I:\MEPC\54\2-12.doc
Forreasonsofeconomy,thisdocumentisprintedinalimitednumber.Delegatesare
kindly asked to bring their copies to meetings and not to request
additional copies. INTERNATIONAL MARITIME ORGANIZATION IMO E MARINE
ENVIRONMENT PROTECTION COMMITTEE 54th sessionAgenda item 2 MEPC
54/2/1228 February 2006 Original:ENGLISH HARMFUL AQUATIC ORGANISMS
IN BALLAST WATER Report of the first meeting of the GESAMP-BWWG
Note by the Secretariat SUMMARY Executive summary:
Thisdocumentcontainsthereportofthefirstmeetingofthe
GESAMPBallastWaterWorkingGroup(GESAMP-BWWG)
includingtheevaluationoftheproposalsforapprovalofActive Substances
submitted by Germany and the Republic of Korea Action to be taken:
Paragraph 4 Related document: MEPC 53/24
1MEPC53instructedtheSecretariattoexplorethepossibilityofestablishingatechnical
groupundertheauspicesofGESAMPtoreviewtheproposalsforapprovalofBallastWater
ManagementsystemsthatmakeuseofActiveSubstances.Throughsustainedeffortsandunder
significant time pressure, a GESAMP-Ballast Water Working Group was
established and held its
firstmeetingfrom23to27January2006toevaluatetwosubmissionsbyGermanyandthe
Republic of Korea.
2AlthoughtheCommitteedidnotconsiderthenon-confidentialdescriptionofthe
technology by the Republic of Korea, as it was the case for
Germany, the proposal for approval
bytheRepublicofKoreawasacceptedforevaluationbytheGESAMP-BWWGwiththe
understanding that if submitted to MEPC 54 by the 13-week deadline
will still leave four weeks for delegations to submit relevant
information in time for the evaluation. 3It should be noted that,
according to the estimates done by the GESAMP-BWWG, at least
20weeksareneededfortheevaluation,productionandsubmissionofthereportinaccordance
withtheCommitteesGuidelinesforsubmissionofdocuments,withanadditional8weeksfor
thepreparationofthemeeting.Membersare,therefore,kindlyrequestedtosubmitthe
non-confidentialdescriptionoftheirmethodologiestothesessionofMEPCbeforetheone
expectedtobedecidedonBasicApproval,orattheearliestopportunityafter,butnotafterthe
28 week deadline before the Basic Approval session of the Committee
(see table in annex 2). MEPC 54/2/12- 2 - I:\MEPC\54\2-12.doc
Action requested of the Committee
4TheCommitteeisinvitedtotakeintoaccountthereportofGESAMP-BWWGwhen
decidingontheBasicApprovalforthetwoproposalsandtoconsiderthetimelinecontainedin
paragraph 3 for future submissions. *** MEPC 54/2/12
I:\MEPC\54\2-12.doc ANNEX 1 GESAMP-BALLAST WATER WORKING GROUP 1st
meeting GESAMP-BWWG 1/920 February 2006 Original:ENGLISH REPORT OF
THE FIRST MEETING OF THE GESAMP-BALLAST WATER WORKING GROUP Table
of Contents Section Paragraph Nos. Page Nos.
1INTRODUCTION............................... 1.1 1.43 2ISSUES OF
CONFIDENTIALITY..... 2.1 2.33 - 4 3TERMS OF REFERENCE.. 3.1 3.44 -
5 4DEVELOPMENTOFADRAFTMETHODOLOGY FORINFORMATIONGATHERINGANDTHE
CONDUCT OF WORK OF GESAMP-BWWG.. 4.1 4-16 5 7
5REVIEWOFPROPOSALSFORAPPROVALOF ACTIVESUBSTANCESSUBMITTEDBY GERMANY
AND THE REPUBLIC OF KOREA. 5.1 5.10 7 - 10
6MATTERSARISINGFROMRECENTIMO ACTIVITIES.. 6 10
7CONSIDERATIONOFQUERIESFROMMEMBERS AND INDUSTRY 7.1 7.2 10 - 11
8FUTUREWORKPROGRAMMEANDTENTATIVE DATE FOR THE NEXT MEETING.. 8.1
8.4 11 - 12 9CONSIDERATIONANDADOPTIONOFTHE REPORT.. 9.1 9.4 12 MEPC
54/2/12 ANNEX 1 Page 2 GESAMP-BWWG 1/9- 2 - I:\MEPC\54\2-12.doc
ANNEXES ANNEX 1LISTOFMEMBERSATTENDINGTHEFIRSTSESSIONOFTHEGESAMP BW
WORKING GROUP ANNEX 2AGENDAFORTHEFIRSTSESSIONOFTHEBALLASTWATER
WORKING GROUP OF GESAMP ANNEX
3TERMSOFREFERENCEFORTHEGESAMP-BALLASTWATER WORKING GROUP ANNEX
4DRAFTMETHODOLOGYFORINFORMATIONGATHERINGANDTHE CONDUCT OF WORK OF
GESAMP-BWWG ANNEX 5REVIEWOFPROPOSALSFORAPPROVALOFACTIVESUBSTANCES
SUBMITTED BY GERMANY (PERACLEAN OCEAN) ANNEX
6REVIEWOFPROPOSALSFORAPPROVALOFACTIVESUBSTANCES SUBMITTED BY
REPUBLIC OF KOREA (ELECTROCLEAN) MEPC 54/2/12 ANNEX 1 Page 3 - 3 -
GESAMP-BWWG 1/9 I:\MEPC\54\2-12.doc 1INTRODUCTION
GESAMPBallastWaterWorkingGroup(GESAMP-BWWG)washeldatIMO
Headquarters,
London,from23to27January2006,underthechairmanshipofMr. Finn
Pedersen.Alistof
membersattendingthisfirstmeetingisshowninannex1,andtheagenda,asapprovedbythe
Group, is set out in annex 2.
1.2Mr.RenCoenen,IMOTechnicalSecretaryofGESAMP,drewattentiontothehistory,
developmentsandmeritsofGESAMPastheadvisoryscientificandmulti-disciplinarybody
withintheUnitedNationssystem.Mr.DanduPughiuc,HeadoftheIMOsOfficeforBallast
WaterManagement,andtheSecretaryforthismeeting,briefedtheGrouponresolution
MEPC.126(53),whichhadbeenadoptedinsummer2005,concerningtheProcedurefor
ApprovalofBallastWaterManagementSystemsthatmakeuseofActiveSubstances(G9).
Essentially, the approval procedure consists of two steps:
!Basicapproval:AnAdministrationofaMemberoftheOrganizationmayproposean
approval of a Ballast Water Management System based on a
satisfactory submission of a manufacturer developed in accordance
with the (G9) and the further details of criteria as
beingdevelopedbytheGESAMP-BWWG.Inprinciple,thebasicapprovalallowsthe
furtherdevelopmentoftheBallastWaterManagementSystemthroughfull-scaleon-board
ship development and testing.
!Finalapproval:Whenfull-scaleon-boardshipdevelopmentandtestinghasbeen
satisfactorily completed, the Member of the Organization may apply
for a final approval of a Ballast Water Management System in
accordance with Regulation D-3.2.
TheOrganizationwillrecordtheBasicandFinalApprovalofActiveSubstancesand
PreparationsandBallastWaterManagementsystemsthatmakeuseofActiveSubstancesand
circulate the list once a year including the following information:
!NameofBallastWaterManagementsystemthatmakeuseofActiveSubstancesand
Preparations; !Date of approval; !Name of manufacturer; and !Any
other specifications, if necessary. When a final approval has been
given and the respective Active Substance included in the IMO
list,therespectiveAdministrationmayissuetheTypeApprovalCertificateinaccordancewith
the guidelines developed by the Organization.
1.3GESAMP-BWWGwastaskedtodevelopmethodologiesandinformationrequirements
for conducting its work and to review the proposals submitted by
Governments of IMO Members for the approval of Active Substances in
accordance with the Terms of Reference developed by the Committee
and accepted by the GESAMP Inter-Secretariat. 1.4The Group
considered its terms of reference and included some small
amendments.The terms of reference, as agreed by the Group, are
shown at annex 3. 2ISSUES OF CONFIDENTIALITY
2.1ApplicationsforBasicApprovalregardingtheuseofActiveSubstanceshadbeen
submittedbytwomembersoftheOrganization,namely,GermanyandtheRepublicofKorea.MEPC
54/2/12 ANNEX 1 Page 4 GESAMP-BWWG 1/9- 4 - I:\MEPC\54\2-12.doc The
Secretariat informed the Group that part of the information
packages submitted by Maritime Administrations of IMO Members was
non-confidential and was considered for submission to MEPC 54.The
Secretariat further emphasized that members of this Group were
obliged to keep relevant data of the submission confidential to
protect the commercial interests of the producing companies.The
Group suggested that, after completion of the approval procedure,
the following data and information should no longer be regarded as
confidential: !The name and address of the applicant
!ThenamesandaddressesofthemanufacturersoftheActiveSubstanceand/orthe
preparation (if different) !The names and content of the Active
Substance(s) in the preparations and the name of the preparation
!Thenamesofothersubstanceswhichareregardedasdangerousaccordingtothe
UN GHS or relevant IMO regulations and contribute to the hazard
documentation of the preparation !Physical and chemical data
concerning the Active Substance and preparation !A summary of the
results of the tests required pursuant to Section 4.2 of the
Procedure to establish the effects of the substance(s) or
preparation(s) on humans and the environment !Recommended methods
and precautions against dangers resulting from handling, storage,
transport and fire !Any means of rendering the active substance or
preparation harmless !Safety data sheets !Methods of chemical
analysis !Methods of disposal of the product and of its packaging
!Procedures to be followed and measures to be taken in the case of
spillage or leakage !First aid and medical advice to be given in
the case of injury to persons.
2.2Inevaluatinganapplication,theGroupreservesitsrighttobaseitsevaluationonany
availableinformationandtousethisinformationforjustifyingitsconclusionsand
recommendationsinitsevaluationreportsirrespectiveofconfidentialityissues.However,the
GroupwouldrecommendthattheOrganizationpriortosubmissionoftheGroupsevaluation
reporttotheMEPCconsultswiththeMemberoftheOrganizationhavingproposedtheBallast
WaterManagementSystem.Incaseswheretheevaluationreportcontainsconfidential
information, the Organization should decide on the future
procedures.
2.3IncasetherewererequeststoIMOformoreinformationregardinganapplication,the
Organizationwouldprovidethenameandaddressoftheresponsiblenationaladministration
whichoriginallysubmittedtheapplicationfortheBasicApproval.Itcouldthenrespond,asit
feels appropriate. 3TERMS OF REFERENCE
3.1AnexpandedversionoftheTermsofReferencehadbeenproposedtothe
GESAMP-Ballast Water Working Group.The Group, at its first session,
reviewed the expanded
formandintroducedsomesmallamendments.Theexpandedversion,asadopted,isshownin
annex 3.GESAMP is invited to confirm the Terms of Reference as
annexed to this report. MEPC 54/2/12 ANNEX 1 Page 5 - 5 -
GESAMP-BWWG 1/9 I:\MEPC\54\2-12.doc
3.2WhenconsideringitsTermsofReference,theGroupnotedthedisproportionality
betweentheresourcesavailablefortheapprovalsystemdevelopedforBallastWater
ManagementSystemsthatmakeuseofActiveSubstancesandthefarmorecomprehensive
internationalauthorizationsystemsforbiocidesandpesticides.Internationalauthorization
systems for biocides and pesticides make use of detailed guidance
documents developed through
yearsofexperience.Theevaluationofriskstohumanhealthandtheenvironmentisaprocess
that requires substantial resources from the authorizing
administrations. 3.3Consequently,theGroupconsidereditoverly
optimistictoexpectthatawellelaborated draft methodology for
information gathering and conduct of work of the GESAMP-Ballast
Water Working Group could be developed during the few meeting days
available, as well as thorough evaluations of proposals for
approval of two applications regarding Active Substances.
3.4TheGroupalsosuggestedthatMEPCmaywishtolookfurtherintotheProcedurefor
approvaloftheuseofBallastWaterManagementsystemsthatmakeuseofActiveSubstances,
withaviewtoaligningtheevaluationproceduresandthelevelsofambitionwithsimilar
internationalsystemsforauthorizationoftheuseoftoxicchemicalsas,e.g.,biocidesand
pesticides. 4DEVELOPMENTOFADRAFTMETHODOLOGYFORINFORMATION GATHERING
AND THE CONDUCT OF WORK OF GESAMP-BWWG
4.1TheGroupnotedthattheMEPCProcedureforapprovalofballastwatermanagement
systems that make use of active substances (G9) would form the
basis for its work.In addition,
thesubmissionoftheEuropeanCommissionMEPC54/2/1toMEPC54wasseenasuseful
guidanceindefiningtheapproachesforevaluationofproposalsforapprovalofActive
Substances. 4.2Prior to the meeting, the Secretariat had developed
and circulated a first draft of a Draft
MethodologyforInformationGatheringinAccordancewiththeProcedureforBallastWater
ManagementSystemsthatmakeuseofActiveSubstances(G9),whichwasbasedonthetwo
aforementioned documents.The Group appreciated the work done and
considered the document as a good starting point for the further
development of the methodology requested.
4.3However,indiscussingthepossibleapproaches,theGroupalsonotedanumberof
apparent inconsistencies in Procedure (G9).
4.4Someofthedatarequiredforpreparation(mixturesofsubstances)accordingto(G9)
wereseenasinappropriate.Theseincludepartitioncoefficients,biodegradationand
bioaccumulation data, as it is the individual substances in the
preparation that may, or may not, degrade or accumulate rather than
the preparation itself.
4.5TheGroupconsideredtheappropriatenessofconductinglong-term(chronic)toxicity
testingwithpreparationsandtreatedballastwaterandconcludedthatthiswouldhavetobe
considered on a case-by-case basis. In general, when a complex
mixture is released to the aquatic
environment,theindividualsubstancesinthemixturewillmostlikelybehavedifferently
(i.e.
somesubstancesmaydegrade,somemaysorbtoparticulatematter,somemayevaporate,
etc.) and after a short time, the organisms in the environment will
not be exposed to the original mixture any more. Therefore, only in
cases where the use results in very frequent releases to the
sameenvironmentfromdifferentshipsandwhereorganismsintheenvironmentthereforemay
befrequentlyexposedtotreatedballastwater,anassessmentbasedonlong-termtestingofthe
preparationand/orthetreatedballastwatermaybeappropriate.Incaseswhereonlyinfrequent
MEPC 54/2/12 ANNEX 1 Page 6 GESAMP-BWWG 1/9- 6 -
I:\MEPC\54\2-12.doc releases take place, an assessment based on the
long-term testing of the individual substances in the preparation
would be more useful. 4.6The Group discussed various approaches for
structuring the draft methodology. Although a structure reflecting
the sequential order of assessment of the hazards and risks to the
ship, the
crewandtheaquaticenvironmentmighthavebeenpreferred,theGroupconsideredthatthe
structure of Procedure (G9) should be followed. This was further
emphasized by the fact that the Group was informed that several
applications were under development in various Member States (cf.
agenda item 8). 4.7It is the intention that the draft methodology
should serve two purposes. On the one hand, it should be guidance
to applicants on what to consider in their development of a dossier
for the Ballast Water Management system using Active Substances. On
the other hand, it should also be
guidancetotheGroupinitsevaluationandreviewofapplications.TheGroupfurthernoticed
that,forthemoment,theguidanceismainlyintendedtorelatetodossierssubmittedforbasic
approval.Furthermore, the Group considered that a submission for
final approval could probably not be standardized, as a basic
approval on a case-by-case basis might include preconditions that
needtobeaddressedduringthefull-scaledevelopmentandtestingandeventuallyreportedin
connection with the application for the final approval. 4.8The
draft methodology developed by the Group is attached as annex
4.MEPC is invited to comment on the draft and review its contents,
as appropriate.
4.9TheGrouprecommendsthatfutureapplicationsforbasicapprovalofaBallastWater
ManagementSystemshouldbepreparedinaccordancewiththemethodologyproposedbythe
Group (cf. Annex IV) in order to ensure the completeness of the
application and to facilitate the Groups work.
4.10Inaddition,forfutureapplications,theapplicantisrequestedtocompleteakeydata
summary table to enable the Group to have an overview of the
properties of the product. A blank
keydatasummarytablehasbeendevelopedbytheGroupforthispurposeandisincludedin
annex 4.
4.11Theassessmentofthepotentialriskstotheenvironmentbasicallyrequiresthata
PredictedEnvironmentalConcentration(PEC)canbeestablishedandcomparedtoaPredicted
No-Effect-Concentration(PNEC).WhenthePECdoesnotexceedthePNEC,itisconsidered
likely that no unacceptable toxic effects will occur.
4.12Indiscussingpossiblescenariosfordischargeoftreatedballastwatertotheaquatic
environment,theGrouprealisedthatinformationwasnotavailableonbasicassumptions
regarding the likely volume of treated ballast water, the duration
and frequency of discharge, and
thedimensionsofthereceivingaquaticenvironmentincludingarea,watervolume,waterflow,
etc. Therefore, the Group considered the need to develop a generic
Emission Scenario Document
(ESD)onballastwaterinawaysimilartotheESDs,developedbytheOECD,onantifouling
paints as well as multiple other ESDs for various product types
developed by the OECD, EU and
USA.Adevelopmentofthemostlikelyscenario,bothshort-andlong-term,fordischargeof
treatedballastwaterincludingdocumentationofappropriatemodelsisneeded.Consideringthe
effortsneededfordevelopingsuchESDs,theGroupdecidedthatdevelopmentofanESDfor
ballastwaterwouldnotbepossiblewithintheverylimitedtimeavailable.InsteadtheGroup
recommendsMEPCtoinitiatesuchadevelopment,whichpertainstoallBallastWater
Management systems and is seen as crucial for a thorough evaluation
of the environmental risks of discharge of ballast water. MEPC
54/2/12 ANNEX 1 Page 7 - 7 - GESAMP-BWWG 1/9 I:\MEPC\54\2-12.doc
4.13TheGroupalsonotesthatseveralassessmentfactors(thevalueusedtodeterminethe
PNEC from the no-effect concentration determined experimentally)
are currently in international use. The Group intends to discuss
assessment factors at the next meeting. 4.14Section 2.3 of the
Terms of Reference for the Group gives a mandate to assess the risk
to
crewsafety.TheGroupthereforethinksthattheapplicantshouldberequiredtoprovidea
preliminaryassessmentofriskstoship,crewandtheenvironment,whichisnotarequirement
stated in the Procedure (G9).
4.15TheGroupconsideredthattoxicityoftreatedballastwateratdischargeneedsspecial
attention. Usually, 100% ballast water will contain active
ingredients above the LC50 of the most
sensitivespecies.Theriskassessmentrequirestheuseofadilutionfactor(theamountof
short-termdilutionthatoccursastheballastwaterenterstheaquaticenvironment)inorderto
conclude that products may be used safely. The Group was unsure as
to whether the intention of
MEPCwastopreventtheuseofproductsthatrequiredtheuseofadilutionfactortoreacha
favourable conclusion in the risk assessment. The Group requested
clarification of this issue from MEPC.
4.16TheGrouptooknoteoftheintentiontolimittheeffectstotheenvironmentasmuchas
possible,basedontherequirementofthePEC/PNECratio3 -predict
discharge concentrations at selected time intervals - effects of
Active Substances etc. on primary producers (algae) consumers
(crustaceans) and predators (fish) as well as secondary poisoning
of mammalian and avian top-predators
-incaseoflackofbioconcentrationpotential(BCF 3, testing should
include:
!Onebioconcentrationfactor(BCF)determinedinabioconcentrationstudy(attwodosing
levels)withfish(e.g.OECD305)orbivalves.TheBCFshouldbebasedon
uptake/eliminationkinetics(k1/k2).Thehalf-lifeforeliminationshouldbereported.Fat
content in marine fish typically ranges between 0.5 and 15% of the
whole body weight. BCF should be normalized to 6% fat.
!Thebiomagnificationandpersistenceinthefoodwebshouldbediscussedbasedonthe
results from aquatic toxicity testing, mammalian toxicity
evaluation and bioaccumulation and biodegradation data.
!Therearenodatarequirementsonbio-availabilitysinceitisconsideredthatthebio-availability
in the toxicity test systems is equivalent to the conditions under
assessment. If the bioavailability of the Active Substance or
relevant chemical in the discharge or the receiving environment is
to be assessed, consequently the bio-availability in the toxicity
testing is to be reconsidered. Active substance Information on
other components Relevant chemicals 3.2.6Food web/population
effects The biomagnification and persistence in the food web should
be discussed based on the results from aquatic toxicity testing,
mammalian toxicity evaluation and bioaccumulation and
biodegradation MEPC 54/2/12 ANNEX 1 Page 29 - 29 - GESAMP-BWWG 1/9
I:\MEPC\54\2-12.doc data. An assessment of secondary poisoning is
redundant if for the substance of concern absence
ofbioaccumulationpotentialcanbedemonstrated(BCF500L/kg,usingfreshormarinewater
MEPC 54/2/12 ANNEX 1 Page 32 GESAMP-BWWG 1/9- 32 -
I:\MEPC\54\2-12.doc depending on kind of aquatic ecosystem where
discharge is intended. At least one system
withhighorganicmatter/nutrientcontentandonewithloworganicmatter/nutrient
content should be tested (see above)
!Astudyonaerobictransformationoflowconcentrationsoforganiccontaminants
according to OECD guideline 309 (Aerobic Mineralization in Surface
Water - Simulation Biodegradation Test) or equivalent guidelines,
using fresh or marine water depending on the kind of aquatic
ecosystem where discharge is intended !Where relevant, a study on
photo-transformation in water [e.g. US EPA OPPTS 835.2210 (1998)
and/or OECD Guidance document on phototransformation in water
(1997)] Active substance Information on other components Relevant
chemicals 3.4.2Bioaccumulation, partition coefficient,
octanol/water partition coefficient Testing should include: !Data
on bioconcentration and biomagnification, which have already been
detailed earlier in this document
AstudyintothelogPowaccordingtoOECDguideline107[PartitionCoefficient
(n-octanol/water):ShakeFlaskMethod]orequivalenttestguidelines.Forveryhydrophobic
compounds a slow stirring method is required: !The partition
coefficient between solids and liquids should be determined [e.g.
according
toEUTechnicalGuidanceDocumentonRiskAssessment(2003)foratleastthree
inocula, including freshwater sediment, marine sediment, and
particulate matter (sludge)].
Ifnomeasureddataareavailableforaspecificadsorbingmaterial,itisassumedthatall
adsorption can be related to the organic matter of the medium, viz.
standardization to Koc. This is only valid for non-ionic
substances. For ionic substances the Kp values and the test
characteristics (%clay, CEC, %o.c., pH) should be reported. Active
substance Partition coefficient n-octanol/water including effect of
pH (5 to 9) and temperatureInformation on other components Relevant
chemicals 3.4.3Persistence and identification of the main
metabolites in the relevant media (ballast water, marine and fresh
waters)
Therouteofdegradationinthetestsrequiredundersection3.4.1ofthisdocumentistobe
characterized, based on a mass balance including mineralization and
formation of bound residue. Metabolites formed in relative amounts
of >5% of the initial dose at any point in time are to be
identified. For relevant chemicals the application shall contain
all data as specified before, since they are subject to the
decision making criteria. Active substance Information on other
components Relevant chemicals MEPC 54/2/12 ANNEX 1 Page 33 - 33 -
GESAMP-BWWG 1/9 I:\MEPC\54\2-12.doc 3.4.4Reaction with organic
matter The reaction of active substances that are radical producing
agents, with organic matter shall be addressed qualitatively as to
identify products of concern to the environment. Radical producing
chemicalsarecapableofforminghalogenated(chlorinated,brominated)hydrocarbonswhich
may be of concern to environmental or human health, in the presence
of organic matter. For these
substances,thefreelyandotherwisereasonablyavailableinformationshouldbepresentedand
discussed in relation to the proposed manner of application, since
they are subject to the decision making criteria. Active substance
Information on other components Relevant chemicals 3.4.5Potential
physical effects on wildlife and benthic habitats
Datarequirementsconsistofphysical-chemicalpropertiesalsorequiredlater.Furtherguidance
can be found in the MEPC approved hazard evaluation procedure
published as GESAMP Reports and Studies No. 64. Preparation Active
substance Information on other components Relevant chemicals
Ballast water 3.4.6Potential residues in seafood As appropriate,
data shall be submitted to assess the risk that residues of the
active substance end
upinseafood,thepossibleimpactonconsumersafetyandthelevelofresiduesthatmaybe
tolerated in seafood. Any available monitoring data on residues of
the substance in seafood shall be submitted. Preparation Active
substance Information on other components Relevant chemicals
3.4.7Any known interactive effects Any knowledge (or absence of
this knowledge) on interactive effects of the Relevant Chemicals
with the ballast water, with other preparations to be used in
ballast water, with other physical or
chemicalmanagementoftheballastwater,orwiththereceivingenvironment,shouldbe
reported. Active substance Information on other components Relevant
chemicals
3.5Physicalandchemicalpropertiesfortheactivesubstancesandpreparationsand
treated ballast water, if applicable (G9: 4.2.1.5)
DataarenecessaryfortheActiveSubstances,theirpreparations,thetreatedballastwateron
boardandtheRelevantChemicalsdischargedtoallowfortheidentificationofhazardsforthe
crew, the ship and the environment. 3.5.1Melting point Preparation
Active substance Information on other components MEPC 54/2/12 ANNEX
1 Page 34 GESAMP-BWWG 1/9- 34 - I:\MEPC\54\2-12.doc 3.5.2Boiling
point Preparation Active substance Information on other components
3.5.3Flammability (flash point) Preparation Active substance
Information on other components 3.5.4Density (relative density)
Preparation Active substance Ballast water 3.5.5Vapour pressure,
vapour density Preparation Active substance Information on other
components 3.5.6Water solubility/dissociation constant Active
substance Water solubility and effect of pH (5 to 9) and
temperature on solubility where relevantDissociation constant
(pKa)Information on other components Relevant chemicals Water
solubility and dissociation constant 3.5.7Oxidation/reduction
potential Preparation Active substance Ballast water also redox for
ballast water used in type approval testing 3.5.8Corrosivity to the
materials or equipment of normal ship construction Preparation
Active substance Information on other components Relevant chemicals
Ballast water 3.5.9Autoignition temperature Preparation Active
substance 3.5.10Explosive properties Active substance
3.5.11Oxidising properties Preparation Active substance MEPC
54/2/12 ANNEX 1 Page 35 - 35 - GESAMP-BWWG 1/9 I:\MEPC\54\2-12.doc
3.5.12Surface tension Preparation Active substance 3.5.13Viscosity
Preparation Active substance 3.5.14Thermal stability and identity
of relevant breakdown products Active substance 3.5.15Reactivity
towards container material Preparation Active substance 3.5.16pH
Preparation Ballast water used in type approval testing
3.5.17Salinity Ballast water used in type approval testing
3.5.18TOC, DOC, % particulate matter Ballast water used in type
approval testing 3.5.19Other known relevant physical or chemical
hazards Preparation Active substance Information on other
components Relevant chemicals Ballast water 3.6Analytical methods
at environmentally relevant concentrations (G9: 4.2.1.5)
3.6.1Analytical methods at environmentally relevant concentrations
Preparation Active substance
AnalyticalmethodsforthedetectionofActiveSubstancesindischargewaterandsediment,at
environmentallyrelevantconcentrations,arerequired.Themethodsincludingsamplingshould
be proven to be workable. Relevant chemicals Analytical methods for
the detection of Relevant Chemicals in discharge water and
sediment, at
environmentallyrelevantconcentrations,arerequired.Themethodsincludingsamplingshould
be proven to be workable. 4Use of the Preparation 4.1The manner of
application
TheproposalshouldincludethemannerofapplicationofthepreparationfortheBallastWater
Management (BWM), including required dosage and retention time (G9:
4.2.6). In relation to point 7 of the Procedure, the dossier should
contain the necessary data addressing the following items: MEPC
54/2/12 ANNEX 1 Page 36 GESAMP-BWWG 1/9- 36 - I:\MEPC\54\2-12.doc
!Thetechnicalmanualorinstructionsbythemanufacturer,includingtheproduct
specification,processdescription,operationalinstructions,detailsofthemajor
componentsandmaterialsused,technicalinstallationspecifications,systemlimitations,
and routine maintenance should be provided (BWWG), including
quantity to be added to ballast water and maximum concentration of
the active substance therein. !Recommended methods and precautions
concerning handling, use, storage, and
transport!Procedurestobefollowedincaseoffire,andnatureofreactionproducts,combustion
gases etc. !Emergency measures in case of an accident !Possibility
of destruction or decontamination following release in the marine
environment !Procedures of waste management of the active substance
!Possibility of reuse or recycling !Possibility of neutralization
!Conditions for controlled discharge !Amount of substance on board
ship
Riskmanagement(e.g.forneutralizationoftheActiveSubstanceincaseofemergencyorif
PEC/PNECatdischarge>1)shouldbedescribed.Thesemanagementmeasuresareanintegral
part of the Ballast Water Management System and should be evaluated
in the assessment of the ballast water
discharge.Theriskmanagementmeasuresproposedshouldbeevaluatedinrespecttothehazardstoship,
personnel and the environment. 5Material Safety Data Sheets (G9:
4.2.7)
Withrespecttoclassificationofhazards,adetailedtechnicalguidancedocumenthasbeen
prepared for the United Nations Globally Harmonized System of
Classification and Labelling of Chemicals (GHS) to aid in
interpreting data for classifying substances as dangerous.
Reference is
alsomadetotheMEPCapprovedhazardevaluationprocedurepublishedasGESAMPReports
andStudiesNo.64underthetitleTheRevisedGESAMPHazardEvaluationProcedurefor
ChemicalSubstancesCarriedbyShips,whichreflectstheGHSformarineenvironmental
protectionaspects.Theapplicantisreferredtothisdocumentforamoredetailedguidanceon
hazard
identification.Forthepreparation,eachactivesubstance,eachhazardouscomponent,andeachRelevant
Chemical, the classification under the GHS, and a Material Safety
Data Sheet (G9: 6.3.2) should be provided by the applicant. Key
data for these should be summarised in the Key Data Summary Table.
6Risk Characterisation 6.1Screening for persistence,
bioaccumulation and toxicity (G9: 5.1) 6.1.1Persistence (G9:
5.1.1.1)
Persistenceispreferablyassessedinsimulationtestsystemstodeterminethehalf-lifeunder
relevant conditions. Biodegradation screening tests may be used to
show that the substances are
readilybiodegradable.Thedeterminationofthehalf-lifeshouldincludeassessmentofrelevant
chemicals. MEPC 54/2/12 ANNEX 1 Page 37 - 37 - GESAMP-BWWG 1/9
I:\MEPC\54\2-12.doc For persistence and degradation data
requirements, see 2.4.1 and 2.4.3 of this document.
6.1.2Bioaccumulation (G9: 5.1.1.2)
Theassessmentofbioaccumulationpotentialshouldusemeasuredbioconcentrationfactorsin
marine(orfreshwaterorganisms).Wheretestsarenotapplicable,orlogPow
60 days in marine water, or > 40 days in freshwater,a or >
180 days in marine sediment, or > 120 days in freshwater
sedimenta BioaccumulationIfLogPoctanol/water!3,thenexperimental BCF
required. BCF > 2,000 ToxicityChronic NOEC < 0.01 mg/l a For
the purpose of marine environmental risk assessment half-life data
in freshwater and freshwater sediment can be overruled by data
obtained under marine conditions.
ActiveSubstancesorPreparationsidentifiedasPBTsubstancesaccordingtoparagraph
6.4.1of the Procedure shall not be approved. 6.2Evaluation of the
treated ballast water (G9: 5.2) The advantage of toxicity testing
on the ballast water discharge is that it integrates and addresses
the potential by-products of the formulation and interactions with
the system. 6.2.1Basic approval Testing should be performed in
laboratory (G9: 5.2.1) 6.2.2Final approval Discharge test with
whole system (G9: 5.2.2).
InaccordancewithRegulationD-3.2,aBallastWaterManagementsystemusinganActive
SubstanceorPreparationtocomplywiththeConvention(whichreceivedbasicapproval)must
beapprovedbytheOrganization.Forthispurpose,theMemberoftheOrganizationsubmitting
anapplicationshouldconducttheTypeApprovaltestsinaccordancewithGuidelinesfor
ApprovalofBallastWaterManagementSystems.Theresultsshouldbeconveyedtothe
MEPC 54/2/12 ANNEX 1 Page 38 GESAMP-BWWG 1/9- 38 -
I:\MEPC\54\2-12.doc
Organizationforconfirmationthattheresidualtoxicityofthedischargeconformstothe
evaluationundertakenforBasicApproval.ThiswouldresultinFinalApprovaloftheBallast
WaterManagementsysteminaccordancewithRegulationD-3.2.ActiveSubstancesor
Preparations that have received Basic Approval by the Organization
may be used for evaluation
ofBallastWaterManagementsystemsusingActiveSubstancesorPreparationsforFinal
Approval (G9: 8.2.1). 6.2.3Determination of holding time
Thetestdatashouldbeusedtodeterminethenoadverse-effectconcentrationupondischarge.
The half-life, decay and dosage rates, system parameters and
toxicity should be used to determine
theamountoftimeneededtoholdthetreatedballastwaterbeforedischarge(5.2.7).An
indicationoftheuncertaintyoftheholdingtimeshouldbegiven,takingintoaccountvariables
(e.g. temperature, pH, salinity and sediment loading). 6.3Risk
characterisation and analysis 6.3.1Reaction with organic matter
(see G9: 4.2.1.3; this report 2.4.4) The reaction with organic
matter of active substances and preparations that produce free
radicals should be addressed qualitatively, so as to identify
products of concern to the environment. 6.3.2Characterisation of
persistence (G9: 5.3.5)
TherouteofabioticandbioticdegradationoftheActiveSubstancesandPreparationsunder
aerobicandanaerobicconditions(see2.4.1above)shouldbeassessed,resultinginthe
characterizationofthepersistenceoftheActiveSubstances,PreparationsandRelevant
Chemicals in terms of degradation rates under specified conditions
(e.g. pH, redox, temperature). 6.3.3Prediction of discharge
concentrations
BasedontheinformationonfateandbehaviourofActiveSubstancesandPreparations,the
discharge concentrations at selected time intervals should be
predicted (G9: 5.3.8). 6.3.4Assessment of potential for
bioaccumulation For Active Substances and Preparations, the
potential for bioaccumulation should be assessed in
marineorfreshwaterorganisms(fishorbivalves)ifthelogarithmoctanol/waterpartition
coefficient (log Pow) is >3 (G9: 5.3.7). 6.3.5Effects assessment
The effect assessment of the Active Substances, Preparations and
Relevant Chemicals is initially based on a dataset of acute and/or
chronic ecotoxicity data for aquatic organisms, being primary
producers(algaeorseagrasses),consumers(crustaceans),predators(fish),andshouldinclude
secondary poisoning to mammalian and avian top-predators, as well
as data for sediment species (G9: 5.3.9). In the effect assessment
only toxicity studies reporting on dietary and oral exposure are
relevant, as the pathway for secondary poisoning refers exclusively
to the uptake of chemicals through the
foodchain.Itisnecessarytoextrapolatethresholdlevelsformarinespeciesfromterrestrial
speciesassumingthereareinterspeciescorrelationsbetweenlaboratorybirdspeciesandmarine
predatorybirdspeciesandbetweenlaboratorymammals(e.g.rats)andtheconsiderablylarger
marine predatory mammals.
Anassessmentofsecondarypoisoningisredundantifthesubstanceofconcerndemonstratesa
lackofbioaccumulationpotential(e.g.,BCF