The opinion of the court was delivered by: HOGAN
Thomas F. Hogan, United States District Judge
brought this action on April 23, 1986, seeking to suspend and revoke the license defendants
issued permitting marketing of the pseudorabies vaccine "Omnivac." The case is before the Court on the parties' cross-motions for summary judgment. After consideration and review of the motions, oppositions, replies, supporting memoranda, and the entire administrative record, the Court shall grant defendants' motion and deny plaintiffs' motion.
The United States Department of Agriculture Animal & Plant Health Inspection Service ("USDA-APHIS") controls the production and marketing of veterinary medicines including vaccines through a licensing process under the Virus-Serum-Toxin Act ("VSTA"), 21 U.S.C. §§ 151-158 (1982), and applicable regulations, 9 C.F.R. pt. 102 (1987). USDA-APHIS may grant a license only after reviewing a product and evaluating its safety, efficacy, purity, and potency. 9 C.F.R. § 102.3(b) (2) (ii) (1987). Vaccines and other veterinary biological products that are prepared using biotechnological or "genetic engineering" procedures must comply with these licensing regulations. E.g., Final Policy Statement for Research and Regulation of Biotechnology Processes and Products, 51 Fed. Reg. 23,336 (June 26, 1986).
In addition, USDA-APHIS is subject to the requirements of the National Environmental Policy Act ("NEPA"), 42 U.S.C. §§ 4321-4370 (1982), and the agency must prepare an environmental impact statement for any major federal action having a significant impact on the human environment. No environmental impact statement is required if the agency finds that the action will have no significant impact. To determine the impact of an action, the agency must prepare an environmental assessment, which summarizes the available environmental evidence and presents the agency's analysis of relevant data. 40 C.F.R. § 1508.9 (1987). USDA-APHIS guidelines implementing NEPA require preparation of an environmental assessment "for each proposed new action." APHIS Guidelines Concerning Implementation of NEPA Procedures. 44 Fed. Reg. 50,381, 50,382 (Aug. 28, 1979). The parties do not dispute that the licensing of Omnivac was a "proposed new action" requiring an environmental assessment.
The license application at issue was submitted to USDA-APHIS in December, 1984, by Biologics Corporation, a subsidiary of TechAmerica Group Inc. Novagene, Inc., had developed the vaccine in 1982, under the guidance of Dr. Saul Kit. The vaccine was designed to combat pseudorabies, a contagious disease affecting swine and other livestock. In its natural state, the pseudorabies virus may retreat to the nerve cells of a recovered animal and lie dormant, unaffected by the body's immune system. The dormant virus may be reactivated in this outwardly healthy animal and may then spread to other animals as the carrier "sheds" the virus.
Existing pseudorabies vaccines have been prepared from killed or modified live strains of the virus. The modified live virus vaccine is assertedly the most effective, but generally retains the ability to be harbored in the host's nerve cells and then spread to other animals. While these animals are not infected with a disease-producing virus, they will test positive for infection, complicating diagnosis and health programs.
Omnivac was developed by weakening an existing modified live strain of the virus (Bucharest strain). Researchers deleted the gene that produces the enzyme thymidine kinase ("TK"), which is essential for the survival and replication of the virus. As a result, the TK- vaccine virus cannot survive and multiply in nerve cells, unlike the existing wild strain and weakened vaccine virus strain.
The Administrative Record documents the progress of TechAmerica's application through USDA-APHIS's review process. Dr. George Shibley, Senior Staff Microbiologist at the Veterinary Services Division of USDA-APHIS, monitored the license procedure for Omnivac. Declaration of Dr. George Shibley ("Shibley Decl."), para. 9. After a little more than one year of review, testing, and reporting, USDA-APHIS issued a United States Veterinary Biological Product License to TechAmerica on January 16, 1986. USDA-APHIS did not issue or prepare an environmental assessment or environmental impact statement before it granted the license. The Foundation on Economic Trends petitioned USDA-APHIS in early April, 1986, to revoke or suspend the Omnivac license, based in part on USDA-APHIS's failure to comply with NEPA. The agency suspended the license and prepared a lengthy environmental assessment to document the environmental concerns that were "fully identified and reviewed by Department officials prior to licensing the vaccine." Environmental Assessment, Administrative Record ("Admin. Rec."), Tab 22B.
(1) deletion of the genetic element necessary for reproduction prevents the TK- virus from establishing latency;
(2) conventional methodology had been used to render the Bucharest virus strain noninfectious ...