By EAS Senior Consultant Charles Eirkson
FDA’s Center for Biologic Evaluation and Research (CBER) released new industry guidance in May 2015 on environmental assessments for investigational new drug applications (INDs), biologics license applications (BLAs) and supplements to BLAs.
The guidance includes recommendations on what to consider in assessing whether to submit an environmental assessment (EA) for gene therapies, vectored vaccines, and recombinant viral or microbial products. It also contains recommendations on what to include in an EA and what to expect once an EA is filed.
The guidance, Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant viral or Microbial products, finalized draft guidance issued in June 2014 and it supplements the agency’s 1998 Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications.
The National Environmental Policy Act (NEPA) enacted in 1969 requires all Federal agencies to address the environmental impact of their actions. But many classes of actions are excluded and do not require an EA or an environmental impact statement (EIS). The CBER guidance considers how to decide whether an EA is needed for INDs and licensing applications, as well as other circumstances. It also lists the information that should be in the EA, including, for example, the substances subject to the proposed action, the potential environmental effects, mitigation measures, and alternatives to the proposed action.
NEPA requires an EA to support any Finding of No Significant Impact (FONSI). If some environmental impact may be expected from an action, NEPA requires an EIS.
The processes for applying NEPA’s provisions are extensively outlined by the Council on Environmental Quality (CEQ) regulations found in 40 CFR Parts 1500-1508. FDA’s regulations for meeting its NEPA obligations are found in 21 CFR Part 25.
Court challenges on NEPA grounds are common and any deviation from the NEPA procedures can result in agency actions not moving forward — including actions on approvals of regulated products. Because of the possibility of a court challenge, all scientific assessments need to be rigorous and credible.
As with all agency guidance, the document reflects the agency’s latest thinking on the subject and it is not mandatory to follow the recommendations. An alternative approach may satisfy the relevant statutes and regulations, but it is a good practice to contact the agency ahead of time to check that any proposed alternative approach would raise any red flags. Environmental documents are reviewed by a limited staff at FDA and they review a lot of documents. Any alternatives from the expected approach requires extra staff time and effort to review and reach a decision.
Other FDA Centers have released separate environmental impact guidance over the years for food additives, human drugs, veterinary drugs and tobacco products, including:
Animal drugs and veterinary products
- Environmental Impact Assessment for Veterinary Medicinal Products Phase II Guidance
- Environmental Impact Assessments (EIA’S) for Veterinary Medicinal Products (VMP’s-Phase I (VICH GL6, CVM Guidance for Industry 89, 2001)
- Environmental Impact Considerations
- 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