1 INTRODUCTION
Clasification Society 2024 - Version 9.40
Statutory Documents - IMO Publications and Documents - Circulars - Ballast Water Management - BWM.2/Circular.13/Rev.4 – International Convention for the Control and Management of Ships' Ballast Water and Sediments, 2004 – (20 July 2017) - Annex – Revised Methodology for Information Gathering and Conduct of Work of the GESAMP-BWWG. Approved by MEPC 71 on 7 July 2017 - 1 INTRODUCTION

1 INTRODUCTION

 This document contains the Methodology for information gathering and conduct of work of the GESAMP-BWWG when undertaking technical evaluations in accordance with the Procedure for approval of ballast water management systems that make use of Active Substances (G9) (adopted by resolution MEPC.169(57), as revised, hereinafter referred to as Procedure (G9)).

1.1 Terms and definitions

For the purpose of this Methodology, these definitions are intended to supplement those in the Ballast Water Management Convention to facilitate a consistent evaluation of submissions:

  • .1 Ballast Water Management Convention (the Convention) means the International Convention for the Control and Management of Ships' Ballast Water and Sediments, 2004.

  • .2 Ballast Water Management means mechanical, physical, chemical and biological processes – either singularly or in combination – to remove, render harmless, or avoid the uptake or discharge of harmful aquatic organisms and pathogens within ballast water and sediments.

  • .3 Ballast Water Management System (BWMS) means any system which processes ballast water such that meets or exceeds the ballast water performance standard in regulation D-2. The BWMS includes ballast water treatment equipment, all associated control equipment, piping arrangements as specified by the manufacturer, control and monitoring equipment and sampling facilities. For the purpose of this Methodology, BWMS does not include the ship's ballast water fittings, which may include piping, valves, pumps, etc., that would be required if the BWMS was not fitted.

  • .4 Preparation means any commercial formulation containing one or more Active Substances including any additives. This term also includes any Active Substances generated on board for purposes of ballast water management and any Relevant Chemicals formed in the ballast water management system that makes use of Active Substances to comply with the Convention.

  • .5 Active Substance (AS) means a substance or organism, including a virus or a fungus, that has a general or specific action (chemical or biological) on or against harmful aquatic organisms and pathogens.

  • .6 Relevant Chemical (RC) means transformation or reaction product that is produced during and after employment of the ballast water management system in the ballast water or in the receiving environment and that may be of concern to the ship's safety, aquatic environment and/or human health.

  • .7 Other Chemical (OC) means any other substance, other than the Active Substance(s) or Relevant Chemicals, potentially associated with the system either intentionally or resulting from the treatment of ballast water.

  • .8 Basic Approval (BA) means the preliminary approval of Active Substances and the ballast water management system that uses them in order to comply with the Ballast Water Management Convention. Basic Approval should confirm that the available information does not indicate possible unacceptable adverse effects or a potential for unreasonable risk to environment, human health, property or resources. This should include consideration of potential risks associated with the Active Substance during full-scale deployment on commercial ships when possible.

  • .9 Final Approval (FA) means the approval of a ballast water management system using an Active Substance or Preparation to comply with the Convention and includes an evaluation of the whole effluent toxicity (WET) tests performed as part of the land-based Type Approval process in accordance with the Guidelines for approval of ballast water management systems (G8). The review does not include the re-evaluation of efficacy testing results conducted by Administrations under the 2016 Guidelines (G8). The Final Approval should confirm that previous evaluations of risks to ship, crew and the environment including storage, handling and application of Active Substances or Preparations remain valid and the concerns expressed during the Basic Approval process have been addressed, as well as that the residual toxicity of the discharge conforms to the evaluation undertaken for Basic Approval.

  • .10 GESAMP-Ballast Water Working Group (GESAMP-BWWG), also being referred to as the Group, means the Technical Group consisting of independent experts acting in their individual capacity that review the proposals for approval of ballast water management systems that make use of Active Substances submitted by the Administration and report, through the GESAMP, to the MEPC. When reviewing the proposals, the Group should take account of any other relevant data as well as other relevant information submitted to it, or the Group is aware of, because of its members' expertise.

  • .11 GESAMP is the IMO/FAO/UNESCO-IOC/WMO/IAEA/UN/UNDP/UNEP/UNIDO Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection, an advisory and multi-disciplinary body consisting of specialized experts nominated by the sponsoring agencies. Experts working for the GESAMP act independently in their individual capacity.

  • .12 Land-based testing means a test of the BWMS carried out in a laboratory, equipment factory or pilot plant including a moored test barge or test ship, according to parts 2 and 3 of the annex to the 2016 Guidelines (G8), to confirm that the BWMS meets the standard described in regulation D-2 of the Convention.

  • .13 Major components means those components that directly affect the ability of the system to meet the ballast water performance standard described in regulation D-2.

  • .14 System Design Limitations (SDL) of a BWMS means the water quality and operational parameters, determined in addition to the required type approval testing parameters, that are important to its operation, and, for each such parameter, a low and/or a high value for which the BWMS is designed to achieve the performance standard of regulation D-2. The System Design Limitations should be specific to the processes being employed by the BWMS and hould not be limited to parameters otherwise assessed as part of the type approval process. The System Design Limitations should be identified by the manufacturer and validated under the supervision of the Administration in accordance with the 2016 Guidelines (G8).

  • .15 Holding time means the total time during which treated ballast water will be held in a simulated ballast water tank for the purpose of verifying biological efficacy under the 2016 Guidelines (G8).

  • .16 Storage period means the total time during which treated ballast water will be held in a simulated ballast water tank for the purpose of identifying the worst-case concentrations of Relevant Chemicals in treated and discharged ballast water.

1.2 Abbreviations used in the text

< less than
less than or equal to
> greater than
greater than or equal to
μg microgram
   
AS Active Substance
ASF interspecies allometric scaling factor
ASTM American Society for Testing and Materials
   
BA Basic Approval
BCF bioconcentration factor
BIOinh bioavailability factor for inhalation
BMD benchmark dose
b.p. boiling point
Bw body weight
BWMS ballast water management system
   
°C degree Celsius (Centigrade)
CAS Chemical Abstracts Service
Cc cubic centimeter
CEC cation exchange capacity
CFabs correction factor for absorption
CFdr correction factor for dose regime
CMR carcinogenicity, mutagenicity and reproductive toxicity
   
D day(s)
DNEL Derived No-Effect Level
DMEL Derived Minimal Effect Level
DOC dissolved organic carbon
DT50 half-life of a substance
   
EC50 effect concentration, 50% (median effective concentration)
EHC environmental health criteria
EHS Evaluation of Hazardous Substances
ESF observed effect scaling factor
EU European Union
   
FA Final Approval
   
G gram
G9 Procedure for approval of ballast water management systems that make use of Active Substances (G9), as revised, adopted by resolution MEPC.169(57) in April 2008
GESAMP IMO/FAO/UNESCO-IOC/WMO/IAEA/UN/UNDP/UNEP/UNIDO Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection
GESAMP-BWWG GESAMP-Ballast Water Working Group
GHS Globally Harmonized System
GLP good laboratory practice
   
H hour(s)
HES human exposure scenario
   
IARC International Agency for Research on Cancer
IC50 inhibition concentration, 50%
IMO International Maritime Organization
IR ingestion rate
ISF intraspecies differences factor
ISO International Organization for Standardization
IUPAC International Union of Pure and Applied Chemistry
   
Kd sorption coefficient
Kg kilogram
Koc organic carbon-water partition coefficient
Kow octanol/water partitioning coefficient (also Pow)
Kp sorption coefficient for ionic substances
   
L litre
LC50 lethal concentration, 50%
LD50 lethal dose, 50%
LLNA local lymph node assay
LOAEL lowest observed adverse effect level
LOD Limit of Detection
LOEL lowest observed effect level
Log Pow logarithm of the octanol/water partition coefficient
   
MADC Maximum Allowable Discharge Concentration
MAMPEC Marine anti-foulant model for PEC calculation
MAMPEC-BW Marine anti-foulant model for PEC calculation for ballast water
MARPOL International Convention for the Prevention of Pollution from Ships
MEPC Marine Environment Protection Committee
Mg milligram
mL millilitre
m.p. melting point
   
Ng nanogram
NOAEC No Observed Adverse Effect Concentration
NOEC No Observed Effect Concentration
NOAEL No-Observed-Adverse-Effect Level
NOEL No-Observed-Effect Level
NTP National Toxicological Programme
   
OC Other Chemical
OECD Organisation for Economic Co-operation and Development
Organization the International Maritime Organization
OSF other interspecies scaling factor
   
PBT Persistence, Bioaccumulation and Toxicity
PEC Predicted Environmental Concentration
PNEC Predicted No Effect Concentration
POC Particulate organic carbon
POEM UK Predictive Operator Exposure Model
Pow Octanol/water partition coefficient (also Kow)
PPE protective personal equipment
   
QAPP Quality Assurance Project Plan
QA/QC Quality Assurance/Quality Control
QFC quantity of fish consumed
QSAR Quantitative Structure-Activity Relationship
   
RC Relevant Chemical
RCR Risk Characterization Ratio
   
SDL System Design Limitation
SFdur scaling factor for exposure duration
SOLAS The International Convention for the Safety of Life at Sea
   
TLV threshold limit value
TOC Total Organic Carbon
TRC total residual chlorine
TRO total residual oxidant
   
US EPA United States Environmental Protection Agency
   
WET whole effluent toxicity test
WHO World Health Organization
Wt weight

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