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There was a general agreement that a tiered approach for notification requirements would be the most appropriate, as well as align with other international regimes. Since there are so many different F&DA products, appropriate information and schedules should be developed based upon each product's risk profiles. A potentially more hazardous product should have a more rigorous data requirement and vice versa. Pharmaceutical commodity groups suggested that at the very least, minimal data requirements must be comprehensive enough to determine environmental fate and safety. Products in which the average aquatic concentration is less than one part per billion should not require a submission unless there are special circumstances requiring an environmental assessment such as the presence of hormones and cytotoxic substances. Once sufficient data are available to indicate that the drug substance is unlikely to pose a risk to the environment, additional data requirements could be terminated. This group also suggested that consideration should be given to what is required under other federal acts, for example the Feeds Act and Seeds Act, in order to reduce duplication and to impose more stringent requirements than those already existing for similar products within the same product line.
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