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