The Animal and Plant Health Inspection Service (“APHIS”) of the U.S. Department of Agriculture (USDA) has the responsibility to prevent the introduction and dissemination of plant pests and to control noxious weeds under the Plant Protection Act (“PPA”), 7 U.S.C. § 7701 et seq. This authority has been interpreted by APHIS to authorize regulation of genetically engineered plants intended for experimental field release testing, and for commercial production. The regulations issued by APHIS and administered by its Biotechnology Research Services division require permits (or in some cases notifications) for field tests of genetically modified plants, and authorize petitions for deregulation of genetically modified plants intended for commercial production.

In back to back decisions in early February, the District Court for the District of Columbia and the District Court for the Northern District of California granted motions for summary judgment holding that the National Environmental Policy Act, 42 U.S.C. § 4321 et seq. (“NEPA”) required APHIS to undertake more substantial environmental reviews. Both cases illustrate the increasing scrutiny courts are paying to the procedures used by APHIS to make decisions in this area and the importance of environmental documentation to market access.

International Center for Technology Assessment v. Johanns – Field Release Permits for Glyphosate Resistant Creeping Bentgrass and Kentucky Bluegrass

Key Facts: In the regulatory decision challenged in this case, APHIS issued permits to the Scotts Company to field test glyphosate resistant (i.e. “Roundup Ready”) creeping bentgrass and Kentucky bluegrass. The International Center for Technology Assessment (“ITCA”) challenged the decision arguing that APHIS failed, among other things, to correctly determine the significance of the potential environmental impacts associated with the field trials, in violation of NEPA.

The NEPA Issue: APHIS had issued the field test permits for these two modified plants under a “categorical exclusion” in its regulations that exempted “permitting, or acknowledgement of notifications for, confined field releases of genetically engineered organisms and products” from the requirement for NEPA review. 7 C.F.R. § 372.5(c)(3)(ii). There is, however, an exception providing that where “a categorically excluded action may have the potential to affect “significantly” the quality of the “human environment,” . . . an environmental assessment or an environmental impact statement will be prepared.” 7 C.F.R. § 372.5(d). An example of a situation to which this exception applies is “’[w]hen a confined field release of genetically engineered organisms or products involves new species or organisms or novel modifications that raise new issues.” § 372.5(d)(4).

The court found substantial evidence in the record supporting these permits as a case for triggering the exception and conducting a NEPA review. It noted that considerable concern had been expressed by environmental groups, land managers, federal agencies and other organizations and individuals about gene flow, enhanced weediness, and an increase in the use of other herbicides more toxic than glyphosate. Among other things, both creeping bentgrass and Kentucky bluegrass were noted to have been categorized by a variety of organizations, including a consortium of ten federal agencies as either invasive weeds or “alien plant invaders.”

The field tests under these permits had long since been completed at the time of the decision. The relief granted by the court was to enjoin APHIS from processing any future permit under these regulations without inquiring whether the categorical exclusion was warranted or whether an environmental assessment should be prepared.

Geertson Seed Farms, et al., v. Mike Johanns – Decision to Deregulate Glyphosate Resistant Alfalfa

Key Facts: In this case, organic and conventional alfalfa growers challenged APHIS decision to grant a permit filed by Monsanto to deregulate its genetically engineered glyphosate resistant (“Roundup Ready”) alfalfa, the first perennial plant of this type. As part of its decision-making process, APHIS prepared an Environmental Assessment (“EA”) on the proposed action and took public comments. Many of the comments opposed deregulation on grounds that:

  • Gene transmission may occur between Roundup Ready alfalfa and organic alfalfa due to the pollination by bees, an event that could affect the ability of organic and conventional farmers to market their Roundup Ready free alfalfa products in the U.S. and in markets such as Japan that do not permit Roundup Ready alfalfa.
  • Deregulation of Roundup Ready alfalfa and the concomitant increase in the use of Roundup will cause the development of additional glyphosate resistant weeds, as well as a dramatic increase in the amount of Roundup used in the environment.

In June of 2005, APHIS issued a Finding of No Significant Impact and approved Monsanto’s deregulation petition, concluding that its alfalfa should be deregulated and sold with no further direct regulation by USDA. APHIS concluded that it would be up to the individual organic seed or hay grower to take steps to assure that its crops would not include any genetically engineered alfalfa. It also found that states could establish production zones, if they wished, and that exports to Japan would not be affected since Japan permits contamination of up to 1%. APHIS agreed with commenters that deregulation could lead to the development of additional glyphosate resistant weeds, but found that such impact was not significant given the development of weed resistance to every herbicide. APHIS expressed the view that “good stewardship may be the only defense against this potential problem.”

Geerston Seed Farm and others argued that the decision was arbitrary and capricious and should be vacated for a number of reasons, including APHIS failure to conduct a more significant environmental inquiry in the form of an environmental impact statement.

The NEPA Issue: In a case of first impression, the court evaluated the issue of whether the introduction of a genetically engineered crop that might significantly decrease the availability or even eliminate all non-genetically engineered varieties is a “significant environmental impact” requiring the preparation of an environmental impact statement.

The court’s analysis begins with the purposes of NEPA. These include:

  • Attain[ing] the widest range of beneficial uses of the environment without degradation, risk to health and safety, or other undesirable and unintended consequences, and
  • Maintain[ing], wherever possible, an environment which supports diversity and variety of individual choice. 42 U.S.C. 4331(b)(3) and (4).

The court held that a federal action that eliminates a farmer’s choice to grow non-genetically engineered crops, or a consumer’s choice to eat non-genetically engineered food, is an undesirable consequence within the meaning of the first of these two goals. The court also held that such elimination would be inconsistent with the goal of maintaining diversity and variety of individual choice. The court noted that “the government’s apparent belief that the farmers’ and consumers’ choice is irrational because the engineered gene is similar in all biological respects to a gene found in nature (although never in alfalfa) is beside the point. An action which potentially eliminates or at least greatly reduces the availability of a particular plant – here, non-engineered alfalfa – has a significant effect on the human environment.” (Slip op. at 13-14).

The court also found that the analysis conducted by APHIS on the issue of emerging weed resistance was unconvincing. First, the court noted that APHIS could not conclude that this impact was not significant simply because weed species develop resistance to all herbicides. It also rejected APHIS reliance on good stewardship as the solution as neither the EA or the FONSI (Finding of No Significant Impact) contained any analysis as to what constitutes good stewardship or how likely it is to be practiced successfully. Finally, the court noted that “one would expect that some federal agency is considering whether there is some risk to engineering all of America’s crops to include the gene that confers resistance to glyphosate.” (Slip op. at 17).

The court was unmoved by APHIS argument that these arguments were economic in nature and not within the zone of interest protected by NEPA. The court brushed this aside noting that, while they were economic interests (fear of loss of markets for organic and conventional alfalfa), they were interrelated with natural or physical environmental effects and thus fell within the protected zone of interest. The Court ordered APHIS to prepare an Environmental Impact Statement (“EIS”).

International Center for Technology Assessment v. Johanns (D.C.D.C., Civ. Action 03-00020)(dec. Feb. 5, 2007); Geertson Seed Farms v. Johanns (N.D.Ca., Civ. Act. No. C 06-01075)(dec. Feb. 13, 2007).