Home

活性物質を利用するバラスト水管理 システム承認の手順（G9

Contents

1. gt Ei r3 lt ma gaa as lt Aa Oo gt gt G 53 pag a ca c Oo oo OO OOR m tn oo gt 2 BB EO EE ca oo BSS 5E a8 gom E oo oR BS LE C3 oO o Oo oO IE 3 o0 eS r3 a9 mie Om B omg E OES H EL BEES ES Soa El ndm cH nma m a og On El m E ca 200 Co 3 r3 Oo a 3 a Haas a aa r3 ooo 3 oo 5 Aag D ono ca nm oo ca m o0 E oO oo og oo oOo 3 o o oo oOo gt H 22 sis HE oo Bo aa ca H Oo mg Cr a oo oO aS _ oo 4 oO r3 n bose ogp200 sa E3 r3 LE Bong ad EE Ed r3 Boog 2800 99 oo Ooo 3 E oo200 o 53 H r3 oo oo 0o02
2. e OOODDODOODOODOODOODODODADOODOODOODOODOODODO OOODDODOODOODDODDODODODOADODODODOADOADOADOODY AA AAAABAABRAABAAAAAAABARERAAAAAAdALDADAAE DODE upggaumdgtzutdtttttl GESAMP 70000000 GESAMP Reports and Studies I UI DU D e 00000000000 OOODDODOODOODDODDODODODOADODODODODODOADOODOODO OOODDODOODOODDODDODODODOADODODODOODOADOODOODO e ODOODODOODODOODODDO 620 2D o 0000000 UUDIUDUUDUDUUDUUDUUDUDUUDUUDUUDUUDUUDDUUDDUD D uuu 3 160 0000000 GOOD 4210 4000000000000000 OOODOOOODODDODOODODOADODODODOODODOOODODOODDODO 42 4 2 Data set for Active Substances and Preparations 42 4 2 1 A proposal for approval should include information onthe 42 1 QQ QQ00000000000000000000 properties or actions of the Preparation includi
3. 32 e 0000000 5 3 12 The effect assessment of the Active Substances 5312 DOO000 Preparations and Relevant Chemicals should include a screening on carcinogenic mutagenic and endocrine disruptive properties If the screening results give rise to concerns this should give rise to a further effect assessment UUDUDUDDUDDUDDUDUDUUDUDUDUGUDUDBDDDDDP in vivet DH D I in vitro 0 DD D OOOOOOOOOOOGO fulllifecydel 111 D D U EL e 5 3 11 An assessment of sediment species is redundant if the 53 1 potential of the substance of concern to partition into the lt 1 H E B D D sediment is low e g Koc 500 L kg OOODDODOODOODDODODODODODOADODODODODADOADOADOODY OOODOOODODODDUDO DODOOODODOODODODOODOLDGSODO 53 110 3 150000 gt
4. un Dn nn 0 0 0 00000 00 j un up X DUDUDUDUUDOD nna 4 0000800 008 K x 00000000000100 ES OO IMO 0 nnppnpnnnnuunnnn u 860000000000 00000000000000 C MEPCU 0 0 un OOO C x 0000 OO m OOO UU DOODODOODODODODOODDODOOODODODDODOODODOOD 3 00000000 MOOIODODODOOOODODDLULD MEPCOOODODOOODODOODIODOOD 0000 MEPCODODOODOD 2 AOODOODOODODOODODODODOODODOO OOODOOOOD 18 4 0000 OOODDODOODOODDODDODODODOADODODODOADOADOADOODO OOOODODDODOODDODOODOADODODOODOADODODDODOODAOODOO OOODOOOODODODODOODDODOODODOOD 1 00 3000000 20 6 6 OO 2000000 200 000000 00 9 OO 3000000 20 ent OO 3000000 20 Msosi Du 30 6 Du 30 D OO 300 O 00000000000
5. OOODDODOODODODOODOODODOADOODOUDOODOODOODDOLD 49 DU uu DU utu OOODOODODODODOODODOOLDPECI 0 091000 EI co DOODOODODODOO 200ODOODOOOADODOODOODODO 30000000000 d DOODOODODOOLD MUU SOODDODOODODOODODODODOOOODODOU UUDIUDUUDUDDUUDUUDUUDUDUUDUUDDUUDUUDUUDDUDDOD OOODOODODOODODDOUDODLD VOODODOODOODODOO OOODDODOOUDODODOODOODODODADOODOODOODOODOODDOLD OOODDODOOUDODODOODOODODODOADOODOODOODOODOODDOLD UUUIUDUUDUDUUDUUDDUUDUDUUDUUDUUDUUDUUDUUDUDD U DU t L1 ET LI E ET El EI ER EET EE ES ODOODOADOODOODDODO OOODDODODODOODOUDOODODDODODODOUDOODOODOODO OOODDODOODODDODODODODODOADODOOLOADOODOODOO OOODODODOODODDODODODOODOADODOODLODADOODOODOO OOODODDODUDOODY Lr
6. 0 0 0 900000 0 27 OODDOOOOAOODODOOOAAODDOOOAAAAODODUDDOAAAODODOO UUUUDUUUUUUUDDUUDUUUUDUDUDUUUUUUDUUUUUDDUUL UUUIUUUDUUDUDDUUDUUUUDUDUUUUUUUDUDUDDUDUDUDUD UUDUDUUDUUUUDUUUDDUUUDUDUDDUUUUUUDUDDUUUUDUDUD OODDODOOOAAOAODODODOOAOADUODOOAAODODOOOAAODOOODO OODODOOOAOOODDODOOOAOADO 1 1111111 Australia NICNAS http www nicnas gov au ECETOC Technical Report JACC Report http www ecetoc org content Default asp PageID 32 Canada Priority Substance List Assessment Report http www ec gc ca substances ese eng psap final main cfm EU Risk Assessment Report http ecb jrc it home php CONTENU DOCUMENTS Existing Chemicals RISK ASSESSME NT REPORT OECD S
7. D OOOOOOOOOCOOOOOOOOOOCOOOOOOOOOOOOOOOOOOOG OOODDODOODOODDODODODODODOADODODODOADOADOADOODO WDSODODOODODODODOOOODY OLDOECDAA OUOODOODODOODOODODODOOOODODOODOODODO OOODDODOODOODDODDODODODOADODODODOODOADOODOODO ODOODODOODODODODOODDODOOODODODODODLOODDODO OOOOOODOOOOOODOLOD biomagnification bioconcentration PBTOUOLUOOLU B 511020000 53700000000000 uuu 33 34 5 RISK CHARACTERIZATION 5100000000 Eb ne U ey mus should be conducted see 0 0 0 T 2 Bioaccumulation tests 2 000000 The assessment of the potential for bioaccumulation should use measured bioconcentration factors in marine 0 0 0 00 or freshwater organisms Where these tests are not 0000000000000 lePow 3H D D DD
8. OOODOUDOODODODODOODDO IMOIUUUUIUUUUUDUDUDUDU L1 L1 L1 L1 10000 00000 0 1 UU IMO IMODOOg IU UUUUUDDUUUDDUUDUUDUDDUUDDUDDUDUUDUDUUDDUDUD OOODOODODOODODODODOODODO OOOODOODY 12 222 0000000000000 JF EP EI EI EI EI EI OO OO ET 2 2 3 PBT 1 1 1 1 PBT HB I I U Persistent E HH D D 1 I I I T Bioaccumulative OOO 224 DODOODODOODOODDODOO 1 EIE EE EI EE E EL EE EE IE EI EE EIE 221 EI ta E el HE HE EE HE IE E EI IE BEE ODOODODOODODDODOODODOO 68 OUD D uuu UUIDDUDUDUDUDUDUDUDUDUDBUDUDBDUGuDUuDUUuUD
9. OOOOOOOOOOOOOOO 6 4 1 In order to approve the application the Organization 641 should determine that the Active Substances D00000 0000000000000 0 00 Preparations or Relevant Chemicals are not Persistent 0 0000 0 0 00 0 0 Bioaccumulative and Toxic PBT Preparations that 0 0 0 exceed all these criteria Persistence Bioaccumulation and Toxicity in the table below are considered PBT 0 PBTOOOOOUOAO Table 1 Criteria for identification of PBT substances PBTI D Criterion PBT criteria uu PBT L Ll L Persistence Half life dp d uuu gt 60 days in marine water or OU gt 600 0 0 7 40 days in freshwater or OD 400 d D gt 180 days in marine sediment or gt 120 days in freshwater sediment pun UD Bioaccumulation BCF gt 2 000 of 00000 BCF gt 2 000 OO LogPoctanol water 23 Log octanolwater 23 Toxicity Chronic NOEC lt 0 01 mg l D O0 O NOEC gt 0 01 mg l For the purpose of marine environmental risk assessment half life data Ul Ul Ul U U Ul Ul U LI LT in freshwater and freshwater sediment can be overruled by data
10. e 1 1 0089 MO 3 3SI OOODOODODOODODOODODDODOOOODOUODADODODODOODO OOODOUDOODODDODOODODODODODODOODODDU KS DOOOODO 0 DOODOODOODODODODODDODUKS PowOOODO Kocs 0 41x Pow O 000 Karickhoff 1981 T L Pow I I 11 DU U LI 0 1 OOOOOOOOOOOOO KocDOODOODODOODOUODODODDODOOOODY e OECDDDUDDUUD 1060 OD D 0 21 Oo Ooo e 00000000 5 33 The reaction with organic matter of Active Substances and 533 0 0 0 0 0 Wis ow winsimawew DDDDODOODDDDODDDDDDODOD 111111 11111 111 1111111011 1 1111111111 1
11. 20O0O0DODO D Uu DU Uu D 11 OOODOODOO 0 OOG OD OOODOOODODOODDODOO ODDOODODOOODODOODOUDOODODDOOLD Gs OOODOODOOD OOODDODOODOODDODDODODODOADODODODODADODADOODOODO OOODDODOODOODDODDODODODOADOODOUDODODOADOODOODOO 10 GSODODODODOODDOD 221 000000 ODOODOUDDODOODODODODOODOODOODOMDOODADODODOODOO OOODOOOODODDODOUIODODOODODDODOODODOODODOOO OOODODOODOD DODIDIDOOODODODODODOODDOODODOODDOLD TB Ad 91101 EEF BA Add 0111111111 141 111111111111 DEUED 1111111111 1111 0 DOU 2 OOODDODODODOODDODDODODODOADOODOODOADODODOODOOD OOODOOOODODDLUDGSODODDODOODODODODODODODODODOODDOD OOODDODOOUOODDODDODLODODOADOODOODADODODOODOOD OOOODOODODODDOODUDOUDOUGSDOODDODDOODDODODOOD 90 OOODOODODOODODODODOODOO 11 OOODOOOODODDUODDODDADOODODOODODOADODODODOOOODO
12. Median Lethal Concentration 0000 OOODOODODOODODODODOODODO OOODOODODOODODODODOODDODOOODODODDODOODODOO OOODOODODOODODODODOODDODOOODODODDODOODODOO OOODOODODOODODODODOODODOOODODOODDODO OOODOOOU SOODODODODOODDOD OOODOODOODOOOODOODOODO OOODODO D uuu ODOLDOECDOODODOODOODDODOOD OOODODOODOODDODOO IDOOOODODODODOODODUO SOOODODOODOODDODOO Lowest Observed Effect Concentration OOOO DU Uu 0000000000 NOEC lt MATC lt Maximum acceptable toxicant concentration TO March NOEC L L DB D D H 6 OOODDODODODOODOODOODDODOODOODOOODODOODOODY L1 OOODDODODODOODOODOODDODOODOODOOODADOODOODY 5 LU NOAEC No Observed Adverse Effect Concentration JO 0 0 0 00 NOEC No Observed Effect Concentra
13. 1 0 0 0 9 TSS OOODOOODODODDODOODODOODOL TSS O OODODDODOODOODODOOUOODOODOOD EE 3 2 Ed 1 1 Oo C L1 Ed L1 1 1 Ea Oo 1 L1 L1 id L1 x 1 r3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 EJ r3 pr EJ p E 4 D 2 CJ 2 LU LU OD OD OD OD OD OD OD OD OD OD OD OD OD U LU OD Ed p3 Ed r3 1 Ed Ed C3 Ed HEER HERO HA HEHE HO EX Elegy 0 0 0 0 0 0 0 0 0 0 0 El ET EST BR EE HEHE ER HIE EES ESI BEE BE EE ED BR 1 E 17 EST ES HE EJ HE EE HEB EE 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ELE 1 14 EST TA EE EE TE EN AE EI E 1 4 EL SES sib EER Ez eer ESSE EL ESE 13 OOODDODOODOODDODDODODODOADODODODOADOADOODOODO OOODDODOODOODDODDODODODOODOODOODODODODOODOODOO OOODDODOODOODDODDODODODOODOODOUDODOODOODOODOO 225
14. OOODOODODOOODODOODDODOODODOO OOODDODOODODDODDODODODOADOOODOALODADOODOODOO OOODDODOODOODDODDODODODOADOODODODADODADOODOODO 98 0 lt OOODOODOODODOOODODODODDODOODODOUDODLDLUGDUODDODO 16 IMOODODDOODODDODOODODODOODOADOOLDIMODODOODOODOODY 5 9 OOOO 9UIDDUDDUDDUDDUDUUDUDUUUDDODUUD UUUIDUUDUUDDUDDDUDUDUDDUDDUDDUDUUDDDUDUDUUD OOUW OOODOOOODOODDODOO OOODO MOODODDODODO MOODODDODOOOODODDODO OOODOOOUDOODOODOODODDADOODDODOODODODADODDOD 17
15. 1 8 The Technical Group should review the comprehensive proposal along with any additional data submitted and report to the Organization whether the proposal has demonstrated a potential for unreasonable risk for environment human health property or resources in accordance with the criteria specified in this procedure L3 C3 C3 C3 OO L3 c3 c3 Ooo ETEA GE oono OOOO Oc 9 The Technical Group s report should be in written form and circulated to the Parties Members of the Organization the United Nations and its Specialized Agencies intergovernmental organizations having agreements with the Organization and non governmental organizations in consultative status with the Organization prior to its consideration by the competent Committee 10 The Committee of the Organization should decide whether to approve any proposal introduce any modifications thereto if appropriate taking into account the Technical Group s report 11 The Member of the Organization that submitted the application to the Organization should inform in writing the applicant about the decision made with regard to the respective Active Substance or Preparation and their manner of application 12 Active Substances or Preparations receiving basic approval by the Organization may be used for prototype or type approval testing based on the
16. 11 0 0 000000 0000000000000 0 2 10 23000 00 00000 0 0000000 010 00 91 1 11 gt MOODOOO MEPC 2 ODOODOUDOODODOODOODOO 21 ODOODUODOODODOODOODOO 2 1 1 00000 o OOOO GSDOOODODOODDODOODOUODODODODODOODODOODUOODDODOOLD 2110000000 34m D UD utu DUUIDDUDDUDDUDUDUUDUDDUDUDBDDDUGUDUDGUDUDUDUDUDUDUDUDUDUDUDUDUDUuDULU OOODOOOODODDODOODU 3 U 2 0000 OOODDODOODOODDODDODODODOADODODODOADOADOODOODY dAAdAdAdAAdAdAddABAAAAdAAABEADEREAEPADAODARDEADHOBDA OOODODODGSIODO 2 ADODODODOODDODOOODODODODODOODODOO OOODDODOODOODDODDODOODOADOODOUDODOODOODOODOO 20 OOODOODUDOADOODDODOOODODOODDODOO 9 00 OOODDODOODOODDODDOULODODOADODODODOADOODOODOOD OOODDODOODOODDOD
17. PBUOODOODODOODODOODODOODODDUDO200DODO D2ODOODODOODODOODOODOODODOODODODODOODODOO 0000 OOODDODOODOODDODDODODODOADOODOODODOADOODOODOO mad d d DEBE AA BA AdAAdAdAABOADAAEREAEDABRAAAARABRAE RA OOODDODOODOODDODDODODODOADOODOODODOODOODOODOO MEPCO ODOOOODODOODODODODO IDODOOODODODODODOODODO lt Ll r3 PC 125 53 J D DODIDODDOGSOODOODODODADOODDODOO El ES OOODOODODOO OOODOOD 0 0 OOODDODODODOODOODOODOODOODDODDO 9101000090 1 0 E llech Ed i EST LI E 130000000 6 Da 0 0 6 OOODOOODODODDODOODODODODODOOODODODOODOODDOLD OOODOMEPCDODOOOODOODOODOODODOOUOODDODOO u ut Experts on the Scientific Aspects of Marine Environmental Protection u 0 0 000 U 0 UNESsco locQOOO000000000 0 80000000000 UU uut oO Ek EE OOo OO N LU 9 00000 65 GesAMP goog 1111 20060 10 231111 2700000000 1
18. 8 1 2 4 G9 G9 5 3 G9 8 1 2 8 G9 8 1 2 10 G9 MEPC
19. e 00000000000000 http www epa gov waterscence WET 50 33200000000 5 2 6 A dilution series including a 100 ballast water discharge 5 2 6 100 E HH D E ED E D E D E C 00 0 would be tested to determine the no adverse effect level 0 00 be the rede Eu dada Mn E H H H H o H H H o O H H H H H H H H O H H o H ibe DDDDDDDDDDDDDDDDDDDDDDD no modelling or plumes analysis would be used The rationale for taking a conservative approach is that there could be multiple discharges into one location even though this is not necessarily the case DID 3312 i 0000000000 0 1 NOECOOO NOECDOOOOOODODODODOOOOODOODODOOOOOOOOO oOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOO 000 0 00000 0 8 0 0 PNEC Predicted No Effect Concentration OE
20. OOODOOADODODODOOOODODODODOODDODOODODOODODOODOIO OOODDODOODOODDODDODOODOADOODOUDODODODOODOODOO OOODOOOODODDOOODODOODODODODODODOOOODODDODULDGSODOO OOODOOOODODDODOODODOODODODODODDO 45 5 2 Toxicity testing of the treated Ballast Water 52 uu 5 2 1 Toxicity testing is necessary for the Active Substance or 521 OO Preparations see section 4 2 1 and 5 3 and the treated 0 Ballast Water Discharge as covered in this section The advantage of conducting toxicity testing on the Ballast UU Water Discharge is that it integrates and addresses the OU potential for interactions of the Active Substances and UU Preparations with the possible by products uu 1 For the basic approval process the discharge testing should 1 OOOO be performed in a laboratory using techniques and OOOO equipment to simulate Ballast Water Discharge ooog following treatment by the Preparation Ono g Ono Ono Ono Ono Ho Ho Ho Ha Ha 1 2 For final approval the discharge testing should be 0000 performed as part of the land based type approval OOOO process using the treated ballast water discharge Ono 5 3 2 Both the Active Substance or Preparation as well as the 532000000000000000 treated Ballast Water Discharge should be subject to 3 toxicity testing in order to protect the receiving
21. 331 0000000 ceppgu 2 47 OOODODOO 09 EE SEE EIE GEI Ed WEE Ed 5 2 2 The applicant should provide both acute and chronic 522 toxicity test data using standardized test procedures to gggggggagamggguggzgsgzgg determine the toxicity of the Preparation and Relevant 00 000 00 00 0 0000 000 0 0 Chemicals as used in conjunction with the Ballast Water 0 0 Management system This testing approach should be performed on the treated Ballast Water Discharge as the UInnuunuugnnugnngugnaugnu Ballast Water Management system could either mitigate or enhance the adverse effects of the Preparation or Relevant Chemicals 5 23 The discharge toxicity tests should be conducted on 523 samples drawn from the land based test set up which 0000000000000000000000 would be representa
22. obtained under marine conditions PBTOOODOODDODOODODOODODODODOODOODODDODODODO MO 3ODODODODOODUDOOLD 64100 200000000000000000 PBTOODODOOOODODODODOODDODOODODDODOOODOO c9 ODOODODODDOODDODDOODOODODOODOODODODDOODDODOO PBTODOOOODODOOD OOODOOOODODDUODU PBTODODOODODODDOODODODODOODODO OOODDODOODOODDODDODODODOADOODOODODODADOADOODOO OOODDODOODOODDODDODODODOADOODOODODODOADOODOODOO OOODOODUDODOOOODODU PBTODOOUOODDODOODODDODOOOOOO OOODOODUDOADOODDODOOODODOODDODOO 214 ODODDODOOOODODODODOODODOOD DOODDOODDODODDOODOODODOODOODDODDOODODODODOODO OOODOOOUDOODODOOD 22 5 3 Risk characterization and analysis 53 1 000 0000 5 3 1 For the basic approval process fate and effect testing 531 0 109909099090090880000 80 should be performed in the laboratory with Active 8 Substances and Preparations This section lists information that could be useful for a preliminary risk 1 111 10 characterization SSDODOODODODOOUDODODODOOODODODOODOODODOOLD OOODOOODUDOODODOODOUDODADODDGSDOODDODOOODODOODDODO OOODDODOODOODDODDODODODOADOODOUDODOODOODOODOO OUDOOOODUDDOOOODDODOOOODDOOOODDDOOOODDODOOOOO 8 210 GO JI SSDOUODDODOOODODOODODOODODOOL
23. 0 OECD O00000 3 OOODDODOODODDODODODODODOADOODOODODOODOODO OOODOODODODODOO 0090 0 US EPA OPPTS 835 2210 1998 1 000000000000 OECDODODOODO 199700 6 40 DOU 313 0 OODOUULUOPBTODOUOUOOOOODOOOUAUABOOOO ODOBEFOOODODDOODOODD PowODODODOODODOOODODODOODO OU PowDODDOODODODODOODODOOODODODODOODODOOODODODO OODODOOOOOOOODDODODOOOOOAOODODODODAOOOOOODDUDODOOOOOOO 5 3 6 The partition coefficients solids water partition coefficient e Kd and or organic carbon normalized distribution 32 6 1 TN 8 U 1 i coefficient Koc of the Active Substances Preparations and Relevant Chemicals should be determined 5 3 7 For Active Substances and Preparations the potential for 537 bioaccumulation should be assessed in marine or 000000 3000000 dogPow 300 0 freshwater organisms fish or bivalves if the logarithm OOOOOOODOOOOODOOOOOOOOOg octanol water partition coefficient logPow is 73
24. D D D D LU ASTM American Society for Testing and Materials D DJ EPA Environmental Protection Agency GESAMP The Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection IMO International Maritime Organization 0 IPCS International Programme on Chemical Safety D JIS Japanese Industrial Standard OOO MEPC Marine Environment Protection Committee D D OECD Organization for Economic Cooperation and Development TO 0 OPPT Office of Pollution Prevention and Toxics D UU E E E EE EE EE EE D D WHO World Health Organization GO 1 1 111 L 1 HD UUDIDUUDUDDUUDUDUD ILUDUUDUDDUUDDUDUDU OD DU Uu Convention on Biological Diversity CBD Organization IMOQ 18000 0 1993 1 DU LL EE El EE ES El EIE EE EE EE E H EE HE HE EE EE OD DO OODODOODOODOODOOLD OODODOODUDOODOODDILIDOM OOODOODUDOODOODDODOO 200000 19970 HOOOOOOOOOO I UU UI DU Uu Uu UU I UI D U UUIODUUDUDDUDDUDUDUDUUDUUDUUDUDUUDUUDUUD OOODODODOODOODDODODODODODOADOODOLODODOODOOD OODODOODUDOODOODDODOO OODODOODUDOODOODDODOO OOODOOD
25. 0 0 8 0000901000 8 OOODODOOMDODODODOODODOODOAULODADODODODOODODOO OOODDODODODOODOUDOUDOODOODOODOODOODOODUVO OOODDODOODOODDODODODODODOADOODOODADODOADOODOODO OOODOOOODOODDODOO MODODODODODDODOODO HD 120000 Lol Ed EI EI EI EI EU E E FF 1 i UUUuuun 00000000 MEPCS3 0000000000000 0 0 MeErcs3 wP9 0 OO i D 1 0000 J ETE EI OOODDODOODDOODDODDODOODOODODOADLODADOODOODY OOODOODUDODODODADOODODOODODOODADDOOODOODOODO OOODOOOODODDODOODODOODOLDOULDMEPCDODOODOODDO MEPCDOODOOOODODDODODOODODOOD MEPCDUDODODOODOUODODOOOODODODODOODODOOD EI EI HI H EI EYE 621 EI 0070 UUUDIDDUUUDDUIODDUODUDDUUDDODUDODDUDUUDUDUUUDUUDUDU OOODOOOODOODDODOODODOOGODOODOODOOD L2ODOODODODODOODOODODOODOODODOOD SOO0OODODOOOADODOODO 350000
26. L3 ELI o 5 9 6 2 That this information does not indicate possible unacceptable adverse effects to environment human health property or resources 200 oo0p0p 200 MEPCDUODOODOODDODOOOODODODODOODODOODODOODOODDODOD OOODOODUDIDDOOOODODLODODODDOODODOOADODODOODODOO OOODOODUODOODODOODODOODOUODOD MO 370000000000 OOODOOOODODODODODDODOODOD 36 00000000 6 3 Ship and personnel safety 6 3 00000 6 3 1 In order to protect the ship and personnel safety the 6 3 1 technical group should evaluate the physical and chemical hazards see paragraph 4 2 1 4 to ensure that potential hazardous properties of the Active Substances Preparations or Relevant Chemicals formed in the treated ballast water should not create any unreasonable risk to the ship and personnel Proposed procedures for the use and technical equipment introduced needs to be taken into account 00 0 DO 0 DO 0 DO 0 DO 0 DO 0 H m O 3 OOOOOOO OOOOOOO OOEOOOO C3 C3 L3 OOEOOOO OOOOOOO 0 0 DO L3 L3 C3 C3 L3 L3 C3 6 3 2 For the protection of personnel involved in the handling and storage of the Active Substances and Preparations 6 3 2 the proposal should include relevant M SDS The O
27. rum m mm m Oo ag 32523 Oud mau 220E 3 ca 2002 e005 20 1 0 oss E ooo MO S005 ogp2gpo ooo r3 ca a ca n Oooo r3 E mm mum mn mi 28 o00000 ca cafes on os jo Fos jon 3 m a 15 L cen LIGSOODOODODOODOODDO GSDOODODODOODODOODOODOODODODODODDODADOODODOOLD OOODDODOODOODDODODODOODOADOODOUDODODADOADOODOO OOODOODUDOODUODOODGSODODODADOODDODOODOODOODODOO OOODOODUDOOODODOODDODOODODOODOUODODODODODOOOODO 12c90 00000000000 1 1 1 D D 110 GSODOODOUOODODODODODOODODOODULDO MEPC 53 WP9 62 1 OOODOODOUDOODOADODDODOODOAODODOODUDOODODOOLDO a gg Ag Te 1141 101411141114 111101411111111411111101111111411 Uu 9 Gs DODOODODDODOODUDOODODODODOOOODODODODOODDODOO OOODO G9DOODOOOODODOOUOODDODOODODOODODODODOODOO OOOOOUO
28. 4 2 7 A proposal for approval should include Material Safety Data Sheets M SDS MSDS 4 3 Assessment report 4 3 1 A proposal for approval should include an assessment report The assessment report should address the quality of the test reports the risk characterization and a consideration of the uncertainty associated with the assessment T Uo m Oooo oog Oooo OOOO OOO Corto OO O00 Corr nooo 20 BABAR Bo nooo g 20 nooo g 0000 g nooo n nooo nooo nooo RE nooo nooo nooo nooo 5 RISK CHARACTERIZATION SOOOUUU000 5 1 Screening for persistency bioaccumulation and toxicity 51110 11 0 00 u Ul 4 00 D 5 1 1 An assessment on the intrinsic properties of the Active Substance and or Preparation such as persistency 511 00000 bioaccumulation and toxicity should be conducted see 00000 Table 1 in Section 6 00000 Persistence tests Persistence should preferably be assessed in simulation test systems that determine the half life under relevant conditions Biodegradation screening tests may be used to show that the substances are readily biodegradable The determination of the half life should include assessment of relevant chemicals Onoo Oooo One ooo EIE 2 Bioaccumulation tests The assessment of the potential for bioaccumul
29. C3 C3 E3 C3 C3 E3 C3 E3 C3 C3 C3 E3 C3 C3 C3 E EE El gc OOOO 4 L3 C3 EJ C3 EJ E3 C3 C3 EJ EJ EJ EJ E3 EJ E3 OOO E C3 paz C3 C3 esa C3 C3 L1 C3 C3 C3 C3 C3 L3 L3 L1 C3 C3 C3 C3 C3 C3 L3 L1 C3 C3 CJ L3 L3 L1 C3 C3 C3 C3 C3 C3 C3 L3 L1 C3 L3 E32 C3 C3 C3 C3 L3 L1 C3 C3 C3 E3 L3 L1 E3 C3 C3 C3 L3 L1 man C3 C3 C3 C3 C3 L3 L1 C3 C3 C3 CJ C3 L3 E32 C3 C3 C3 C3 L3 L1 C3 C3 C3 E3 C3 C3 C3 C3 C3 C3 E3 C3 C3 C3 C3 C3 C3 CJ L3 L1 59 8 3 Notification of approval 8 3 1 The Organization will record the Basic and Final Approval of Active Substances and Preparations and Ballast Water Management systems that make use of Active Substances and
30. dd dAadAAdAdEAdABAAAdAAAdEEADRREEREODEAODHADEAED HE 11 OOODOOODODODDODOODODOADODODODOODDODO ODOODOUDOODODDODOODODOODODODODODDODODODOODOD 470 OOO S7O0ODDODOOOODODIDOAUOODDODOOODADODODODOODODOO OOODOODODOOODODOODDODOODODOODOULODODODODODOODOOD http www env go jp chemi kagaku kashinkaisei html 35 1 0 0 lU http www jaish gr jp user anzen hor tsutatsu h04 html 20DOODODOODODOODOODDOD 42 10 OOODOOOODODDODOODODOOD 4 2 Data set for Active Substances and Preparations 42 4 2 1 A proposal for approval should include information on the 4 2 1 properties or actions of the Preparation including any of its components as follows 20 g OO g o 20 g 2 Data on mammalian toxicity acute toxicity effects on skin and eye chronic and long term toxicity developmental and reproductive toxicity carcinogenicity and mutagenicity Oooo Oo OOOOOOO BO m EE m 1 ap 1 cg bey Ge pm 21 1 OOODDODOODOODDODDODODODOADODODODOADOOADOODOODO OOODOODOODODOODOODDO OOODOOOODODODO
31. MO 22200 22400000000 3 13 0000000000 OOODOOOODODDODOODODOADODODODOODODOOODODOODDODO OOODOOOUDODLDPBTODODODODOODDODOODODOODODODODOODOO D 5 RISK CHARACTERIZATION 500000000 5 1 Screening for persistency bioaccumulation and toxicity SiN 000M0000000000000000000 5 1 1 An assessment on the intrinsic properties of the Active 2M i gt RT I Substance and or Preparation such as persistency bioaccumulation and toxicity should be conducted see IDUDIU Table 1 in Section 6 3 3 Toxicity tests Acute and or chronic ecotoxicity data ideally covering 01 the sensitive life stages should in principle be used for the assessment of the toxicity criterion 29 DUUDIDUDDUDUDUDUUDUDDBDGUDDUDDDUDUDUDDUDIDU 539000000000 OOODOOOUSOUDODOODODODODOODOODODOOADODODODOODODOO OOODOOOODOODDODO 5 RISK CHARACTERIZATION SOOOOOOOO 5 3 Risk char
32. ooooooHo nooo ETETETETEETE ERAAN mru rrr ra A ua iF 2222 EX E3 DEJES EYE ER ESTEE an D 11 D 00 RL D D D D D D D u 00000 00000 a OOOAOOOOOOOR OOOOOOOEOOOO OOOOOOOSOOOO ef eo fc aeu E3 mn an un un un EXETEYES 2220202222 2 2 03 3 3 535 3 L3 C3 C3 C3 CJ L3 L3 L3 C3 L3 C3 C3 3 3 Ballast Water Management systems that make use of Active Substances and Preparations must be safe in terms of the ship its equipment and the personnel to comply with the Convention 3 4 The approval of Active Substances and Preparations using viruses or fungi for use in Ballast Water Management Systems is not addressed in this procedure The approval of such substances for Ballast Water Management should require an additional consideration by the Organization in compliance with regulation D 3 of the Convention if the use of such substances is proposed 4 GENERAL REQUIREMENTS 4000000 4 1 Identification 41 4 1 1 The proposal for approval of an Active Substance or a Preparation should include a chemical identification and description of the chemical components even if generated onboard A chem
33. BCE hem bemsinied wing Guuniasse SARUDUUDDDDDDDDDDUUUUU Structure Activity Relationship Q SAR models e puit 7 90000000000 00000000000 freshwater organisms fish or bivalves if the logarithm 3000000 D degPow 300 0 0 octanol water partition coefficient logPow is gt 3 00008 1 8 1 9 64100 1 1 00000 1 0 0 BMF 00000000000 1 1 1 1 1 1 1 1 11 1111111000 1 11 1 tL 8 GIO 811 1111101111
34. Ei o rH EXEJE3EJETIEYXETEY a o of EI OO Oo oo EJ Om L1 C3 C3 C3 C3 E3 C3 C3 oo 000 D us li mmm pi a isa OO 0 UO 0 UD OECD OO 1993 42 4 H0000 1 Both a Quality Management Plan QMP and a Quality Assurance Project Plan QAPP Guidance on preparation of these plans along with other guidance documents and other general quality control information are available for download from the International Organization for Standardization ISO www iso org 2 The QMP addresses the quality control management structure and policies of the Test Organization including subcontractors and outside laboratories 3 The QAPP is a project specific technical document reflecting the specifics of the system to be tested the test facility and other conditions affecting the actual design and implementation of the required experiments b 4 2 5 Dossiers already used for registration of chemicals can be submitted by the applicant to satisfy the required data needed for the evaluation of Active Substances and Preparations according to this procedure A N 4 2 6 The proposal should describe the manner of application of the Preparation for Ballast Water Management including required dosage and retention time A N ON
35. Qo po dex Eh es vtr cores G 8 ww0 0 0 0 Y 0 0 0 OOODOODUDOODODLDCASODODO OOODOODODOODODOODODO ODOODOODODOOODODODODODOODOLD OODODOODODOOADODODODOODOO ODOODOODODOOODODODODODOODOLD OOODOOOODODDODOODODOOLD TOGO DOC SSDOODIDODO O pH c9 000 1 4 1 0 DU uuu 3200000000 32 1 000000 4 2 Data set for Active Substances and Preparations 42 4 2 1 A proposal for approval should include information on the 1 its components as follows 5 Analytical methods at environmentally relevant 5 concentrations 5 D hse properties or actions of the Preparation including any of 000000 000000 5 3 15 An analytical method suitable for monitoring Active 5315 Substances and Preparations in ballast water discharges 1 00000000000000000000 should be available G90 0 4211 SSOOOOGOOOOOOOOOOOOOOOOOOOOOOOOOOOOOGO DUUIDDUDDUDUDUDUDUDUDDUDUDBDDBDUUDUDUDUDUDUDUD
36. 00 0 80000 WOO MEPC 26 3 DO 20051 70 1 5111 0000000 MEPCSODOOODODODODOODOO 0 9 uu D uuu IMO OOODOOD 00000 00000 00000 00 BDUDDUDU 00000000 MEPC 53 WP 7 l MEPC54 G9 IMO IMO G9 4 2 6 1 8 1 2 3
37. D uu L1 1 EF 1 I 1 1 1 1 1 Co CI 1 EI r3 EI Ee EI a EI r3 EI 1114111111 111111 1 0000100900 00 0 08 10000000 uu MT T TRE an 1 EE SEE SR DS du V e ERE do VR e oed ed uS beoe d cue d 6 IIIDDDUDDUDDUDUDDUDDUDUDUDBUDBDUDBDUDBDUDBUUDBDUBDBUUDBUBUDUD cae t tes 7 nA HS Ed BEP 7 Tabi BU BYR BNR EE EL B BE OUDE ie de Ge o wre 4 U PI 7 T2 de ale BET BAAD OH DODO ED DEDE EIE BUE BE e ve tte ct 9 130000000 Mod KORE E SRM a Seen et 9 gt R de A 10 ee ee ee EE 10 Opa CYSEGR rN eR OE 10 xR nad aes or er Gr 11 gt gt HHB P x sient ee Pese aaa sau hawkers 13 DD SPEDE WL DET DI ee enearo erea EE 13 2240 AE Ne Kia UR TT CD EU rra e kes 13 DE EER EDE EED ED ED ED EED DE E Dis Fr 14 AE Tiri HE eke VANE ere a meen dd tenured Revere dIe n 14 111 ED EI oe dak aa E EE BE EE EO af aa E esee 16 1 000000000000 0000 16 EE Veen ee eM pog ii Re er E N OE ramis 16 102 On EE MI ese aes os
38. environment from toxic effects due to discharges OOODDODOODOODDODDODODODOADOODOUDODODODOODOODOO OOODOOOODY OOODDODOODOODDODDODODODOADODODODODODOODOODOODO OOODOODODDODOD 00000000000000 NOECO PNEC UD UD LI OOOOODODOOODODOODOODOODODOODODADOODODOOD OOODODODOODODDODODODOODOODODOOLULOODOODOOD OOOODOODDODUODDOODLOLONOECOODDODOOO OOODOODOODOODOODODOOOOOPNECODODO OOODDODOODOODOUDODODODOADOODOO OOODDODOODOODOODODODODOADOODOO OOODODODODOODODOOLDDDODOODADOADODDODOOOODO PN OD OD OD OD EIE SEE EE ES UDDUDD 1000 UDDUDD 1910 0 0000000 NOECO PNECOOUOUOUOO OOOOODUODOOODODOODDODOODODOODODODOODODODOODODOO OOODDODOODOODDODDODODODOADODODODODADOADOODOODO 46 9 0 OOODOOOODODODODODDODOODODO VOOOODAOOADAOOUOOOOO ODOODODOODODODODODDODOODODO UUIUUDUUUUDUUUUUDUDUDODUDUUDU
39. 00000000000 c90 O OPBTOOODDODOODODOODODODODOOODADDODOODOODODD OOODDODOODOODDODDODODODOOADOODOUDODOODOODOODOO OOODDODOODOODDODDODODODOADOODOODODOOADOODOODOO OOODDODOODOODDODDODODODOADOODOUDADODADOODOODOO OOODDODOODOODDODDODODODOOADOODOODODOODOODOODOO da adAAdAdEAABAAAdAAOABEADEBEEBADAOARADEADHOR BA OOODOOOUDODDUDOODODODADOODDODOADODODODOODODOO 23 OOODOOODOOAODOOO OOODDODOODOODDODDODODODOADODODODODADODADOADOODY OOODOOOODODDODOODODOODODDOADODADODODAODOODODOO o OOOODOODODODDOODODOUODOODOADUOAODODDOODDODDOO OOODOOOODOODDODOODODOODODODODOODODOIM 9 1 420 6 OOODOOOODODODODOODODOODODOODODDODODO GOUD 52 e OOODOODODOODODDODOODODOGSDOO 7100 7 20 e 00000000000 O 00000000000000000000000000000000000000 OOODOOOUDODDGSUOO SOO 6 OOODOOOODODDODOODODOADODDODOODODOOODODOODDODO OOODOOOUDOODDODOODODOADODDODOODODOOAODODOODODO OOODOOODODOODDODOODODOODUDGYDOS2 AAOODODOODDODOO 0 14
40. 2 0 00000 0 00000000 0088000000000003 1 0 0 000000000000 chronic toxicity 11 0 EOOOOUODUO 0 989 1 11 1111 110 1 1 1 1 1 1 1 1 0 1980 utat o053 II 1 101010111 Ou 0 ODOODO DUUDUUDUD OUOODOODOODOODU 2005 8 1000 0 2005 ODOODUDODADODDOLD Ver 1 01 Lu ACGIH American Conference of Governmental Industrial Hygieniest Inc
41. BD ED EO BA BEE ELE EER DER eee 38 2 n Arua radon ee ON 42 Sco EDD S yank apes ee ee ee ee ee ace 44 e Lt Pn PN 44 FEN gt n Drs ERE EE OER EED El di o Pee rh ET ee id 45 3 2 Bed nes eSI ORR EA NENN quM 45 S S PEB Ei ee 45 er ee EO EA daan 47 Sp a am asan La de 51 hn e SE 52 EE cc S E ETE ACE H BUH DEDI osse iet ate tp Y at t nC on ane 53 54 35000000000 SHEER EIDE LD EM 00 OE 54 AER NER E B TR 56 3 co EE ER y m a MCN PEOR ED 57 AAR AA DAE BEA 911111 BEP ELE AA BE E B EP DE ED c ti eo n 58 Lu OOODDODOODOODDODDODODODOADOODOUDODOODOODOODOO ACR BCF BMF ECs GLP in vivo in vitro Koc LCso LOEC MATC Acute to chronic ratio MOU 0 0 0 00 P Bioconcentration Factor 0 0 0 0000 Biomagnification Factor Median Effective Concentration 0000 Good Laboratory Practice ju EED Eos zm LES Fe E Ell
42. D Total Suspended Solids 0 0 0 0 DDDDDODODUDU Assessment factor OOOOOOOOAOODOOOODOOOODOOAOODOOOODOOOODOOOODOOOODO OOOOOOOOOODOOOODOOOODOOOODOOAOODOOOODOOOODOOOODO OOOOOOOOOODOOOODOOOODOOOODOOOODOOOODOOOODOOOODO OOOOOOOOOODOOOODOOOODOOOODOOOODOOOODOOOODOOOOO 0 Sub lethal gt OOOOOOOOOOOOOOOOOOOOOOOODOOOOODOOOODOOOOOO OOOO UD threshold OOOO genotoxicity D OOOOOOOOOODOOOODOOOODOOOODOOAODOOOODOOMOOOODO JU 0 trophic level OOOOOOOOOOOOOOOOOOOOOOOODOOOOODOOOODOOOOOO 1 0 0000000 endpoint OOOOOOOOOODOOOODOOOODOOODOOO
43. Preparation including any of 0000 0000000000000000 000 its components as follows nnum 3 Data on environmental fate and effect under aerobic and 3 1 0988 99 89899889 9980088 anaerobic conditions modes of degradation biotic abiotic bioaccumulation partition coefficient octanol water coefficient D persistence and identification of the main metabolites 0000000000000000000 0 in the relevant media ballast water marine and fresh waters 001088 reaction with organic matter potential physical effects on wildlife amp benthic habitats uu potential residues in seafood and any known interactive effects 1 o UUUIUDDDUUDDUDUDDUDUDU PBTOODOODODOODODDOLDPOD OOODOOOUDODDODOODODOODODLODODODDODOGOD 51 10 10 5 RISK CHARACTERIZATION 500000000 5 1 Screening for persistency bioaccumulation and toxicity 510000 00000000000000000000 5 1 1 An assessment on the intrinsic properties of the Active gt UDUDUDAOODDDOODDODDDUDDDOU Substance and or Preparation such as persistency UUDUDUDBDDUDDUDUDUBDUDDDDDDU bioaccumulation and toxi
44. The applicant should provide both acute and chronic toxicity test data using standardized test procedures to determine the toxicity of the Preparation and Relevant Chemicals as used in conjunction with the Ballast Water Management system This testing approach should be performed on the treated Ballast Water Discharge as the Ballast Water Management system could either mitigate or enhance the adverse effects of the Preparation or Relevant Chemicals 5 2 3 The discharge toxicity tests should be conducted on samples drawn from the land based test set up which would be representative of the discharge from the Ballast Water Management system 5 2 4 These toxicity tests should include chronic test methods with multiple test species a fish an invertebrate and a plant that address the sensitive life stage The preference is to include both a sub lethal endpoint growth and a survival endpoint Either freshwater or marine test methods should be tested Currently there is no compelling physiological or empirical proof that marine organisms are more sensitive than freshwater organisms or vice versa Should this however be demonstrated for the substance under consideration this should be taken into account 5 2 5 The test results to be provided include acute 24 hour 48 hour 72 hour and 96 hour Lethal Concentration at which x 96 of the test organisms die LCx No Observed Adverse Effect Concentrations NOAECS chronic No Observed Effec
45. and Ballast Water Management systems that make use of Active Substances PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES G9 1INTRODUCTION 1 1 This procedure describes the approval and withdrawal of approval of Ballast Water Management systems that make use of Active Substances to comply with the Convention 59 OOD 69 On mn mn mn mn mn e nun 22 H and their manner of application as set out in Regulation D 3 of the International Convention for the Control and Management of Ships Ballast Water and Sediments The Convention requires that at withdrawal of approval the use of the relevant Active Substance or Substances shall be prohibited within 1 year after the date of such withdrawal 1 2 To comply with the Convention Ballast Water Management systems that make use of Active Substances or Preparations containing one or more Active Substances shall be approved by the Organization based on a procedure developed by the Organization 1 3 The objective of this procedure is to determine the acceptability of Active Substances and Preparations containing one or more Active Substances and their application in Ballast Water Management systems concerning ship safety human health and the aquatic environment This procedure is provided as a safeguard for the sustainable use of Ac
46. carried out in accordance with internationally recognized guidelines Preferably Organization for Economic Cooperation and 1 Development OECD Guidelines for Testing of Chemicals 1993 or other eguivalent Oo p OECD U D ECDODOODOOOODODOODOODODOOO oECD HL B HL D B D DU D OUOOOODODOODDOOODDOAODDU GSODOO OOOODDOODDOUODO OPPTSOOOODOODDOODOAODODODD http Www oecd org document 23 0 2340 en 2649 34379 1948503 1 1 1 1 00 html 222 11111 11 1111110190 0 5 3 13 The effect assessment of the Active Substances Preparations and Relevant Chemicals taking the indicated information into account should be based on internationally recognized guidance DU DU 5313 000000 00 UD 00000 00000 Such as relevant OECD guidelines or equivalent gt 0000000 8 0 0 5 3 14 The results of the effect assessment are compared to the results of the discharge toxicity testing Any unpredicted 5314 00909111 00008080 results e g lack of toxicity or unexpected toxicity in the UDDUDDUDDUDUDDUDUU
47. e OECD I D D 0 4290 LENA I e 00000000 e OECDODOUODUO 40000000000 SODODODODOODODY e OECDODOUODU 40000000000 OODODODODOODODY BUOODODOODOODODOOODODOODODOOADOAODODOODOODOOD OOODOO e OECDODOUODU 4200000000 e OoECD jD UH D U 4300000 00000000 e 00000000 e OECDODOUODUO 4400000000 e OEFCDUOUOUU Il DH DH H DB D D I e ol DH DH H DO D ULU e OECDODOOUODUO 4 I0DOUDOOODODOOODODOO e 4220DODO OOOODODODOODOODDOD 37 9 0000000000 5 3 12 The effect assessment of the Active Substances 5312 OOOOOg Preparations and Relevant Chemicals should include a screening on carcinogenic mutagenic and endocrine disruptive properties If the screening results give rise to concerns this should give rise to a further effect assessment Oooo Oooo Oooo
48. gt oOo N 632 53 03 53 63 C3 B C3 C3 c3 c cd 5 oo Y L3 r3 On Om On On On OOO00000000 Oo Oo Oo Oo Oo L3 oOoooo O GLPUOOOODO http www safe nite go jp kasinn glp glptop html 22 5 000000000000000 Ll LJ r3 c9 DODOODODODODOOODUDODDODOODODOODODODODOODDODOO OOODOOODUDOODDOODOODODODODOODDODOO 4 2 5 Dossiers already used for registration of chemicals can be submitted by the applicant to satisfy the required data needed for the evaluation of Active Substances and Preparations according to this procedure OOODDODOODOODDODODODODODOADODODODODADOODOODOODO OOODDODOODOODDODODODOODOOADOODOUDODOODOODOODOO OOODOODUDOODODOODOD 2220 2240OOOODODODODOODODOO OOODDODOODOODDODODODODODOODOODOUDODOODOODOODOO GSOOOODODOODODODUDOODDO 25 226 0000000000 GSDOOODODOODDODOODODODODODDODOODODOUDULDODODO DOODOOODOUODUODODOOUOUOUO http www safe nite go jp risk riskdoc2 html 23 DOODOOODOOODODOODODOOODO GUDD LODODDODOOODADODODODOODOUOODODOODOODDOD 8 1 1 AII proprietary data should be treated as confidential by saiiggagagagagagagaauaedcaet
49. guidelines developed by the Organization An Active Substance or Preparation may be used for Prototype or Type Approval testing for the approval of different BWMS without going through basic approval again Guidelines for approval of prototype ballast water treatment 69 technologies and Guidelines for approval of Ballast Water ODO0000000000000000000000000 Management Systems 8 2 Final approval 82 0000 8 2 1 In accordance with regulation D 3 2 a Ballast Water Management system using an Active Substance or 82 1 Preparation to comply with the Convention which received basic approval must be approved by the Organization For this purpose the Member of the Organization submitting an application should conduct the Type Approval tests in accordance with Guidelines for Approval of Ballast Water Management Systems The results should be conveyed to the Organization for confirmation that the residual toxicity of the discharge conforms to the evaluation undertaken for Basic Approval This would result in Final Approval of the Ballast Water Management system in accordance with regulation D 3 2 Active Substances or Preparations that have received Basic Approval by the Organization may be used for evaluation of Ballast Water Management systems using Active Substances or Preparations for Final Approval Z wo C3 E3 C3
50. kg wet 6 3 Ship and personnel safety 6 3 1 In order to protect the ship and personnel safety the technical group should evaluate the physical and chemical hazards see paragraph 4 2 1 4 to ensure that potential hazardous properties of the Active Substances Preparations or Relevant Chemicals formed in the treated ballast water should not create any unreasonable risk to the ship and personnel Proposed procedures for the use and technical equipment introduced needs to be taken into account 6 3 2 For the protection of personnel involved in the handling and storage of the Active Substances and Preparations the proposal should include relevant M SDS The Organization should evaluate M SDS mammalian toxicity data and chemical properties hazards see paragraphs 4 2 1 2 and 4 2 1 4 and ensure that potential hazardous properties of the Active Substances Preparations or Relevant Chemicals should not create any unreasonable risk to the ship or personnel This evaluation should take into account the different circumstances that a ship or personnel may face in its trade e g ice tropical humidity etc 6 4 Environmental protection 6 4 1 In order to approve the application the Organization should determine that the Active Substances Preparations or Relevant Chemicals are not Persistent Bioaccumulative and Toxic PBT Preparations that exceed all these cri
51. of the Active Substances Preparations and Relevant Chemicals concerned The risk evaluation should qualitatively take into account cumulative effects that may occur due to the nature of shipping and port operations 67 Od OO NOEC gt 0 01 mg l HU LU DU UU U UL UU UU LL UU V U UE U U U V UU UUUUUUUUUUUUUDUUUUUU UU UUUUUU 6 4 2 0 0 DO 0 0 0 L3 C3 C3 C3 C3 C3 C3 L2 C3 C3 C3 E3 EJ L3 L3 C3 6 4 3 The risk evaluation should consider the uncertainties involved in the application for approval and as appropriate provide advice on how these uncertainties can be dealt with 7 REGULATION OF THE USE OF ACTIVE SUBSTANCES AND PREPARATIONS 7 1 Handling of Active Substances and Preparations 7 1 1 The proposal for approval of Active Substances and Preparations should include information on their intended use and application The quantity of Active Substances and Preparations to be added to the ballast water and the maximum allowable concentration of the Active Substances therein should be described in the instructions provided by the manufacturer The system should ensure that the maximum dosage and maximum allowable discharge concentration are not exceeded at any time 7 2 Hazard documentation and labelling 7 2 1 The proposal should include M SDS as required The M SDS sh
52. which x of test organisms show 1 0 effect ECx as appropriate based on the experimental oooga design mo 31390e0OOOOOOOOOOOOOOOOOO OOODOOOODOODDODOOLDSOOODODODODOODODOO 1 up 313 000000000000000000000000 OOODDODOODOODDODODODODODOADODODODODADLODOADOODOODO D D D U E D U NOECO 9 OOODDODODOUODODOODOODODODADOODOODOODOODOODOD OD NOECODODOODODOODOUDODOODODOODODOODOODODOO 48 PEC PNEC 11 1 10 10100 D U PECI PNEC DUUDDUDDDBDUDUDUDUUDUDDBDUDBDDBDUDUDUDDDBDUUDUUDUDUDUDUDUDDUDLDUUDU OOOO 000000000000000000000N OOODOGSDOD 527DOOOODODODODOODODOOODODOODDOODOOD OOODODOODODDODOODODOODOULDODOODODODODOOOODOO ODOODOUDOODODDOODDOODODOADOODDODOOODODODDULIOODO OOODOUDOODODDODOODODOO OOODDODDODODODOUDODODODDODODODOUDOADOODO
53. 000 6 eP MS Word 0 0 OOODOOOODODDODOODODODOOOODODDOULD MEPCODOOOODO MEPC 53 24 2 28 0000 O0 0000 MOODOODDODOOOODODDODOODODOOD 6 GOODDODOO ODOODODDOUDLUMEPCDOODOODDUO GSOODODOODODOODOOOODO D Uu 000 00000 ODOODOOD O 100 8975 1111010000 122 TEL 03 5521 8246 FAX 03 3581 3348 1111111111 aan uuu O 100 8918 D DU D I 3 TEL 03 5253 8636 FAX 03 5253 1641 19 L LOOODODOODOODODOOD ODOODODOODOODDODOODOULODADODDODOOODODODODODOOD Mo OOOODOODODOOOOODDODOOOOOOOOOOO GESAMP The GESAMP Ballast Water Active Substances Working Group 0 00000000 0 0000000000000000 80000000000 0 0 0 2006 0 10 0 1110000000
54. 0000 000008008008 1S PEC PNEC s Nd 0000000000000000 00000000 dun 00000 0 00000000 0 0 0000000000000000000000000 0 0 0 0000000 0 0 0 00000000000000000000000000 0 0 0000000 0 80000000000000000 0000000000 0 0 1 000 OECD Emission Scenario Document for Antifouling Paints 0 the EU Technical Guidance Documents on Risk Assessment 0 0 000 Pech PNECOOOOOOO 0 0000000 8 0 080000000000000000000000000 0 9000 D http www oecd org document 46 0 2340 en 2649 34373 2412462 1 1 1 1 00 html 10 OO http ech jrc it new chemicals 53 D DO D 1110 PEC PNECH 10ODOOOODOODDOODODODODOODOODDODOD 1000 0000 3511110100 0 6 EVALUATION CRITERIA 6 The Organization should evaluate the application for approval based on the criteria in this section Dn 6 1 The information that has been provided should be complete 61 of sufficient quality and in accordance with this procedure i
55. 000000 ODODOUAUOOODABAOOAODUOOOOADADAOOWAEOUADAODAUAOOOO DOAODOUOOOOAAODOOADADUOUUWAOOADAUADUAUOAOAODADOO OOODDODUD2DOODUODODOODOODOODUDOODOODOOOODOO DU uuu IU D2 OO D2 1OO00000000T0 1 50um0 0000000 1m 1100000000 OOOAOO 10 umAOAOA 50umQQO0000000000 1 0 100000 3 10 BR BARE RA AA AR AG AB a R 200000000000T1 a nnnnnnnnn n 1 nog O00 10081 OO 1 cfu EX ea as noggg n lg 1 cfu cfu colony forming unit Q D D U JU 100 mL D O 250 cfu B UU OOOOOOOODOOOLO 100 mL 100 cfu OOOO OOODOODOODD DOODOODOODOOODODOOUDOODODOODOO OOODDODOODOODDODODODODODOADOODOOODODOODOODOO OOODODODOODOODOODDODOOO
56. 00000000 8800 0 000000000 0 0 0 0000000000000 8 80000000 0000000000 0 0 OOODOODODOODODODADOODDODOOODODODDODOODODY 0 El El HE OOODOODUDOODODDODOOODODODODODOUODODUSSOODOOLD OOOOLOO adsorption coefficient Koc UU halflife OOOO uncertainity 0 000 00 0 0000000000000 0 0080000000000 0 0 000 0 00 000000 00 8800000000800000000000 0 00000 0000000000 00000000 8 8000000000 I UI D D B U OU side product 0000 0000000 0 0 0 fre radical 0000000 0 0 00000 00008000000 1 501 8 OOODOOLODNADODDODOOODODODODODOOOODODOODOODODO OOODOODODOODODODODOODDODOOODODODDODOODODOO chronic and long term toxicity
57. 00000000000000 0 OOODDODOODOODDODDODODODOADODODODODODOOADOODOODO OOODOODODOODODODODODOODOUODODODODODOODDOD l OODOOODOODOOODOODDOODOUDDOODOODDOODDODOOD OOODODOUDOODDODOO GIOUOU 44000000000 S3OOOOOOOOOOOOOOGO GOOD S20OOODOOODOOAODOOODOOO 6OOOODODODODOODODOODODOADOADODODOOOODO 9 OOODOODODOODODDODOODODOOODODOODODOO 8 DOOODOOODOODOOODOODOOODODOADOODODOODOODDOO OUOOODOODOUODOUDOUODOODOOODOODOOODOODDO OOODOODODOODODODODOODDODO PT 26 380000 OOODDODOODOODDODDODODODOADODODODODODOADOODOODO OOODOODODOOODODOODDODOODODOODOULODODODOODOODOO 5 2 Toxicity testing of the treated Ballast Water 52 OOOOOOOOOOOOOg 5 2 1 5 2 10 00 2 For final approval the discharge testing should be 2 000000000000000000000000 performed as part of the land based type approval process using the treated ballast water discharge i a a Unnnnunnouuagnou 8 2 Final approval 82 0000 8 2 1 In accordance with regulation D 3 2 a Ballast Water 82 1 OO 32000000000000000 Management system using an Active Substance or 000 0 0000000000000000000 Preparation to comply with the Convention which I I received basic approval must be approved by the Organization For this purpose the Member of the uuuuuuuuuuuuunununununu Organizat
58. 4 1 1 1 1118 101010 1110 00 0 10100 000 0 U log PowD 1111111111 1 7 D U D leg Pew BCFI 1111 LU U 1 1 1 1 1 10 3 15900 8 530 BL B UO BEL B 7E D UO DI D U U logPow gt 3 U ugggagguuuguuualittllutldutlttlBCcr legPow lll U D D U L U 11111 101 1 11 lgPow gt 30 0000 2000000000000000 1 110 111 1 logPow 300000000000000 BEFOOUOUOOOOOOOOOOOOOOOUOODOOOODOUOOOOO 600 92500 1 1 1 1 1 1010010101 grow 00000000 BCF 500 e OECDOODOOD 3050 OOODODOODOODODY ODOODODOODODOODODDO 620 20 e 000000000000 5 3 9 The effect assessment of the Active Substances 539 QD0000000000000000000000 Preparations and Relevant Chemicals is initially based 000000000 0000000 0 0 0 on a dataset of acute and or chro
59. CD SIDS Manual Screening Information Data Set Manual of OECD Programme on co operative Investigation of High Production Volume Chemical D PNEC PNEC D D wes ss iddo En E HU ii EG 300000000000000000 ATH 300000000000000000 ia NEGERI 3OOOOOOOOOCOOO WO 313 PNEC 0000000 6 0 OOODDODOODOODDODODODODODOADODODODOADOOADOODOODO ODOODOUDOODODDODOODOAODODOODODODODDODODOOD 10000 OU PNECI UD D UU LU 00000 00000 00000 0 D D O00 DU x z um um um 3 um um o um 51 OOODOOOODODODODOODDODOODODOOODOUODDDODOODODOO 333 OODODOO 5 2 7 The acute and chronic toxicity test data in conjunction with 52 7 00 the information in Section 4 2 1 should be used to 0 determine the holding time necessary to achieve the no i uu adverse effect concentration
60. D discharge assessment should give rise to a further elaboration on the effect assessment 1 24 OOODOODOUDODOECDOOODOLDOGESAMPODODDOODODOODOODOODO D LE DI GESAMP Reports and Studies No 64 OD OODODODODOODODOO OOODOUDOODOODDODOODOADOADODOODOOODODODOODOODDOD OOODOOOODOODDODOODODOADODDODOODOADOOAODODOODODO OOODOOODODODDODOODODOADODODODOODODOOODODOODDODO OOODOODUDOODODODODOOOADODODODOODDODY 224 OODOODODOODODDODOO cep 4240 OODOODDODOOODODODODOODOODOULDODOODDODOO 4 2 4 The testing process should contain a rigorous guality control quality assurance programme consisting of 1 Both a Quality Management Plan QMP and a Quality Assurance Project Plan QAPP Guidance on preparation of these plans along with other guidance documents and other general quality control information are available for download from the International Organization for Standardization ISO www iso org 2 The QMP addresses the quality control management structure and policies of the Test Organization including subcontractors and outside laboratories 3 The QAPP is a project specific technical document reflecting the specifics of the system to be tested the test facility and other conditions affecting the actual design and implementation of the required experiments B el T
61. DDO 1 0 iDOOODOOODDOODO NOAELODODODOODODOODOODODO PECH PNEC 8 OOODOODODOODODDODOODODOPNECODOODOODODONOEC l OOODOODODOODODDODOODODOODODOODOODO PNECDODOO OOODDODODODODODOUDOODODODADOODOODOODOODOODDOD OOODOODODOODODDODOODODOODGSUOD 5314000000000 OOOODOODY a DOODOODDODOODODOODODOODODO OOODDODODODODODOUDODDODDODODODOUDOADOODODDO OUDOOODDODDOOUDODOODOOUDOOODOUDOOODDOUDOODODOODO b ODOOOODODODODOODODOOD OOODDODODODODODOUDODODODDODODODOUDOADOODODODO OOODDODODOUODODOODOODODOADOODOODOODOODOODOD ODOODDODODOUDODODOUDOODODODADOODOUDOODOODOODDOD OOODOODODOODODDODOODODOODODODODO WY 33300000 OOODOOADODDODOODODDODOODODOODODODODOODDODOO
62. DLU GO UU 4DOOOODODODODOODODOODOULODODODDODOOOOIDO HD 30 GSDOODOUDOODOODDODOOODODODDODOOADOADUODOAHDOODDODY D Uu 0 9 e JIUUUUIUUUUUDUDUDUDUUUUUUUUUUDUDUDUDDUUU 98 22 221 000000000 Oooo L3 4 2 2 A proposal for approval should include the above dataset 422 either for the Preparation or for each component 1 0000000000000000000 separately and a list of the name and relative quantities 0000 00000 0 00000000 0 0 in volumetric percentages of the components should be also attached As described in Section 8 1 all proprietary EE Te O00 data should be treated as confidential 23 ODOODOODOODOODOODOODODOODOODOOUDOODOODDOODDOLD OD GO OD42 AODODOODOODOODOUODODODODODOOOODODOODODO ODOODODOODODDODOODODOOODODODODODO 222 0000000000000 GOOD 4230ODODOODODOOUDODODODOOODODODOODOODODOOD 0000 4 2 3 The tests for Active Substances and Preparations should be 4 2 3
63. DODODOADODODODOADOODOODOOD OOODUO BEDOODODOODODOODOODODODOOOODODODODOODODO OOODDODOODOODDODDODODODOADOODOODODODADOODOODO IBCOOOODODODOOAOODODOOOOOOODODODOOO OODODOODOOOODODODDOOOADODUDOOOAAADDOOOUOOIBE Ea I q Sg EL m RS SE e NO a L3 L3 10 0000 11 1 UUUUUDUUUUUDDUUDUUmBCIUDUDUUDUUUUDUDUUUUUDD UUIUUDUUUUUDUDUUUUUDUDUUUUUDUDUUUUUDUUUDUU 8 e DD 4214 e OODDOOOOOOD e 91 1 01 6320000000000000 00 0 0 MSDSI 55 37000000000 4 3 Assessment report 43 4 3 1 A proposal for approval should include an assessment 431 0 00000000000000000000 report The assessment report should address the quality 0 00 of the test reports the risk characterization and a I I consideration of the uncertainty associated with the EE 000
64. DODODODOADOODOODODODADOADOODO OOODDODODODODODOUDOODOODOODOODGSOOD 213000000 OOODOOODUODOODDODOODODOODOODOOADODDUDOODGIODO OD OD OD Q UUIODUDDUDDUDDUUDUDDUUDDUUDUUDUUDUDUUDUUDUU OOODDODOODOODDODDODODODOADOODOODODOODOODOO OOODDODOODOODDODODOULODODOADOODOODODOODOODOO OOo 212 000000000000000 OOODOODOODODODODODOULODODODDODOAULOADOODOO OOODOUDOODOODDODOODOOODODODOODODODODOOOOODO OOOO OOODDODOODOODOODODODODOADOODOO El EI L1 L1 EA L1 L1 OOODDODOODOODOOODODOODOOD OODDODOOODODODDODODOOAODDODOO OOODDODOODOODOOODODOODOOD OOOODOODODODODOO OOODDODOODOODOOODADOODO OOODDODOODOODOOODADOODO 111111110 1111411 11111111111141114111111 0 OOODOODODOODODODODOODOLD 53 E1 AOA 53 E1 EL Om EU Ll EI EI EU El EE ES dl E iln SERT 21281 ES EE EXE p E
65. DOODODOODODODODODDO o 0000 E OOODOODOODOODOULD OODOODDOODOODOODOULD ES E5 Ei UUUIDUDDUDDUDDDUUDUDDUUDDUDDDDUU OOODODODDODOODODUOLDDOODODOODOUDOODODODOOLD e OECD HUDDUUD 400000000000 e OECD HDUUD 4020000000000 e OECD JHUDDUUD 4030000000000 e 00000000 UUDDDUDUDBDUDDUDBDUDDDUDUpPH2IDDDUDU HSDOODODOODOODODOO OOODDODOODOODDODDODODODOADODODODOADOADOODOODO 36 OOODOODODPHDOUDOODODODODOODDODOOODOADODODODOODOODY OOODODOODODODODOODDODOOODODODODODLOODDODO OOODDODODOUODODOUDOODODODADOODOUDOODOODOODDOD OOODODODODOODODOODODODADOODDODOOODADOODDODOO e OECD e OECD ODDODOO ODOD DO UDDUDD 4500000000000 ODOODOUDOODODODODOODDODOOODOADODODODLOODDOD e 311 406 Maximization GPMT Buehler
66. DOODOODOODODOODOODOODOODOODDOODDOD D Uu e 0 1 1 D 2010000000000 e OEDDDDDDD 220000000000000000 e 0 OOODOODODODODODOOOODODOODODDODODO 40000 1170 0 30 UU OODDOOOOLDDOOOOLDDDOOOOODLUDODOOOODDD http www env go jp chemi kagaku matl2 pdf 6020 EPA Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms http www epa gov waterscience WET disk2 120 30 000 UUDIUODUUDUDDUUDUUDUUDUDUDUUDUDUUDUUDUUDUUDDUDUDDOD UUUIDUDDUDDUDDDUUDUDDUUDDUDDUDDUU e 000000000000 5390 0000000000U0000000 OOODOUDOODODDODOODODOOLDPBTODOODODOU OOODOUDOODODDODOODODOOOO SODODOODODODODOOOODO OOODDODOODOODDODDODODODOADODODODODODOODOODOODO U0 G9 OECDOUUUUU 2010000000000 0101 11 0 2N0000000000 OECDO 00000 220 OECDO 1 1 UO HE 2150 D UL UL BE BE 7E 7E DE D D EPA Short term Methods for Estimating the Chronic Toxic
67. IDS Initial Assessment Report IUCLID Chemical Data Sheets http ecb jrc it ESIS U S EPA IRIS http www epa gov iris U S DHHS NTP Technical Report http ntp apps niehs nih gov ntp_tox index cfm WHO Environmental Health Criteria http Www who int ipcs publications ehc en U S EPA ECOTOX AQUIRE AOUatic toxicity Information REtrieval http w chemdb nies go jp aquire aquire htm DUUDDUDDUDDUDUDUDGGCSUUDDDDDUDUUUDUUUDUUUDUDUDDUDUDuDuuu http www nihs go jp ICSC http www env go jp chemi risk O WebKiss Plus http w chemdb nies go jp 28 http www safe nite go jp japan Haz_start html e http wwwdb mhlw go jp ginc index j html e E PBT Profile http www pbtprofiler net e Environmental Health Criteria EHC Monographs http www i nchem org pages ehc html e http physchem ox ac uk MSDS 90 6
68. ODOODOODOODOODOODOODODOODOODOODOODOODDOODDOLD OOODOOOODODDODOODODOOLDOIDDODOODODODADOODODY OOODOOOODODDODOODODOOLD e OECDODOUODUO 4100000000 e OECDOODOUDO 4530 DHL D UO 000000000 OOODDODOODOODDODDODODODOADODODODOADOADOODOODO D uuu UUIUDUUDUDDUUDUUDDUUDUDUUDUUDDUUDUUDUDUDDUUDUDOD e 471 Salmonella typhimurium E D D D e OECD DI D 473D in vitro D D D D D U UO U D LI UI e OECD I D III I 0 D D D UU D D DU D UO D DE D U D DI 3 1 5 OODODOODODDODOOAOODODOODOODODY OOODDODOODOODDODDODODODOADODODODOOADOOADOODOODO O00000 20000 SOODODOODOODOODODOODODODODOODODOO OOODOOOUDODDODOODODOODODODODODDODOGODU 421030 8 OOODOOOUDODDODODOOLDPBTODOODOODODOODODODODOODODOO OOODDODOODOODDODDODODODOADOODOODODOOADOODOODOO OOODOO 38 4 2 Data set for Active Substances and Preparations 42 4 2 1 A proposal for approval should include information onthe 42 1 QQ QQ00000000000000000000 properties or actions of the
69. ODOOIM L1 ECo ECODOODODO 14000 NOECOODODODOO 000 UDPBTUDIDDUUDDUUUDUDDDDUDDDDDUDIDGO9DDUD 64 10 OOODDODOODOODOODODODODOADOODOUDOOLD D uuu 1 0 0 OOOODDODO OODOODDODO OOODOOOO EI 0 1 EI II 2000 U BEE P SES EA AF DH EL EO 3 1 0 10 D mm D et D UI UU ACRI 11 7 on 4
70. ODOOOODOOOODOOOODO OOOOOOOOOOOAOOOAOOOOODOOOOOODOOOODOOOOOODOODO UD irritation 1 screening 0000000 1 reproductive and developmental toxicity 2 biomagnification 5 0 100 0 9 00000 D D biomagnification O0 O O DD bioaccumulation P bioconcentration biomagnification bioaccumulation bioconcentraion 7 O biomagnification OO OOOOODODOOOOOOODO O00 608801 0 000000000000 010
71. SSE SER ET EE ES ERSTE TF EST IE El EST EST EE ill EE EE TE SES ETS Ed ET cl 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 Ed Eh Ez TER CES Toe E eS Ed a ESI E ED E VE BE EE ET E GEI OIE E I TE ES EIE EE gt ES IET EZ EEN EI Ez EI ME EE EI E A EER E ES COEM EI EY EI E A AE EA ESI E El ETE EP HE EE E EI pajo E 7 me YN EST CES FINE VIE 1 epo pue SET LA E ET SET EIER EA EST ES EIEN FA ESI LE EER 121 del BEST mm CES SE EST EIER z EST LI ER E AE Et EI EI EA ET EN EI Ed EST SEI Lx MEI EI TESE EN EKEN ed ee di EIS EN HEEL ER Es 7 CT UDD OOO UDD UU UDD UU UU EZ ESI LES ESI EET ES an 1 9 L3 p3 LJ p Ed Susan D R er al 1999 http pubs acs org hotartcl est 99 research es981218c rev html 21 213PBT DO H DU D D 0 GOD ODOODODOODODOODOODOODODODODODDODODOODODOOLD OOODDODOODOODDODDODODODOODOODOUDODOODOODOODOO OOODDODOODOODDODDODODODOADOODOUDODOADOODOODOO OOODDODOODOODDODDODODODOADOODOODODODODOADOODOO OOODOOLDPBTODOOOUL GODO 64100000
72. UDOODOODDODOO 1 Marine Environment protection Committee MEPC 199300 19920 00000000000000 00 1992 1010101100 1 tit International Maritime 1 1 1 4 8 H D U OOODOODODOODODDODOIMIDO OOODOODODOO 200499 20 9000 4 IMOODODOO OOOOOOODDDDUDOUAOOODDDDUOOAAOODODODODDDOOOOI ANNEXO OD OODODDODOOOODODODODOODODOODUDOODOODODO OODODOODUDOODOODDODOO 11 0109000 o 2o IUUIUUIUUDUUUUDUUUDUDUDUDUUU LU OOODOOODUDOODOODOODODODODOODDODOOD OODODOODODOODODDU D AOOD OOODOODODODA DODOUDODDODOOODOADODO 20 B 1 1 1 1 B 300 1600 300 1700 0
73. UDUDUDUDUDUDUDUU uDLU OOODOODODOOODODOODDODOODODOOD OOODOOODODODDODOODODOODODOU 53000000 3 150OMDO OOODDODOODOODDODDODODODOADOODOODODODOADOADOODOO OOODDODOODOODDODDODODODOOADOODOUDODOODOODOODOO OOODOODUDOADODODODOOODODODDODOODODOODUDDOLUD NOEC OOODOODODOOODODODDODOODOLD 44 322 O0ODODOODODOODOODOO 4 2 6 The proposal should describe the manner of application of 42 6 00 the Preparation for Ballast Water Management including 0 required dosage and retention time og Ooo OOODDODOODOODDODDODIDOODOADODODODOODOADOODOOD 7LODOODDODOOODADODODODOODODOODODOODOODDOD ODOODOODOODOODOODOODODOODOODOODOODOODOODDOD 3 2 3 MSDS O 4 2 7 A proposal for approval should include Material Safety 4 2 7 00000000000000 0 0 0 5 np Data Sheets M SDS oooogg UUUIDDUIDDUDDDUUMMSDSUDUUUDUDUUUUDUDUDUUDDUUUUD OOODOOOLUDIISODODODOOODDISOODODODDOOODU MSDSOOODDODO OOODOLUOMSDSO 6SOODODOODOODDODOOODADODODDODOO OOODDODOOUODODOODOODODODADOODOODOODOODOODOD 000 MSDSOODODODODOODOODODODODODODDOODODODODOOOODY D uuu 3310000000000000
74. a ees n OO cour OO ooog E EXE TE 8 00 81 0000 811 DOOOOAUDAODOAUDIEHOOUDOOOU 812 000000000000 1 11 1 111 1 1 1 1 1 000000 2 Upon completion the manufacturer should prepare an Application on the Active Substances and Preparations and submit it to the Member of the Organization 11 1 11 1 concerned 3 The Administration having received a satisfactory application should as soon as possible propose an approval to the Organization OOOUOODUMOUAADUO 00000 4 Members of the Organization may propose an approval 5 The Organization should announce and set the time frame for the evaluation of Active Substances and Preparations 6 Parties Members of the Organization the United Nations and its Specialized Agencies intergovernmental organizations having agreements with the Organization and non governmental organizations in consultative status with the Organization may submit information that is relevant to the evaluation 7 The Organization should establish a Technical Group in accordance with its rules of procedure ensuring that proprietary data should be treated as confidential
75. acterization and analysis 53 0000000 5 3 9 The effect assessment of the Active Substances 53 9 Preparations and Relevant Chemicals is initially based on a dataset of acute and or chronic ecotoxicity data for aquatic organisms being primary producers algae or sea grasses consumers crustaceans predators fish and should include secondary poisoning to mammalian and avian top predators as well as data for sediment species O 0 0 L3 C3 J EER 11 10 1024 Ere 4218080000080 DOW DO BU DU 4 2 1 A proposal for approval should include information on 421 00000000000000000000000 the properties or actions of the Preparation including any 1 0000000000000000000 of its components as follows D Ll D 1 Data on effects on aquatic plants invertebrates fish and other biota including sensitive and representative organisms OU acute aquatic toxicity u chronic aquatic toxicity endocrine disruption sediment toxicity D D bioavailability biomagnification bioconcentration and food web population effects OOODOOODODOODDODOODODODODODDOLD o 00000000000 ODOODOOD 539 OODOOOODOODOODOODOODOODOODOODOOD D uuu 3O0ODOODOO
76. ation should use measured bioconcentration factors in marine or freshwater organisms Where these tests are not applicable or if logPow lt 3 Bio Concentration Factor BCF values may be estimated using Quantitative Structure Activity Relationship Q SAR models 3 C3 C3 L3 C3 C3 C3 59 C3 C3 C3 E3 C3 C3 L3 E3 C3 C3 EI ELE L3 L3 C3 C3 C3 CJ EICI ADGA 3 Toxicity tests 63 Acute and or chronic ecotoxicity data ideally covering the sensitive life stages should in principle be used for the assessment of the toxicity criterion 5 2 Toxicity testing of the treated Ballast Water 5 2 1 Toxicity testing is necessary for the Active Substance or Preparations see section 4 2 1 and 5 3 and the treated Ballast Water Discharge as covered in this section The advantage of conducting toxicity testing on the Ballast Water Discharge is that it integrates and addresses the potential for interactions of the Active Substances and Preparations with the possible by products 1 For the basic approval process the discharge testing should be performed in a laboratory using techniques and equipment to simulate Ballast Water Discharge following treatment by the Preparation 2 For final approval the discharge testing should be performed as part of the land based type approval process using the treated ballast water discharge 5 2 2
77. ballast water before discharge 5 3 Risk characterization and analysis 5 3 1 For the basic approval process fate and effect testing should be performed in the laboratory with Active Substances and Preparations This section lists information that could be useful for a preliminary risk characterization 5 32 Both the Active Substance or Preparation as well as the treated Ballast Water Discharge should be subject to toxicity testing in order to protect the receiving environment from toxic effects due to discharges 5 3 3 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 5 3 4 The rate of abiotic and biotic degradation of the Active Substances and Preparations under aerobic and anaerobic conditions should be assessed resulting in the identification of relevant metabolites in the relevant media ballast water marine and fresh waters 5 3 5 The rate of abiotic and biotic degradation of the Active Substances and Preparations under aerobic and anaerobic conditions should be assessed resulting in the characterization of the persistence of the Active Substances Preparations and Relevant Chemicals in terms of degradation rates under specified conditions e g pH redox temperature 5 3 6 The partition coefficients solids water partition coefficient Kd and or organic carbon normalized distributi
78. circulate the list once a year including the following information Name of Ballast Water Management system that make use of Active Substances and Preparations Date of approval Name of manufacturer and Any other specifications if necessary 8 4 Modification 8 4 1 Manufacturers should report any modifications in names including trade and technical name composition or use of the Active Substances and Preparations in the Ballast Water Management systems approved by the Organization to the Member of the Organization The Member of the Organization should inform the Organization accordingly 8 4 2 Manufacturers intending to significantly change any part of a Ballast Water Management System that has been approved by the Organization or the Active Substances and Preparations used in it should submit a new application 8 5 Withdrawal of approval 8 5 1 The Organization may withdraw any approval in the following circumstances 1 If the Active Substances and Preparations or Ballast Water 70 Management system that make use of Active Substances no longer conforms to requirements due to amendments of the Convention 2 If any data or test records differ materially from data relied upon at the time of approval and are deemed not to satisfy the approval condition 3 If a request for withdrawal of approval is made by the Member of the Organization on behalf of the ma
79. city should be conducted see 0000 Table 1 in Section 6 1 000000 1 Persistence tests Persistence should preferably be assessed in simulation test systems that determine the half life under relevant conditions Biodegradation screening tests may be used 000000000000000000000 0 to show that the substances are readily biodegradable The determination of the half life should include O0OAOA0A0OABADADADADOn assessment of relevant chemicals uu 000000000 GOOI 4 10 1 9 0 DU DDD 534000 535O0O0DODOODODOODODOODODODODOODDOD ODOODODOODODODODODODODOOOOD 39 5 3 4 The rate of abiotic and biotic degradation of the Active Substances and Preparations under aerobic and anaerobic conditions should be assessed resulting in the identification of relevant metabolites in the relevant media ballast water marine and fresh waters 5 3 5 The rate of abiotic and biotic degradation of the Active Substances and Preparations under aerobic and anaerobic conditions should be assessed resulting in the charact
80. ention OOOOOH a Oooo 4 Relevant Chemicals means transformation or reaction products that are produced during the treatment process or in the receiving environment and may be of concern to the aquatic environment and human health when 60 discharged 3 PRINCIPLES 3 1 Active Substances and Preparations may be added to the ballast water or be generated on board ships by technology within the Ballast Water Management system using an Active Substance to comply with the Convention nog ma ua an nog 00g nog Cnm nog nog ooo ooo ooo ET TE ooo ooo ooo ooo ooo ooo oo oo oo oo 3 2 Active Substances and Preparations accomplish their intended purpose through action on Harmful Aquatic Organisms and Pathogens in ships ballast water and sediments However if the ballast water is still toxic at the time of discharge into the environment the organisms in the receiving water may suffer unacceptable harm Both the Active Substance or Preparation as well as the Ballast Water Discharge should be subjected to toxicity testing in order to protect the receiving environment or human health from toxic effects due to the discharges Toxicity testing is needed to determine if an Active Substance or Preparation can be used and under which conditions the potential of harming the receiving environment or human health is acceptably low Oooo
81. erization of the persistence of the Active Substances Preparations and Relevant Chemicals in terms of degradation rates under specified conditions 5 3 4 Oooo Oooo Oooo Oooo L3 L3 53 L3 Og L3 EE L3 L3 L3 L3 L3 5 3 5 nun ms noo BAAS Sees EE EIS HEES ooog ooog ooog nooo nooo LE fg E E EO HER OOOOA C3 C3 C3 c3 C3 L3 C3 c3 c3 c C3 C3 C3 c3 e g pH redox temperature U OOO UU OD OOODDODOODOODOUDOOODODOOADOODOODOODOODODO OOODOODOODOODDODODODODODODODODOOADLOADOODOODY OOODOODUDOODODODODOOODOADODDODOODODOOLD OECD OD 1 pHODOODODOOOODDOODOODODOU pHS 7 9 OECD O00000 3010000000000 5 1 1 1 Duda 306DODODODOODODO 1 98 301 OOODOODODODODOO Uu OOO 0 0 0 0 0 OOODOOOODODODODOODDODOODODOODOULODODODO Koc 7500 L kg I O0 OECD 3080 OODODOODODOODOOODDOO OOODDODOODODDODODODOODOADOODOODODOODOODO I10DDODOOODODOODODOO 100000
82. ertaken assessment of PBT and the discharge with scientific knowledge of the Active Substances Preparations and Relevant Chemicals concerned The risk evaluation should qualitatively take into account cumulative effects that may occur due to the nature of shipping and port operations 6 4 3 The risk evaluation should consider the uncertainties 6 4 3 involved in the application for approval and as appropriate provide advice on how these uncertainties can be dealt with Oo Oo OOO r3 oo o Ej EJ E EJ L3 LL ooo Ha Oooo 52600000000 ru 09 OPEC O PNEC ODOODOOOODOODDODOODODOODULDPECDODOODOODOD OECD SIDS Manual JU O PECO PNEC DODOOOODOODODOUOD 0 508 600038 mc D0DDDDDDODUUDUUD 0008888008 00008 8 8 8 8 0000000
83. evant Chemicals 3AMOODODOODODOADOOODOAOAODDOODDOODODOADOOODO 9 9 000212 0000000009 0 9 OOODDODOODOODDODDODOODOADOODOUDODOOADOODOODOO 1 1010100000 312 O0ODOUDOODOODODOO 4 2 Data set for Active Substances and Preparations 42 properties or actions of the Preparation including any of its components as follows A proposal for approval should include information on the 4 2 1 g ggggggggugu 4 2 1 Dant o 0000000000000000 00 U D GESAMP Reports and Studies No 64440 OODODOODOOOODO 2 1
84. ew De Y Y O OOOhO nana le 16 2 EE HE EE dd AO ELE OADM ese i e on do ae o edes 16 3 D0000000 OR ad ema tei mer d acd OR N NT 18 AS ER S o one bc Ee YF CON 07 8 19 BEE DE EE en ee sa Y RYN DYN ANN 19 re re re er eer 19 Tg gd gn ln DA ars Foss atx rez bess 20 1 0000000000000000 20 Eel Eh NO 20 ee rune oc 20 LY AE RE Re ee 20 2 3 2 EE ENE H BH eN YU RYD cle Fae O Y ur 21 Ra Par EE BR ELDERS Ge A A ee 22 22 214 OR RR RED UR DE OE ENE 23 EE BERE D EG Nr 23 gt gt CU ED toe de ee se esc oe 24 2 2 2 TH TE EID TE AD EO EER EI EE each O ur CT 24 2 23 naa We aa ATR EE ea ane 25 25 225000000000000000 DI CEE E a a S SE ih AU XI 26 2 26 TTA TE KEN ESE PEE Ch op asa dre ie ERU eY 26 23 EDE IO Y ee ERU e rtm Sot Gat 26 SEE Besa Baw ee ee alee AEG pope 26 26 3110000000 27 or EE EED Bn Re EJ HEEL NUM ee susu sua ea 29 SA ERG MER Gh EE psta um sp a SD aD Pen SSH N 35 L5 E AE E E EP
85. g on carcinogenic mutagenic and endocrine disruptive properties If the screening results give rise to concerns this should give rise to a further effect assessment 5 3 13 The effect assessment of the Active Substances Preparations and Relevant Chemicals taking the indicated information into account should be based on internationally recognized guidance Such as relevant OECD guidelines or equivalent 5 3 14 The results of the effect assessment are compared to the results of the discharge toxicity testing Any unpredicted results e g lack of toxicity or unexpected toxicity in the discharge assessment should give rise to a further elaboration on the effect assessment 5 3 15 An analytical method suitable for monitoring Active Substances and Preparations in ballast water discharges should be available 6 EVALUATION CRITERIA The Organization should evaluate the application for approval based on the criteria in this section 6 1 The information that has been provided should be complete of sufficient quality and in accordance with this procedure 6 2 That this information does not indicate possible unacceptable adverse effects to environment human health property or resources 66 0 0 0 0 0 0 0 DO DD O0000 BCF 500L
86. he test bed The Member of the Organization I I 1 Request for Organization additional 1 gt data set Confirm residual toxicity of discharged ballast water I IMO Technical Group with the evaluation under the basic approval 1 L Approve the Ballast Water Management system that Organization MEPC make use of Active Substances The Member of the Organization Publish list of approvals 12 U DO oo oo oo oa oo oo oo oo aI aI aI aI aI AO AO AO AO AO Lr Lr Lr E L1 L1 E OOODODOODODODODOODDO IMOOOOODOADOUADAOAOAOO 111111 1111101111111111111 1 11 1111 AE OO DB OE Uu OOODOODUODOODODODODOOOODO
87. ical identification should be provided for any Relevant Chemicals 4 2 Data set for Active Substances and Preparations 4 2 1 A proposal for approval should include information on the properties or actions of the Preparation including any of its components as follows 1 Data on effects on aquatic plants invertebrates fish and other biota including sensitive and representative organisms acute aquatic toxicity chronic aquatic toxicity endocrine disruption sediment toxicity 61 bioavailability biomagnification bioconcentration and food web population effects 2 Data on mammalian toxicity acute toxicity effects on skin and eye chronic and long term toxicity developmental and reproductive toxicity carcinogenicity and mutagenicity 3 Data on environmental fate and effect under aerobic and anaerobic conditions modes of degradation biotic abiotic bioaccumulation partition coefficient octanol water coefficient persistence and identification of the main metabolites in the relevant media ballast water marine and fresh waters reaction with organic matter potential physical effects on wildlife amp benthic habitats potential residues in seafood and any known interactive effects 4 Physical and chemical properties for the Active Substances and Preparations and the treated ballast water if applicable melting point boiling poin
88. ion submitting an application should conduct ODOOUAODOODOADAOODAUDAOOY the Type Approval tests in accordance with Guidelines 000 for Approval of Ballast Water Management Systems The results should be conveyed to the Organization for confirmation that the residual toxicity of the discharge 000000000 320000000000 conforms to the evaluation undertaken for Basic Approval This would result in Final Approval of the I I i 5 i i Ballast Water Management system in accordance with regulation D 3 2 Active Substances or Preparations that have received Basic Approval by the Organization may be used for evaluation of Ballast Water Management systems using Active Substances or Preparations for Final Approval 57 PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES G9 pump RESOLUTION MEPC 126 53 Adopted on 22 July 2005 PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES G9 THE MARINE ENVIRONMENT PROTECTION COMMITTEE RECALLING Article 38 a of the Convention on the Inte
89. ity of Effluents and Receiving Waters to West Coast Marine and Estuarine http www epa gov nerleerd westmethman htm ISO 10253 Water quality Marine algal growth inhibition test with Skeletonema costatum and Phaeodactylum tricornutum OOOO00 8 1 11 1 8 NOEC lt 0 01 mg 00000000 0 8 0 18 0 300000000000 31 OD NOECUOODODDOODOODOODODOODUDLOOECDODODOU 21000000 OOODDODOODOODDODDODODODOADODODODODADOOADOODOODO ODOODODOODODODODOODDODOOOODOLD NOECODOODOOOOD NOECODODDODODOODODOOOODODDODUODOODU NOEC OOODODDUDOODO i 48 960 00 ECse I I I DU DU I UU DU UI U UU NOECODOOOOODODO 10008 000000 i UUUDUDDUDUUDDUUDDUUDDUUUDUUUDUUUDUUUDDDUU OOODOOOODOODDU NOECDUOODODUODOOPBTOODOODOOODODO OOODOOODUDOODDO
90. lattl u the Organization and its Technical Group the Competent 1 00000000000000000000 0 0 Authorities involved and the evaluating regulatory 000000 scientists if any 10 MO DOODOODOADOADOODY DO D U D L 0 OOODOODODOOODODOODDODOODODOOD Ei Ei 3 G9UOOOOOOOOOOOOGO 3 4OUDOODODOOOODODODODOODODOODODDDODOODODOLD OOOOODOOODOODODOODDOODDODOODOODDODOODSIOODODOO DU Uu 3 11 0000000 9 DU Uu 26 4 GENERAL REQUIREMENTS 4000000 4 1 Identification 41 OO 4 1 1 The proposal for approval of an Active Substance or a 411 Preparation should include a chemical identification and description of the chemical components even if generated onboard A chemical identification should be provided for any Rel
91. ng any of 0000 000000000 00000 00000 its components as follows unn 4 Physical and chemical properties for the Active Substances 4 890 899098980 9 009880 and Preparations and the treated ballast water if applicable uu melting point OOO boiling point nma flammability 0 0000 density relative density vapour pressure vapour density 00000 A Unn K water solubility dissociation constant pKa 00000 40000 pKall oxidation reduction potential 0000000 corrosivity to the materials or equipment of normal ship construction autoignition temperature and other known relevant physical or chemical hazards 00 0000000000000000000 0 OODOOODDOOODODOAODODOAODODOAOODOOAODODAAODODAAODOA ODOOOODOOODODOOODOOOODOOOODODOOODOOOODDOOOODDOO OOODOODUDOODOODDODY o 1 00000000 OUPAOODOOOCASOOOOOOOOOOOOOO EC USO 2 000000000000 3 5 4 5 6 OOO 7 0000 86 OO 9 O00000 10 000 11 Da d U 0198 B d BD B B O U UI UI V CI DI 12 00 0 pKa 13 0000 000000 14 00000000000000 15 0000000000000000 000000000 16 00000000 17 00000000000 isa 0000000000000000 000000000000000000000000 OOO 00000 43
92. nic ecotoxicity data for 0000 000 0 000 0 00000 0 000 aquatic organisms being primary producers algae or sea grasses consumers crustaceans predators fish and should include secondary poisoning to mammalian and UDUDDUDDUDUUDUDUUDUDDUD avian top predators as well as data for sediment species 5 3 10 An assessment of secondary poisoning is redundant if the 5 3 10 H o H O H o H H H H H D H H H H o H H O H o substance of concern demonstrates a lack of bioaccumulation potential e g BCF lt 500 L kg wet a T B in L i Ban E SOOL kg Wet weight for the whole organism at 6 fat 0 e OODOODOODOOODODOODOODOODOODOOUDOOODODOODOOD D uuu e OODOODOODOOODODOODOODOODOODOOUDOOODODOODOOD OOODOODOD OOODOODODODOD OOOGSODO S310OOOOMOOOOOOOOOOOOOOOOOOOOOOOOOG OOODOOOODODDODOODODOODODODODODDO 314000000000 1 9 uuu
93. nufacturer 4 If unreasonable harm to environment human health property or resources is demonstrated by any Member of the Organization or observer to have been caused by the approved Ballast Water Management system that make use of Active Substances or Preparations Appendix Approval Scheme for Active Substance or Preparation and Ballast Water Management systems that make use of Active Substances 71 Appendix Approval Scheme for Active Substance or Preparation and Ballast Water Management systems that make use of Active Substances 1 BASIC APPROVAL Discharge Test data Discharge Time Submit Etc Only laboratory scale data is necessary and discharge time is predicted in simplified dilution model The Member of the Organization Dossiers of existing registration may be submitted Evaluate as confidential Risk Characterization and Analysis Basic Approval by and report to Organization submit application Request for additional data set Organization i 34 IMO Technical Group Organization MEPC For approved Active Substances the Organization circulates the list to the Parties The Member of the Organization 2 FINAL APPROVAL Manufacturer Using Active Substances that have received basic approval Data set Discharge Test data Discharge Time Discharge test with whole Type Approval according to relevant IMO guidelines system on t
94. on coefficient Koc of the Active Substances Preparations and Relevant Chemicals should be determined 5 3 7 For Active Substances and Preparations the potential for 65 bioaccumulation should be assessed in marine or freshwater organisms fish or bivalves if the logarithm octanol water partition coefficient logPow is 73 5 3 8 Based on the information on fate and behavior of Active Substances and Preparations the discharge concentrations at selected time intervals should be predicted 5 3 9 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 algae or sea grasses consumers crustaceans predators fish and should include secondary poisoning to mammalian and avian top predators as well as data for sediment species 5 3 10 An assessment of secondary poisoning is redundant if the substance of concern demonstrates a lack of bioaccumulation potential e g BCF 500 L kg wet weight for the whole organism at 6 fat 5 3 11 An assessment of sediment species is redundant if the potential of the substance of concern to partition into the sediment is low e g Koc 500 L kg 5 3 12 The effect assessment of the Active Substances Preparations and Relevant Chemicals should include a screenin
95. ould describe appropriate storage and handling together with the effects of degradation and chemical reactivity during storage and should be included in the instructions provided by the manufacturer 7 2 2 Documentation of hazards or the M SDS should conform to the UN Globally Harmonized System of Classification and Labelling of Chemicals GHS and the relevant IMO regulations e g the IMDG Code and guidelines e g the GESAMP Hazard Evaluation Procedure Where these regimes are not applicable relevant national or regional regimes should be followed 7 3 Procedures and use 7 3 1 Detailed procedures and information for safe application of Active Substances and Preparations on board should be supplied and comply with the approval conditions such as maximum allowable concentration and maximum discharge concentration if any 8 APPROVAL 8 1 Basic approval 8 1 1 All proprietary data should be treated as confidential by the Organization and its Technical Group the Competent Authorities involved and the evaluating regulatory scientists if any 8 1 2 Procedure to be followed 1 The manufacturer should evaluate the Active Substances or Preparations and the potential discharge in accordance with the approval criteria specified in this procedure 68 uuu 7100000000 711 00000 LI D D D OOOOO BH L2 C3 C3 C3 C3 CJ nooo m nooo m nooo m nooo m nooo m a eo s
96. rganization should evaluate M SDS mammalian toxicity data and chemical properties hazards see paragraphs 4 2 1 2 and 4 2 1 4 and ensure that potential hazardous properties of the Active Substances Preparations or Relevant Chemicals should not create any unreasonable risk to the ship or personnel This evaluation should take into account the different circumstances that a ship or personnel may face in its trade e g ice tropical humidity etc oo oo ooo Sa 6 Nn Ci pm zu 4 e 3 o o mm mm rn o Lr S o L3 C3 C3 C3 C3 C3 Foo e yoo L3 de Cm aa t2 T ijo Hn 310 24 o o0000g g0 Onno soy a a 31 2 a y EI 00 00000 mn HEER HEER OO EE ua mm 0 0 IMO OQ The International Code for The Construction and Equipment of Ships Carrying Dangerous 54 Chemicals in Bulk OD ODDODOODODOODODOODODOODOODOODOLDIBE OOODDODOODOODDODDO
97. rnational Maritime Organization concerning the functions of the Marine Environment Protection Committee conferred upon it by the international conventions for the prevention and control of marine pollution RECALLING ALSO that the International Conference on Ballast Water Management for Ships held in February 2004 adopted the International Convention for the Control and Management of Ships Ballast Water and Sediments 2004 the Ballast Water Management Convention together with four Conference resolutions NOTING that Regulation A 2 of the Ballast Water Management Convention requires that discharge of ballast water shall only be conducted through Ballast Water Management in accordance with the provisions of the Annex to the Convention NOTING FURTHER that Regulation D 3 2 ofthe Annex to the Ballast Water Management Convention provides that Ballast Water Management systems that make use of Active Substances or Preparations containing one or more Active Substances used to comply with this Convention shall be approved by the Organization based on a Procedure developed by the Organization NOTING ALSO that resolution 1 adopted by the International Conference on Ballast Water Management for Ships invited the Organization to develop this Procedure as a matter of urgency HAVING CONSIDERED at its fifty third session the draft Procedure for Approval of Ballast Water Management systems that make use of Active Substances developed by the Ballas
98. t flammability density relative density Vapour pressure vapour density water solubility dissociation constant pKa oxidation reduction potential corrosivity to the materials or equipment of normal ship construction autoignition temperature and other known relevant physical or chemical hazards 5 Analytical methods at environmentally relevant concentrations 4 2 2 A proposal for approval should include the above data set either for the Preparation or for each component separately and a list of the name and relative quantities in volumetric percentages of the components should be also attached As described in Section 8 1 all proprietary data should be treated as confidential 4 2 3 The tests for Active Substances and Preparations should be carried out in accordance with internationally recognized guidelines Preferably Organization for Economic Cooperation and Development OECD Guidelines for Testing of Chemicals 1993 or other equivalent 4 2 4 The testing process should contain a rigorous quality control quality assurance programme consisting of 62 0000000 0 Lac Oooo Oo Og Oooo Oo L3 Og u pKa
99. t Water Working Group 1 ADOPTS the Procedure for approval of Ballast Water Management Systems that make use of Active Substances as set out in the Annex to this resolution 2 INVITES Governments to apply the Procedure as soon as possible or when the Convention becomes applicable to them and 3 AGREES to keep the Procedure under review 58 D MEPC 126 53 2005 70 22000 G9 38 ANNEX PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES G9 Contents 1INTRODUCTION 2 DEFINITIONS 3 PRINCIPLES 4 GENERAL REQUIREMENTS Identification Data set for Active Substances and Preparations Assessment report 5 RISK CHARACTERIZATION Screening for persistency bioaccumulation and toxicity Toxicity testing of the treated Ballast Water Risk characterization and analysis 6 EVALUATION CRITERIA Ship and personnel safety Environmental protection 7 REGULATION OF THE USE OF ACTIVE SUBSTANCES AND PREPARATIONS Handling of Active Substances and Preparations Hazard documentation and labelling Procedures and use 8 APPROVAL Basic approval Final approval Notification of approval Modification Withdrawal of approval Appendix Approval Scheme for Active Substances or Preparations
100. t Concentration NOEC and or Effect Concentration at which x of test organisms show effect ECx as appropriate based on the experimental design 64 piu oo 32 C nooo Oo nooo H o mn aO g ooooo 523 000000000 G C3 L3 CJ oong EET E L3 C3 C3 C3 L3 CJ 5 2 6 A dilution series including a 100 ballast water discharge would be tested to determine the no adverse effect level using the statistical endpoints NOEC or ECx An initial analysis could use a conservative approach where the dilution capacity would not be taken into consideration no modelling or plumes analysis would be used The rationale for taking a conservative approach is that there could be multiple discharges into one location even though this is not necessarily the case 5 2 7 The acute and chronic toxicity test data in conjunction with the information in Section 4 2 1 should be used to determine the holding time necessary to achieve the no adverse effect concentration upon discharge Knowing the half life days decay rate dosage rate volume of system and toxicity tests with time series then a computational model can be used to determine the amount of time needed to hold the treated
101. teria Persistence Bioaccumulation and Toxicity in the table below are considered PBT Table 1 Criteria for identification of PBT substances Criterion PBT criteria 6 3 1 Sa lt go n no 5 5 2 L3 L3 e Oo o 3 22 2 2 22 OAOOOOOOOER m OOOOOR sie am La o0000 EO ia lt oo000gp Onno a a ro so 3 3 22 2 2 os os fos oo oes Loy OOOOOOOYEO EXE EE E Persistence Half life 7 60 days in marine water or gt 40 days in freshwater or 7 180 days in marine sediment or 7 120 days in freshwater sediment Bioaccumulation BCF gt 2 000 or LogP octanot water 23 Toxicity Chronic NOEC gt 0 01 mg l UU uu BCF gt 2 000 00 LogPoctanol water gt 3 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 6 4 2 The Organization should determine the overall acceptability of the risk the Preparation may pose in its use for Ballast Water Management It should do so by comparing the information provided and the undertaken assessment of PBT and the discharge with scientific knowledge
102. tion 00 000 OOODDODODODOODOODOODDODOODOODOOODADOODOODY PBT criteria PBT 1 I DL PEC PNEC Pow QSAR SIDS TSS Persistence J OO Bioaccumulation O 00 EL O Toxieity 0 OO OOOOOOOOOOOOOOOOOOOOOOOOOOOOOOA PBTOOOOOOOOOOOO Predicted Environmental Concentration O00000 Predicted No Effect Concentration L a octanol water coefficient DO 0000 00000 000 Kow dog PowQ OU log Kow l DOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOGO Quantitative Structure Activity Relationships 0 0 0 0 0 00 Screening Information Data Set OECD gPVCDO DD D D
103. tive Substances and Preparations 1 4 This procedure is not intended for the evaluation of the efficacy of Active Substances The efficacy of Ballast Water Management systems that make use of Active Substances should be evaluated in accordance with the Guidelines for Approval of Ballast Water Management Systems 1 5 The goal of the procedure is to ensure proper application of the provisions contained in the Convention and the safeguards required by it As such the procedure is to be updated as the state of knowledge and technology may require New versions of the procedure will be circulated by the Organization following their approval 2 DEFINITIONS 2 0 2 1 For the purposes of this procedure the definitions in the 21 Convention apply and 1 Active Substance means a substance or organism including a virus or a fungus that has a general or specific action on or against Harmful Aquatic Organisms and Pathogens 2 Ballast Water Discharge means the ballast water as would be discharged overboard oO OOOOOH pH 3 Preparation means any commercial formulation containing one or more Active Substances including any additives This term also includes any Active Substances generated onboard for purposes of Ballast Water Management and any relevant chemicals formed in the Ballast Water Management system that make use of Active Substances to comply with the Conv
104. tive of the discharge from the Ballast 0 0000000000000000000 00 Water Management system oo 5 2 4 These toxicity tests should include chronic test methods 324 QOOQUO0000000000000000000 with multiple test species a fish an invertebrate and a 1101 0 plant that address the sensitive life stage The OOOOOOOOOOOODODOOOOOOOOOg preference is to include both a sub lethal endpoint OOOOOOOOOOOOOOOOOOOOOOg growth and a survival endpoint Either freshwater or 1 0 00 0000 0000000000 000 0 0 marine test methods should be tested 0 Currently there is no compelling physiological or bnubD DDUDDOUDDDDDDHDDHDDU empirical proof that marine organisms are more sensitive U i i 1 oe freshwater organisms or vice versa Should this owever be demonstrated for the substance under consideration this should be taken into account 5 2 5 The test results to be provided include acute 24 hour 52 5 48 hour 72 hour and 96 hour Lethal Concentration at 240 480 720 960 0000 0 0 0 xe 000 which x of the test organisms die LCx No Observed Adverse Effect Concentrations NOAECs chronic No DE E 2 Observed Effect Concentration NOEC and or Effect Concentration at
105. upon discharge Knowing the half life days decay rate dosage rate volume of system and toxicity tests with time series then a L computational model can be used to determine the uu amount of time needed to hold the treated ballast water uu before discharge 5 3 8 Based on the information on fate and behavior of Active Substances and Preparations tne discharge 7 DDUDUUUUUUDUDDDDDDDDDDD predicted HOO WO 3311 11 1111111111 111 11 1 111 1 11101 11 11 111 11 1 11 1 11 111 111 111111 11 11 111 111 1 11101 1 1 11 11 1 1 1 11 1 11 111 111 111111 11 1 10 1 1 11 11 1 111 1 11 1 11 111111 1 1 111 1 1 1 11 1111 11 1 11 111 111 111111 111 1 1 1 1 1 01 1 11 1 1 11 1 11 111 111 111111 1111 111 111 1110110101 01 111111 1 1 1 1 111 1 111111 111111 1010 52 34QH0000UU00U0000 6 4 2 The Organization should determine the overall 6 4 2 acceptability of the risk the Preparation may pose in its use for Ballast Water Management It should do so by comparing the information provided and the und

Download Pdf Manuals

Related Search

Related Contents

SERVICE MANUAL Level 1&2  Estilbo Vitaminado  ARCS 取扱説明書  Fujitsu FUTRO S900  UBEF7F(37-39)  Porter-Cable 725 Saw User Manual  Mode d`emploi Tattoo Temporaire      Soleus Air PE1-09R-30 User's Manual  

Copyright © All rights reserved. Failed to retrieve file