Answer: FDA requires submitters to include an analysis of the potential environmental impact resulting from the production, use, and disposal of the food-contact substance.
Effective Aug. 24, 2000, the agency has adopted the same categorical exclusions from the need to file an environmental assessment (EA) to notifications that had applied to petitions and Threshold of Regulation submissions. The exclusions eliminate the need for environmental assessments in the case of notifications for substances that are 5 percent or less of finished articles, components of coatings, and components of repeated-use articles.
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