What are the environmental impact considerations of waste products from the manufacture or use in the approval of nanoproducts by FDA?
The National Environmental Policy Act (NEPA) requires federal agencies to consider the environmental effects of any “major federal action” they propose to take, by preparing an environmental assessment (EA) or environmental impact statement (EIS) as appropriate. Agencies can establish categorical exclusions for categories of actions that do not individually or cumulatively have a significant effect on the human environment. However, agency procedures must provide for extraordinary circumstances in which a normally excluded action may have a significant environmental effect. Extraordinary circumstances identified in FDA’s regulations under which its categorical exclusions would not apply include potential for serious harm to the environment and actions that adversely affect an endangered, threatened or otherwise specially protected species.
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