Shipping Dangerous Goods. Course Content I.Background information II.Infectious substances –Category A: classification, packaging, labeling and documentation.

Shipping Dangerous Goods

Course Content

I. Background information

II. Infectious substances– Category A: classification, packaging,

labeling and documentation– Category B classification, packaging,

labeling and documentation– Exempt human specimens

III. Class 9 shipping– Dry Ice

Dangerous Goods, Definition:Materials or substances having hazardous properties which, if uncontrolled, are capable of posing a risk to health, safety, property or the environment.

If you don’t value life, other reasons for concern:

•Civil penalty for individual up to $50,000 for each violation•Criminal penalty for individual up to $500,000 and/or imprisonment up to 5 years•Penalties double if there is serious injury or death•In addition to the individual, the institution may be charged

Regulatory Authorities

•UN International Civil Aviation Organization (ICAO)•International Air Transport Association (IATA)•Department of Transportation (DOT)/Federal Aviation Administration (FAA)•United States Post Office (USPS)•Individual Air Carriers (FedEx, Alaska Airlines)

Regulations

IATA Dangerous Goods Regulations

Department of Transportation 49 CFR.171-180

Domestic Mail Manual – Publication 52

IATA Dangerous Goods Regulations

Key Points

• Based on UN Model• In general, are the most restrictive

• DOT will accept• Post Office will accept

Training Requirements

Anyone who handles, offers for transport, or transports dangerous goods must be trained to perform the duties required by their employer.

Three areas of training are required;

1. General Awareness/Familiarization Training – Training designed to provide familiarity with the general requirements of dangerous goods regulations

2. Function Specific Training – Training that specifically addresses the functions the employee performs: for example, preparing and offering a shipment of infectious substances and the use of dry ice in transport

3. Safety Training – Training that instructs the employee of hazards associated with dangerous goods as well as safe handling and emergency response procedures – OSHA Blood Borne Pathogen (BBP) standard (29 CFR 1910.1020) may be used to meet DOT requirements

Employer Certification Requirements

TestingDemonstrationOral Written

Certificate of TrainingEmployer must have for each employeeTrainee’s nameDate of examDescription of training materials used to meet training requirementsName and address of trainerTest ScoreSpecific topics for which the employee is trainee

Certificate Validity2 years for IATA3 years for DOTAs needed

Responsible Parties

ShippersCarrier/Operator

Receiver

Shipper’s Responsibilities

• Classify• Identify•Select proper packaging• Packing• Mark and label• Document• Make arrangements

Operator’s Responsibilities

• Must detect errors• Use acceptance checklist• Ensure safe loading, storage, and transport• Inspect for damage or leaks• Report any problems to the proper authorities

Receiver’s Responsibilities

• Help obtain import permits, if needed• Inspect package for damage or leaks• Verify itemized list of contents• Report back to shipper• Report leaking packages to appropriate authority

List of Dangerous Goods

Exce

rpt f

rom

Tab

le

Classes of Dangerous Goods

Nine classes of dangerous goods (class indicates type of hazard not degree)

Class 6 Toxic and Infectious SubstancesDivision 6.2 Infectious Substances

Class 9 MiscellaneousDry Ice

Infectious SubstancesA material known or reasonably expected to contain a pathogen

Pathogen – a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion), that can cause disease in humans or animals

Infectious substances come in 2 forms:Cultures – an infectious substance containing a pathogen that is intentionally propagated

Patient Specimens – human or animal material collected directly form humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and it components, tissue and tissue swabs, body parts, and specimens in transport media.

Infectious substances have multiple categories:Category A – An infectious substance in a form capable of causing

Permanent disabilityLife threatening or fatal to otherwise healthy humans or animalsOccurs upon exposure

Category B – An infectious substance that is not in a form generally capable of causingPermanent disabilityLife threatening or fatal to other wise healthy humans or animalsOccurs upon exposure

Exempt Human Specimens – Specimens that do not, or are not likely to contain an infectious substance, are not subject to the regulations if the specimen is packed in a manner that prevents leakage

Examples of Category A SubstancesBacillus anthracis (cultures only) Dengue virus (cultures only)Coccidioides immitis (cultures only) Rabies virus (cultures only)Lassa virus Hepatitis B virus (cultures only)Shigella dysenteriae type 1 (cultures only) Yersinia pestis (cultures only)

Examples of Category B SubstancesStaphylococcus aureus Escherichia coli, verotoxigenic,Cryptococcus neoformans Streptococcus pneumoniaeRabies virus Streptococcus pyogenesHepatitis B virus Stenotrophomonas maltophilia

Examples of Exempt Human SpecimensBlood or urine specimens for cholesterolUrine screening for drugs or alcoholBiopsies to detect cancerSpecimens for antibody detection

Non-Regulated Materials

Unless the following meet the criteria for inclusion in another class or division, are not subject to the regulations:

• Substances with a low probability of containing an infectious substance, or where the concentration of the infectious substance is at a level naturally occurring in the so it cannot case disease when exposure to it occurs• Micro-organisms that do not cause disease in humans or animals• Substances that have been treated so that the pathogens have been neutralized or deactivated• Foodstuffs and environmental samples, such as water or a sample of dust or mold which would not be considered a significant source of infection• Dried blood spots or specimens for fecal occult blood detection placed on absorbent filter paper or other material and blood, blood components, tissues or organs collected for the purpose of transfusion or transplantation

Classification Flow Chart

Using the Dangerous Goods List

Name (Proper Shipping Name) UN No.

Class or division Subsidiary risk Hazard Labels Special provisions

UN packing group

Biological substance, Category B 3373 6.2 None

Infectious substance, affecting humans 2814 6.2 Infectious

A81 A140

Infectious substance, affecting animals, only 2900 6.2 Infectious

A81 A140

Dry ice 1845 9 MiscellaneousA48

A151 No longer III

Proper Shipping Name• All dangerous goods must be assigned a proper shipping name• Proper shipping names must be spelled exactly as they appear on the list

of dangerous goods

UN Numbers• Each proper shipping name is assigned a UN number• The UN number can be used to identify the dangerous good• The UN number is useful when English is not the native language• The UN number appears alongside the proper shipping name

Hazard Labels• Hazard labels indicate the class or division of dangerous goods

Special Provisions• Special provisions give detailed information in the handling of packages

containing the specific dangerous good

Special Provisions

A 48The completed package does not require testing

A81 Shipments involving body parts, organs or whole bodies infected with a Category A Infectious substances may exceed the quantity limits for Passenger or Cargo aircraft

A140The proper shipping name for Category A Infectious substances must be supplemented with the technical name (scientific name) on the Shipper’s Declaration for Dangerous goods. The technical name is not recommended to be marked on the outside of the package. If the technical name is not known or if the specimen is proficiency testing, the technical name “suspected Category A Infectious substance” must be included.

A151Quantity limits for dry ice do not apply when dry ice is used as a refrigerant in pallets.

Proper PackagingDangerous goods need to be packed in such a way that the specimen is protected against leakage or spillage during transport

Quantity Limits and Packing InstructionsPassenger Aircraft Cargo Aircraft

Name (Proper Shipping Name) UN No. Class or division Subsidiary risk Hazard Labels Special provisions

Excepted Quantity

Packing instruction

Max net quantity per

packagePacking

instruction

Max net quantity per

package

Biological substance, Category B 3373 6.2 None EO 6501 L primary 4 L or 4 kg 650

1 L primary 4 L or 4 kg

Infectious substance, affecting humans 2814 6.2 Infectious A81 A140 EO 620 50 ml or 50 g 620 4 L or 4 kg

Infectious substance, affecting animals, only 2900 6.2 Infectious A81 A140 EO 620 50 ml or 50 g 620 4 L or 4 kg

Dry ice 1845 9 Miscellaneous A48 A151 EO 954 200 kg 954 200 kg

Proper Packaging Continued

Triple packaging required for: Category ACategory BExempt human specimen

UN specific packaging required for Category A

Manufacturer’s test packaging systems and copies of these reports must be shown to the inspectors upon request

StepBiological Substance, Cat.B (UN3373)

PI650 Solid CO2/Dry Ice PI954Infectious Substance (UN2814 or

UN2900) PI6201 Place sample in a leakproof primary

receptacle or vial. Vial caps must be sealed with tape, paraffin, parafilm. The volume must be 1L or less.

If shipped by ground--not regulated, else it must be put in a container that allows the release of pressure and prevents rupture.

Prepare a Dangerous Goods (DG) Declaration. Packaging must be UN certified. Place sample in a leakproof primary receptacle or vial. Vial caps must be sealed with tape , paraffin, parafilm.

2 Sample vial is then placed in a leakproof secondary packaging. Examples of secondary packaging are: plastic canister, sealed plastic bag, sealed styrofoam, screw cap can. Total volume of samples must be 4L or less. Primary or secondary package must be able to withstand and internal pressure of 95 kPa and a temperature range of -400to 550C.

Place the dry ice outside the secondary packaging.

Sample vial is then placed in a leakproof secondary packaging. Examples of secondary packaging are: plastic canister, sealed plastic bag, sealed styrofoam, screw cap can. Either primary receptacle or secondary must be able to withstand an internal pressure of 95kPa and a temperature range of -400to 550C.

3 Place absorbent material between primary receptacle and secondary packaging. Examples of absorbent material are: cellulose wadding, cotton balls, paper towels, commercial absorbent packets. Cushioning is required if multiple primary containers are present.

Mark the net weight of the solid dry ice on the outside of the package in kilograms.

Place absorbent material between primary receptacle and secondary packaging. Examples of absorbent material are: cellulose wadding, cotton balls, paper towels, commercial absorbent packets. Multiple primary receptacles must be cushioned.

4 Place the above in an outer packaging. Examples are corrugated cardboard box, wood box, rigid plastic cooler, rigid plastic box. Side of box must not be less than 100 mm. Entire package must be able to pass drop test of 1.2 meters.

For infectious substances (column on right): •Declare the dry ice on the Dangerous Goods (DG) label with complete shipping name and UN ID# UN1845. •Use a Class 9 Miscellaneous DG label.

Place the above in an outer rigid packaging. Examples are corrugated cardboard box, rigid plastic cooler, rigid plastic box. The smallest external dimension must be at least 100mm. Outer packaging must bear the UN specification mark.

5 Enclose an itemized list of contents between the secondary packaging and outer packaging.

N/A Enclose an itemized list of contents between the secondary packaging and outer packaging.

6 If air waybill is used, under Nature and Quantity of goods write Biological Substance, cat. B UN3373. Write the Name and Telephone number of person responsible for shipment on outside of package or airway bill.

N/A Write the Name and Telephone number of person responsible for shipment on outside of package. Write shipper and consignee information on outside of package. Orientation labels should be on opposing sides.

7 Place a UN3373 diamond shaped sticker on outside of box. Orientation labels should be on opposing sides.

Class 9 Miscellaneous Hazard label. Class 9 Proper Shipping Name, UN Number and quantity label on the outside of the package.

Place: 1. Proper shipping Name and UN no. label on the outside of the package. 2.The division 6.2 Hazard Label on the outside of the package. 3. complete dangerous goods form.

Comparison Chart of Sample Handling & Packaging

Packaging for Exempt Human Specimens

The following is required for shipping exempt human specimens:

• Triple packaging consisting of• Leakproof primary receptacle• Leakproof secondary packaging• Outer packaging must be strong enough to safely contain

contents throughout the trasport.• minimum size for outer package is 100mm on one surface

• Absorbent material must be placed between the primary and secondary packaging

• Multiple primary receptacles must be cushioned

• Primary receptacles must be secured with positive means (tape, paraffin, parafilm)

Miscellaneous General Packaging Rules

Reuse is allowed if outer shipper is in good condition

Other dangerous goods cannot be packed with infectious substances except for:

Preservatives & transport media < 30 ml per primary receptacleDry ice

Packaging Consideration for Refrigerants

Types of refrigerants that may be used:Dry iceGel packs or phase change material (PCM) packsLiquid nitrogenWet ice

All refrigerants are to be placed outside the secondary packaging If wet ice is used, it must be placed in a leakproof container Dry ice must never be placed inside a sealed primary receptacle or sealed secondary packaging due to the risk of explosion. The packaging must permit the safe release of carbon dioxide gas.

If liquid nitrogen is used, the liquid nitrogen must be absorbed in porous material such that there is no free standing liquid nitrogen – “dry shipper.” Other special conditions apply when shipping with liquid nitrogen where there is free standing liquid nitrogen in the package.

No shipper’s declaration is required if dry ice is used to refrigerate category B substances.

Marking and Labeling

Shipping information requiredShipper informationConsignee InformationName and telephone number of responsible personAppropriate hazard labelsAppropriate handling labels

Hazard & Handling Labels

Category A

Biological Substance, Category B

Exempt Human Specimen

Dry ice

Infectious substances, affecting humansUN2814x ________________ mls.

Handling Labels

Orientation label for liquid dangerous goods

NEW (1/1/2013) OLD

Cargo aircraft only – Required when primary container of Category A is > 50 ml

Infectious substances, affecting humansUN2814 ( )

Shipper

Consignee

Responsible PersonName & telephone No.

UN

Example of a Category A Shipment Without Dry Ice

Infectious substances, affecting humansUN2814 ( )

mls

Shipper

Consignee

Responsible PersonName & telephone No.

UN

Example of a Category A Shipment With Dry Ice

Shipper

Consignee

Person ResponsibleTelephone No.

Example of a Category B Shipment Without Dry Ice

Shipper

Consignee

Person ResponsibleTelephone No.

Example of Category B Shipment With Dry Ice

Shipper

Consignee

Example of Exempt Patient Specimen Without Dry Ice

Overpacks

Each package placed into an overpack must be individually marked, labeled and addressed as if it were being shipped independently. Once packages are placed in the overpack, the marks, labels and other information has to be reproduced on the overpack.

Shipper

Consignee

Person ResponsibleTelephone No.

OVERPACK

Shipper’s Declaration

A document called the “Shipper’s Declaration for Dangerous Goods” must accompany every Category A package.

At least 3 copies must be must be preparedThe shipper keeps one copyThe carrier takes 2 and delivers one to the consignee

The shipper must keep the Shipper’s Declaration at least 2 years and include the date of acceptance by the initial carrier

A Shipper’s Declaration is not required for dry ice UN 1845 unless it is used as a refrigerant for dangerous goods which require a Shipper’s Declaration

FedEx Requirements for Shipper’s Declaration

FedEx requires all Shipper’s Declarations to be prepared using only the following methods

• FedEx approved vendor software application• Preapproved shipper proprietary software, or• FedEx Express Automated Shipping Solutions that

have dangerous goods error checks

620

954

3 Fibreboard boxes X 150 ml

Overpack used

620

954

Emergency Response for Infectious Substances

Any person responsible for carriage or receipt of packages containing infectious substances who becomes aware of damage to or leakage from such a package, must:

Avoid handling the package unless wearing appropriate PPE

Inform the appropriate local Public Health authority

Notify the shipper and the consignee and person responsible

In case of incidents involving Category A Infectious substances, call the 24-hour emergency response number indicated on the Shipper’s Declaration

Keep unauthorized personnel away

Do not allow clean-up of the spill or disposal of the material except under the supervision of an expert

Incident Reporting

Anyone who is in contact with a dangerous good when an incident occurs must report the incident to the appropriate authorities in accordance with the authority’s requirements. The following information needs to be relayed:

1. Name of reporter2. Name and address of person represented by reporter3. Phone number where reported can be contacted4. Date, time, location of incident5. The extent of injury, if any;6. Class or division, proper shipping name and quantity of hazardous materials involved, if such

information is available; and7. Type of incident and nature of hazardous material involvement and whether a continuing

danger to life exists at the scene.

Telephone reporting is required whenever:

8. A hazardous material has been directly involved in:The death of a personA person receiving an injury required hospitalizationThe general public is evacuated for one hour or more;A major transportation artery or facility was closed or shut down for one hour or more; orThe operational flight pattern or routine of an aircraft was altered;

9. Fire, breakage, spillage, or suspected contamination occurs involving an infectious substance other than a regulated medical waste;

10.A situation exists of such a nature that, in the judgment of the person in possession of the hazardous material, it should be reported to the CDC even though it does not meet the above criteria

Detailed Incident Reports

49CFR 171.16Each person in physical possession of a hazardous material at the time that any of the following incidents occurs during transportation (including loading, unloading, and temporary storage) must submit a Hazardous Materials Incident Report on DOT Form F 5800.1 within 30 days of discovery of the incident.

Examples of incidents requiring detailed incident reports• Any of the immediate reporting incidents• An unintentional release of hazardous material• An undeclared hazardous material is discovered

Online copies of the report are available at: https://hazmatonline.phmsa.dot.gov/incident/

An incident report must be retained for 2 years at the reporter’s place of business. The report must be updated within the first year if:

• A death occurs from injury caused by the hazardous material• There was a misidentification of the hazardous material• Additional damage, loss or related cost was incurred and not know at the time of the

incident

Security Awareness Training

Any company or institution who handles or transports dangerous goods should train any staff in contact with the dangerous goods concerning the potential security risks associated with the dangerous goods.

Dangerous goods should only be offered to operators that have been appropriately identified.

This training should include all aspects of security risks including:• Nature of the risks• Recognition of risks• Practices used to reduce risks• Procedures for a security breach

Security training must be in accordance with a national security plan or equivalent level of training Initial training for hazmat employees should occur within 90 days after employmentRecurrent training should be performed whenever there are changes to the security protocols or at least every 2 years and the employer must retain records of security training

The following are suggested areas for security awareness and best practices:

Restrict access to dangerous goods only to trained and qualified staffEscort visitors and other unauthorized personnelRecord entry into sensitive areas and the purpose of the visitRecord the identity of the escort and the times of entry and exitEnsure that doors and cabinets are locked when staff is not presentMonitor area remotely when staff is not in the areaProtect the chain of custody by using tamper-evident methods as it relates to your package Create an audit trail for specimensConsider using serialized packaging

Security Plan

Any shipper or operator who handles and/or transports Category A infectious substances should adopt a security plan to guard against potential incidents.

The security plan must include an assessment of transportation security risks for shipments of hazardous materials, including site-specific or location-specific risks associated with facilities where the hazardous materials are prepared for transportation, stored, or unloaded incidental to movement, and appropriate measures to address the assessed risks.

At a minimum, the security plan must include:Measures to confirm information provided by job applicants hired for positions that involve access to and handling of the hazardous materials covered by the plan

Measures to address the assessed security risks of shipments of dangerous goods covered by the security plan enroute from origin to destination, including shipments stored incidental to movement.

Identification by job title of the senior management official responsible for overall development and implementation of the security plan.

Security duties for each position or department that is responsible for implementing the plan or a portion of the plan and the process of notifying employees when specific elements of the security plan must be implemented.

A plan for training dangerous goods employees in accordance with the regulations.

Security Plan, Continued

The security plan must include:

Transportation security risk assessment

Be in writing

Be reviewed annually and revised/updated as necessary

Be available to employees who are responsible for implementing it and be consistent with personnel security clearance or background investigation restrictions and a demonstrated need to know

Notification of employees when the plan is updated or revised

Be available to appropriate officials when requested

References

IATA Dangerous “Goods Regulations, 52 Edition, Canada, 2011

SafTPak, Compliance Training Reference Manual for the Safe Transport of Division 6.2 Infectious Substances, Biological Specimens, Dry Ice and Related materials, Edmonton, Alberta, 2011

Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Rules and Regulations, 49CFR 172.101