Stauffer Chemical Co. v. Food & Drug Administration

• Decision Date: 20 January 1982
• Docket Number: No. 80-5769,80-5769
• Citation: 670 F.2d 106
• Parties: STAUFFER CHEMICAL COMPANY, Plaintiff-Appellant, v. FOOD & DRUG ADMINISTRATION, Defendant-Appellee.
• Court: U.S. Court of Appeals — Ninth Circuit

Page 106

670 F.2d 106

STAUFFER CHEMICAL COMPANY, Plaintiff-Appellant, v. FOOD & DRUG ADMINISTRATION, Defendant-Appellee.

No. 80-5769.

United States Court of Appeals, Ninth Circuit.

Argued and Submitted Dec. 11, 1981.

Decided Jan. 20, 1982.

Eugene I. Lambert, Washington, D. C., for plaintiff-appellant.

Susan J. Atkinson, Washington, D. C., for defendant-appellee.

Appeal from the United States District Court for the Central District of California.

Before WRIGHT, KENNEDY and SKOPIL, Circuit Judges.

SKOPIL, Circuit Judge.

The district court found no jurisdiction because Stauffer failed to exhaust its administrative remedies.

Some exhaustion requirements are statutorily specified jurisdictional prerequisites. Others are judicially developed and courts have discretion to modify them. Montgomery v. Rumsfeld, 572 F.2d 250, 252-53 & nn.2-3 (9th Cir. 1978). The FDA does not argue that exhaustion is statutorily prescribed here. As a result, the district court had jurisdiction and discretion to require exhaustion. In exercising its discretion a court balances "the interests of the agency in applying its expertise, correcting its own errors, making a proper record, enjoying appropriate independence of decision and maintaining an administrative process free from deliberate flouting, and the interests of private parties in finding adequate redress for their grievances." Stratman v. Watt, 656 F.2d 1321, 1326 (9th Cir. 1981) (quoting Montgomery v. Rumsfeld, supra, 572 F.2d at 253).

The district judge balanced the relevant factors, though he erred in calling the question jurisdictional rather than discretionary. He held that "(t)he opinion letter from Mr. Quinn (did) not initiate any enforcement action by the FDA", and that "in this case, which involves interpretation of complex agency rules and comprehension of scientific data in an area over which the FDA clearly has jurisdiction, the agency must not be deprived of an opportunity to develop and scrutinize a complete administrative record." He noted that Stauffer would "suffer no extraordinary hardship if judicial review is withheld at this time." He noted that there was no evidence that filing a petition to amend the standard with the FDA would be futile. It is therefore unnecessary to remand to permit the district court to exercise its discretion. Compare Stratman v. Watt, supra.

In general, action by subordinate agency officials is not final agency action subject to judicial review. See Abbott Laboratories v. Gardner, 387 U.S. 136, 151, 87 S.Ct. 1507, 1516, 18 L.Ed.2d 681 (1967); National Automatic Laundry & Cleaning Council v. Shultz, 443 F.2d 689, 700 (D.C.Cir.1971). FDA regulations permit interested persons to appeal decisions of a subordinate FDA employee to that employee's supervisor. 21 C.F.R. § 10.75(a)(3) (1981). Review is discretionary, but will be granted to review important policy questions and where required by delegations of authority. 21 C.F.R. § 10.75...