Code of Federal Regulations Title 21. Food and Drugs § 21.25.21 Extraordinary circumstances

(a) Actions for which available data establish that, at the expected level of exposure, there is the potential for serious harm to the environment;  and

(b) Actions that adversely affect a species or the critical habitat of a species determined under the Endangered Species Act or the Convention on International Trade in Endangered Species of Wild Flora and Fauna to be endangered or threatened or wild flora or fauna that are entitled to special protection under some other Federal law.