## Facts

- Consumer plaintiffs sued the Secretary of Health and Human Services and the FDA Commissioner seeking declaratory and injunctive relief challenging FDA approval of Monsanto’s recombinant bovine somatotropin (rbST) drug, Posilac, used to increase milk production in dairy cows.
- FDA approved Posilac as a new animal drug and required animal-health warnings and conditions of use on the drug’s label to address known risks to treated cows (including mastitis and reproductive issues).
- FDA decided not to require special labeling on milk or dairy products from rbST-treated cows, finding no material or sensory differences in the finished milk and no demonstrated human health risk at approved use levels; FDA allowed truthful, qualified voluntary “rbST-free” labeling.
- For NEPA compliance, FDA prepared an Environmental Assessment and issued a Finding of No Significant Impact rather than preparing a full Environmental Impact Statement.
- The case was decided on cross-motions for summary judgment; the court found plaintiffs presented no admissible evidence creating a genuine dispute of material fact and reviewed the agency action on the administrative record.

## Issues

1. Whether FDA’s approval of Posilac was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law under the APA and FDCA safety requirements for new animal drugs.
2. Whether FDA unlawfully refused to require mandatory labeling of milk and dairy products from rbST-treated cows under the FDCA and APA, including based on an asserted consumer “right to know.”
3. Whether FDA’s NEPA review was inadequate because it relied on an Environmental Assessment and FONSI instead of preparing an Environmental Impact Statement.

## Decision

- The court granted summary judgment for defendants and intervenor Monsanto and denied plaintiffs’ motion.
- FDA’s approval of Posilac was upheld as supported by the record and not arbitrary or capricious.
- FDA’s refusal to mandate consumer-product labeling for dairy from rbST-treated cows was upheld as lawful and within FDA’s discretion.
- FDA’s Environmental Assessment and decision not to prepare an Environmental Impact Statement were upheld as adequate under NEPA and not arbitrary or capricious.

## Legal Principles

- Under APA “arbitrary and capricious” review, a court does not substitute its judgment for an agency’s scientific determinations; it asks whether the agency considered relevant factors and articulated a rational connection between facts found and the choice made.
- The FDCA requires FDA to deny a new animal drug application if the drug is not shown to be safe for its intended use; FDA may address known animal-health risks through conditions of use and warnings on the drug label.
- The FDCA’s labeling framework focuses on preventing false or misleading labeling and requiring disclosures when necessary to address safety issues or prevent consumer deception; consumer interest alone does not compel disclosure absent a material difference in the food or a demonstrated health or safety basis.
- NEPA requires an EIS only for major federal actions significantly affecting the physical environment; an agency may rely on an Environmental Assessment and FONSI where it reasonably finds no significant environmental impact, and NEPA does not require analysis of speculative chains of economic or social effects.

## Conclusion

The court upheld FDA’s rbST drug approval and related regulatory choices, holding that plaintiffs failed to produce admissible evidence to defeat summary judgment and that FDA’s scientific, labeling, and NEPA determinations were rational, record-supported, and entitled to deference under the APA.


Stauber v. Shalala, 895 F. Supp. 1178 (W.D. Wis. 1995)