## Facts

- Monsanto and other manufacturers produced acrylonitrile copolymer used to make “unbreakable” beverage containers.
- FDA found that small amounts of acrylonitrile monomer could migrate from the containers into beverages.
- FDA associated acrylonitrile exposure with potential toxic and carcinogenic effects and evaluated the product under the Federal Food, Drug, and Cosmetic Act (FDCA) food additive provisions.
- The FDA Commissioner issued a final order concluding that the copolymer (through monomer migration) was a “food additive” and that the administrative record did not demonstrate safety as required for approval.
- The Commissioner amended the applicable regulation to state that specified acrylonitrile copolymers were not authorized for use in fabricating beverage containers.
- Petitioners sought judicial review, disputing the “food additive” classification, the safety determination, and requesting remand based on Monsanto’s claimed new non-migrating container technology.

## Issues

1. Whether a polymer used in beverage containers, where residual monomer migrates into beverages, qualifies as a “food additive” under FDCA § 201(s) because its intended use may reasonably be expected to result in becoming a component of food.
2. Whether substantial evidence supported the Commissioner’s finding that petitioners failed to provide the affirmative demonstration of safety required by FDCA § 409(c)(3)(A), justifying a prohibition on use in beverage containers.
3. Whether the court should remand for FDA consideration of Monsanto’s post-decision claim that it developed a container with no acrylonitrile migration, or confine review to the existing administrative record.

## Decision

- The court largely upheld the Commissioner’s final order.
- It agreed that substances used in food-contact materials that migrate, or may reasonably be expected to migrate, into food fall within the statutory definition of “food additive.”
- It sustained the Commissioner’s conclusion that the record did not establish the required showing of safety and that FDA could bar the challenged use absent such a showing.
- It declined to set aside or remand the order based on Monsanto’s asserted new non-migrating container, treating that assertion as extra-record material to be presented to FDA in subsequent administrative proceedings.

## Legal Principles

- Under FDCA § 201(s), a substance can be a “food additive” if its intended use in packaging or holding food results, or may reasonably be expected to result, directly or indirectly, in the substance becoming a component of food.
- The food additive approval scheme places the burden on proponents to provide an affirmative demonstration of safety; lack of conclusive proof of harm does not satisfy FDCA § 409(c)(3)(A).
- Courts generally defer to FDA’s technical and scientific judgments if the agency explains its reasoning and the decision is supported by substantial evidence in the administrative record.
- Judicial review of agency action is ordinarily confined to the record before the agency at the time of decision; later-developed evidence is addressed through renewed or supplemental agency proceedings.

## Conclusion

The D.C. Circuit sustained FDA’s treatment of migrating acrylonitrile monomer from beverage containers as a regulated food additive and upheld the agency’s prohibition because petitioners did not meet the statute’s required safety showing, while directing that post-decision technological claims be pursued through further FDA proceedings rather than on judicial review.


Monsanto Co. v. Kennedy, 613 F.2d 947 (D.C. Cir. 1979)