188 6:10-4

Mengenese (25) *-52 3:10-4*-54 1 10-3 modius (45) Rh-103m 1x10-1*-56 1x10-3 Rh-105 1x10-3

Nrcury (80) Hg-197e 2x10-3 Rteidita (37) %-86 7x10-4Hg-197 3:10-3

Ruthenita (44) Ru-97 4x100Hg-203 2x104b-103 84104

21ybdenue (42) Mo-99 2x10-3 Ru-105 1:10-3b-106 1:10 4

Noodyalue (60) Nd-147 6 10-4*

W -149 3:10-3 Sauerita (52) Se-153 8:10-4

Nichel (28) N1-65 1A10-3 Scandius (21) $c.44 4:10-4#Sc-47 9 10

Niobita (41) 2 -95 1x10-3 $c-48 3 104(Coltabius) i

%-97 9 10-3 Selenius (34) Se.75 3:10-3

Damita (76) Oo-185 7410-4 Silicon (14) 51-31 9:10-3Os-191e 3:10-3De-191 2 10-3 Silver (47) Ag-105 1 10-3

4De-193 6:10-4 Ag-110e 3510Aq-111 4x10 8

Pelledius (46) Pd-103 3:10*3Pd-109 9:10-4 Sodita (11) Ne-24 2x10-3

Phospierus (15) P-32 2x10 4 $trontius (38) $r-85 1:10*3$r-89 1x10 4

Platintse(78) Pt-191 1 10-3 St-91 7m10-4

P1-193e 1u10-2 Gr-92 7 10-4Pt-197a 1:10-2Pt-197 in10-3 Sulfur (16) 5-35 9:17-8 6510-4

Puteesita (19) K-42 3:10-3 Tentelus (73) Te-182 4:10-4

Presmodynita (59) Pr-142 3 10-4 factuietius (43) fc 96m 1:10-1Pr-141 5:10 4 fc-v6 in10"I

- 31 -_ - _ _ - _ _ - _ _ _ _ .

r~o

a .

415-19.7t(136C) Esempt eeneentestiene (Cont.) 4539272(136C) Esempt concentrations (Cont.)'

Column !! Column !!Column Liquid Column Liquid

I and Solid 1 and SolidCes con- concen- Ces con- concen.

Element (stonic contration tretion Elonent (atomic centration tretionnumber) lootope uC1/e1 uC1/ml number) !aotope uti/ml uC1/m1

T;11urius (52) Te-125m 2x10-3 Sete- and/or geese.Te-127m 6104 unitting radioactiveTe-127 3:10-3 meterisi not listedTe-129m 3:10 4 dove with a half-fe-131m 6x104 life of less then 3fe-132 3:10-4 years 4x10-10 j,j g-6

T rbiun (65) Tb-160 4x10 4 %te 1: *ny radioisotopes transform into

isotopes which are also radioactive. In expressingThallius (81)' T1-200 4:10-3 the concentrations in 39.64(136C), the activity

T1-201 3:10-3 stated is that of the perent lectopo and tales into11-202 1:10-3 account the daughters.T1-204 1x10-3 %te 2: For purposes of 39.3(7), dere there le .e

combinetton of tentopes involved, the limit for the 'Thu11ue (69) Im-170 Sx10-4 combination should be derived as follows:

Te-171 Sul0-3 Determine for ear:h teotope in the product theratio betoon the radioactivity concentration present

fin (50) $n-113 9 10-4 in the product and the ezenpt radioactivitySn-125 2:10-4 concentration established in 39.64(136C) for the

*

epocific isotope een not in cambination. The sua ofTungsten (74) W-181 4:10-3 su:h ratios may not onceed "1" (i.e., witty).

(*1frum) .,

W-187 7:10-4 Emanples/

Venelium (23) Y-48 3:10 4 Concentration of footope 4 in Product*

Esempt concentration of tootope AXenon ($4) Xe-131m 4:10-4

Xe-133 3:10-6 Concentration of footope B in Product _

Xe-135 1:10-4 Esempt concentration of Isotope 8 -

Ytterblue (70) 4-17) 1:10 3 hte 3 Yalues are given in Column I only forthcee motoriale norselly used me gases.

Yttrium (39) Y-90 2 10-4 *te 4: Concentration values in Chlumn !! ehallY-91e 3:10-2 be unpressed as uC1/g for solide.

Y-91 3:10-4Y-92 6:10-4Y-93 3:10*4

Zine (30) Zn-65 1:10-3Zn-69m 7:10-4Zn49 2x10-3

Zirconius (40) Zr-99 6:10-4Zr-97 2104

- 32 -

_ - _ _ _ _ - _ _ . . _ _ _ _ _ _. __ _______ -_ - ____________ .- - ,_ - _ - ---

.

_

~.

'. a

.

4&39.7)(13eC) Exempt gsentitles. ' 4539.7)(136C) Esempt spentitles (Cont.)

Radioactive Mic ro- Radioactive Mic ro-Meterial curies Meterial curies

Mtimony-122 (Sb 122) 100 Gerosilta-71 (Ge 71) 100Antimony-124 ($b 124) 10 Gold-195 (Au 195) 10Antimony-125 ($b 125) 10 Gold-198 ( Au 198) 100Arsenic-73 (As 73) 100 Gold-199 (Au 199) 100Arsenic-74 ( As 74) 10 Nfnitse-181 (Hf 181) 10C oonic-76 (As 76) 10 blotta-164 (No 166) 100Ateenic-77 ( As 77) 100 Hydrogen.) (H 3) 1,000Berlue-131 (8e 131) to Indita-111 (!n 111) 1008erita-133(Be133) 10 Indita-113e (In 113e) 100Berita-140 (8e 140) 10 Indita-114e (In 114=) 10Cemuth-210 (81210) 1 Inditm-115e (In 115m) 100Bromine-82(8r82) 10 Indita-115 (in 115) 10Cadelta-109 (Cd 109) 10 todine-123 (! 123) ICOCadmius-115e (Cd 115m) 10 todine-125 (! 125) 1

~

Caseita-115 (Cd 115) 100 todine-126 (I 126) 1

Calcita-45 (Ce 45) 10 todine-129 (! 129) 0.1Calcita-47 (Ce 47) 10 todine-131(!131) 1

Carbon-14 (C 14) 100 fodine-132 (1 132) 10Ceritm-141 (ce 141) 100 lodine-133 (1 133) 1

Certtm-143 (Ce 143) 100 todine-134 (1 134) 10Carita-144 (Ce 144) 1 todine-135 (1 135) 10Ceetim-129 (Co 129) 100 ftidius 192 (ft 192) 10Cesita-131 (Ce 131) 1,000 tridita-194 (!r 194) 100Costin-13em (Ce 134m) 100 tron-$2 (Fe $2) toCasita-134 (ca 134) 1 fron-SS(Fe$$) 100Cesita-135 (Ce 135) 10 tron-59 (Fe 59) 10Cselta-136 (Ce 136) 10 Krypton-85(Kr85) / 100Casium-IJ7 (Ce 117) 10 Krypton-87 (Kr 87) 10Dilorine-36 (C136) 10 Lenthanus 140 (Le 140) 10Clorine-38 (C13A) 10 Lutetita-177 (Lu 177) 100Chromium-51 (Cr $1) 1,000 kngenese-52 (Mn $2) 19Cobalt-S7 (Co $7) 100 engenese-54 ('ti 54) 10Cobalt-She (Co $8's) 10 hogenese-56 Mi (.56) 10Cobglt-$8 (Co 58) to *rcury-197m (N 197=) 1C0Cobelt A0 (Co 60) 1 Mercury-197 (Hg 197) 100Copper-64 (Cu 64) 100 Wrcury-203 (Hg 201) 10Dyeproeita-165 (Dy 165) 10 51ybdenta-99 (N 99) 100Dysproetta-166 (Dy 166) 100 bodyeius-147 (Nd 147) 100Erbita-169 (Er 169) 100 Needpolta-149 (f6f 149) 100frblue-171 (Er 171) 100 Nicket-59 (Ni $9) 100Curopita-152 (fu 152) 9.2h 100 Nickel-43 (N161) 10[u opita 152 ([u 152) 13 yr 1 Nickel-65 (Ni 65) 100furopita-154 (tu 134) 1 Niohtue-9h (Nb 93m) 10furopitan-135 (fu 155) to 41oh!6m 95 (* 95) 10Flterine 18 (F 16) 1,C00 Niobita-97 (% 97) 10Cerfolinium-153 (Cd 153) 10 Ouelue-185 (De 185) 10Calottnita-159 (Cf 157) 100 Oselue-19te (01 191e) 100C 111ue-47 (Ce 67) 100 Omitm-191 (Cs 191) 100Celtlim-72 (Ge 72) 10 Oweitn 19) (Os 191) 100Careenius-48 (Ce AD) 10 Palladita-103 ($'d 103) 100

- )) .. _ - _ _ _

_ - _ _ _ _ _ - _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _. . _ _ _. .,

. .

*

4751927)(13ec) (sempt gematittee (Cont.) 453937)(13ec) Esempt gentities (Cont.) ~

Radioactive Micro- Radioactive Mic ro.%nterial curies 4terial curies

Palladium-109 (Pd 109) 100 Tellurium-12hm(fe127m) 10Phosphorue-32 (P 32) 10 Tellurium-127 (Te 127) 100Platinta-191 (Pt 191) 100 fe11wita-129n (Te 129m) 10

Pietinum-193m (Pt 193m) 100 fe11urium-129 (Te 129) 100

Plotinta-193 (Pt 193) 100 fe11urium-131e (Te 131a) 10

Pietinun-197m (Pt 197e) 100 fe11urium-132 (Te 132) 10

Platinta-197 (Pt 197) 100 Terbits.160 (Tb 160) 10

Polonium-210 (Po 210) 0.1 Tha111un-200 (il 200) 100

Potesolun-42 (K 42) 10 Thellium-201 (il 201) 100

Poteesita-43 (K 43) 10 The111ta-202 (il 202) 100Preseodymium-142 (Pr 142) 100 Thallium-204 (il 204) 10Preevodynium-143 (Pr 143) 100 Thulium-170 (ie 170) 10

Promethita-147 (Pm 147) 10 Thulium-171 (Te 171) 10

Promethium-149 (Pm 149) 10 fin-113 ($n 113) 10

menlun-186 (Re 186) ~100 fin-125 (Sn 125) 10

monita-188 (Re 188) 100 ftmgeten-181 (W 181) 10

medium-103m (* 103e) 100 fungston-185 (W 185) 10

modita-105 (Rh 105) 100 ftmgeten-107 (W 127) 100'R41 dita-81 (4 81) 10 Venedius48 (V 48) 10

bbidium 86 (Mb 84) 10 Xenon-131e (Xe 131e) 1,000R41 dita-87 (Rb 87) 10 Menon-133 (Xe 133) 100

Ruthenium-97 (Ru 97) 100 Xenon-135'(Xe 135) 100*

Ruthenita-103 (Ru 103) 10 Ytterbium-175 (Yb 175) 100 -.

Ruthenium-105 (Ru 105) 10 Yttrium-87 (Y 87) 10

Authenium-106 (Ru 106) 1 Yttrium-80 (Y 88) 10

Samarium-151 (Se 151) 10 Yttrita-90 (Y 90) 10,

Senerita-153 ($m 153) 100 Yttrim-91 (Y 91) 10

C andita-46 (Sc 46) 10 Yttrita-92 (Y 92) / 100

Conditm47 (Se 47) 100 Yttrium-93 (Y 93) 100

Candita-48 (Se 40) 10 Zinc-45 (2n 65) 10

Selenita-75 (Se 75) 10 Zinc-49m (2n 69m) 100

O licon-31 ($1 31) 100 Zine-49 (2n 69) 1,000Silver-105 (4g 101) 10 21rconita-93 (2r 93) 10Clver-110m.( Ag 110m) 1

Silver-til ( Ag 111) 100 Any radion:tive seterialSodita-22 (N4 22) 10 not listed dove other thenSodita-24 (No 24) 10 alphe emitting radioactiveCrontism-85 (Se 85) 10 meterial . 0.1Crentite-49 (St 89) 1

Crontita 90 (St 90) 0.1Crontius-91 (Sr 91) 10 4539 74(13eC) Grape of audient umme of redleest.Crontium-92 ($r 92) 10 ive noteela1.Sulphw -35 ($ 33) 100 Ocoup 1. the of propered redlopharmaceuticale fortentatta-182 (fe 182) 10 certeln diagnostic studlee involvires measuremente ofTechnettun-96 (fc 96) 10 uptake, dilution and escretion (does not include usesfechnetius-9hn (fc 97e) 100 involving imaging wil tueur locatirations).Technettun-97 (fc 97) 100 (1) Diranium-Si se m2dium chrunste or leeledTechnetius-99e (fc 99e) 100 himon serim albtenin.Technetium-99 (fc 99) 10 (2) Cobalt-57 se leeled cyanocobalanin.f;1turita-125e (fe 125e) 10 (3) Cobalt-$8 es leeled cyanocobalanin.

- 34 -

_- _. -

e s.

.

514 dorius-99/technetita-99e generatore for(4) Cobalt-60 es labeled cyanocobalanin. (1) 3

(3) todine-123 en sodium iodide. the slution of technetita-99n se pertechnetete.(6) todine-125 as sodita iodide, iodinated hunen (2) Technetita-99e as pertechnetete for une with

eerum albumin, oleic acid, or modita lothalanete. reagent kits for properation and use of radiopherse-(7) todine-131 es sedita iodide, iodinated htman ceuticate containing technetita-99e as provided in

serim albinin, labeled rose bengel, triolein, or (3) and (6) of this group.oodita todahippteste. (3) Reagent kite for preparation of technetits-

(8) tron-59 es citrate. 99e labeled(9) Pbteesium-42 as chloride. (e) Sulfur colloids

(10) Sodita-24 as chloride. (b) Pentatete soditag(11) Technetinen-99m as pertechnetete. (c) Htman oerus albumin microepherset(12) My radioactive seterial in a radiopheres. (d) Polyphosphateep

ceutical and for e diagnostic une involving measure. (e) Macroeggregated homen eetus albumingmonts of uptehe, dilution, or encretion for idsich e (f) Etidronate soditag9estice of Claimed Investigational Exemption for a (g) Stennous pyrophosphatesNoe Drug" (IND) or a "New Drug Application" (NOA) has (h) 14 men sortm albtminbeen eccepted by the Food and Drug Administration (1) Medronete soditas(f0A). (j) Clucoptete soditm3 and

(k) Onidronate sodius.Grom !!. time of propered radiophoroscouticate (4) fin-113/indita-11 h generetore for the

f;r diagnostic ettalles involving imaging mid tueur slution of indita-lik as chloride.loc alizations. (S) Yttritm-87/ strontium-8h generatore for the

'

(1) Chrastun 31 as htmen eorus albumin. elution of strontiim-87e. '

(2) Fitarine-18 in solution. (6) Any generator or reagent hit for properation(3) Ce111un-67 as citrate. and diagnostic une of a radiophemeceutical contain-

| (4) Q 1d-198 in colloidal form. ing radioactive meterial for seiich generator et

(S) Indium-113e se chloride. reagent hit a "Not ice of Claimed Investigational(6) todine-12) es codium lodido. Esseption for a New Drug" (!NO) or a "New Drug Applii(7) todine-125 es sodita lodide or fibrinogen. cottorf (NOA) hee been accepted by the food mid Drug(8) todine-131 se sodite lodide, lodinatal hinwi Administration (FDA).

serun albumin, sacromsgregated iodinated husen eerus ,

elbimin, colloidal (elcroeggregated) lodinatet husen Crew IV. the of properet ratiophorescouticolo

i serue albtain, romu bengel, or sodiun todohipptrete. for certain therapeutic uses that do ru)t Hr)tisell)(9) Mercury-197 as chlormerodrin. require hospitalization for purpsene of radiation!

(10) feercury-203 as chlormerodrin. eefety.(11) Selenita-75 ne solenasethionine. (1) lodine-131 se todido for treatment of hypier.(12) Strontita-85 se nittste. thyroidien and cardise dysftsiction.(13) Strontium-eh as chloride. (2) Phosphorue-12 as solthle phosphete far treet-(14) Technetium-99e se pertechnetete, sulfur ment of put)cythweis vere, leubate, and bone metes-

colloid, or sentonggregatef htmei sorta albumin. teses.(IS) Thelliun-201 en chloride. (3) Phnept2rus-32 as colloidet chronic pnosphoto(16) Ytterbita-169 es pentetste sodium. for intrecovitary treatment of enlignwit effusions.(17) Any ruficactive meterial in a reflopherse- (4) Any twilanctive meterial in a rollopheme-

cautical propered from a reagent hit 11stof in (3) of ceut ic al erst for a therapeutic une not normelly

Cro wn !!!. requiring huepitalisation for ptepnees of refletinna y relicoctive meterial in a radiopherse- eefety for teilch a "%tice of Cletoed Investigational(18) n

| cautical and for e diagnoetic use involvtrag imaging [mmaption for a be Drug" (IN0) or a "New Drug App 11neept those in geoeous forms for editch a "%tice of cetion" (NOA) hee bee) accepted by the food etwf Druj'

Claimed Investigational Enemption for a leew Orug" Administration (FDA).(190) or a "Nw Ortas Applicotiorf (NOA) hoe 1,eenaccepted by the food and Drug Administration (FDA). Croup V. the of preoered relicphemecauttaats fur

certain theropeutic uwe that twteetly re vite

Croup !!!. the of generatore mid remjent kite for hospitellretion for purposes of railotion se'ety.tre preparation ont une of reflos#iste.e:suticale con. (1) 0o1419s es colloid for intrecevitory trout.teining radios ttve meterial for certeln dingnostic cent of melignaat effusions.vene.

- 33 -_ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ - _ _ -

_ _ _ _ _ _ _ . _ _ _ _ _ - - - _ - . - _ - - - - _ - _ - - - - - - --c

. .

(2) todine-131 es lodide for treatment cf thythid 4&39,75(136C) Unite foe' bened licensee (Cont.) *

carciname.(3) Any radioactive meterial in a radiopharmo-

coutical and for a therapeutic use normally requiring Radioactive Col . 1 Col. !!hospitetization for r adiation eefety reasons for Meterial c uries curiesneiich a "festice of Claimed Investigational Exemptionfor a New Drug" (IN0) or a "New Orta; Application"(N04) hee been accepted by the Food and Drug Admini- Cednita-115 10 0.1stration (FDA). Calcita-45 1 0.01

Calcita-47 10 0.1Croup VI. Use of sources eM devices containing Carbon-14 100 1.

radioactive meterial for certain medical uses. Cerita-141 to 0.1(1) heericitm-241 es e sealed source in a device Cerita-143 10 0.1

for bone mineret analysle. Certim-144 0.1 0.001(2) Cestim-137 encased in needles eM opplicator Coelim-131 100 1.

cette for topicat , interstittel, and intrecavitary Cesium-134m 100 1.*reatment of cancer. Cesita-134 0.1 0.001

( 3) Cobalt-60 encased in needles and applicator Cesium-135 1 0.01celle for topic al, interstitiet, eM intracevitary Ceelta-136 10 0.1treatment of cower. Cesita-137 0.1 0.001

(4) Ocid-198 es seeds for interstitial tr steent Chlorine-36 1 0.01cf cancer. Dilorine-38 100 1.

(S) todire-125 as e oestal source in a device for Diromita-51 100 1.,'bone mineral snelysis. Cobalt 57 10 0.1

. (6) todine-125 es needs for for interstitial Cobalt-Sibe 100 1.treatment of concer. Cobelt-58 1 0.01

(7) tridium-192 es seede encesad in nylon ribbon Cobalt-60 0.1 0.001 |for interstitiet treatment of cancer. Copper-64 10 0.1

(8) Relon-222 es osede for topicol, interstittel, Dysproeita-165 100 1. *Iand intreresitory treatment of cancer. Dysproe tta-166 10 0.1 |

(9) Redita-226 se e sealed source for topical, Erbita-169 10 0.1 i

interstitial, and intracevitary treatment of concer. Erbita-171 to 0.1 |

(10) Strontiim-90 eested in mi applicator for Europita-152 (9.2 h) 10 0.1treetnent of superficist eye conditione. Europium-152 (13 y) 0.1 / 0.001

Eurpot ta-154 0.1 0.0014579.7S(136C) Unite Per breed 11eweses. Europlue-155 1 0.01

Fluorine-18 100 1.Gadolinita-153 1 0.01

Radioactive Col. 1 Col. !! Calotinita-139 to 0.1Meterial curies curies Galliim-72 10 0.1 l

Germanita-71 100 1.,

Gold-198 10 0.1Aritimony-122 1 0.01 Cold-199 to 0.1Antimony-124 1 0.01 N fnita-181 1 0.01Antimony-123 1 0.01 *1mita-166 10 0.1Caenic-7) 10 0.1 Heirogen-1 100 1.Ceente 74 1 0.01 Indita-113m 100 1.C oenic-76 1 0.01 Indita-114m 1 0.01C oenic =77 10 0.1 Indite-flle 100 1.

Serita 131 10 0.1 tr=11ta-11$ 1 0.01Be r ita-140 1 0.01 lodine-125 0.1 0.001Roryllius-7 10 0.1 lodine 126 0.1 0.001

81 =eut h-210 0.1 0.001 lodine-129 0.1 0.001C~oreine-82 10 0.1 todine 131 0.1 0.001 l

f**hita-109 1 0.01 lodine-112 10 0.1Co.ht ta-11 M 1 0.01 todine-131 1 0.01

|

- 16 - |

_ _ _ _ _ _ _ _ - _ _ _ _ - _ _ .-- -

--

,m . _ __. _ _- _ _ .__ _ _ _ _ _ _ _ .

. i

o

*

4 5 79.75(13dC) Limite fee bened lisenese (Cont.) 4 5 39.75(136C) Limite For broad 11eenese (Cont.)

Radioact ive Col. I Col. !! Radioactive Col. 1 Col . !!Meterial curies curies Meterial c uries curive

lodine-134 10 0.1 Ri41 dita-87 1 0.01todine-135 1 0.01 Ruthenita-97 100 1.tridium-192 1 0.01 Ruthenita-103 1 0.01Iridita-194 10 0.1 Authenita-105 10 0.1Iron-55 10 0.1 Ruthenita-106 0.1 0.001fron-59 1 0.01 Samerlue-151 1 0.01Krypton-85 100 1. Samerita-15) 10 0.1Krypton-87 10 0.1 Scandita-46 1 0.01Lenthanita-140 1 0.01 Scandita-47 10 0.1Lutetita-177 10 0.1 Sc andita-48 1 0.01Mengoneso-52 1 0.01 Seienita-75 1 0.01Manganese-54 1 ,0.01 5111 con-31 10 0.1Mengenese-56 10 0.1 S11ser-105 1 0.01Nrcury-197e 10 0.1 Silver-Iton 0.1 0.001N rcury-197 10 0.1 Silver-lil 10 0.1 ,Nrcury-203 1 0.01 Sodita-22 0.1 0.001'Q1ybdenta-99 10 0.1 Sodita-24 1 0.01Neod)=1ta-147 10 0.1 Strontita-8% 1,000 10.Noody=1ta-149 10 0.1 Strontita-45 1 0.01Nic kel-59 10 0.1 Strontita.89 1 0.01Nic kel-63 1 0.01 Strontiim-90 0.01 0.0001'Nic kel-65 10 0.1 Strontlue-91 10 0.1 .

Niobius-9)is 1 0.01 Strontita-92 to 0.1Niobita-95 1 0.01 Sulphur-35 10 0.1Nichtte-97 100 1. Tantelta-182 1 0.01Deelta-185 1 0.01 factriotius-96 10 / 0.1Ometta-191e 100 1. Technetita-97a 10 0.1Deelta-191 10 0.1 fechnetilm-17 10 0.1Omelue-193 10 0.1 Technetita-99e 100 1.Pelledita-103 to 0.1 f ec hnatita-99 1 0.01Palladita-109 10 0.1 Tellurius-12% 1 0.01Phuephorue-32 1 0.01 Tellurium-127m 1 0.01Plotimm-191 10 0.1 Tellur ita-127 10 0.1Ptetinus-19.% 100 1. Te11utita-129e 1 0.JIPlatimm-19) 10 0.1 Tellurita-129 100 1.Platinta-197e 100 1. Telluctus-131e 10 0.1Platimm-197 10 0.1 featurita-132 1 0.01Pulonita-210 0.01 0.0001 forbium 160 1 0.01 1

Pot asetus-42 1 0.01 thallita-200 10 0.1Praesodymita-142 10 0.1 the111ta-201 10 0.1

Pree od>=1ta-14) 10 0.1 Thellito 202 to 0.1Promethium-147 1 0.01 Thellite 204 1 0.01Promethita-149 10 0.1 Thulita-170 1 0.01Refita 226 0.01 0.0001 Thulium-171 1 0.01monita-186 10 0.1 fin-11) 1 0.01menius-189 10 0.1 fin-125 1 0.01

! %odita-10h 1,000 10. 1'aigst en-181 1 0 01Rho <itta 10) 10 0.1 fungeton 105 1 0.01Rubidita R6 1 0.01 fungeten-107 to 0.1

- 37 -_ _ _ _ . _ _ _ _ - _

r

. .

4&3927S(13et) Unite flot beoed lleenese (Cont.) for transport packages each cf diich cont ine radidactive meteriel having a specific activity less then,or equel to, 0.002 microcurie per gene.

Radioactive Col. I Col. 11 39.77(3) A licensee is esempt from all transpor-hterial curies c uries totion requirements, other then 39.78(136C) and

39.92(136C),. dth respect to shipment or carriage ofthe followings

vanadium-48 1 0.01 e. Pac kages containing to more than Type AXenon-131e 1,000 10. quantities of radioactive meterials or

Xenon-133 100 1. b. Packages transported between lacetions withinXenon-135 100 1. the thited States which contein only americius orYtterbium-175 10 0.1 plutonlue in special form with an aggregate radio-Yttrius-90 1 0.01 activity not to suceed 20 turies.Yttrita-91 1 0.01Yttrium-92 10 0.1 4&)9.78(136C) Traimportetten of licensed aster-

Yttrium-93 1 0.01 ist.

Zinc.65 1 0.01 30.78(1) Each licensee dio trenoporte licensedZinc 69m 10 0.1 meterial outside of the confines of the licensee'sZinc.69 100 1. plant or other place of use, or dio delivers licensedZirconium-93 1 0. 01 meterial to a corrier for transport shall:

~

Zirconius-?S 1 0.01 e. Comply with the applicable requiremente,Zirconius-97 1 0.01 appropriate to the mode of transport, of the regule-

tions of the U.S. Department of freneportationg,

Any radioactive meterial b. Amews that any special inetttettone needed tocther then source meter- safely open the package are sent to or have been m>Mtel, special nucteer evettable to the consigrwe.seterial, or alpha mettling 39.78(2) If, for any reason, the regulettorm ofradioactive meterial not the U.S. Diperteent of Transportation are not appli-liatal dove. 0.1 0.001 cable to e shipment of licenood meterial, the licon '

ene shall conform to the standerde e,ef requirementeof ttwee ragulettorm to the ease rattent se if the

4539.76(13eC) Trenoportation of radiomettee enter. shipment were esject to the regulations.ist . W person ohelt deliver reficactive meterial too corrier for treempurt or transpirt ruficactive 4539.79(136C) franspott et'- ral lleonese flotesteriet eucept se eutterited in a generet or spect. carrieve.fic liconee leeued by the agency or se ensepted in 39.79(1) A general license le hereby teeued to39.77(136C). any comanon or contra:t r.orrier not esempt under

39.77(13AC) to receive, possess, transport, and store4539.7F(13ec) Transportetten esemptione. refiometive esteriet in the regular enurse of trair

39.77(1) Can=>n contra:t terriere, freight carriage for another or storage incident thereto,forwerefore, etef werehnueaman who are e* ject to the providef the transp3rtation eeuf stormp to in accord-requirmeente of the U.S. Deperteant of itanoportetton ence with the applicele require, ente, sppropriate toin 49 CfR 170 throingh 169, the U.S. Postal Service in the mode of transpnet, of the U. S. Copertment ofthe Natal '.orwice Nouel (Oneestic 411 * nuel), fraisportation insofer es sich requiremente relate to$setion 124.3 Arcorporetsi by re foretc e, 19 CfR the loof tre; aref atorop of pechagee, plocerdit 3 ef111.11 (1974), armt Iowe 0=pertment of freispirtetton the trenopartire; vehic le , = =f incident reporting.are essept frta these rulee to the estent that they kiy rusti fication of incident referraf to in thete

transport or store refloactive meterial in the requ= U.S. thportment of freisportation requirmients shalllet coutes of their carriage for another or storop be filed eith, or mete to, the agency.incident thereto. Crmein mid contract carriere sho 39.79(2) A general license is hereby teeimd toare not e4 ject to Ltw requiremente of tre U.S. any private carrier to tranepirt reflonctive meter.Department of Trewpsttetton, U.S. Notel Servlee or let, provided the transpartet ton le in teordance

fowe depetteent of franspottetton are eeject to eith ttw applicable requiremente, oppropriate to the39.76(1360) eivl other opplieste rulee. onde of tronenstt, of the U.S. Depettavnt of Trois-

39.7F(2) hiy liconeas le esmoot from 19.76(1)6C) partstion insofer se awh requiremente relate to theto the vetent that the licensee delivete to e carrier tomfitw; wat storefe of packages, plar:ardive; of the

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_ _ _ _ . - _ __ _ _- _ _

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transportiru; vehic le , and incident ' reportituj. Any 1986, emcept inder special arrangenent gproved bynotification of incident referred to in those U.S. the U.S. Department of Transportation in accordanceDepartment of Transportation requiremente shall be with 49 CfR 173.471.filed with, or made to, the agency.

39.73(3) Persons *o transport radioactive meter. 47b39.82(136C) Transport et'-7 rel IJcense for

tal pursusnt to the general licensee in 39.79(1) or Dai specificetlan container.(2) are erempt fran the requirements of 470- 01epter 39.82(1) A general license le instad to any40 to the outent that they transport radioactive 1*censee of the agency to troisport or to deliver tometerial. a carrier for transport licensed meterial in e speci.

Fication container for a Type 8 quantity of radio.4539.80(136C) Trampertation--general License fler active seterial as specified in the regulations ofimC appreeed penhages. the U.S. 00T in 49 CfR Ports 173 and 178.

39.80(1) A general license is hereby issued to 39.82(2) This ger.eral license applies only to eany licensee of the agency to transport, or to deli. licensee 40 hee a quality soeurance progens approvedver to a carrier for traraport, licensed meterial in by the ejency as satisfying the groviolone ofa package for sich a license, certificate of comp 11 39.9)(136C) .ence, or other approvst has been leeued by the U.S. 39.82(3) This general license applies only to eNuclear Regulatory Coweission. licensee who

39.80(2) This uneral licorse applies only to the e. No a copy of the specifications and,

licensee eat b. Complies with the terms and conditions of thes. Ns a copy of the specific license, certifcate specification and the opplicable requirseents of thle

cf compliance, or other approval of the package wid part.

hoe the drevings and other docueents soferenced in 39.82(4) The general license in 39.82(1) isthe approval relating to the use and saintenance of ethject to the limitation that the specific atit.:.

the packagirq arut to the actions to be taken prior to container any not be uset for e ehlpmint to e loce.shipeent l tion outside the thited Statoe efter August 31,19M

b. Cump11ee with the tones and conditions of the except tnder special arranjenent e approved by U.S.licones, certificate, nr other opproval, se appli. DOT in accordance eith 49 CfR 173.472.cable, eral the applicable requirenente of the trone.portation requiremente in this chapterg and 4 5 39.P3(136C) Osteerst licermee of fbreign

c. Prior to the liceness's first use of the peck. appreeed package..

ego, hen registered with trW U.S. Mclear Regulatory 39.83(1) A rpneral License le testad to e,

Comeinelon. licensee of the agency to transport or to deliger tod. No e cymlity aestrance program as required by a estrier for trennport licensed material in a peck.

39.9)(136C) approved by the egency. m;e the design of shich hee been approvej in a for.39.80(3) The general license in 39.80(1) opplies sign national ccupotent astrurity certificate which

only een the package approval authorias use of the hoe been revetidoted by the U.! 00T as meeting t5epacirage toder this general license. applicable requirements of 49 Cff 171.12.

39.80(4) for pseviously apprsvad type O pneboges 39.8)(2) This general item w spplies only towhich are not designatet se either O(U) or B(M) the ehlpnente pude to or frue locat ions out side the

WC Certificate ur C.xopliance, the general license le thited States.nihject to addit tocol restriction of 39.01(136C) . 39.fl3( 3) This rieneral licones applion only to a

liceisse +o t4579.81(136C) fresportetten previously approved e. Hee e enpy of the applicable certificate, theType B penhagog. revelidation, arif the rarewirge est other scumente

39.81(1) A Type 8 p*:ksujo pieviously morosed by referencei in the certifiante relating to the une end,the NNC, but twt designete f me O(U) or O(M) in the saintenance of the pockentra; eral to the actlJie to be

MC Certificate of Cn=pliance, say be used uwier the taken prior to ehlpmenti erufgeneral 11renee of 39.8C(116C) eith Lt. folloeing b. Cepline with ttui terret wid condittune of theaitattional lietteliorm e certificate eel revelidation est with the applicable

e. f abricatiesi nr the pochegirq w,,9 entiefector. requiremente of thle chopter. '

ilt timoteted b9 fore August 31,19M, se ebenetreetad'by application of its etel wher in unoident.e matn 474 f t.84(13t.C) frataportetten gwwrel ll enes for

U. % MtC re;ulatiu m i esad f)pe A. flaelli Class !! gech'opee.h. The package ony not be us** for e ahlps.eint to 39.f)4(1) A tros t et lice,$se le taeiehr teste d in

o location outelde the thited $letes ef twr 8 met 11e any llevosos to trer.emtt fleelle meter nel, or tot,

31 .- - . _ _ _ _ - _ - _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ - _ _ _ _ _ - _ _ _ _ _ _ _

._ . _ _ _ _ _ _ _ - - ,-__

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deliv:r fle'ello met: rial to o carri;r for transport, present , except that plyethylene any be used fo r"if the met:ri:1 to shipped as o risella Class I! packing cr wreppingpackage. e. tkenium-233 is not present, and the enount of

39.84(2) This generet license applies only son a plutonita does not exceed 1 percent of the anotsit ofpackage containe no acre then a Type A quantity of w enita-235 andradioactive material, including only one of the f. The. anotsit of uranita-235 is limited asfollowing a follows :

e. lb to 40 grams of uranita-235: or (1) If the flesile radionuclides are not uni-b. 15 to 30 grass of wenium-233 or formly distributed, the maxista enount of uranita-235c. th to 25 grams of the fisels radionuclides of por package may not exceed the value given in the

plutonita, sucopt that for encapsulated plutonium- following numbersberyllita neutron sources Jn special form, and A1quantity of plutonita eey be present; or Table I

d. A combination of fisele radionuclides in 41chthe sus of the ratios of the amount of each rafio- thanita enrichment in Peralseible maxistanuclide to the corresponding maximus enounts in weight percent of grane of uranius-23539.84(2), perajrephs "a," "b ," and "t: ," does not utentum-235 not exceeding per packageexceed unity.

39.84(3) This general license applice only *en, 24 40except es specified below for encapsulated plutonita- 20 42beryllius sources, a package containing n)to then 15 15 45grams of fiselle radionuclides le labeled with a 11 48transport indes not less then the number given by the 10 $1

following equation, dere the pedage containe x 9.5 52 %

gree of wenita-235, y gree of uranius-233, and a 9 54

| grame of the fles!!e radionuclidee of plutontim: 8.5 558 57

ciniatm transport e (0.4u + 0.67y + m) (1 - j5,) 7.5 59-

indeu x+y+z 7 60 - -

6.5 62For a package in $1ch the only fleelle meterial 6 65

la in the fone of encopeuteted plutonita-beryllia 5.5 68neutron sources in special form, the trenesmet indes 5 72beeed on criticelly considerettane may be taken as 4.5 76/- .

0.026 times the number of grees of the fleelle reflo- 4 80nuclides of plutonius in oncees of 15 grane. In all 3.5 88cases, the traraport indes must be rounded up to one 3 100decimal place, and may not escoed 10.0. 2.5 120

2 164

475 39.85(13st) Transp etat h rat 11eense For 1.5 272c

restricted, flee 11e close !! peeluge. 1.35 32039.85(1) 4 generet licorne is twraby instad to 1 680*

eny licensee to transport fles11e motorial, or to 0.92 1200*deliver fleelle enterial to e corrier for transport,if the meterial le ehlpped as a fleelle Claes !! 'Pur suant to its agressent with the U.S. noteleerpar ksge. fbeguietory Omnelselon, mjency juristiction extende

39.85(2) This generet 11 cones applies only sens only to 350 grees of u?anita-235.a. The package contatro no sure then a type A

quantity of radioactive seterials (2) If the fles11e radionuclides are distributedb. 51ther berylliam nor hydrogenous meterial triiformly (i.e. , cannot form a lettice arrangement

enriched in deuterita le presenti within the packaging) the ensimas mootrit of uranlue-c. The total mese of graphite present dies not 235 per package may not encent the value given in the

encoed 150 lines the total mees of utentue-235 plus followitw; tehlespluton 1uel

d. 04etences having a higher hydrogen densitythat water, e.g., certain hydrocerbon olle, are not

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'Table II 470-39.se(136C) Transp rist'.- ;edine detensin-

etion.Uranium enrichment in Pennissible maximun Prior to each shipment of licensed meterial, the

weight percent of grene of uranium-235 Licensee shall ensure that the package with itsuranium-235 not exceeding per packsce contents satisfies the applicable requirenent s of,

this chapter.and of the license. The licensee shall4 84 determine thet3.5 92 39.88(1) The package is proper for the contents3 112 to be shipped 32.5 148 39.88(2) The package is in unispaired physical2 240 condition ancept for superficial defects su:h as1.5 560* marks or dents:1.35 800* 39.88(3) Each closure device of the packaging,

including any required gasket, is preperly installed I

(Pursuant to its agreenent with the U.S. 4 clear and secured and free of defects:Regulatory Consission, egency jurisdiction extende 39.88(4) Any system for containing liquid isonly to 350 grens of wenium-235. adequetely sealed and hee afequate space or other

specified provision for expansion of the liquidsg. The transport index of each package based on 39.88(5) Any pressure relief device is operable

criticality considerations is taken as ten times the and set in accordance with written procedurestnumber of grans of treniun-235 in the peckage divided 39.88(6) The package has been loaded and closedby the moulunun alloweblo number of grame per package in accordance with written procedures:

,

in accordance with Table 1 or 11 above se applicable. 39.88(7) Any structural part of the package seiichcould be used to lift or tie dossi the package during

470-M.86(136C) Famelle eterial _ 4 1ons as to transpo rt is rendered inoperable for that pirposenedstowe properties. then the isotopic sundance, triless it satisfies design requirements specified by

'

mese, concentration, degree of irrefistion, degree of the U.S. Heleur Regulatory Consission.moderation, or other pertinent property of fissile 39.88(8) Outside removable contaninetion.

'

material in any package is not leioun, the licensee e. The level of renovable radioactive contanin-shall package the fissile material ne if the unknowi etion' on the external sur faces of each packageproperties have credible values that will cause the of fered for ehlpment is as low as reasonably achiev-mrruimun nuclear reactivity. able. The level of nonfined radioactive contani,-

ation say be detensined by wiping an ared of 300470-39.87(136C) Treensportatlan--prellainery deter- square centimeters of the sur face concerned with

einetlene. Prior to the first use of any puckaging an esorbent seterial, unitu; nederate preestre, eruffor the shipment of ruficactive meterials measuring the act ivity and the wiping setorist.

39.87(1) The licensee shall ascertoire that there Sufficient osasureenents must be taken in the snettre m defects idilch could significantly reduce the appropriate locations to yield a represent ativeef fectiveness of the packaging. essesseent of the nonfixed contamination levels.

39.87(2) Where the maximun nonnel operating pres. Except me provided mder 39.88(8)"b," the amount ofsure will encoed $ poi getsje, the !!censee shall test radioactivity momeured on any single wipirq meterialthe containment systan at an internal pressure et then esermjed over the surface wiped, must not exccadleast 50 percent higher then the movinun normel oper. the limite given in 39.88(9) at any time duringetirq pr essur e to W rify the capability of that tr ansprt . Other methode of esseennent of equel orc>eten to esintain its structural integrity at that greater efficiency may he used. Ilhen other methodepree str e. are usef the detection efficiency of the method used

39.87()) The licensee shall conspicuously and must be tekon into accomt ersi in no case may thedur ely eath the pen:kagirq with its sudel rasaber, nonfined contasninstion on the en t ernal stefaces ofgrose weight, erwt a package identific ation number the packeje exceed ten times the limits listed in

assignef by the U.S. Melear Regulatory Commiselon. 39.88(9).Prior to applying the model nunber, the licenses h. In the case of packages transprtei eschall &termine that the packagirvj hwa been fabri. exclusive une ship %nte by tall or hignway reity, theceted in accordance with the dtaign opptoved by the nunflaed radioactive contmination et uny tirse duringU.S. Mclest Regulatney Commiselon. transport aant not exceed too tiaes the levele pre.

scribed in 39.H8(R)"e". The levels et the bsginning

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cf transport mu t not excced the lev 13 prescribed in vehic 13, et any point two met;rs from the verticc139.88(8)"a.a planes projected from the outer edges of the vehiclet

39.88(9) Removable external radioactive contanin- and

ction wipe limits are as follows: d. Tio millirem / hour in any norse 11y occupiedpositions of the vehicle, except that this provision

does not apply to private motor carriers dien personsNximus Permissible occupying these positions are provided with special

Limits health supervision, personnel radiation exposure

monitoring devices, and training in accordance withContaminant uCi/cm2 dpe/cm2 40.21(3).

39.88(12) A package must be prepared for trans.Beta-gamma emitting radio- port so that in still air at 100*F (30'C) and in the

nuclides; all radionuclides shade, no accessible surface of a package sculd havewith half-lives less than a temperature exceeding 122'F (50'C) in a nonexclus-ten days natural uranius; ive use shipment of 180'F (82*C) in an exclusive usenatural thorium uranius-2353 shipment. Accessible package sur face temperaturesuranian-238: tho rium-2 323 shall not exceed these limits at siy time dJring

thoriue-228 and thorium-230 transportation.dien contained in ores orphysical concentrates . . . . . . 10-5 .-22 473-39.89(1 MC) Transpartstion--eir transport of

All other alpha esitting plutonium.r adionuclides . . . . . . . . . . 10-6 2.2 Ptatwithstandiru; the grovisions of any general

licenses and notwithstanding any exemptions stateddirectly in this chapter or included indirectly by

39.88(10) External radiution levels around the citation of U.S. Department of Transportation reguls-package and around the vehicle, if applicable, will tions, as sesy be gplicable, the licensee shall

not exceed 200 millitem per hour at any point on the assure that plutoniue in any form is not transportedexternal surface of the pa:kage $ any time during by air or delivered to a carrier for air transport,

transportation. The transport index shall mt exceed mlesesten. 39.89(1) The plutonius is contaired in a medical

39.88(11) For a package transported as exclusive dev' ice designed for individus1 husen application s oruse by rail, highway or veter, radiation levels 39.89(2) The plutonlue is contained in a materialcuternet to the package may exceed the limits speci- in ditch the specific activity is not greyter thanfled in 39.88(10) but must not exceed any of the 0.002 microcuries per gree of meterial and in Wiichfollowing s the radioactivity is essentially (siiformly distri-

e. 200 millirne/ hour on the accessible external buted; or

surface of the package oniese the followirvj condi- 39.89(3) The plutonius is shipped in a singletions are met, in ditch cose the limit is 1000 milli. package containing no more than A2 quantity of pluta=cae per hour. niue in any isotope or form and is shipped in accord.

(1) The shipment is made in a closed transport once with 39.78(1%C): orvehicles 39.8?(4) The plutonius is shippws in a packaje

(2) Provisione are ende to accure the package 80 specifically authorized for the shipment of plutoniumthat its pnettion within the vehicle tenains fixed by air in the Cert ific at e of Compliance for thatdurirg transportations and package issued by the U.S. Ntclear Regulatory Commis-

(3) There oro no loading or unloading operatione sion.between the beginning and end of the transportation

b. 200 milliren/hout at any paint on the outer 470-39.90(136C) f r angu tt ation--records.surface of the vehicle, including the upper and lower 39.90(1) Each licenses shall maintain for e pnt-surfaces, or, in the case of an open vehicle, at any tod of t m years after shipment a record of errhpoint on the sortical plance projected free the outer shipnent of licensed adterial not stempt trider 39.77edges of the vehicle, on the upper surface of the (136C), showing, diere applicable st o =1, and on the lower esternst sur f ace of the e. Identification of the packaging by nodelvehiclei ntaber I

c. 10 milliras/ hour at wty paint tm noters frue b. Verific at ion that there are r:3 significantthe vertical plwie representel by the outer lateral defects in the packaging, as shipped |sur f ac eg of the vehicle, or, in the case of an opon

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c. W1une and identification of cwlant: (4) 20 curies of oiher non-special fona radio-d. Type and quantity of licensed material in each nuclides for which A2 is less than or equal to 4

package, and the total quantity of each shipment; curies; oro. Date of the shipments (5) 200 curies of other nonspecial form radio- {f. Mune and address of the trenefereeg nuclides for sich A2 is greater than 4 curies. Ig. Address to which the shipment was made; and 39.92(3) Each advance notification required by fh. Results of the determinations required by 39.92(136C) shall contain the following information (39.88(136C) The name, address, and telephone nunber of the {

a.39.90(2) The licensee shall make available to the shipper, carrier, end receiver of the shipment;

agency for inspec tion, upon reasonable notice, all b. A description of the nuclear weste containedrecords required by this chapter. in the shipment as required by the regulations of the

U.S. Department of Transportation, 49 CFR 172.202 and470-39.91(136C) Transportation--reports. 172.203(d);

The licensee shall report to the agency within c. The point of origin of the shipment and thethirty days: seven-day period during which departure of the ship-

39.91(1) Any instance in sich there is signi'i- ment is estimated to occur |

cant reduction in the effectiveness of any authorized d. The seven-day period durirtj Aich arrival of. packaging during use; and the shipment at State boundaries is esti:nated to

39.91(2) Details' of any defects with ,_ safety cccur;

eignificance in the packaging after first use, with e. The destination of the shipment, and thethe means employed to repair the defects and prevent seven-day period during which arrival of the shipmenttheir recurrence. is estimated to occur; and

! |,

f. A point of contact with a telephone number fo'r 1

470-39.92(136C) Advance notification of transport of current shipment information.j nuclear imete. 39.92(4) The notification required by 39.92(1)

39.92(1) Prior to the transport of any nuclear shall be made in writing to the office of each appro-waste outside of the confines of the licensee's priate governor or governor's dosignee and to the

|facility or other place of use or storage, or prior agency. A notification delivered by mail must be' !to the delivery of any nuclear waste to a carrier for postmarked at least seven days before the beginning ]transport, each licensee shall provide advance noti- of the'seven-day period during *ich departure of the lfication of such transport to the governor, or gover- shipment is estimated to occ ur . A notification

, nor's designee, which can be obtained from a nailing delivered by messerger must reach the offic,e of thelist available upon request from the Director, Office governor, or governor's designee, at least four days

} cf Rate Programs, U.S. % clear Regulatory Dommis- before the beginning of the seven-day period dJringI sion, Washington, D.C. 20555. The notification must which departure of the shipment is estimated to|

be provided to the tyvernors or governor's designee occur. A copy of the notification shall be retainedcf each state through nich the weste will be trans- by the licensee for one year.ported. 39.92(5) The licenses snall notify ea:h appro-

| 39.92(2) Advance notification is required only priate governor, or governor's designee, and the| *en t a;ency of any changes to schedule info r: pat ion pec-! The nuclear waste is required to be in Type B vidad pursuant to 39.92(1). Such notification shalla.

packaging for transportation; be by telephone to a responsible individual in theb. The nuclear waste is being transported to, office of the governor, or governor's designee, of

through, or across state boundaries to a disposal the appropriate stats or states. lhe licensee shall|cite or to a collection point for transport to a maintain for one year a record of the name of the '

disposal site; individual contacted,

The quantity of licensed material in a single 39.92(6) Each licensee who cancels a nuclaa rc.

package exceeds: waste shipment, for thich advance rotificaton has| (1) 5,000 euries of special form radionuclides; been sent, shall send a concellation notice to the

(2) 5.000 curies of mconpressed gases of Argon- governor, or governor's designee, of each appropriate| 41, Krypton-85m, Krypton-87, Xenon-131n, or Xenon- state and to the agency. A copy of the notice shall

135; be retained by the licersee for one year.(3) 50,000 curies of Argon-37, or of mcompressed

igases of Krypton-85 or Xenon-133, or of Hydrogen-3 as 470-39.93(136C) Transportation--quality assurance |o gas, as lumincus paint, or absorbed on solid nater- requirement.|

|

ial;39.93(1) Each licensee shall establish, maintain, '

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' -and executo o quality asstranca progran ts verify, byprocedures such me checking, auditing, and in:pec-tion, that deficiencies, deviations, and defective

material and equipment relating to the shipment ofpackages containing radioactive motorials, are proup-tly identified and corrected. Prior to the use ofany package for the shipment of radioactive material,each licensee shall obtain agency approval of itsquality assurance progran.

39.93(2) Each licenses shall doctament the qualityassurance progran by witten procedures or instruc- O

tions and shall carry out the progran in acordance <

with those procedures throughout the pericd dJring j

which packaging is used. The licensee shall identifythe material and cosponents to be covered by the

quality assurance program.39.93(3) The licenses shall maintain sufficient

written records to demonstrate compliance with the

quality asstrance progren. Records pertaining to theuse 'of a package for shipment of radioactive materialmust be retained for a period of tw )ers aftef' ship-

.nent.

47539.94(136C) Effeetive dete. Otring the seeandcoesion of the 70th General Assembly (1984) existingIon Code chapter 136C was amended by 1984 Iona Acts,01 apter 1286, authorizing the governor to enter intoan agreement with the U.S. Nuclear Regulatory Consnis-cion (NRC) thereby enabling th3 Iows state department - .

cf health to license and further regulate byproduct,source and anall quantities of special nuclear radio- . . . -

'

active materials. The signing of such an agreementw ,

'ia authorized in federal legislation taider Subsection274b of the Atomic Energy Act of 1954, as amended. f

Chapter 39 as amended will became effective on the -

-date the governor and NRC sign the stbject agreement.

,

,

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Rems per

CalendarQuarter

CHrTER 40STAMMS F(R PROTECT 10N ACAINST RADIATION mole body; head and trunk; active

blood-forming organs: lene of eyes470--40.1(134C) Purpose end scope. or gonads 1 1/4

40.1(1) This chapter establishes standards for

protection against radiation hazards. Except as Hands and forearms; feet and ankles 18 3/4ctherwise specifically provided, this chapter appliesto all licensees and registrants. It is the purpose Skin of whole body 71/2er the rules in this chapter to control the posses-sion, use and transfer of sources of radiation by any b. A licensee or registrant may permit an iridivi-licensee or registrant in etch a manner that the dual in a restricted area to receive a total occupe-total dose to an individual does not exceed the stan- tio7al dose to the whole body greater than thatdards of radiation grotection grescribed in this permitted mder 40.2(1)a, provided:chapter. Pbthing in this chapter shall be inter- (1) During any calendar quarter, the total occu-preted as ~ limiting the intentional exposure of pational dose to the . hole body shall not exceedpatients to radiation for the purpose of medical three rees.diagnosis or therapy. (2) The dose to the thole body, then added to the

40.1(2) In addition to complying with the acetaulated occupational dose to the whole body,. requirements set forth in this chapter, every reason- shall not exceed 5(N-18) rems =here "Pr equals the.able e f fort should be made to maintain radiation individual's age in years at the last birthday; andExposures, and releeses of radioactive material in (3) The licensee or registrant has determined theoffluents to mrestricted areas, as low as is reason- individual's acctnulated uccupational dose to tt +ably achievable. 1he term "as low as is reasonably thole body on agency Form SFD-2.0-793 or on a clearachievable" means as low as is reasonably achievable and legible record containirg all the informationtaking into accomt the state of technology, and the required in that form and has otherwise compliec withecononics of improvements in relation to benefits to the requirements of 40.3(1). An used in 40.2(1)b,. ,

the ptblic health and safety, and other societal and " dose to the thole body" shall be deemed to includesocioeconomic considerations, and in relation to the any _ dose to the whole bcdy, gonads, active blood-utilization of ionizing rafiation in the ptblic forming organs, head and trunk, or lens of eye.interest. 40.2(2) Reserved.

40.1(1) References to CFRs in this chapter aref

those in effect on January 1,1986. 475 40.3(136C) Detensinetion of accumulated doom. _

40.3(1) Each licensee or registrant shall require470-40.2(136C) Fermiselble domes, levels and concen- any individual, prior to first entry of the indivi-tretions. dual into the licensee's or registrant's restricted

40.2(1) Radiation dass standards for individuals area during each emplopent or erk assignment mderin restricted areas. For determinirq the doses such ciretastances that the individual will reelvespecified in 40.2(1), e dose from X or gamma rays or is likely to receive in any period of one calerxfar

with energies up to 10 MeV may be asstmed to be quarter an occupaticnal dose in excess of 25 percent I

squivalent to the exposure measured by a properly of the applicable standards specified in 40.2(1)"a"

calibrated appropriate instr nent in air at or near and 40.5(1), to disclose in a written, signed state-the body surface in the region of the highest dose ment, either

rate. a. Thet the individual had no prior occupationala. In accordance with the grovisions of 40.3(1) dose during the current calendar quartor; or

and except as provided in 40.2(1)"b," no licensee or b. The nature and amomt of any occupational doseregistrant shall possess, use, receive, or transfer which the individual may have received during thesources of radiation in stch a manner as to cause any specifically identified et:rrent c alendar quarter,

individual in a restricted area to receive in any from sources of radiation possessed or controlled bypariod of one calendar quarter fece all sources of the other person.radiation a total occupational dose in excess of the 40.3(2) Each licensee or registrant s5all main-standards specified in the following tables tain records of stch etatements mtil tte egency

authorizes disposition.

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40.3(3) Beraro pomitting, purcuent to 40.2(1) ' the applicabla accumulcted dos) v51ue far the indivi-"b,* any individu:1 in o rectricted area to receive dual as of that date, as specified in 40.2(1)"b"(2),an occuputional radiation dose in excese of the stan- the excess may be disregarded.derde specified in 40.2(1)"a," each licensee or regi-ctrant shall: 470-40.4(136C) Exposure of individuals to concentre-

a. Cbtain a certificate on agency Form SHD-2.0- tions of ratioactive materlat in air in restricted793 or on a clear and legible record containing all areas.the information required in that form, signed by the 40.4(1) Fermissible concentrations.individual, showing each period of time after the a. W licensee shall possess, use, or transferindividual attained the age of eighteen in which the radioactive material in etch a manner as to permitindividual received an occupational dose of radia. any individual in a restricted area to inhale a quan-tion; and tity of radioactive material in any period of one

b. Calculate on agency form SHD-2.0-793 in accor- calendar quarter greater than the quantity whichdance with the instructions appearing therein, or on tould result from inhalation for forty hours per weeka clear and legible record containing all the infor- for thirteen weeks at miform concentrations ofnation required in that form, the previously accunu- radioactive material in air specified in 40.22(136C) ,lated occupational dose received by the individual Table I, Column 1.and the additional dose alloted for that individual (1) Sirce the concentration specified for tritius

under 40.2(1)"b." oxide vapnr s.ssumes equal intakes by skin absorption40.3(4) In the preparation of agency form S}O- and inhalation, the total intake pennitted is twice

2.0-793, or a clear and legible. record containing all that which would result from inhalation alone at thethe information required in that form, the licensee concentration arcified for H-3(S) in 40.22(136C),

cr re;istrant shall makes Table I, Column 1 for forty hours per week for thir-a. A reason 21e effort to obtain reports of the teen seeks. *

individual's previously accumulated occupational (2) For radon-222, the limiting quantity is thatdose. For each period for which the licensee or inhaled in a period of one calendar year.registrant obtains such reports, the licensee or (3) For radioactive material designated "Sub" in

' . registrant shall use the dose shom in the report in the " Isotope" column of the t&le, the concentration

preparing the form. In any case where a licensee or value specified is based upon exposure to the mater 'registrant is male to obtain reports of the indivi- ial as an . enternal radiation a urce. Individualdual's occupational dose for a previous complete exposures to these materials may be accomted for ascalenfar quarter, it shall be assumed that the indi- part of the limitation on individual dose invidual has received the occupational dose specified 40.2(1). These nuclides shall be stbject to the

in ihichever of the followirg columns apply precautionary procedures required by 40.4(2)in.(4) Witiply the concentration values specified -

Colunn 2 in 40.22(136C), Table I, Column 1 by 6.3 x 109 milli-Column 1 Assumed Dose liters to obtain the quarterly quantity limit.

Assumed Dose in Rems for (5) Nltiply the concentration valuo for fh-222r

I in Rees for Calendar specified in 40.22(136C), Table _ I, Coluen 1 by 2.5 xCalendar QJarters 109 milliliters to obt ain the annual quantity limit.Quarters Beginning (6) If the radioactive material is of stch formPrior to on or After that intake absorption through the skin is likely,

Part of Body January 1, 1961 January 1, 1961 individual exposures of radioactive material shall becontrolled so that the uptake of radioactive material

mole body, by any organ from either inhalation or absorption orgonada, active both routes of intake in any calendar quarter does

blood-forming not exceed that which would result from inhaling suchcrgens, head and radioactive material for forty hours per seek for

trunk, lens of eye 3 3/4 1 1/4 thirteen weeks at uniform concentrations specified in40.22(136C), Table I, Cblunn 1.

b. Retain and preserve records used in preparing (7) Significant intake by ingestion or injectionagency Form SHD-2.0-793 until the agency authorizes is ;resuned to occur only as a result of circun-their disposition. If calculation of the indivi- stances such as accident, inadvertence, poor proce-

dual's accumulated occuptional' dose for all periods dure, or similar special conditions.prior to January 1,1961, yields a result higher than

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-~ 1. Such intak30 must be evclusted and accounted (2) *In asserament cf a porticulte individuel'a

for by techniques and procedures as may be appro- intahs of radioactive meterial is necessary, intakespriate to the circumstances of the occurrence. less than those thich sculd result from inhalation

2. , Exposures so evaluated shall be included in for too hours in any one day or for ten hours in anydetermining ihether the limitation on individual one neek at miform concentrations specified incuposures in 40.4(1)e has been exceeded. 40.22(136C), Table I, Coltsin I, need not be included

(8) Regulatory guidance on assessment of indivi- in such assessment, provided that for any assesamentdual intalars of radioactive material is given in the in excess of these amounts the entire anomt isU.S.. % clear Regulatory Commission Regulatory Guide included.8.9, " Acceptable Concepts, Models, Equations and 40.4(2) Precautionary procedures.

. Assumptions for a Bioassey Progran." Single copies a. lhe licensee shall, as a precautionary po-cf Regulatory Guide 8.9 are available from the Office cedure, use process or other engineering controls, toof Standards Development , U. S. telear Regulatory the extent practic able , to limit concentrations of

Commission, Washington, D.C. 20555, upon written radioactive material in air to levels below thoserequest. *ich delimit an airborne radioactivity area as

b. % licensee shall possess, use or transfer defined in 470-38. 2( 136C) .cixtures of . U-234, U-235, and U-238 in soluble fonn b. men it is impracticable to apply process or

in such a manner as to permit any individual in a other engineering controls to limit concentrations ofrestricted area to inhale a quantity of sich material radioactive material in air below those defined inin excess of the intake limits specified in 40.22 470-38.2(136C), other precautionary procedures, such(136C), Table I, Colunn 1. as increased swveillance, limitation of erking

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(1) If such soluble uranium is of a form sich times, or provision of respiratory protective equip-that absorption through the skin is likely, indivi- ment, shall be used to maintain intake of raficactive

duel exposures to such material shall be controlled material by any individual within any period of sevenso that the uptake of sich meterial by any organ from consecutive days se far below that intake of radio-

cither inhalation or absorption or both routes of active material idiich would result from inhalation ofintake does not exceed that sich sculd result from sich material for forty hours at the triiform concen-

inhaling such eaterial at the limita specified in trations specified in 40.22(136C), Table I, Column ?40.22(136C), Table I, Orluun 1. as is reasonably achievable.

(2) Signif'. cant intala, try ingestion or injection (1) Wenever the intale of radioactive materialis . presumed to occur only as a result of circum- by . any individual exceeds this forty hnur controi

ctances such as accident, inadvertence, poor proce- measure, the licensee shall make such evaluations saddure, or similar special conditions. take such actions as are necessary to aeswe against

1. Such intakes must be evalueted and accounted recurrence. jfor by techniques and procedures as may be appr o- (2) The licensee shall maintain records of sichpriate to the circunstancer of the occurrence. occurrences, evaluations, and actions taken in a

2. Exposures no evaluated shall be included in clear and readily identifiele fo rm suit e le for

determining whether the limitation on individual suonary review and evaluation.exposwes in 40.4(1)a has been excewded. 40.4(3) men respiratory protective equipment is

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c. For purpores of determining compliance with used to limit the inhalation of airborne radioactive !

the requirements of 40.4(136C), the licensee shall meterial pesuant to 40.4(2)b, the licensee may makeuse suitable measurements of concentrations of radio- allowence for such use in estimating exposuren of |,

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active material in air for detecting and evaluating individuals to seh material povided that stchairborne radioactivity in restricted areas and in equipment is used as stipulated in the U.S. Nrlear,

addition, as appenpriate, shall use measwanents of Regulatory Commission Regulatory Qaide 8.15, "Accep-radioactivity _ in the body, measurements of radio- table Programs for Respiratory Protection."activity excreted from the body, or any canbination 40.4(4) Notwithstanding the provisions of 40.4(2)of such measurements as may be necessary for timely and 40.4(3), the agency may impose further restric-

' detection and assessment of individual intakes of tions:radioactivity by exposed individuals. a. 01 the extent to which a licensee may make

(1) It is asaused that an individual inhales allowance for use of respirators in lieu of provi-

re11oactive material at the airborne concentration in sions of process, containicent, ventilation, or othere!.ch the individual is present u11ess the individual engineering controls, if application of such controlsuses respiratory protective equipment pursuelt to is found to be practicable; and

40.4(3). b. As might be necessary to asswe that thei

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respiratory prctective program of the licensee is '

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adequato in limiting exporures cf personnel to cir- cuch a manner as to crGita in any mrestricted trs3-borne radioactive material. from such sources of radiation in their poIseraion:

40.4(5) The licensee shall notify, in eriting, s. Radiation levels diich, if an individual tere

the agency at least thirty days before the date that continuously present in the area, could result in therespiratory protective equipment is first used mder individual's receiving a dose in excess of two milli-the provisiors of 40.4(136C). rems in any one hour; or

40.4(6) A licensee tho uns authorized to make b. Radiation levels diich, if an individual were

cllowance for une of respiratory protective equipment continuously present in the area, could result in theprior to the effective date of this rule shall bring individual's receiving a dose in excess of 100 milli-the licensee's respiratory protective program into reme in any seven consecutive days.confomance with the requirements of 40.4(3) within 40.6(2) Any person may apply to the agency for anone year of that date, and is exempt from the exemption under 38.3(1) of radiation rules fran therequirements of 40.4(5). limits upon levels of radiation in mrestricted areas

7 specified in 40.6(1) resulting from the applicant's470-40.5(1MC) Expoews of minors. For determining possession or use of sources of radiation.the dos 7s specified in 40.5(136C), a dose from X or a. Such applications stould include informationgeene rays with energies up to 10 MeV may be assumed as to anticipated average radiation levels, use

to be equivalent to the exposwe . measured by a factors and occupancy times for each m restrictedproperly calibrated appropriate instrument in air at area involved.ce near the body surface in the region of the highest b. The agency may approve the proposed limits ifdose rate. the applicant demonstrates to the satisfaction of the~

40.5(1), No licensee or registrant shall possess, agency that the . groposed radiation levels are notune or transfer sources of radiation in such a manner likely to cause any individual to receive a dose toas to cause any individual within a restricted area, the diole body in any period of one calendar year ihwho is under eighteen years of age, to receive in any excess of 0.5 rem.

' period of one calender quarter from all sources ofradiation in such licensee's ce registrant's posses- 470-40.7(136C) Cbncentration of radioactivity in

- clon a , dose in excess of to percent of the standards effluents to mrostricted areas.'

cpecified in the table in 40.2(1)a. 40.7(1) A licensee shall not possess, use or-

40.5(2) m licensee shall possess, use or trans- transfer licensed material so _as to release to an| fcr radioactive material in such a manner as to cause mrestricted area of radioactive material in concen-

' any individual within a restricted area,[who is under trations Wiich exceed the limits specified in 40.22'

j

cighteen years of age , to be exposed to airborne (136C) , Table II, except as authorized pwsuant toradioactive material in an average concentration in 40.14(2)"a" or' 40.7(2) ._ For purposes of 40/7(136C),excess of the limits specified in 40.22(136C), Table concentrations may be atersjed over a period not -II. . For purposes of this subrule, concentrations may greater than one year.be averaged over periods not greater than a week. 40.7(2) An application for a license or amendment

40.5(3) The provisions of 40.4(2)b and 40.4(3) may include proposed limits higher than those speci-shall apply to exposwes stbject to 40.5(2) except fled in 40.7(1). The agency may approve the proposed

| that the references in 40.4(2)b and 40.4(3) to limits if the applicant demonstrates:40.22(136C), Table I, Column i shall be deemed to be a. That the applicant has made a reasonablereferences to 40.22(136C), Table II, Column 1. effort to minimize the radioactivity contained in

effluents to meestricted areas; And

470-40.6(136C) Phamiselble levels of radiation fra b. That it is not likely that. radioactive mater-

| external sources in erestricted areas. The intent ial discharged in the effluent iculd result in theof this rule limits radiation levels .so that it is exposure of an individual to concentrations of radio-unlikely that individuals in unrestricted areas would active material in air or water exceeding the limits

. receive a dose to the diole body in excess of 0.5 rem . specified in 40.22(136C), Table II.in any one year. If in specific instances, it is 40.7(3) An. application for higher limits pursuantdetennined by the agency that this intent is not met, to 40.7(2) shall include infomation demnstratingthe agency may, pursuant to 38.7(136C), impose such that the applicant has made a reasonable effort toadditional requirements on the licensee or registrant minimize the radioactivity discharged in effluents toas may be necessary to meet the intent. unrestricted areas, and shall include, as pertinent:

40.6(1) Except as nuthorized by the ogency pw- a. Information as to flow rates, total volume ofsuant to 40.6(2), no licensee or registrant shall effluent, peak concentration of each radionuclide inpossess, use, or trans fer saurces of rafiation in the effluent, and concentration of each radionuclide

,

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. _ _ _. _ _ _ _ __

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- -In the effluent everagtd over o perird of one ye:r et er f2od by a cuitabla sample cf an exposed popult.tisnthe point dere the effluent leaves a stack, tse, group, averaged over a period not exceeding one year,pipe, or similar conduit; teuld otherwise exceed the daily intake resulting

b. 4 description of the properties of the efflu- from continuous exposure to air or water containingents, including: one-third (1/3) the concentration of radioactive

(1) Dionical composition. material specified in 40.22(136C), Table II.(2) Physical characteristics, including suspended 40.7(6) The provisions of 40.7(136C) do not apply

solido content in liquid effluents, and nature of gas to disposal of radioactive material into sanitary

cr aerosol for air effluents. eewege systems, *ich is governed by 40.14(3).(3) The hydrogen ion concentrations (pH) of.

liquid effluenta; And 470 40.8(13dC) Ikdors reqdrisq fwnishisq of

(4) The size rarge of particulates in effluents bloemosy services. there necessary or desirable inrolessed into air. order to aid in detensining the extent of an indivi-

c. A description of the anticipated htsman occu- dual's exposure to concentrations of radioactive

pancy: material, the agency may incorporate license provi-(1) In the meestricted area dere the highest sions or issue an order requiring a licensee or

concentration of radioactive material from the efflu- registrent to make available to the individual appro-ent is expected; and priate bioassay services and to furnish a copy of the

(2) In the case of a river or strean, a descrip- reports. of such services to the agency.tion of water uses d3wnstrean from the point of

~release of the effluent.d. Information as to the hignest concentration of 470 40.9(136C) .Precastionary parecedures.

cach radionuclide in an unrestricted area, including 40.9(1) Surveys. Each licensee or registrent

anticipated concentrations averaged over a period of shall make or cause to be made such surveys as may heone years necessary to establish compliance with those rules.

(1) In air at any point of hunos occupancy; or 40.9(2) Personnel monitoring. Eacn licensee or(2) In inter et points of use do ristream fram the registrant shall supply appropriate personnel moni--

point of release of the effluent. toring eouipment to, and shall require the use o f*

e. The background concentration of radionuclides such equipment by: .

in the receiving river or strean prior to the rolesse a. Each individual who enters a restricted area -of liquid effluent. mder. stch circumetancos that the individual re-m

. f. A description of the environmental monitoring ceives, or is likely to receiva, a dose in any calen-squipment, including consitivity of the system, and der quarter in excess of 25 percent of the applicab1.s

,.

procedures and calculations tu determine concentes- value specified in 40.2(1)"s." f

- tions of radionuclides in the erestricted area and b. Each individual mder eighteen years of agepossible reconcentrations of radionuclides; And edio enters a restricted area under such circunstances

g. A description of the inste treatment facili- that the individual receives, or is lively to re-

ties and procedures used to reduce the concentration ceive, a dose in any calender quarter in excess ofof radionuclides in effluents prior to their release. five percent of the splicable ;telue specified in

40.7(4) for the purposes of 40.7(136C), the 40.2(1)"a."concentration limits in 40.22(136C) , Table II shell c. Each individual thu enters a high radiation

cpply at the boundary of the restricted ares. area,

s. 1he concentsation of radioactive material dis- 40.9(3) Caution eigns, labels, and signals.charged through a stack, pipe, or similar conduit may a. General.be detennined with respect to the pnint *ere the (1) Except se otherwise authorized by the agency,catorial leaves the conduit. symbols prescribed by 40.9(3) shall use the conven-

b. If the conduit discharges within the restric- tional radiation caution colors (magenta or purple onted area, . the concentration at the boundary may be yellow background). The symbol prescribed by this

detsenined by applying appropriate factors fcr dilu- section%.s the consentional tnree-blade designs* *tion, dispersion, or decay between the point of dis-

charge and the boendary. I R/01ATION 5 9B01.

40.7(5) In addition to limiting concentrations ineffluent streans, the agency may limit quantities of 1. sess-hatch 2:ea is to be megents or purple,radioactive material released in air or water during 2. Backgromd is to be yeller.s specified period of ti:ne if it appears that the

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daily intake of radioactive eaterial from air, weter,11

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_ . _ . _ _ _ _ _ _ _ _ _ - _ . . . - . . _ . . _ . . . _ _ _ _ _ _ - . _ _ _ ._

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j not included in 40.9(3)c(2) and 40.T(3)c(4) far con-~trolling access to high radiation areas. The agencymay approve the proposed alternatives if the licensee.

# or registrant demonstrates that the alternative

methods of control will grevent mauthorized entry

| into a high radiation area, and that the requirement,'' ' of 40.9(3)"c"(3) is met.

| (6) Each area in which there may exist radiatione levela in excess of 500 rams in one hour at one meter! from a sealed radioactive source that is used to

M|a'6 i

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irradiate materials shall have entry control devices

and alarms meeting the criteria specified in Section

(2) In addition to the contents of signs and 20.203(c)(6) of 10 CFR Part 20.labels orescribed in this rule, a licensee or regi- (7) The requirements of 40.9(3)"c"(6) shall not

ctrant may provide on or near such signs and labels apply to radioactive sources that are used in tele-

,any additional information dich may be appropriate therapy, industrial radiography, or in completely

to aidity individuals to minimize exposure to radi- sel f-contained irradiators. In the case of open

ation. field irradiators in which certain of the criteria

b. Radiation areas. Each radiation area shall be specified in 40.9(3)"c"(6) are impracticable, equiv-conspicu3usly posted with a sign or signs bearing the alent protection shall be provided by license condi-

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radiation caution symbol and the wrds: tions.

d. Airborne radioactivity areas. Each airborneCAUTION (OR "DANTR") radioactivity area shall be conspicuously posted with

. RADIATION AREA a sign or signs bearing the radiation cautic1 symboland the erdes

c. = High radiation areas.(.1) Each high radiation area shall be conspic- CAUTION (OR "DANTR")

uously posted with a sign or signs bearing the radi- AIRBOR'E RADI0 ACTIVITY AREA. r. tion caution symbol and the wards: *

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e. Additional requirements.

CAUTION (OR "DANTR") (1)- Each area or roan in sich any radioactive

HIGH RADIATION AREA , material, other than natural uranlun or thorius, is

used. or stored in un mount exceeding ten times the(2) Each entrance or access point to a high radi- quantity of radioactive material speci_fied in

. ction area shall ber 40.23(136C) of this chapter - shall be conspicuously -,

1. Equipped with a control device which shall posted with a sign or signs bearing the radiation

cause the level of radiation to be reduced below that caution symbol and the words:ct sich an individual might receive a dose of 100

tillirems in one hour upon entry into the area; or CAUTION (OR "DANTR")2. Equipped with a control device which shall RADI0 ACTIVE MATERIAL

energize a conspicuous visible or audible alene sig-nal in such a manner that the individual entering the (2) Each area or room in which natural uranium orhigh radiation area and the licensee or a supervisor thoriun is used or stored in an anomt exceeding 100

cf the activity are made aware of the entry; or times the quantity specified in 40.23(136C) shall be3.. Nintained locked except during periods den conspicuously posted with a sign or signs bearing the

access to the area is required, with positive control radiation caution symbol and words:cver each individual entry.

(3) The controls required by 40.9(3)"c"(2) shall CAUTION (OR ,"DANTR")bo est211shed in such a way that no individual will RADIDACTIVE PATERIAL

be prevented from leaving a high radiation area.(4) In the case of a high radiation area ests- f. Q)ntainers.

lished for a period of tnitty days or less, direct (1) Except as provided in 40.9(3)"f"(3), eac hsurveillance to prevent mauthorized entry may be centainer of radioactive material shall bear a dur-cdastituted for the controls required by 40.9(3)c(2). able, clearly visible label irientifying the radio-

(5) Any licensee or registrant may aoply to the active contents.egency for an exemption to use alternative methods (2) A label required pursuant to 40.9( 3)" f"(1 )

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ch:11 bort the radiati:n caution cymb:1 and the po'ted with a cautian Sign because of the pr'sence of-

words: a sealed source, provided the radiation level 12

inches fram the surface of the cource container orCAUTION (OR " DANGER") housing does not exceed five millirema per hour.

RADIDACTIVE MATERIAL 40.10(2) Roons or other areas in hospitals are

not required to be posted with caution signs, and

1. It shall also provide sufficient infomation control of entrance or access thereto pursuant to

to permit individuals handling or using the contain- 40.9(3)c is not required because of the presence ofcrs, or erking in the vicinity thereof, to take patients containirg rafion:tiv e material provided

precautions to avoid or minimize exposures. that there are personnel in attendance to will take2. As appropriate, the infonaation will include the precautions necessary to prevent the exposcre of

radiation levels, kinds of material, estimate of any individual to radiation or radioactive materialactivity and date for sich a:tivity is estimated. in excess of the limits est411shed in the rules in

(3) %twithstanding the provisions of 40.9(3)f(1) this chapter.

labeling is not required: 40.10(3) Caut ion signs are not required to be1. For containers that do not contain radioactive posted in areas or rooms containing radioactive

caterial in quantities greater then the applicable material for periods of less than eight hours pro-

quantities listed in 40.23(136C). vided that:2. For containers containing only natural uraniun a. The material is constantly attended dJring

or thorius in quantities no greater than ten times such periods by an individual who shall tale the

the applicable quantities listed in 40.23(136CT. precautions necessary to prevent the exposure of rny3. For containers that do not contain radioactive individual to radiation or radioactive material in

material in concentrations greater than the appli- excess of the li; nits establisPed in this chapter; and

cable concentrations listed in 40.22(136C), Table I, b. Such area cr room is subject to the licensee'sColumn 2. or registrant's control. /

4. For containers den they are attended by an 40.10(4) A room or other area is not required to 1

individual tho . takes the precautione necessary to be gusted with a caution sign , and control is notprevent the exposure of any individual to radiation required for each entrance or access point to a roomor radioactive seterial in excess of the limits or other area thich is a high radiation area solely-catablished by the rules in this chapter. because of the presence of radioactive material,

5. For containers then they are in transport and prepared for trsneport and packaged and labeled inpackaged and labeled in accordance with regulations accordance with regulations of the U.S. Department ofpelished by the U.S. Department of Transportation. Transportation.

6. Fcr containers which are accessible only to 40.10(5) A room or other area is not required to

individuals authorized to handis or use them or to be posted with a cauthion sign because of' the pre- -work in the vicinity thereo f, providud that the sence and use of a diagnostic X-ray machine in thecontents are identified to s;ch individuals by a healing arts govided the X-ray systen otherwisereadily available written record. These would meets the requirements of 470--chapter 41.include containers in lecations su:h as interfilled

canals, storage vaults, cr het cells; and 470-40.11(136C) Instruction of personrul. Instruc-

7. For manufacturity and process equipment such tions required for individuals voriing in or fr e-

as piping and tanks. quenting any portion of a restricted area are speci-(4) Each licenseo shall, prior to disposal of an fled in 40.21(136C) .

empty uncontaninated container to unrestricted areas,renove or deface the radioa-tive material label or 470 40.12(136C) Storage and control of sources ofctherwise clearly ino cate that the container no radiation.lorger contains radioactive material. 40.12(1) Sources of radiation shall be secured

g. Radiation machines. All radiation machines against mauthorized removal fran the place of stor-shall be labeled in a manner inich cautions indivi- age.

duals that radiation is produc.ed when the machine is 40.12(2) Sources of radiation in an mrestrictedbeing operated. area and not in storage anall be tended mder the

constant surveillance and imediate control of the470-40.1C(136C) Exceptions free pating and labeling licensee or registrant.requirements. %twithstandirg the gevisions of

40.9(3): 47G-40.13(136C) Procedures for picking g, receiv-

40.10(1) A roon or area is not required to be iry , and openity packages.

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-40.13(1) Each licensso so expects to receivo e no letsr than these hours artst the packags ispackage containing quantities of radioactive material received at the licensee's facility if received dur-in excess of the A2 quantities specified in 470-- ing the licensee's nonnel torking hours, or eighteen38.14(136C): hours if received after normal working hours.

a. If the package 'is to be delivered to the 40.13(6) If radiation levels are found on thelicensee's facility by the carrier, make arrangements external sur face of the package in excess of 200to receive the package den it is offered for deliv- millirens per hour, or in excess of 10 millirens percry by the carrier; or hour at 1 meter from the external sur face of the

'

b. If the package is to be picked up by the package, the licensee shall immediately notify, bylicensee at the carrier's terminal, make arrangements telephone and telegraph, the final delivering carrierto receive notification fram the carrier of the arri- and the agency.vel of the package, et the time of arrival. 40.13(7) Each licensee shall establish and main-

40.13(2) Each licensee 50 picks up a package of tain procedures for safely opening packages in sich,

radioactive material from a carrier's terminal shall radioactive material is received and shall assurepick up the package expeditiously upon ~ receipt of that such procedures are fbilowed and that &enotification from the carrier of its arrival. consideration is given to special instructions for

40.13(3) Each licensee upon receipt of a package the type of package being opened.of radioactive material, shall monitor the external

curfaces of _ the package for radioactive contaninetion 475 40.14(136C) Neste disposal.caused by leakage of the radioactive contents. The 40.14(1) General requirement. % licensee shallmonitoring shall be performed as soon as practicable dispose of any radioactive material except:cfter receipt, but no later than three hours after a. By transfer to an autterized recipient as pro-

the package'is received at the licensee's facility if vided in 470-39.55(136C); orreceived during the licenoce's nonnel torking hours b. As authorized pwouant to 40.7(136C) aNdor eighteen hours if received after normal working ' 40.14(2) to 40.14(6).

. hours. Such monitoring need not be performed on: 40.14(2) Method of obtaining approval of proposed-

s. Packages containing less than 1 millicurie of disposal proc 0dures.beta esitting, gamme emitting or both; radioactive a. Any person may apply to the agency for approv-

*

catorial or -10 microcuries of alpha emitting radio- al of proposed procedures to dispose of radioactive'- active material; material in a manner not'otherwise authorized in this

b. Packages containing no more than 10 milli- chepter.curies of radioactive material consisting solely of (1) Each application shall include a description,

tritium, carbon-14, sulfur-35, or iodine-125; of the radioactive material, including the quantitiesc. Packages containing only special form radio- and kinds of radioactive material and fevels of

active material or gases; radioactivity involved, and the proposed manner and -d. Packages containing only radiactive material conditions of disposal.

in other than liquid form, including h-99/Tc-99m (2) The applic ation, dere appropriate, should

generato rs , and less than the A2 quantity specified also include en analysis' and evaluation of pertinentin 470-38.14(136C) of these regulations; and information as to the

e. Packages containing only radionuclides with 1. Nature' of the environment, including topo-'

|half-lives of less than thirty days and a total quan- graphical, geological, meteorological, and hydro-

i tity of no more than 100 millicuries. logical characteristics.

| 40.13(4) If removable radioactive contamination 2. Usage of ground ~ and surface waters in thein excess of 0.01 microcurie per 100 square conti- general area.

,- meters of package surface is found on the external 3. The nature ' and location of other potentially

| tefaces of the package, the licensee shall immedi- affected facilities; and4

(tely- notify, by telephone and telegraph, the final 4. Procedures to be observed to minimize the risk! delivering carrier and the agency. of mexpected or hazardous exposures.

40.13(5) Each licensee or registrant, upon b. The agency will not consider any applicationreceipt of a package containing quantities of radio- for a license to receive radioactive material from

active material in excess of the A2 quantities speci- other persons for disposal on land. Authorizationj fled in 470-38.14(136C), other than those transported for awh land disposal of radioactive testes must be( ~ by exclusive use vehicle, shall monitor the radiation sought from the - Nuclear Regulatary Conunission, Iows

| legels external to the package. The package shall be Department of hter, Air and este Management, and| monitored as soon as practicable after receipt, but Midwest Interstate tow-level Radioactive Weste

( Compact Commission.

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*L 40.14(3) Dispon-1 by eclease inta sanittry sewag2 weight cf the entiro animal; provided, hoever, tis-

cystems. cue c:y not be di posed of unctr 40.14(6)"a" in aa. % licensee shall discharge radioactive mater- manner that could permit its use either as food for

ial into a sanitary sewage system unless: htmana or as animal feed.(1) It is readily soltble or dispersible in b. % thing in 40.14(6)"s," however, relieves the

water. licensee of paintaining records showing the receipt,(2) The quantity of any radioactive material trans fer mi disposal of stch radioactive material

released into the systen by the licensee in any one as specified in 470--38.4(136C).day does not exceed the larger of: c. % thing in 40.14(6)"a" relieves the licensee

1. The quantity which, if diluted by the everage from complying with other applicable federal, statedaily quantity of sewage released into the sewer by and local rules governing any other tovic or hazard-the licensee, will result in an average concentration ous property of these esterials.cqual to the limits specified in 40.22(136C) , TableI, Coltan 2; or 475-40.15(136C) Classification of radioactive inste

2. Ten times the quantity of stch material speci- for near-surface disposal.

fled in 470--40. 23(136C) . 40.15(1) Considerations. Determination of the(3) The quantity of any radioactive material classification of weste involves two considerations.

released in any one month, if diluted by the average First, consideration must be given to the concentra-

monthly quantity of water released by the licensee, tion of long-lived radionuclides and their shorter-till not result in an average concentration exceeding lived precursors dose potential hazard will persist

the limits specified in 40.22(136C), Table 1,-Coltan long after such precautions as institutional con-2. trols, imprwed inste form, and deeper disposal have

(4) The gross quantity of radioactive material, ceased to be ef fective. These precautions delay theExcluding hydrogen-3, and carbon-14 released into the time den long-lived radionuclides could cause expt -sewage systen by the licensee does not exceed one sures . In addition, the magnitude of the potentidcurie per ye ar . The quantities of hydrogen-3 and dose is limited by the concentration and availabilitycarbon-14 released into the sanitary sewage system of the radionuclide at the time of the exposure. '

cay rot exceed five curies per year for hydrogen-3 Second, considaration must be given to the concentes-and 1 curie per year for carton-14. tion of shorter-lived redinnuclides for which.

b. % licensee shall discharge radioactive ester- requirenents on institutional controle, weste form ,sal into an individual sewage disposal systaa usaf and disposal methods are effective.for the treatment of westewster serving only a single ' 40.15(2) Classes of deste.dwelling, office building, industrial plant, or a. Class A waste is waste that is usually cegrc-

institution except .as specifically approved by the gated from other teste classus at the disposal site.agency pursuant to 40.7(136C) and 40.14(2). The physic al fo m and characteristics of Class A

c. Excreta from individuals tndergoing medical teste must meet the minimta requirensnts set forth indiagnosis or therapy with radioactive material shall 40.16(1). If Class A inste also meets the steility

be exempt froa any limitations contained in 40.14(3). requirements set forth in 40.16(1), it is not neces-40.14(4) Dispsal by burial in soil. % licensee sary to segregata the teste for discosal.

shall dispose of radioactive material by burial in b. Class B weste is meste that must mest moresoil except as specifically approved by the agency rigorous requirements on weste fann to ensurc stabil-ptesuant to 40.14(2). ity after oiapsal. The physical form and charmter-

40.14(5) Disposal by incineration. % licensee istics of Class 8 waste must meet both the ministachall incinerate radioactive material for tbo purpose and attility requirments set forth in 40.16(136C) .cf dicposal or preparation for disposal except as c. Class C weste is weste that not only must meetspecifically approved by the agency ptr suant to more rigorous requireeents on veste fann to ensure40.7(136C) and 40.14(2). stability but also requires additional measures at '

40.14(6) Disposal of specific iestes. the disposal facility to protect against inadvertenta. Any licenses may dispose of the following intrusion. The physical fann and cheracteristics of

radianctive material wtthout regard to its radio- Class C waste must meet both the icinimun and stabil-sctivity: ity requirements cet forth in 40.16(136C).

(1) 0.05 microcurie or less of hydrogen-3 or 40.15(3) Classifiention detemined by long-lived,

carbcn-14 per gran of medita used for liquid scintil- radionuclides. If the waste containa only radio-

lation comtings or nuelides listed in A0.15(4), classificatien shall be

(2) 0.05 mierneurie or less of hydrogen-3 or determined as fellows:carbcn-14 per gesa o animal tissue averaged over the |

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o. If'the concentration does not exceed 0.1 tim:0 40.15(6)-

the value in 40.15(4), the weste is Clane A.b. If the concentration acceede 0.1 times the Concentration,

vclus in 40.15(4), the weste is Class C. curies / cubic meter,

c. If the concentration exceeds the value in Radionuclide Column 1 Column 2 Coltan 340.15(4), the weste is not generally acceptable fornear-owface disposal. Total of all radio-

. d. for westes containing mixtures of radio- nuclides with lessnuclides listed in 40.15(4), the total concentration than 5-year half-life 700 * *

; shell be determined by the sta of fractions rule

i described in 40.15(9). H-3 40 * *

|

! 40.15(4) Co-60 700 * *,.

Radionuclide Concentration Ni-63 3.5 70 700

| C-14 8 curies /ctbic meter Ni-63 in activatedC-14 in activated metal 80 curies /csic meter metal 35 700 7000

Ni-59 in activated metal 220 curies /ctbic meterb94 in activated metal 0.2 cwies/ctbic meter Sr-90 0.04 150 7000

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Tc-99 3 curies /ctbic meterI-129 0.08 eurlee/ cubic . meter Cs-137 1 44 4600

Alpha emitting traneuranic .

,'radionuclides with half-lifegreater than five ) ears 100 nanocuries/gres *There are no limite established. for these radio-Pu-241 3,500 nanocuries/ gram nuclidae in Class 8 or C westes. Practical con-On-242 20,000 nanocwies/gres siderations .such as the effects of external radia-, ,

| '

~ R>226 100 . nenocuries/ gram tion and internal heat generation on transportation,

| handling, and disposal alli limit the concentratione * .

' for these westes. These westes shall be Class Bi 40.15('5) Classification determined' by short-lived misse the concentrations of other radionuclides in! radionuclidos. If the weste does not contain any of f 40.15(6) determine the weste to be Class C indepen-

the radionuclides listed in 40.15(4), classification dont of these radionuclides.shall be determined bened on the concentrations shom /in 40.15(6). If a nuclide is not listed in 40.15(6), 40.15(7) Classification determined by both long -it does not need to be considered in determining the and short- lived radionuclides. If the weste con-

moto class. tains a mixture of radionuclides, some of *ich are

a. If the concentration does not exceed the value listed in 40.15(4), and some of dich are listaf in. in 40.15(6), Coltan 1, the mete is Class A. 40.15(6), classific ation shall be determined as

b. If the concentration exceeds the value in - follows:40.15(6), &lian 1, but does not exceed the value in a. If the concentration of a radionuclide listed40.15(6), Column 2, the weste is Class B. in 40.15(4) is less than 0.1 times the value listed

c. If the concentration exceeds the value in in 40.15(4), the close shall- be that determined by.40.15(6), Column 2, but does not exceed the value in the concentration- of radionuclides listed in

40.15(6), hitan 3, the weste is Close C. 40.15(6).d. If the . concentration exceeds . the value in b. If the concentration of a radionuclide listed

| 40.15(6), Qalten 3, the mete le not generally accep- in 40.15(4) exceeds 0.1 times the value listed intable for near-owface disposal. 40.15(4), the weste shall be Class C, provided the'

| o. For metes containing mixtwee of the radio- concentration of relionuclides listed in 40.15(6)nuclides listed in 40.15(6), the total concentration does not exceed the value shom in Column . 3 of'

.shall be determined by the sus of fractione rule 40.15(6).,

40.15(8) Classification of wastes with radio-described in 40.15(9). .

nuclides other than ttose listed in 40.15(4) andI

40.15(6). If the weste does not, contain any radio-nte11 des listed in either 40.15(4) and 40.15(6) it isClass A.

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|- 40.15(9) The Cun cf the fracti;ns rulo far clx- gener; ting, quantities cf t:xic gese3, v;por3, or

tures of radionuclides. For determining classifice- funes hannful to persons transporting, handling, ortion for inste that contains a mixture of radionu- disposing of the waste. This does net apply to ,

clides, it is necessary to detemine the sun of radioactive gaseous weste packaged in accordance withfractions by dividing each radionuclide's concentra- 40.16(1)"h."tion by the appropriate limit and adding the result- g. Pyrophoric materials contained in westes shalling values. The appropriate limits must all be taken be treated , prepared , and packaged to be nonflan-fran the same column of the same tele. The sun of mable. )the fractions for the column must be less than 1.0 if h. *stes in a gaseous fone shall be packaged atthe weste class is to be determined by that colunn. an absolute pressure that does not exceed 1.5 atmos- )

Example: A weste contains Sr-90 in a concentration pheres at 20*C. Total activity shall not exceed 100 ,

of 50 curies per meter c@ed and Cs-137 in a concen- curies per container. Itration of 22 curies per meter csed. Since the 1. Westes containing hazardous, biological, l

concentrations both exceed the values in 40.15(6), pathogenic, or infectious material shall be treated '

Column 1, they must be coopered to Column 2 values. to reduce to the maximum extent pacticable theFor Sr-90 fraction, 50/150 x 0.33; for Cs-137 frac- potential hazard from the nonradiological materials.tion, 22/44 0.5: the sun of the fractions = 0.83. 40.16(2) The following requirements are intendedSince the sun is less than 1.0, the weste is Class D. to provide stability of the weste. Stability is

'

40.15(10) Determination of concentrations in intended to ensure that the veste does not' degradewestes. The concentration of a radionuclide may be and affect overall stability of the site through

determined by indirect methods swh as use of Ilcaling slunping, collapse, or other failure of the disposal

fac tors dich relate the inferred concentration of mit and thereby lead to water infiltration. St@ il .

one radionuclide to another that is measured , or ity is also a factor in limiting exposure to artradionuclide material accomtabilty, if there is inadvertent intruder, since it provides a recogni:-reasonable assurance that the indirect methods can be sie and noMispersible waste.

correlated with actual measurements. The concentra- e. Weste shall have structural stability. A

tion of a radionuclide may be ateraged over the structurally stable unste form will generally main-

volume of the waste, or neight of the weste if the tain its physical dimensions and its form, under the

units are expressed as nanocuries per gran. expected disposal conditione such as weight of over-burden and compaction equipment, the preserce of

470-40.16(136C) Radioactive unste characteristics. moistur e, and microbial activity, and internal fac-

40.16(1) The following are minimua requirements tors seh es radiation effects and chemical changes.for all classes of waste and are intended to facili- Structural stabilit>can be provided by the weste formtate handling and govide protection of health and itself, processing the inste to a stable j onn, orf

safety of personnel at the disposal site. placing the weste in a disposal container or struc-

a. Westes shall be packaged in conformance with ture that provides steility after disposal.

the conditions of the license issued to the site b. %twithstanding the provisions in 40.16(1)coperator to thich the inste will be shipped. Were and de liquid instes, or testes containing liquid,

the conditions of the site license are more restric- shall ba converted into a fo rm that contains os

tive than the provisions of these regulations , the little freestanding seid noncorrosive liquid as is

alte license conditions shall govern. reason ely achievable, but in no case shall theb. Wastes shall not be packaged for disposal in liquid exceed 1 percent of the volme of the issta

cardboard or fiberboard boxes. ihen the waste is in a disposal container designed toc. Liquid menete shall be packaged in sufficient ensure steility, or 0.5% of the voluee of the weste

absorbent material to absorb twice the volume of the for weste processed to a stele form.liquid. c. Wid spaces within the teste and between tne

d. Solid wastes containing liquid shall contain weste and its packags shall be reduced to the extentes little freestanding aM rnncorrosive liquid as is pr actic able ,reasonably achievanle, but in no case shall the

liquid exceed 1 percent of the volune. 470-40.17(136C) Radioactive unste labeling. Eache. % ste shall not be readily capable of datena- package of seste shall be clearly 12eled to identify

tion or of explosive decomposition or reaction at ehether it is Class A, Class B, or Clasa C tests, in

normal presoures and teope ratures , or cf explesive accordance with 40.15(1MC).| reaction with wuter.

f. hate shall not contain, or be capotle of 470-40.13(136C) Reserved.

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475-40.19(136C) * Transfer fbr Caposal and anni- cigned c:py of the canifxt from the collector.

feste. f. Include one copy of the manifest with the40.19(1) Each shipment of te ste to a licensed shipment;

land disposal facility shall be accompanied by a g. Retain a copy of the manifest with docmenta-shipment manifest that contains the nane, address, tion of acknowledgement of receipt as the record ofand telephone number of the person generating the transfer of . licensed meterial as required by theseweste. The manifest shall also include the nane, rules;

address, and telephone number of the person trans- h. For any shipments or any part of a shipnentporting the waste to the land disposal facility. The for sich acknowledgement of receipt has not beencanifest shall also indicate as completely as practi- received within the times set forth in 40.19(136C),

csle: A physical desc ription of the teste; the conduct an investigation in accordance with 40.19(7).weste volune, radionuclide identity and quantity; the 40.19(5) Any weste collector licensee to handlestotal radioactivity; and the principal chemical only prepackaged teste shall:fo rm. The solidification agent shall be specified. a. Acknowledge receipt of the neste from the

Wastes containing more than 0.1 percent chelating generator within one seek of receipt by returning aagents by weight shall be identified and the weight signed copy of the manifest;percentage of the chelating agent estimated. Wastes b. Prepare a new manifest to reflect consolidated

classified as Class A, Class B, or Class C in 40.15 shipments; the new manifest shall serve as a listing

(136C) shall be clearly identified as sm h in the or index for the detulled generator manifests.canifest. The total quantity of the radionuclides Copies of the generator manifests shall be a part ofH-3, C-14, Tc- 99 and I-129 shall be shoors.

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the new manifest. The weste collector may prepare a40.19(2) The manifest required in 40.19(1) may be new manifest without attaching. the generator mani-

chipping papers used to meet U.S. Orpartment of fests, provided the new manifest contains for eachTransportation or U.S. Environmental - Protection package the information specified in 40.19(1). The

Agency regulations or requirements of the receiver, collector licensee shall certify that nothing haaprovided all the required information is included. been done to the waste which would invalidate the

40.19(3) Each manifest shall include a certifica- generator's certification,

tion by the weste generator that the transported c. Forward a copy of the new manifest to the landcaterials are properly classified, described, pac k- disposal facility operator at the time of shipment;

aged, marked, and labeled and are in proper condition d. Include the new manifest with the shipment tofor transportation according to the appli.:able regu- the-disposal site;

lations of the U.S. Department of Transporation and e. Retain a copy of the manifest with documenta-the agenc y. An authorized representative of the tion of acknowledgement of receipt as the record ofweste generator shall sign and date the manifest. transfer of licensed material as required by these

40.19(4) Any licensee to transfers teste to a regulations, and retain information from generator

land disposal facility or a licensed veste collector manifests mtil disposition is authorized by the

shall comply with the following requirements. Any agency; andlicensee who transfers waste to a licensed waste f. For any shipments or any part of a shipmentprocessor so treats or repackages teste shall comply for sich acknowledgement of receipt is not receivedc:ith the requirements of 40.19(4) "d" to "h." A within the times set forth in this rule, condet an

licensee shall: investigation in accordance with 40.19(7).s. Prepare all testes so that the weste is 40.19(6) Any licensed waste processor to treats

,

| classified according to 40.15(1360) and meets the or repackages mestes shall:I .weste characteristics requirements in 40.16(136C); s. Acknowledge receipt of the weste fran the

b. Label each package of veste to identify generator within one seek of receipt by returning awhether it is Class A weste, Class B weste, or Class signed copy of the manifest.C waste, in accordance with 40.15(136C); b. Prepare a new manifest that meets the require-

c. Conduct a quality control progran to assure ments of 40.19(1),40.19(2) and 40.19(3). Preparationcompliance with 40.15(136C) and 40.16(136C); the pro- of the new manifest reflects that the ;rocessor is

gran must include management evaluation of audits; responsible for the weste.d. Prepare shipping manifests to meet the c. Prepare all testes so that the ne ste is

requirements of 40.19(1) and 40.19(3); classified according to 40.15(136C) and meets thee. Forward a copy of the manifest to the intended esiste characteristics requirenent in 40.16(136C) .

recipient, at the time of shipment ; or, deliver to e d. Label ea:h package of weste to identifycollector at the time the waste is collected, obtain- * ether it is Class A waste, Class B waste, or Classing ac knowledgement of receipt in the form of a

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*- C istto, in acccrdanca with 40.15(136C) and 40.17 (1) Rocards ef individual expo uro to radiction(136C). and to radioactive material Aich must be maintained

e. A quality control progree shall be conducted pursuant to the provisions of 40.20(1)a and recordsto assure compliance with 40.15(136C) and 40.16 of bioasesys, including results of whole body comt-(136C) . The program shall include manageisent evalu- ing examinations, made pursuant to 40.8(136C) shallstion of audits. be preserved until the agency authorizes disposition.

f. Forward a copy of the new manifest to the (2) Records of the results of swveys aid noni-disposal site operator or waste collector et the time toring which must be maintained pursuant to 40.20(1)of shipment, or deliver to a collector at the time "b" shall be preserved for two years after completionthe weste is collected, obtaining acknowledgement of of the survey except that the following records shallreceipt in the form of a signed copy of the manifest be maintained mtil the agency authorizes theirby the collector. dispositions

,g. Include the new manifest with the shipment. 1. Records of the results of surveys to determine I

h. Retain copies of original manifests and new compliance with 40.4(1).manifests with document ation of aciciowledgement of 2. In the absence of personnel monitoring data,receipt as the record of transfer of licensed mater- records of the results of surveys to determine exter-ial required by these regulations. nal radiation dose; and

1. For any shipnent or part of a shipment for 3. Records of the results of surveys usted towhich acknowledgement is not received within the evaluate the release of radioactive effluents to thetimes set forth in this rule, conduct en investigs- environment.

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Lion in accordance with 40.19(7). (3) Records of disposal of licensed material made. 40.19(7) Any shipment or part of a shipment for pursuant to 40.14(2) to 40.14(6) and 40.15(136C) to

dich acknowledgement is not received within the 40.19(136C) shall be maintained mtil the agencytimes set forth in this rule must authorizes their disposition. ,'

Be investigated by the shipper if the shipper (4) Records sich must be maintained pwsuant t;a.7has not received notification of receipt within this chapter may be the original or a reproduced copy i

twenty days after transfer; and or microform if euch reproduced copy or microfors bb. Be traced and reported. The investigation duly authenticated of authorized personnel and th.

shall include tracirrj the shipment and filing a nicroform is capable of producinq a clear and legible'report with the agency. Each licensee 40 conducts a copy after storage for the period specified by agencytrace investigation shall file a written report with rules.-the agency within tie weeks of completion of the (5) If there is a conflict bet =een the agency's

,investigation. rules in this chapter, license condition, or oth ewritten agency approval or authorization pertainic.g

470-40.2G(136C) Records, reports, ed notification. to the retention peried for the sans type of record,40.20(1) Recceds of swveys, radiation monitor- the retention specified in the rules in this chapter

ing, and disposal. for sah records shall apply unless the agency, pur-a. Each licensee or registrant shall maintain suant to 38.3(1), of radiation rules, has granted a

rocords showing the radiation expneures of all indi- specific exemption from the record retention require-viduals for som personnel monitoring is required ments specified in the rules in this cbspter.under 40.9(2). d. The discontinuance o f, or c urtailment of.

(1) Such records shell be kept on 52-2.0-794, in activities does not tellese the licensee or regi-accordance with the instructions contained in that strant of responsibility for retaining all recordsform, cr on clear and legible records containing all required by 40.20(136C). A licensee or registrantthe informetion required by SHD-2.0-794. may, however, requitst the agency to accept such

(2) The doses entered on the forms or records records. lhe acceptarce of the records by the agencyshall be for periods of time not exceeding one celee- relieves the licensee or registrant of subsequentdar quarter. responsibility only in respect to their preservation

b. Euch licensee or registrant shall maintain as requirod by 40.20(1).records in the case mits used in this chapter, 40.20(2) Reports of theft or loss of licensedshowing the results of surve;s required by 40.9(1), material.monitoriruj required by 40.13(3) 40.13(5) and 40.13(6) a. Each licensee shall report to the agency, byand disposals made meer 40.14(2) to 40.14(6) and telephone, imediately after it determines that a40.15(136C) to 40.19(136C). loss or theft of licensed material has occurred in

c. Preearvation of records, such quantities and mder awh circunstances that it

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appe re ta the licenses that a editantial h;z:rd any * (2) The release cf redbactivo notarial in~result to poreano in unrestricted erees concentratione dich, if averaged over a period of

b. . Each licensee so makes a report shall provide twenty-four hours, muld exceed 500 times the limitsthe following informations specified for euch materiale in 40.21(136C), Table

(1) A description of the radioactive asterial II; or

involved, including kind, quantity, chemical, and (3) A loss of one day or more of the operation ofphysical forms any facilities affected or

(2) A description of the circumetences under (4) Damage to property in excese of $2,000.sich the lose or theft occurred; c. Any report filed dth the agency prouent to

(3) A statement of . disposition or probable dis- 40.20(3) shall be propered in such a menner that. position of.the radioactive esterial involved; names of individuals to here received meessive

(4) Radiation exposures to individuele, circtan- doses will be stated in a separate part of the

stances mder $1ch the expoewee occurred, and the report. ,

extent of possible hazard to persons in meestricted 40.20(4) Reserved. Screast 40.20(5) Reports of overeupoewes and excessive

(5) Actions which have been taken, or will be levels and concentrations.taken, to recover the materials a. In addition to any notification required by

(6) Procedures or measures sich have been or 40.20(3), each licensee or registrant shall male atill be adopted to prevent a recurrence of the loss report in witing dthin thirty days to the agency

cr theft of licensed meterial and of~

(7) Subsequent to the filing the witten report (1) Each exposure of an individual to radiation

the liconese shall also report any s4stentive addi- in excess of the applicable standards in 40.2(1MC),tional inforation on the lose or theft sich becomes 40.5(1) or the radioactive meterial licones.available to the licensee. (2) Each exposure of an individual to radioactiv'e

40.20(3) Notification of incidente. meterial in acees of the applicable limits in. ,

I -e. Immediata. notification. Each licensee or 40.4(1)e, 40.4(1)b, 40.5(2) or the licones. -

registrant shall immediately notify the agency by .(3) Levels of radiation or concentrations oftalophone and telegraph of any incident involving any radioactive meterial in a restricted area in meses ~*

source of radiation possessed by the licensee or of any other applicable limit in the license. '.

registrant and which may have caused or threatene to (4) Any incident for which notific ation is-

causes required by 40.20(3); and(5) Levels of radiation or concentrations of-(1) A does to the whole body of any individuni of f

25 rams or more of redistion; a does to the skin of radioactive meterial, eother or not involving'exces-the whole body of any individual of 150 rene or more eive exposure of any individual, in an er,detricted.sf radiations or a does to the feet, ankles, hands, ores in excess of ten times any applicable limit est -

cr forearms of any individual of 375 rene or more of forth in this chepter or in the license.

radiations or b. Each report required mder 40.20(5)"e" shall(2) The release of radioactive material in con- doenribe the extent of exposure of individuals to

contrations . sich, if. aretaged over a periud of radiation or to radioactive material, includirup esti.

tuenty-four hours, would exceed .5,000 times the mates of each individual's exposure se required by

limits specified for such materiale in 40.21(1MC), 40.20(5)"c" levels of radiation and concentrations. Table 11 or of radioactive material involved; the cause of the

(3) A loss of one erking mek or more of the expoetre, levels, or concentrations; and correctiveoperation of any facilities effected or steps taken or ' planned to soeure against a recur-

- (4) . Damage to property in oceae of $200,000, rence.'

b. Twenty four hour notification. Each licensee c. Any report filed with the agency pursuant tocr registrant shall dthin twenty-four hoere notify 40.20(5) shall include for each individual aposed

the agency by telephone and telegraph of any incident the name, social security ntauber, and date of birth,involving any source of radiation possesecd by them and an estimate of the individual'a dose. lhe repcrt

and sich may have caused or threatene to causes shall be prepared so that this information is stated(1) A does to the sole body of any individual of in a separate part of the report.

5 rems or more of radiations a dose to the skin of 40.20(6) Reserved.the sole body of any individual of 30 rams or more 40.20(7) Vacating gramises. Each specific

cf redistion s or a dose to the feet, unkles, hands, licensee shell, no less then thirty days be fore

ce foreanne of 75 reos or more of radiation; or vacating or relinquishing possession or control ofpromises which may have been contanineted with

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.radio tivo met: rial as o result d the lic:ns:o'o the docunent applies, shall be conspicuouf, and sh:11activitico, notify the agency in writing cf intent to be r placed if defaced c'r cit: red.vacate. hen deemed necessary by the agency , the 40.21(3) Instructions to scrkers,

licensee shall decontaninete the promises in such a a. All individuals working in or frequenting anymenner as the agency may specify. portion of a restricted areas

(1) Shell. be kept informed of the storage, trans-4440.21(136C) hticos, instrictions and reports to ter, or use of sources of radiation in och portionsworkers; inspections. of the restricted area.

40.21(1) Purpose and sc ope . Rule 40.21(136C) (2) Shall be instructed in the health protectionestablishes requirements for notices, instructions problems associated with exposure to radiation orand reporte by licennees or registrants to indivi- radioactive meterial, in precautions or procedures toduels engaged in activities under a license or regi- minimize exposure, and in the purposes and functionsctration and options available to such individuals in of protective devices onployed.connection with agency inspections of licensees or (3) Shall be instructed in, and instructed to

registrants to sacertain compliance with the provi- observe , to the extent within the worker's control,clone of the Act and rules, orders and licenses the applicable provisions of these rules and licensesissued thereunder regarding radiological working for the protection of personnel fran exposures toconditions. The rules in this chapter apply to all radiation or radioactive material occurring in etch

persons eho receive , possess, une, om or transfer areas.sources of radiation registered with or licensed by (4) Shall be instructed of their responsiblity tothe agency pursuant to 470--chapter 39. report granptly to the licensee or registrant ar*y

_

40.21(2) Posting of notices to orkers. condition which may constitute, lead to, or cause oa. Each licensee or registrent shall post current violation of the Act, these rules, and licenses or

c: pies of the following documentet mnecessary exposure to radiation or radioactive(1) 470--chapter 40. meterial .

'

(2) The license, certificate of registration, (5) Shall be instructed in the appropriatu

* conditions or documents incorporated into the license response to ternings made in tha event of any musual~ by reference and amendments thereto. occurrence or malfunction that may involve esposure

(3) The operating procedures applicable to activ- to radiation or radioactive materials andities under the license or registration; and (6) Shall be advised as to the radiation wrposure

(4) Any notice of violation involving radiologi- reports sich scrkers shall be furnished pursuant tocal working conditions, proposed imposition of civil 40.21(4).

~ penalty, or order issued pwsuant to 470--chapter 38, b. The extent of these instructions shall tic*

and any response from the licensee or regiotrant. conenensurate with potential radiological healtii'

/b. If posting of a doctsaent specified in protection problems in the restricted area.

40.21(2)"a"(1), 40.21(2)"a"(2) or 40.21(2)"a"(3) is 40.21(4) Notifications and reports to indisi-

not practicable, the licensee or registrant may post duals.o notice dich describes the document and etstes a. !!adiation exposure data for an individual andwhere it ssy be examined. the results of any measuronents, analyses, and calcu-

c. An agency Form SHD-2.0-792 "Petice to Employ- lations of radioactive material deposited nr retainedees" shall be posted by each licensee or registrant in the body of an individual shall be reccrted to theas required by these rules. individusi as specified in 40.21(4). The information

d. Agency documents posted pursuant to 40.21(2)a reported shall include data and results obtained pt r-(4) shall be posted within five working days after suant to these rules, orders, or licence conditions,tsceipt of the documents from the agency: The licen- as stuwn in records neintained by the licensee or

see's or registrant's response, if any, shall be registrant pursuant to 40.20(1)"a" and 40.20(1)"c" .posted within five scrking days after dispatch fran Each notification and report shallt

the licensee or registrant. Such documents shall (1) Be in writing.

remain posted for a minimum of five oorking days or (2) Include appropriate identifyirvj data such asuitil action correcting the violation has been com- the name of the licensee or registrant, the name ofpleted, *ichever is later. the individual, and the individual's social security

c. Documents, notices, or forms posted pt.rsuant nimiber.to 40.21(2) shall appear in a sufficient number of (3) Include the individual's ex;nstee informa-

places to permit individuals engaged in work under tions andthe license or registration to observe then on the (4) Cantain the following statenent : "Thisway to or from any particular work location to wnich report is furnished to you under the provisions of

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the I ma Ct;to department of he;1th'0 rulo 470-40.21 40.21(6). The 11cene53 ce regictrant may = company(136C). You should preserve this report for further agency inspectors during other phases of an inspec-refe rence ." tion,

b. At too request of the worker each licensee or c. If, et the time of inspection, an individual

registrant shall advies etch erker of their annual has been authorized by the erkers to represent thanexposure to radiation or radioactive material as during agency inspections, the licensee or registrantshom in records maintained by the licensee or regi- ahall notify the inspectors of stch authorization andttront pursuant to 40.20(1)a and 40.20(1)"c." shall give the workers' representative an opportmity

c. At the request of the erker each licensee or to accompany the inspectors dJring the inspection ofregistrant shall furnish such worker with a report of physical working conditions.their torker's exposwo to radiation or radioactive d. Each workers' representative shall be routine-meterial upon termination of employment. ly engaged in work under control of the licensee or

(1) Such report shall be ftrnished within thirty registrant and shall have received instructions asdays from the time of termination of emplopent or specified in 40.21(3).tithin thirty days after the exposure of the indivi- e. Different representatives of licensees or

dual has been determined by the licensee or regi- registrants and workers may accompany the inspectorsctrant *1chever is later. during different phases of an inspection if there is

(2) The report shall cover each calendar quarter no resulting interference with the conduct of the

in sich the sorker's , activities involved exposure to inspection. % wever. only one sorkers' representa-sources of radiation and shall incitaje the dates and tive at a time may accompany the inspectors.locations of tork mder the license or regislration f. With the ap;roval of the licensee or regi-

. in which the worker participated. strant and the workers' representative, en individual. d. men a licensee or registrant is required so is not routinely orgaged in verk mder control ofpursuant to 40.20(5) to report to the agency any the licensee or registrant, for example, a consultant

- exposure of an individual to radiation or radioactive to the licensee or registrant or to the iorkers'

material, the licensee or the registemt shall also representative, shall be afforded the opportmity toprovide the individual of a report on the exposure accompany ejency inspectors during the inspection ofdata included therein. Such reports shall be trans- physical working conditions.titted at a time not later than the transmittal to g. %twithstanding the cther provisions of

the agency._

40.21(5), agency inspectors are authorized to refusee. R the request of a verker so is terminating to - pennit accompaniment by any individual so

employment in a given calendar quarter with the deliberately interferes with a fair and orderly

licenses or registrant in oork irwolving radiation inspection.dose, or of a worker who, shile employed by another (1) With regard t areas containing ir formationperson, is terminating assigranent to work involving classified by an agency of the U.S. (bvernment in the -radiation dose in the licensee's or registrant's interest of national security, an individual do I

facility in that calervier quarter, each licensee or accompanies an inspector say have access to sehregistrant shells information only if authorized to do so.

(1) Provide to ech sich sorker, or to the (2) With regard to any area containing proprie-( worker's designes, at termination, a written report tary in formation, the workers' representative forI regarding the radiation done received by that verker that area shall be an individual previously author-

from operations of the licensee or registrant during ized by the licensee or registrant to enter that

that specifically identified calendar quarter or area.fraction thereofI or 40.21(6) Consultation with workers during inspec-

f (2) Provide a written estimate of that dose if tions.

the finally determined personnel monitoring results a. Agency inspectors may consult privately withj

are not arallable at that time. Estimated doses iorkers concernirq matters of occupational radiationshall be cleetly indicated as such, protection and other matters related to applicable

40.21(5) Presence of representatives of licensees provisions of these rules and licenses to the extentce registrants and werkers during inspection. the inspectors dean necessary for the conduct of an

a. Each licensee or registrant shall afford to effective and trotough inspection.the agency at all reasonable times opportunity to b. During the course of an inspection, any workerinspect meterials, machines, ectivities, fac ilities , may bring privately to the a'.tention of the inspec-promises, and records pursuant to these rules. tors, either orally or in writing, any past or pre-

b. Durirq at inspection, agency inspectors nay sent condition mich the worker has reason to believe,

consult priv s tt*1y with workers as specified in may have contributed to or caused any violation of|

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*

Ac t , these rules, cr license condition, cr any m- exicts or has occur red , the emironmentcl he ,lth'

'

nec:seery cuposure cf an individual ta sources cf section sh:11 notify the complcinant in writing ofradiation mder the licerace's or registrant's con- sich determination.trol. Any such notice in writing shall comply with (1) The complainant may obtain review of stc hthe requirmeents of 40.21(7)"e." detenninetion by semitting a witten statenent of

c. The provisions of 40.21(6)"b" shell not be position with the agency.interpreted as autho rization to disregard instruc- (2) the agency will provide the licensee ortions pursuant to 40.21(3). registreit with a copy of such statement by certified

40.21(7) Requests by wrkers for inspections. meil, excluding, et the reqtust of the complainant,s. Any worker or representative of workers the nuns of the complainant.

believing that a violation of the Act, these rulee, (3) The licensee or registrant say s4mit sier license conditione existe or has occurred in work opposing written statement of position with theunder a license or registration with regard to radio- agency to will provide the complainant with a copylogical working conditions in dich the worker is of such statement by certified mail.engaged may request en inspection by giving notice of b. than the request of the complainant, thethe alleged violation to the envitorunental health agency may hold an informal conference in sich the

coction of the lowe state department of health. complainant and the licensee or registrant may orally(1) Any such notice snell be in writing, shall present their views.

set forth the specific gromds for the notice, and (1) An infonnel conference may also be held atshall be signed by the worker or representative of the request of the licensee or registrant, but dis-the scrkers. clostre of the identity of the conplainent will be

_

(2) A copy shall be provided to the licensee or made only after following receipt of written authori-registrant by the environmental health section no 2ation. from the complainant.later than at the time of inspection except that, (2) After considering all written and oral viewsupon the request of the sorker giving such notice, presented, the agency shall effirm, modify, or re'-the erker's name and the naus of individuals verse the previous determination and furnish the

referred to therein shall not appear in such copy or complainant and the licensee or registrant a written.

on any record published, released, or made available notification of the decision and the reason therefor.by the envitormental health section, except for good c. If the agency detennines that an inspection iscause show1. not warranted because the requirements of 40.21(7)"a"*

,

b. If, upon receipt of such notice, the environ- have not been set, the conplainant shall be notified

mental health section determines that the complaint in writing of such determination. Such determinationat Lts the requirements set forth in 40.21(7)"s," and shall be without prej udice to the filing of a new

that there are reasonable grounds to believe that the complaint meeting the requirements of 40.21(7)"a."clieged violation exists or has occurred, an inspec- /tion shall be mado es soon as practicable to deter-

mine if such alleged violation suists or has oc-

curred. Inspectione pursuant to 40.21(7) need not belimited to matters referred to in the complaint.

c. N) licensee, registrant, or contractor or

cobeontractor of a licoruee or registrant shall

discharge or in any eenner discriminate ogsinst anyerker because such verker has filed any complaint orinstituted or caused to be instituted any proceedingunder these rules or has testified or is dout totestify in any such proceeding or because of theexercise by etch iorker on behalf of the torker or

cthers of any option afforded by this chapter.40.21(8) Inspectione not arranted--informal

review.a. If the environmental health section deter-

cines, with respect to a complaint under 40.21(7),

that an inspection is not wurrented because there areno reasonable gro mde to believe that a violation j'

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475 40.22(136C) Concentretless in air sui unter above netwat bechground.~

40.22(1) Single radionuclideo

Table I Table IIElement !aotope Column 1 Column 2 Column 1 Column 2(atomic Air Water Air Waternumber) (uCi/ml) (uC1/ml) (uC1/ml) (uC1/ml)

Actinium (89) Ac'-227 5 2x10-12 6x10-58x10 13 2x10-414

I h10-11 9x10 3 9x1P 3x10-4Ac-228 S 8x10-8 3x10-3 3x10-9 9x10-5

1 2x10-8 h10-3 6x10-10 9xjg 5

Americius (95) An-241 S 6x10-12 1xig-4 2x10-13 4x10-4I 1x10-10 4

An-242n S 6:10-12 8x10 4 4x10-12 3x10-5'

I 3x10-10 1x10 32x10-13 4x10-6

12 5

An-242 S 4x10-8 3x10 3 9x10 9 9x10 4I 5xig-8 4x10 3

1x10- 1x1T

An-243 5 6x10-12 4x10 4 2x10-9 1x10-41x10- 2x10-13 4x10-6

I 1x10-10 8x10-4 4x10-17 3x10-5An-244 5 4x10-6 1x10-1 1x10-7 5x10-3

I 2x10-5 1x10-1 8x10-7 5x10-3~

5Antimony (51) Sb-122 5 2x10-7 8x10-4 6x10-93x10 5I 1x10 7 8x10 4 5x10-9 3x10-

Sb-124 S- 2x10-7 7x10-4 5x10-9 2x10-51 2x19 8 7x10-4 10

Sb-125 5 5x10-7 3x10-3 7x10 82x10 5

'2x10-I h10-8 h10-3 9x1g-10 1x10 41x10-

Argon (18) Ar-37 Sob 6x10-3 1x10-4- -

Ar-41 Sah 2x10-6 4x10-8-,

,

Areenic (33) As-73 5 2x10-61x10 7

7x304 5x10-42

I 4x10-71x10 3 1x10 8

5x10-48

1x10- 5As-74 S 3x10-72x10 3 4x10-9 5x10 5,

1 1x10-7 2x10- 5x10 5As-76 S 1x10-7 . .. 6x10-4 4x10-9 2x1TI 1x10-7 6x104 3x10 9 2x10-5

As-77 5 5x10-7 2x10-3 2x10-8 8x10-5I 4x10-7 2x10-3 1x10-8 / 8x10-5

10 2x10-4'

Aetatine (85) At-211 S 7x10-9 5x10-52x10 9 7x10-51 3x10-8 2x10-3 1x10-

3 4Berlun (56) 8e-131 S 1x10-6 5x10 3

4xig-82x1047 1x10-8 2x10I

4x10 7 h10 4 4x10-9 3x10 551x10- 8x104 1x10-9 2x10-

Be-140 5'

| I 4xig-8 7x10

10 2x10-2 h10-11 6x10 48erkelium (97) 8k-249 59x10 7 2x10-2 4x10-9 6x1 74I 1x10-

7 6x10-3 5x10-9 2x10 4Bk-250- S1x10 6 6x10-3 4x10-8 2x1T4

I 1x10-|

3'

8eryllius (4)- Be-7 5 6x10-6 5x10-2 2x10-7 2x10 3I ~1x10-6 5x10-2 4x10-8 2x10-

Blanuth (83) 81-206 S 2x10-7 1x10-3 6x10-9 4x10-5I 1x10-7 1xto-3 5x10-9 4x10-5

81-207 5 2x10-7 2x10-3 6x10-9 6x10-5I 1x10-8 2x10-3 5x10-10 6x10-5

9 1x10-3 2x10-10 4x10-581-210 S6x10 9 3 2x10-10 4x10-5I 6x10-

1x10 2 h10-9 4x10481-212 S 1x10-71x10 2 7x10-9 4x10-4I 2x10-7 1x10-

Bromine (35) Be-82 S 1x10-6 8x10-3 4x10-8 3x10-4I 2x10-7 1x10-3 6x10-9 4x10-5

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L 47440.22(136C) Concentratione 'in air ad not:r above netwat baciapround. (Cont.)40.22(1) Single radionuclideo

Tele I Table IIElement !actope Coluen 1 Cblumn 2 Column 1 Column 2(atomic Air Water Air Water

l number) (uC1/ml) (uci/ml) (uci/ml) (uC1/el)

Cadelun (48) Cd-109 S 5x10-8 5x10-3 2x10-9 2x10-41 7x10-8 5x10-3 h10-9 2x10-4

Cd-115m S 4x10-8 7x10-4 1x10-9 3x1g 5I 4x10-8 7x10-4 1x10-9 h10-5

3 5Cd-115 5 2x10-71x10 3

8x10-93x10 5

1 2x10-7 1x 10- 6x10-9 4x10-

Calcium (20) Ca-45 5 h10-8 h10-4 1x10-9 9x10-61 1x10-7 5x10-3 4x10-9 2x10-4

Ca-47 5 2x10-7 1x10-3 6x10-9 5x10-51 2x10-7 1x10-3 6x10-9 3x10-5

C:lifornium (98) Cf-249 5 2x10-12 1x10-45x1012

4x10-614

I 1x10-10 7x10 4 3x10 13510-5

5Cf-250 S 5x10-12 4x10-4 2x1012 1x10 5I 1x10 10 7x10-4 3xig 144x10-63xt0-

12 42x1010 1x10 4 6x1012 5

Cf-251 S -

I 1x10 12 ex10 4 3x10 13 h10 6Cf-252 S 6x1011 2x17 2x10 12 7x10 6I h10 10 2x10-4 1x10 11 7x10 43Cf 253 S 8x1010 4x10 3 3x10 11 1x10 41 8x10 12 4x10 6

3x10- 1x10 7Cf-254 S5x1012 4x10 6

2x10-13 1x10 7I 5x10- 4x10- h10-13 ix10-

Carbon (6) C-14 S 4x10-6 2x10-2 1x10-7 8x10-4(CO ) 54 5x10-5 1x10-6. - ..

2

5'Carium (59) Ce-141 5 4x10-7 3x1C-3 2x10-8 9x10 5 -9I 2x10-7 h10 3 5c10 9 9x10 5Ce-143 S 3x10-7 - 1x20-3 9x17 4x10 5I

2x10 8 1x10 47x10-9 4x10 5

7 3101x1 g- 3 gig 4 3x1010 1x10 5Ce-144 S

1 6:10-9 h10- 2x10- 3xig-

/Cesius (55) Cs-131 S 1x10-5 7xto-2 4x10-7 2x10-3 .

I 3x10-6 3x10-2 1x10-7 9x10-4Ca-134m 5 4x10-5 2x10-1 1x10-6 6x10-3

I 6x10-6 3x10-2 2x10-7 1x10-3Cs-134 S 4x 10-8 h 10-4 1x10-9 9x10-6

5I 1x10-0 1x10-3 4x10-10 4x378 1x10 4Cs-135 5 5x10-7 h10 3 2x10 9 2x1C-41 9x10-8 7x1g-3 3x1 g-

Cs-136 5 4x10 7 510-3 1x10-8 7x10-55

1 2x10-7 2x10-3 6x10-9 6x17Cs-137 5 6x10-8 4x10 4 2x10-9 2x10-5

I 1x10-8 1x10-3 5x10-10 4x10-5

011orine (17) Cl-36 5 4x10-7 2x10-3 1x10-8 gx10-51 2x10 8 h10 3 8xig 10 6x10 5

Cl-38 5 3x10-6 1x10-2 9x10-8 4xjg-41 2x10-6 1x10-2 7x10-8 4x10-4

Diromium (24) Cr-51 S 1x10-5 5x10"2 4x10 7 2x10 3I 2x10-6 3x3o-2 ex t g-8 2x10-3

Cou lt (27) Co-57 5 3x10-6 2x10-2 1x10-7 5x10-46x10-9 4x17"31 2x10-7

1 10-'2 7Co-Sen S 2x10-5 8x10 2 6x10 7 3x10 3I h10-6

6x 10 3h10- 2x10 %

Co-58 5 ex10 8 4x10 31x10-87

1x10~!-

9 %10-I >x 10- h 10- 2x10 8Co-60 s 3x10-7 ix10-3 1x1010 5x10 5'I 9x10 9 1x10 3 h17 g j a-

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470-4032(136C) Concentretiene in air and' toter above netwal bachgramd. (Ccnt.)40.22(1) Single radionuclideo

Table I Table IIElement Isotope Column 1 Column 2 Column 1 Calumn 2(stomic Air Water Air Waternumber) (uC1/ml) (uC1/el) (uC1/el) (uC1/ml)

Copper (29) Cul64 5 2x10-6 t,jo-2 7x10-8 3:10-4I 1x10-6 6 10-3 4x10-8 2x10-4

Curtun (96) On-242 5 1x1010 7x10-4 4x10 12 2x1g-51 2x10-10 7x10-4 6x10-12 2x10-5

On-243 S 6x1012 1,10-4 2x10-13 5 10-6I 1x10-10 7,g0-4 3x10-12 2x10-5

On-244 S 9 10-12 2x10 4 3x10-13 7x10-61 1x10-10 8x10-4 3x10-12 3x10-5

Cm-245 S 5x1012 1xig 4 2x10-13 4x10-612 5

1 1x10-10 8x10-44x10 13 3x10 6On-246 S 5x1012 1x10 4 2x13-

On-247 S 5x1012 8x10 44x10-12 4x10 5I 1x10-10 4 3,j g-

1,tg- 2x10 13 4x10-6

On-248 S 6x10 13 1x10 5 4x10 14 2x10-51 1x10-10 6x10-4 12

2x10- 7

On-249 5 1x10-5 4x10 24x10-13 4x10 6I 1x10-11 5

1x10 36x10- 4x10-7 2x10-I 1x10-5 6x10-2 4x1U-7 2x10-3

2 4Dysprosius (66) Dy-165 5 3x10-4 1x10 2 9x10-8 4x10 41 2xig-6 1 jg 3 7x10 8 4x10 5Dy-166 S

2x10 7 1x10 38x10-9

4x10 57

1 2x10- 1x10- 7x10-9 4x10-

Einsteiniun (99) Es-253- S 8x10-10 7x10-4 3x10-11 2x10-511 5I 6x10-10 7x10-4 2x1010 2x10 5Es-254m S 5x10-9 5x10 4 2x10 10 2x10 5I 6x10-9 5x10-4

Es-254 5 2x1011 4x10 4 2x10 13 2x10 56x10 12 1x10 5

11x1010 4x10-4 4x10 11 1x10 5

10

5x10- g,j g 42x1011 3x10-5

3x17-Es-255 SI 4x10-10 8x10-4 1x10-

3 5Erbius (68) Er-169 S 6x10-7 3x10 32x10-8 9x10 5I 4x10 7 3x10- 1x10-8

Er-171 5 7x10-7 3x10-3 2xig-8 9x10 41x10-1 6x10-7 h10-3 2x10-8 1x10-4

Europium (63) . Eu-152 S4x10 7

2x10-3 1x10-8 6x10-573 1x10-8 6x10-5'

(T 9.2 hes) ! 3x10- 2x10 3 4x10-10 8x10-5'

gEu-152 S 1x10-8

2x10 3 10 5(T :13 yrs) 1 2x10-8 2x10 4 6x10 10 8x1g 5r 9 6x10- 1x10 10 2x10 5Eu-154 54x10 9 6x10-4 2x10 9 2x10 4

*

1 7x10-8 6x10 3 3x10- 2x10-Eu-155 S

9x10 8 6x10-3 3x10-9 2x10-4I 7x10-

Fermiun (100) Fa-254 5 6x10-8 g,gg 3 2x10-9 1x10-43

2x10-9 1x10-41 7x10-84x10 3 10 5

Fm-255 S 2x10-8 1x10 3 6x1010 3x10 51 1x10-8 1,jg-

4x10 10 9,gg-7h10-

Fa-256 S 3x10-9 3xig-5 1x10-I 2x10-9 h10-5 6x10-11 9x10-7

Fluorine (9) T-18 5 5x10-6 2x10-2 1x10-7 8x10 41 3x10-6 j,jo-2 9x10-8 5x10-4

Gadolintun (64) Cd-153 S 2x10-7 6x10 38x10-9 2x10-43

I 910-86x10 3

3x10 9 MO47 5

Cd-159 5 5x10 7 2x10 3 2x10-8 8x10 5I 4x10- M D- 1x10-8 8x10-

- 20 -

r

. .

47tb 40.22(136C) Concedratione in air and eter este netwat bacinground. (Cont.)-

40.22(1) Singlo radionuclideo

T ele I Te le II

Element !aotope Column 1 Column 2 Column 1 (blumn 2(stonic. Air Water Air Weterneber) (uci/el) (uC1/el) (uC1/el) (uC1/ml)

3 5Gallium (31) Go-72 S 2x10-71x10 3

8x10-94x10 5

1 2x10-7 1x10- 6x10-9 4x10-

Gennanius (32) Go-68* S 4x10-6 2x10-2 1x10-7 8x10-41 1x10-8 10

Go-71 S 1x10 5 h10-2 5x10 7 h10-3- -.

4x10-I 6x174 5x10-2 2x10-7 2x10*3

3Gold (79) k 195* S 8x10-6 4x10-2 3,1g-7 ist

8 6x10 3 2x10-9 2x116x10 6 5x10-3 4x10-8 2x1k-1% S 1x10-

1 6x10-7 4x10 3 2x10 81x18

7 3 5N -198 53x10 7 2x10 3 1x10 9 5x10 58x17 h10 41 2x10 6 1x10 3 4x10-8 2x10 4I 8:10-7 5x10 3 3x10-8 2x10-1x10-k -199 5

4xtP,

Hefnium (72) Hf-181 S 4x10-8 2x10 3 1x10 9 7x10-5I 7x10-8 2x10-3 3x10-9 7x10-5

4 5R31mium (67) Ho-166 S 2x10-7 9x10 4

7x10-93x10 5I 2x10-7 9x10- 6x10-9 3x10-

Hydrogen (1) H-3 S h10-6 1x10-1 2x10-7 h103I 5x10-6 1x10-1 2x10-7 3x10-3

Sub 2x10-3 4x10-5---

Indius (49) In 113e S 8x10-6 4x10-2 3x377 gx3g 3*

2 3I 7x10-6 4x10 42x10-7 1x1T4x10-9 2x10 9In-line S 1x10-7

'

5x10 2 3x3o-8I 2x10-8 5x10 4 7x10-10 2x1G 4

1

In-115m S 2x1 76 4x1o-1x1g 2I 2x10-6 1x10 36x10-8 4x 3 g-4

3xtr 9x10-9 9x10 5In-115 S 2x10-71 3x10-8 3x10-3 1x10-9 / 9x10-5

5 11 7Iodine (53) 1-125 5 5 10-9 4x10 3 8x10 9

2x17

6:10 5 6x10 112x10 41 2x177 7

1-126 5 8x10-9I h1P7 3x10-3

9,1g 8 3x10 55x17

I-129 5 2x10-9 1x175 1x10 11 9x10 82x10 3 6x10 4I 7x10-8 6x10 3 2x10-

I-131 S 9x10 9 6x10-5 2x10 10 3x10 73,jg 81x10- 6x175I h1P7 2x10 3

1-132 S 2x10 7 2x10 33x10-9 8x10 4

7 3 ''

h10- 3x10-8 2x10 6I9x10 8 2x10-4 4x10 9 3xig 5

10I-133 53x10 7 1x10-3I 2x10- 7x10- 4x10 I

1-134 5 5x10-7 4x10 26x10-93 2x1T

I Ix10-6 2x10- 1x10-7 6x10 4I-135 5 1x10-7 7x10-4 1x10-9 4x10-6

1 4x10-7 2x10 3 1x10-0 7x10 5

48 2x1 7Iridius (77) Ir-190 S 1x10-6 6x10 3 4x10 8 2x10 41 4x10-7 5x10-3 1x10-Ir-192 S 1x10-7 1x10-3 4x10-9 4x10 +

53 9x10-10 4x17I 3x10-8 1x10 3 8x10-9 3410 5Ir-194 5 2x10-7 1x10-1 2x10-7 9x10-4 5x10-9 3x10-5

Iron (26) Fe-55 S 9x10-7 2x10-2 3,50-0 gu t 0-4

1 1x19-6 7x10 2 h10 8 2x10 3Fe-59 S 1=10-7 2x10 3

5 10-7 6x 10-53

I 5x10-6 2x10- 2x10-9 5x10-5

- 21 -

*I

. .

47540.22(136C) Concentratisse in air and Eter above notwel banhground. ( Cont.) *

40.22(1) Single radionuclides

Table I Table IIElement lootope Calten 1 Cblumn 2 Column 1 Qaltan 2(etomic Air Water Air Weternumber) (uC1/ml) (uti/ml) (uC1/el) (uci/el)

Krypton (36) Kr-85m S4 6x1C-4 1x10-7- --

Kr-85 Sub 1x10-3 3x10-7-- --

Kr-87 Se 1x10-6 2x10-8- ..

Kr-88 S4 1x10-6 2x10-8- --

7 7x10 4 5x10-9 2x10 5Lenthenum (57) Le-140 S2x10 7 7x10-4 4x10-9 2x10-5I 1x10-

Lead (82) Pb-203 S 3x10-6 1,1g-2 9x10-8 4x10-4I 2x10-6 1x10-2 6x10-8 4x194

12 1x10-7Pb-210 5 1x10-10 4,g g 6 4,g 0 122x10 4I 2x10-10 S 10 3 8:10 10 5Pb-212 S 2x10-8 ul0-4

6x1010 2x10 51 2x10-8 5x10 4 7x10- 2x1 7

8 1x10 4Lutetita (71) Lu-177 S 6x10-7 3x10 3 2x10 8 1x10-41 5x10-7 3x10-3 2x17~

5knganese (25) *-52 S 2x10-7 1x10-3 7x10-9 3x10 59 3x10I 1x10-7 9x10 4 5:10 8 1xtr4h-54 S 4x10-7 4x10 33 1x10-

I 4x10-8 3,10 3 1x10 9 1x10 47 4m-56 5

8x10 7 4x10 33 10-8 1x10 4

I h10- 3x10- 2x10-8 t, j g-.

%rcury (80) Hg-197m S 7x10-7 6x10 3 3x10-8 2x10 4'

I 8x10-7 5x10 33x10-8 2x10-43

6 4x10-8 3x10-4'Hg-197 51x10 6 94tg 7 9x1r8 5x10-4! 3x10- 1x10-

5Hg-203 S 7x10-8 ~ ~~ 5x10-4 2x10-9 2x10 41 1x10-7 3x10-3 4x10-9 1x10-

8 2x 10-4Nolybdenun (42) M2-99 5 7x'10-7 5x10 3 h109 4x10-5I 2x10-7 1x10-3 7x10 j

3 12 7x10-5Noodynius (60) Nd-144 S 8x10-11 2x10 3 3x10 11 8xig-5I 3x10-10 2x10- 1x10-Nd-147 5 4x10-7 2x10-3 1x10-8 6x10-5

1 2x10-7 2x10-3 8x10-9 6x10-5Nd-149 5 2x10-6 8x10-3 6x10-8 3,j 0-4

1 1x10-6 8x10-3 5x10-8 3,10-4

Nepttnita (93) Np-237 S 4x10 12 9x10 5 1x10 II 3x19 6I 1x10-10 9x10-4 4x10-12 3x10-3

Np-239 S 8x10-7 4x10 3 3x10-8 3, j g-4

I 7x10-7 4x10-3 2x10-8 g,j g-4

Nickel (28) N1-59 S 5x10-7 6x10 22x10-8 2x10-43

I 8x10-7 6x10- 3x10-8 2x10 3

9 h10-5N1-63 S 6x10-8 8x10-4 2x1,0 8I 3x10-7 2x10-2 3, g 8 y,j

Ni-65 S 9x10-7 bc10-3 h10- 1x1

I 5x10-' 3x10-3 2x10-8 1x1

2 4Niobita (41) 2-93m S 1x10-7 1x10 2

4x10-9 4x10 4I 2x10-7 1x10 3

5:10-92-95 5 5x10-7 3x10 3

2x10-8 4x10 4 ,1x10 4

I 1x10-7 h10 2 3x10 9 1x10 4P4>-97 5 6xt0-6 3x10 2

2x10-7 9x10 4I 5x10-6 h10- 2x10-7 9x10-

| 7 2x10 3 h10-8 7x10-3| Oseita (76) Os-185 5 5x10 8 2x10-3 2x10-9 7x175

1 5x10-

- 22 -

|

r;

e .

47848.22(136C) Consentrollose in air and inter aheve notical tieelepresid. (Cont.) *.

! 40.22(1) Single regionuclides

Table I Table IIElement Isotope Coltan 1 0:1unn 2 Column 1 Calten 2(atomic Air Water Air Waternumber) (uC1/ml) (uci/el) (uti/ml) (uC1/1il)

.

Os-191m S 2x10-5 7x10-2 6x10-7h10 3

3I h10-6 7,90-2 h10-7 2x10-

Os-191 5 1x10-4 3

I 4x10 7 5:10 3 4x10-8 2x10-4

Os-193 5 4x10-7 h10 3 1x10-8 24104

1 h10-7 2x10 3 1x10-8 6x10-52x10- 9x10-9 5x10-5

Ps11edius (46) Pd-103 $ 1x10-4 1x10-2 8 h10-4I 7x10-7 3 5x10 8 3x10-4Pd-109 S 6x10-7 8x10 33x1 g-

3x 10- 81 4x10-7 2x10-3 2x10 8 % 10 5

1:10- 7xt r5Phosphorus (13) P-32 S 7x10-8

5x10 4 2x10-94 51 8x10-8 7x10- h10-9 2x?O 32x10-

Platinum (78) Pt-191 S 8x10-7 3

6x10-7 4x10 3 3x10-8 1x10 4

Ft-19h S 7x10-6 3x10 2 2x10-8 1 10-4I -

1 5x10-6 3x10 2 2x10-7 1x10-37

3x20 2 2x10 8 1x173Pt-193 5 1x10-61 3xt r7 3jg I g,jg 8 9x10-4

3Pt-197m S 6x10-6 h10 2 1x10-

2x10 3h10- 2xt r 7 1x10-I 5x10-4 3x10-2 2x10-7 9x10'4Pt-197 S 8x10 7 4x10-3 h10-8 1x10-4I 6x 10-7 3x10-1 2x10-8 j ,1 o-4

Plutonlue (94) Pu-236 $ 2x10-12 1x10 4 7x10-14 5:1041 h10-11 8x10-4 1x10-12 3:10-3

'

Pu-239 5 2x10-12 1x10-4 6:10-I4 h10-41 4x10-11 4

Pu-240 5 2x10-12 8x10 4 1x10-12 33,je 6 10-14 3x10 4h 10-

1 4x10-11 8x10-4 121x1012 h 10-3Pu-241 S 9x10-11 7x10-3):10 9 2x1HI 4x17"8 2

Pu-242 5 2x10-12 4x10*4 1x17 1xtr31x10- 6:10-14 / S10-6

1 4x10-11 9x10-4 1x10-12 h1T3Pu-243 S 2x10-6 tugg-2 81 2x10-6 1x10-2 6:10 8 h10-4

8x10- 3x10-4Pu-244 S 2x10-12 1x10-4 6x10-14 4x1g 4I h10-11 3x10-4 1xie-12 t s j e-5

Polonita (04) a 210 5 5x10-10 2x175 2:10-11 7oI h10-10 8x10 4 7410-12 7x10 3h10-

Potasolun (19) K-42 S 2x10-6 gin-3 7,to-3 3,i n-41 1x10-7 6x10-0 4x10-9 2x1T3

Praseodpitta (59) Pr-142 S 2x10-7 h104 7x10-9 53xig 51 2x10-7 9

Pr-141 S 3xtr7 h10 "3 h10 8 h1r}h ig-

I 2x10-7 1x10 3 1x10-1x10- 6x10-9 5x10 3

Pranethius (61) Pm-147 5 6x10-8 6x10-3 2x179 2xt r 4I 1x177 6x10-3 3:10-9 2x10-4Pin-149 5 h10-7 1x10-3 ix10-8 tx10">

1 2x10-7 1strl 8x10-9 4x10-5

Protectinita (91) Ps-230 S 2x10-9 3 111 e 10-10 7x10 3 6x10 11 2x10-4

1x1010 h10-5 3410 14 2x1047x10-12Pa-2 31 S

1x10- 8x10* 4 4x10 129x177

1

Pa-233 S 6x1 &*7 4x173 4x10 8 2h10-32t10- 1 x 10-*I 2v10-7 3410*3 6:10"9 1s tr4

- 23

- - - _ _ _ _ _ _ _ _ _ _ _ -

. _______ _________ _ ___ __ . _ _ _ _ _ _ _ _ _ _ _ __ __

.

. .

479 40.22(136C) Concentratione in air and inter above natural bac%ramd. (Cont.)''

40.22(1) Single radionuclide]

Table I Table IIElement Isotope Column 1 Column 2 Column 1 Column 2(stonic Air Water Air Weternumber) (uci/ml) 'uC1/el) (uC1/el) (uC1/m1)

_

Radium (88) Ra-223 S 2x10-9 2x10-56x1012

7xt r711

I 2x10-10 1,i p.4 g,10- 4,1 e.6Re-224 5 5x10-9 7x10-5 2x10-10 2x10-4

1 7:10 10 2x10-4 2x10-11 h10-4Re-226 5 3x10-11 4x10-7 3x10-12 3x10-8

I h10-11 9x10 4 2x1012 3,19 5Ra-228 5 7x10-11 8x10 4 2x1012

3,j r87 12

I 4x10-11 7x10- 1x10- 3,10-5

Redon (86) h-220 5 3x10-7 1xig-8-

Rn-222 S 3:10-8 3x10-9 --

Benius (75) Re-183 S 3x10-6 2x10 39,j g-8 6x10-42

5x10-9 3:1041 2x10 78x10 3Re-186 S 6x10 7 3x10 3

2x10-8 9x10-57

8x10-9 5x10-5I 2x 10-1x10 2 33,177Re-187 S 9x10-6 7x10 2 3x10 38

1 5x10-74x10 3 2x10 8 2x10 5

Re-188 5 4x10-7 2x10 4 6 10-91x10- 6x10 5

*

1 2x10-7 9x10- h 10--

modium (45) 2-103e S 8:10-5 4x10-1 h10-6 3,gg ?2I 6x10-5 3x10-1 2x10-4 1x10 48 1x10-m-105 5

8x10 7entr37

Ju10 8 1x10-4I 5x10- 3x10-3 2x17

Rubidium (37) %-86 S 3x10-7 2xtr3 1x10-8 7x10~5

2xt r'82x10*5,8 4 '

I 7x10 77x10

2x10- 1x1045x10- 3:10 3%-87 51 7x10-8 . . 5x10-3 2x10-9 2xt r4

Ruthenius (44) Ru-97 5 2x10-0 1xig 2g,j r8 g,g r42

4I 2x10-6 9,37 6:10-8 h10

8xtr5Ru-103 S 5x10-7 2x10-3 2x10"8 j5I 8x10-8 2x10-3 3x10-9 8x10 4

Ru-105 S 7x10 7 3x10 32x10-8 g,gg 43

I h10-7 3:10- 2x10-8 1x10-Ru-106 5 8x10-8 4x10-4 3x10-9 1x10-5

1 6:10-9 Juled 2x10-10 1x10-5

Samarium (62) Su-147 5 7x10-11 2x10-3 2x10-12 6x10-5I 3x10-10 2x10-3 9 10-12 7x10-5

Sm-151 S 6x10-8 1x10-2 2x10 9 4x10 4I 1x10-7 1x10-2 5410-9 4x10-4

Su-153 5 5x10-7 2x10 3 2x10 8 8x10 51 4xtr7 2x10-3 1x10-8 8x10-5

Scandium (21) Sc-46 5 2x10-7 1x10-3 8x10-9 4x175I 2x10-8 1x173 8x10-10 4x10-5

5Sc-47 5 6x10-7 3x10-3 2x10-8 9x10 5

I 5x10-7 3x10-3 2x10-8 9x10 5Sc-48 5 2x10-7 8x10-4 6x10-9 3:10 5

1 1x10-7 lb 104 5x10-9 Ju174

Selentun (34) Se-75 S 1x10-6 9mir3 4x10-8 h101 1 10-7 8x10-3 4x10-9 3x10 4

Silicon (14) 51-31 5 6x10-4 3x10-2 2x10-7 9x10-44

I 1x10-6 6m10-3 h10-8 2x10.

8 eSilver (47) Ag-105 5 6x10-7 h10 3 1x10 9

intr

! 8x10-8 3,3 g.) 3,qg- 1, g g-47 9:10 4 7x10 9 3x10*I

An-110m S 2x10 8 9 10-4 3x10-10 3:10-5I 1 x10-

24 -

. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

e e

* 415 48.22(136C) Consentrat' ions in att and eter shove netwel beehpromd, (Cont.)40,22(1) 51ng13 radionuclideo

Table I Table IIElement !actope Column 1 Glumn 2 Column 1 Column 2(atomic Air Weter Air Weternumber) (uC1/ml) (uci/ml) (uCi/el) (uCi/ml)

Ag-111 5 3x10 7 1x10-3 1x10-8 g,3 75

1 2x10-7 1x10-3 8x10 9 4x10-5

Sodium (11) Nn-22 S 2x10-7 1x10-3 6x10-9 4x1g.5I 9x10-9 9:10-4

3x10 8 3,q g 410 5

No-24 S 1x10-4 6x10 34x10 4 2x10 51 1x10-7 8x10-4 5:10 Ju1T

Strontiun (38) St-85e S 4x10 52x10 1 1x10-6

7x10 31 3

I h10-5 1x10-6'

St-85 S 2x10-7 2x10 3 8:10-97xjn 43:10- 1x10-

1 1x10-7 5x10-3 4x10-9 2x 10-4Sr-89 5 3x1g-8 3x10-4 3x10-10 3x10-6

1 4x10-8 8x10 4 1x10-9 3xig.5St-90 S 1x10-9 1x10-5 3:10-11

3x1C 57

I h10-9 1x10-3 2x10-10 g,jg-4x10-7 2x10-3 2x10-8 7x10-5St-91 S -

I h10A 1x10 3 9 h10 5' Sr-92 S 4x10-7 2x10-3 9x10 8 7x10-52x10-

! h10-7 2x10-3 1x10-8 6x10-5,,

1,.

Sulfw (16) S-35 5 h10-7 2x10 3 9x10-9 6x10 5 I

1 [h10-7 8x10-3 9x10-9 3x10-4

Tantalun (73) Ta-182 5 4x10-81x10 3 1x10-9

4x10 53 5

! 2x*g 8 in10- 7x10-10 g, j 7,

:' Technetiun (4)) I ic.%s S du10-5 g,1g 1 h10-6 - 1x10-2! 3x10-5 1

To,.M S 6x10-73,j g 3 3,$g-6 1x10-2 1); ''

'2x10-I- 1x10 4

I 2x10*7 - 3x10 3 .

5S 2x10-4 h10 7 8x10-9 h10 4

/ ' '

a7 eici??uic 1xtr 8x10-8 4x 10-

'4

7 3 5x10-9 2x10-49- 12x10 5 Sut0 2 ., 4x10*7 2x10 3 I.h.'E7 S

,

lx10- h 0- -

) f 3x10-7 2 0-7 1x10-8' * I g,j y4,

, ~ )u10-5 1

1 1x10-5 2x10 21x10-4 6x10 3fc-9's S.

3

; ic-Te S 2x10-6 8x10 2 >: Suto-7 h10 4'

1x10- 7x10-8 h10-,',

! (x104 5x10-3 2x10-9 2x10*4m-

a e ..rTellurlun ($2) Te-125m S l

4x10 7 h10-3 k10-8 2xN 4

,

7 4

h10 3,

autr 9- 1x1 r |

#Iin10 7 7,r 10-3

,'8Te-127m S " 1x 10- 2x10-

v Ex10 5-

'I J 4x10-8 ''h 10-3 1x10-8 '' , - h 10-',

Te-127 5 2x10-6 Edx10-3 6uto-a ,' 3:10-4'"

J 9x10-7 ' Y 3- 3 h10-8 2x10 4 '*

- '

f Te-129s ^G 8 10-8 ' r f a 0-3 34 0-9 3x W5''

,

/* I \ h10-8 6x 10 '4 , ' 1x1(r9 52x10 4

Is

fe-129 5- 5x10-6 2x10-2 2x10-7 8x10 4> i

! 4x10-6 2x10-2. 1x10 8 6x10-5

7 8x10-'

4:I77 3 1x10-'

Te-131m 5< I 2x10-7 2x10 3

+I '

6x10-9 4x10-51x10 s9x10-4 , 7x 10-9 5 )

es

Te-132 S 2x10-7"

I li 1x10-7 6x10 4 ; Ax10-9 3x10 5 |

'

2x10-

1b-160 $ tu10-7 In10 3 Ju10 9 4x10 5 lTerblun (65) i

I h10-8 1x10-3 1x10-9 4x10-5'

, ,

Thallium (81) Ti-200 5 3:10-6 3,ig-2 9x 10-8 4x10-4.1 - 1 10-4 7:10 3 8

k1-201 3 2x10-4 910-3 4x10 8 2x10 44

. r 11 9x10-7 5x10 3 7x10 8 3104F,10-S

8:10 7 4x10 3;,410-8 h10 47 3 .i/ ?1-202 /

Zx10- h10- 8x10 91, , g 5

-,

' '. 1 i' h10-

f - 25 -, ,

-

.,

- _ _ __ _ _ _ - _ . _ _ _

_

e e

475 40.22(13C) Consedrdiens in air and eter deve netwat beetgreed. (Cont.) -

40,22(1) Sing 13 radionuclideo

Table I Table II- Element Isotope talen 1 Cole n 2 Coluen 1 Column 2(stonic Air Water Air Waterneber) (uC1/el) (uci/el) (uci/el) (uci/el)

T1-204 5 6x12 7 3x1& 3 2xitP8 1xtreI h10-8 2m10-3 9x10-10 6x10-5

Therie (90) h227 5 h1010 h104 1x10 11 2milP5I 2x1tP10 5x104 17 5

% 228 5 9u10-12 2m104 6x1013 2x10 412 h10 13 hitP

5i I6x1012 4x10-4 2x10 14 1x10 42x10 h10-5Th-230 5

1 1x10-U 9x19-4 8x10 132m11P

53x10- 3x10 4Th-231 5 1xity6 7,jgy3 5x10-8 2mitPI 1x10-6 7x10-3 4x10-8 2x10-4,

Th-232 5 h10-11 h10-5 1x1012 2x10-61 3x10-U 1x10-3 1x10-12 4x10-5

Th-naturel 5 6x10-11 6xig-5 2,10-12 2m10-41' 6x10-11 6x104 2x10-12 2x10-5

Th-234 5 6x10-8 h10 4 2x10-9 2mity51 3x10-8 5x10-4 1 x10-' 2x175*

4

,

5Thulium (69) Te-170 5- 4x10-8 j,3 y31x10-'9 5x10 5I- 3x10-8 1x10 3 1x10- kir

Th-171 51x10 7 1x10 2

4,q gy9 h1047 2

1 2m10- 1x17 8x10-9 5x104

Tin (50) h113 5 h10-7 2m10 3 1x10-8 9m10 5'

8x1tP31 5xtr8 2xt r"3 2xt r'9 57 hir, .. in-125 5

1x10 8 5x10-4 k10 ' 2x104I 8x11P 3xitP 2x16, ,

Tungeten (74) W-181 5 2m10-4 1x10-2 8m10-8 - h10 44' I 1xitPI 1xig-2

h10-'8 3x10 4'' ' hit 3 h10- 1x10-W-185 5 h19 7I 1x10-7 3x10-3 h10-I 1x10 4

W-187 '5 h19-7 2mit 3 2x10 87m10-58

6mitP5^

I h19-7 2x10-3 1x10- jUranlun (92) U-230 5 3x1g 10 1x10-4 1x1017

5x1r410 UI 1x19-

1x104hitP htlP44

8x19 3x10-12 3,375U-232 5 1 10-10I h10-11 hitP4 9x19-13 3m19 5

2x10 17h 10-5MU-233 5 5x10-10 h11P4 >

k12- - h10 5! 1x10 10 h10 4U-234 5 6x10-10 9xity4 2x10-11 3x1gy5

,

! 1x1010 9:1gy4 k10-12 h10-5U-235 5

5x1010 8x10 4 2x10123 mig.510 4 H-

I 1xig 10 gig 3 h10- h105U-236 5

6x10 10 1x10 32xtr H -hir5

I 1xitP 1x10- kio-12 3,19 510 5U-238 5

7x10101,9 g-3 h10-12 k10 S

1 1x10- 1x10 3 h1917 kilPU-240 5 2x10-7 1x10-3 8x1tP' 3x175

1 2mitP7 1x1& 3 6x10-9 Ju1tP5tbnetural 5

1x1010 1x10 3 5x1012h11P510 3 12

1 1x10- 1x10- hitP y,j gy5

Venedium (23) V-48 5 2x10-7 9mitP4 6mitP' 3m10-51 6xitP8 8x10-4 2x10 9 3x13 5

Xenon (54) Me-131m h 2x13 5 4,10-7_ ..

b13h h 1xitPS h10-7,

- --

5 3,30-7Xe-133 h1x10 4

.._

Xe-135 h kitP 1x10 7- --

Ytterblue (70) 1b-175 5 7x10 7 3x10 3 2x10 8 1x10 4I 6x10-7 3x10-3 2x10-8 j ,3 g-4

- 26 - I

. _ _ . . . _

,_ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

.

g .-

415 40.22(13dC) Concentrations in air and eter dava natural baclagroimd. ( Cont.)4 0.22(1) Singlo radionuclides

i

itble I Table IIElement Isotope Coltan 1 Colian 2 Column 1 Column 2(atomic Air Waler Idr We.ternumber) (uCi/al) (uti/ml) (uci/ml) (uci/ml)

Yttrium (39) Y-88* S 3x10-7 2x10-3 6x10-9 7x10-51 5x10-8' h10-3 2x10-9 9x10-5Y-90 S 1x10-7 6x10-4 4xta-9 2x10-3I 1x10-7 6x10-4 3x10-9 2x10 5Y-91m S 2x10-5 1x10-1 8x10-7 3x10-31 2x1&-3 1x10-1 ' 6x10- 7 3x10 3Y-91 S 4x10-8 8x10-4 1x10-9 5I h10-3 8x10-4 1x10-9 3x10 53x10-Y-92 S 4x10-7 2x10-3 1x10-8 6x10-51 h10-7 2x10-3 1x10-8 6x10 5Y-93 S 2x10-7 8x104 6x10-9 3x10-5 |I 1x10-7 'N 10-4 5x10-9 h10-) '

Zine (30) Zn-65 S 1x10-7 2x10-3 9I 6x10-8 5x10-3 4x10 9 1x10 0'

2x10- 2x10-4f Zn-69m S 4x10-7 2x10-3 1x10-8 7x30-2l

1 3x10-7 2x10-3 1x10-8 6x10-3~

Zn-69 S 1x10-6 5x10-2 2x10-7 2x10-3I 9x10-6 5x10-7 3x10-7 .2x10-3Zirconium (40) Zr-93 S 1x10-7 2x10-2 4x10-9 8x10-4

f 1 3x10-7 2x10-2 1xje-8 8x10-4Zr-95 S 1x10-7 2x163 9I 3x10-3 2x10-3 4x1& 9 6x104

1x10- 6x10->Zr-97 S 1x10-7 5x10-4 , -4x10-9 2x10-5I 9x10-8 5x10-4 3x1& 9 2x10-5

,

'

hiy single radionuclide '

not listed above idthj decay mode other then

. , , _

Iclpha anission or spon-

' teneous fission and with -

radioactive luslf-lifeless than 2 hours. Stb 1x10-6 3x10-8_ -.jAny single radionuclidenot listed above withdecay mode other thancipha emission or spon-

r taneous fission and with'

radioactive I.alf-life- greater than 2 hours. 3x10-9 9x10-5 1x10-10 3x19 6>

Any single radionuclidenot listed sove, w11chdecays by alpha emissionor spentaneous fission. 6x10-13 4x10-7 2x10-14 3x10-8

I

- 27 -

. . .. .

..

.

.

. _ __ _ _ - _ - _ - _ . _ _ - -

F

, .

OThe blue] for Ge-68, Au-155, and Y-88 'hav3 been rctio3 f. r all the rafitnuclida in the cixtura may

ecleulcted using the committed dose squiv:; lent vclue3 not exceed "1" (i.o. , "thity").

cf ICRP Ptblication 30 for the controlling organ. Example: If radionuclides e, b, and c are present

%te 1: The letter "S" or " I" following the in concentratione Ca, 4, and Ce, and if the appli-isotope symbol denotes the soltble or insoltble chem- cele WC's are WC , WC , and WC respectively,b csical fonn of the element. then the concentrations shall be limited so that the

Note 2: "Sub" means that values given are for following relationship exists:

cubmersion in a semispherical infinite cloud of air-

b2rne material. Ca 4 4%te 3: These redon concentratione are appro- + + <1

priate for protection from radon-222 combined wLth WC, MPCb WCeits short-lived daughters. Alternatively, the values

in Table I may be replaced by one-third (1/3) "erk- b. If .either the identity or the concentration of

ing level". ( A " working level" is defined as any any radio-nuclide in the mixture is not known, the

combination of short-lived redon-222 daughters, limiting values for purposes of 40.22(136C) shall benpolonium-218, lead-214, bismuth-214 and polenium-214,in one liter of air, without regard to the degree of (1) for pwposes of Table I, Coltan 1 6 x 10-13squilibriun, that will result in the ultimate emis- (2) For purposes of Table I, Coltan 2 4 x 10-7cion of 1.3 x 105 HeV of alpha particle energy.) The (3) For pwposes of Table II, Coltan 1 2 x 10-14Table II value may be replaced by one-thirtieth (4) For purposes of Table II, Colunn 2 3 x 10-8(1/30) of a "w2rking level." The limit on radon-222concentrations in restricted areas may be based on an c. If any of the conditions specified below are

annual average. met, the corresponding values specified below may beNote 4: For soluble mixtures of U-238, U-235 and used in lieu of those specified in 40.22(2)"b" dove.

U-234 in air, chemical toxicity may be the limiting (1) If the identity of each radionuclide in the

fac tor. If the percent by weight (enrichnent) of mixture is knom but the concentration of one or moreU-235 is less - than 5, the concentration value for a of the radionuclides in the mixture is not knam, the

forty-hour workweek, Table I, is 0.2 milligrams uran- concentration limit for the mixture is the limit

its per ctbic meter of air average. For any enrich- specified in 40.22(136C) for the radionuclide in the-ment, the product of the average concentration and mixttee having the lowest concentration li: nit; ortime of exposure during a forty-hour erkwek shall (2)- If the identity of each radionuclide in the

not exceed 8 x 10-3 SA uCi-br/mi, where SA is the mixture is not known, but it is knom that certain~

rpecific activity of the uranium inhaled. lhe con- radiantclides specified in 40.22(136C) are- not

centration value for Table Il is 0.007 milligrams present in the mixture, the concentration 1,imit for

uranium per ethic meter of air. 1he specific activ- the mixture is the lowst concentration limit speci-

ity for natural uranium is 6.77 x 10-7 curies per fled in 40.22(136C) for any radionuclide dich is notgran tr anita . The specific activity for other mix- knom te be absent from the mixture; or

tures of U-238, U-235 and U-234, if not known, shallbe

SA = 3.6 x 10-7 curies /gran U U-depleted'SA : (0.4 + 0.38 E + 0.0034 E2) 10 E2 1 0.72

dere E is the percentage by m ight of U-235,expressed as percent.

40.22(2) Mixtures of radionuclides. In any casewhere there is a mixture in air or eter of more than

one radionuclide, the limiting valtes for purposes of40.22(136C) should be determined as follows:

a. If the identity and concentration of each

radionuclide in the mixture are knom, the limitingvalues should be derived as follows: Detennine, for

cach radiantclide in the mixture, the ratio between

the quantity present in the mixture and the limit

otherwise established in 40.22(136C) for the specificradiantelide when not in a mixture. The sem of such

- 28 -

.

. <

'

_ (3) Radionuclide * ~

Table I Table IIColumn 1 Column 2 Column 1 Colunn 2

Air Water Air Water(uC1/ml) (uci/ml) (uci/el) (uci/el)

If it is knom thatSt-90, I-125, I-126,I-129, I-131, (I-133 TableII only) Pb-210. Po-210,At-211, Ra-223, Ra-224,Re-226, k-227, Rm-228,Th-230, Pa-231, Th-232,Th-nat, On-248, Cf-254,and Fm-256 are not present - 9x10-5 3x10-6-

If it is knom that Sr-90,I-125, I-126, I-129, (I-131,I-133. Table !! only),Pb-210, Po-210, Ra-223,Ra-226, Ra-228, Pa-231,Th-nat, On-248, Cf-254,and Fm-256 are not present -- 6x10-5 2x10-6-.

_

If it is knom that Sr 90,I-129, (I-125, I-126. I-131Table II only), Pb-210,Ra-226, Ra-228, On-248,and Cf-254 are not present - 2x10-5 6x19-7-

. If it is knom that (I-129,' Toble II only), Ra-226, and' Ra-228 are not present - 3x10-6 1x10-7--

If it is knom that alpha- *

emitters and Sr-90, I-129,Pb-210, k-227, Ra-228,Ts-230, Pu-241, and Sk-249

.. cre not present 3x1,0 9 - -- - 1x10-e0 _

,

" If it is kno m that alpha-. emitters and I'b-210, Ac-227,

/. Ra-228, and Pu-241 are notpresent 3x10-10 1x10-11- --

If it is knom that alpha-emitters and Ac-227 are notpresent 3x1011 1x10-12- _

If it knom that Ac-227,Th-230, Pa-231, Pu-238,Pu-239, Pu-240, Pu-242,Pu-244,Co-248, cf-249 andCf-251 are nut present 3x10 12 1x10-13 ---

- 29 -

'- . .-

.

. .

d. If a mixtwo of radi:nuclides coneicta (? 470-40.23(136C) Sumntitles fo'r uno dth 4039(3) and -urenlun and its daughters in ore dust prior to chemi- 40.14(3). (Cont.)cal separation of the wenium from the ore, thevalues specified below may be used for uranium and Meterial Microcuriesits daughters through radlun-226, instead of thosefrom s@ paragraphs (1) to (3) above.

.

(1) For purposes of Table I, Column 1,1 x 10-10 Cesium-136 10uC1/mi grosa alpha activity; or 5 x 10-11 uC1/ml Cesium-137 10

natural uranium; or 75 microgrens per c41c meter of 011orine-36 10

air natural uranius. Chlorine-38 10(2) For purposes of Table II, (blumn 1, 3 x 1012 Diranium-51 1,000

uC1/ml gross alpha activity 3 2 x 10-12 uC1/mi natural Cobalt-58m 10

urenlung or 3 micrograms per cubic meter of air Cobalt-58 10 <.

natural uranium. Cobalt-60 1 i

e. For pwposes of this note, a radionuclide may Copper-64 100 |be considered as not present in a mixture if (a) the Dysprosium-165 10

ratio of the concentration of that radionuclide in Dysprosiun-166 100 )the mixture (C ) to the concentration limit for that Erbiun-169 100radionuclide specified in Table II of 40.22(136C) Erbium-171 100

(MPC ) does not exceed 1/10, (i.e., C /MPC -1 1/10) Europium-152 (9.2h) 100

and (b) the sun ef stch ratios for all radionuclides Europiun-152 (13yr) 1

considered are not present in the mixture does not Europium-154 1

cxceed 1/4, (i.e. , C /MFC + C /MPC + . . . i 1/4). Europium-155 10

Fluorine-18 1,000 '

470-40.23(136C) Sumntities fbr use dth 40.9(3) and Cado11niun-153 to

40.14(3). Cadolinium-159 100

Gallium-72 10

Meterial Microcuries Germanium-71 100

Cold-198 100 *

- Gold-199 100

Anericium-241 0.01 Hafniun-181 10I Antimony-122 100 W1mium-166 100,

Antimony-124 10 Hydrogen-3 1,000

Antinony-125 10 Indium-113e /100Arsenic-73 100 Indium-114m 10

Arsenic-74 10 Indita-115m 100

Arsenic-76 10 Indium-115 10! Arsenic-77 100 ledine-125 '1

Barium-131 10 Iodine-126 1

Barium-133 10 Iodine-129 0.1

Barium-140 10 Iodine-131 1

Bienuth-210 1 Iodine-132 10

Branine-82 10 Iodine-133 1

| Cadmius-109 10 Iodine-134 10

! Cadmiun-115m 10 Iodine-135 10l Cartniun-115 100 Iridiun-192 10

Calcium-45 10 Itidium-194 100

C:1cium-47 10 Iron-55 100

| Carborw14 100 Iron-59 10

| Cerium-141 100 Krypton-85 100

Ca rium-143 100 Krypton-87 10

Cerium-144 1 Lanthanue-140 10

Cesiun-131 1,000 Lutetlum-177 100

Cesium-134m 100 Manganese-52 10

Cesium-134 1 %nganese-54 10

Cesiun-135 10 Manganese-56 10

!

- 30 -

ii

.

. .

' 475 40.2)(136C) Sumntities flee uso dth 40,9(3) and 47040.23(136C) Quantities for uma dth 40.9(3) and--

40.14(3). (Cont.) 40.14(3). (Cont.)

Material Microcuries Material Microcuries

Mnreury-197m 100 Silver-110s 1

Mnecury-197 100 Silver-111 100Mareury-203 10 Sodium-22 1

21ybdenun-99 100 Sodium-24 10hoodymium-147 100 Strontium-85 10Neodymium-149 100 Strontium-89 1

Nickel-59 100 Strontium-90 0.1;

Nic kel-63 10 Strontitan-91 10Nickel-65 100 Strontium-92 10Niobiun-93m 10 Sulphur-35 100Niobium-95 10 Tantalun-182 10Niobium-97 10 Technetium-96 10Oneium-185 10 Technetium-97m 100Oneium-191s 100' Technetium-97 100Onmium-191 100' Technetium-99m 100Omnium-193 100 Technetiun-99 10Palladium-103 100 Tellurium-12Sm 10Palladium-109 100 Tellurium-127m 10

. Phosphorue-32 10 Tellurium-127 100Platinum-191 100 Tellurium-129m 10Platinum-193m 100 Tellurium-129 100

. : Platinue-193 100 Tellurium-131m 10Platinus-197m 100 Tellurium-132 10 -

, Platinum-197 100 Terbius-160 10Plutonium-239 0.01 1ha111un-200 100Polonium-210 0.1 Thallium-201 100

'

Pot easium-42 10 Thallium-202 100Praseod pium-142 100 Thallita-204

, j10

Praseodymium-143 100 Thorium (natural) '100 -

Promethium-147 10 Thulium-170 10Pranethium-149 10 Thulium-171 10Radium-226 0.01 Tin-113 10fhanitsn-186 100 Tin-125 10 !Rhenlun-188 100 Tungsten-181 10lhadium-103n 100 Tungsten-185 10Rhodius-105 100 itsigsten-187 100Rubidium-86 10 Wanium (natural) 100 |Rtbidium-87 10 Uranj un-233 0.01 lAthenium-97 100 &anium-234/235 0.01 {Ruthenium-103 10 Vanadiun-48 10Athenium-105 10 Xenon-131m (Xe 131m) 1,000Ruthenita-106 1 Xenon-133 (Xe 133) 100Samarium-151 10 Xenon-135 (Xe 135) 100Senarita-153 100 Ytterbiun-175 (Yb 175) 100Scandita-46 10 Yttrium-90 (Y 90) 10Scandium-47 100 Yttrium-91 (Y 91) 10Sc andlun-48 10 11 trita-92 (Y 92) 100Selenita-75 10 Yttrita-93 (Y 93) 100Silicon-31 100 Zine-65 (Zn 65) 10Silyar-105 10 Zinc-693 (Zn 69en) 100

- 31 -

..- ...___ - . .- ..

? '

. .

* '

47540.23(13dC) Quentities fisc ime dth 40.9(3) mal40.14(3). (Cont.)

Material Microcuries

Zinc-49 (Zn 69) 1,000

Zirconita-93 (Zr 93) 10

Zirconius-95 10

Zirconium-97 10

Any alphe emittingradionuclide not listedabove or mixtwee ofcipha emitters oftsiknom composition. 0.01

Any radionuclide otherthan alpha emittingradionuclides, notlisted above or

_

cixtures of betaemitters of taiknomc a position. - 0.1

Note 1: Thorium (natwal) is based on alpha die-integration rate of Th-232, Th-230 and their daughterprodtets.

Note 2: Uranius (natural) is based on alpha dis-'integration rate of U-238, U-235, and U-234. -

Mate 3: For purposes of 40.9(3) and 40.14(3),where there is involved a cambination of isotopes in --

knom anotsits, the limit for the combination shouldbe derived as follows: Determine, for each lastope

in the combination, the ratio betieen the quantity /

preser.t in the combination and the limit otherwiseestablished for the specific isotope Muni not in

cambination. lhe sus of such retics for all the

isotopes in the combination may not exceed "1" (i.e.,

*tsiitya).

47040.24(136C) Effective date. During the secondcession of the seventieth General Assembly (1984)existing love Code chapter 136C, ses amended by 1984Iowa Acts, chapter 1286, authorizing the gcvernor to

j enter into an agreement with the U.S. Nuclear Regula-tory Q)mmission (NRC) thereby end)1ing the lowe state

|

department of health to license and further regulate| byproduc t , source and anell qtentities of special| nuclear radiometive materials. The signing of such| an agreement is autlurized in federal legislation| under 54section 27Ab of the Atomic Energy Act of

1954, se unended. 01 apter 40 as anended will becomeeffective on the date the govertur and PetC sign thetsject agreement.

These rules are intended to implement Ioie Code01 apter 136C.

- 32 -I

!

L

(- l

. .*,' " Certified cystem" means any X-rcy tystem thich

has one er mors esttified component (e). j" Change 21e filters" means any filter, exclasive

CMMER 41 of inherent filtration, ihich can be removed from the

useful beam through any electronic , mechanical, orSafety Regdrements for hadiation Machinen physical process.

and Radioactive Bhterial. " Coefficient of variation" cc "C" means the ratioof the standard deviation *o the mean value of a

470 41.1(13dC) Amdiation machines in the healing population of observations. It is estimated using

arts. the following equation:41.1(1) Scope. This chapter establishes require- ,

monts, for sich a registrant is responsible, for use n |

of radiation machines by or mder the supervision of C= a = 1 QX,i-X)2_ 1/2 ),

n-1 |an individual authorized by and licensed in accord-_ _

ance with state statutes to engage in the healing X X

erts. The provisions of this chapter are in addition i=1to, and not in asstitution for, other applicable

provisions of these rules. where

41.1(2) De finitions. As used in this chapter,

the following definitions apply s_ = Estimated standard deviation of the population." Accessible swface" means the external surface of

the enclosure or housing prov.ided by the manufac- _ = Mean value of observations in sample.X

twer. .

"Added filtration" means any filtration which is Xi=ith observation in sample.in addition to the inherent filtration.

"Aluminun equivalent" means the thichness of type n = Number of observatione in sample.cleven hmdred aluminun alloy (composed of 99.00 per-cent aluminun minimun and 0.12 percent copper) " Contact therapy system" means an X-ray system

,

cffording the same attenuation, mder specified used for therapy with the _X-ray tse part placed inconditions, as the material in question. contact with or within five centimeters of the sur-

,

" Assembler" means any person engaged in the busi. face being treated."Coritrol" panel" means that part of the X-ray con-ness of assembling, replaciraj or installing one or

more components into en X-roy system or essystem, trol upon inich are nounted the switches, knobs," Attenuation block" means a block or stack, having pushbuttons, and other hardware necessary for man +-

dimensione 20 centimeters by 20 centimeters by 3.8 ally setting the technique factors. /centimeters, of type eleven hundred aluminun alloy or " Cooling curve" means the graphical relationshipcther materials having equivalent attenuation. between the heat mits stored and cooling time.

" Automatic exposure control" means a device Aich "De ad-ean switch" means a switch so constructedcutomatically controls one or more technique factors that a circuit closing contact can be maintained only

by continuous pressure on the switch by the operator.in order to obtain at a preselected location (s) a

required quantity of radiation (See also " Photo- " Detector" (See " Radiation detector"),

timer"). " Diagnostic source assembly" means the tse hous-" Barrier" (See " Protective barrier"). ing assembly with a bean-limiting device attached." Bean axis" means a line fran the source through "Diagnootic X-ray system" means an X-ray system

the centers of the X-rey fields, designed for irradiation of any part of the hunan" Beam-limiting device" means a device thich pro- body for purpose of diagnosis or visualization.

vides a means to restrict the dimensions of the X-ray " Direct scattered radiation" means that scatteredfield. radiatini inich has been deviated in direction only

" Bean monitoring system" means a system designed by materials irradiated by the useful been (Seeto detect and measure the radiation present in the " Scattered radiation").useful been. " Entrance exooaure rate" means the roentgens per

" Certified components": neans components of X-ray mit time at the point there the center of the usefulsystems thich are esject to rules promulgated mder been enters the patient.

P211c Law 90-602, the Radiation Cbntrol for Health " Equipment" (See "X-ray eauipment") .and Safety Act of 1968. " Exposure" means the qmtient of dQ by dra there dQ

is the absolute value of the total charge of ions of

-1-

%A

.

. .

one f.ign produced in air den all the electrcne farms incident X-rey photss cither into o visible'(negatrono and positrone) liberated by photone in e - image or into another fom dich can be made into evolume element of air having mese de are completely visible image by further transformatione.ctopped in air. The special mit of exposure is the " Image receptor support" means, for massographicroentgen. hen the ord " exposure" is used in systene, that part of the systen designed to support470--A0.7(136C) to mean one ~ or more irradiatione of the image receptor in a horizontal plane durirq ean individuell for a healing arte purpose, or in a mammographic examination.more general sense, it will not be ederlined. " Inherent filtration" means the filtration of the

i " Field mission equipment" means equipment sich useful beam provided by the permanently instelleduses en X-ray tse in sich electron emission from components of the t se housing assembly.the cathode is due solely to the action of an elec- "Irrediatiorf means the exposure of setter ioniz-tric field. ing radiation.-

"Filttr" means material placed in the useful been "Kilovolto peak" (See " Peak ttbo potential").tn absort preferentially selected radiations. "kV" means kilovolte. !

91uoroet opic imaging assembly" means a essysten "kyp" (See " Peak ttbe potential"). ,

in mich X-ray photone produce a fluoroscopic image. "kWe" means kilowett second. It is equivalent to

It includes the image receptor (s) such as the image 103 kV mA e, i.e.,

, intensifier and spot-film device, electrical inter-'

locks, if any, and structwal meterial providing (a) kWo alinkage bet wen the image receptor and diagnosticsource seeembly.

~

(X)kV x (Y)mA x (Z)e x kWe s XYZ kWe

" Full been detector" means a radiation detector of 103 kV x mA x e 103cuch elas that the total crose esction of the mexista;

,

clas useful been is intercepted. . " Lead equivalent" noene the thicleises of lead

" General purpose radiographic X-ray system" means affording the sene attenuation, mder specified

any radiographic X-ray systen sich, by design, is conditions, as the meterial in question.| ~ not limited to radiographic examination of specific " Leakage radiation" means radiation ananating frornf

i anatomical regions.. .

the diagnostic or therapeutic aource senembly except1"Goned shield" means a protective barrier for the for *' -

; . testes or ovaries.,

1. The useful been, and,

,

" Half-value layer" means the thicknese 'of speci. 2.- Andistion produced den the expoewe switch orfled meterial dich attenustes the bem of radiation j timer le not activated.to an extent etch th'at the exposure rate is redtcod ' " Leakage technique ' factore" means the techniqueto one-half of its original .value. In this defini- factore associated with the t@e housirq /essemblytion, the contribution of all scattered radiation, sich are used in measuring leakage radiation. 1 hey -cther than any dich might be present initially in are defined as follows:

'

the bem concerned, le deemed to be excluded. 1. For capacitor energy storage equipment, the" Healing acta screening" means the testing of maxistas-rated peak tibe potential and the "maxista- ,

htman beings using X-ray machines for the detection rated nLabor of expneures in an hour for operation etcr evaluation' of health indications when such teste the maximum-rated peak ttbe potential with the quen-cre not specifically and individually ordered by a tity of charge per expoetre being ten millicoulanbo,licensed practitioner of the healing arts legally i.e., ten milliampere seconde, or the minimum obtain-authorized to preacribe each X-ray teste for the pur- able from the mit, tichever le larger.

pose of diagnosis or treatment or as a part of a 2. For field estesion equipment rated for pulsedphysical examination. operation, the seximun-rated peak t be potential and

" Heat mit" means a unit of energy equal to the the maximum-rated number of X-ray pulses in an hourprodtet of the peak kilovoltage, mil 11 amperes, and for operation at the mexista-rated peak ttbe poten-

| esconde, i.e., kVp x mA x second. tial.

| "HYL" (See "Helf-value layer"). 3. For all other equipment, the mexista-rated" Image intensifier" mesis a device, installed in peak ttbe potential and the maxista-rated continuous

ita housing, sich instantaneously conyorts ,en X-rey tthe curront for the maxinta-rated peok ttbo poten-

pottern into a corresponding light image of higher tial.

energy density. " Light field" means that area of the intersectionof the light been from the bean-limiting device and| " Image receptor" meme any device, such as e

fluorescent screen or radiographic film, dich trans- one of the set of planes parallel to and includira

-2-

m.

'

the plane cf the imag3 receptge," dose perim;ter is * Qualified ex pert" means an individual so has*

the locus ff point 3 at s ich the illumin: tion 13 demonitrcted to the satisfaction cf the agency thatone-fourth of the maximun in the intersection. sich individual possesses the knowledge and training

"Line-voltage regulation" meene the difference to meaewe ionizing radiation, to evaluate safety

between the no-load and the load line potentials techniques, and to advise regarding radiation protec-cxpressed as a percent of the load line potential. tion needs. -

It is calculated as a percent of the load line poten- " Radiation detector" seene a device sich in thetial. It is calculated using the following equations presence of radiation provides by either direct or

indirect seene, e signal or other indication suitablePercent line-voltage regulation a for use in measuring one or more quantities of inci-

100 (Vn-VI )/V1 where dont radiation.yn Pts load line potential and "Rediation therapy simulation system" means aV: Load line potential. . fluoroscopic X-ray system intended for localizing theI

volume to be exposed during radiation therapy and -"mA" means millienpere. confirming the position and size of the therapeutic" mas" means milliampere second. irradiation field.

"Nximus line current" means the root-mean-square " Radiograph" means an image receptor on sich thecurrent- in the supply line of an X-ray machine oper- image is created directly or indirectly by an X-ray(ting at its maximun rating. pattern and results in a permanent record.

">bbile equipment" (See "X-ray equipment".) " Radiographic imaging system" means any system" Peak tse potential" means the maximum ve_lue of * ereby a pemanent or suelpennanent image is

the potential dif ference across the X-ray tse during recorded on an image receptor by the action of ioniz-cn expoawe. ing radiation,

" Phototimer" means a method for controlling radi- " Rating" means the operating limits as specifiedction exposures to image receptors by the second of by the component manufacturer.

' radiation sich reaches a radiation monitoring " Recording" means prodtcing a permanent form of aadevice (s) . The rafiation monitoring device (s) is image resulting from X-ray photons (e.g., film, videopart of an electronic circuit sich controls the 'dur- tape).ction of time the t@e is activated (See " Automatic "Registr ant ," as used in 41.1(136C), means anyexposure control"). person so owns or possesses and administratively

" PIT (See " Position indicating device"). controls an X-ray systen *ich is used to deliberate-

"Pbnition indicating devic e" means a device on ly expose hunans or animals to the useful been of thedental X-ray equipment used to indicate the bean systen and is required by 470--chapters 38 and 39 toposition and to establish a definite source-surface register with this agency.

,

' (skin) distance. It may or may not incorporate er " Scattered radiation" means radiation thaE, duringserve as a beam-limiting device. passage through matter, has been deviated in direc-

" Primary protective barrier" (See " Protective tion (See " Direct scattered ra11ation").barrier".) "Seconjary protective barrier" (See " Protective

" Protective apron" muons an apron made of radi- berrier").ction absorbing materials used to reduce radiation " Shut ter" 'neans a device attached to the tubeExposur e. housing assembly which can totally intercept the use-

" Protective barrier" means a barrier of radiation ful been and which has a lead equivalency not less

absorbing material (s) used to redu:e radiation expo- than that of the t@e h3uaing assembly.sure. The types of protective barriers are as " SIT (See " Source-image receptor distance").follow : " Source" means the focal spat of the X-ray tee.

1. " Primary protective barrier" means the mater- " Source-image receptor distance" means the dis-ial, excluding filters, placed in the useful bean, tance from the source to the center of the inout sw-for protection pur poses , to reduce the radiation face of the image receptor.cxpoewe. " Spot check" means an sbreviated calibration

2. " Secondary protectise barrior" means a barrier procedure which is per fermed to assure that a pre-tufficient to attenuate the stray radiation to the vious calibration continues to be valid.required degree. " Spot' film" mems a radiograph *ich is made dur-

" Protective glove" means a glove node of radiation ing a flu)roscopic exssnination to permanently recordobsorbing materials used to reduce radiation expo- conditions which exist during that flu]roscopic pro-sur e . cedure.

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" Spot fila device" means a devico intended to "X-ray equipment" means an X-rcy systen, cW- ~transport or position a radiographic image receptor system, or component thereof. Types of X-ray equip-between the X-ray source and fluoroscopic image ment are as follows:receptor. It includes a device intended to hold a 1. "% bile X-ray equipment" means X-ray equipmentcassette over the input end of an image intensifier mounted on a permanent base with seels or castersfor the purpose of making a radiograph. for moving sile completely assembled.

" Stationary equipment" (See "X-ray equipment"). 2. " Portable X-ray equipment" means X-ray equip-

" Stray r adiation" means the sun of leakage and ment designed to be hand-carried.

ecettered radiation. 3. " Stationary X-ray equipnent" means X-ray" Technique factors" means the conditions of oper- equipment which is installed in a fixed location.

.

ation. 1 hey are specified as follows: "X-ray field" means that area of the intersection1. For capacitor energy storage equipment, peak of the useful been and any one of the set of planes

tse potential in kV and quantity [of charge in mas. parallel to and including the plane of the image2.. For field emission equipment rated for pulsed receptor, whose perimeter is the locus of points at

eperation. peak tse potential in kV and number of sich the exposure rate is one-fourth of the maximun

X-ray pulses. in the intersection.3. For all other equipment, peak tse potential "X-ray high-voltage generator" means a device

in kV and either t4e current in mA and exposure time sich transforme electrical energy from the potentialin seconds, or the product of tse current and expo- supplied by the X-ray control to the tse operatingcure time in mas. _

potential. The device may also include means for

" Transmission detector" means a radiation detector transfonning alternating current to direct current,through dich the useful been or part of the useful filament trans formers for the X-ray tWe(s), high-bene posses. - voltage switches, electrical protective devices, and

'

" Treatment volune' means the region, in the other appropriate elements.patient, to sich a specified dose is intended to be "X-ray systen" means an assemblage of components

delivered. for the controlled production of X-rays. It includes"T4 e" means a1 X-ray t4 e , uileas otherwise minimally en X-ray high voltage generator, an X-ray

tpecified. control, a tse hous,ing assembly, a beam-limiting" T@ e inusing assembly" means the tse housing devic e , and the necessary supporting struc ttr es.- .

with tse installed. It incitsfes high-voltage fila- Mditional components sich fmetion with the systenment transformers and other appropriate elements een are considered integral parts of the system.cuch are contained within the tse housing. "X-ray assystem" means any combination of two or

"Tse rating chart" means the . set of curves sich more components of an X-ray system.

tpecify the rated limits of operation of the tse in "X-ray t s e" means any electron tse johich isterms of the technique factors. designed to be used primarily for the graduction of

"Useful bean" means the radiation thich passes X-rays.

through the t@e housing port or the aperture of the 41.1(3) General requirements. The registrantshall be responsible for directing the operating ofbeam-limiting device then the exposure switch orthe X-ray systems thich have been registered with thetimer is activated.

" Variable-aperture beam-limitirig device" means a agency. The registrant or the registrant's agentbean-limiting device thich has capacity for stepless shall assure that the following requirements are met s

An X-ray systen sich does not meet the provi-adjustment of the X-ray field size at a given SID. a." Visible area" means that portion of the input sions of these rules shall mt be operated for diag-

surface of the image receptor over thich incident nostic or therapeutic purposes then so directed byX-ray photons are producing a visible image. the agency.

" Wedge filter" means an added filter effecting b. Individuals ute will be operating the X-ray .continuous progressive attenuation on all or part of systems shall be afequately instructed in the safe

operating procedures eruf be competent in the safe usethe useful been.

|"X-ray control" meana. a device thich controls of the equipment in accordance with 470--chapter 42

| input power to the X-ray high-voltage generator or as applicable.A chart shall be provided in the vicinity of

the X-ray tse. It includes equipment stch as c.

timers, phototimers, automatic brightness st2il- the diagnostic X-ray system's control panel, whichirara, and similar devices, which control the tech- specifies for all usuul exaninations performed with

nique factors of an X-ray exposure. that s) sten the following informations(1) Patient's anatomical size versus technique

factors;

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(2) Type and tize cf the fil f cr fil -ecreen (2) Writtori safdty grocedurec, as required by'

combination t3 be us:d; 41.1(3)"d," sh:11 indiccto the tsquiremento for(3) Type and focal distance of the grid to be selecting a holder and the procedure the holder shall

used, if any follow;(4) Source to image receptor distance to be used; (3) The human holder shall be prctected as

and required by 41.1(3)"e":(5) Type and location of placement of gonad (4) No individual shall be used routinely to hold

shielding to be used. film or patiente;

d. Written safety procedures and rules shall be (5) Such tolding shall be permitted only in veryprovided to each individual operating X-ray equi p- tsiusual and rare situations: andment, including any restrictions of the operating (6) In those cases dete the patient must hold thetechnique required for the safe operation of the film, except during intraoral exaninations, any por-particular X-ray system. The operator shall be *le tion of the body other than the area of clinicalto demonstrate feniliarity with these rules. interest struck by the useful been shall be protected

e. Except for patients 40 cannot be moved out of by not less than 0.5 millimeter land equivalentthe room, only the staff and ancillary personnel material.required for the medical procedure or training shall 1. Procedures and auxiliary equipnent designed tobe in the roam during the radiographic exposure. minimim patient and personnel exposure carmensurateOther than the patient being examined: with the needed diagnostic information shall be util-

(1) All individuals shall be positioned etch that ized. This is interpreted to inclWe but not beno part of the body will be struck by the useful bess limited to tunless protected by 0.5 milliraeter lead equivalent. (1) The speed of film or screen and film combin-

(2) Staff and ancillary personnel shall be protec- ations shall be the fastest Jpeed consistent with the.tad from the direct scatter radiation by protective diagnostic objective of the examinations.cprone or sole body protective barriers of not less (2) The radiation exposure to the patient shallthen 0.25 millimeter lead equivalent. be the minimum exposure required to prodtre images cf

(3) Patients to cannot be removed from the roon good diagnostic quality.shall be protected from the direct scatter radiation (3) Portable or mobile equipment shall be usedby * ole body protective barriers of 0.25 millimeter only for exsninations *ere it is impractical tolead equivalent or shall be so positioned that the transfer the patient (s) t a stationary radiographicnearest portion of the body is at least two metero installation.

fran both the t*e head ard the nearest edge of the (4)- X-ray systems subject to 41.1(6) shall not beimage receptor. utilized in procedures sere the ocurce to patient

f. Gonal shieldirg of not less than 0.25 milli- distance is less then thirty centimeters.meter lead equivalent shall be used for patients to J. All individuals to are associated Mith thehave not passed the reproductive age during radio- operation of an X-ray systen are subject to thegraphic procedures in sich the gonads are in the requirements of 40.2(1), of the radiation rules.useful best, except for cases in which this would k. Healing arts screening. Any person prognsinginterfere with the diagnostic procedure. to conduct a heolirq arts screening progem ohall not

g. Individuals shall not be exposed to the useful initiate such a progron without prior soproval of thebeen except for healing arts purposes and stch expo- agency. Men requesting etch appreval, that personsure has been authorized by a licensed practitioner shall submit the followirg outlined in 41. l(13). If

of the healing arts. This provision specifically any information sWmitted to tre igency becones

prohibita deliberate exposure for the following invalid or outdated, the egency shall be pronptly

p rposes: notified .

(1) Exposure of an individual for training, demon- 1. Nintenance of records ard associated in for-stration or other nonhealiry-arts purposes: and mation. The registrant shall maintain the following

(2) Exposure of ei individual for the purpose of in formation for each X-ray systen for inspection byhealing arte sc reening except as authorized by the agency.41.1(3)"k." (1) Maximun retirg of techniom factors

h. men a patient or flim :nust be provided with (2) & del and serial nunbers of all certifisolectailiary support during a radiation espusures componenta t

.(1) Mechanical holding devices shall be uced een (3) Alminun equivalent filtration of the useful

the techniqte permits. The writtm safety proc e- bern, incitding any routico veristionidures, required by 41.1(3)"d," chall list individual (4) T*e rating chsrts and coollrq curvesprojections sete holding devices cannot be utilized

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(5) Rhe:rds af surysy3, calibr tiin, ceintcnanco, the mein power switch shall bear the terning cttt: -

and modificctione perfsreed on the X-ray oy: tem (c) ment, legiblo and accectibla ta view: " WARNING: ThioCfter the ef fective date of this chapter 4th the X-ray mit may be dangerous to patient and operator

nanes of persons do performed such services; unless safe exposure factors and operating instruc- |(6) A scale drawing of the room in s ich a tions are observed." I

ctationary X-ray systen is located with such drawing b. Bettery charge indicator. Q) battery-poweredindicating the use of areas adjacent to the room and X-ray generators, visual means shall be provided onan estimation of the extent of occupancy by an indi- the control panel to indicate 4 ether the bettery is

,

vidual in steh area. In addition, the drawing shall in a state of charge adequate for proper operation.includes c. Leakage radiation from the diagnostic source

1. The results of a sirvey for radiation levels assembly. The leakage rajiation from the diagnosticpresent at the operator's position and at pertinent source assembly measured at a distance of one meterpoints outside the room at specified test conditione, in any direction from the source shall not exceed oneor hmdred milliroentgens in one hour den the X-ray

2. The type and thickness of meterials, or lead tse is operated at its leakage technique factors.

cquivalency, of each protective barrier; and Compliance shall be determined by measurements ever-(7) A copy of all correspondence with this agency aged over an area of one hmdred square centimeters

regarding that X-ray systm. with no linear dimension greater than twenty centi-m. X-ray log. Each facility shall maintain an meters.

X-ray log containing the examinations and the dates d. Radiation from components other than the diag-of the exaninetions den the techniques or profedures nostic source assembly. The radiation unitted by a

vary from those specified in the technique chart component other than the diagnostic source assemblyrequired in 41.1(3)"c." shall not exceed two milliroentgens in one hour at

n. Plan review. five centimeters fran any accessible surface of th'e(1) Prior to construction, the floor plans and component een it is operated in an assembled X-ray

equipment strangement of all new installations, or systen under any conditions for d ich it was de-

modific stions of existing installations, utilizing signed. Compliance shall be determined by measure-X-rays for diagnostic or therapeutic purposes shall ments averaged over an area of one hundred squarebe semitted to the agency for review. The required centimeters 4 th no linear dimension greater then.

information is denoted in 41.1(11). twenty centimeters.(2) The agency may require the applicant' to util- e... Bean quality.

ime the services of a qualified expert to determine (1) Half-value layer.the shielding requirements prior to the plan review. 1. The half-value layer of the useful been for a

(3) The review of such plans shall not preclude given X-ray t@e potential shall not be lessjthan thethe requirement of additional modifications should a values show) in Table !. If it is necessary to -

CWeequent analysis of operating conditions indicate determine auch half-value layer at an X-ray tse

the possibility of an individual receiving a dose in potential sich is not listed in T21e I, lineerexcess of the limits prescribed in 40.2(1), 40.2(4) interpolation or extrapolation may be made.and 40.2(5) of the radiation rules.

o. Federal per formance standards. All X-ray TABLE 1

cquipment or other ra11ation machines for sich

applicable performance standards have been prescribedunder 21 CFR 1020 pursuant to 41 USC 263F and sich Half-valuehave been manufactured s@ sequent to the e f fective Design operating Measured layerdate of sic h requirements shall comply dth these range potential (millimetersfederal performance standards in lieu of 41.1(4) to (kilovolts peak) (kilovolts peaks) of aluninum)41.1(10). Persone registered to possess the affectedradiation emitting equipment in loten will be respons-ible to meintain the equipment in compliance 4th Below 50 30 0.3federal performance etendards. 40 0.4

41.1(4) Requirements for all diagnostic X-ray 49 0.5cystems. In addition to other requirements of this

chapter, all diagnostic X-ray systems shall meet the 50 to 70 50 1.2following requirements: 60 1.3

e. Warning labels. The control panel containing 70 1.5

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TA8LE I (Cont.) useful beam", o devies shall link the kVp aslectar'

with the filter (c) and sh:11 prevent an exposura|uiless the minimum enount of filtration required by

Hal f-v alue 41.1(4)"e"(1)1. or 2. is in the useful beau for theDesign operating hasured layer given kVp idlich has been selected.

range potential (millimeters f. Multiple tsee. Were te or more radio-(kilovolte peak) (kilovolto peaks) of aluminum) graphic tses are controlled by one exposure switch,

the tWe or tses dich have been selected shall be

clearly indicated prior to initiation of the expo-

Above 70 71 2.1 sure.80 2.3 g. Mechanic al stepart of t2e head. The t4e90 2.5 housing assembly supports shall be adjusted so that

100 2.7 the t@e housing sesembly will remain stable during110 3.0 an exposure unless tse housing movement is a de-120 3.2 signed fuiction of the X-rey system.130 3.5 h. Technique indicators.140 3.8 (1) The technique factor to be used during an

150 4.1 exposure shall be indicated be fore the exposure

begins, except then automatic exoosure controls areused in thich case, the technigts factors which are

2. The requirements of 41.1(4)"e"(1)1. will be set prior to the exposure shall be indicated.

considered to have been met if it can be demonstrated (2) The requirement of 41.1(4)"h"(1) may be metthat the aluminun equivalent of the total filtration by permanent markings on equipment having fixed tech-in the primary been is not less thei that shows in nique factors. Indication of technique factors shallTable II. be visible from the operator's position except in the

case of spot filme made by the fluoroscopist.~

TABLE II 1. Bean limitation. The useful been shall be*

limited to the area of clinical interest.41.1(5) Fluoroscopic X-rsy systems. All fluoro-*

acopic X-ray systems shall meet the following -Filtration Recuired vs. Operating Voltsee requirements:

a... Primary barrier.Total Filtration (1) The fluorescopic imaging assembly shall be

,

(inherent plus added) provided with a primary protective barrier ditch'

intercepts the entire cross section of the useful

Operating Voltage (millimeters aluminus been at any SIO. -

(kYp) equivalent) (2) The X-rey ttbe used for fluoroscopy shall notproduce X-rays unless the barrier is in position to

lhlow 50 . . . . . . . . . . . . . 0.5 millimeters intercept the entire useful be.un.

50-70 1.5 millimeters b. X-ray field...............

Above 70 . . . . . . . . . . . . . 2.5 millimeters (1) The X-ray field produc ed by nonimace-

intensified fluoroscopic equipment shall not extendbeyond the entire visible area of the Lange recep.

3. Beryllius window t@es shall have a minimum of tor. This requirement applies to field sim for both

0.5 millimeter aluminun equivalent filtration perman- fluoroscopic procedures and spot filming procedures.ently installed in the useful been. In addition:

4. For capacitor energy storage equipment, 1. hans shall be provided for stepless adjust-

compliance with the requirements of 41.1(4)"e" shall ment of the field sizesbe determined with the maximun quantity of charge per 2. The minimun field size at the greatest SIDcu posure. shall be equal to or less than fise by five conti-

5. The required minimal aluminun equivalent meters:filtration shall include the filtration contributed 3. Compliance with 41.1(5)"b"(1) shall be deter-by all materials $1ch are always present betseen the mined with the beam exis indicated to be perpen-

source ord the patient. dicular to the plano of the image receptor.(2) Filtration controls. for X-rey systems thich (2) For image-intensified f1teroecopic ec,uipuent,

huge variable k5 and variable filtration for the neither the length nor the width cf the X-ray field

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O

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in the plane cf the image recept 2r shell exceed that (3) The X-ray "cysten(o) that inctrporttescf the visibla area cf the image rec:pt:r by moro cutomatic exposure contral sh:ll have cufficientthan three percent of the SID. The sun of the excess material placed in the useful beam to produce alength and the excess width shall be no greater than millienperage typical of the use of the X-ray system;four percent of the SID. In additions and

1. Means shall be provided to pennit further (4) X-rpy system (s) that do not incorporate anlimitation of the field; automatic exposure control shall ut ilize a milli-

2. The minimun field sian at the greatest SID, amperage typical of the clinical use of the X-rayshall be equal to or less then five centimeters by system. Meterials (e.g., ettenuation block) shouldfive centimeters and be placed in the useful been son conducting these

3. Compliance shall be determined dth the been periodic menswesents to protect the imaging systen.exis indicated to be perpendicular to the plane of f. Barrier transmitted radiation rete limits.the image recepto r. For rectangular X-ray fields The exposure rate due to transmission through theused with circular image reception, the error in primary protective barrier with the attenuation ' blockcligrunent shall be determined along the length and in the useful beam, combined wLth rajistien from the

t:idth dimensions of the X-ray field sich pass image intensifier, if provided, shall not exceed twothrough the center of the visible area of the image milliroentgens per hour at ten centimeters from anyreceptor. accessible surface of the fluoroscopic imaging assen-

c. Activation of the fluoroscopic t@e. X-ray bly beyond the plane of the image receptor for eachproduction in the fluoroscopic mode shall be con- roentgen per minute of entrance exposure rate. The

trolled by a device hich requires continuous pres- transmitted exposure rate shall be measured in the

sure by the flmroscopist for the entire time of any following mannerscuposure. *en recording serial fluoroscopic images, (1) The exposure rate due to transmission throughthe fluoroscopist shall be able to terminate the the primary protective barrier combined with redl-

X-ray exposure (s) at any time, but seene may be pro- ation from the image intensifier shall be determinedvided to permit completion of any single exposure of by measurements everaged over an area of one hundredthe series in process. equere centimeters with no linear dimension greater

d. Entrance exposure rate allowable limits. The than twenty centimeters.cuposure measured at the point there the center of (2) If the source is below the t21stop, ther

the ueeful been enters the patient shall not exceed measurement shall be made with the input surface of.ten roentgens per minute. Exposure rate limits shall then fluoroscopic imaging assembly positioned thirtybe measured in the following manners centimeters above the tabletop.,

(1) myable gride and compression devices shall (3) If the source is dove the tabletop and the.,

be removed from the useful been during the measure. SID is variable, the measurement shall be pede withment. the end of the beam-limiting device or ' spacer as

(2) If the source is below the table, exposure close to the tabletop as it can be placed, provided

rate shall be measwed one centimeter above the that it shall not be closer than thirty centimeters.

tabletop or cradle. (4) Havable grids and compreesion devices shall(3) If the source is sove the table, the be removed from the useful been during the measure-

cuposure rate shall be measured at thirty centimeters ment.above the t@letop with the end of the bean-limiting (5) The attenuation block shall be positioned indevice or spacer positioned as closely as possible to the useful been ten centimeters from the point of

the point of measwoment. measw enent of entr ance exposure rate and between

(4) In a C-arm type of fluoroscope, the exposure this point and the input surface of the fluoroscopic

rate shall be mesewed thirty centimeters from the imaging assembly.input surface of the flmroscopic lasging essembly. g. Indication of potential and current. During

e. Weswenent of entrance exposure rate shall be fluoroscopy and cinefluorography the kV and the mAmade annually or after any maintenance of the systen shall be continuously indicated.*ich might effect the exposure rate. (bnditions of h. Source-skin distance. The source to skin dis-periodic measurement of entrance exposure rate are as tance shall not be less than:fallows : (1) Thirty-eight centimeters on stationary

(1) The kVp shall be the kV typical of clinical fluoroscopes installed after the e f fective date ofuse of the X-ray system: this rule,

(2) The high level control, if present, shall not (2) Thirty-five point five centimeters onbe activated. stationery fluoroscopee thich are in operation prior

to the ef fectise date of these rules,

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( ~,) 1hirty contimettro on all mobils fluoro- (2) Such cystan3 as do not meet the requirashnto_ scrae2, and of 41.1(5)g ers provided with a meene af indictting

'4) Twenty centimeters fo r image intensified the etmulative time that an individual patient hos

fluroscopes used for specific surgical application. been exposed to X-rays. Procedures shall require in% users operating menuel must provide precautionary stch cases that the timer be reset betusen examin-meetures to be adhered to during the use of this stione. .

dev ice. 41.1(6) Radiographic systems other than dental,1. Fluoroscopic timer. intraoral or veterinarian systase.

(1) Means shall be provided to preset the ctmule- e. General purpose stationary and mobile X-reytive on-time of the fluoroscopic ttbe. The maximum systems.etmulative time of the timing device shall not exceed (1) There shall be provided a means for steplessfive minutes without resetting. adjustment of the sias of the X-ray field.

(2) A signal audible to the fluoroscopist shall (2) Means shall be provided for visually definingindicate the completion of any preset etmulative on- the perimeter of the X-rey field. The total mis-

time. .Suc h signal shall continue to sound sile alignment of the edges of the visually defined fieldX-rays are produceo until the timing device is reset, with the respottive edges of the X-ray field along

j. % bile fluoroscopes. In addition to the other either the length or udth of the visually defined

requirements of 41.1(5) mobile fluoroscopes shall field shall not exceed tic percent of the distance

provide intensified imaging. from the source to the conter of the visually definedk. Control of scattered radiation. field een the sur face upon dich it appears is

(1) Fluoroscopic L21e designs den combined dth perpendicular to the axis of the X-ray been.procedures utilized shall,be etch that no unprotected (3) The agency may grant an exemption on non-part of any staff or ancillary individual's body certified X-ray systems to 41.1(6)"a"(1) and (2)ehell be exposed to unattenuated scattered radiation provided the registrant makes a written application

'

sich originates free mder the table. The attenu- for such exemption and in that application:ttion required shall be not less then 0.25 millimeter 1. Demonstrates it is impractical to comply withlead equivalent. 41.1(6)"a"(1) and (2); and

(2) Equipment configuration den combined with 2. The purpose of 41.1(6)"a"(1) and (2) will beprocedures shall be sich that no portion of any staff met by other meane,cr ancillery individual's body, except the extrem- b. Additional requiremente for str.tionary gensral'ities, shall be exposed to the mattenuated scattered purpose X-ray systems. In addition to the require-

' radiation seeneting from above the tabletop unless monts of 41.1(6)"a"(1) all stationary X-rey systemsthat individualt shall meet the following requirments:

1. Is et least one hundred twenty centimeters (1) Means shall be provided to indicate sen tbfrra the center of the useful bese, or mis cf the X-ray bese is perpendicular to the pla,w

2. The radiation has poseed through not less then of the image receptor, to alip the conter of the0.25 millimeter lead equivalent metsrial (e.g., X-rey field dth respect to the conter of the iminjedrepes, bucky-elot cover sliding or folding panel, or receptor to within tie percent of the SID, and toself-supporting curtaine) in addition to any lead indicate the SID to within two percenti

squivalency provided by the protective apron referred (2) The beam-limitiru; device shall ntmericallyto in 41.1(3)"e." indicate the field size in the piene of the imags

(3) Exceptions to 41.1(5)"k"(2) may be made in receptor to sich it is adjusted; and

same special procedures Aere a sterile field d 11 (3) Indication of field size dimensions and SIONnot permit the une of the normal protective bar- shall be specified in inches or centimeters, andriers. Were the use of profitted eterilland covers shall be such that apert ure sijustmente result infor the barriers is practical, the agency shall not X-ray field dimensions in the plane of the imagepermit etch exception. receptor sich correspond to those indicated by the

1. Radiation therapy simulation systems. Redi- heam-limiting device to within tie percent of the SIDttion therapy simuletion systems shall be except from den the bene mis is indicated to be perpendiculare,11 the requirements of 41.1(5), paragra$s "a," "b," to the plare of the image receptor." f" and "1." c. X-ray systems designed for one image receptor

(1) Sich systems are designeri and used in such a size. Radiographic equipment designed for only oneconner that re individual other than the patient is image receptor size et a fixed SID chall be providedin the X-ray roam durirq periods of time ten the with muans to limit the field at the plane of the

sptem is producing X-rays; and image receptor to dimensions no greater then those ofthe image receptor, and to slip the c entet- of the

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X-ray ficld 4th the contcr cf the image rec ptcr ta 2. A bran-limiting devico having multiplo fixed *within te percent of the SID, or shall be provided apertures suf ficient to meet the requirement for eachwith means to both size and align the X-ray field combination of image receptor size and $1D for sichc ch that the X-ray field at the plane of the image the unit is designed. Permanent, clearly legiblereceptor does not extend bepnd any edge of the image markings shall indicate the image receptor size andreceptor. SID for sich each aperture is designed and shall

d. Systems designed for or provided with special indicate $1ch aperture is in position for use.

attachments for mammography. Radiographic systems f. Timers. Means shall be provided to terminatedesigned only for msnmography and general prpose t~e exposure at a preset time interval, preset pro-

radiographic systems, when special attactments for dt.ct of current and time, a preset number of pulses,mammography are in service, shall bu provijed with or a preset radiation exposure to the image recep-

means to limit the useful bene such that the X-ray tot. In addition, it shall not be possible to make

field at the plane of the image receptor does not an exposure den the timer is set to a "ze ro" or

extend beyond any edge of the image receptor at any "of f" position if either position is provided.

designated SID except the edge of the image receptor g. X-ray control.designed to be adjacent to the chest well dere the (1) An X-ray control shall be incorporated intoX-ray field may not extend beyond this edge by more each X-ray syst's such that an exposure can be

than two percent of the SID. This requirement can be terminated by the operator at any time except for tmet with a system sich perfonas as prescribed in 1. An X-ray of one-half second or less, and41.1(6)"e." When the beam-limiting device and image 2. During serial radiography sen means shall bereceptor support device are designed to be used to provided to permit completion of any single exposureimmobilize the breast during a magnographic procedure of the series in process.

and the SID may vary, the SID indication specified in (2) Each X-rsy control shall be located in such a41.1(6)"e"(3) shall be the maximum SID for sich the my as to meet the following requirements: i

beam-limiting device or aperture is designed. In 1. Stationary X-ray systems shall be required toaddition, each image receptor support intended for have the X-ray control (or exposure switch in theinstallation on a system designed only for manmo- case of podiatry mits) permanently mounted in a

graphy shall have clear and permanent markings to protected area a) that the opere tot is required to

indicate the maximun image receptor size for sich it remain in that protected area during the entire expo - .

is designed. sure and

e. Special purpose X-ray systems. 2. % bile and portsle X-ray systans sich are

(1) Means shall be provided to limit the X-ray used for greater than one week in one location, i.e.,,

field in the plane of the image receptor so that such one room or suite, shall meet the requirements offield does not exceed each dimension of the image 41.1(6)"g"(2)1. /receptor by more than te percent of the SID *en the 3. % bile and portable mits $1ch are 'uned foraxis of the X-ray been is perpendicular to the plane greater that one how and less than one week at oneof the image receptor. location, i.e., one room or suite, shall meet the

(2) Means shall be provided to align the center requirement of 41.1(6)"g"(2)1. or be provided with a| cf the X-ray field with the center of the image 6.5 foot high protective barrier sich is placed at

receptor. to within tw2 percer,t of the SID, or means least six feet from the t*e housing assembly and atshall be provided to both size and align the X-ray least six feet fram the patients or

field such that the X-ray field at the plane of the 4. & bile and portable mits d ich are used to

image receptor does not exterzi beyond any edge of the make en expostre(s) of a patient at the use locationimage receptor. shall meet the requirement of 41.1(6)"g"(2)3 or be

(3) Subparagraphe 41.1(6)"e"(1) and (2) may be provided with a method of X-rey control sich willmet with a systen that meets the requirements for a permit the operator to be at least twelve feet from

| general purpose X-ray system as specified in the ttbo housing assembly during an expostre.41.1(6)"a" or when alignment means are also provided, 5. The X-ray control shall provide visual indi-may be met with either cation observable at or from the operator's protected

1. An assortment of removable, fix ed-apert ure, position senever X-rep are prodtced. In addition,bree-limiting devices sufficient to meet the require- a signal audible to the operator shall indicate thatment for each combination of image receptor size and the exposure has terminated.SID for sich the mit is designed with each sich h. Automatic exposure controls. men an auto-

device having clear and permanent markings to indi- matic exposure control is providedcate the image receptor size and 510 for $1ch it is (1) Indication anall be made on the control paneldesigned; or den this mode of operation is selected

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(2) If the X-rey tes "potenti:1 to equel to cr swfaco cf the diagnostic sourc3 seesebly, with thegr: stir then fifty kyp, the tinimum exposuro time f4r beam-limiting devico fully cpen,field emission equipment rated for pulsed operation 41.1(7) Intraoral dental radiographic e)etem a.ehell be equel to or less then a time interval equi- In addition to the provisions of 41.1(3) and (4), thev;1ont to te puleses requiremente of 41.1(7) apply to X-ray equipment and

(3) The minimun exposure time for all equipment associated facilitise used for dental radiography.

cther then that specified in 41.1(6)"h"(2) shall be Requirenente for extraoral dental radiographic sys-equal to or less than one-sixtieth second or a time tems are covered in 41.1(6).interval required to deliver five mas, dichever is a. Scurce-to-skin distence. X-ray systees

greatert designed for use with an intraoral image receptor(4) Either the product of peak X-ray tse poten- ehall be provided dth means to limit source-to-skin

tial, current, and exposure time shall be limited to distence, i.e., SSD, to not less thansnot more then sixty kWo por exposure, or the product (1) Eighteen centimeters if oper21e dove fiftycf X-ray t4e current and exposure time shall be kVp, orlimited to not more then six hmdred mas per exposure (2) Ten contimeters if not operable above fiftycxcept den the X-ray t@e potential is less than kyp.

fifty kVp, the prodwt of X-ray tse current and b. Field limitation. Radiographic systensexposure time shall be limited to not more than te designed for use with an intraoral image receptorthousand mas per exposureg und shall be provided with means to limit the X-ray been

(5) A visible signal shall indicate when en expo- swh thett

cure hee been tensinated at the limite requtrod by (1) If the minimun SSD is eighteen centimeters or41.1(6)"h"(4) and manual resetting shall be required more, tne X-rey field et the minimun SSD shall bebefore fwther automatically timed exposwee con be containable in a circle having e diameter of no moremade. than seven centimeters; and

i. Reproducibility. With a timer setting of 0.5 (2) If the minimun SSD is less then eighteen

seconde or less, the average exposure period @ contimeters, the X-ray field at the minimun SSD shall'

~ ehall be greater then or equel to 5 times the maximun be containable in a circle having a disneter of noexposure period (T ex) minus the minimun exposure more than six contimeters.

,

period (Tain) den four timer teste are performed (3) The pseition indicating device shall be. shielded and open ended. The shielding shell bo',

,

equivalent to the requiremente of 41.1(4)"c."i .e . , T 15(T ,x - T,in). c. ~ Timere. krsens shall be provided to terminate'

the exposure st a preset time interval, preset pro-j. Source-to-skin distance. All mobile or port- duct of current and time, a preset number of puleee,' '

able radiographic systems shall be provided with or a preset radiation exposure to the image rec ep-means to limit the source-to-skin distance to not tor. In additions"

less then thirty contimeters. (1) It shall not be possible to make an exposurek. Exposure reprcducibility. The exposure repro- when the timer is set to a "zero" or "off" position

ducibility shall meet the following requiremente t if either position is provided.

The coefficient of variation of exposure shall not (2) Reproducibility. With a timer sotting of 0.5exceed 0.10 den all techniqw factore are held seconde or less, the average exposure period (T)constant. This requirement shall be deemed to have shall be greater than or equal to five times thebeen met if, den four exposures are mede at identi- maximus exposure peried (T,,x) ainus tre minimuncol technious factors, that the value of the everage exposure period (Tein) den fo e timer teste enennosure (E) is greater than or equel to five times performed

the maximun exposure (Emax) minue the minimus e,xpo-

rure (Emin)8 _

i.e., T 1 5(Teex - TainI *

1.e., E 1 5(Emax - E min). d. X-rey control.(1) An 4-rey control shell be incorporated into

1. Radiation from capeltor energy storage equip- each X-ray eyetan swh that exposures of or e-hal fment in etendby status. Radiation esitted from the second or more can te ter'nipoted by the operator etX-r ay tse when t he exposure switch or timer is not saiy ties.activated shall not exceed a rate of te milliroent- (2) Stettonary X-rey systces shell be required togene per hour ut five centimetets from any xcessible have en X-ray exposvre switen cord of suf ficient

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length to permit the operator to activ'to the mit et ito leakage technique factges, the leakage radi '4113 in o pr:tected ecco, o.g., egrridor tut:ide the (tlon sh:11 not extcod the welta tpecified at theroan. The procedures required eder 41.1(3)"d" must distence speelfled fbe the closelfication of that

instruct the operator to remain in thet protected X-rey system,cree during the entire expoeweg and 1. Contact therapy systes. Leekage radiation

(3) mbile and portable X-rey eyetems sich are ehall not exceed one hundred milliroentgens per hour1. Used for greater then one wek in one loco- et five contimetere from the se face of the t4e

tion, i.e., one room or suite, shall meet the housing ensembly.requirements of 41.1(7)"d"(2).: 2. G-150 kVp systans. Systems sich are menu-

2. Used for greater then one how and less then factured or installed prior to the effective date of

one wek et one location, i.e., one room or suite, 41.1(8) shall have e leekage radiation sich does notshall either meet the requiremente of 41.1(7)"d" exceed one roentgen in one hour et one meter from the(3)1 or be provided dth a 6.5 foot high protective source.

,barrier sich is placed at least six feet fran the 3. 0-150 kVp systems. Systems 21ch are manu-

| t4e housing seeembly and at least six feet from the factwoo on or after the effective date of 41.1(8)patient or shall have e leakage radiation dich does not exceed

(3) Transportad and used at the patient's loco- one-hedred milliroentgene in one hour at one metertion shall either meet the requirement of 41.1(7)"d" from the source.,

(3)1 or 2. or be provided dth a enthod of X-ray 4. 151 to 999 kVp systems. The leakege radiationcontrol dich will permit the operator to be et leset shall not exceed one roentgen in one hour et onetwelve feet from the tse trusing essembly during en meter fran the source except systens that operate in

1 ex posure. excess of five hundred kV may have a leakage radi-| (4) The X-ray systen shall provide vis'uel indi- stion et one meter fran the source equivalent to the

cttion observsle et or fram the operator's protected exposes within one how of the useful bem et one

position senever X-rays are produced. In addition, meter from the source multiplied by a factor of,

a signal audible to the operator shall indicate that 0.001.the expoewe hee terminated. (2) Personent been limiting devices. Permanent

; e. . Exposure reproducibility. The exposure repro- fixed diaphrague or cones used for limiting the use-.

' ducibility shall meet the following requirements: ful beam shall provide the sene or higher degree of. .

"~

j The coefficient of veristion shell. not ' exceed 0.10 protection as required by the tse housing sesembly.'

*en 'all technique factore 'ere held constant. This .( 3)_ Renovable and adjust 21e been limiting de-requirement shall be deemed to have been met if, een vices.

,

four exposures are made et -identical tech _nique 1. Annovable bem limiting devices shell,' for thei factors, the value of the everage exposure (E) is portion of the useful been to be blocked ,by these| greater than or equel to five times the maximun expo- devices, transmit not more than one percent of the

sure (E6.x) minue the minimum exposure (Gnin): original X-ray bem et the maximus kilovoltage andmaimun treatment filter.

;

2. Adjustable bem limitirq devices insteiled,,

i.e. , E > 5(E , - Emin) . efter the effective date of 41.1(8) shall meet theerequirements of 41.1(8)e(3)1.

f. Adminlettetive controle. 3. Adjustdie been limiting devices instelled'(1) Patient and film holding devices shall be before the effective date of 41.1(8) shell, for the

used den the techniques permit. portion of the X-ray been to be blocked by those(2) Nnither tte tee housing rer the position devices, truimit not more then five percent of the

indicating device shall be hand-held during en expo- original X-rey bem et the maximun kilovoltage andcure. maximun treeteent filter.

(3) The X-ray system shall be operated in euch a (4) filter systen. The filter system shell be somenner that the useful bem at the patient's skin designed thattmeets the requirements of 41.1(7)"b." 1. filters cannot be accidentally displaced from

j (4) Dental fluoroscepy without image intensifice- the useful been at any possible tse orientationition shall not be used. 2. Each filter is merked as to its meterial of

41.1(8) Therapeutic X-ray systems of lese then constrtetion and its thic knees or wedge engle forone m V. edge filters and

e. Equipment requiremente. 3. It shall be possible for the operator to(1) Leekage radiation. Sen the ts e is operated determine the presence or obsence of each filter and

the orientation of each wedge filter in the useful,

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beam *en the operatst is at the contr:1 panel, 2. The timer shall be O cumulativo timer sich*

,

either by di plty et the contr:1 panel ce by direct activct&3 with the radiction and r:tcine its r:adingobservation. efter irradiation is interrupted or terminated .

4. The radiation et five centimeters fran the After irradiation is terminated and before irradi-filter insertion slot ope u0 does not exceed thirty ation can be reinitiated, it shall be necessary toroentrene per hour under any operating conditions. cycle the preset time selector through zero time.

5. T@e immobilization. The t@e housing assem- 3. The timer shall terminate irradiation den ably shall be capable of being imobilized for preselected time has elapsed.ttatior.ory treatments. 4. The timer shall permit accurate presetting and

6. tocol spot merking. The tse housing essembly determination of exposwo times as short as oneshall be so merked that it is possible to determine second.the location of the focal spot to within five milli- 5. The timer shall not permit an exposwo if estmeters, and etch merking shall be readily accessible et zero.

for use during calitration procedures. 6. The timer shall comply with the provisions of(7) Bean block. Contact therapy tse housing 41.1(8)a(13) *ere applicable.

assemblies shall have a removable shield of at least 7. The timer shall not activate mtil the shutter0.5 millimeter lead equivalency at one hmdred kVp is opened den patient irrafiation is controlled by a

that can be positioned over the entire useful been shutter mechanima.cxit port during periods den the been is not in use. (10) Control panel fmetions. The control panel,

(8) Bean monitor system. Systems of greater than in addition to the displays required in other provi-

one hmdred fifty kyp manufactured after the_ effec- sions of 41.1(8) shall havestive date of 41.1(8) shall be provided with a been b. Facility design requirements for systems cap-monitor system sicht 21e of operating above fifty kyp. In addition to

1. Shall include a transmission detector dich is shielding adequate to meet control panel and if acti,-o full been detector and sich is pla:ed on the votion of the X-ray tse is possibles

patient side of any fixed added filters other than a 2. M indication of * ether X-rays are being

wedge filter._

produced,

2. Shall have the detector interlocked to prevent 3. Means for indicatirg kV and X-ray t@e cur-,

incorrect positianing in the useful beamt rent3. Shall not allow irradiation mtil a preselec- 4. Means for terminating an exposure et any times

,

ted value of exposwo of roentgens has been made at 5. A locking device sich d11 prevent mauthor-the treatment control panels izeid 'uee of the X-ray systeeg and

~

4. 91all independently terminate irradiation den 6. For X-ray equipment manufactured after the'

the pre-select ed number of roentgens exposure has effective date of 41.1(8), a positive display of

been reached specific filter (s) in the been. /5. Shall be so designed thst, in the event of a (11) HJ1tiple t@es. When a control panel may ,

cysten malfmetion or electrical gxner failure, the energize more ther; one X-ray tsesdoes administered to e patient prior to the system 1. It shall be possible to activate only one

malfmetion or poter failure can be accurately deter- X-ray tse during any time interval.cined: 2. There shall be wt indication at the control

6. Siell have a display at the control panel panel identifying sich X-ray tse is energized andfran dich reading in roentgens the does at a refer- 3. There shall be an indication at the t@e hous-cnce point in the treatment volume can be calculated ing essembly ten that t@e is energized.

7. 9iall have a centrol panel display sich main- (12) Source-to-petient distance. There shall be

tains the rem 11ng mtil intentionally reset to aerog means of determining the source-to-patient distanceand to within one centimeter.

B. 91all have a control panel display thich does (13) Shutters. thleas it is gx)ssible to bring

not have scale multiplying factors and utilizes a the X-ray output to the inescribed expoews para-

design etch that increasirq dose is displayed by meters dthin five seconds, the entire useful been

ircreasing numbers. shall be automatically attenuated by a shutter having(9) Timer. a lead equivalency not less then that of the tse

*

1. A timer shall be providni Wich has a display housing assembly. In addition |'

Et the treatment control panel. The timer shall be 1. After the mit is et operating peraneters, thegraduated in minutes and fractions of minutes. The shutter shall be controlled electrically by the oper.

timer shall have a preset time selector and an stor from the control panels andclapsed time indicatot .

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2. An'indicati:n gf shutt:r po:ition chail appe:r the doort and, c4sequently, reinititting the expo-at the contral pan:1. Curo tt the contr:1 pen:1.

(14) Low-filtration X-ray te es. Each X-ray c. Surveya, calibrations, spot checks, and oper.cysten equipped with a beryllium or other low- ating procedures.flitration endow shall be clearly labeled as such (1) Surveys.Upon the t4e housing assembly and at the control 1. All new facilities and existing facilities notpanel. previously swveyed, shall have a survey made by, or

b. Facility design requirements for systems cap- under the direction of, e qualified expert. Suchable of operating sove fifty kVp. In addition to swveys shall be done after any change in the facil-shielding adequete to meet requirements of 470 - ity or equipment s ich might cause a significantDieptere 40 and 41, the treatment room shall meet the increase in radiation hazard.following design requirements: 2. The expert shall report findings in writing to

(1) W rning lights. Treatment rooms to sich the person | in charge of the facility and a copy ofaccess is possible through more than one entrance the report shall be maintained by the registrant forshall be provided 4th warning lights, in a readily inspection by the agency.observable position near the outside of all access 3. The survey and report shall indicate alldoors, sich will indicate den the useful been is inetences *ere the installation in the opinion of"on." the qualified expert, is in violation of applicable

(2) Voice commmication. Provision shall be made rules and cite all itens of noncompliance.for two-way aural communication between the patient (2) Calibrations.and the operator at the control panel; however7 *ere 1. The calibration of an X-ray system shall be

excessive noise levels make aural communication performed at intervals .not to exceed one year andimpractical, other methods of commmication shall be after any change or replacement of components sichused. could cause a change in the radiation output. -

(3) Viewing systems. itindows , mirrors, or 2. The calibration of the radiation output of theclosed-circuit television, or an equivalent system X-ray systen shall be per formed by or under the

shall be provided to permit continuous observation of direction of a qualified expert so is #1ysic ally

preson't at the facility during such calibration.the patient during irradiation aM shall be so'

located that the operator can observe the patient 3. Calibration of the radiation output of an

from the control panel. Den the primary viewing X-ray systen shall be - performed with a calibrated

cystem is by electronic means, (e.g., television), an instrument. The calibration of such instrument shallc1 ternate viewing system, shall be available for use be directly traceable to a national standard. The,

in the event of electronic failure. instrument shall have been calibrated dthin the

(4) Additional requirements. Treatment roome proceding tm years. fwhich contain an X-ray systems espable of operating 4. The calibrations made pursuant to 41.1(8)"c"above one hundred fifty kVp shall meet the following (2) shall be such that the does at a reference pointadditional requirenents: in soft tissue can be calculated to within g five

1. All necessary shielding except for any been percent.interceptors shall be provided by fixed barriers: 5. The calibration of the X-ray systen shall

2. The control panel shall be outside the treet- include, but not be limited to verification that the

ment room X-ray system is operating in compliance with the

3. All doors of the treatment roan shall be design specifications 3 the exposure rates for erbclectrically connected to the control panel such that combination of field size, technique factors, filter,

X-ray production cannot occur unless all doors are and treatment distance used; the degree of congrwruclosed between the radiation field and the field iruficate :

4. men the doors referred to in 41.1(8)"b"(4)3 by the localizing devit.e if such device is present scre opened site the X-ray tse is activated, X-ray and an evaluation of the mifonnity of the radiation

production shall terminate within one second, or the field sysseetry for the field sizes used and any

radiation at a distance of one meter from the source dependence upon tse housing assembly orientation.shall be reduced to less than one hundred milliroent- 6. Records of calibration performed pursuant togene per hour within one seconds and 41.1(8)c(2) be maintained by the registrant for tm

5. After the radiation output of the X-ray tse years after completion of the calibration.has been affected by the opening of any door referred 7. A copy of the most recent X-ray s) stem cali-to in 41.1(8)b(4)3 it shall be possible to restore bretion shall be evellable for use by the operator et

,

the X-ray system to full operation only upon closing the control panel.|

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(3) Spot checke. Spot checks shell b] perfamed ' Dose monit1 ring cysten* means o system cf dev' ices'

on X-ray cystems c peblo cf cperction Ct grntcr than f;r the detection and display cf quantitiro cf redi-1one hmdred fifty kVp. Such spot checks shall meet ation. '

the following requirements: "Q)se monitor unit" means a mit fran =hich the1. The spot-check procedures shell be in triting absorbed dose can be calculated.

and shall have been developed by a qualified expert. " Existing. equipment" means therapy systems stbject |2. The measurements taken during the spot checks to 41.1(9) ver re manufactured on or before July 1,

shall demonstrate the degree of consistency of the 1980. Icperating characteristics inich can affect the radi- " Field finttening filter" means a filter used to {ction output of the X-ray system. homogenias the dose rate over the area of a useful

3. The spot-check procedure shall spec 1fy the bean of X-rmye.frequency at which tests or measurements are to be " Field size" means the dimensions of an area in aperfonned plane perpendicular to the specified direction of the

4. The procedures shall also note conditions been of incident radiation at a specified depth in awhich shall require that the systen be recalibrated phantom and defined by specified isodose lines.in accordaru:e with 41.1(8)"c"(2): and " Gantry" means that part of the systen supporting

5. Records of spot-check measurements performed and allowing possible movements of the radiationpursuant to 41.1(8)"c (3) shall be maintained by the head.a

registrant for two years following su:h measuranents. " Interruption of irradiation" means the stopping(4) Operating procedures. of irradiation with the possibility of continuing1. Therapeutic X-ray systens shall not by left irradiation without resetting of operating conditions

unattended unless the systen is secured pursuant to at the control panel.41.1(8)"a"(10)5. "Isocenter" means a fixed point in spece located

2. men a pelient must be held in position for at the intersection of the rotation axes of theradiation therapy, mechanical supporting or restrain- principal movements of the therapy system.ing devices shall be used. "M2ving been therapy" means tr.distion therapy with

3. The ttbo housing assembly shall not be held by relative displacement of the use ful been and theen individual during exposures. patient during irradiation.

4. Pb individual other than the patient shall be "New equipment" means systems stbject to 41.1(9)in the treatment roon unless etch individual is pro- which were manufactured after the effective date of

,

tected by a barrier sufficient to meet the require- this rule.

ments of 40.2(1) of radiation rules. hb individual 'b real treatment distanc e" sesne the distanceCther than the patient shall be in the treatment room between the virtual source and a reference gxalnt onduring exposures when the kV exceeds 150. the central exis of the useful been. The reference

5. The X-ray systen shall not be used in the point is located at a position there the patient will#

administration of radiation therapy unless the be placed during radiation therapy.requirements of 41.1(8)"c"(2) and 41.1(8)"c"(3)4 have " Patient" means an individual stbjected to examin-been met. ation and treatment.

41.1(9) X-ray and electron therapy systems with " Phantom" means a volume of material behaving in aenergies of one Me V eM sbove. Rule 41.3(136C) manner similar to tissue with respect to the attenu-

cucept 41.3(3)"g"(3) and (4) shall apply to medical stion and scattering of rallation.facilities using therapy systens with energies one " Primary dose monitoring systan" mean* a systemMeV and above. thich will monitor the quantity of radiation produced

a. De finitions. In addition to the definitions during irradiation and which will terminate irradi-

provided in 41.1(2), the following definitions shall ation sen a preselected number of dose monitor mitsbe applicable to 41.1(9): have been acquired.

" App!!cator" means a structure thich indicates the " Radiation treatment pr esc ription" means theextent of the treatment field at a given distance absorbed dose which is intended to be delivered tofrcus the virtual source aM which may or may not the treatment voltane.incorporate the been limiting device. " Radiation head" means the struct ure fran thic h

"Been s:sttering filter" means a filter used in the useful been energes.ceder to acatter a beme of electrons. " Redundant dose monitoring combination means ad

" Central acis of the bear." means a line passing combination of tw dome monitoring systerns in *hichthrou@ the virtual sourcs and the center of the both e) stems are arranged to terminate irrediation inplane figure formed by the edge of the final been accordance with a preselected number of does munitorlimiting device. mits.

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.

. .

(Secondary does monitoring cysten* means otystem F&r each system, the registrant shall det:rmine,s ich will t:neinsta irradiction in the event of or obtain from the manufacturer, the leakage radi-failure of the primary systen, ation existirq et the positione specified in 41.1(9)

" Shadow tray" means a device attached to the radi- "b"(1)2 for the specified operating conditions.Ction head to support auxiliary bene limiting mater. Records on radiation leakage shall be maintained attal. the installation for inspection by the agency.

" Stationary been therapy" means radiation therapy (2) teskage radiation outside the patient area.without relative displacement of the useful been and 1. The does equivalent in ran due to leakagethe patient during irradiation. radiation, except in the area specified in 4141(9)

" Target" means that port of a radiation source "b"(1)1 son measured at any point one meter from thesich intercepts a boas of accelerated particles with path of the charged porticle, before the chargedctheequent emission of other radiation. particle striles the target or window, shall not

" Termination of irrafistion" means the stopping of exceed 0.1 percent for X-ray leakage nor 0.05 percentirradiation in a fashion s ich will not permit for neutron leakage of the maximus does equivalent incontinuance of irradiation without the resetting of ran of the mattenuated useful been measured at thecperating conditions at the control panel. point of intersection of the central axis of the bema

" Treatment field" means the area of the patient's and the circular plane specified in 41.1(9)"b"(1)1.skin sich is to be irradiated. 2. The registrant shall determine, or obtain from

" Virtual source" means a point from sich refi- the manufacturer, the actual leakage radiation exist-ttion appears to originate. ing at the positions specified in 41.1(9)b(2)1 for

~b. Equipment requirenents. specified operating conditione. Meestrements shall(1) teskage radiation to the patient area. be averaged over en area up to but not exceedirg one1. New equipment shall meet the following hmdred symre centimeters at the psitione speci-

requirementet fled. i

For all operating conditions, the dose equivalent (3) Bean limiting devices. Adjustable or inter-in ras due to leakage radiation, including X-rays, changeable bene limiting devices shall be provided,clectrone, and neutrons, at any point in a circular and etch devices shall transmit no more than twoplane of te meters radius centered on and perpendic- percent of the useful been for the portion of the*

ular to the central amis of the been at the normal useful been Alch is to be attenuated by the been*treatment distance and outside the maximus use ful limiting device. The neutron component of the useful .beam, shall not onceed 0.1 percent of the mexistm bene shall not be included in this requirement.

does equivalent in tem of the unattenuated useful hasurements shall be averaged over an aree up to but,

been measured at the pint of intersection of the not exceeding one hmdred square centimeters at thecentral axis of the been and the plane sur face. normal treatment distance. /%asurements shall be overaged over en area up to but (4) Filters.not exceeding one hundred square centimeters at the 1. If the absorbed done rate information requiredpositions specified. by 41.1(9)"b"(16) relates exclusively to operation

for each systen the registrant shall determine, or with a field flattening or been scattering filter inobtain from the manufacturer, the leakage radiation place, seh filter shall be renovable only by the useexisting at the positions specified in 41.1(9)"b"(1)1 of tools.for specified operating conditions. Records on leak- 2. In systens *1ch utilize a systen of wedge

|age radiation shall be maintained at the installation filters, interchangeable field flattening filters, orfor inspection by the agency. interchange *1e been scattering filters irre11ation

2. Existirq equipment shall meet the following shall not be possible mtil a selection of a filterrequirements: has been made at the treatment control panel; an

The leakage radiation excluding neutrons at any interlock systen shall be provided to prevent irradi-point in the aree specified by 41.1(9)"b"(1)1 *ete ation if the filter selected is not in the correctcuch area intercepts the central axis of the bene one position an indication of the wedge filter orienta-

i meter from the virtual source, shall not exceed 0.1 tion with respect to the treatment field shall be

| percent of the maximum dose equivalent in ran of the provided at thse control panel, by direct observationmattenuated use ful bene meastred at the pint of or by electronic means den medge filters are used; a

j intersection of the central axis of the been and the display shall be provided at the treatment controlcurface of the referenced circular plane. Nasur e. panel showing the filter (e) in uset each filter sichments shall be averaged over en eres up to but not is removable from the systen shall be clearly identi-exceeding one hmdred square centimeters at the psi- fled as to that filter's meterial of construction,

tions specified. thickness, and the wedge angle for wedge filters 3 and

Il - 16 -

7

** an interlock shall be provided to prevent irradiation TABLE IV~

if any filter selection operation corried cut in the

treatment room does not agree with the filter seloc-tion operation carried out et the treatment control %eorbed Does et thepanel. Maximun Photon Surface as a fraction of

(5) Bose quality. The registrant shall deter- Energy in MeV the Maximun %eorbed Dasecine, or obtain from the manufactwer, data suf fic-

isnt to assure that the following be en quality 1 0.80requiremente are met 2 0.70

0.601. The absorbed does resulting from X-raye in a 5 .

useful electron bene at a point on the central axis 15 0.50cf the been ten contimetere greater then the practi- 35 0.40sel range of the electrone shall not exceed the 50 0.20volwe etsted in ~ Table III. Linear interpolation

shall be used for values not stated.4. Compliance with 41.1(9)"b"(5)3 shall be

TABLE III detemined by meesw esente made within a phantomusing an instrument sich will allow extrapolation tothe swface absorbed doses use of a phantom those

sias and placement meet the requirements of 41.1(9)"b"(5)2 removal of all beam modifying devices ieich_

Maximun Energy X-Ray %eorbed Dose as can be removed without the use of tools, except forof Electrons a Fraction of Huximun been scattering or beam flattenirvj filters and theBeen in WV %eorbed Dose largest field elas available 21ch dcas not exceed

fifteen contimeters by fifteen centimeters.1 0.03 5. The registrant shall detensine, or obtain frA

15 0.05 the manufacturer , the maximum percentage <bearbed35 0.10 does due to stray neutrone in tM useful been for

,

- 50 0.20 specified operating conditions.(6) Sean monitorirq. All therapy systems shell'

'

be provided with radiation detectore in the radiation2. Compliance with 41.1(9)"b"(5)1 shall be deter- head.'

1. New equipment shall be provided 4th at lor.st' cined ustry a measurement within a phantom witl the ".

incident surface of the phantom at the normal treet- too radiation detectors. The detec tors shallment distance and normal to the central axle of the incorporated into two monitoring oysteme!arrarg64been the largest field elas ovellable sich does not either as e primary / primary combination or es aexceed fifteen centimeters by fifteen contimetereg primary / secondary conbination.and a phantom whose cross-sectional dimensione exceed 2. Existirq equipment shall be provided with atthe measurunent radiation field by at least five least one radiation detector. This detector shall becentimetare arrj mbose depth is sufficient to perform incorporatad into a prieery systen.the required meeswetent. 3. Each primary system shall have e detector

3. The absorbed does et a surface locatad at the s ich is a transmission detector and a full bewnnormal treet.aent distance, at the point of intersec- detector and thich le placed on the patient's side nrtion of that surf ace with the central axis of the any fixed added filtere other than a wedge filter,useful been disring X-rey irradiation, shall not The detector shall be removable only with tools and

i exceed the limite stated in Table IV. Lineer intera shall be interlocked to prevent incorrect position.

palation shall be used for values not stated. ing. Each detector shall be capable of independentlymonitorirq erd contro111rq the use ful te en . Ea:hdetector shall fone part of a dose monitoring systemfrun whose readings in dow monitor mits the ab-sorbed risse at a referenced paint in the treatment

volume con be e.alculated.4. For new equipment, the design of the dose

anonitority systws of 41.1(9)"b"(6)3 ohell eseurethat tN wwlfmetienirg of one oystm snell notaf foet tne cocract fmeticalng of the accond systm.

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. -- - - - - - - . - - - - . _ - - - - _ . _ . . - - - __-. - - - ._ - -

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In addition the failuro af any clament eith may b3 2. Each primary cystem shall t:risinato irradio-'

common to both systems shall terminate the useful tion den the preselected number of duas monitor,

[l been. The failure of any element common to both sys- mits hee been detected by the eyeten. I

tame 'dich could effect the correct function of both (10) Interruption switches. It shell be pose- l

i ' cystane shell terminate irradiation. itle to interrupt irradiation and equipment movementeS. Each does monitoring eyete shall have a leg- et any time fem the operator's peeltlan et the '

ible display at the treatment centrol panel. Each treatment control panel, following an interruption,'

'display shall meintain a reading stil intentionally it shall be poselble to restert Arradiation by oper- |

Ij reset to anro g have only one scale mid no scale stor action dthout any reeelection of operating

| multiplying factore in new equipment 3 and utilias a conditions. If any cheige is made of a precolected! design such that increening dose is displayed by value during an interruption the equipment shall go| increasing mmbers and shall be so designed that, in to teemination condition.

the event of an overdosage of radiation the absorbed (11) Teemination suitches. It shall be possible f,,

| does may be accurately determined under all norme1 to terminate irradiation and equipment movemente, orconditions of use or foreseeable failures. go from en interruption condition to toimination

j 6. In the event of power failure, the does moni- conditione, et any time from the operator's position4 L: ring information required in 41.1(9)"b"(6)3 dio- et the treatment control panel.

played at the control penet et the time of failure (12) Timer.! shell be retrievable in et leest one system. 1. A timer shall be provided W11ch hee e displaye

4 (7) Bom symmetry. et the treatment control panel. The timer shall be_

; 1. for new equipment each therapy machine shall graduated in minutes and decisels of minutes. The

; have the capsility of compering the does retes in timer shell have a preset time eclector eruf an

cach of the fotr quadrants of the centeel eighty per- elapsed time indicator. '

, ,

.cent of the useful bem. Bem syunetty information 2. The timer shall be a cumulative timer sich

,

{ ehell be displayed at the treatment control panel, switches on and off dth the rallation and retains'

i and such display shall be cap 61e of indicatirg e its reading efter irradiation is interrupted ori

!',differential of more then five percent betusen any terminated. It shall be necessary to are and esbee-te of the quadrant does rates. be seynenetty in quantly reset the elopeed time indicator end the

I excess of tenty percent shall automatically termin- preset time selector efter irradiation is tossinated' ''

* ete the useful bem. before irradiation shell ageln be possible., .

|- 2. Been symmetry requirments of 41.1(9)"b"(7)1 3.*-lhe timer shall terminate irradiation den e| ehell be met if the user can demonstrate to the / preselected time hee elopeed if the dose monitoring

.' cetiefection of the agency that edeepsete fail-eefe systems fell to de so.

| protection against the bem anyimetry le incorprireted (13) Selection of radiation type. Equipment cep-into the inherent design of the accelerator. able of both X-rey therapy and electron therapy shall

,

3. Ih existing equipment dere the agency hee most the following requiremontes! determined that been symmetry le inedeepsete the use 1. Irrellation shall not be snoeible mtil ei of an eutametic been sayunetry warning systen may be selection of radiation type hem been neds * st the

'required. treatment control penet.

(0) Selection and display of does annitor units. 2. An interlock syste shall be provided to i,

1. Irradiation shall ret be possible until e enetre that the equipment can amit only the radiaton'

selection of a number of does monitor tesite hee been type sich hee been selected.made et the treatment control panel. 3. An interlock eyeten shall be provided to pre-

2. After useful bem termination, it shall be vent irradiation if any selected operatione carried inecessary to manually ' reset the preselected ease out in the treatment room do not agree d th the

monitor unite before treatment can be reinitiated. eclected operatione carried out et the treatment

3. The preselected reanber of dose monitor unite control penei.ehe11 be displayed et the treatment control panel 4. M interlock eyeten shall be provided to pre- ;

mtil reset manually for the neut irradiation. vent irradiation dth X-reye den electron appli.

(9) formination of irradiation by the does moni- catore are fitted and irradiation with electrone dentaring systen. eccessorise specific for X-ray therapy are fitted:

1.* Each required monitoring syst en, shell be and

capable of independently terminating irrefistion. 5. The radiation type selected shall be displayedProvisione shall be made to Leet the correct opers- et the treetment control penet be fore oral duringtion of each systen. Arradiation.

r

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*'(14) Selection of energy. iquipment cepebl3 of dose reta exceeds o v:1ue trica the specified m.

*,

generating radiation beene tf dif f; tent energies mun. The v:1us et 21ch the irradittion cillshall meet the following requirements:terminated shall have e record maintained by tt1. Irradiation shall not be possible until e registrant.

selection of energy hee been made et the treatment (17) Location of focal spot and been oriente.control penet.tion. The registrant shall determine, or obtain from2. M interlock systen shall be grov ided to the manufacturer, the location with reference to en

ensure that the equipnent can operate only in the accessible point on the radiation head of tmode $1ch has been selected. 1. The X-ray target or the virtuel source of3. M interlock systen shall be provided to pre. X-rays.vent irradiation if any selected operatione corried 2. The electron window or the acettering foil.Out in the treatment roan do not agree with the 3. All possible orientatione of the useful been.selected operatione carried out et the treatment (18) Systen checking facilities. Capabilities;control panel.

shall be provided so that all radiation safety inter-4. The energy selected shall be displayed at the locks can be checked. Sen greselection of any oftreatment control panel before and during irradie- the operating conditions requires action in thet ion. i

treatment roon and at the treatment control panel,(15) Selection of stationary been therapy or mov- selection et one location shall not give a display ating been therapy. Equipment capable of both station-the other location until the requisite selected oper-ary been therapy and moving been therapy shall meet stions in both locations hose been completed.the following requirenentes

(19) Shadow trays shall be designed etch that the,

1. Irrediation shall not be possible until e skin entrance. does dim to electrons prodtred withinselection of stationary been therapy or moving been the shadow tray are minimized.therapy hoe been male et the treatment control penet. c. Facility and shielding requiremente. In uddi,.2. An interlock systen shall be provided to tion to 470--chapter 40, the following designensure that the equipment een operate only in the requiremente shall applyt

- mode sich has been selected. (1) Except for entrance doors or been intercep-3. M interlock systen shall be provided to pre- tors, all the required berriere shall be fluedvent irradiation if any selected operatione carried barriere.out in the treatment roos do _not agree with the (2) The treetsent control panel shall be located'selected operatione carried out et the treatment outside the treatment roan.control panel.

(3)- Windows, otrrors, closed-circuit television,4. An interlock systen shall be provided to-tone. or other equivalent viewing systems shall be provided>

inste irradiation if the movement stope during moving to pensit continuous observation of the patient dur -been therapy. ing irradiation and shall be a2 located Ahet theS. Moving been therapy shall be em controlled operator may observe the patient from the treatment

that the required relationship between the number of control penet. men the viewing systen is by elec.does monitor mite and movement is obtained. tronic means (e.g., televison), an alternate viewing6. The mode of operation shall be displayed at system shall be provided fbr une in the event ofthe treatment control panel. failure of the primary systen.

(16) Absorbed dose rate. For new equipnent, a (4) Proviolon shall be made for two-way aurelcysten shall be provided which will allow the ab- countnication between the patient and the operator atsorbed dose rate at a reference point in the treet- the treatment control panel. tbwever, dere exces-eent volume to be calculated. The rallation detec- elve noise levele males aurel casustoication imprac-tore specified in 41.1(9)"b"(6) may form part of thle tical, other methode of canomication shall be used.cysten. In additions

(5) Treatment rooms to *ich access le possible1. The gutient of the number of dose monitor through more then one entrance shall be provided 4thmite by time shall be displayed et the treatment warnitu) lights, which will indicate den the usefulcontrol penet. been in "on" in a readily observable pneition neer2. If the equipnent can deliver under any condi- the outside of all accese doors.

tiene an * sorbed dose rate et the norwel treatment (6) Interlocks shall be provided etch that alldistance more than twice the maximun value specified

entrance doore must be closed before treatment can beby the manufacturer's enticipated dose rate for any initiated or continued. If the radiation been lecaichinn paranetere utilized, a device shall bevided sich terminates irre11stien *en the soorbed

interrupted by any door opening, it shall be possiblepro-

to restore the machine to operation only by closing

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the door and t: initiating suposura by meneel action the c:1Cretion det: minatione sovo shall be pro-et the control pene!. vided in sufficient detail such that the absorbed

d. Surveys, calibratione, spot checks, and oper- dose to tissue in the useful been may be calculatedeting procedures. to within 3 five percent.

(1) Surveye. 6. Ibcords of the calibration perfanned pursuont1. All new facilities, and enf eting recilities to 41.1(9)"4"(2)1 shall be meinteined by the regi-

not previously owveyed, shall have e survey mode by, strent for two para efter completion of the cellbre-or under the direction of, e qualified emport. Such tion.surveys shell be done ofter any change:in the facil- 7. A copy of the latest calibration performedity or equipment sich eight ceues e significant pursuant to 41.1(9)"d"(2)1 shall be evellable for useincreens in radiation heterd. by the operator et treatment control panel.

2. The registrant shall obtain a witten report (3) Spot checks. Spot cheche shall be performedcf the owvey from the quellfied esport and a copy of on systn e e4 ject to 41.1(9). Such spot checksthe report shall be trenanitted by the registrant to shall meet the following requiremontesthe agency. 1. The opt-check procedures shall be in witing

3. The survey and report shall indic ate all and shall have been developed by a qualified expert.instances there the installation, in the opinion of 2. The mesewesents taken during spot checksthe quellflod expert, is in violation of applicsle shall demonstrate the degree of consistency of therules and shall cite the rule violated. operating cherectoristics thich can effect the rafi-

(2) Calibrations. stion delivered to e patient during a therapy proco-1. The calibration of systens e4 ject to 41.1(9) dure.

ehell be performed before the systen le first used 3. The spot-check procedwee shall specify thef;r irrefistion of a patient and thereafter at time. frequency at which teste or mesewesente are to beintervale dich do not onceed six isonths and after per formed. *

eny change sich eight significantly alter the cali- 4. for systone in thich been quality can verybretion, spettel distribution, or other cherectorist- eignificantly, spot checke shall include qualityice of the therapy beam. chec ke.

- 2. The calibration shall be performal wwfor the S. mere a systen hoe built-in devices thichdirect supervis,lon of a qualified emport. provide e self-check of any pereneter during irradi-- .

3. Calibration of the does er'uivelant of the etion, the spot-check procedwee shall require thattherapy been 'shall be performed with a meneuronent the. parameter be independently verified at specifiedinstrument. The calibration of inich is directly time intervals.trace 4 1e to national standards of supuewe'or 6. The reasons for opt-checke thich are erraticCecrbed dose, eruf dtich shall have been cellbrated or inconsistent with cellbration dets 9 ell behwithin the preceding two pers. promptly irweetigated and corrected before the systen

4. Calibrations made pursuant to 41.1(9)"d"(2) is used for patient irradiation.ehell be ewh that the does at a reference point in 7. menever a spot check indicates e significentsoft tissue can be celeulated to within 3 five per. change, as specified in the qualified expert's spotcent. check procedures, in the operating cherectorieltice

5. The calibration of the therapy been ehe11 of a s yst en, the syntes shall be rec e11 brat ed seinclude but not be limited to the following determin. required in 41.1(9)"d"(2).etiones Verification that the equipment la operating 8. Records of spot-check meneuremente performedin compliance with the design specifications concern- pursuant to 41.1(9)"d"(3) ehell be maintained by thetruj the light localizer, the side light and back. registrant for e period of one war.pointer alignment isth the isoconter, then appli- (4) Operating procedures.c elo, veristion in the eule of rotetton for the 1. No individual other that the patient shall betable, gentry, and jaw opten, and been flatnese and in the treatment roan during treatment of a patient.sweetry et the specified depths. 2. If a patient must be held in position during

The esposure rete or does rate in air and at ver- treatment, mechanical suppirting or restrainirv;

i:ue depths of water for the range of field slaes devices shall be used.used, for each effective energy, and for each treet. 3. The systen ohell not be used in the etnini-ment distance used for radiation therepy the corw stration of radiation therapy unlese 41.1(9)"d"(1),gruence betimen the refistion field auf the field (2) and (3) have been met.Indicated by the localizing device. 41.1(10) Veterinary medicine radiogtephic instel-

| The triiformity of the refletion field and it s latione,

dependency upon the direction of the useful beam; and s. Equipment.

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3

. .,

(1) IN proter:t}c t@e housing shall be equiv:1 3. The dimenelec Cf tQ toon(C) cencerned,,

ont to tho 'requirervets of 41.1(4)c. 4. The type n! occupency of all tdjacent areas(2) Diaphruges or cones shall be provided for incluelve of the spence dove and telJw the toon(s)

colliristirq the useful been to the area of clinical Concerned. If there is an t st erior well, show dis.interest and shall procit*e the aeme der;tes of protec. terce to the closest eres(s) diere it le likely thattion se is required of the houstrq. Individuele say t,e present.

(3) The total flitration termanently ir, thw use. S. The make and model of the X-ray equipment enofut been shall not be leas theri 0.5 millimetere alue. the ensimus technique factorieinum equivalent for machin.c operating up '.o fifty 6. The type of esseninetion(s) or treatmeit(s)kVp,1.5 millimeters aluminun equivalent for machines ditch will be performed with the e ,,1peent.operating between fifty to seventy ky , enri 1.S (2) Information on the entic1pstod oorkload ofp

callimetere elusinun equivalent for machines orv ret. the X-ray system (e).ing stove seventy kyp. (3) A report including all beste assonptione

(4) A device shall be provided to terminets the used, shall be stbeltted with the piene,caposure efter a preset time or espostre. b. & served.

($) A Asad-ean type of esposure switch shall be 41.1(121 llece rv ed.'

provided, Logether with en electrical cord of suffic. 41.1(13) Information to be stbmitted by twerstmlent length, so that the operator can stand out of proposing to condtet heelirij arts acreening. Per mane |

I the useful bene and at least sin feet from the animal requesting that the poency approva e healin) arts iduring all X-ray exposures. sc reenirv) progran anell semit the followirg infus. )

D. Structural shielding. All well, ceiling, and motion and evaluetton |floor erese shall be equivalent to or prnvided with e. Nano eraJ mldress of the appliennt end, diere|

epplic able protectivo barriers to assure cut.pliancri app 11celo, the'nweae and addresses of agents within *with 40.2(1), 40.2(4) and 40.2($) of redistiin rulee. this state.

c. (ber ating procedures. - b. Giseases or coeditions for welch the X-rey(1) The operator shall sterd well away true tho ' i,xmel stione are to be used.'

useful been and the animal dteltv) radiographic espo. a. Cert tiption in detail of the X-ray exeein.,

sures. atione prorve4 in tty, screentry program.,

(2) t42 tr>dividual other than the operator shall d. Description of the population to be numained '

be in the X-ray tone Wille esposures are beira; made in the octmen'.ty progree, i.e., age, seu, physicalunless etch individual's assistance le required. condition, ard ott.et appropriate information.

(3) When an animal must be held in position dur.. e. An evaluation of any leiom etternate methodsing ratiography , mechanical suppracting or restraf rilrg not involving ionizing relistion ditch could achieve

'

devices should be used, if Ltw animal must be held the goele of the screentruj progr ee ens diy theseby an individual, that individual shall be protected methode erw not used in pre fers.<e to the X-raywith appropriate shieldirq devices, etch as ptotec. esmoinations.

'Live gloves and apron, and he shall be si posittorwd f. An 'e'eluation by a qualif1=1 expoet'"J thethat no part of his body will be ytrtsk by the useftd X-ray system (4 to be usef in tim rcreening pr gum.been. The enrosure of any individual used for this The evolustion by Ltv omlitief mport shal. sho wpurpneo shall be monitored. that etch system (s) .4 satisfy all requirenen:e of

41.1(11) Information on radietion shieldirv) these rulee.required for plan reviene. g. A deer:ription of the diagnoetic fils quality

e. In order for the ar;ency eyeluoting entwidirg montrol pg ogr ee.requirements for a r adiation inst e11stion, thz h. A aopy of the tectrilqta chart for the X-rayfollowirq information must be etbalstod. euweinetton procedures to be used.

(1) its plane should Wie, no a minimun, the 1. ite qualifications of each irritvidual Wu will

followirg s be e,=istity the X-ray syntan(s).1. Thn normal lo:stion of ti.4 X-r ey systege's J. The qualificatione of the indiviJuel wo will

relistion gurts the po r t 's tesvol anj traverse be supervistry the operators of the X-rey systne(s).'

Ilmits general direction (s) cf Live use f ul osam: 7.e extent of eurarvision erd the cettux! of erklocatinne of any windows and dooral the location of garforwance evaluation shall be specified,

,

the operator's boothi ord the location of the X-ray k. Its twei eruf afdtces of ttyi irujividual ihncontrol panel. will interpret the rafiograp'i(s).

2. The structural composition an1 thicknees or ). A description of tho procedures to be user' jnlead equiv alent of all ieille , daars, partitions, swivistrij the Irviividuals tcreened mid their pelotafloor, eni ce111rq of the roo*(e) corcerned. practitionere of tle hem 11rq erte of Ltw reeutte rf

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,

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the screening broceduto and any further medic 1 needs c. All oested sources, cont:ining soro then 100indic ated. cicrocuries cf redi:ective meterial with a h:1f-lifs

m. A description of the procedures for the reten- greater then thirty doye, or 10 mic rocuries oftion or dispoettion of the radiographe end other redlun-226, shall be tested for leakage or contanin-recorde pertaining to the X-rey enaninetione. etion or both at intervals not to exceed six months

or at such other intervels se are approved by the

47S41.2(13dC) uso of sealed redieartive sources in egency, the U.S. Meleer Regulatory Omanission, enthe hosting arte. agreement state, or a licensing state and described

41.2(1) Scope. The provisions of this chapter by the manufacturer on the label etteched to theapply to all licensees so use sesled soutese in the soutee, device, or poreenent conteiner thersof, or inhosting arte and are in addition to, and not in es- the leaflet or brochure sich secompenlee the sourceetitution for, other applicable provisions of these or device. Each source or device shall be en testedrulee. prior to its first use mless the supplier furnishes

11.2(2) Definitions. As used in this chapb, e certificate that the source or device hee been sothe following definitione apply: tested within ein months prior to the transfer.

"Brechytherapy" means a method of radiation ther- b. tenu teste shall be capable of detecting thespy in sich an encopeul ated source or group of presence of 0.005 microcurie of radianctive meterialsources is utilized to deliver bete or gamme radi- on the test eenple or, in the case of radium, the

etion et a distence of up to a few contimeters, by escape of redon at the rete of 0.001 microcurie persurface, intescovitary, or interstitial application. twenty-fow hours. The test eenple shall be tenen

" Teletherapy" means therapeutic irradiation in from the source or fran the surfaces of the device in$1ch the source of radiation le et a distance from sich the source is permanently or sem1 permanentlythe body. momted or stored on sich ona might expect contenin.

41.2(3) Interstittel, intrecevitary, and super. etion to acetmulate. Records of leek test resultsfic1el opplicetions. ehe11 be lept in mite of microcurles and meinteinst

a. Accomtsbility, storage and transit. for inspection by the agency.(1) Except se otherwise specifically authorized c. My leek test condteted pursuant to 41.2(4)"a"

by the egency, each licensee shall provide accomte- which revents the presence of 0.005 microcurie or-

bility of oseled sources and shall leep a record of more of renovele contesination or, in the case of- -

the leeue end return of all sealed sources to their radium, the secepe of redon at the rate of 0.001'piece of storage. microcurie oer twenty-four hours, shall be considered

(2) Each licensee shall conduct a physical inven- evidence that the sealed source is leeking. The,

tory at intervals not to exceed sie months to accomt licensee shall 'immediately 'with drew the source frmfor all sources and devices received and poseeeeed. use and cause it to be decontanineted and repelred urhcorde of the inventories shall be maintained for to be dis; meed of in accordence with agency ' rules. A-inspection by' the egency and shall include the report shall be filed within five days of the test

quantittee armi kinde of radioactive material, loce. with the agency, describing the equipment involved,tion of sources and devices, erut the date of the the teste results, and the corrective action taken.inventory. 41.2(S) Radiation swveys.

(3) Each licensee shall follow the radiation e. The monimun radiation level et a dieterte ofeefety and handling instruc tione approved by the one seter from the patient in som brachytherapy

agency, the U. S. Nu: lear Regulatory Canntesion, en sources have been inserted shall be determined by

agreement state, or a licensing state wid furnished , monstrement or calculation. This radiation levelby the manufacturer on the label ettsched to the shall be entered on a patient's chart and sipe ni

source, device, or permanent container thereof, or in required mder 41.2(6).the leaflet or brochure Alch accompentee the source b. The radiation levels in the patient's room andcr device, and maintain such instrtction in a legible the sterounding area shall be determined, recorded,and conveniently eve 11ebte form. and maintained for inspection by the agency.

(4) Each licensee shall assure that needles or c. The licensee or registrant shall oestre thatstenderd medical applicator celle containirs; cobalt- patients treated with cobalt-40, cesium-137,60 as wire, reflun-226, or costun-137 ere not opened iridium-192, or reflun-226 implante renein hospital.Alle in the liconeee's possession misee specific- ired mtil e source comt and radiation survey of theC11y authorized by a license instad by the agency. patient confirm that all implante have been removed.

b. beetved. 41.2(6) Sipe end recorde.41.2(4) Testing emeled sources for leakage and e. In afdition to the requirements of 40.9(3) of

contaninetion. r efistion rules, the bed, cWicle, or toon of the

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. . _ _ _ _ .

e *

hoepital brachytherapy patient shall be marked with o (7) Thors sh' ell be ct the housing and at the,.

cign indicating the pr:sonco af brachytherapy control panel a warning devico that pleinly indicctsosource (s). 1his sign shall incorporate the radiation * ether the been le "on" or "off."c)mbc1 and specify the radionuclide, activity, date, (8) The equipment shall be provided with a lock-and individuel(s) to conteet for radiation oefety ing devi::e to prevent mouthorized use.instrw tione. The sign is not required provided the (9) The control penet shall be provided with acucoption in 40.10(2) of radiation rulee le met. timer that automatic ally terminates the expoewe

b. The following information shall be included in after a preset time.the patient's chart s (10) Provisions shall be made to permit contin-

(1) The radionuclide administered, number of unus observation of patiente dwing irradiation.sources, activity in millicuries, and time and dote b. Reserved.cf administration: 41.2(8) Operation. W individual shall be in the

(2) The exposure rate at one meter, time the treatment room abring irradiation mless that indi-determination une made, and name of the individual vidual is the patient. Nachanical restraining orso made the detetuinetion; supporting devices shall be used for positioning the

(3) The radiation symbol; and patient, if necessary.(4) The precautionary instructione necessary to 41.2(9) Testing for leekage and contamination.

assure that the exposure of individuele does not Teletherapy sources shall be tested for leekage andcxceed that permitted mder 40.2(1) of radiation contamination in accordance with 41.2(4). Teste ofrules. leakage may be made by wiping secessible surfa:es of

_ ,

41.2(7) Sealed source teletherapy the housing port or collimator site the source is in

. a. Equipment. the "o f f" position and measuring these wipes for(1) The housing shall be so constructed that, at transferred contamination..

one meter from the source, the maximum exposure rate 41.2(10) Calibration and physical decay determin-does not exceed 10 milliroentgene per hour een the atione.

^ been control mechanism is in the "off" position. The a. Calibration measuremente shall be performed byaverage exposure rate meeswed at a representative licensees on each teletherapy mit:

_ number of pointe about the housing, each one meter (1) Prior to the first use of the mit for treet-, " from the source, shall not exceed two milliroentgene ing htsmans.per hour. (2) Prior to- treating humans: menever spot-

(2) For teletherapy oculpment installed after the check seaswanents indicate that the output valueoffective data of this rule, the leakage radiation differs by more that five percent from the value

'mesewed at one meter from the source een the bean' / obtained at the last calibration corrected mathemati-

' control anchselen is in the "orf position shall not cally for phyelcal decay;cxceed 0.1 p rcent of the useful been exposure rete. (3) Prior to treating htmane following / replace-

'

"(3) Adjunt21e or removele bean-defining dio- ment of the radiation source or following reinstal-

phragme shall allew trensnisolon of not more then lation of the teletharapy mit in a new location;five percent of the useful . bean.

,

of the tele, therapy mit that includes removal of the(4) Prior to treeting humans following any repair

(4) The been control machenism shall be of apositivo design esoable of acting in any orientation source or major repair of the componente eseociatedof the housing for sich it le designed to be used. with the source exposwe assembly; andin addition to en autoestic closing device, the (5) At intervale rot exceeding one year.mechenian uhall be designed so that it can be menu. b. Cal}bration moesuremente shall incitde deter-

| ally returned to the "off" position with a minimus mination of trisk of exposwe. (1) The exoosure rate or dose rate to an accuracy

| (5) The closino device shall be so designed as to within three percent for the range of field sizes and| r: turn automatic ally to the "o f f" position in the for the range of distances, or for the axis distance,

event of err / breeledom or interruption of the acti- used in radiation therapy.vtting fbece and shall etey in the "o f f" position (2) The congruence beteeen the radiation fieldmtil activated from the control panel. and the field indicated by the light been localizing

(6) ten any door to the treatment roon is device;I cpened, the been control mechanien shall autoestic- (3) The miformity of the radiation field and its

clly and rapidly restore the mit to the "off" posi- dependence upon the orientation of the useful bean;tion arvi cause it to remain there mtil the mit is (4) Timer securacy: aMreactivated from the control panel. (5) The accure:y of all distance measuring de-

vices used for treating hunene.

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The expo:wo rots er does rats v:lue3 ehd1 be cytten cellbettiin. (b[imetry cystens cclibrtted by'c.

estracted mothematictlly far physic 1 decey at inter- the altern:tivs method shall not be used for tele-vela not exceeding one month. therapy calibration meeswomente.

d. Calibration measuremente armi physical decay 41.2(13) Qualified expert.crrrections shall be performed by an export quellfied e. 1he licensee shall determine if an individualby training and experience in accordance with is an expert. quellfied by training and experience to41.2(13). calibrate a teletherapy u it and establish procedures

41.2(11) Spot-check measurements. for, and review the results of, spotcheck meeswo-

e. Spot-check measurements shall be perfonned on monte. The licensee shall determine that the expert scach teletherapy unit et intervale not exceeding one (1) le certified by the American Board of Radiol-month.

,

ogy in Therapeutic Radiological Physics, Radiologicalb. Spot-check meeswanents shall incitsle deter- Physics, Ibentgen-Ray and Gamme-Rey Physics, or X-ray

mination of: and Radium Physics; or ,(1) Timer accuracy (2) Hee a master's or doctorate degree in phys-(2) The congruence between the radiation field ic e , biophysics , radiological physics , or health

and the field indicated by the light bem localizing physice; one year of full-time training in therapeu-device; tic radiological physics, and one year of full-time

(3) The accuracy of all distance measuring experience in a radiotherapy facility including

devices used for treating hunene; personally conducting a celibration and spot check of(4) .The exposure rete, does rate, or a quantity at least one teletherapy uilt.

related in a letows menner to these rates 16r one b. Licensees or registrente that have theirtypical set of operating conditione; and teletherapy unite calibrated by individuele ute do

(5) The difference between the measwanent made not meet those criteria fbe minimum training andin 41.2(11)"b"(4) and the anticipated output ex- experience may request a license amendment exceptirigpressed as a percentage of the siticipated output. them fras 41.2(13)"a." The request should includeThe anticipated output is the volun obtained at the the name of the proposed expert, e description of the

[ ' leet calibration' corrected mothematically for physi - individual's training and experience including infor-* ~ cel' decay.

,

motion similar to that specified in 47.2(13)"a"(2),c. Spot-check meeswanente shall, be performed in reporte of at least one calibration and spot-check-

accordance with procedures established by art expert progran bened on meeswesente personally made by the~

qualified by training and experience ' 1n a:cordance proposed expert dthin the last ten years, and wit-,

with 41.2(13)"e." A qualified expert need not actu- ten endorsement of the technical qualifications of,

c11y perform , the spot-check measuremente. If a the proposed esport from personal letowledge by,'squalified export does not perform the spot-check physicist certified by the American lhard of

~ meeswanente, the results of the spot-check measure- Radiology ' in one of the specialities listed in -mente shall be reviewed by a qualified expert within 41.2(13)e(1).fifteen days. 41.2(14) Records. The licensee or registrait

41.2(12) Dosimetry systen calibration. shall maintain, for inspection by the agency, recordee. Calibration aseewonente shall be performed of the maaewanente, teste, corrective a:tions, and

usiruj .e dceinstry systs that has been calibrated by instrument calibratione made under 41.2(10) andthe National ihreau of Raiderde or- by a Regional 41.2(11) and records of the licensee's or regi-

Calibration Laboratory accredited by . the American strant's evaluation of the expert's training and

Associatinn of Physiciste in 4dicine. 1he dosimetry experience made uider 41.2(13).cysten shall have been calibrated ethin the previous a. Records of teletherapy calibration meeswo-

tie years and after any servicing that any have monto and calibration of the instrumente used to seheeffected systen calibration. these measurements shall be preserved for five years,

b. Spet-check meeswesents shall be performed after campletion of the teletherapy calibration.using a dosimetry systes that hee been calibrated in b. Records of spot-check measurements and correc-accordance et5 41.2(12)"e." Alternatively, e dosi- tive actions and calibration of instrumente used tometry systen used solely for spot-check measuremente selse spot-check measuremente shall be preserved formay be calibrated by direct intercamperleon dth a two years after completion of the spot-check meenwo-

,

systen that has been calibrated in accordance with mente and corrective actions.41.2(12)"e." This alternative calibration method c. Records of the licensee's or registrant's

shall have been per formed within the previous one evaluation of the qualified export's training and

year and after each servicing that any have effected experience shall be preserved for five ) ears after

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i '.

the quellfied expert's last perfgemanco of a celibra- a:colcrctst in the he:. ling crts will be is; tad on1*ytion gf the licenses'0 cr regiEtrant's tclctherapy ifs

smit. (1) The individuals designated on the applicationas the users have substantial training and experience

41b41.)(136C) Radiation amfety roupstrements fbr in deep therapy techniques or in the use of particleparticle enesteratore. accelerstore.to treat humano; and

41.3(1) Purpose and scope. (2) The individuel designated on the applications. This rule establishes procedures for the as the user is a physician.

registration and the use of porticle accelerators. 41.3(3) Radiation safety requirmente for the useb. In addition to the requirements of this rule, of particle accelerator.

cli registrante are e4 ject to the requirements of a. thneral provisions.470- chapters 30, 39 and 40. Registrante engaged in (1) This escule establishoe radiation sa fety

industrial radiographic operations are adject to the requirements fbr the use of porticle a:celerators.

requirements of 41.4(136C) and registrants engaged in The provisions of the e4 rule are in addition to, andthe healing arts are s4 ject to the requirments of not in sestitution for, other applicable provisions

41.1(136C). Registrants engaged in the prodtetion of of these rules.radioactive material are s4 ject to the sequirments (2) The registrant shall be responsible fbr

of 470--chapter 39. assuring that all requirements of this rule are met.41.3(2) Registration procedure. b. Limitations.a. Registration requirements. % person shall (1) % registrant shall permit any person to act

receive, possess , use, transfer, own, or acquire a as an operator of a particle accelerator tntil' stch

particle accelerator except .as authorized in a regi- personsstration issued pwsuant to these rules. The general 1. Has been instructed in radiation safety andprocedures for registration of particle accelerator shall have demonstrated an understanding thereoffacilities are included in 470- chapter 39. 2. Has received copies of and instruction in this

b. General requirements for the issuance of a rule and the applicable requirements of 470--chapterregistration for particle accelerators. In addition 40, pertinent registration conditions and the regi-

to the requirements of 470--chapter 39, a registre- strant's operating and emergency' procedures, and,

tion application for use of a particle accelerator shall have demonstrated . understanding thereof; and -

will be approved only if the agency determines that: 3. Hee demonstrated competence to use the ,(1) The ' applicant is galified by reaann of particle accelerator, related equipment, and swvey

traininq and . experience to use the accelerator in instrtaments dich will be employed in the registrants"

question for the ptspose requested in accordance with ' assignment.41.3(136C) and 470--chapter 40 in such a manner as to (2) Either the radiation safety comunittee or thehinbalze danger to p4 11c health and safety or radiation safety officer shall have the auttlutity toproperty; terminate the operatione et a particle accelerator

(2) The applicant's proposed or existing equip- facility if sich action le demed necessary to pro-

ment, facilities, operating and emergency procedures tact health and minimian danger to public. health andrmre adequate to protect health and minimize danger to safety or property.p@lic health and safety or property; c. Shielding and safety design requirements.

(3) The issuance of the registration will not be (1) A qualified expert, specifically accepted by

inimical to the health and safety of the p@lic, and the agency shall be consulted in the design of athe applicent satisfies any applic 41e special particle accelerator installation and called upon toesquirement in 41.3(2)"c." perform a radiation survey when the accelerator is

(4) The applicant has appointed a ratistion first cepeble of producing radiation.

safety officer. (2) Each particle accelerator installation shall(5) The applicant or the applicant's staff hee be provided with sich primary and socordary barriers

- cestantial experience in the use of particle se are necessary to assure compliance with 40.2(1)accelerators and training sufficient for application and 40.2(5) of radiation rules.ta its intended usesg. d. Particle accelerator controls anf interlock

(6) The applicant hee an adequate training pro- systems.gran for operators of particle accelerators. (1) Instrtmentation, readouts and controls on the

c. liman use of particle accelerators. In addi- particle a:celerator control consols shall be clesrlytion to the other requirements set forth in 470- identified and easily discernibls.chapter 39, a registration for use of a perticle (2) All entrances into e target room or other

high radiation area shall be provided with interlocks

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.

s e

that shut down the machine mder conditirne cf 1. Athorized by the radidtiin sofoty caemittee-berrier penetr tion. or radiation safety officers

(3) men an interlock systen has been tripped, it 2. Recorded in a permanent log and a noticeshall only be possible to reeune operation of the posted at the accelerator control console and

accelerator by menuelly resetting controls et the 3. Terminated as soon as possible.position where the interlock hee been tripped, and (6) A copy of the current operatirug ersi thelastly at the mein control console. emergency procedures shall be maintained at the

(4) Each safety interlock shall be on a circuit accelerator control panel.I dich shall allow its operation independently of all g. bdiation monitoring requirements.

Ether safety interlocks. (1) There shall be avellable et each particle

(5) All eefety interlocks shall be fail-ea fe , accelerator facility appropriate portable monitoririg1.e., designed so that any defect or component fail- equipment sich is operable and has been calibrated

uro in the interlock systen prevents operation of the for the appropriate radiations being produced at the';accelerator. facility. Such equipment shall be tested for proper

(fd 4 acre button or other emergency pour cut- operation daily and calibrated at intervals not to

cff switch chall be located and easily identifiable exceed one year and after each servicing and repair.in all high rutiation areas. Such a cutoff switch (2) A radiation protection swvey shall be per-shall incitsfe a manual reset so that the accelerator formed and documented by a qualified expert specific-

.cannot.be restarted from the accelerator control con- ally approved by the agency ten changes have beensole without resetting the cutoff switch. made in shielding, operation, equipment, or occupancy

"e. Warning devices. of adjacent areas.(1) . All locations designated as high radiation (3) Radiation levels in all high radiation areas

creas, end . entrances to seh locations shall be shall be continuously monitored. The sonitoringequipped with smally observable warning lights that device's shall be electric ally independent of thecperate den , and,only sen, radiation is being accelerator control and interlock systens and capableproduced.-

,of providing a remote and local readout with v,isual

,(2) Except in facilities designed for human expo- or audible alarms at both the control | panel and at

cure, each high radiation area shall have an audible entrance to high radiation areas, arti other appro-*

warning device sich shall be activated for fifteen priate locations, so that. people entering or' present-,

seconds prior. to the possible creation of such high become aware of the existence o,f the hazard..

radiation , area. Such erning device shall be clearly (4). All area monitors shall be calibrated atdiscernible in all high radiation areas and all radi- intervals not to exceed one year and after each

etion etees. servicing and repair.,

(3) Berriers, temporary or otherwise, and path- (5) menever applicable, , periodic surveys shallumys leading to high radiation areas shall be identi- be made to determine the amount of airborne partic-fied in accordance with.stbrule 40.3(3). ulate radioactivity present in areas of ~ airborne

f. (Decating procedures. hazards.(1) Particle accelerators, when not in operation, (6) Whenever applicable, periodic smear surveys

shall be secured. to prevent mouthorized use. shall be made to determine' the degree of contanin-(2) The safety interlock systen shall not be used etion in target and other pertinent' areas.

to twn off the accelerator been except in an ener- (7) All area surveys shall be made in accordancegency. with the written procedures established by a quali-

(3) All safety and mening devices , including fled expert or the radiation safety officer of the

interlocks, shall be checked for proper operability particle accelerator facility.

ct intervals not to exceed three months. Results of (8) Records of all radiation protection steveys,cuch tests shall be maintained at the accelerator calibration results, instrumentation tests, and sneer

facility for inspection by the agency. results shall be lept current and on file at each,

(4) Electrical circuit diagrams of the acceler- accelerator facility.

ttor and the associated interlock systems shall be h. Ventilation systens.hept current and maintained for inspection by the (1) Meana shall be provided to enstre that per-

, agency and shall be available to the operator at each sonnel entering any area where airborne radioactivity |

accelerator facility. may be produced will not be exposed to airborne,

(5) If, for any reaman, it is necessary to inten- radioactivity material in excess of those limits |tionally bypees a safety interleck or interlocks, specified in 40.7(136C), Tele I of radiation rules. |Cu:h action shell be:

i

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* *.

- (2) A regittrant, as required by 40.2(6), cf " Industrial radiography" means the examin;tirn of I.

radiction rules oh-11 not vent, rcl:ase cc ethert:ise the cacresc!pic structuro cf matcriclo by nondestruc-tive metrods using sources of radiation. !disc harge airborne radioactive material to en

uncontrolled area dich exceeds the limits specified " Permanent radiographic installation" means an |

in 470--40.7(136C) , Table II, except as authorized installation or structwo designed or intended for j

pursuant to 40.4(2) or 40.2(6) of radiation rules. radiogra$y and in which radiography is regularly i

I

fgr pwposes of 41.3(3)"h"(2) concentrations may be performed." Personal supervision" mesis supervision in $1chaveraged over a period not greater than one ye ar.

.

radiographer is physically present at the site i

,

Every reasonable effo rt should be made to maintain the

c leases cf radioactive meterial to uncontrolled *ere sources of radiation and associated equipment |

areas as far below these limits as practicable. are being used , etching the performance of the ,

radiographer's assistant and in stch proximity that j

470-41.4(136E) Radiation amfety requirements fbr immediate assistance can be given if required.

industrial radiographic operation. " Radiographer" means an individual sc perfotins or

41.4(1) Pur pose . The rules in this chapter personally stpervises industrial radiographic oper- i

|cetablish radiation safety requirements for persons ations and who is responsible to the licensee or|

using sources of radiation for industrial radio- registrant for assuring conpliance with the regaire-

graphy. The requirements of this chapter are in ments of these rules,

addition to , and not in s@stitution fo r , other " Radiographer's assistant" means any individual

applicable requirements of these rules. who, under the personal superviolon of a radio- |'

41.4(2) Scope. The rules in this chaptet apply grapher, uses sources of radiation, related handlingto all licensees or registrants wto use sources of tools, or radiation survey instrunents in industrialradiation for industrial ra$1ography. Except for radiography. .

those rules of this chapter clearly applicable only " Radiographic exposure device" means any instru,-

, to sealed radioactive sources, both radiation mach- ment containing a sealed source fastened or contained

ines and sealed radioactive sources are covered by therein, in s ich the sealed source or shieldingthereof may be moved, or otherwise chervjed, fran a

. this chapter.

41.4(3) Definitions. As used in this chapter, shielded to mehielded position for purposes of mak-

the following definitions apply ing a radiographic exposure. ,i

" Cabinet radiography" means industrial radiography " Shielded position" means the location within the' '

conducted in an encloswe or c61 net so shielded that radiographic exposwa device or storege containerradiation levels at every location on the exterior . which',' by manufacturer's design, is the proper loca-meet the limitatione specified in 40.6(136C) . tion for etorage of the sealed source."

" Cabinet X-ray system" means an X-ray systen with " Shielded-room radiography" means industriel

_ the X-ray Libe installed in an enclosure sich, radiography conducted in a 'rocm so shiel'ded thatindependent of existing architectural structuree radiation levela at every location on the exteriorexcept the floor on .hich it may be plac ed , is r,eet the limitations specified in 470--40.6(136C) .intended to contain at least that portion of a mater- " Source changer" means a device designed and used

ial being irradiated, provide radiation attenuation, for replacanent of sealed sources in radiographicand exclude personnel from its interior during gener- exposure devices, includiruj these source changersction of X radiation. Included are all X-ray systens also used for transpo rting and storage of sealed

designed prinarily for tre inspection of carry-on sources.

baggage at airline, railroad, and bus ter ninsla, and "Stors)e container" means a device in *ich sealedin similar fecilities. An X-ray ttbe used within a sources are transported or stored.

shielded part of a building, or X-ray equipment $1ch "Tamporary job site" means any location eeremay temporarily or occasionally incorporate portable industrial radiography is performed other than theshielding, is not considered a chinet X-ray spten. location (s) listed in a specific license or certifi-

" Certified cabinet X-ray system messis an X-ray cate of registration.a

systee sich has been certified in accordance with 21 41.4(4) Limits on levels of radiation for radio-CFR 1010.2 as being manufactured and essembled pur- graphic exposure devices and storage cent ainers.sunnt to the provisions of 21 CFR 1320.40. Radiographic cxposure devices penasuring less than

" Enclosed radiography" means industrial radio- fot.r inchca fran the sealed source storage positionto any exterior swface of the device shall have nography conducted in an enclosed chinet or rcom and

includes esbinet radiography and shielded roon radio- tsdietion level in excese of 50 millircentgens oarhour at six inches fran any exterict awface of thegraphy.

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device. Raidiographic expo:wo devices measwing a 41.4(8) Leak t= ting , repair, tagging, opening,"cinimum of for inches from the sealed source storage modification ano replacement of sealed sources.position to any exterior swface of the device, and a. The replacement of any sealed source fastenedc11 storage containers for sealed sources or outer to or contained in a radiographic exposure device and,

containers for radiographic exposwo devices, shall leak testing, repelr, tagging, opening, or any otherhave no radiation level in excess of 200 milliroent- modification.of any sealed source shall be performedgens per hour at any exterior swface, and 10 milli- only by persons specifically authorized to do so byroentgens per hour ' at 39.4 inches fran any exterior the agency, the U.S. Nuclear Regulatory Commission,

icw face. lhe radiation levels specified are with the or an agreenent state.sealed source in the shielded position. b. Each sealed source shall be tested for leakage

41.4(5) Locking of sources of radiation. at intervals not to exceed six annths. In thes. Each source of radiation shall be provided absence of a certificate from a transferor indicating,

; with a lock or lockable outer conta,iner designed to that a test has been made within the six month periodI prevent mauthorized or accidental production of prior to the transfer, the sealed source shall not be

i radiation or removal or exposwe of a sealed source put into use mtil tested.

| and shall be kept locked at all times except when c. The leak test shall be capable of detectingunder the direct swveillance of a radiographer or the presence of 0.005 microcurie of renovableradiographer's assistant, . or as may be otherwise contanination on the sealed source. An acceptabletuthorized pursuant to 41.4(17). Each sto rage leak test for sealed sources in the pLesession of a

container and source changer likewise shall be radiography licensee muld be to test at the nearest~

provided with a lock and shall .be lept locked sen accessible point to the sealed sources storage posi-containing sealed sources except when the container tion, or other appropriate measuring point by a

is mder the direct swveillance of a radiographer-or procedure to be approved pesuant to 39.31(5)"e" ofrediographer's assistant. radiation rules. Records of leak test results shall

b. Radiographic exposwe devices, source chang- be lept in mits of microcuries and maintained for

crs, and storage container's prior to being moved inspection by the agency for six months after the

from one location to another and also prior to being next required leak test is perfonned or mtil thesecured at a given loc ation, shall be locked and sealed source is tranferred or disposed.cwveyed to asswe that the sealed source is in the d. Any test conducted pasuant to 41.a(8)"b" and'shielded position.

_

"c" which reveals the presence of 0.005 microcurie or41.4(6) Storage precautions. Locked radiographic more - of renovable radioactive material shall be

exposure devices, source changers, . storage contain- considered evidence that the sealed source is leak-j~

crs, and radiation machines shall. be physically ing. The licensee shall hamediately dthdraw the

secured to prevent tempering or removal by mauthor- equipment involved from use and shall cause/it to beized personnel. decontanineted and repaired or to be disposed of in

41.4(7) Radiation survey instruments. accordance with rules of the agency. Within five

| a. The licensee or registrant shall maintain days after obtaining results of the test, the

| tuf ficient calibrated and operable radiation survey licensee or registrant shall file a report with the

| instrtsnents to :neke physical ~ radiation surveys as agency describing the equipment involved , the testrequired by this chapter and 40.9(1) of radiation results, and the corrective action taken.

rules. Instruaentation required by this stbrule e. A sealed source sich is not fastened to or

thall have a range such that 2 milliroentgens per contained in a radiographic exposure device shallhour through 1 roentgen per hour can be measwed. have pennanently attached to ~it a durable tag at

b. Each radiation survey instrument shall be least one inch square bearing the prescribed radia-calibrated : tion caution symbol in conventional colors, magenta

(1) At energies appropriate for use and at inter- or purple on a yellow background, and at least thevals not to exceed three months and after esch instructions:instrument servicing.

i

I (2) Such that accure:y within plus or minus 20 DANT R I,

|percent ca1 be demonstrated; and RADI0 ACTIVE MATERIAL |

| (3) At two or more widely separated points, other DO NOT HANDLE.

than zero, on each scale. NOTIFY CIVIL AUTHORITIES IF FOUNDc. Records of thcse calibrations shall be main-

tained for tm years after the calibration date for 41.4(9) Quarterly inventory. Each licensee orinspection by the agency. registrant shall conduct a quarterly physical inven-

tory to accomt for all sealed sources received or

IL

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m

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,po:sessed by them. The racerd) of tEs invent: ries maint ined far inspectiin by the agency mtil their

sh:11 be mainteined far to years fran the d'to cf dispo ;cl 10 cuthorized.the inventory for inspection by the agency and shall 41.4(13) Training and testing for radiographers

|include the quantities and kinds of radioactive and radiographer's assistants.material, the location of sealed sources, arvj the a. The licensee or registrant shall not permitdate of the inventory. any individual to act as a radiographer, as defined

41.4(10) Utilization logs. Each licensee or in this chapter, mtil sich individuals

registrant shall esintain current logs sich shall be (1) Has been instructed in the s@jects outlinedkept evallable for inspection by the agency for te in 41.4(22). '

years fran the date of the recorded event, showing (2) Hee received copies of and instruction in thefor each source of radiation the following rules contained in this chapter ed the applicable

|information s rules of 470--chspter 40, appropriate license or i

|a. A description thfch includes, if svallable, certificate of registration and the licensee's or

the male and model number of each source of radiation registrant's operating and emergency procedures; jcr storage container in thich the sealed source is (3) Has danonstrated competence to use the licen-located, see's or registrant's sources of radiation, radio-

b. The identity of the radiographer to thom graphic exposwe devices, related handling tools, andcsoigned; and radiation survey instruments; and

c. Locations there used and dates of use. (4) Hos demonstrated an mderstanding of the41.4(11) Inspection and maintenance. instrtetions in 41.4(13)"a" by successful completiona. Each licensee or registrant shall ensur, that of a witten test and a field examination on the

checks for obvious de fects in radiation machines, subjects covered. .

radiographic exposure devices, storage containers, b. Tyr licensee or registrant shall not permit .and source changers are performed prior to each day any indiv 41ual to act as a radiographer's assistant.,o f une. as defined in this chapter, mtil stch individuals

b. Each licensee or regiatrant shall condtet a (1) Has receivoj copies of and instructions in

program of at least quarterly inspection and mainton- the licensee's or registrant's operating and amer-

' ance of radiation machines, radiographic exposure gency procedures.'

,

devices, storage containers, and source changes to (2) Has demonstrated competence to use, mder theassure proper functioning of components important to personal supervision of the radiographer, the sources:tafety. All appropriate parts shall be maintained in of radiation, radiographic exposure devices, relatedaccordance with manufacturer's specifications. handling tools, and radiation survey instruments

*

Records of inspection and maintenance shall be main- .' thich will be used; and.

tained for inspection by the agency mtil their (3) Has demonstrated an understanding of thedisposal is authorized by the agency. instructions in 41.4(13)"b" by successfully/camplet-

c. If any inspection conducted pursuant to ing a written or oral test and a field examination on41.4(11)"a" or "b" reveals damage to components the stbjects covered.'

critical to radiation sa fety, the device shall be c. Records of the above training, including

removed from service mtil repairs have been made. copies of witten teste and dates of- oral tests and

41.4(12) Permanent radiographic installations. field examinations, shall be maintained for inspec-

Permanent rafiogrophic installations having high tion by the agency for three years following termin-radiation ares entrance controls the type described ation of employment.in 40.9(3)"c"(2)2. and 40.9(3)c(2)3. and 40.9(3)"c" d. Each licensee or registrant shall conduct an(4) of radiation rules shall also meet the following internal audit program to ensure that the agenc y's

requirements: radioactive material license conditions and thea. Each entrance that is used for personnel licensee's or registrant's operating and emergency

access to the high radiation area shall have both procedures are followed by each radiographer and

visible and audible warning signals to warn of the radiographer's assistant. These internal audits

preennce of radiation. The visible signal shall be shall be performed at leest parterly, and each

activated by radiation. The audible signal shall be radiographer shall be audited at least annually.activated then an ettesnpt is made to enter the Records of internal audits shall be maintained forinstallation while the nource is exposed. inspection by the agency for te yeara from the date

b. The control device or alann system shall be of the audit.testod for proper operation at the beginning of each 41.4(14) Operating and emergency procedures. Theperiod of t'se . Records of these tests shall be licensee's or registrant's operatirg and energency

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procedures shall includa in:tructions in ct 10%t the swycya required by 41.4(19)"b" and "c" to determine"falle ing: that the sealed source has returned to the shielded

a. 2ndling and use of sources of radiation to be position after an exposwe, the radiographer's assis-employed such that no individual is likely to be tant shall be under the personal supervision of acxposed to radiation doses in excess of the limits refiographer.cctablished in 470--chapter 40; 41.4(17) . Sec urity. During each radiographic

b. 4thods and occasions for conducting radiation operation, the radiographer or radiographer's assis-curveys; tant shall maintain a direct surveillance of the

c. 4thods for controlling access to radiographic operation to ga otect against mouthorized entry intoareas; a high radiation area, as defined in 470--chapter 38

d. 4thods and occasions for locking and accuring exceptsources of radiations a. Were the high radiation area is equipped with

e. Phreonnel monitoring and the use of personnel a control device ,or alarm systen as desc ribed in

monitoring equipment, including steps that must be 40.9(3)"c"(2): or 'taken immediately by radiography personnel in the b. %ere the high radiation area is locked toevent a pocket dosimeter is found to be off-ecale; protect against mauthorized or accidental entry.

f. Transportation to field locations, including 41.4(18) Posting. htwithstanding any provisionspacking of sources of radiation in the vehicles, in 40.10(3) of radiation rules, areas in sich radio-posting of vehicles, and control of sources of radi- graphy is being performed shall be conspicuouslyction during transportation; posted as required by 40.9(3)"b" and 40.9(3)"c"(1) of

g. Minimizing exposwe of individuals In the radiation rules.event of an accidenti 41.4(19) Radiation surveys and survey records.

h. The procedure for notifying proper personnel s. % radiographic operation shall be conductedin the evert of an accident; unless . calibrated and operable radiation surve'y

1. mintenance of records; and instrumentation, as described in 41.4(7) is availableJ. The inspection and maintenance of radiographic and used at each site sere radiographic exposwes

exposure devices, source changers, storage contain- are made.

[ ' crs, and radiation eachines. b. A ~ survey "with ' a radiation survey instrument41.4(15) Personnel monitoring control. shall be made after ,each -radiographic exposw e to - -e.. The licensee or registrant shall not permit - determine that the se'eled source has been returned to

~

any individual to act as a radiographer or as a its- shielded position. The entire circumference of

radiographer's assistant unless, at all times during , the radiographic exposure device shall be surveyed.radiographic operations, each stch individual wars a If the radiographic ' exposwo device has a ' source

guide tibe, the su' vey shall also inclufe 1;he guidedirect reading pocket dosimeter ~and either a film r'

badge or a thermoluminescent dosimeter (TLD). Pbcket tib e. -

dosimeters shall have a range fram zero to at least c. A physical radiation survey shall be made to200 milliroentgens and shall be recharged daily or at determine that each sealed source is in its shieldedthe start of each shift. Each film badge or TLD position prior to securing the radiographic exposure,

chall be assigned to and worn by only one individual. device or storage container, as specified in 41.4(5).b. Pochet dosimeters shall be read and exposures d. A physical radiation survey shall be safe

recorded at least once daily. after each radiographic exposwe using refiationc. Pocket dosimeters shall be checked for correct machines to determine that the machine is "off."

response to radiation at periods not to exceed one e. Records shall be lept of the surveys requiredyear. Acceptable dosimeters shall read within plus by 41.4(19)"c." Such records shall be maintained forer minus 30 percent of the true radiation exposure. inspection by the agency for two years after comple-

d. If et individual's pocket dosimeter is dis- tion of the survey. If the survey as used to deter-

charged beyond its range, the individual's film badge mine an individual's exposure, however, the records

er TLD shall issuediately be sent for processing. of the survey shall be maintained until the agency

e. Reports received from the film badge or TLD outhorizes their disposition'.processor and records of daily poclet dosimeter read- 41.4(20) Records required at temporary jobsites.ings shall be lept for inspection by the agency mtil Each licensee or registrant conducting industrial

the agency authorizes disposition. radiography at a t:ssporary jobsite shall have the41.4(16) Supervision of radiographers' assis- following records available at that site for inspec-

' tents. menever a radiographer's assistant uses tion by the agency:radiographic expodwe devices, sealed sources or a. #ppropriate license or certifieste of regis-

related source handling tools, or conducts - radiation tration or equivalent docunent;

,

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_b. (bertting and am:rgency procedurts: approvcl has been granted by the Agency pursuant toc. Applicablo rul:o 38.3(1) of radi: tion rulco.d. Survey records required pursuant to 41.4(19) 41.4(22) Subjects to be covered during the

for the period of operation et the site; instruction of industrial radiographers.Daily pocket dosimeter records for the periode. Fundenentals of radiation safety.a.

of operation at the site; and (1) Characteristics of radiation.f. The latest instrument calibration and leak (2) thits of radiation dose and quantity of

test records for specific devices in use at the radioactivity.cite. Acceptable records include tags or labels (3) Significance of radiation dose:dich are affixed to the device or survey meter. 1. Radiation protection standards.

41.4(21) Special requirements and exemptions for 2. Biological effects of refiation.enclosed radiography. (4) Levels of radiation fran sources of radia-

a. Systens for enclosed radiography designed to tion.cllow admittance of individuals shall: (5) Methods of controlling radiation doser

(1) Comply with all applicable requirenents of 1. Marking time.this chapter and 470--40.6(136C). If such a system 2. Working distances.is a certified csinet X-ray systen, it shall comply 3. Sielding.with all applicable requirements of this chapter and b. Radiation detection instrunentation to be21 CFR 1020.40. used.

(2) Be evaluated at intervals not to exceed one (1) Une of radiation survey instruments:year .to assure compliance with the applicable 1. (beration.

. requirements as specified in 41.4(21)"a"(1). Records 2. Calibration.- of these evaluations shall be maintained for inspec- 3. Limitations.

tion by the agency for a period of too years after (2) Survey techniques.the evaluation. (3) Use of personnel monitoring equipment s

b. Certified cabinet X-ray systems designed to 1. Film badges.- cxclude individuals are exempt from the requirements 2. 1hermoluminescent dosimeters.

,cf this chapter except that: 3. Pocket dosimeters.

(1) Operating personnel must be provided with c. Radiographic equipment to be used.cither a film badge or a therincluninescent dosimeter, (1) Remote handling equipment .and reports of the results must be maintained for (2) Radiographic exposure devices and setal ed

-inspection by the agency. sources.(2) Pb registrant shall pennit any individual to (3) Storage containers.

cperate a cabinet X-ray systen mtil such individual (4) Operation and control of X-ray equipment.has received a copy of ed instruction in the oper- d. The requirenents of pertinent fed'er al ucting procedures for the unit and has demonstrated state regulations.competence in its use. Records sich demonstrate e. The licensee's or registrant's written oper-compliance with this s4 paragraph shall be maintained sting and emergency procedures.for inspection by the agency mtil disposition is f. Case histories of radiography accidents.tuthorized by the agency.

(3) Tests for proper operstion of high radiation 475-41.5(136C) Radiation safety requiremento forcrea control devices or slam sptens, dere appli- metytical X-ray equipment.cable, must be conducted, recorded and maintained in 41.5(1) Purpose and Scope. This chapter providesaccordance with 41.4(12). special requirements for analytical X-ray eouipment.

(4) The registrant shs11 perfom an evaluation, The requirements of this chapter are in addition to,

tt intervals not to tr_.ceed one year, to detemine ao1 not in ssstitution for, applicable requirementsconfomance with 470--40.6(136C) . If stch a systen in other chapters of these rules.

is a certified c s inet X-ray syst en, it shall be 41.5(2) De finitions. As used in this chapter,evoluted et intervals not to exceed one year to the following definitions applydetermine conformance with 21 CFR 1020.40. Records " Analytical X-ray equipnent" means equipitent usedof these evaluatiom shall be maintained for inspec- for X-ray diffraction or fluorescence malysis.tion by the agency for a period of tw) years after " Analytical X-ray system" means a group of compon-the evaluation. ents utilizing X or genma rays to determine the

c. Certified cabinet X-ray systems shall be main- elenental composition or to ermine the microstruc-tained in compliance with 21 CFR 1020.40 unless prior ture of materials.

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"Fcil-Ocfa ch:ractcrictics" means a design f:st'uro in:tcIled cftcr (sffectivo'd to cf thic rule), warn 'Mich causes been port shutters to close, or other- ing devices shall have fail-safe characteristics.wise ' prevents emergence of the primary beam, upon the c. fbrts. thused ports on rafiation source hous-

fciture of a safety or warning device. ing shall be secured in the closed position in a

" Loc al conponents" means part of an analytical manner sich will prevent casual openirg.X-ray system and include areas that are struck by d. Labeling. All analytic al X-ray equipmentX-rays swh as radiation source housings, port and shall be 12eled with a readily discernible sign or

shutter assemblies, collimators, sample holders, signs bearing the radiation s)nbol and the words:caneras, goniometers, detectors, and shielding, but (1) " CAUTION--HIGt INTENSITY X-ray EAM," ordo not include power supplies, trans fo rmers, ampli- words having a similar intent, on the X-ray source

fiers, readout devices, and control panels. housing; and"%rmal operating procedures" means step-by-step (2) " CAUTION RADIATION--THIS EQUIPENT PRODUCES

instructions necessary to accomplish the analysis. RADIATION WHEN EERGIZED," or erds having a similarThese procedures shall include sample insertion and intent, near any switch that energizes an X-ray t@ecanipulation, aquipment alignment, routine mainten- if the radiation source is an X-ray tse; or

ance by the registrant or licensee, and date record- (3) " CAUTION--RADI0 ACTIVE MATERI AL ," or words

ing proc edures , sich are related to radiation having a similar intent, on the source housing insOfety. accordance with 40.9(3) of radiation rules if the

"Open-been configuration" means an malytical rajiation' source is a radionuclide.

X-ray systen in which an individual could accidently e. Shutters. (h open-been configurationsplace some part of their body in the primary beam installed after July 1,1980, each part on the radi-

path during normal operation. ation source housing shall be equipped with a shutter" Primary bean" means radiation sich passes that cannot be opened mless a collimator or a coup-

through an aperture of the source housing by a direct ling has been connected to the port.path from the X-ray tse or a re11oactive source f. krning lights.

located in the radiation source housing. (1) A1 easily visible warninr light 14eled with41.5(3) Equipment requirements. the e rds "X-ray ON," or mrds haviry a similar

a. Safety device. A device sich prevents the intent, shall be located:

entry of any portion of an individual's body into the 1. %ar ~ any switch that energizes an X-ray tse-primers X-ray been path or sich causes the bean - to and shall be illuninated only sen the tse is ener-be shut off upon entry into its path shall be pro- gized; orvided on all open-been configurations. A registrant 2. In the case of a radioactive sourcs, near any

may apply to the agency for an exenption from the switch that opens a housing shutter and shall bercquirement of a safety device. Such . application illuminated only when the shutter is open. /,shall include: (2) th equipment installed after July' 1, 1980,

(1) A description of the various safety devices warning lights shall have fail-safe characteristics.that have been evaluated. g. Radiation sourc e housing. Each radiation

(2) The reason each of these devices cannot be source housing shall be subject to the followingused; and requitanents:

(3) A description of the alternative methods that (1) Each X-ray t@e housirg shall be equippedvill be amployed to minimize the possibility of an with an interlock that shuts off the tse if.it isaccidental exposure, including procedures to assure removed from t'ie radiation source housing or if thethat operators and others in the area will be in- housing is disassembled.formed of the absence of asfety devices. (2) Each radioactive source housing or part cover

b. %rning devices. or em:h X-ray t@e h)usirq ehall be so constructed(1) Open-been configurations shall be provided that, with all shutters closed, the radiation mes-

with a readily discernible indication of t swed at a distance of five centimeters from its1. X-ray t2e "on-of f" status located near the surface is not capable of prodwing a dose in excess

radiation source housing, if the primary been is of 2.5 millirems in one hour. For systems utilizingcontrolled in this manner; or X-ray t@es, this limit shall be met et any specified

2. 91 utter "open-closed" status located near each ts e rating. 1

port on the radiation source housing, if the primary h. Generator cabinet. Each X-ray generator shall

been is controlled in this manr'er. be supplied with a prctective esinet Aich limits |

(2) Warning devices shall be l abeled so that leakage radiation measured at a distance of five I

their purpose is easily ident i fied . 01 equiprent centimeters from its ste fac e stc h that it is not I

I

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1

' capatilo cf producing a does in excess of 0.25 cilli- b. Bypes31ng. W individual shall bype30 o**

'

re in one hour. esfcty devica cr interlock ml:s3 cich individual has

41.5(4) Aree requirment. obtained the approval of the radiation safety offi-e. Radiation levels. The local components of an cor. Such approval shall be for a specified period

analytical X-rey system shall be located and arranged of time. then a safety device or interlock has beenand shell include sufficient shielding or access bypassed, e,readily discernible sign bearing thecontrol such that no radiation levels exist in any wrds " SAFETY DEVICE NOT WORKING," or erde having earea surrounding the loc al component group sich similar intent, shall be placed on the radiationcould result in :s does to an individual present source housing.therein in excess of the does limits given in c. Regoir or modification of X-ray t4e systems.

,

470--40.6(136C) . For systes utilizing X-rey tees, Except as specified in 41.5(5)"b," no operation '

these levels shall be met at any specified tse involving removal of covers, shielding meterials orreting. t4e housing or edifications to shutters, colli-

,

b. Surveys. ' motors, or bem stops shall be porformed without(1) Radiation' seveys, se required by 40.9(1) of ascertaining that the tse is off and dll remain off

radiation rules, of all analytical X-r ay systems mtil safe conditions have been restored. The maintufficient to show compliance 4th 41.5(4)"a" shall switch, rather than interlocks, shall be used fbrbe performed routine shutdom in properation for repairs.

1. than instellation of the equipment, and at d. Radioactive source replacement, testirg orleast once every twelve months thereafter; repelt. Radioactive source housings shall be opened

2. Following any change in the initial ar_tange- for source replacenant, leak testing, or other main-ment, number, or type of local components in the tenance or repair procedures only by individualssystun;

, euthorized to specifically conduct sch procedures

3. Following any maintenance requiring the dis- under a license issued by the U.S. Nuclear Regulatory(seenbly or removal of a local component in the Comunission, an agrement state, or a licensing state'.cystem; 41.5(6) Personnel requirements.

- 4. During the performance of maintenance and . a. Instruction. 2 individual shall be permitted

aligrunent procedures if the procedures require the to operate or maintain analytical X-ray equipment'

presence of a Finary X-roy bem den any local miess sich individual hee received instruction in*compnnent in the syste is disessembled or removed; and demonstrated competence as tor

*5. Any time a visum1 inspection of the local (1) Identification of refiation hazards associ-

- components in the systes reveals an ibnormal condi- ated with the use of the equipment;tion; and

,

/ (2) Significance of the various radiation ern-

6. Itionever personnel monitoring devices show a ing, safety devices, und interlocks incorporated into+

' significant increase over the movious monitorirq the equipment, or the reasons they have fiot beenperiod or the readings are approaching the limits installed on certain pieces of equipment end thetpecified in 40.2(1) of radiation rules, extra precautions required in etch cases;

(2) Radiation survey seeswaments shall not be (3) Proper operating procedures for the equip-required if a registrant or liconese can demonstrate ment;compliance with 41.5(4)s to the satisfaction of the (4) Recognition of symptoms of sn acuta localized

. agency. expostre; and;

c. Posting. Each area or roan containing analyt- (5) Proper procedures for reporting an actual ocical X-rey equipment shall be conspicuously posted suspected exposure.cith a sign or signs bearing the radiation symbol and b. Personnel monitoring.

j the ords " CAUTION--X-ray EQUIPPENT" or erde having (1) Finger or wist dosimetric devices shall be'

o similar intent in accordance with 40.9(3) of radi- provided to and shall be used by:ction rules. 1. Analytical X-ray equipment erkers unirg sys-

,

41.5(5) Operating requirements, teus having an open-bo m configtration and nota. Procedures. % mal operating pocedures shell equipped dth a safety device; and

be writtcn and available to all analytic al X-ray 2. Personnel saintsining analytical X-ray equip-squipment erkers. % -individuel shell be pensitted seent if the maintenance procedures require the gre-to operste analytical X-ray equipment in any manner sence of a primary X-ray bem den any local compon-cther than that specified in the grocedures mlesa ent in the analytical X-ray systan is disassembled orcuch individual has obtained witten approval of the removed.radiation safety officer. (2) Reported ciose values anall not be used for I

ther purpcce of determiniry compliance with 40.2(1) of |1

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*radictisn rulco mies) evclusted by a qualified witcline service opercticns cr este faco trac er'cupert. studios.

"Well bore" means a drilled hole in sich wireline47541.6(136C) Itadiation amfety respairements Ihr service operations and steswface tracer studies are

utroline service operations and seewface tracer per fo.med .ctudies. "Well logging" means the lowering and raising of

41.6(1) Purpose. The rules in this chapter measwing devices or tools sich may contain sourcescotablish radiation safety requirements for persons of radiation into well

I using sources of radiation for dreline service res or cavities for the pwpose of obtainingcperations including mineral logging, radioactive information about the well or adjacent formations.markers, and seswface tracer studies. 1he require- " Wireline" means a cable containing one or moremonts of this chapter are in addition to, and not in electrical conductors s ich is used to lower andss etitution for, the requirements of 470--chapters tales logging tools in the tell bore.;

38, 39 and 40. " Wireline service operatiorf' means any evaluation41.6(2) Scope. The rules in this chapter apply or mechanical service sich is performed in the tell

to all licensees do use sources of radiation for bore using devices on a wireline.wireline service operations including mineral log- 41.6(4) Prohibition. No licensee shall performging, radioactive markers, or sesurface tracer wireline service operations with a sealed source (s)ctudies. miess, prior to commencement of the operation, the

41.6(3) th finitions. As used in this chapter, licensee has a written agreement with the well oper-the following definitions apply: ~

ator, well omer, drilling contractor, or land omer

" Field station" means a facility sere radioactive thatt

sources may be stored or used and from sich equip- e. In the event a sealed source is lodged dom-ment is dispatched to temporary jobsites. hole, a reasonable ef fort at recovery will be madei

"Inj ection tool" means a device used for con- andtrolled assurface injection of radioactive tracur b. In the event a decision la made to abandon thematerial. sealed source domhole, the requirements of 41.6(9)

" Logging supervisor" means the individual 40 shall be met.provides personal supervision of the utilization of 41.6(5) Equipment control for wireline service' '

eources of. radiation at the well site. operations and assurface tracer studies.

" Logging tool" means a device used esaurface to a.- Limits on levels of radiation. Sources ofperform well-logging. radiation shall be used, stored, and transported in,

" Mineral logging" means any logging performed for .such a manner that the transportation requirements ofthe purpose of mineral exploration other than the oil 470--chapter 39 and the does limitation req 61rementscr gas. of 470--chapter 40 are met.

'

-

" Personal supervision" means guidance and instruc- b. Storage precautions.tion by the supervisor 40 is #1ysically present at (1) Each saurce of radiation, except acceler-

the jobsite and watching the performance of the oper- ators, shall be provided with a storage or transportction in seh proximity that contact can be main- container. The container shall be provided 4th atained and issnediate assistance given as required. lock, or tanper seal for calibration sources, to

j " Radioactive marker" means radioactive material prevent mouthorized renoval of, or expostre to, theplaced steur face or on a struct wo intended for source of radiation.c@ surface use for the purpose of depth determination (2) Sources of radiation shall be stcred in a

| Cr direction orientation. manner sich will minimiar danger from explosion or" Source holder" means a housing or assembly into fire.

*1ch a radioactive aource is placed for the purpose c. Tranaport prec autions. Transport containeraof facilitating the handling and use of the source in shall be physically secured to the transportingwell-logging operations. vehicle to prevent accidental loss, taipering, or

"Subewface tracer study * means the release of a mauthorized removal.c4 stance tagged with radioactive material for the d. Radiation survey instrtssents.purpose of tracing the movement or position of the (1) The licensee shall maintain sufficient cali-,

tagged s@ stance in the well bore or adjacent forma- brated and operable radiation survey instrtamenta attion. each field station to make physical radiation strveys

"Tanporary jobsite" meane a location to d ich as required by this chapter and by 40.9(1) of rodi-radioactive materials have been dispatched to perform ation rules. Instrumentation shall be capable of

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,

ne'ruring 0.1 cillir:entgen per hour thrcugh tt Itst 2. Soutcro cf redisectivo matsritle with a half-20 tilliroentgene per hour. lifa af thirty d ys cr lecc;

(2) Each radiation survey instrument shall be 3. Sealed sources of radioactive material in

c alibrated: gaseous form;1 At intervals not to exceed six months and 4. Sources of beta-emitting or gamma-emitting or

cfter each instrument servicing; both radioactive material with radioactivity of 100

2. At energies and radiation levels appropriate microcurie or less; and

for use; and 5. Sources of alpha-omitting radioactive material'

3. So that accuracy within plus or minus 20 'with an activity of 10 microcuries or less.

percent of the true radiation level cui be demon- f. Quarterly inventory. Each licensee or regi-ctrated on each scale. strant shall conduct a quarterly physical inventory

(3) Calibration records shall be maintained for a to accou1t for all sources of radiation. Records ofperiod of te years for inspection by the agency. | inventories shall be maintained for two ) ears from

e. Leak testing of sealed sources. the date of the inventory for inspection by the

(1) Requirenents. Each licensee using sealed agency and shall include the quantities and kinds ofsources of radioactive material shall have the sources of radiation, the location sete sources ofsources tested for leakage. Records of leak test radiation are assigned , the date of the inventory,

results shall be kept in mits of microcuries and and the name of the individual conducting the inven-maintained for inspection by the agency for six tory.

months after the next required leak test is performed g. Utilization records. Each licensee shallor mtil transfer or disposal of the sealed source. maintain current records, *ich shall be kept avail-

(2) Method of testing. Tests for leakage shall able for inspection by the agency for tm years frombe performed only by persons specifically authorized the date of the recorded event, showing the followingto perfone swh tests by the agency, the U.S. Nuclear information for each source of radiation:Regulatory Commission, an agreement state, or a (1) Make, model number and a serial number or clicensing state. The test sample shall be taken from description of each nource of radiation used;the surface of the source, source holder, or from the (2) The identity of the tell-logging supervisorEurface of the device in sich the source is stored or field unit to som assigned;

or mouited and on which one might expect contanin- (3) locations tere used and date of use; and -

_ 4) In the case of tracer caterial end radioact-(ction to accumulate. The test aanple shall be

analyzed for raficactiv e contamination, and the ive markers, the utilization record shall indicate

analysis shall be capable of detecting the presence the~ radionwlide and activity used in a particular

of 0.005 microcurie of radioactive meterial on the well.test samplo. h. Design, per formance, and certification crite -

(3) Interval of testing. Each sealed source of is for sealed sources used in domhole operations.radioactive material shall be tested at intervals not (1) Each sealed source, except those containing ~to exceed six months. In the absence of a certifi- radioactive material in gasenus form, used in dom-cate from a transferor indicatirq that a test has hole operations and manufactured after (insert a datebeen made prior to the transfer, the sealed source one ) ear after the effective date of this chapter)chall not be put into use uitil tested. If, for any shall be certified by the manufacturer, or other

reason, it is susp3cted that a sealed source may be testing organization accepteble to the agency , toleaking, it shall be removed from service insediately meet the following minimum criteria:and tested for leaksge as soon as practical. 1. Be of dosly encapsulated construction;

(4) teaking or contaminated sources. If the test 2. Contain radioactive material whose chemic alreveals the presence of 0.005 microcurie or more of and physical fones are as incolsle and nondispers-leakage or contaninetion, the licensee shall innedi. ible as practical; and

(tely withdraw the source from use and shall cause it 3. Has been individually pressure tested to at

to be decontaminated, repaired, or disposed of in least 24,656 pounds per square inch absolute withoutaccordance with these rules. A report describing the failure. I

'

squipment involved, the test results and the correc- (2) for sealed sources, except 'those containingtive action taken shall be filed with the agency. radioactive material in gaseous fans, acquired after

(5) Exemptions. The following nources are eranp- (inserti a date one war arter tne effective date ofted fr om the priodic leak test requirenents of this chapter), in the absence of a certificate from a41.6(5)"e"(1) through (4): trans feror certifyiq that an individual sealed

1. Hydrogen-3 suurces; source weets the requirenents of 41.6(5)"h"(1), the

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4

-.._._._.-..__.,# _ . , , _ , _ . - . - . --. _ . - .

r - 1

1

. e \

es: led tourca shall not be put into use mtil etch U.S. %ctser Reguletsry . (bemiccirn, an a3rceent- |det:noinations and tuting havo been perfsrmed. etcto, er a licen:ing ctata.

'

(3) Each sealed source, except those containing 41.6(6) Requirmente for personnel safety,radioactive meterial in gaseous form, used in down- e. Training requiremente.hole operations after (insert a date one year after (1) % licensee shall permit any individual tothe effective date of this chepter) shall be certi- act as a logging supervisor as de fined in thisfled by the manufacturer, or other testing organiza- chapter etil etch individual hast

tion acceptable to the agency, as meeting the sealed 1. Received, in a course recognized by thesource perfonnance requirmente |for oil tell-logging agency, the U.S. % clear Regulatory (bemission, anas contained in the American National Standard N542, agreement state, or a licensing state, instruction in"$saled ' . Rodioactive Sources, ' Classification" in the stbjects outlined in 41.6(12) and demonstrated aneffect on (the effective date of this chapter). understanding thereof;

(6) Certification documente; shall be maintained 2. Road and received instruction in the rulee jfor inspection by the agency for a period of tie contained in this chapter and the applicable sections '

yearn efter source disposal. If the source is aban- of 470--chapters 38 and 40 or their equiv alent,doned dowshole, the certification documents shall be conditions or appropriate licones or certificate of

maintained mtil the agency authorizes disposition. registration, and the licensee's operating and emer-1. L2eling. gency procedures, and demonstrated an understanding |(1) Each source, source holder, or logging tool thereof; and i

containing radioactive meterial shall bear a durable, 3. Demonstrated competence to use sources oflegible, and clearly vielble merking or labelT dich raliittion, related handling tools, and radiation'has, as ' a minista, the standard radiation caution survey instrtments dich will be used on the job.cymbol, without the conventional color requitment, (2) % licensee shall permit any individual toand the following wordings assist in the handling of sources of radiation tatil

stch individual has:DANGER ((R CAUTION) 1. Road or received instruction in the liconese's

RADIOACTIVE operating ed emergency procedures and. ' demonstratedan understanding thereof and

- This labeling shall -be on the mellest camponent 2. Demonstrated banpetence to use,, mder the.trane' ported as a separate piece of equipment.. personal supervision of the logging supervisor, the

(2) ' Each transport container shall have perman- sources of radiation, related handling tools, andently attached to it a durable, legible, and clearly radiation survey instruments sich will be used onvisible label dich has, as a minista, the standard the job.radiation caution symbol and the' following wordings (3) The licensee shall maintain employeef rainingt

records for inspection by the agency for two . yearsDANGER ((R CAUTION) following termination of employment.

RADIDACTIVE: b. (5erating sid mergency saocedures. The.

NOTIFY CIVIL AUTHORITIES ((R NME (F C(MPANY) licensee's operating and emergency. procedures shallinclude instructione in at' least the~ following

J. Inspection and maintenance. (1) Handling and use of sources of radiation toi (1) Each licensee shall conduct, at intervals not 'be u ployed so that no individual ~ is likely 'to be

to exceed six months, a progem of inspection and exposed to radiation donos in excess of the standards

j maintenance of source holders, logging tools, source established in 470--chapter 40.j handling tools, storage containers, trmoport con- (2) Methods and occasions for conductitup radia-

| toiners, and injection tools to asetro proper label- tion surveys.ing and physical condition. Records of inspection (3) Methods and occasions for locking and secur-'

and maintenance shall be maintained for' a period of ing sources of radiation.tio years for inspection by the agency. (4) Personnel monitoring and the use of personnel

(2) If any inopoetion conducted ptreuent to monitoring equipment.41.6(5)"j"(1) reveals damage to labeling or compon- (5) Transportation to temporary jobsites andente eriticel to eadiation sefety, the device shal1 field atations, Including the peckaging and placingbe removed fran service mtil repairs have been made. of sources of radiation in vehicles, placarding of

(3) The repair, opening, or modification of any vehicles, and securing sources of radiation duringsealed source shall - be per formed only by persons transportation.cpecifically authorized to do ao by the agency, the (6) Minimizing exposure of individuals ire the

event of an accident.

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t

T.

*(7) Proceduro fcr notifying ;Ir:per personn:1 in (2) Radittiin twvsy3 er cr.lculcti:ns sh211 be,

the event cf an accident. cado and rectrded for the redir. tion levels in occu-(8) Maintenance of recorde. pied pzeitions L:1d on the exterior of each vehicle

(9) Inspection and maintenance of sourt:e holders, used to transport radioactive material. Such surveyslogging tools, source handling tools, storage con- or calculations shall include each source of radi-tainers, transport containers, armi injection tools. stion or combination of sources to be transported in

(10) Procedure to be folloied in the event a the vehicle.sosted source is lodged domhole. (3) After removal of the sealed source from the

(11) Procedures to be used for picking up, logging tool and before departing the jobsite, thereceiving, and opening packages containing radioact- logging tool detector shall be energized, or a surveyive material. meter used, to answa that the logging tool is free

c. Personnel monitoring. of contaninetion.(1) M)' licensee shall permit any individual to (4) Radiation swveys shall be made and recorded

act as a logging supervisor or to assist in the hand- at the jobsite or well-head for each tracer oper-ling of sources of radiation miese each stch indi- ation, except those using hydrogen-3, carbon-14, andvidual imers either a film badge or a thermolumine- sulfur-35. These surveys shall include measurementsscent dosimeter (TLD). Each film badge or TLD shall of radiation levels before and after the operation.be assigned to and worn by only one individual. (5) Records required pursuant to 41.6(8)"a"(1) to

(2) Personnel monitoring records shall be main- (4) shall include the dates, the identification oftained for inspection uitil the agency authorizes individual (s) making the survey, the idontificationdisposition.

_ of survey instrument (s) used, and m exact descrip-41.6(7) Precautionary procedures in logging and tion of the location of the survey. Records of these

othsurface tracer operations. surveys shall be maintained for inspection by thee. Security. DJring each logging or tracer agency for tie. years after completion of the survey,

application, the logging supervisor or other desig- b. Ibcuments and records required at field str -noted employee shall maintain direct surveillance of tions. Each licensee shell maintain, for inspectimthe operation to potect against uisuthorized o- by the agency, the following documents and recoresmnecessary entry into a restricted area, as defined for the specific devices and sources used at thnin 470--chapter 38. field station:

b. Handling tools. The licensee shall provide (1) Appropriate licones, certificate of registra-and require the use of tools that will asswa remote tion, or equivalent document;handling of nealed sources other than low-activity (2)' Operating and ens.rgency procedures;

~

calibration sources. ' (3) Applicable rules;c. Stesurface tricer studies. (4) Records of the latest survey instrument es! : ~(1) Protective gloves and other appropriate pro- bretions pursuant to 41.6(5)"d"; '

tactive clothing and equipment shall be used by all (5) Records of the latest leak test resultspersonnel handling ruficactive tracer material. pursuant to 41.6(5)"e."Precautions shall be taken to avoid ingestion or (6) Quarterly inventories required oursuant toinhalation of radioactive material. 41.6(5)"f."

'

(2) Ptr licensee or registrant shell cause the (7) Utilization records required pursuant toinjection of radioactive material into potable aqui- 41. 6( 5)"g."fers without prior written authcrization frun the (8) Records of inspection and maintenanceagency. required pursuant to 41.6(5)"j"; and

d. Particle accelerators. fta licensee or regi- (9) Survey records required pursuant toctrant shell permit aboveground testirq of particle 41.6(A)"a."accelerators, designed for use in well-logging, idiich c. Dieunents and records required at temporaryresults in the poduction of radiation, except in jobsites. Each licensee conducting operations at acreas or facilitise controlled or shielded so that temporary jobsite shall have the following documentsthe requirements of 40.2(1) and 40.6(136C) of radi- and records available et that site for inspection byt, tion rules, as applicable, are met. the at;ency:

41.6(8) Radiation surveys and records. (1) Operating and energency proceduree;a. Radiation surseys. (2) Survey recorda required pursuant to

(1) Radiation surveys or calculations shall be 41.6(8)"n" for the period of operstien at the site;made and recorded for each area where radis % tive (3) Eviderce of current :elibration for the radi-materlato are storod. ation swvey instruments in uce at the sites and

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. _ _ _ - _ _

| w.

(4) Mn opercting in the cttto mder r'ecipre- er regictrant shall grovid) O pomanent plaque fo r'city, o copy cf the appropricto license, c:rtific;to po ting the well or well-b ro. An acc ptabl3 plaqueof registration, or equivalent document (s). is sho m in 41.6(13). This plaque shella

d. %tification of incidents, sendonnent , and e. Be constructed of long-lasting material, sehlost sources. as stainless steel or monal; and

(1) %tification of incidents and sources lost in b. Contain the following information engraved onCther than domhole logging operations shall be made its facesin accordance with appropriate provisions of 470- (1) The word " CAUTION";chapter 40. (2) The r'adiation symbol without the conventional

(2) menever a sealed source or device containing color requirement;radioactive material is lodged domhole, the licensee (3) The date of tendonnent;shells (4) The name of the well operator or well omer:

1. %nitor at the swfece for the presence of (5) The fiell name and tell identification nun-radioactive contaninetion with a radiation survey ber(s) or other designation;instrument or logging tool during logging tool (6) The sealed source (s) by radionuclide andrecovery operations; and quantity of activity:

2. %tify the agency immediately by telephone if (7) The source depth and the depth to the top ofradioactive contamination is detected at the surface the plug; andcr if the source appears to be damaged. (8) An appropriate ierning, depending on the

41.6(9) When it becomes apparent that ef forts to specific circunstances of each abandonment. Appro-recover the radioactive source will not be success- priate ternings may includesful, the licensee shall: 1. "Do not drill below. plug back depth,"

a. Advise the nell operator of the rules of the 2. "Do not enlarge casing ," or1:ie geological survey regarding sendonnent and an 3. "[b not re-enter the hole," followed by th'ecppropriate method of sendonnent, thich shall words, "before contacting the Iowa state departmentinclude r of health."

(1) The 1:amobilization and sealing in place of 41.6(11), The lic_ensee shall heediately notifythe radioactive source with a cement plug; the agency by telephone and essequently by- confirm-

(2) The setting of a shipstock or cther deflec- ing letter if the licensee or registrant knows or has 'tion device; and reason to believe .that radioactive material has been

(3) The momting of a pomanent identification lost in or to en mderground pottle inter source.

plaque, at the surface of the well, containing the Such notico shall designate the .well location andcppropriate infomation required by 41.6(9)"d." shall describe the magnitude and extent of loss of

b. htify the agency by telephone, giving the radioactive material, assosa the consequencesi of smhcircunstances of the loss, and request approval of loss, and explain efforts planned or being taken to

the proposed sendonnent procedures, and mitigate these consequences.c. file a written report with the agency within 41.6(12) S4jects to be included in training

thirty days of the abandonnent, setting forth the courses for logging supervisors.following infomation a. Fundamentals of radiation safety

(1) Date of occurrence and a brief description of (1) Disracteristics of radiation.tttempts to recover the sources (2) thits of radiation dose ed qmntity of

(2) A description of the radioactive source radioactivity.

involved, including radionuclide , quantity, and (3) Significance of radiation doseschemical and physical fom; 1. Radiation protection standards.

(3) Surface location and identification of iell: 2. Biological effects of radiation dose.(4) Results of efforts to immobilize and set the (4) Levels of radiation fran sources of radis-

source in place; tion.

(5) Depth of the radioactive source; (5) Methods of minimizing radiation doses(6) Depth of the top of the cement plug 1. Wrking time,(7) Depth of the well; and 2. Wrking distance, and(8) Infomation contained on the pemanent 3. Sielding.

identificatfon plaque. b. Radiation detection instrunentation to be

41.6(10) Radioactive material-sealed source aban- used:doned. senever a sealed source containirg radio- (1) Use of radiation survey instruments:active material is tendoned domhole, the licensee 1. Cheration.

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_ _ _ _ _ _ _ _ _____________----J_

. . - _ -

*- 2'. Calibration, and* ~

,

3. Limit" tion].(2) Survey techniques.(3) Use of personnel monitoring equipment.c. Equipment to be used(1) Handling equipment.(2) Sources of radiation.(3) - Storage and control of equipment.(4) Operation and control of equipment. I

c. The requiremonte of pertinent federal andtiete regulations.

d. The licensee's written operating and emergencyprocedures.

1he licensee's recordleseping procedures.e.I

41.6(13) Plaque for identifying sells containingsealed sources containing radioactive material aban-doned dowthole.

-

[C(NPANY NAME].[WELL IDENTIFICATION]

CAUTION~

.

,

(OE 2 CURIE CS-137 RADI0 ACTIVE SolstCE ABANDOED)3-3-75 AT 8400 FT. PLUG 8ACK DEPTH 8200 FT.

'

00 NOT RE-ENTER THIS WELL BEFORE CONTACTING'

~ RADIOLOGICAL EALTH PROGtAM'

I(MA 5 TATE DEPARTMENT (F EALTH -'

-

' iTre sian of the plaque shall be convenient for use on ~~

'

ociive or inactive wolle, e.g., a seven-inch square. -' Letter sias of the word "CAUII0er should be approxi--mately twice the lettsr size of the rest of the /--

"information, e.g.,1/2-hch and 1/4-inch letter size,f

'

roepectively.

410-41.7(136C) Effective date. tharing the secondc ssion of the seventieth General Assembly (1984)existing Ious Code chapter '.36L*. wse amended by .1984town Acts, chapter 1286, authorizing the governor toenter into an agreement with the U.S. Nuclear Regula-tiry thamission (NRC) thereby enabling the lowe statedepartment of health to license and father regulatebyproduct, source and enall quantities of epcialnuclear radioactive materials. The signing of owhan agressent is authorized in federal legislationunder Subsection 274b of the Atomic Energy Act of1954, as seended. Diopter 41 as amended will becameeffective on the date the governor and 96tC sign the

,

object agreement. *

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A V

ARC 342B because of the u1 availability of appropriately

HEALTH DGARTENT [470] qualified persons under 42.1( 136C) . A conditionalexemption shall be granted for limited periods of

Pursuant to Sections 135.11(15) and 136C.3( 3 ) , time to be prescribed by the agency at the agency'sThe Code, the Iowa Department of Health hereby discretion and in accordance with the purposes of

adopts Title IV, Radiation Emitting Equipment, 42.1(136C). A conditional diagnostic radiographerChapter 42, " Operating Procedures and Standards for shall be limited by the egency to those rightsuse of Radiation Emitting Equipment", Iowa Admin- specified in the exemption notice and be under theistrative Code. direct supervision of a licensed practitioner.

TITLE IV 42.1(3) Minima eligibility requirements.RADIATION EMITTING EQUIPENT a. Graduation from high school or its equivelent

CHAPTER 42 b. Attainment of eighteen years of age.OPERATING PROCEDURES AND STANDARDS FOR c. Ability to adequately perform necessary dut

USE OF RADIATION EMITTING EQUIPMENT without constituting a hazard to the health470-42.1(136C) Minlaua training standards for safety of patients or operators.

diagnostic radiographers. 42.1(4) Training requirements.42.1(1) Definitions. a. General diagnostic radiographer. Succesa. " Approved course of study" means a curriculum completion of a Committee on Allied Health Ed

and associated training and testing materials which tion and Accreditation approved course of studythe agency has determined is adequate to train equivalent to prepare the student to demonstrstudents to meet the requirements of 42.1(136C). competency in the following areastb. " Clinical education" means the direct partici- (1) Radiation protection of patients and worker

pation of the student in completion of diagnostic including monitoring, ehielding, units of measurstudies. ment and permissible levels, biological ef fects -c. " Contrast media" means material intentionally radiation, and technical consideration in reduci

administered to the human body to define a part(s) radiation exposure and frequency of retakes; ,.

which is not normally visualized radiographically. (2) Technique and quality control to aci.ied. " Diagnostic radiography" means the science and diagnostic object ives with minimum patient exp 3

"art of applying X-radiaticn to human beings for sure, including X-ray examinations, X-ray producdiagnostic purposes ot her than in dent al radio- tion, films, screens, holders and grids, techniquegraphy. It shall include adjustment or manipula- conversions, film processing, artifacts, image

_

tion of X-ray equipment and appurtenances including quality, film systens and centrol of secoMaryimage receptors, positioning of patients and pro- radiation for the specified category;

cessing of films in such a manner as to materially (3) Patient care, including but nct limited to,affect the radiation exposure of patignts. aseptic techniques, emergency procedures and first

e. "ticensed practitioner" means a person aid, and contrast media; ^

licensed or otherwise authorized by law to practice (4) Positioning, including normal and abnormal| medicine, osteopathy, chiropractic, or podiatry, anatomy and projections;

f. " Student" means a person enrolled in and (5) Radiographic equipment and operator mainten-participating in an approved course of study. ance to include X-ray tubes, grids, standardization

g. " Supervision" means responsibility for and of equipment, generators, preventive maintenance,i control cf quality, radiation safety eM protec- basic electricity, film processors and maintenance,

tion, and technical aspects of tne application of collimators, X-ray control consoles, tilt tables,

ionizing radiation to human beings for diagnostic ancillary equipment, fluoroscopes end electrical_

or therapeutic purposes. and mechanical safety; /!! h. "X-radiat ion" means penetrating electro- (6) Special techniques, incluaing stereo, body _

| magnetic radiation with energy greater than 0.1 kV section radiography, pelvimetry, image intensifica- ,

Iproduced by bombarding a metallic target with fast tion, photo timing and m bile units; andelectrons in a high vacuum. (7) Clinical experience sufficient to demonstrate

42.1(2) Types of operators, competency in the application of the sove as ,

s. " General diagocstic radiographer" means a speci fied in the revised 1978 edition of the! person, other than a licensed practitioner, who " Essentials and Guidelinas of an Accredited Eouca-

applies X-rMistion to any part of the human body Lion Progre for the Rahographer" of the American |for diagnostic purposes sile under the supervision Medical Association's Comnittee on Allied Healthof a licenced practitioner. Education and Accreditation. .

b. " Limited diagnostic radiographer" means a b. Limited diagncotic radiograpner.

person, other tnan a licensed practitioner or (1) Completion of an approved coursa of study te ,

dental radiogracher, who applies X-radiation to one prepare the student to demonstrata capetency inspecific body part while under the supervision of a the following areas:

11censeo practitioner. The exceptions to the one 1. Radiation protection of pettent s aM uorkeebody part restrictico are including monitoring, shtelding, units of measure-

|(1) The limited individual may perform both chest ment and permissible levels, biological ef fects 4

and estromity radiogrephic examinations if that radiation, and technical considerationc in reducincindividual has received appropriate clinical exper- radiation exposure and fraquency of rst akes;>

ience during the didactic training required under 2. Technique and quality control to achieve dieg-r

42.1( 4)"b" aM 42.1( 5)"b", and , nostic objectives witn mininum patient exposure toI (2) When an individual gsins the status of a include X-ray examinatien, X-ray production, films.

limited diagnostic rtdio as outlined in screens, holderc end grids, technique eenversiers. -

42.1(4)"b"(2s, (3) or (4) grapher~

that Individual may per- film processing, artifacts, imege quality, Nla

. form the permitted radiographic procedures. systms and control of secordary radiation for thec. " Conditional diagnostic radicgrapher (hard- specified eategory;'

j ship)" me ans a diagnostic X-ray machine ope rstar 3. f at ient care, including but not limited ! ),,

- who has minimal clinical competency but does not aseptic techniques, entgency procedures aM ri mfully w t the appropriate requirenents of 42.1( 3'. sid;

ard 42.1(4) or is not otherwise covered under 4. PoJitioning, including no rraal ard aboo mi42.1( 5) , 42.1(6) or 42.1(8), but in s ich ceae anatomy eM projections for the specific cateqc ry;there 13 substant ial evidence thst the pecple in 5. Radiographic equipment and operater C Ln- -

the laealat f of the state in ihacn this exempticn ance to incluoe X-ray t ubes, grids, starviart r at ivis ocught, would be dented odequate health chre of equtpment, generstora, preventive malr.twnce,

* I. - . - -

.,

w - w- - . y. --- - -,y.

basic clictricity, filn processori and maintenanco, 3. e litt-cr from the institution providing~

,

collinaters, X-ray control consoles, tilt tables, didactic tecining which indicates the empicyee'sancillrry equipment, fluoroscopes and electrical anrollment status and course dates; andand mechanicci safety; 4. an outline of the clinical experience of the

6, Special techniques limited to those required employee. This should include the number of radio- ,'

by the cpecific category; and graphic examinations performed by type, who deter-/l. Clinical experience sufficient to demonstrate mined the quality of the radiograph and that

person's qualifications to do so.competency in the application of the above asepecified in the revised 1978 edition of the Subrule 42.1( 4), paragraph "b", stbparagraph (4),"Ersenticls and Guidelines of an Accredited Educs- is rescinded tw years subsequent to the effectivetions! Program for the Radiographer" of the date of rule 42.1(136C).

c. Certification by the A;nerican Regist ry ofgNerstan.Hedical Association's Committee on Allied7h Edur ation and Accreditation. Radiologic Technologists or the American Registry

Technolo meets the42.1( 136C) gists% individual may apply X-radiation to reore of Clinical Radiography

e specific part of the htsnan body for diaq- minimum requirements of .

! purposes if the individual meets the d. Individuals engaged in the practice of diag-ents of 42.1(4)"b"(1), and 42.1(5)"b", and nostic radiography for two or more years prior to,a course of clinical training approved by the effective date of 42.1(1%C) must meet thetment from a radiologist to then certi- requirements of 42.1(4)"a" or "b" as appropriate or

'yindividual's competency to perform certain demonstrate the adequacy of their training andradiographic procedures. The individual experience including all existing credentials, toperform those diagnostic radiographic pro- the agency in order to be considered as meeting the3

, certified by the radiologiot. The follow- requirements of 42.1( 136C) .3;rmation and statements will need to be pro- 42.1(5) School accreditation. j

the department s a. Graduates of schools accredited by the ;

$ e diagnostic radiographic procedures which Committee on Allied Health Education and Accredits-'.

ividual may perform; tion who have successfully completed en appropriate g

course of study in diagnostic radiography (will be |

j.s a name and qualifications of the certifying -

considered to meet the requirements of 42.1 2)"a".' ody part(s) aMkjist ard a list of the c,.lon([s) they nave certified the individual to b. Graduates of programs recognized by the Iowa e

State Department of Health in consultation with the ;: rm g

professional societies and boards of examiners for !ilf the it'dividual has not successfully com-ad O training program wnich meets the require- appropriate course of study in diagnostic radio- !

$

graphy (will be considered to meet the requirementa.c set forth in 42.1(4)"b" and 42.1(5)"b", aof 42.1 2)"b". *Mr from the institution providing didactic

iLining- Alch indicates the employee's enrollment 42.1(6) Exemptione. <

1tus and course dites; and o. Students enrolled in and participating in ana reprecentati.e of the lows cpproved progra or opproved course of study for% permission for

it] Departmeat of Health to conprehensively clagnostic radiography or an approved school af ,

?alu:t3 whether the individual meets the training medicine, osteopathy, podiatry, and chiropractic,~

f|)who as a part of their course of study, apply _

)jand:rd,(3) An individual employed in a diagnostic radio-ionizing radiation to a human being Wnle under the ||I

tephy facility unich has a work loed of less than supervision of a licensed practitioner. The pro- s

,000 examinations per year and which provides jectea completion date of such a program or coursety-four hour ontvice in a hospital will be per- of study shall be within a time period equal to or

'[.sitted to apply X-raciation to any part of the less than twice that required for a full-time j

usan t:ody at that facility if the individual com- student . 3,

pletes c training progren recognized by the depart- t. Licensed practitioners as defined in 1:!!imant, as cutlined la 42.1(4)"b"|1) and 42.1(5)"b" 42.1( 1)"e" .

,and has received clinical trsining frun a codiclo- c. Conditional diagnostic radiographer as defined' gict to then certifies in writing thu specific undar 42.1 2)"c".eprocedurrs the individual is competent to perform. 42.1(?) Enfor::mment.

a. Any individual, except a licensed cractitioncehgThe trciniry progrm must cover the aroas cut 11nad defined in 42.1(1)"e" who operateo X-ray equipentin 42,1(4)*b", the anai.o:ty and physiology of the

hntire bcdy, pocitioning and technt@es relatiss to in tne pract ice of diagnos tic radicgrapny. shallthe procedures ta % perfomed eM appropriat e meet the requirenents of 32.M 13oC).?linicci training wolen includes all parts of the b. Any percon includity a licensed practitioner

i bsan bcdy. The certif ying rtdic togist must be cefined in 42.1(1)"s" eo mploys an indivioual in ;

' drectly responsible f ar tha iNividual's clistic21 the practice of d2agncstic radiogr3phy may do so*%faining. only if that individual meeta the requirements of* (4) An individual per formrq diagnostic radio- 42.1( 136C) .raphy in s hospital for less tr.an twc yearc criar 42.1(E) Reciprccity. Any pe rson so is the

te thu sf rectiv:. date of 42.1(136C) is considered holoce of a current cert ificate in diagnost ic

.as setting the r3quirements of 4'!.!!1360) provised radiograohy issued by another state, jurisdiction,'that this Artiividual meet s the reoult erverts of agency or recognized professional registry my be

= 42. l(4)ab"(!) and 42.1(5 Pb" and receives clinical eensidereo by the scenef to meet the requirementa'

' trainiry f rom o radiologist who then certifies his of 42.1(1760), provided that tre agency fiMs thater aer competence to perform certain radicgraphic the standares and procedJtes for C3rtification inmeedures. Eech imiviM1 will te 11xited to the state, jurisdiction, agency or recognized pro-,

Jhno dis 990stic radiogrephy preceoutes certified fessional regist ry which issued the certificate,& the rWclogist. Persarm seeking to gustify an af ford protection to t**e puolic equivalent to that

1. tndivicun! under this tule must submit the folicw- a f fo r@d b y 42.1(135C).; (q'informtion to the cepartment: The ef fective cate of 42.1(1MC) shall be January

f 1. the disonostic radiogtephw procedures wnich 12, 1983The individual msy perform; Rule A2.1(1360) is interded to impleme r.t Iowa

1. tbs nnme am qus!1fjestions of t'v cutif ying Code de:tien 13dC.3(3).rdiologiat , ard a list of t he t ody partM cndMajection(3) te or t'e nos certified the indi-tida21 to ;ntfots;

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