in 1979 by the Environmental Protection Agency (EPA) to implement the 1978 amendments. It seeks declaratory and injunctive relief from the operation of the challenged portions of FIFRA and the EPA's regulatory practice and procedure as set forth in the regulations.
Mobay is a major developer of pesticides and has been for many years. It has spent millions of dollars in research and development and experimentation and analysis. Production of pesticides is essential to the production of food throughout the world. The evaluation and registration of pesticides are essential to the protection of people. How both interests are to be accommodated has occupied the industry and the government for many years. Both interests have long sought an accommodation, but the result achieved thus far has left Mobay, and we suspect many other developers, exasperated and frustrated. As technology improves, more products are developed, but the need for protection increases.
Mobay's complaints are understandable. Certainly a better accommodation can be devised by the human mind, and it must be, if the industry is to succeed in developing the sophisticated pesticides which will be required in the years to come.
However, for the reasons which follow we cannot grant either declaratory or injunctive relief, in our judgment.
In essence, Mobay attacks three features of FIFRA's new regulatory scheme. First, EPA's use of data previously submitted by one applicant to support the application for registration filed by a later applicant. Second, disclosure provisions which make certain trade secret data submitted to EPA available to the public and to government contractors. Third, EPA's policy of issuing, for the time being, only conditional registrations and of requiring, from time to time, general, as opposed to specific and detailed, data requirements in order to maintain the conditional registrations.
These features of the regulatory scheme, Mobay claims, render research and development in the pesticide industry unprofitable and impractical. It says that chemical companies will not devote large amounts of money and time to developing new pesticides if they know that their trade secret data will be disclosed to others; if another company may obtain a registration by relying entirely on their data and submitting none of its own; if EPA is continually imposing new conditions on them which they must meet in order to keep their products on the market; or if EPA does not publish definite data requirements specifying exactly what tests and studies must be submitted.
In short, Mobay contends that the scheme is now arbitrary and uncertain.
The defendant offered justification for both the FIFRA amendments and EPA's interpretation of those amendments, expressed in its regulations. The defendant contends that Congress and the EPA acted together to increase competition in the pesticide industry, present all scientific data necessary for informed regulatory decisions before EPA, protect the proprietary rights of data submitters, inform the public about the effects of the chemicals contained in the pesticides, and ease the burden EPA has long borne in processing thousands of applications for registration and analyzing innumerable items of data. In other words, despite FIFRA's and the regulations' seeming inscrutability, and their allegedly appropriative data sharing scheme, and the interminable registration process, Congress and EPA have devised a rational scheme designed to meet several needs and satisfy diverse interests.
Numerous exhibits were introduced at trial, and both sides have filed extensive pretrial and posttrial briefs. These, together with our review of the transcripts of the able direct and cross examination of both sides' witnesses, have facilitated our understanding of FIFRA and the regulations, and our perception of Mobay's objections to them.
The Federal Insecticide, Fungicide, and Rodenticide Act
Enacted in 1947, the Federal Insecticide, Fungicide, and Rodenticide Act, ch. 125, 61 Stat. 163 (1947), initially provided for a simple and straightforward registration process. An applicant seeking to register his pesticide -- or "economic poison" as it was called then, see id, § 2(a) -- was required to file with the Secretary of Agriculture
his name and address, the name of the pesticide, a complete copy of the labeling and a statement of all claims made for it, including directions for use, and, if requested by the Secretary, a full description of the tests made and the results thereof upon which the claims were based. Id. § 4a, 61 Stat. 167. If he deemed it necessary for the effective administration of the Act, the Secretary could require the applicant to submit the complete formula of the pesticide. Id. § 4b.
The early FIFRA made it unlawful for any person to reveal or use to his own advantage information relative to product formulas, acquired by authority of the Act, id. § 3c(4), and provided penalties for violations. Id. § 8, 61 Stat. 170.
The Secretary registered the pesticide if it appeared that its composition was such as to warrant the proposed claims made for it and if it and its labeling and other submitted materials complied with the Act. Id. § 4b, 61 Stat. 167-68. If the Secretary was dissatisfied with an application, he would notify the applicant of the manner in which the application failed to comply with the Act, and permit him to make the necessary corrections. Id. § 4c, 61 Stat. 168.
The Secretary was authorized to cancel the registration of any pesticide after it had been registered for five years, unless the registrant requested that it be continued in effect. Id. § 4e. The Secretary was also authorized to cancel a registration at any time on his own motion "in order to protect the public." Id. § 4c.
FIFRA was virtually reenacted in 1972
(and then amended in 1975
) as a response to growing public concern about public health and the ecological effects of pesticides. The new FIFRA provided for a more complete registration process and stronger enforcement measures, and heralded a policy of thorough scientific analysis of pesticide chemicals before making them available to the public. Now, under § 3(c)(5), not only does an applicant for registration have to show that his pesticide's composition is such as to warrant the proposed claims for it and that its labeling and other submitted materials comply with the Act before he may obtain a registration, but the EPA must also determine that the pesticide will perform its intended function without unreasonable adverse effects on the environment, and that, when used in accordance with widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects on the environment. Federal Environmental Pesticide Control Act of 1972, Pub. L. No. 92-516, § 2, 86 Stat. 980-81 (codified at 7 U.S.C.A. § 136a(c)(5)(1980)).
Under § 3(c)(3), EPA must review the data submitted with an application and, "as expeditiously as possible," either register the pesticide or notify the applicant that his application does not comply with FIFRA. Id., 86 Stat. 980, 7 U.S.C.A. § 136a(c)(3).
Under the 1972 amendments, data submitters for the first time were given proprietary rights in their data. Section 10(a) permitted them to mark any portions of their data which they considered to be trade secrets or commercial or financial information, and section 10(b) prohibited the EPA from disclosing those portions.
The amendments affected data submitters' rights in another way. As under the 1947 Act, applicants still had to submit full descriptions of the tests made and the results thereof upon which their claims were based, if they were requested to do so by EPA. But Congress added the following, to what was now § 3(c)(1)(D):
Data submitted in support of an application shall not, without permission of the applicant, be considered by the Administrator in support of any other application for registration unless such other applicant shall have first offered to pay reasonable compensation for producing the test data to be relied upon and such data is not protected from disclosure by section 10(b).