FORMULA v. Heckler
| Decision Date | 31 December 1985 |
| Docket Number | No. 84-5747,84-5747 |
| Citation | 779 F.2d 743 |
| Parties | FORMULA, et al., Appellants v. Margaret M. HECKLER, Secretary of Health and Human Services, et al. |
| Court | U.S. Court of Appeals — District of Columbia Circuit |
Appeal from the United States District Court for the District of Columbia (D.C.Civil Action No. 82-3406).
Katherine A. Meyer, with whom William B. Schultz and Alan B. Morrison, Washington, D.C., were on the brief, for appellants.
Marcia A. Johnson, Atty., U.S. Dept. of Justice, Washington, D.C., of the bar of the Supreme Court of Neb., pro hac vice, by special leave of court, for appellees. Richard K. Willard, Acting Asst. Atty. Gen., John R. Felder and Vicki G. Golden, Attys., U.S. Dept. of Justice, Washington, D.C., and Thomas Scarlett, Chief Counsel, Food & Drug Admin., Rockville, Md., were on the brief, for appellees.
Before ROBINSON, Chief Judge, STARR, Circuit Judge, and McGOWAN, Senior Circuit Judge.
Opinion for the court filed by Circuit Judge STARR.
This case presents a challenge to portions of the Food and Drug Administration's regulations pertaining to infant formula, 1 published at 5 C.F.R. Secs. 106.1-106.120 (1984) and promulgated pursuant to the Infant Formula Act of 1980, Pub.L. No. 96-359, 94 Stat. 1190 (codified principally at 21 U.S.C. Sec. 350a (1982)). The regulations at issue address (1) quality control procedures by manufacturers of infant formula for assuring the nutrient content of such products, (2) quality factor requirements aimed at ensuring nutritional quality during the formula's shelf life, and (3) recordkeeping requirements.
Appellants challenge these regulations as violative of both the Infant Formula Act and the Administrative Procedure Act. The complainants consist of FORMULA, a non-profit organization; Public Citizen Health Research Group; Consumer Federation of America; and two couples representing themselves and their children (referred to collectively hereinafter as "FORMULA"). FORMULA brought suit in United States District Court for the District of Columbia, seeking a declaratory judgment that the Food and Drug Administration's final rule "violates the Infant Formula Act of 1980, 21 U.S.C. Sec. 350a, et seq., and the Administrative Procedure Act, 5 U.S.C. Sec. 706." Complaint at 1-2. FORMULA sought "an order requiring the FDA to issue regulations that prescribe mandatory quality control and testing procedures, including adequate record-keeping and audit procedures, in accordance with the Infant Formula Act at 1980." Id.
Both FORMULA and the FDA moved for summary judgment. In a published opinion, the district court denied both motions without prejudice. FORMULA v. Schweiker, 572 F.Supp. 862, 866 (D.D.C.1983). At a subsequent status conference, the district court directed the FDA to provide further materials explaining the "industry framework" to aid the court's understanding of the manner in which the rules would operate and whether the regulations were lawful. The FDA supplied the affidavit of Taylor M. Quinn, Associate Director for Compliance of the FDA's Bureau of Foods; FORMULA thereafter was permitted, over the FDA's objection, to take Mr. Quinn's deposition. 2 On the parties' subsequent renewed cross-motions for summary judgment, the district court granted the FDA's motion and dismissed appellants' suit. FORMULA v. Schweiker, 593 F.Supp. 346, 348 (D.D.C.1984). This appeal ensued.
After careful review of the administrative record, we affirm the district court's judgment. We hold that the district court correctly determined that there were no remaining genuine issues of material fact, that summary judgment was properly awarded to the FDA on the basis that the FDA's final regulations were not unlawful under the Infant Formula Act of 1980, and that the regulations constituted a proper exercise of the agency's discretion in effectuating the purposes of the statute.
For many infants in this country, infant formula provides the sole source of nutrition. Deficiencies in an infant formula--for example, the absence of an essential nutrient--may therefore have a seriously deleterious effect on infants' nutrition and development. In 1979, precisely this development took place, when a number of infants were exposed over a significant period to two infant formula products of Syntex, Inc., namely Neo-Mull-Soy and Cho-Free. These two products were deficient in chloride, a nutrient essential to infants' proper development. Staff of the Subcomm. on Oversight and Investigations of the Senate Comm. on Interstate and Foreign Commerce, 96th Cong., 2d Sess., Infant Formula: Our Children Need Better Protection 6 (Comm. Print 1980) (hereinafter "Committee Print"). The chloride deficiency arose when the manufacturer stopped adding salt--sodium chloride--to Neo-Mull-Soy and Cho-Free in the spring of 1978 in order to reduce the sodium content of the two products. Notwithstanding this substantial change in the formulas' ingredients, Syntex failed to conduct a single chloride assay on these products for approximately eighteen months after this reformulation. Committee Print at 19. Thus, the deficiency went undetected until after infants began to experience severe problems. Id. Indeed, the consequences of Syntex's conduct for some infants were highly serious. Over 100 infants developed hypochloremic metabolic alkalosis, a rare and potentially lethal chemical abnormality caused by the insufficient levels of chloride in their diets. H.R.Rep. No. 936, 96th Cong., 2d Sess. 4 (1980) (hereinafter "House Report"); S.Rep. No. 916, 96th Cong., 2d Sess. 3 (1980) U.S.Code Cong. & Admin.News 1980, p. 2858, (hereinafter "Senate Report"). The serious medical problem was further exacerbated, the Senate Subcommittee found, by the FDA's inappropriate handling of the recall of the deficient formulas 3 and Syntex's failure to cooperate in effectuating the recall. 4 Committee Print at 3-4.
These unfortunate incidents provided the backdrop for substantial legislative activity that quickly ensued. Beginning in the fall of 1979, several members of Congress introduced bills addressing infant formula nutritional standards. 5 The Subcommittee on Health and the Environment of the House Committee on Interstate and Foreign Commerce held hearings on the proposed legislation in February and March 1980. Nutritional Quality of Infant Formula: Hearings on H.R. 6590, H.R. 6608, H.R. 5836, and H.R. 5839 Before the Subcomm. on Health and Environment of the House Comm. on Interstate and Foreign Commerce, 96th Cong., 2d Sess. (1980). On March 23, 1980, the Subcommittee approved a working draft of a bill that consolidated the proposed legislative approaches and ordered the version approved reported out as a clean bill. House Report at 3-4. On March 26, 1980, twelve members of Congress introduced H.R. 6940, which reflected the Subcommittee's actions to date. 126 Cong.Rec. 6779 (1980). A similar scenario unfolded in the United States Senate. 6
Thereafter, both the House of Representatives and the Senate approved a bill, and the President signed the measure into law on September 26, 1980. 126 Cong.Rec. 27,798 (1980). As enacted, the Infant Formula Act departs substantially from the traditional regulatory mode with respect to food products. The statute provides that infant formula "shall be deemed to be adulterated" if (1) it fails to provide twenty-nine specific nutrients listed in 21 U.S.C. Sec. 350a(g) (1982), id. at Sec. 350(a)(1)(A); (2) it fails to "meet the quality factor requirements prescribed by the Secretary under this section," id. Sec. 350(a)(1)(B); or (3) "the processing of such infant formula is not in compliance with the quality control requirements prescribed by the Secretary under this section." Id. Sec. 350a(a)(1)(C). Of especial importance to this case, the statute further provides as follows:
The Secretary may by regulation--
(A) revise the list of [required] nutrients (B) revise the required level for any [required] nutrient ...;
(C) establish requirements for quality factors for such nutrients; and
(D) establish such quality control procedures as the Secretary determines necessary to assure that an infant formula provides nutrients in accordance with this section and establish requirements respecting the retention of records of procedures required under this clause (including maintaining necessary nutrient testing records).
Quality control procedures prescribed by the Secretary shall include the periodic testing of infant formulas to determine whether they are in compliance with this section.
Id. Sec. 350a(a)(2).
Subsection (e) of the statute prescribes recordkeeping requirements for manufacturers and defines the FDA's oversight and enforcement role with respect to recordkeeping. It provides as follows:
(1) Each manufacturer of an infant formula shall make and retain such records respecting the distribution of the infant formula through any establishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the formula. No manufacturer shall be required under this subsection to retain any record respecting the distribution of an infant formula for a period of longer than 2 years from the date the record was made.
(2) To the extent that the Secretary determines that records are not being made or maintained in accordance with paragraph (1), the Secretary may by regulation prescribe the records required to be made under paragraph (1) and requirements respecting the retention of such records under such paragraph. Such regulations shall take effect on such date as the Secretary prescribes but not sooner than the 180th day after the date such regulations are promulgated. Such regulations shall apply only with respect to distributions of infant formulas made after such effective date.
Id. Sec. 350a(e).
Subsection (g) sets forth in tabular form the twenty-nine...
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