BIOTECHNOLOGY REGULATORY SERVICES (BRS)
In response to the Geertson lawsuit (see Part III, BRS) requiring the preparation of an Environmental Impact Statement (EIS) pertaining to herbicide tolerant alfalfa, the United States Department of Agriculture (USDA) recently announced its intent to prepare an EIS. See Dept. of Agriculture, APHIS, Environmental Impact Statement; Determination of Regulated Status of Alfalfa Genetically Engineered for Tolerance to the Herbicide Glyphosate, Notice of Intent to Prepare an Environmental Impact Statement and Proposed Scope of Study, 73 Fed. Reg. 1198 (2008).
The U.S. court of appeals for the Ninth Circuit recently affirmed the decision of the district court in Geertson holding that the district court's injunction prohibiting future planting of GE alfalfa was appropriately issued. Neither the government nor Monsanto and Forage Genetics questioned the existence of a NEPA violation. Instead, the legal criteria upon which the injunction was based and the scope of it were challenged. A key issue was whether the district court erred in not holding an evidentiary hearing before entering the injunction. For a variety of reasons, the court, in a 2-1 decision, held that such a hearing was not required.
The Center for Food Safety (CFS), among others, apparently buoyed by its recent success in Geertson in the Northern District of California in challenging USDA's deregulation of genetically engineered (GE) herbicide-tolerant alfalfa (see Part III, BRS), has filed another lawsuit in the same district court, this time opposing the deregulation of another GE herbicide-tolerant crop, sugar beets. See Center for Food Safety, et al. v. Charles Connor, et al., Case No. C 08-00484 JSW (N.D. Cal.) (Jan. 23, 2008).
The above complaint alleges violations of the National Environmental Policy Act (NEPA), the Administrative Procedure Act, and the Plant Protection Act (PPA), as before involving alfalfa, although the latest filing is more streamlined. Apparently this is in an attempt to utilize only arguments that were previously successful. The latest suit again challenges, on substantive and procedural grounds, BRS's finding of no significant environmental impact claiming, for example, that it failed to take the "hard look" required by NEPA and, that, under the PPA, its findings about the lack of plant pathogenic and weediness properties of the GE sugar beets are unsupported by the evidence in the administrative record. Therefore, CFS seeks to vacate (nullify) BRS's deregulation decision, requiring instead that the agency prepare a full EIS and prevent the planting of GE herbicide-tolerant sugar beets. This relief is similar to that sought and granted in the GE alfalfa case.
Although USDA revised its NEPA procedures in mid 2007, the timing of both of its deregulation decisions in 2005 concerning alfalfa and sugar beets is similar. It is therefore plausible that whatever shortcomings the district court previously found in the alfalfa deregulation decision will again apply to the sugar beet decision, particularly since the same district court is involved. The late timing of the lawsuit after the deregulation decision in 2005 apparently is based on the fact that the CFS just learned that commercial planting would begin in spring 2008.
Similar to the adventitious presence of "unapproved" Bt 10 corn found last year in food supply (see Part III, CFSAN), another such Bt product, Bt 32, was also recently discovered. No food safety or environmental problems were believed to exist, based on its low level and similarity to another "approved" event, Bt 22. See USDA, EPA, and FDA Statement on Genetically Engineered Corn "Event 32" (Feb. 22, 2008) available at http://www.aphis.usda.gov/newsroom/content/2008/02/ge_corn_e32.shtml.
APHIS recently published a notice seeking information about the potential effects of animals with "genetically engineered" traits on U.S. livestock health (see Part III, BRS). See USDA, APHIS, Genetically Engineered Animals. Request for Information, 73 Fed. Reg. 54360 (2008). This long-awaited notice, which was published in conjunction with CVM's draft guidance on GE animals (see Part IV, CVM), addresses possible regulation under the Animal Health Protection Act governing the prevention of the introduction and spread of livestock diseases and pests within the U.S.
