GMOs are regulated in the United States under the Coordinated Framework for Regulation of Biotechnology, published in 1986, pursuant to previously existing statutory authority regulating conventional products, with a focus on the nature of the products rather than the process in which they are produced.

Plant GMOs are regulated by the US Department of Agriculture’s Animal and Plant Health Inspection Service under the Plant Protection Act. GMOs in food, drugs, and biological products are regulated by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. GMO pesticides and microorganisms are regulated by the Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide and Rodenticide Act and the Toxic Substances Control Act. The form of regulation varies depending on the type of GMO involved.

I. Introduction

The United States does not have any federal legislation that is specific to genetically modified organisms (GMOs). Rather, GMOs are regulated pursuant to health, safety, and environmental legislation governing conventional products. The US approach to regulating GMOs is premised on the assumption that regulation should focus on the nature of the products, rather than the process in which they were produced.[1]

Compared to other countries, regulation of GMOs in the US is relatively favorable to their development. GMOs are an economically important component of the biotechnology industry, which now plays a significant role in the US economy.[2] For example, the US is the world’s leading producer of genetically modified (GM) crops. In 2012, of the 170.3 million hectares of biotech crops globally, the United States accounted for 69.5 million, over 40% of the total.[3] For several crops grown in the US, genetically engineered varieties now make up the vast majority of the crop. In 2013, 93% of the soybeans, 90% of the cotton, and 90% of the corn grown in the US were genetically engineered for either herbicide tolerance or insect resistance.[4]

The US is not a party to the Cartagena Protocol on Biosafety.[5] As a signatory but a nonparty to the parent Convention on Biological Diversity, it cannot become a party to the Protocol.[6] It has participated in meetings as a nonparty observer, however.[7]

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II. Public and Scholarly Opinion

A. Public Opinion

Public opinion on GMOs in the US is mixed. A series of polls conducted over five years, from 2001 to 2006, found that public understanding of biotechnology was relatively low, and that consumers were relatively unaware of the extent to which their foods included genetically modified ingredients.[8] Support for the introduction of genetically modified foods into the food supply held steady at 26 to 27% of respondents in favor over that time period, while opposition to the introduction of such foods fell from 58 to 46% over the period.[9]

Polls indicate strong support for labeling of GMO foods; one recent poll found 93% of respondents supporting mandatory labeling.[10] The same poll found three-fourths of Americans expressing concern regarding GMOs in food; nearly half indicating they were aware that many processed or packaged foods contain genetically modified ingredients; around half saying they would not eat genetically modified vegetables, fruits, and grains; three-quarters stating they would not eat genetically modified fish; and two-thirds saying they would not eat genetically modified meat.[11]

B. Scholarly Opinion

Several scientific organizations in the US have issued studies or statements regarding the safety of GMOs indicating that there is no evidence that GMOs present unique safety risks compared to conventionally bred products. These include the National Research Council,[12] the American Association for the Advancement of Science,[13] and the American Medical Association.[14]

Groups in the US opposed to GMOs include some environmental organizations,[15] organic farming organizations,[16] and consumer organizations.[17] A substantial number of legal academics have criticized the US’s approach to regulating GMOs.[18]

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III. Structure of Pertinent Legislation

There is no comprehensive federal legislation specifically addressing GMOs. GMOs are regulated under the general statutory authority of environmental, health, and safety laws.

A policy statement published in 1986 by the Executive Office of the President, Office of Science and Technology Policy (OSTP) entitled the Coordinated Framework for Regulation of Biotechnology (Coordinated Framework)[19] sets forth the basic approach to the regulation of GMOs in the US. The Coordinated Framework was the outgrowth of efforts by an interagency working group formed in 1984 to address whether the regulatory framework that pertained to conventional products was adequate for products derived from biotechnology. The working group concluded that existing laws as then implemented, supplemented with new regulations, were adequate to address regulatory needs.[20] A proposed notice was published and comments were requested.[21] The final Coordinated Framework policy notice confirmed that the regulatory jurisdiction over biotechnology products would be allocated in the same manner as conventional products, using existing laws governing conventional products.[22]

The three main agencies involved in regulating GMOs are the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).

A. Animal and Plant Health Inspection Service

APHIS regulates the planting, importation, or transportation of GM plants pursuant to its authority under the Plant Protection Act (PPA),[23] which authorizes the Secretary of Agriculture to “prohibit or restrict the importation, entry, exportation, or movement in interstate commerce of any plant, plant product [etc.] if the Secretary determines [it] is necessary to prevent the introduction . . . of a plant pest or noxious weed within the United States.”[24] By regulation, APHIS classifies most GM plants as plant pests or potential plant pests and as “regulated articles.”[25] Under the PPA, a regulated article must receive prior approval from APHIS before it is introduced.[26]

APHIS grants authorization to use GM plants in three ways: through a notification process, a permitting process, or a determination of nonregulated status.

1. Notification Procedure

The notification procedure is available to plants that are not classified as noxious weeds, or weeds in the release area, if certain criteria and performance standards are met.[27] The criteria include that the plant must be a species that APHIS has determined may be safely introduced; the genetic material must be stably integrated; the expression of the genetic material must not result in plant disease; etc.[28] The performance standards govern shipment, storage, planting, and testing, and are intended to prevent the plant from being released from containment.[29] When the applicant sends a notification to APHIS, APHIS will respond within a prescribed time with an acknowledgement or a denial.[30] If the notification is denied, the applicant may apply for a permit.[31]

2. Permit Procedure

The permit procedure requires an applicant to submit information concerning, among other things, the donor organism, the recipient organism, the composition of the regulated article; the expression of altered genetic material in the regulated article and the molecular biology of the system used to produce the article; the locality where the donor and recipient organisms and the regulated article were developed; the purpose of the regulated article; the quantity to be introduced; processes to prevent release; the intended destination, use, and distribution; and the final disposition of the regulated article.[32] If APHIS grants the permit, it is subject to conditions designed to ensure both that the regulated article remains contained and that APHIS can maintain regulatory oversight.[33] Failure to comply with the conditions can result in withdrawal of the permit.[34]

3. Determination of Nonregulated Status

GM plants that have been tested and have been shown not to pose a risk may be eligible for a determination of nonregulated status.[35] A petition for determination of nonregulated status must include detailed biological information on the regulated article and the recipient organism, published and unpublished scientific studies, data from field tests, and other information designed to assist APHIS in determining whether the plant constitutes a pest.[36] Upon receipt of a petition, APHIS publishes a notice in the Federal Registerand allows sixty days for public comment.[37] APHIS has 180 days to approve in whole or part or deny the petition.[38]

B. Food and Drug Administration

The FDA regulates the safety of all human and animal food products in the US (other than meat, poultry, and eggs), as well as drugs and biological products.

1. Food

The FDA’s primary statutory authority is the Federal Food, Drug, and Cosmetic Act (FFDCA),[39] which authorizes the agency to regulate, among other things, “adulterated food,”[40] defined as food that “contains any poisonous or deleterious substance that may render it deleterious to health,”[41] and “food additives,”[42] which include “any substance [that may] becom[e] a component or otherwise affect[] the characteristics of any food.”[43] The FFDCA prohibits the sale of adulterated or misbranded food.[44]

Under the FFDCA, substances added to food can be classified either as “food additives,” which require approval from the FDA that they are safe before they can be marketed,[45] and substances added to food classified as “generally recognized as safe” (GRAS), as to which preapproval is not needed.[46]

In a 1992 policy statement, the FDA reaffirmed that in most cases it would treat foods derived from GMOs like those derived from conventionally bred plants, and that most foods derived from GM plants would be presumptively GRAS. However, with respect to a GMO product “that differs significantly in structure, function, or composition from substances found currently in food,” premarket approval of the substance as a food additive would be required.[47]

The FDA encourages developers of new plant varieties intended for food use, including GMOs, to engage in a consultation procedure with the FDA, in order “to ensure that human food and animal feed safety issues or other regulatory issues (e.g. labeling) are resolved prior to commercial distribution.”[48] The consultation procedure is meant to enable the FDA to determine if regulatory action is needed with respect to food derived from the new variety such as “significantly increased levels of plant toxicants or anti-nutrients, reduction of important nutrients, new allergens, or the presence in the food of an unapproved food additive.”[49] Among the issues subject to consultation is the food safety of new proteins in new plant varieties, including those developed through genetic engineering.[50] The FDA makes detailed information regarding completed consultations publicly available.[51]

2. Animals

The FDA also asserts jurisdiction over genetically engineered animals, pursuant to its authority to regulate “new animal drugs” (NADs) under the FFDCA.[52] Under the FFDCA, NADs are deemed generally unsafe unless the FDA has approved a New Animal Drug Application (NADA) for the particular use of the drug.[53] Except in cases in which the FDA exercises discretion to decline to require compliance,[54] or where the drug is only for investigational use and thus need only conform to specified exemptions,[55] the FDA requires a genetically engineered (GE) animal to be the subject of an approved NADA based on a demonstration that it is safe and effective for its intended use.[56] A NADA for a GE animal must include information on the animal’s identification; chemistry; clinical purpose; labeling; components and composition; manufacturing methods, facilities, and controls; safety and effectiveness; environmental impact; and other information.[57]

3. Drugs

The FDA also has regulatory authority over drugs generally. Companies interested in introducing a new drug into the US market in most cases must submit a New Drug Application (NDA) to the FDA, which must include extensive information and data on the drug’s safety and effectiveness, such as the drug’s chemistry, manufacture, animal and in vitro studies, clinical data, and the like.[58] Drugs developed through genetic engineering must go through the same NDA process as other types of drugs.

4. Biological Products

The FDA also regulates medical products classified as “biological products,” which includes vaccines, serums, blood products, and the like, under relevant provisions of the Public Health Service Act (PHSA).[59] Biological products, whether involving genetic modification or not, must be licensed by the FDA before they can be introduced. The licensing procedure for biological products requires submission to the FDA of detailed information on laboratory and clinical studies, manufacturing methods, and other information relevant to whether they are safe and effective for their intended purpose.[60]

C. Environmental Protection Agency

The EPA regulates pesticides and microorganisms developed through genetic engineering.

1. Pesticides

The EPA regulates the manufacture, sale and use of pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).[61] Under FIFRA, pesticides must not cause “unreasonable adverse effects on the environment,”[62] which is defined to include both safety to the environment and safety in food for consumption.[63] FIFRA requires all pesticides to be registered with the EPA before they can be distributed commercially.[64] Pesticides must be tested and shown to be safe before they can be registered.[65] A registration application must include information regarding testing, identity of the product, draft labeling, information on tolerance of residues, and other safety-related information.[66]

Pursuant to its authority under FIFRA, the EPA regulates plants that are genetically modified to produce substances intended to control pests as to both their environmental safety and their safety in food, termed plant-incorporated protectants (PIPs).[67] The standard registration procedures for pesticides apply to PIPs, unless they are made exempt by regulation.[68] PIPs are exempt from FIFRA registration if the PIP is used in a crop used in food and its residues are exempt from regulation under the FFDCA,[69] if the PIP is an inert ingredient listed as exempt by the EPA,[70] or if the PIP is from a plant that is sexually compatible with the recipient plant.[71] With respect to those PIPs that are exempt, if the producer of the PIP obtains information regarding adverse effects from the PIP on human health or the environment, it must share it with the EPA.[72]

2. Microorganisms

The EPA also has authority to regulate GMOs under the Toxic Substances Control Act (TSCA).[73] The TSCA authorizes the EPA to regulate chemical substances that may present an unreasonable risk of injury to health or the environment.[74] Manufacturers of covered substances must submit a premanufacture notification to the EPA.[75] The EPA has determined that GMO microorganisms are chemical substances subject to regulation under the TSCA.[76] The EPA has established regulations specifically for microorganisms that require submission of a Microbial Commercial Activity Notice (MCAN) before they are used for commercial purposes.[77] The Notice must include information describing the microorganism’s characteristics and genetic construction; byproducts of its manufacture, use, and disposal; health and environmental effects data; and other information.[78]

D. National Environmental Policy Act

The National Environmental Policy Act (NEPA)[79] requires federal agencies in some cases to prepare Environmental Assessments (EAs) of federal actions, such as adopting a policy or approving a permit, to determine if they are likely to significantly impact the environment.[80] If a federal action is likely to have a significant impact, the agency must prepare a more detailed evaluation called an Environmental Impact Statement (EIS).[81] Federal agency approvals of GMOs may require an EA or an EIS in some circumstances.[82]

E. State Law

State law generally plays little role in the regulation of GMOs in the US. The federal preemption doctrine, which bars conflicting state regulation when Congress intends federal regulation to occupy a particular field, precludes many aspects of state regulation of GMOs.[83]

A rare example in which one state’s law is more stringent than federal law on GMOs involves a bioengineered tropical aquarium fish known as the GloFish, which is unregulated at the federal level,[84] but has been banned by the California Fish and Game Commission.[85]

Some municipal governments in the US have banned GMO crops. For example, in California, the counties of Marin and Mendocino have enacted ordinances forbidding the cultivation of GMOs.[86] In Hawaii, Kauai County and Hawaii County similarly have banned the cultivation of most GMO crops.[87]

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IV. Restrictions on Research, Production, and Marketing

The nature of restrictions on GMOs with respect to research, production and marketing in the US vary with the different regulatory regimes that cover various aspects of genetic modification.

A. Animal and Plant Health Inspection Service

The introduction of GM plants requires prior approval from APHIS, by means of a notification, permitting, or a determination of nonregulated status procedure. (See Part III(A), above.)

B. Food and Drug Administration

1. Foods

The FDA regards most GMO foods as presumptively falling within the category of “generally regarded as safe,” thus not needing premarket approval, but a GMO product “that differs significantly in structure, function, or composition from substances found currently in food” requires premarket approval as a food additive. (See Part III(B)(1), above.)

2. Animals

In most cases, the FDA requires a genetically engineered animal to be approved by means of a New Animal Drug Application based on a demonstration that it is safe and effective for its intended use. (See Part III(B)(2), above.)

3. Drugs

FDA requires those wishing to introduce a new drug into the US market, whether it involves genetic modification or not, to submit a New Drug Application (NDA) to the FDA, with detailed information on the drug’s safety and effectiveness. (See Part III(B)(3), above.)

4. Biological Products

The FDA requires all biological products, regardless of whether or not they are developed by genetic modification, to be licensed by FDA before they can be introduced, with detailed information on whether they are safe and effective for their intended purpose. (See Part III(B)(4), above.)

C. Environmental Protection Agency

Under FIFRA, the EPA requires all pesticides to be registered prior to commercial distribution, and the registration must include information on their safety. The EPA also requires PIPs to comply with the pesticide registration procedures, unless they meet the criteria for exemption from these procedures. (See Part III(C)(1), above.)

Under TSCA, the EPA requires those wishing to use microorganisms for commercial purposes to submit a Microbial Commercial Activity Notice (MCAN). (See Part III(C)(2), above.)

D. Labeling of GMOs

There is no law in the US requiring that GMO foods or foods with GMO ingredients be labeled to so indicate. Proposed federal legislation, the Genetically Engineered Food Right-to-Know Act,[88] which would mandate labeling of any GMO food or food with a genetically modified ingredient, has been introduced in the last several Congresses, but has never advanced beyond the committee stage in either chamber. At the state level, a 2012 California initiative mandating labeling of GMO foods, and a similar 2013 Washington State initiative, both failed.[89]

The FDA has regulatory authority to prevent false and misleading labeling of foods and drugs. With respect to genetically engineered foods, the FDA has stated in policy documents that if a GM food product is not materially different from its traditional counterpart, there is no need to label or change the name of the product, but name changes are appropriate when a food from a GM plant is so different from its traditional counterpart that the usual name no longer adequately describes the new food, or if there is a safety issue to which consumers should be alerted, such as the presence of allergens.[90]

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V. Restrictions on Releasing Organisms into the Environment

Because US regulation of GMOs focuses on the nature of the products, rather than the process in which they were produced, the extent to which there are restrictions on releases of GMOs into the environment depends on the GMOs in question. (See the discussion of the different regulatory regimes for different types of GMOs, Part III, above.)

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VI. Restrictions on GMOs in Foodstuffs

GMOs are not restricted categorically from the US food supply. As discussed above, the FDA treats foods derived from GMOs like those derived from conventionally bred plants, and therefore most foods derived from GM plants are classified as presumptively “generally recognized as safe.” However, with respect to a GMO product “that differs significantly in structure, function, or composition from substances found currently in food,” premarket approval of the product is required. (See Part III(B)(1), above.)

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VII. Liability Regime

All of the various statutory schemes under which GMOs are regulated in the US provide for civil and criminal penalties. For example, violations of the PPA are subject to substantial civil or criminal penalties;[91] knowingly importing or moving any regulated article for sale or distribution in violation of the PPA is punishable by a fine, imprisonment up to five years, or both.[92] The liability provisions of the FFDCA list several practices that can lead to significant civil or criminal penalties, including imprisonment.[93] Violations of FIFRA and TSCA similarly are subject to civil or criminal penalties.[94]

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VIII. Judicial Decisions / Prominent Cases

A landmark case of significance in the early development of the US biotechnology industry was the US Supreme Court’s 1980 decision in Diamond v. Chakrabarty,[95] holding that genetically engineered microorganisms can be patented. This decision “contributed to a revolution in biotechnology that has resulted in the issuance of thousands of patents, the formation of hundreds of new companies, and the development of thousands of bioengineered plants and food products.”[96]

Outside of patent law, however, the role of the US courts in shaping regulatory policy with respect to GMOs has been limited. A common theme among many court decisions on GMOs has been the judiciary’s deference to agency expertise in determining how to regulate them.

The Supreme Court’s decision in Monsanto Co. v. Geertson Seed Farms[97] involved a challenge under NEPA to APHIS’s decision to issue a determination of nonregulated status to Monsanto’s Roundup Ready Alfalfa (RRA), a genetically engineered variety of alfalfa, after making a “finding of no significant impact” determination instead of preparing an environmental impact statement (EIS). The district court ruled that an EIS was required, and as a remedy enjoined APHIS from deregulating RRA, in whole or in part, pending completion of the EIS, and also enjoining almost all planting of RRA nationwide.[98] The Supreme Court reversed, ruling that the district court exceeded its authority in enjoining APHIS from partially deregulating RRA and enjoining the planting of RRA. It concluded that APHIS should be allowed to structure a partial deregulation order while completing the EIS.[99]

In Alliance for Bio-Integrity v. Shalala,[100] the plaintiffs challenged the FDA’s 1992 policy statement that GMO foods that are similar to conventional varieties would be presumptively deemed “generally recognized as safe” (GRAS)[101] and that they need not be labeled.[102] The district court declined to rule that the FDA’s decision that genetic modification does not “materially” alter foods and to presume GMO foods are GRAS was arbitrary and capricious, stating that “the rational for [court] deference [to agency decision making] is particularly strong when the [agency] is evaluating scientific data within its technical expertise.”[103] As to labeling, it said that given FDA’s decision on the GRAS issue, it would also find that the FDA’s interpretation of the FFDCA’s labeling requirement was reasonable.[104]

Other GMO cases have similarly displayed the tendency of US courts to defer to agency decision making.[105]

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Luis Acosta
Senior Legal Information Analyst
March 2014

[1] Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products 6 (Sept. 2001), http://www.pewtrusts.org/uploadedFiles/www pewtrustsorg/Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf.

[2] The Biotechnology Industry in the United States, Select USA, http://selectusa.commerce.gov/print/industry-snapshots/biotechnology-industry-united-states (last visited Nov. 5, 2013) (stating there are 1300 firms and 1.3 million employees in biosciences in the US, and 5.8 million employees in related industry sectors).

[3] Int’l Serv. for the Acquisition of Agri-Biotech Applications, ISAAA Brief No. 44-2012, Global Status of Commercial Biotech/GM Crops, Executive Summary, http://www.isaaa.org/resources/publications/briefs/44/ executivesummary/default.asp (last visited Nov. 5, 2013).

[4] Economic Research Service, Adoption of Genetically Engineered Crops in the US, Recent Trends in GE Adoption, United States Department of Agriculture, http://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us/recent-trends-in-ge-adoption.aspx#.UobvBXL92Dk (July 9, 2013).

[5] Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Jan. 29, 2000, 39 I.L.M. 1027, http://bch.cbd.int/protocol/text/; Parties to the Protocol and Signature and Ratification of the Supplementary Protocol, Convention on Biological Diversity, http://bch.cbd.int/protocol/parties/ (last updated Sept. 10, 2012).

[6] Bureau of Oceans and International Environmental and Scientific Affairs, Frequently Asked Questions on the Cartagena Protocol on Biosafety (CPB),U.S. Department of State (Feb. 23, 2004), http://2001-2009.state.gov/g/ oes/rls/or/2004/29751.htm.

[7] See, e.g., id. (noting participation as nonparty in first Meeting of the Parties to the Protocol).

[8] Memorandum from the Mellman Group to the Pew Initiative on Food and Biotechnology, Review of Public Opinion Research 1 (Nov. 16, 2006), http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Public_Opinion/ Food_and_Biotechnology/2006summary.pdf.

[9] Id. at 3.

[10] Allison Kopicki, Strong Support for Labeling Modified Foods,N.Y. Times (July 27, 2013), http://www.nytimes. com/2013/07/28/science/strong-support-for-labeling-modified-foods.html; see also U.S. Polls on GE Food Labeling, Center for Food Safety, http://www.centerforfoodsafety.org/issues/976/ge-food-labeling/us-polls-on-ge-food-labeling# (last visited Nov. 12, 2013)(citing multiple polls showing support for mandatory labeling ranging from 93 to 96% percent).

[11] Kopicki, Strong Support for Labeling Modified Foods, supranote 10.

[12] Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health, National Research Council, Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects 180 (2004), http://www.nap.edu/openbook.php?isbn=0309092094 (“[N]o adverse health effects attributed to genetic engineering have been documented in the human population.”); Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants, Board on Agriculture and Natural Resources, National Research Council, Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation 49 (2002), http://www.nap.edu/openbook. php?isbn=0309082633 (“The transgenic process presents no new categories of risk compared to conventional methods of crop improvement, but specific traits introduced by both approaches can pose unique risks.”)

[13] AAAS Issues Statement on Labeling of Genetically Modified Foods, California Council on Science and Technology (Nov. 1, 2012), http://www.ccst.us/news/2012/1101aaas.php. (“[C]rop improvement by the modern molecular techniques of biotechnology is safe. . . . [C]onsuming foods containing ingredients derived from GM crops is no riskier than consuming the same foods containing ingredients from crop plants modified by conventional plant improvement techniques.”)

[14] American Medical Association, Policy No. H-480.958, Bioengineered (Genetically Engineered) Crops and Foods, http://www. ama-assn.org/resources/doc/PolicyFinder/policyfiles/HnE/H-480.958.HTM (last visited Nov. 10, 2013) (reaffirming prior conclusion that “no evidence that unique hazards exist either in the use of rDNA techniques or in the movement of genes between unrelated organisms”).

[15] See, e.g., Support Sustainable Agriculture, Greenpeace USA, http://www.greenpeace.org/usa/en/campaigns/ genetic-engineering/ (last visited Nov. 12, 2013); Genetic Engineering, Sierra Club, http://www.sierraclub. org/biotech/ (last visited Nov. 12, 2013).

[16] See, e.g., Policy, Organic Seed Growers & Trade Association, http://www.osgata.org/policy/ (last visited Nov. 12, 2013).

[17] See, e.g., Genetic Engineering and Biotechnology, Organic Consumers Association, http://www.organic consumers. org/gelink.cfm (last visited Nov. 12, 2013); GE Foods, Center for Food Safety, http://www.center forfoodsafety.org/issues/311/ge-foods (last visited Nov. 12, 2013).

[18] See, e.g., Gregory N. Mandel, Toward Rational Regulation of Genetically ModifiedFood, 4 Santa Clara J. Int’l L. 21 (2006), http://digitalcommons.law.scu.edu/cgi/viewcontent.cgi?article=1015&context=scujil; Maria R. Lee-Muramoto, Reforming the “Uncoordinated” Framework for the Regulation of Biotechnology,17 Drake J. Agric. L. 311 (2013), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2175622; Debra M. Strauss, Defying Nature: The Ethical Implications of Genetically Modified Plants, 3 J. Food L. & Pol’y 1 (2007), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1302506; Sheryl Lawrence, What Would You Do With a Fluorescent Green Pig?: How Novel Transgenic Products Reveal Flaws in the Foundational Assumptions for the Regulation of Biotechnology,34 Ecology L.Q. 201 (2007), http://www.boalt.org/elq/documents/elq34-1-05-lawrence-2007-0430.pdf.

[19] Coordinated Framework, 51 Fed. Reg. 23,302 (June 26, 1986), available in manuscript format at http://www. aphis.usda.gov/brs/fedregister/coordinated_framework.pdf.

[20] Id. at 3 (PDF manuscript pagination).

[21] OSTP, Proposal for a Coordinated Framework for Regulation of Biotechnology, 49 Fed. Reg. 50,856 (Dec. 31, 1984).

[22] Coordinated Framework, supra note 19, at 6–8.

[28] 7 C.F.R. § 340.3(b).

[29] 7 C.F.R. § 340.3(c).

[30] 7 C.F.R. § 340.3(e).

[31] 7 C.F.R. § 340.3(e)(5).

[33] 7 C.F.R. § 340.4(f).

[34] 7 C.F.R. § 340.4(g).

[36] 7 C.F.R. § 340.6(c).

[37] 7 C.F.R. § 340.6(d).

[38] Id.

[41] 21 U.S.C. § 342(a).

[46] 21 U.S.C. § 321(s) (excluding substances from definition of “food additive” that are “generally recognized . . . to be safe.”).

[47] FDA, Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22,984 (May 29, 1992), available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ Biotechnology/ucm096095.htm.

[48] FDA, Guidance on Consultation Procedures: Foods Derived from New Plant Varieties (rev. Oct. 1997), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096126.htm.

[49] Id.

[50] FDA, Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (June 2006), http://www.fda.gov/Food/Guidance Regulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096156.htm.

[51] FDA, Completed Consultations on Bioengineered Foods, http://www.accessdata.fda.gov/scripts/fcn/fcn Navigation.cfm?rpt=bioListing (last updated May 31, 2013).

[52] FDA, Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs (rev. May 17, 2011), http://www.fda.gov/downloads/AnimalVeterinary/GuidanceCompliance Enforcement/GuidanceforIndustry/UCM113903.pdf (hereinafter GE Animals Guidance). The FFDCA definition of “new animal drug” includes articles “intended to affect the structure or function of the body of . . . animals.” 21 U.S.C. § 321(v). The FDA reasons that the “rDNA construct in a GE animal that is intended to affect the structure or function of the body of the GE animal, regardless of the intended use of products that may be produced by the GE animal,” and thus all GE animals are NADs for purposes of regulation. GE Animals Guidance at 6. While the FDA could regulate all GE animals, it has determined it will decline to regulate those that are under the jurisdiction of other agencies. Id. at 7.

[54] GE Animals Guidance, supranote 52, at 7–9.

[55] Id. at 9–12.

[56] Id. at 12–13.

[57] Id. at 14–20.

[64] 7 U.S.C. § 136a(a) (2012).

[65] 7 U.S.C. § 136a(c)(5) (2012).

[68] 40 C.F.R. § 174.1 (2013), http://www.ecfr.gov/cgi-bin/text-idx?SID=c72e2a2a61e1ad7b08706bfe11c90051& node=40:25.0.1.1.23&rgn=div5#40:25.0.1.1.23.1.19.1 (“Unless otherwise superseded by this part, the regulations in parts 150 to 180 of this chapter apply to plant-incorporated protectants.”).

[70] 40 C.F.R. § 174.21(c) (2013).

[82] See, e.g., GE Animals Guidance, supra note 52, at 19 (describing EA requirement in New Animal Drug Application to enable FDA to either prepare an EIS or make a finding of no significant impact).

[83] Doug Farquhar & Liz Meyer, State Authority to Regulate Biotechnology Under the Federal Coordinated Framework, 12 Drake J. Agric. L. 439, 461–71 (2007), http://students.law.drake.edu/aglawjournal/docs/agVol12 No3-Farquhar.pdf.

[84] FDA Statement Regarding GloFish (Dec. 9, 2003), http://www.fda.gov/AnimalVeterinary/Development ApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm161437.htm (“In the absence of a clear risk to the public health, FDA finds no reason to regulate these particular fish.”).

[85] Kenneth R. Weiss, State Takes Dim View of GloFish, Bans Sale,L.A. Times (Dec. 4, 2003), http://articles.latimes. com/2003/dec/04/local/me-glofish4.

[86] Marin County, Cal. Code ch. 6.92 (2013), available at http://library.municode.com/index.aspx?clientID=16476 (select title 6, then select chapter 6.92); Mendocino County, Cal. Code ch. 10A.15 (2013), available at http://library.municode.com/index.aspx?clientId=16484 (select title 10A, then select chapter 10A.15).

[87] Andrew Pollack, Limits Approved for Genetically Modified Crops in Kauai, Hawaii,N.Y. Times (Oct. 16, 2013), http://www.nytimes.com/2013/10/17/business/limits-approved-for-genetically-modified-crops-in-kauai-hawaii. html?_r=0; Christopher D’Angelo, Hawaiian Islands Take More Steps to Limit Spread of GMO Crops, Reuters (Dec. 6, 2013), http://www.reuters.com/article/2013/12/07/usa-gmos-hawaii-idUSL2N0JL1RL20131207. The Hawaii County ordinance permits GM papaya to be grown on the island. Id.

[89] Mark Lifsher, Prop. 37 Backers Vow to Continue Food Regulation Efforts, L.A. Times (Nov. 7, 2012), http://articles.latimes.com/2012/nov/07/business/la-fi-prop37-genetic-food-labeling-20121108; Stephanie Strom, Food Companies Claim Victory Against Labeling Initiative in Washington State, N.Y. Times (Nov. 6, 2013), http://www.nytimes.com/2013/11/07/us/politics/food-companies-claim-victory-against-labeling-initiative-in-washington-state.html.

[90] FDA, Statement of Policy: Foods Derived from New Plant Varieties, supranote 47, § VI, Labeling.

[92] 7 U.S.C. § 7734(a)(1)(B) (2012).

[94] 7 U.S.C. § 136l (2012), http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section136l& num=0&edition=prelim (civil and criminal penalties for violating FIFRA); 15 U.S.C. § 2615 (2012), http://uscode. house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section2615&num=0&edition=prelim (civil and criminal penalties for violating TSCA).

[95] Diamond v. Chakrabarty, 447 U.S. 303 (1980), available athttp://laws.findlaw.com/us/447/303.html.

[96] Douglas Robinson & Nina Medlock, Diamond v. Chakrabarty: A Retrospective on 25 Years of Biotech Patents, Intell. Prop. & Tech. L.J., Oct. 2005, at 12, available at http://www.bannerwitcoff.com/_docs/library/articles/ Chakrabarty.pdf.

[97] Monsanto Co. v. Geertson Seed Farms, 130 S. Ct. 2743 (2010), slip op. available at http://www.supremecourt. gov/opinions/09pdf/09-475.pdf.

[98] Id., slip op. at 2–6.

[99] Id., slip op. at 16–24.

[100] Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000), available at http://scholar.google. com/scholar_case?case=9837177635976803502&q=116+F.+Supp.+2d+166+&hl=en&as_sdt=20006.

[101] See discussion supra, Part III(B)(1).

[102] Seediscussion supra, Part IV(D).

[103] Alliance for Bio-Integrity v. Shalala, 166 F. Supp. 2d at 177.

[104] Id. at 178–79.

[105] See, e.g., Center For Food Safety v. Vilsack, 636 F.3d 1166 (9th Cir. 2011), slip op. available at http://cdn.ca9.us courts.gov/datastore/opinions/2011/03/03/10-17719.pdf (in case challenging APHIS’s deregulation of Roundup Ready sugar beets, finding absence of irreparable harm to justify injunction); Center For Food Safety v. Vilsack, 718 F.3d 829 (9th Cir. 2013), slip op. available at http://cdn.ca9.uscourts.gov/datastore/opinions/2013/ 05/17/12-15052.pdf (in case challenging APHIS’s deregulation of Roundup Ready alfalfa, deferring to agency determination that RRA was not a “plant pest”).

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Last Updated: 12/30/2020