## Facts

- The FDA issued a 1992 policy statement on foods derived from new plant varieties produced using recombinant DNA (rDNA) techniques.
- The policy treated genetic engineering as similar to conventional breeding and focused regulatory attention on the characteristics of the final food rather than the production process.
- The FDA stated that most foods produced with rDNA techniques would be presumed “generally recognized as safe” (GRAS) and therefore generally not regulated as “food additives” requiring premarket approval.
- The policy established a voluntary premarket consultation program in which producers could share data with FDA before marketing genetically engineered (GE) foods.
- A coalition of organizations and individuals (including scientists, consumers, and religious leaders) challenged the policy and FDA actions permitting specific GE foods to enter commerce.
- Plaintiffs alleged health risks (toxins/allergens), environmental harms, and interference with religious dietary practices due to the absence of mandatory GE labeling or segregation.
- The parties filed cross-motions for summary judgment on statutory, administrative, and constitutional claims.

## Issues

1. Whether the FDCA permits FDA to treat most GE foods as presumptively GRAS and not “food additives” subject to premarket approval.
2. Whether the 1992 policy was a legislative rule requiring APA notice-and-comment procedures or a nonbinding interpretive rule/policy statement.
3. Whether NEPA required an environmental assessment or environmental impact statement for the 1992 policy or FDA’s related actions.
4. Whether FDA’s refusal to require GE labeling or segregation violated RFRA, the Free Exercise Clause, or a claimed consumer “right to know.”

## Decision

- The court granted summary judgment for the government and denied plaintiffs’ motion.
- The court held FDA acted within its FDCA authority in applying a product-focused approach and presuming most GE foods are GRAS, while retaining authority to regulate novel or significantly altered substances as food additives.
- The court held the 1992 policy was a general policy statement/interpretive rule, not a binding legislative rule, so APA notice-and-comment was not required.
- The court held NEPA did not require an EA or EIS because the policy was interpretive and did not itself authorize or directly cause environmental effects constituting “major Federal action.”
- The court rejected RFRA and Free Exercise claims, finding no substantial governmental burden where the asserted harm stemmed from the government’s choice not to mandate labeling of private products.
- The court rejected the “right to know” labeling theory, accepting FDA’s view that rDNA use is not, by itself, a material fact absent changes to safety, nutrition, or other relevant characteristics.

## Legal Principles

- Under the FDCA, substances that are GRAS are exempt from the food-additive premarket approval regime; FDA may evaluate safety based on the characteristics of the final food rather than the method used to develop it.
- Courts generally defer to an agency’s scientific and technical judgments when reviewing challenged regulatory determinations under arbitrary-and-capricious standards.
- An agency statement that announces how it intends to exercise discretion and imposes no binding obligations is typically an interpretive rule or policy statement exempt from APA notice-and-comment rulemaking.
- NEPA duties attach to “major Federal actions” significantly affecting the environment; an interpretive policy that does not itself change legal status or authorize activity may fall outside NEPA’s trigger.
- RFRA requires a substantial governmental burden on religious exercise; a government decision not to compel private-party labeling ordinarily does not constitute such a burden.
- The FDCA’s labeling requirements focus on material facts; absent material differences in the food’s attributes, process-based disclosure may be treated as non-mandatory.

## Conclusion

The district court upheld FDA’s 1992 framework for regulating genetically engineered foods, finding it consistent with the FDCA and APA, not subject to NEPA environmental review on the record presented, and not required by RFRA, the First Amendment, or any general “right to know” theory to mandate GE labeling.


All. for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000)