Laura Karvosky

February 5, 2007

The United States Department of Agriculture (USDA) decided on November 24, 2006 to deregulate genetically engineered (GE) rice, known as LL601, after it contaminated the food supply.[1] The rice, a herbicide-tolerant crop[2] manufactured by Bayer CropScience, was authorized for field-tests between 1998-2001.[3] Field release permits are designed to confine the regulated article to the specific test site. However, the contamination the LL601 rice into the commercial rice supply is yet another example of the failure of our system to adequately regulate genetically engineered crops.

On August 18, 2006 the USDA announced that the LL601 rice, which was unapproved for human consumption, illegally contaminated rice grown for food use.[4] This announcement came more than 6 months after the contamination was first discovered by Riceland Foods, Inc a farmer-owned rice cooperative, and reported to Bayer.[5] Before informing the USDA or the public, Bayer proceeded to conduct its own tests to confirm the contamination.[6] Finally on July 31, 2006 Bayer disclosed the contamination to the USDA.[7]

The same day that the USDA announced the contamination, Bayer filed a request for the deregulation of LL601.[8] In the United States, biotechnology is regulated by the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) according to the Coordinated Framework established in 1986.[9] The USDA regulates GE crops through their Animal and Plant Health Inspection Service (APHIS) under the Plant Protection Act (PPA)[10] The USDA's Animal and Plant Health Inspection Service's congressional mandate under the Plant Protection Act is to protect America's agriculture.[11] Specifically, APHIS is responsible for protecting America's agriculture from "plant pests" which is broadly defined to include organisms that directly or indirectly injure or damage plants or plant products.[12] Genetically engineered organisms that qualify as plant pests are considered "regulated articles."[13]

The "introduction" of regulated articles into the environment can occur only upon notification or upon the issuance of a permit in conformance with applicable APHIS regulations.[14] The APHIS permit regulations are codified in 7 C.F.R. § 340 which is titled "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reasons to Believe are Plant Pests."[15] APHIS permits are required for both the release of regulated articles into the environment ("release" permits) and for the interstate movement and importation of regulated articles ("movement" permits).[16]

A party can petition for deregulation of their GE crops. Once a GE crop is deregulated, the requirements of a regulated article no longer apply.[17] After contaminating the food supply, Bayer applied for deregulation of the herbicide-tolerant LL601 rice strain and requested a determination that the LL601 rice was not a plant pest and therefore, not a regulated article under 7 C.F.R. § 340.[18] Bayer asked that the deregulation occur through an expedited process under 7 C.F.R. § 340.6 that allows APHIS to "extend a determination of nonregulated status to other organisms."[19] Specifically, Bayer requested that APHIS extend its "determination of nonregulated status issued in response to APHIS petition number 98-329-01p for glufosinate-tolerant rice transformation events LLRICE06 and LLRICE62, the antecedent organisms. Because rice line LLRICE601 is similar to antecedent rice lines LLRICE06 and LLRICE62."[20]

In response to Bayer's petition, the USDA received public comments on its decision. Many comments strongly opposed the deregulation of LL601. For example, the Union of Concerned Scientists (USC) argued that the USDA should not consider deregulation "until it fully investigates the contamination incident and determines whether Bayer's non-compliance with USDA performance standards or inadequate performance standards were responsible."[21] The USC was concerned that the USDA "would send the wrong message to the biotech industry - that companies will not be held accountable if they ignore U.S. regulations."[22] The Center for Food Safety (CFS) also issued comments in response to Bayer's petition for deregulation. The CFS argued that "[a]bsent plans to commercialize LL601, Bayer's intent with this deregulation can be seen only as an attempt to relieve itself of liability for the adverse financial consequences of allowing the illegal entry of a regulated article (LL601 rice) into the environment and food supply."[23]

Despite the strong influx of comments against deregulation, the USDA announced in November 2006 that the LL601 strain of rice was deregulated. This deregulation highlights the faults in our regulatory system with regards to GE crops. The USDA must ensure that GE crops, unapproved for commercial use, do not contaminate our food supply. If contamination occurs, the USDA must forcefully investigate the incident and hold the company in charge responsible. By deregulating the LL601 crop, the USDA has essentially allowed Bayer to escape the consequences of its inadequate containment of LL601.

[1] APHIS Deregulates LL601 Rice Trait, Delta Farm Press, Dec. 8, 2006, available at http://deltafarmpress.com/mag/farming_aphis_deregulates_ll/.

[2] Herbicide-tolerant crops are "[c]rops that have been developed to survive application(s) of particular herbicides by the incorporation of certain gene(s) either through genetic engineering or traditional breeding methods. The genes allow the herbicides to be applied to the crop to provide effective weed control without damaging the crop itself." Press Release, USDA (Aug. 2006), available at http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2006/08/0306.xml.

[3] Id.

[4] Press Release, supra note 2.

[5] Comments from the Union of Concerned Scientists to USDA (Oct. 10, 2006), available at http://www.ucsusa.org/food_and_environment/genetic_engineering/llrice601-comments.html.

[6] Id.

[7] Id.

[8] Animal and Plant Health Inspection Service, 71 Fed. Reg. 53076 (Sept. 8, 2006).

[9] Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (June 26, 1986).

[10] Plant Protection Act, 7 U.S.C. §§ 7701-7772 (2000).

[11] See 7 U.S.C. § 7701.

[12] 7 U.S.C. § 7702(14).

[13] 7 C.F.R. § 340.1.

[14] 7 C.F.R. § 340.0(a)(1).

[15] 7 C.F.R. § 340.0-.9

[16] 7 C.F.R. § 340.4(b).

[17] Animal and Plant Health Inspection Service, 71 Federal Register 53076, 53077 (Sept. 8, 2006).

[18] Id.

[19] Petition for determination of nonregulated status, 7 CFR 340.6(e)(2) (2007).

[20] Animal and Plant Health Inspection Service, 71 Federal Register 53076 (Sept. 8, 2006).

[21] Comments from the Union of Concerned Scientists to USDA, supra note 6.

[22] Id.

[23] Comments from the Center for Food Safety to USDA/APHIS (2006), available at http://www.saveourseeds.org/downloads/LL601_Comments_to_APHIS_on_Bayer_Dereg_Petition_FNL2_%20Oct1006.pdf.