(1) An initial proposal shall include adequate
documentation containing at least the following:
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(a) identification of the anti-fouling system
addressed in the proposal: name of the anti-fouling system; name of
active ingredients and Chemical Abstract Services Registry Number
(CAS number), as applicable; or components of the system which are
suspected of causing the adverse effects of concern;
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(b) characterization of the information which
suggests that the anti-fouling system or its transformation products
may pose a risk to human health or may cause adverse effects in non-target
organisms at concentrations likely to be found in the environment
(e.g., the results of toxicity studies on representative species or
bioaccumulation data);
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(c) material supporting the potential of the toxic
components in the anti-fouling system, or its transformation products,
to occur in the environment at concentrations which could result in
adverse effects to non-target organisms, human health, or water quality
(e.g., data on persistence in the water column, sediments and biota;
the release rate of toxic components from treated surfaces in studies
or under actual use conditions; or monitoring data, if available);
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(d) an analysis of the association between the
anti-fouling system, the related adverse effects and the environmental
concentrations observed or anticipated; and
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(e) a preliminary recommendation on the type of
restrictions that could be effective in reducing the risks associated
with the anti-fouling system.
(2) An initial proposal shall be submitted in
accordance with rules and procedures of the Organization.