Fmali Herb, Inc. v. Heckler

• Decision Date: 15 September 1983
• Docket Number: No. 82-4604,82-4604
• Citation: 715 F.2d 1385
• Parties: FMALI HERB, INC., Plaintiff-Appellant, v. Margaret M. HECKLER, * et al., Defendants-Appellees.
• Court: U.S. Court of Appeals — Ninth Circuit

Page 1385

715 F.2d 1385

FMALI HERB, INC., Plaintiff-Appellant, v. Margaret M. HECKLER, ^* et al., Defendants-Appellees.

No. 82-4604.

United States Court of Appeals, Ninth Circuit.

Argued and Submitted May 9, 1983.

Decided Sept. 15, 1983.

Barry Grossman, Edward T. Hand, William F. Baxter, Nancy C. Garrison, Dept. of Justice, Washington, D.C., for defendants-appellees.

William R. Pendergrast, Hamel, Park, McCabe & Saunders, Washington, D.C., J. Bruce McCubbrey, Fitch, Even, Tabin Appeal from the United States District Court for the Northern District of California.

Flannery & Welsh, San Francisco, Cal., for plaintiff-appellant.

Before PECK, ^** FLETCHER, and PREGERSON, Circuit Judges.

FLETCHER, Circuit Judge:

This case presents a question of first impression arising under section 201(s) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(s). The issue is whether the Food and Drug Administration (FDA) has properly interpreted the statute, which provides that the safety of substances added to food may be established by experience based on common use in food prior to 1958. We conclude that, even according the deference due an administrative agency's interpretation of a statute that it is responsible for enforcing, the challenged FDA regulation does not fairly reflect either the language or purpose of the "common use in food" portion of section 201(s). We therefore reverse the district court's declaration that the regulation is valid.

I BACKGROUND

Section 201(s) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(s) (1976), defines a "food additive" as a substance, added to food, that is

not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.

The question whether a substance is a "food additive" is significant because all "food additives" must by law undergo costly pretesting procedures before they may be marketed to the public. See 21 U.S.C. § 348 (1976).

In 1974, the FDA promulgated a regulation defining the term "common use in food" for purposes of section 201(s). The regulation states that " '[c]ommon use in food' means a substantial history of consumption of a substance by a significant number of consumers in the United States." 21 C.F.R. § 170.3(f) (1982) (emphasis added). Thus, according to the regulation, no substance may be newly introduced into the United States without either pretesting satisfactory to the FDA or general recognition among experts, based solely on scientific evidence, that the substance is safe for the intended use, no matter how widespread or prolonged the history of use of the substance in food in regions outside the United States.

Appellant Fmali Herb, Inc., is an importer of Chinese food products. In its business, Fmali wishes to import foods containing herbs traditional in China that have never been widely used in the United States. One such food is a jelly or honey-like product, known as renshenfengwangjiang, that normally contains schizandra seed. The FDA has ruled that renshenfengwangjiang may be sold in the United States only if it does not contain schizandra seed, because schizandra seed has not been scientifically tested and because it was not commonly used in the United States prior to 1958. The FDA held that evidence of long and widespread use of schizandra seed in China is not admissible in aid of establishing that schizandra seed is safe for human consumption.

Fmali filed an action in district court seeking a declaratory judgment that the

                FDA regulation codified at 21 C.F.R. § 170.3(f) is invalid as an erroneous interpretation of section 201(s).   No fact issues were disputed, and the parties filed cross-motions for summary judgment.   The district court, agreeing with the FDA that evidence of use of a substance in food in a foreign country may be unreliable to show safety, dismissed Fmali's action
                

II DISCUSSION

A. Ripeness.

Fmali brought the present action in order to obtain pre-enforcement review of the FDA's regulation. Fmali has not attempted to secure FDA clearance for any specific product. The posture of the case thus requires us to decide the validity of the regulation in the abstract, without reference to the regulation's application to a particular product, although prior FDA rulings have been cited. The hypothetical nature of the necessary inquiry suggests that the case might not be ripe for adjudication.

However, the Supreme Court in Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), sanctioned pre-enforcement review of an FDA regulation in a similarly-postured case. The Court held that such a challenge is neither statutorily nonreviewable, id. at 141-48, 87 S.Ct. at 1511-15, nor unripe for declaratory judgment adjudication, id. at 148-56, 87 S.Ct. at 1515-20. Following Abbott Laboratories, we conclude that the district court properly assumed jurisdiction of the declaratory judgment action filed by Fmali.

B. Scope of Review.

Administrative regulations fall into two categories: legislative regulations and interpretive regulations. 2 K. Davis, Administrative Law Treatise § 7.8, at 36 (2d ed. 1979). Legislative regulations are "issued by an agency pursuant to statutory authority and ... implement the statute." Batterton v. Francis, 432 U.S. 416, 425 n. 9, 97 S.Ct. 2399, 2405 n. 9, 53 L.Ed.2d 448 (1977). Such regulations have the force and effect of legislation, and may not be set aside because a court would have read the statutory mandate differently. Id. at 425, 97 S.Ct. at 2405. An interpretive regulation, by contrast, is one issued pursuant to an agency's interpretation of a governing statute, without delegated legislative power. See 2 K. Davis § 7.8, at 36. Since the FDA is not instructed by statute to define the term "common use in food," we assess 21 C.F.R. § 170.3(f) as an interpretive regulation.

Regulations interpreting statutory terms are given important but not controlling significance. Our task is limited to determining whether the FDA's construction of section 201(s) is "sufficiently reasonable" to be adopted by a reviewing court. Zenith Radio Corp. v. United States, 437 U.S. 443, 450, 98 S.Ct. 2441, 2445, 57 L.Ed.2d 337 (1978) (quoting Train v. Natural Resources Defense Council, 421 U.S. 60, 75, 95 S.Ct. 1470, 1479, 43 L.Ed.2d 731 (1975)). To uphold the regulation, we need not find the FDA interpretation to be the only reasonable one possible. Train, 421 U.S. at 75, 95 S.Ct. at 1479. However, the regulation cannot be sustained if it is contrary to the "plain meaning" of the statute and its legislative history. See, e.g., General Electric Co. v. Gilbert, 429 U.S. 125, 145, 97 S.Ct. 401, 412, 50 L.Ed.2d 343 (1976). We must therefore consider whether the challenged regulation represents a reasonable construction of section 201(s). ¹

C. History, Structure and Language of Section 201(s).

During the early 1950's, a House Select Committee chaired by James J. Delaney The House subcommittee reached a relatively early consensus that the bill should not contain a blanket "grandfather clause" automatically exempting from coverage all substances already used in food. See, e.g., Federal Food, Drug, and Cosmetic Act (Chemical Additives in Food): Hearings on H.R. 4475 Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 84th Cong., 2d Sess. 28 (1956) (statement of Rep. Delaney) [hereinafter cited as Chemical Additives Hearings ]. At the same time, members of Congress recognized that many ordinary food ingredients had never been scientifically tested, but had long been used without evidence of health hazards. To require exhaustive laboratory analysis and pretesting of these additives was opposed because it would serve no useful purpose and would unduly burden both the food industry and the Government. Id. at 40 (statement of Rep. Miller).

                following investigation, registered concern about the many recently developed chemicals being added to improve the texture, color, flavor and shelf life of packaged foods.   See H.R.Rep. No. 2284, 85th Cong., 2d Sess. 2 (1958).   Legislation was introduced in the 83rd, 84th, and 85th Sessions of Congress for the purpose of subjecting such chemical additives to pretesting for safety.   Id.  One problem confronted by the draftsmen was how to deal with chemical substances already in general use as food ingredients.
                

As the legislation moved toward passage, several alternative approaches were written into the bills submitted to the House subcommittee for consideration. See Food Additives: Hearings on Bills Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 85th Cong., 2d Sess. 45-46 (1958) [hereinafter cited as Food Additives Hearings ]. One type of bill allowed exceptions to the pretesting requirement only for substances generally recognized as safe by scientific experts, based on testing. E.g., H.R. 7700, H.R. 7798, and H.R. 7938, 85th Cong., 1st Sess. (1957). The second variety allowed exceptions to pretesting for only those substances that had been approved, formally or informally, by the FDA. ² E.g., H.R. 8390 and H.R. 8629, 85th Cong., 1st Sess. (1957). Finally, a number of bills allowed an exception for substances shown "through prolonged use in food" to be safe for the intended use. E.g., H.R. 6747, H.R. 8112, and S. 1895, 85th Cong., 1st Sess. (1957). It was one of these latter bills, H.R. 6747, that eventually won Administration approval and was enacted, with modifications, by Congress.

Assistant Health, Education, and Welfare Secretary Elliott L. Richardson described in House hearings the effect of the "prolonged use" language in the H.R. 6747. He commented that,

with respect to existing additives generally...