APHIS Announces New Process for Determination of Nonregulated Status for Genetically Engineered Organisms

On February 29, 2012, the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA) announced that it was changing the process by which it considers petitions for the determination of nonregulated status for genetically engineered organisms in order to facilitate increased public involvement at early stages of the process. The new process splits the current process into two parts, with an initial notice announcing the availability of the petition for nonregulated status and a latter notice providing APHIS’ draft decision-making documents for comments.

The Plant Protection Act, 7 U.S.C. § 7701 et seq., authorizes APHIS to “prohibit or restrict the importation, entry, exportation, or movement . . . of any plant, plant product, biological control organism, noxious weed, article, or means of conveyance if . . . necessary to prevent the introduction . . . or the dissemination of a plant pest or noxious weed.” APHIS defines “plant pest” as any organism which “can directly or indirectly injure or cause disease or damage in or to any plants or parts thereof, or any processed, manufactured, or other products of plants.” 7 C.F.R. § 340.1. Under section 340.6 of APHIS regulations, any person may submit a petition for a determination that an article should not be regulated under the Plant Protection Act on the ground that there is no reason to believe that such article is a plant pest. If such petition meets the requirements set forth in section 340.6, the petition is deemed complete and ripe for a determination as to regulated or nonregulated status.

Under the current process, APHIS prepares a draft plant pest risk assessment (PPRA), as well as a draft environmental assessment (EA) required by the National Environmental Policy Act (NEPA), prior to publication of any notice. APHIS then publishes a notice in the Federal Register, which includes an announcement of the petition, the PPRA and the EA. Upon completion of the 60-day comment period, APHIS reviews and evaluates the comments and prepares a final PPRA, EA and the requisite NEPA decisionmaking document – either a Finding of No Significant Impact (FONSI) or notice of intent (NOI) to prepare a full environmental impact statement (EIS).

Under the new process, APHIS will publish a preliminary notice consisting solely of the availability of the petition and then later publish a separate notice which includes the draft PPRA and EA documents. The new process is designed to “provide two separate and specific opportunities for public involvement in the decisionmaking process” and is being implemented as part of the USDA Customer Service Plan, which “seeks to improve the Agency’s customer service processes.”

After the first notice announcing the availability of the petition, APHIS will accept written comments concerning the determination of nonregulated status for 60 days. The contents of the second notice will depend on APHIS’ determination of whether the petition raises “substantive new issues.” If APHIS decides that the “petition involves gene modifications that do not raise substantive new biological, cultural, or ecological issues,” then APHIS will announce this determination along with the availability of the PPRA, EA and FONSI documents. If APHIS does not receive any comments warranting changes to this preliminary determination, the determination will become final without any further Federal Register notice. A slightly different approach will be taken when APHIS determines, after the first notice has been published, that the petition raises substantive new issues. Under this approach, APHIS will solicit comments on the draft EA and PPRA for 30 days before publishing final versions in the Federal Register.

The changes to the participation process become effective today, March 6, 2012—the date of publication of the notice in the Federal Register. The changes will apply to all subsequently received petitions and those petitions for which APHIS has not yet completed a draft EA and PPRA. The changes do not impact the current requirement of section 340.6(d)(3) that APHIS will “furnish a response to each petitioner within 180 days of receipt of a completed petition.”