The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions and to ensure that the interested and affected public is informed of the environmental analyses. The Food and Drug Administration (FDA) considers the environmental impacts of its actions as an integral part of its regulatory process. FDA regulations at 21 CFR 25 (“Environmental Impact Considerations”) specify that environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), abbreviated drug applications, applications for marketing approval of a biologic product, supplements to such applications, investigational new drug applications (INDs) and for various other actions, unless the action qualifies for a categorical exclusion.
FDA’s environmental impact regulations were established in 1977. Under the President's reinventing government initiatives, announced in April 1995, FDA reevaluated and revised its environmental regulations to reduce the type of actions that require an EA and, consequently, the number of EAs that require an environmental analysis. FDA issued for public comment a notice of proposed rulemaking on May 1, 1996 (61 FR 19476), that proposed additional categorical exclusions for those actions that have been identified as normally not having a significant impact, individually or cumulatively, on the quality of the human environment. The final rule was published on July 29, 1997 (62 FR 40569), and became effective August 28, 1997.
All applications or petitions requesting Agency action must be accompanied by either an EA or a claim of categorical exclusion. Failure to submit one or the other is sufficient grounds for refusing to file or approve the application (21 CFR 314.101(d)(4), 601.2(a) and (c), and 25.15(a)). An EA that is adequate for filing is one that addresses the relevant environmental issues. An EA adequate for approval is one that contains sufficient information to enable the Agency to determine whether the proposed action may significantly impact the quality of the human environment.
Categorical exclusions for human drugs and biologics are found at 21CFR 25.31. Note that the FDA will require at least an EA for any specific action that ordinarily would be excluded if “extraordinary circumstances” indicate that the specific proposed action may significantly affect the quality of the environment.
CDER's Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications (Issued 7/1998) provides detailed information on a variety of topics related to preparing and filing EAs.
The environmental impact review function resides in the Science and Research Staff, Office of Pharmaceutical Science (Contact: Raanan A. Bloom, Ph.D., OPS Environmental Officer, firstname.lastname@example.org).
Page updated: January 26, 2011