On appeal from the United States District Court for the Middle District of Pennsylvania; D.C. No. 1:CV-90-0746.
Sloviter and Mansmann, Circuit Judges, and Sarokin, District Judge*fn*
The issue before the court is whether the Food and Drug Administration's final rule barring the sale of "fresh" potatoes treated with sulfites should be invalidated because large portions of the administrative record upon which the FDA based its decision were not available for public review during the notice and comment rulemaking period.
Factual and Procedural Background
The decision to impose a regulatory ban on the use of sulfites to preserve fresh potatoes*fn1 grew out of an FDA inquiry into health and safety problems caused by the use of sulfites as food preservatives. In 1985 the Federation of American Societies for Experimental Biology issued an FDA-commissioned report stating that use of sulfites on fresh fruits, vegetables, and potato products had posed serious health risks to approximately one million sulfite-sensitive individuals. In the same year, an FDA ad hoc advisory committee reached a similar conclusion and recommended that the FDA prohibit the use of sulfites on fresh potatoes and raw fruits and vegetables. The FDA also analyzed sulfite-related consumer complaints and its own follow-up reports. Based upon this information, the FDA concluded that "a consensus no longer exists among qualified experts that this use of sulfiting agents is safe." 52 Fed. Reg. 9826 (Mar. 15, 1990).
In 1986 the FDA adopted a regulation requiring the labels on packaged and labeled foods containing detectable amounts of sulfites to indicate the presence of sulfites. Also in 1986 the FDA revoked the "Generally Recognized As Safe" (GRAS) status of unpackaged fruits and vegetables (not including potatoes) that are sold raw or presented to the consumer as fresh, such as in a restaurant or at a salad bar.
In 1987, the FDA determined to extend its regulatory ban to the fresh potato industry. On December 10, 1987, the FDA, acting pursuant to its notice and comment rulemaking authority, announced in the Federal Register a proposed regulation revoking the GRAS status of fresh potatoes containing sulfites and banning the use of sulfiting agents on fresh potatoes. The FDA concluded that a ban was necessary in that there was no established safe minimum sulfite level, and the danger that restaurant and food-service patrons would unknowingly consume sulfite-treated fresh potatoes could not be addressed adequately by reliance on written warnings or those warnings which might be communicated by restaurant personnel. The ban was scheduled to take effect on April 16, 1990.
In accordance with 21 C.F.R. 10.40(c)(2), which requires that in a notice and comment rulemaking proceeding, the decision of the Commissioner "will be based solely upon the administrative record,"*fn2 the FDA, in its notice announcing the proposed regulation, indicated that the documents relevant to the determination to ban the use of sulfites on fresh potatoes were on file with the FDA's Dockets Management Branch. 52 Fed. Reg. 46968, 46970 (Dec. 10, 1987).*fn3
The plaintiffs, the National Coalition of Fresh Potato Processors, which includes approximately 100 potato processing companies, and three of its individual members, participated in the notice and comment process; each individual plaintiff submitted citizen petitions and the coalition, on behalf of its members, submitted comments. It is undisputed that during the notice and comment period, none of the plaintiffs visited the Dockets Management Branch in order to examine the administrative record said to have been compiled by and relied on by the FDA in promulgating the rule banning sulfites in the processing of fresh potatoes.
On April 11, 1990, the plaintiffs filed suit for declaratory judgment and injunctive and mandatory relief in the United States District Court for the Middle District of Pennsylvania, challenging the proposed sulfite ban and seeking a temporary restraining order preventing the ban from taking effect.
The plaintiffs' primary challenges to the regulation centered upon allegations that the ban on the use of sulfites to preserve fresh potatoes was unfair in that the use of sulfites in processing other types of potatoes and in other products, such as shrimp, was unaffected. The plaintiffs also alleged that the sulfite ban was based upon unreasonable and unsupported assumptions concerning the behavior of consumers, especially those who know themselves to be sulfite-sensitive and was based, too, upon the conclusion, not rationally supported by the record, that there were a number of viable sulfite alternatives. Other challenges to the proposed ban included allegations that the FDA had ignored citizen petitions filed with the agency and had violated its own regulations in failing to respond to these petitions, that public health risks would be created by the use of sulfite alternatives, that the FDA had failed to issue or rule upon a request for a mandatory stay of the ban, and that the agency had failed to take into account the fact that the ban would "destroy" the fresh potato industry. The plaintiffs alleged that, in light of these factors, the FDA's adoption of the final regulation was "arbitrary, capricious, otherwise not in accordance with law, and without observance of procedure required by law, in violation of the [Administrative Procedure Act], 5 U.S.C. § 706. . . ."*fn4
Finally, the plaintiffs challenged the FDA's failure to consider the plaintiffs' petition for reconsideration, asking that the agency repeal the final rule or permit the use of sulfites at a reduced level. The plaintiffs noted in the complaint that they had "submitted this petition [for reconsideration] notwithstanding the fact that the plaintiffs had been unable to obtain from the FDA a complete copy of the administrative record. When the petition was submitted, FDA had provided only 46 of 83 volumes of the record and . . . the entire record has still not been provided." The FDA's failure to grant the petition for reconsideration was also alleged to violate 5 U.S.C. § 706.
On April 13, 1990, the district court issued a temporary restraining order enjoining the FDA from enforcing the sulfite ban until April 25, 1990, when a hearing on the motion for preliminary injunction was scheduled to take place. On May 1, 1990, the district court issued a memorandum and order vacating the temporary restraining order and denying the plaintiffs' motion for a preliminary injunction. The court concluded that the FDA "has ...