Pineapple Growers Ass'n of Hawaii v. Food and Drug Administration, No. 80-7521

CourtUnited States Courts of Appeals. United States Court of Appeals (9th Circuit)
Writing for the CourtBefore MERRILL, TRASK and PREGERSON; MERRILL
Citation673 F.2d 1083
PartiesPINEAPPLE GROWERS ASSOCIATION OF HAWAII, Petitioner, v. FOOD AND DRUG ADMINISTRATION, Respondent.
Docket NumberNo. 80-7521
Decision Date07 April 1982

Page 1083

673 F.2d 1083
PINEAPPLE GROWERS ASSOCIATION OF HAWAII, Petitioner,
v.
FOOD AND DRUG ADMINISTRATION, Respondent.
No. 80-7521.
United States Court of Appeals,
Ninth Circuit.
Argued and Submitted Jan. 14, 1982.
Decided April 7, 1982.

Page 1084

Clausen Ely, Jr., Covington & Burling, Washington, D. C., for petitioner.

John J. Powers, III, Dept. of Justice, Washington, D. C., argued for respondent; Mark C. Del Bianco, Washington, D. C., on brief.

Petition for Review of an Order of the Food and Drug Administration.

Before MERRILL, TRASK and PREGERSON, Circuit Judges.

MERRILL, Circuit Judge:

Pineapple Growers Association of Hawaii (PGAH) petitions for review of an order of the Food and Drug Administration (FDA) overruling without hearing PGAH's objections to certain amended regulations governing standards of identity for canned pineapple, and confirming the effective date of those regulations.

The regulations were promulgated pursuant to Section 401 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 341. 1 The procedures for promulgation of such regulations are set forth in 21 U.S.C. § 371(e). 2

The United States is a member of the World Health Organization and of the Food and Agriculture Organization of the United Nations. The Codex Alimentarius Commission formed by those organizations adopts recommended standards for food products which member countries are then obliged to consider for adoption. See 37 Fed.Reg. 21102 (1972). In the United States this is done by FDA promulgation of regulations under § 341.

In 1973, the FDA promulgated a regulation providing that "(a)ny interested person may petition (FDA) to adopt a Codex standard ... by proposing a new standard or an appropriate amendment of an existing standard...." 21 C.F.R. § 130.6 (1981). Such petitions are to be published by the FDA in the Federal Register. Id.

Pursuant to this regulation, the California Canners and Growers (Growers), a cooperative organization, petitioned FDA to amend the United States canned fruit identity standards for ten fruits, including pineapple. The organization noted that much of the fruit produced by its members was marketed internationally and that adoption of the Codex standards would facilitate international trade.

Page 1085

The FDA published the Growers' proposed amended standards of identity in January 1974. 39 Fed.Reg. 2368 (1974). PGAH objected to the proposal on the grounds that representatives of the United States pineapple industry had not been consulted as to its wisdom, and that it would facilitate foreign competition to the detriment of Hawaiian pineapple producers. PGAH also proposed a substitute amendment to the standards of identity for pineapple. As a result of the PGAH objections, the Growers' proposed amendment as to pineapple was stayed while the standards for other fruits were amended to bring them into line with the Codex standards. See 40 Fed.Reg. 5762 (1975).

In July 1979, six years after the Growers had first advanced their proposal and after PGAH had twice submitted revised petitions to amend the pineapple standards, FDA in a final rule adopted the standards now at issue. 44 Fed.Reg. 40276 (1979). PGAH objected to the final rule insofar as it (1) authorized "pieces or irregular pieces" as an additional style of canned pineapple, 3 and (2) authorized "pineapple juice and water" as an optional packing medium for all styles of canned pineapple. 4 On June 27, 1980 FDA published a revised final rule rejecting PGAH's objections and denying its hearing request. 45 Fed.Reg. 43389 (1980). PGAH petitioned for reconsideration on July 25, 1980, but FDA denied the petition on April 3, 1981, stating that PGAH's objections were inadequate to justify a hearing. The present petition for review followed. The question presented is whether FDA's denial of the PGAH hearing request was in violation of PGAH's rights under § 371(e)(3).

PGAH asserts that its petition presents factual issues bearing upon its contention that the new pineapple standards will confuse, mislead, and disappoint consumers; and that the Act grants a right to hearing upon those issues which it is beyond the discretion of the FDA to deny. It contends that the legislative history of the Act establishes that Congress intended to require FDA to conduct hearings whenever an adversely affected party interposes objections. 5

It is now clearly the law, however, that the language of § 371(e)(3) does not require a hearing in every case in which an adversely affected person files an objection. The provision of § 371(e)(2) that the objections must state the grounds therefor would seem to make it clear that FDA is to appraise the sufficiency of those grounds. At a minimum an objection to a proposed regulation must raise a material issue concerning which a meaningful hearing might be held. As the court stated in Dyestuffs and Chemicals, Inc. v. Flemming, 271 F.2d 281, 286 (8th Cir. 1959), cert. denied, 362 U.S. 911, 80 S.Ct. 681, 4 L.Ed.2d 619...

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10 practice notes
  • Community Nutrition Institute v. Young, Nos. 84-1153
    • United States
    • U.S. Court of Appeals — District of Columbia Circuit
    • September 24, 1985
    ...closely, because hearings are appropriate only where material objections to the FDA's actions exist. See Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 1085 (9th Cir.1982); Pactra Industries v. Consumer Product Safety Comm'n, 555 F.2d 677, 684 (9th Cir.1977); Dyestuff and Chemicals, Inc. v.......
  • Food for human consumption: Irradiation in production, processing, and handling of food— Ionizing radiation in treatment of food; x-ray maximum permitted energy level,
    • United States
    • Federal Register April 09, 2007
    • April 9, 2007
    ...that evidence should raise a material issue of fact concerning which a meaningful hearing might be held (Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 1085 (9th Cir.1982)). Where the issues raised in the objection are, even if true, legally insufficient to alter the decision, the agency ne......
  • Separate Parts In This Issue Part III Health and Human Services Department, Food and Drug Administration,
    • United States
    • Federal Register August 05, 2003
    • August 5, 2003
    ...must raise a material issue of fact concerning which a meaningful hearing might be held. (See Pineapple Growers Association v. FDA, 673 F.2d 1083, 1085 (9th Cir. 1982).) Where the issues raised in the objection are, even if true, legally insufficient to alter the decision, the agency need n......
  • Color additives: Mica-based pearlescent pigments,
    • United States
    • Federal Register July 20, 2006
    • July 20, 2006
    ...should raise a material issue of fact concerning whether a meaningful hearing might be held (Pineapple Growers Association v. FDA, 673 F.2d 1083, 1085 (9th Cir. 1982)). Where the issues raised in the objection are, even if true, legally insufficient to alter the decision, the agency need no......
  • Request a trial to view additional results
2 cases
  • Community Nutrition Institute v. Young, Nos. 84-1153
    • United States
    • U.S. Court of Appeals — District of Columbia Circuit
    • September 24, 1985
    ...closely, because hearings are appropriate only where material objections to the FDA's actions exist. See Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 1085 (9th Cir.1982); Pactra Industries v. Consumer Product Safety Comm'n, 555 F.2d 677, 684 (9th Cir.1977); Dyestuff and Chemicals, Inc. v.......
  • Community Nutrition Institute v. Novitch, Civ. A. No. 83-3846.
    • United States
    • United States District Courts. United States District Court (Columbia)
    • March 22, 1984
    ...necessarily hold a hearing on such objections to a final order, see, e.g., Pineapple Growers Association v. Food and Drug Administration, 673 F.2d 1083 (9th Cir.1982), nor grant the requested stay. See, e.g., Allan v. Securities and Exchange Commission, 577 F.2d 388 (7th...

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