Annex 3 - Required Elements of a Comprehensive Proposal
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Statutory Documents - IMO Publications and Documents - International Conventions - AFS - International Convention on the Control of Harmful Anti-Fouling Systems on Ships, 2001 - Annex 3 - Required Elements of a Comprehensive Proposal

Annex 3 - Required Elements of a Comprehensive Proposal

  (1) A comprehensive proposal shall include adequate documentation containing the following:

  • (a) developments in the data cited in the initial proposal;

  • (b) findings from the categories of data set out in paragraphs (3)(a), (b) and (c), as applicable, depending on the subject of the proposal and the identification or description of the methodologies under which the data were developed;

  • (c) a summary of the results of studies conducted on the adverse effects of the anti-fouling system;

  • (d) if any monitoring has been conducted, a summary of the results of that monitoring, including information on ship traffic and a general description of the area monitored;

  • (e) a summary of the available data on environmental or ecological exposure and any estimates of environmental concentrations developed through the application of mathematical models, using all available environmental fate parameters, preferably those which were determined experimentally, along with an identification or description of the modelling methodology;

  • (f) an evaluation of the association between the anti-fouling system in question, the related adverse effects and the environmental concentrations, either observed or expected;

  • (g) a qualitative statement of the level of uncertainty in the evaluation referred to in subparagraph (f);

  • (h) a recommendation of specific control measures to reduce the risks associated with the anti-fouling system; and

  • (i) a summary of the results of any available studies on the potential effects of the recommended control measures relating to air quality, shipyard conditions, international shipping and other relevant sectors, as well as the availability of suitable alternatives.

  (2) A comprehensive proposal shall also include information on each of the following physical and chemical properties of the component(s) of concern, if applicable:

  • melting point;
  • boiling point;
  • density (relative density);
  • vapour pressure;
  • water solubility / pH / dissociation constant (pKa);
  • oxidation/reduction potential;
  • molecular mass;
  • molecular structure; and
  • other physical and chemical properties identified in the initial proposal.

  (3) For the purposes of paragraph (1)(b) above, the categories of data are:

  • (a) Data on environmental fate and effect:

    • modes of degradation/dissipation (e.g., hydrolysis/photodegradation/ biodegradation);
    • persistence in the relevant media (e.g., water column/sediments/biota);
    • sediments/water partitioning;
    • leaching rates of biocides or active ingredients;
    • mass balance;
    • bioaccumulation, partition coefficient, octanol/water coefficient; and
    • any novel reactions on release or known interactive effects.

  • (b) Data on any unintended effects in aquatic plants, invertebrates, fish, seabirds, marine mammals, endangered species, other biota, water quality, the seabed, or habitat of non-target organisms, including sensitive and representative organisms:

    • acute toxicity;
    • chronic toxicity;
    • developmental and reproductive toxicity;
    • endocrine disruption;
    • sediment toxicity;
    • bioavailability/biomagnification/bioconcentration;
    • food web/population effects;
    • observations of adverse effects in the field/fish kills/ strandings/ tissue analysis; and
    • residues in seafood.

    These data shall relate to one or more types of non-target organisms such as aquatic plants, invertebrates, fish, birds, mammals and endangered species.

  • (c) Data on the potential for human health effects (including, but not limited to, consumption of affected seafood).

  (4) A comprehensive proposal shall include a description of the methodologies used, as well as any relevant measures taken for quality assurance and any peer review conducted of the studies.

Parent topic: AFS - International Convention on the Control of Harmful Anti-Fouling Systems on Ships, 2001
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