Amchem Products, Inc. v. Gaf Corporation and Douglas M. Costle, Administrator, Environmental Protection Agency

594 F.2d 470, 9 Envtl. L. Rep. (Envtl. Law Inst.) 20610, 1979 U.S. App. LEXIS 14886
CourtCourt of Appeals for the Fifth Circuit
DecidedMay 7, 1979
Docket76-3801
StatusPublished
Cited by11 cases

This text of 594 F.2d 470 (Amchem Products, Inc. v. Gaf Corporation and Douglas M. Costle, Administrator, Environmental Protection Agency) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fifth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Amchem Products, Inc. v. Gaf Corporation and Douglas M. Costle, Administrator, Environmental Protection Agency, 594 F.2d 470, 9 Envtl. L. Rep. (Envtl. Law Inst.) 20610, 1979 U.S. App. LEXIS 14886 (5th Cir. 1979).

Opinion

TJOFLAT, Circuit Judge:

The primary issue on this appeal is the effective date of the amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §§ 135-135k (1976) (superseded Oct. 21, 1976 by 7 U.S.C. §§ 136-136y), enacted by the Federal Environmental Pesticide Control Act of 1972 (FEPCA), Pub.L. No. 92-516, 86 Stat. 973 (1972). Those amendments provide, in pertinent part, that an applicant for registration of a pesticide under FIFRA must offer compensation for the use of scientific test data submitted by a prior applicant. Am-chem Products, Inc. (Amchem) appeals from a judgment holding that the amendments were not in effect when GAF Corporation (GAF) applied for a registration on the basis of test data developed and submitted by Amchem. We reverse.

*472 I

A. Facts

Amchem is a developer, producer, and marketer of herbicides, plant growth regulators, and plant hormones. GAF is a manufacturer of basic chemicals. In 1961 these two companies entered into a screening agreement under the terms of which GAF was to develop new chemical compounds with possible agricultural uses and then submit these chemicals to Amchem for evaluation and development as commercial products. Pursuant to this agreement GAF submitted and Amchem tested a compound now known as ethephon. Amchem determined that ethephon had substantial commercial value as a plant growth regulator and formulated it into a marketable product with the trade name Ethrel.

Before Amchem could sell Ethrel in interstate commerce, it had to obtain registrations for specific uses of the product from the Environmental Protection Agency (EPA) as required by FIFRA. Amchem submitted extensive scientific test data regarding the safety and efficacy of Ethrel in support of its applications. This data was developed by Amchem over a period of several years and at a cost of several million dollars. EPA issued registrations for the use of Ethrel on cherries and tomatoes on April 24, 1973, and for apples on July 26, 1973.

On November 12, 1973, GAF filed with EPA an application for registration of its product Cepha, a plant growth regulator with ethephon as the active ingredient. GAF’s application set forth the chemical composition of Cepha, a proposed label, and stated that Cepha was identical to the already registered product Ethrel. EPA requested only one scientific study from GAF in support of its application. Registrations for use of Cepha on cherries, tomatoes, and apples were issued on February 28, 1974. EPA acknowledges that it registered Cepha in reliance upon test data submitted by Amchem in support of the Ethrel application and that Cepha could not have been registered without consideration of that data. This data was neither shown to nor made available to GAF for inspection; EPA simply used it internally. Amchem never gave permission for its data to be used in this fashion, and GAF never offered to compensate Amchem for the use of the data.

B. The Statutory Provisions

FIFRA was enacted in 1947 as a regulatory statute for pesticides. Prior to its amendment by FEPCA, FIFRA prohibited the shipment in interstate commerce of any pesticide 1 not registered with EPA. To obtain a registration, an applicant had to submit the complete formula of the pesticide, a proposed label with warnings and directions for use, and any test data required by EPA to support the safety and efficacy of the product. The statute provided that information relative to product formulas was not to be disclosed except to specified persons. 7 U.S.C. § 135a(c)(4) (1976). FIFRA was silent as to the status of supporting test data except to say that when such data was submitted by EPA to an advisory committee for evaluation it was confidential in the hands of that committee. Id. § 135b(c). It was the consistent practice of EPA to refer to test data submitted by a prior applicant when considering a subsequent application for registration of a product with the same ingredients. 2

FEPCA completely rewrote FIFRA. Among the substantive changes made were the extension of FIFRA to completely in *473 trastate use of pesticides and the requirement that pesticides be classified for general or restricted use. Important changes were also made in the treatment to be accorded test data. Section 3(c)(2) of FI-FRA as amended, 86 Stat. 980, required EPA to make public, within 30 days after issuance of a registration, the data relied upon to support the registration. This requirement did not apply to trade secrets. Additionally, section 3(c)(1)(D), id. at 979-80, prohibited EPA from considering previously submitted data in support of a subsequent application unless the second applicant offered to compensate the first one. If the data were trade secret, the permission of the first applicant was also required. The relevant provisions are set forth in the margin. 3

FEPCA was enacted on October 21, 1972. The effective dates of its amendments to FIFRA are controlled by section 4 of FEP-CA, which provides in relevant part:

Sec. 4. (a) Except as otherwise provided in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended by this Act, and as otherwise provided by this section, the amendments made by this Act shall take effect at the close of the date of the enactment of this Act, provided if regulations are necessary for the implementation of any provision that becomes effective on the date of enactment, such regulation shall be promulgated and shall become effective within 90 days from the date of enactment of this Act.
(b) The provisions of the Federal Insecticide, Fungicide, and Rodenticide Act and the regulations thereunder as such existed prior to the enactment of this Act shall remain in effect until superseded by the amendments made by this Act and regulations thereunder: Provided, That all provisions made by these amendments and all regulations thereunder shall be effective within four years after the enactment of this Act.
*474 (c)(1) Two years after the enactment of this Act the Administrator shall have promulgated regulations providing for the registration and classification of pesticides under the provisions of this Act and thereafter shall register all new applications under such provisions.
(2) After two years but within four years after the enactment of this Act the Administrator shall register and reclassify pesticides registered under the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act prior to the effective date of the regulations promulgated under subsection (c)(1).

86 Stat. 998-99. At the core of this lawsuit is the relation of section 4 to section 3(c)(1)(D).

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594 F.2d 470, 9 Envtl. L. Rep. (Envtl. Law Inst.) 20610, 1979 U.S. App. LEXIS 14886, Counsel Stack Legal Research, https://law.counselstack.com/opinion/amchem-products-inc-v-gaf-corporation-and-douglas-m-costle-ca5-1979.