## Facts

- The FDA issued final regulations governing foods for special dietary uses by adding to 21 C.F.R. Part 80 and revising 21 C.F.R. Part 125; the regulations were signed July 25, 1973 and set to become fully effective December 31, 1974.
- The rulemaking followed a long administrative process: a 1962 proposal, a 1968 hearing notice, nearly two years of hearings generating over 32,000 pages of testimony and thousands of pages of exhibits, plus extensive post-hearing submissions.
- Tentative final orders were signed in January 1973 by Commissioner Charles C. Edwards; formal objections were due April 20, 1973.
- After Edwards resigned, Alexander M. Schmidt became Commissioner on July 12, 1973 and signed the final regulations 13 days later, during which time he also signed numerous other regulations and notices for publication.
- The final regulations recited that the Commissioner had considered the evidence, the hearing examiner’s report, and objections.
- Petitioners (a trade association and a manufacturer) asserted it was physically impossible for Schmidt to have personally reviewed the entire administrative record (including extensive exceptions and additional correspondence) within the available time.
- Petitioners moved for leave to depose Commissioner Schmidt (or, alternatively, to appoint a special master and obtain related discovery) to examine whether he personally performed the review allegedly required before issuing the regulations.

## Issues

1. Whether a court reviewing agency rulemaking may permit discovery to depose an agency head to test whether he personally considered the record and objections before issuing final regulations.
2. Whether the presumption of regularity is overcome by circumstantial doubts arising from the record’s size and the short time between an official’s appointment and issuance of final rules.
3. Whether the “mental process” doctrine bars inquiry into an agency head’s internal deliberations absent a strong showing of bad faith or improper behavior.

## Decision

- The Second Circuit denied the motion to depose Commissioner Schmidt and denied the requested alternative relief, including appointment of a special master for equivalent inquiry.
- The court held that probing the Commissioner’s personal consideration and deliberative steps would intrude into protected decisionmaking processes.
- The court concluded that petitioners’ time-and-volume arguments did not amount to the kind of showing required to justify such extraordinary discovery.

## Legal Principles

- Courts generally apply a presumption of regularity to official agency action; a reviewing court does not require proof that a high-ranking official personally read every part of a large record.
- Absent a substantial showing of bad faith or improper behavior, courts will not authorize discovery aimed at an agency head’s mental processes, including deposition testimony about how the official reached the decision.
- An agency head may rely on staff work, summaries, and explanatory materials (such as detailed regulatory preambles responding to objections) in conducting high-level review of complex rulemaking records.

## Conclusion

The court refused to allow discovery seeking to depose the FDA Commissioner to test his personal review of a voluminous rulemaking record, holding that the presumption of regularity and the bar on probing an agency head’s mental processes control unless challengers make a substantial showing of bad faith or improper behavior.


Nat'l Nutritional Foods Ass'n v. Food & Drug Admin., 491 F.2d 1141 (2d Cir. 1974)