598 F.Supp.3d 98
S.D.N.Y.2022Background
- Plaintiffs (several environmental and public-health organizations) challenged the FDA’s denial of a 2014 citizen petition seeking revocation of a 2005 Threshold of Regulation (TOR) exemption that allows sodium perchlorate monohydrate (an antistatic additive) in certain food-contact plastics.
- The FDA granted TOR Exemption No. 2005-006 permitting perchlorate up to specified concentrations in finished articles for dry foods; TOR exempts substances expected to migrate into food at or below 0.5 ppb.
- FDA scientists’ Total Diet Studies (2008 and an updated 2016 study with a 2017 report) found perchlorate widely detectable in foods and showed higher levels in later samples; Plaintiffs argued the studies required revocation of the TOR exemption.
- Plaintiffs alleged the FDA (1) ignored its own studies, (2) failed to consider cumulative exposure (perchlorate plus other sources/related substances) as required by the Food, Drug, and Cosmetic Act, and (3) failed to account for multiple contacts with perchlorate-containing materials in its migration/consumption analysis.
- FDA denied the petition (2017) and Plaintiffs’ objections (2019); the district court reviewed the denial under the APA, applied deferential review for citizen-petition denials, and upheld the FDA’s decision on summary judgment.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA unlawfully failed to consider its 2016 Study and 2017 Report in denying the citizen petition | Plaintiffs: FDA ignored important (and agency-authored) data showing increased perchlorate in the food supply; omission made the decision arbitrary and capricious | FDA: The citizen-petition record is limited to materials submitted under 21 C.F.R. §10.30; Plaintiffs did not include those studies in the petition or timely supplement; agency not required to consider extra-record materials | Court: Denied — FDA was not required to consider studies not in the administrative record; omission was not arbitrary given petition rules and available remedies (new petition) |
| Whether FDA was required under the Food, Drug, and Cosmetic Act to assess cumulative exposure (perchlorate plus other sources or related substances) before granting/maintaining a TOR exemption | Plaintiffs: The Act requires considering cumulative effects; TOR exemption here violates statutory safety duty because multiple small exposures can accumulate | FDA: TOR framework (and Monsanto precedent) permits agency to treat de minimis migration as non-food-additive exposure and need not apply §348’s full cumulative analysis where migration is negligible; 0.5 ppb threshold embodies conservative safety margin | Court: Denied — FDA reasonably exercised discretion under Monsanto and TOR rule; agency need not conduct broader cumulative analysis for de minimis exposures below the 0.5 ppb threshold |
| Whether FDA improperly underestimated exposure by using a single-use migration protocol and failing to account for multiple contacts with perchlorate-containing articles | Plaintiffs: Multiple contacts across the food chain could raise dietary concentrations above the TOR threshold; single-use protocol understates exposure | FDA: Its methodology used conservative assumptions (e.g., assuming contact with all foods and maximum use levels) and single-use protocol is more protective for estimating dietary concentration; repeated-use items dilute migration over larger food mass | Court: Denied — FDA’s migration/consumption assumptions were reasonable and conservative; decision not arbitrary |
Key Cases Cited
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (sets arbitrary-and-capricious review standard for agency rulemaking)
- Monsanto Co. v. Kennedy, 613 F.2d 947 (D.C. Cir. 1979) (agency may treat de minimis migration into food as not triggering full food-additive regulation)
- Henley v. FDA, 77 F.3d 616 (2d Cir. 1996) (very narrow, deferential review of agency denials of citizen petitions)
- Kisor v. Wilkie, 139 S. Ct. 2400 (2019) (deference to agency interpretations of ambiguous rules in technical areas)
- Camp v. Pitts, 411 U.S. 138 (1973) (administrative record is the focal point for judicial review)