Continental Chemiste Corporation v. Ruckelshaus

• Decision Date: 11 May 1972
• Docket Number: No. 71-1828.,71-1828.
• Citation: 461 F.2d 331
• Parties: CONTINENTAL CHEMISTE CORPORATION, Petitioner, v. William D. RUCKELSHAUS, Administrator, and Environmental Protection Agency, Respondents.
• Court: U.S. Court of Appeals — Seventh Circuit

461 F.2d 331 (1972)

CONTINENTAL CHEMISTE CORPORATION, Petitioner, v. William D. RUCKELSHAUS, Administrator, and Environmental Protection Agency, Respondents.

No. 71-1828.

United States Court of Appeals, Seventh Circuit.

Argued January 21, 1972.

Decided May 11, 1972.

John M. Moelmann, D. Kendall Griffith, D. Patterson Gloor, Louis A. McLean, Northfield, Ill., for The Continental Chemiste Corp., petitioner; Hinshaw, Culbertson, Moelmann, Hoban & Fuller, Chicago, Ill., of counsel.

Alan S. Rosenthal, Dept. of Justice, Thomas H. Kemp, Michael C. Farrar, Environmental Protection Agency, Washington, D. C., L. Patrick Gray, III, Asst. Atty. Gen., Washington, D. C., for respondents.

Before HASTINGS, Senior Circuit Judge, and KILEY and STEVENS, Circuit Judges.

STEVENS, Circuit Judge.

If use of an economic poison in compliance with the directions on its label will cause certain food to become "adulterated" within the meaning of the Food, Drug and Cosmetic Act (FDCA),¹ is the poison necessarily "misbranded" within the meaning of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)?² If not, the registrations of petitioner's products were improperly cancelled since, as a matter of fact, proper use of the products is not injurious to man. On the other hand, if the question is answered affirmatively, we must decide whether the failure to obtain a so-called "tolerance" for petitioner's products either as an added poisonous and deleterious substance,³ or as a "food additive,"⁴ means that even harmless traces of residue on foods result in "per se adulteration" under FDCA. In any event, we must give consideration to both FIFRA and FDCA to decide this case.

Petitioner manufactures three smoke insecticides containing a chemical known as "lindane."⁵ Because lindane is an economic poison, the products have been registered with the Department of Agriculture since 1955.⁶ Each of the three products, when activated by a match, dispenses a cloud of poisonous particulate which kills bugs. The labels contain directions for proper use and advice to avoid prolonged breathing of the smoke, contact with skin and eyes, and ingestion, and to keep out of reach of children. The directions contemplate use of the product in the home, advising that pets and fish be removed, and: "Cover tightly or remove any food in rooms to be treated."⁷

The principal market for petitioner's products is for home use; its most significant hazards are the danger of inhalation and the risk that the smoke will penetrate coverings and leave residues on food.

In 1969 the Agricultural Research Division of the Department of Agriculture (ARS) concluded a series of studies of lindane products used in thermal vaporizers. Two general types of lindane vaporizers were being marketed, one which operated continuously and the other which volatized fixed quantities on a "one-shot" basis. The former, or continuous type, was approved for use in industrial establishments, but not for home use. Petitioner's products are of the latter type.⁸ The studies indicated that continuous lindane vaporizers were in fact being used widely in homes, and that residues of lindane on food posed a threat to human health. Accordingly, ARS concluded that continued registration of lindane products intended for vaporizers was contrary to the requirements of FIFRA. Notices of cancellation were therefore sent to the entire industry in April, 1969.

At least four manufacturers, including petitioner, exercised their statutory right to have the matter referred to a scientific advisory committee. The committee concluded that "existing data are sufficient to indicate the reality of human hazard,"⁹ and recommended that "cancellation of registrations of all lindane products intended for vaporization should be maintained."¹⁰ Acting on that recommendation, on October 5, 1970, the Administrator of ARS entered findings of fact and conclusions relating generally to the registration of lindane products for use in vaporizing devices. His order stated that the "notices of cancellation of registrations of the products involved in this proceeding are hereby affirmed."

Petitioner then filed a timely request for a public hearing to raise objections to the cancellation of its three registrations based, in part, on differences between its products and the other products which had been considered especially dangerous. In addition to the difference between infrequent "one-shot" applications and continuous use,¹¹ petitioner contends that the particles of its smokes are much larger than the particles of vapor produced by other lindane products and, therefore, much less apt to penetrate food coverings. It is undisputed, however, that some penetration of food coverings, other than metals and glass, does result from the use of petitioner's products.

Prior to the public hearing, the Secretary of Agriculture's responsibilities under FIFRA were transferred to the Administrator of the Environmental Protection Agency, the respondent herein. After a full evidentiary hearing, on September 20, 1971, the Examiner submitted findings and conclusions recommending that the cancellations be vacated. He found that petitioner had met its burden of proof and that its products "contain directions for use which are necessary and if complied with adequate for the protection of the public"; and that "when used as directed or in accordance with commonly recognized practice" the products are "not harmful to living man."¹² The Hearing Examiner's opinion is comprehensive and relates specifically to petitioner's products rather than to the industry in general.

Counsel for the Pesticides Office of respondent filed exceptions to the Hearing Examiner's recommended findings and order, stressing particularly the danger from inhalation of lindane and, secondarily, the danger from residues on food. The exceptions were reviewed by a judicial officer of the agency. It is the opinion of the Judicial Officer which raises the legal question stated at the beginning of this opinion.

The Judicial Officer agreed with the Hearing Examiner's findings and conclusions pertaining to the question of exposure by inhalation. With respect to the question of residues, however, he ruled as a matter of law that "any presence of lindane on processed or served food is per se contamination."¹³ He did not disagree with the Examiner's finding that the amount of residue was not toxicologically significant, but held that since the food and Drug Administrator had not established a tolerance for lindane residues on food for human consumption pursuant to § 406 or § 409 of the FDCA, 21 U.S.C. §§ 346 and 348, even a harmless trace results in "adulteration." He concluded that "all FIFRA labels should bear directions for use adequate to insure conformity to all pertinent regulations of other government agencies."¹⁴ He therefore ordered that petitioner's registrations be cancelled, subject to reinstatement if the labels were modified to prohibit use in areas where food is prepared, served or stored.

We stayed that order and must now determine its validity. There are three distinct theories which might support the order. Although respondent now relies on only the third, to discuss that theory intelligently it is necessary to understand why the first two are inapplicable. We shall therefore discuss the effect of (1) FIFRA apart from the requirements of FDCA; (2) the sections of the FDCA which relate to food which bears or contains any added poisonous or deleterious substance, 21 U.S.C. § 342(a) (2) (A) and § 346; and (3) the "food additive" amendments to FDCA enacted in 1958, 21 U.S.C. § 342 (a) (2) (C) and § 348.¹⁵

I.

The subject matter of FIFRA¹⁶ is economic poisons. The basic purpose of the statute was to regulate the labeling of such products to provide purchasers with assurance of effectiveness and safety when used in compliance with the manufacturer's instructions. Until the manufacturer persuades the Administrator (formerly the Secretary of Agriculture) that his proposed labeling is adequate and that use of the product in compliance with directions is safe, the product may not be registered; unregistered economic poisons may not be sold in interstate commerce.

Registrations must be renewed at five-year intervals. Because of the continuing potential for harm from the use of such poisons, the Administrator retains a continuing right to cancel (or if an emergency exists, immediately to suspend)¹⁷ a registration. In cancellation proceedings, as in applications for initial registration, the manufacturer has the burden of proving that his product is not "misbranded" within the meaning of the Act. Stearns Electric Paste Company v. Environmental Protection Agency, 461 F.2d 293, pp. 304, 305 (7th Cir. 1972).

The statutory definition of the term "misbranded" incorporates a substantive standard of product safety. There are several tests which must be met. The directions accompanying the product, if complied with, must be "adequate for the protection of the public";¹⁸ warning statements, if complied with, must be "adequate to prevent injury to living man"¹⁹ and other useful life. The substantive standards, phrased in terms of protection of the public and impact on living man, require consideration of the aggregate effect of a product's use upon the environment, including not only its potential for harm, but also the benefits which would be lost by removing it from the market.²⁰

In this case, the tests of product safety as set forth in FIFRA's definition of "misbranded" were met by petitioner. The Hearing Examiner expressly found that petitioner had sustained its burden of proof. Although the Judicial Officer did not enter all of the Examiner's recommended findings, we are satisfied that they are supported by the record.²¹ Since FIFRA itself does not condition entitlement to registration on compliance with any other statute, the language of FIFRA clearly supports the Hearing...