§ 25.25 - Retroactive environmental consideration.

(a) FDA may consider the need for preparing an EIS for an existing FDA regulation, approval, or other action, whether or not previously subject to environmental analysis, when there is new information before the agency that suggests that the action may significantly affect the quality of the human environment.

(b) If FDA notifies an applicant or petitioner who obtained an existing FDA approval that new information suggests that the approval may have signficant environmental effects and that an EA is therefore required, the applicant or petitioner shall submit an EA as described in § 25.31 for the approval. A notification under this paragraph will be in writing.