Resolution
MEPC.126(53)
PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF
ACTIVE SUBSTANCES (G9)
(Adopted
on 22 July 2005)
amended
by MEPC 53/24/Add.1/Corr.1 4 October 2005
THE
MARINE ENVIRONMENT PROTECTION COMMITTEE,
RECALLING
Article 38(a) of the Convention on the International 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 of the 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 Ballast 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.
Annex.
PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF
ACTIVE SUBSTANCES (G9)
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 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
he 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 Active 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.
For the purposes of this procedure, the definitions in the 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.
.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 Convention.
.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 discharged.
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.
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.
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.
4.1.1
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 chemical 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;
-
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;
- prsistence 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 & 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 point;
- 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 guidelines5.
_____________
5 Preferably Organization for
Economic Cooperation and Development (OECD) Guidelines for Testing of Chemicals
(1993) or other equivalent tests.
4.2.4
The testing process should contain a rigorous quality 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.
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.
4.2.6
The proposal should describe the manner of application of the Preparation for
Ballast Water Management, including required dosage and retention time.
4.2.7
A proposal for approval should include (Material) Safety Data Sheets ((M)SDS).
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.
5.1 Screening for
persistency, bioaccumulation and toxicity
5.1.1
An assessment on the intrinsic properties of the Active Substance and/or
Preparation such as persistency, bioaccumulation and toxicity should be
conducted (see Table 1 in section 6).
.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
to show that the substances are readily biodegradable. The determination of the
half-life should include assessment of relevant chemicals.
.2
Bioaccumulation tests:
The assessment
of the (potential for) bioaccumulation should use measured bioconcentration
factors in marine (or freshwater) organisms. Where these tests are not applicable,
or if logPow <3, Bio Concentration Factor (BCF) values may be estimated
using (Quantitative) Structure-Activity Relationship ((Q)SAR) models.
.3 Toxicity
tests:
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
sections 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
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
tested6.
____________
6 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 % of the test organisms die (LCx), No
Observed Adverse Effect Concentrations (NOAECs), chronic No Observed Effect
Concentration (NOEC) and/or Effect Concentration at which x % of test organisms
show effect (ECx), as appropriate based on the experimental design.
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 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.
5.3.2
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 distribution coefficient (Koc)) of the Active Substances,
Preparations and Relevant Chemicals should be determined.
5.3.7
For Active Substances and Preparations, the potential for bioaccumulation
should be assessed in marine or freshwater organisms (fish or bivalves) if the
logarithm octanol/water partition coefficient (logPow) is >3.
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 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.
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 guidance7.
____________
7 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.
The
Organization should evaluate the application for approval based on the criteria
in this section.