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FOUNDATION ON ECONOMIC TRENDS v. THOMAS

March 6, 1986

FOUNDATION ON ECONOMIC TRENDS, et al., Plaintiffs,
v.
Lee A. THOMAS, et al., Defendants



The opinion of the court was delivered by: HOGAN

 THOMAS F. HOGAN, District Judge.

 Plaintiffs, various individuals and non-profit environmental organizations, seek injunctive relief against the Environmental Protection Agency's ("EPA") issuance of an experimental use permit ("EUP") to Advanced Genetic Sciences, Inc. ("AGS"), which authorized AGS to conduct a field test of bacteria strains altered by recombinant DNA technology. Plaintiffs contend that the EPA's issuance of the permit violated the requirements of the Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. §§ 136-136y ("FIFRA"), the National Environmental Policy Act, 42 U.S.C. §§ 4321, et seq. ("NEPA"), and the Administrative Procedure Act, 5 U.S.C. § 706(2)(A) ("APA"). Industrial Biotechnology Association ("IBA"), of which AGS is a member, was permitted to intervene as a defendant. The case is before the Court on plaintiffs' motion for preliminary injunction, the motions for summary judgment filed by defendants and IBA, and plaintiffs' motion for relief under Rule 56(f) of the Federal Rules of Civil Procedure. The Court heard oral argument of counsel on the pending motions on February 28, 1986. Upon consideration of the memoranda in support of and opposition to the motions, the arguments and representations of counsel in open court, and the entire record of this case, the Court concludes that the motion for preliminary injunction should be denied and that the Rule 56(f) motion should be denied. The Court withholds decision on the motions for summary judgment filed by defendants and intervenor.

 FINDINGS OF FACT

 EPA regulates the sale and distribution of pesticides in the United States under FIFRA through the statute's registration scheme, which prohibits the registration, and hence the use and marketing of pesticides which cause "unreasonable adverse effects on the environment." 7 U.S.C. § 136c(d). Any person seeking to test an unregistered pesticide may apply to the EPA for an EUP, which will control the conditions under which the testing may take place. EPA may only issue a permit if it finds that the proposed experiment is needed to produce data necessary for registration, and that the experiment will not cause unreasonable adverse effects on the environment. FIFRA § 5, 7 U.S.C. § 136c. Tests involving genetically engineered microbial pesticides must be presented to the EPA, to determine whether an EUP is necessary. The agency set out this requirement in a policy statement in the Federal Register, on October 12, 1984, as an interim measure to ensure agency supervision of the release of genetically engineered organisms into the environment. Administrative Record 6 (hereinafter "Ad. Rec."). Pursuant to their interim policy, EPA began its review of AGS' proposed recombinant DNA experiments involving genetically altered strains of Pseudonomas Syringae (P. syringae) and Pseudonomas Flourescens (P. fluorescens) late in 1984. Ad. Rec. 7; 8. The naturally-occurring strains of these bacteria are involved in the formation of ice crystals on plant surfaces, known as "ice nucleation." Ice-nucleating active (INA) bacteria promote frost formation and non-ice nucleating active (INA-) bacteria inhibit frost formation. Both forms of bacteria coexist in nature, although INA predominate. Through recombinant DNA technology, AGS has deleted genetic material from the INA- bacteria to produce INA- bacteria, in an effort to control frost damage on plants.

 In August, 1984, following a request by several of the plaintiffs herein, the Hazard Evaluation Division ("HED") of the EPA Office of Pesticide Programs initiated its interim policy with review of several proposed recombinant DNA experiments which had been recommended for approval by the Recombinant DNA Advisory Committee of the National Institutes of Health. *fn1" Ad.Rec. 1:2. When informed of EPA's notification and EUP requirements, AGS submitted its INA- proposal to EPA, with supporting data, and formal EPA review began on October 31, 1984. Ad.Rec. 7. HED concluded that the test was not likely to pose significant risks to humans or the environment, but determined that AGS would have to provide more information before testing could be conducted under an EUP. Ad.Rec. 13. HED's specific areas of environmental concern were the dissemination of the mutant bacteria from the test site, the survivability and colonization abilities of the bacteria, and the possible effects from its release on precipitation patterns. Id.

 HED's preliminary conclusions were reviewed by independent scientists on a subpanel of the FIFRA Scientific Advisory Panel ("SAP") in January, 1985. *fn2" The SAP subpanel generally agreed with HED's conclusions. Ad.Rec. 36. In February, 1985 HED informed AGS that an EUP would be required for its proposed field test, and that additional data would have to be submitted on the bacteria's competitiveness, ability to colonize, host specificity and pathogenicity. Ad.Rec. 33, 37. AGS submitted a modified proposal in June, 1985, and included data responsive to the HED's requests. Ad.Rec. 42, 43. In addition, AGS requested a waiver of some of the EPA's additional standard data requirements, pursuant to 40 C.F.R. § 158.45. EPA published notice of this application in the Federal Register on August 21, 1985, and requested public comments. Ad.Rec. 54. HED's initial scientific position that the proposal presented no foreseeable risk issued on August 27, 1985, was reviewed by the U.S. Department of Agriculture, the Food & Drug Administration and NIH. Ad.Rec. 58-60. Public comments from plaintiff the Foundation on Economic Trends ("FOET") questioned the agency's conclusions about the bacteria's novelty, competitiveness, pathogenicity, and atmospheric role. Ad.Rec. 61. FOET also urged more laboratory study of the bacteria's effects. Id.

 HED responded to FOET's concerns about the bacteria's role in precipitation by contacting the scientists FOET had referenced in their comments, and by contacting other meteorological scientists. Ad.Rec. 66-68, 70-73. The SAP subpanel finally concluded that the experiment was unlikely to pose significant risks and recommended approval of the application. Ad. Rec. 75. On November 5, 1985 HED summarized their final position, and responded specifically to public comments, concluding that, in light of the evaluated data and the limited scale of the proposed tests, the lack of the mutant's competitive advantage over the natural INA bacteria, AGS' experiment "does not pose a significant risk of adverse environmental impact." Ad.Rec. 76:3; 77:6. HED addressed FOET's concerns about precipitation effect, "novelty" of the mutant, the need for further testing, the toxicology of the bacteria, and EPA's waiver of certain additional data requirements. Ad.Rec. 76:3-9.

 The agency issued EUPs to AGS on November 14, 1985, effective December 1, 1985 through November 30, 1986. Ad.Rec. 81, 83. Plaintiffs filed this suit the same day, alleging that the agency action violated FIFRA, and was arbitrary, capricious and an abuse of discretion. Plaintiffs filed an amended preliminary injunction request on January 26, 1986.

 Under the EUP, AGS can conduct a field test of INA- bacteria on a 0.2 acre site, in Monterey County, California, not less than 15 days after it notifies the agency of its intent to begin testing. An interim local ordinance passed in Monterey County prohibits the release of any genetically altered bacteria prior to March 28, 1986, preventing the test from occurring before that time. Additionally, the EPA has begun an investigation of AGS and its research facility following media reports that possible unauthorized open-air tests of the mutant bacteria have occurred. EPA represented to the Court that it will complete its investigation no later than March 24, 1986, and the parties have stipulated that no testing shall occur under the EUP before then.

 CONCLUSIONS OF LAW

 The Court has jurisdiction over this matter under FIFRA § 16(a), 7 U.S.C. § 136n(a), and section 702 of the APA, 5 U.S.C. § 702. To determine whether a preliminary injunction should issue in this case, the Court must weigh four factors:

 
1) Has the petitioner made a strong showing that it is likely to prevail on the ...

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