FDA Solicits Feedback on Information Collection Related to Environmental Assessments
The Food and Drug Administration (FDA) has called for comments on a proposed information collection included in a guidance document titled “Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition [CFSAN].” Under the National Environmental Policy Act of 1969, FDA must consider the environmental impact of its actions, including those related to food contact substance notifications; exemption requests for food additives; and petitions for GRAS affirmation, food additives and food colorings, food labeling, health claims, and nutrient content claims.
FDA has since, however, amended its rulemaking to exclude certain classes of actions “that do not individually or cumulatively have a significant effect on the human environment.” Instead of routinely requiring information about the production of FDA-regulated articles, FDA has eliminated the previously required environmental assessment (EA) and provided guidance “to help industry submit a claim of categorical exclusion or an EA” to CFSAN. This guidance addresses the following questions: (i) “What types of industry-initiated actions are subject to a claim of categorical exclusion?”; (ii) “what must a claim of categorical exclusion include by regulation?”; (iii) “what is an EA?”; (iv) “when is an EA required by regulation and what format should be used?”; (v) “what are extraordinary circumstances?”; and (vi) “what suggestions does CFSAN have for preparing an EA?.”
The FDA notice of proposed information collection includes the estimated reporting burdens for likely respondents, which include businesses “engaged in the manufacture or sale of food, food ingredients, and substances used in materials that come into contact with food.” The agency will accept comments until September 20, 2010. See Federal Register, July 21, 2010.
