By Charles Eirkson, EAS Independent Consultant
The National Environmental Policy Act (NEPA, 1969), requires that potential environmental impact of actions, e.g., approvals of new drugs, biologics, food additives, be addressed by the U.S. Food and Drug Administration (FDA). In addition to FDA, NEPA requires that all Federal Agencies must address the environmental impact of their actions through administrative processes outlined by the NEPA. These include:
- justification and preparation of a Categorical Exclusion,
- research and preparation of an Environmental Assessment (EA) to support a Finding of No Significant Impact (FONSI), or
- research, preparation and publication for comment of an Environmental Impact Statement (EIS) in support of a Record of Decision (ROD) when environmental impact may be expected from an action.
EAS Consulting Group helps clients meet their obligations for FDA NEPA environmental documentation for human and veterinary products, human biologics, food, and tobacco products with their expert consultant staff.
The regulations must be followed by the Federal Agencies in the development and preparation of the environmental documents. The processes and legal frameworks for applying NEPA are extensively outlined by the Council on Environmental Quality (CEQ) regulations found in Code of Federal Regulation (CFR) Title 40 Part 1500.
Court challenges on NEPA grounds are a common practice and any deviation from the NEPA procedures, processes and applications can result in actions not moving forward. These include actions taken by the FDA on approval of regulated products. FDA’s regulations for meeting its NEPA obligations are found at Title 21 CFR Part 25.
Because of the possible court challenge and the need for doing a credible scientific assessment, the FDA has prepared the referenced Environmental guidance documents for the use of their regulated industries and themselves. The guidance published by the FDA give specific information for determining whether a categorical exclusion from preparing an environmental assessment (EA) or an EA is needed for various actions including investigations and approval of the subject products, e.g.., biologics, human drugs, veterinary drugs and food additives. The guidance also often provides scientific recommendations for conducting studies with operating procedures, subject to good laboratory practice review, and endpoint standards for determining effects. Information may also be provided for preparing and submitting EAs. A list of these guidance documents and their internet locations is provided below.
FDA Environmental Guidance Documents
- Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
- Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition – Appendix C (Preparing an Environmental Assessment for Processing Aids Used in the Production of Food-Packaging Materials but that Are Not Intended to Remain as Components of Finished Food-Packaging Materials)
Human Drugs and Biologics
- Environmental Assessment: Questions and Answers Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity
- Guidance for Industry Environmental Assessment of Human Drug and Biologics Applications
- Guidance for Industry for Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant viral or Microbial products.