BIOTECHNOLOGY REGULATORY SERVICES (BRS)
In 1986 with the publication of the Coordinated Framework USDA first proposed process-based regulations for the introduction of “genetically altered organisms” in accordance with the Federal Plant Pest Act and other statutes that have now been superseded by the Federal Plant Protection Act (FPPA). It took only roughly a year to finalize those regulations in 1987 as part of 7 CFR Part 340.
The focus of the regulations are on so-called “regulated articles,” which are any organism that has been altered or produced through genetic engineering where the donor organism, recipient organism, vector, or vector agent is a plant pest. An organism is “genetically engineered” if it is made by the use of R-DNA techniques, which is left undefined. The basis for regulation is the use of R-DNA and the presumption that organisms listed in the regulations, including any parts thereof, or containing DNA or RNA sequences, plasmids, and other parts or copies of organisms that are listed in the regulations, are plant pests and thus subject to permit and other requirements. The regulations include coverage of transgenic arthropods (e.g., insects) and other invertebrates. See, e.g., Dept. of Agriculture, APHIS, Availability of Environmental Assessment for a Proposed Field Trial of Genetically Engineered Pink Bollworm, Notice of Availability and Request for Comments, 71 Fed. Reg. 7503 (2006).
A few limited exemptions are permitted for any plant pest contained in E. coli K12, for example. See 7 CFR § 340.3(b). Certain regulated articles may be introduced without a permit via a notification process if certain performance and other standards are met. See 7 CFR § 340.3(b). This feature of the regulations was added in 1993, as well as a Petition for Determination of Nonregulated Status, which is submitted for commercialization, although conditions can be imposed as part of the deregulation process.
A permit is required for release in the environment at least 120 days in advance of the proposed release. A variety of other limited permits are possible for interstate movement or importation, as well as a courtesy permit for organisms which are not subject to regulation. Permit and deregulation decisions are subject to NEPA requirements. For a list of permit and deregulation decisions, see http://www.isb.vt.edu/cfdocs/ISBtables.cfm. See also Permits With Environmental Assessments as of 20 Aug. 2007, http://www.aphis.usda.gov/brs/biotech_ea_permits.html, Petitions of Nonregulated Status Granted or Pending by APHIS as of 13 Dec. 2007, www.aphis.usda.gov/brs/not_reg.html.
Notably, plants engineered for pharmaceutical or industrial uses, sometimes called plant manufactured pharmaceuticals (PMPs) and plant manufactured industrial products (PMIPs), microorganisms, arthropods, and other invertebrates are not subject to notification procedures and must go through the permit process. See, e.g., 7 CFR § 340.3(b)(4)(iii). PMPs and PMIPs are typically regulated via permits and are not deregulated, at least for now.
APHIS announced in July, 2007 a significant overhaul of its Part 340 regulations with the publication of a draft programmatic environmental impact statement. This announcement was preceded by a notice of intent to prepare the EIS. See Dept. of Agriculture, APHIS, Environmental Impact Statement; Introduction of Genetically Engineered Organisms, Notice of Intent to Prepare an Environmental Impact Statement and Proposed Scope of Study, 69 Fed. Reg. 3271 (2004) and Dept. of Agriculture, APHIS, Introduction of Organisms and Products Altered or Produced Through Genetic Engineering, Notice of Availability of Draft Environmental Impact Statement and Request for Comments, 72 Fed. Reg. 39021 (2007). BRS is considering changing its deregulation process, to include conditional approvals, a new tiered system to regulate organisms based on differential risks, such as with noxious weed potential or unusual traits that pose risks to the environment, or plants containing pharma or industrial products. Approximately 20,000 comments were received. Proposed rules are expected in May and a final rule by the end of the year. The draft EIS is available at http://www.aphis.usda.gov/brs/pdf/complete_eis.pdf.
APHIS is planning to issue a proposal in January considering the need to regulate transgenic animals, specifically the environmental animal health issues of genetically engineered traits under the Federal Animal Health Protection Act (FAHPA), according to the latest semiannual agenda published in December. See Dept. of Agriculture, Semiannual Regulatory Agenda, 72 Fed. Reg. 69755, 69762-69763 (2007).
Similar to FDA and EPA, USDA was also involved in the StarLink® episode, primarily in the context of testing for StarLink®, localizing commodity grain channels containing it and helping to ensure their diversion to appropriate non-human consumption markets. This topic is discussed further below in the context of GIPSA.
USDA was also deeply involved in a different way in 2000 in the inadvertent mix-up involving some 500,000 bushels of soybeans that had been contaminated with corn grown for pharmaceutical use. The company involved agreed to pay a penalty of $250,000 to reimburse USDA for destroying the soybeans and posted a $1 million bond and agreed to meet higher field testing compliance requirements. The soybeans never reached the human or other animal food supply, but did raise questions about the adequacy of government regulation of plant-based drugs.
In part in response to the pharma corn episode, APHIS published in March 2003 a notice tightening permit conditions for field tests of plants with pharmaceutical or industrial traits. See Dept. of Agriculture, APHIS, Field Testing of Plants Engineered to Produce Pharmaceutical and Industrial Compounds, Request for Comments, 68 Fed. Reg. 11337 (2003). A guideline has also been prepared jointly by the three key federal agencies on biological drugs and other drugs made with transgenic plants, which address confinement issues, among other topics. See Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals at www.fda.gov/cber/gdlns/bioplant.pdf. See also Dept. of Agriculture, APHIS, BRS, Draft Guidance for APHIS Permits for Field Testing on Movement of Organisms with Pharmaceutical or Industrial Intent (Jan. 9, 2007), at www.aphis.usda.gov/brs/pdf/Pharma_Guidance.pdf.
A recent incident similar to StarLink® involves the bioengineered variety of rice called LLRICE601 and LLRICE604 that express a tolerance to a particular herbicide, which was found in non-engineered rice lines. USDA has announced that there does not appear to be any violation of its regulations, so there will be no follow-up enforcement action. See U.S. Department of Agriculture, News Release No. 0284.07, USDA Concludes Genetically Engineered Rice Investigation, at http://www.usda.gov/wps/portal?contentidonly=true&contentid=2007/10/0284.xml.
As with FDA and EPA, USDA has also issued its version of a guidance on adventitious presence. See Dept. of Agriculture, APHIS, APHIS Policy on Responding to the Low Level Presence of Regulated Genetically Engineered Plant Materials, Notice of Availability of Policy Statement, 72 Fed. Reg. 14649 (2007).
BRS has been successfully sued on various administrative and environmental grounds over its regulation of the field testing in Hawaii of pharma plants. See Center for Food Safety v. Johanns, 451 F.2d 1165 (D.HI 2006).
Besides the Hawaii lawsuit involving pharma plants, USDA has been the subject of a number of other suits, typically under NEPA. Most recently, in Geertson Seed Farm v. Johanns, Dkt. No. 06-1075 (N.D.Ca., Feb. 14, 2007), USDA was held to not have adequately addressed under NEPA the environmental risks associated with Round-up Ready alfalfa and therefore must prepare an environmental impact statement (EIS) before it again allows such alfalfa to be commercialized. USDA therefore has recently announced that such alfalfa is now regulated and that the agency will prepare an EIS, as required by the court. See Dept. of Agriculture, APHIS, Return to Regulated Status of Alfalfa Genetically Engineered for Tolerance to the Herbicide Glyphosate, Notice, 72 Fed. Reg. 13735 (2007).
Similarly, in International Center for Technology Assessment v. Johanns, Dkt. No. 030020 (D.D.C., Feb. 5, 2007), USDA was held to have illegally approved open air field trials of glycosate-tolerant creeping bentgrass by claiming the trials were categorically excluded from the need for an environmental risk assessment, among other findings. An appeal by Scott’s was recently dismissed by the appeals court. See Docket No. 07-5238 (D.C. Cir. March 17, 2008).
APHIS has recently concluded an investigation involving the same genetically engineered glycosate-tolerant creeping bentgrass. An agreement was reached to resolve allegations that the company sponsoring the product failed to comply with performance standards and permit conditions for field trials, improperly moved genetically engineered grass seed, as well as failed to conduct a field trial in a way that ensured that neither glycosate-tolerant creeping bentgrass nor its offspring would persist in the environment. The settlement agreement involved a civil penalty of $500,000. See News Release, Release No. 0350.07, USDA Concludes Genetically Engineered Creeping Bentgrass Investigation at http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2007/11/0350.xml.
