Reforming The Uncoordinated Framework For Regulation Of

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Reforming The Uncoordinated Framework For Regulation Of

Transcript Of Reforming The Uncoordinated Framework For Regulation Of

REFORMING THE “UNCOORDINATED” FRAMEWORK FOR REGULATION OF
BIOTECHNOLOGY

Maria R. Lee-Muramoto*

I.

Introduction.......................................................................................... 312

II. Looking Back: Lessons Learned......................................................... 316

A. Still Forcing Square Pegs Into Round Holes—Who Is

Regulating What? .......................................................................... 316

1. USDA ..................................................................................... 317

2. FDA ........................................................................................ 320

3. EPA......................................................................................... 322

B. Twenty-Five Years of Experience with the Coordinated

Framework .................................................................................... 323

1. The GE Genie Is Out of the Bottle ......................................... 323

2. Where GE Proponents Missed the Mark ................................ 324

3. Where GE Opponents Missed the Mark ................................. 330

C. Trade as a Key Driver: 2006 WTO Decision in U.S. v. E.U. ....... 333

1. Fundamental Differences in Approach ................................... 334

2. What Did the United States Really Win? ............................... 335

III. Reasons Why the Coordinated Framework Must Change ................... 337

A. The Premise of the Coordinated Framework Is Flawed and

Outdated, but Other Factors Conspire to Maintain the

Status Quo ..................................................................................... 337

1. Science Then and Now ........................................................... 338

2. Innumeracy as an Excuse........................................................ 342

3. American Consumers: Lack of Knowledge and Apathy ....... 343

B. The Coordinated Framework Is Substantively Deficient:

Examples of Past and Current Failures ......................................... 343

1. StarLink .................................................................................. 344

2. ProdiGene ............................................................................... 345

3. Monarch Butterfly .................................................................. 346

4. GloFish ................................................................................... 347

5. AquaBounty’s AquAdvantage Salmon................................... 348

C. The Current System Cannot Accommodate the Next

Generation of GE Products ........................................................... 350

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1. The Trends with GE Foods ..................................................... 350 2. The Need to Feed an Ever-Growing Population..................... 352 3. The Impact of Climate Change ............................................... 353 IV. Moving Forward—Proposals for Change and Key Obstacles ............. 354 A. Legislative and Policy Initiatives are Necessary............................ 354 1. Discard the Concept of “Substantial Equivalence”................. 355 2. Incorporate Systematic Risk Assessment into Regulations .... 356 3. Post-Market Monitoring as Part of the Risk
Management Process .............................................................. 358 4. Institute a System of Coordination Among the Three
Agencies.................................................................................. 359 5. Improve Transparency: Building Consumer Trust and
Confidence .............................................................................. 362 6. Encourage Independent Research and Investments in
Alternative Technological Paradigms ..................................... 363 B. Real Obstacles to Moving Forward................................................ 364
1. Lack of Political Will to Drive the Necessary Changes.......... 364 2. True Reform Will Require Changes Beyond the
Coordinated Framework ......................................................... 365 IV. Conclusion ........................................................................................... 366

I. INTRODUCTION
The AquaBounty AquAdvantage salmon is symbolic of much that is wrong or inadequate with the regulatory framework for agricultural biotechnology in the United States.1 The Food and Drug Administration (FDA) was recently _________________________
* LL.M., Golden Gate University (GGU) School of Law, 2011; J.D., GGU School of Law, 1995; M.S., GGU School of Business, 1995; B.A., University of California, Los Angeles, 1989. The author would like to thank professors Alan Ramo, Helen Kang, and Deborah Behles, GGU School of Law, for their invaluable guidance and thoughtful comments throughout the research and writing process of this Article. Special thanks also to the students at the Drake Journal of Agricultural Law for their skillful editing. Any errors and omissions are the author’s own.
1. See Helena Bottemiller, Alaska Senators Seek GE Salmon Ban in Budget, FOOD SAFETY NEWS, Oct. 19, 2011, http://www.foodsafetynews.com/2011/10/alaska-senators-seek-gesalmon-ban-in-budget-debate/ (“Developed by Massachusetts-based AquaBounty Technologies, the engineered fish, formally known as AquAdvantage salmon, are essentially Atlantic salmon with an inserted growth gene from a Chinook salmon and an antifreeze gene from an ocean pout. They grow twice as fast as typical Atlantic salmon and require approximately 10 percent less feed to achieve the same weight.”).

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on the verge of approving AquAdvantage as the first genetically engineered salmon for human consumption when Congress stepped in to halt the approval process.2 The mounting opposition that stopped the FDA approval not only cited major environmental, health, and economic concerns with the salmon, but also the failure of the FDA approval process to require adequate safety assessment, a general lack of transparency through the approval process, and public engagement expressing their concerns.3 The FDA relied heavily on only four studies in the approval process, with one of the studies nearly twenty years old, and the other three supplied by AquaBounty itself.4 In addition, while the National Environmental Policy Act (NEPA) requires the agency to prepare an environmental impact statement for any major regulatory action that could significantly impact the environment, it has not done so to date.5 To make matters worse, even though a recent poll showed that an overwhelming seventy-eight percent of Americans do not want genetically engineered salmon to be approved without more research, the FDA considered putting the salmon on the market without requiring labeling.6 In all, not only was the FDA resting its approval of the ge-

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2. Letter from Mark Begich et al., U.S. Senators, to Margaret A. Hamburg, M.D., Comm’r, U.S. Food & Drug Admin. (July 15, 2011), available at http://stopgefish.files.word press.com/2011/07/senate-july-2011-hamburg-fda-ge-salmon-final.pdf; Letter from Don Young et al., Members of Congress, to Margaret Hamburg, M.D., Comm’r, U.S. Food & Drug Admin. (July 15, 2011), available at http://stopgefish.files.wordpress.com/2011/07/ house-fish-letter-final-final7-15-11.pdf; see also Press Release, Ctr. for Food Safety, U.S. Congress Turns Up the Heat on Genetically Engineered Salmon (July 18, 2011) [hereinafter Congress Turns Up the Heat], available at http://www.centerforfoodsafety.org/ 2011/07/18/u-s-congress-turns-up-the-heat-ongenetically-engineered-salmon/ (describing Congressional action opposing genetically engineered salmon).
3. Begich, supra note 2; Young, supra note 2. 4. Meeting on AquAdvantage Salmon Veterinary Med. Advisory Comm., U.S. Food & Drug Admin. 293 (2010) (statement of Wenonah Hauter, Exec. Dir., Food & Water Watch), available at http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM230471.pdf. 5. Press Release, Food & Water Watch, Troubling Emails Reveal Federal Scientists Fear FDA Approval of Genetically Engineered Salmon: “May They [the FDA] Should Watch Jurassic Park” (Nov. 15, 2010) [hereinafter Troubling Email], available at http://www.foodand waterwatch.org/pressreleases/ troubling-emails-reveal-federal-scientists-fear-fda-approval-ofgenetically-engineered-salmon/. 6. Meeting on AquAdvantage Salmon, supra note 4, at 292–93; see also Press Release, Food & Water Watch, National Consumer Organization: Halt Approval of Genetically Engineered Salmon Until FDA Conducts Tests on Long-Term Health Effects of Consuming Genetically Engineered (GE) Meat (Sept. 20, 2010) [hereinafter Halt Approval of Salmon], available at http://www. foodandwaterwatch.org/ (search “halt approval”; then follow “National Consumer Organization: Halt Approval . . . (GE) meat” hyperlink) (explaining that a poll, conducted by Food & Water Watch and Lake Research Partners, further demonstrated that ninety-one percent of Americans

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netically engineered salmon on flawed scientific principles, it was doing so without adequate risk assessment and safety testing, without a monitoring plan in place for post-market risk management, and without coordination with the Environmental Protection Agency (EPA) to adequately evaluate potential environmental risks.
Biotechnology7 has the potential to yield significant benefits to mankind, particularly in the area of agriculture and food production, but can also present considerable risks to human health and the environment if left unchecked. In the United States, no body of law specifically governs biotechnology.8 Recognizing that some oversight was necessary, the White House Office of Science and Technology Policy (OSTP) promulgated the Coordinated Framework for Regulation of Biotechnology (Coordinated Framework) in 1986, which utilized existing laws rather than enact new ones.9 Historically, the United States has paid little attention to the process of biotechnology, reasoning that it was not inherently risky.10 OSTP’s underlying focus was the promotion of growth and competitiveness for what was then an emerging and highly promising biotechnology industry.11 Since then, despite significant flaws and a history of deficiencies in oversight, this outdated framework and its policies continue to be the framework for regulating agricultural biotech products in the food system.

believe that until the agency can perform adequate safety studies, the FDA should not approve transgenic pigs, chicken, and cattle into the food supply).
7. See Proposed Policy Regarding Certain Microbial Products, 49 Fed. Reg. 50,880, 50,906 (Dec. 31, 1984) (defining biotechnology as the application of “biological systems and organisms to technical and industrial processes”); see also PEW INITIATIVE ON FOOD & BIOTECHNOLOGY, ISSUES IN THE REGULATION OF GENETICALLY ENGINEERED PLANTS AND ANIMALS 2 fig.1.1 (2004) [hereinafter PEW INITIATIVE ON FOOD & BIOTECHNOLOGY, ISSUES IN REGULATION], available at http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Reports/food_ biotech_regulation_0404.pdf (explaining that biotechnology “encompasses techniques used for centuries, including traditional plant and animal breeding techniques and the use of microorganisms in fermentation and food processing” and defining “modern biotechnology” to include “techniques that involve the direct manipulation of genetic materials, including recombinant DNA (rDNA) techniques and cell fusion,” whereas “recombinant DNA technology generally involves the isolation and in vitro manipulation of discrete DNA segments containing the genetic material of interest and their insertion into a host organism”).
8. See PEW INITIATIVE ON FOOD & BIOTECHNOLOGY, ISSUES IN REGULATION, supra note 7, at 1, 3.
9. Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (Jun. 26, 1986).
10. Gregory N. Mandel, Toward Rational Regulation of Genetically Modified Food, 4 SANTA CLARA J. INT’L L. 21, 21 (2006) [hereinafter Mandel, Toward Rational Regulation of Genetically Modified Food].
11. Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. at 23,302– 03.

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The root of numerous controversies surrounding genetically engineered (GE)12 foods can be traced, in large part, to an inadequate regulatory system that divides power and oversight among three government agencies: the EPA, FDA, and USDA.13 The Coordinated Framework implicates at least twelve existing federal laws, none of which are designed to handle novel genetically engineered foods or to address the potential risks these products may present.14 The agencies were left to creatively interpret each statute to fulfill their regulatory objectives. This system has “led to a regulatory approach that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured.”15 As a result, it fails to adequately protect consumers and safeguard the environment and our ecosystems.
Potential commercial benefits cannot be fully realized from the biotech industry’s perspective because the regulatory scheme over-regulates and subjects members to multiple agency jurisdictions and a complex, but haphazard maze of overlapping rules, regulations, and processes.16 It creates uncertainties that deter

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12. “New varieties of animals, plants, and microorganisms created through genetic engineering are referred to as being ‘genetically engineered,’ ‘bioengineered,’ or ‘transgenic.’ The term ‘genetically modified’ is technically imprecise since virtually all food has been modified on a genetic level by humans through selection and conventional breeding.” PEW INITIATIVE ON FOOD & BIOTECHNOLOGY, ISSUES IN REGULATION, supra note 7, at 2 fig.1.1. Genetic engineering involves inserting genes responsible for particular traits in one species of organism into the genome of a different, unrelated species. Id. A “transgene” is a gene or genetic material that has been transferred naturally or by GE techniques from one organism to another. See id. at 103 fig.4.1. These terms will be used interchangeably throughout this Article.
13. See Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. at 23,303 (describing the relevant agencies and their functions in the administration of the Coordinated Framework).
14. See PEW INITIATIVE ON FOOD & BIOTECHNOLOGY, ISSUES IN REGULATION, supra note 7, at 7 tbl.1.1 (identifying the twelve federal laws as the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), the Plant Protection Act (PPA), the Virus Serum Toxin Act (VSTA), the Animal Health Protection Act (AHPA), the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), the Egg Products Inspection Act (EPIA), the Animal Damage Control Act (ADCA), the Animal Welfare Act (AWA), and the National Environmental Protection Act (NEPA)). See generally Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (describing the applicable laws).
15. Gregory N. Mandel, Gaps, Inexperience, Inconsistencies, and Overlaps: Crisis in the Regulation of Genetically Modified Plants and Animals, 45 WM. & MARY L. REV. 2167, 2172 (2004) [hereinafter Mandel, Gaps, Inexperience, Inconsistencies, and Overlaps] (arguing that most problems and concerns arising in this field are the result of a deficient statutory and regulatory structure).
16. Id. at 2172.

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investment in new technologies or firms and discourages research and development efforts.17
This Article will focus on how the United States can reform the current regulatory system for agricultural biotechnology given the significant political, economic, and social challenges the regulations governing this industry pose. The proposed reform will emphasize four key objectives to be achieved through legislative mandates. First, the Coordinated Framework was built upon dated scientific principles18 that have since proven to be flawed, and the doctrine of “substantial equivalence,”19 the premise and driving force behind the U.S. regulatory system, is no longer credible and should be abandoned. Second, systematic risk assessment and safety testing must be incorporated into the pre-release or pre-market review process. Third, post-market monitoring must be instituted as part of the overall risk management program. Lastly, a system of coordination should be developed for the three agencies involved in biotech monitoring.
Aside from legislative changes, policy objectives should strive to encourage independent research and investments. Transparency should be improved because continual success for the industry will depend on society’s willingness to purchase and consume food produced through biotechnology.20 In order for this to take place, consumers must trust that regulators are being forthright with them while exercising proper oversight.21

II. LOOKING BACK: LESSONS LEARNED A. Still Forcing Square Pegs Into Round Holes—Who Is Regulating What?

Currently, determining which laws apply and which agency governs agricultural biotechnology depends on the nature of the organism and the product’s intended use.22 Based on the characterization and claims the producer makes, a GE product can be subjected to multiple and overlapping rules and processes of
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17. Mandel, Toward Rational Regulation of Genetically Modified Food, supra note 10, at 38–39.
18. See generally Don Lotter, The Genetic Engineering of Food and the Failure of Science—Part 1: The Development of a Flawed Enterprise, 16 INT’L J. SOC. AGRIC. & FOOD 31 (2009) (describing the scientific developments related to genetically engineered food).
19. Genetic Engineering at a Historic Crossroads, SIERRA CLUB (Mar. 2001), http://www.sierraclub.org/biotech/report.asp.
20. Rebecca M. Bratspies, Biotechnology, Sustainability and Trust, 18 KAN. J.L. & PUB. POL’Y 273, 275 (2010) [hereinafter Bratspies, Biotechnology, Sustainability and Trust].
21. Id. 22. PEW INITIATIVE ON FOOD & BIOTECHNOLOGY, ISSUES IN REGULATION, supra note 7, at 8.

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the three regulatory agencies under the Coordinated Framework.23 It can also bypass the framework entirely.24 The Government Accountability Office (GAO) pointed to these types of problems in a November 2008 report.25 Among the shortcomings mentioned is the lack of a coordinated program “for monitoring and evaluating the use of marketed GE crops to determine whether they are causing (1) undesirable effects to the environment or economic harm to non-GE segments of agriculture through the unintended spread of GE traits or (2) food safety concerns, such as the unintentional introduction of pharmaceutical or industrial compounds into the food supply.”26 GAO advised the three agencies to develop a risk-based strategy to monitor the use of GE crops, which remained mostly unimplemented a year later.27
Since many statutes utilized under the Coordinated Framework predated the advent of biotechnology, each of the three agencies, over time, adopted its own haphazard patchwork of rules and guidelines to address the competing needs of the industry, its duty to protect the public and the environment, and to compensate for the deficiencies in the statutory and regulatory structure.28
1. USDA
The USDA is responsible for protecting and promoting American agriculture.29 In that role, a primary duty is to regulate potential noxious weeds30 and

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23. See id. “For example, the development of crop plants that were genetically engineered to make their own pesticides presented the agencies with a product that was simultaneously a potential plant pest, a food, and a pesticide.” Id.
24. See discussion infra Part III.B.4. 25. U.S. GOV’T ACCOUNTABILITY OFFICE, GAO-09-60, GENETICALLY ENGINEERED CROPS: AGENCIES ARE PROPOSING CHANGES TO IMPROVE OVERSIGHT, BUT COULD TAKE ADDITIONAL STEPS TO ENHANCE COORDINATION AND MONITORING (2008). 26. Id. at 4; see also Carey Gillam, Special Report: Are Regulators Dropping the Ball on Biocrops?, REUTERS, Apr. 13, 2010, http://www.reuters.com/article/2010/04/13/us-usa-gmosregulators-idUSTRE63C2AJ20100413 (describing the GAO report). 27. GOV’T ACCOUNTABILITY OFFICE, supra note 25, at 46; Gillam, supra note 26. 28. See Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302, 23,302–03 (June 26, 1986) (calling for the application of preexisting laws to the regulation of the developing biotechnology industry); see also Mandel, Gaps, Inexperience, Inconsistencies, and Overlaps, supra note 15, at 2172 (“Though the history of biotechnology is relatively short, it already is filled with numerous regulatory lapses . . . . Considering that genetically modified products are regulated pursuant to statutes enacted decades prior to the advent of biotechnology itself, these deficiencies are not entirely surprising.”). 29. USDA, STRATEGIC PLAN FY 2010–2015 iv (2010). 30. Plant Protection Act, 7 U.S.C. § 7702(10) (2006) (defining “noxious weed” to include “any plant or plant product that can directly or indirectly injure or cause damage to crops . . .,

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plant pests31 that can harm the agricultural industry.32 In the exercise of authority derived from predecessors to the Plant Protection Act (PPA),33 the Animal and Plant Health Inspection Service (APHIS) within the USDA classified most GE plants as plant pests or potential plant pests.34 Thus, APHIS became responsible for the regulation of GE organisms and products pursuant to the PPA.35 Under the PPA, a “regulated article”36 must receive authorization from APHIS prior to introduction or release into the environment.37
Authorization from APHIS can come through a notification or permitting process.38 Simple notification to APHIS prior to release is sufficient for most GE plants. In fact, nearly ninety-nine percent of field tests, imports, and interstate movement of GE plants take place under the notification, rather than the permit requirements of the PPA.39 “Prior to conducting a field trial of a new transgenic plant, a developer must perform a risk evaluation on the plant to determine whether the plant may be a plant pest. No consideration of any other risks, such as other human health or environmental risks” is required.40 When the permit

livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment”).
31. Id. § 7702(14) (defining “plant pests” to include any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: (A) A protozoan, (B) A nonhuman animal, (C) A parasitic plant, (D) A bacterium, (E) A fungus, (F) A virus or viroid, (G) An infectious agent or other pathogen, (H) Any article similar to or allied with any of the articles specified in the proceeding subparagraphs).
32. Id. § 7712 (granting the Secretary of Agriculture the authority to regulate noxious weeds and plant pests).
33. See Mandel, Toward Rational Regulation of Genetically Modified Foods, supra note 10, at 31 (noting the Plant Protection Act, enacted in 2000, essentially consolidated authority from two previous statutes, the Federal Plant Pest Act and the Federal Plant Quarantine Act). Both were originally enacted to regulate non-indigenous plant species. Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302, 23,342–43 (June 26, 1986).
34. 7 C.F.R. § 340.2 (2012). 35. See PEW INITIATIVE ON FOOD & BIOTECHNOLOGY, ISSUES IN REGULATION, supra note 7, at 7. 36. 7 C.F.R. § 340.1 (defining “regulated article” to include “[a]ny organism which has been altered or produced through genetic engineering, if the donor organism, recipient organism, or vector or vector agent belongs to any genera or taxa designated in § 340.2 [a list of known plant pests] and meets the definition of plant pest, or is an unclassified organism . . . altered or produced through genetic engineering which [APHIS] determines is a plant pest . . . .”). 37. Plant Protection Act, 7 U.S.C. § 7711(a); 7 C.F.R. § 340.0. 38. 7 C.F.R. §§ 340.3–.4. 39. COUNCIL ON ENVTL. QUALITY & OFFICE OF SCI. & TECH. POLICY, CASE STUDY NO. III: HERBICIDE-TOLERANT SOYBEAN 4 (2001), available at http://www.whitehouse.gov/ files/documents/ostp/Issues/ceq_ostp_study4.pdf. 40. Mandel, Toward Rational Regulation of Genetically Modified Food, supra note 10, at 33 (citing 7 C.F.R. § 340).

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process is triggered for the remaining one percent, the primary emphasis is confinement in the field site to prevent the plants or their progeny from crosscontamination with other plants and from persisting in the environment.41 An applicant can also petition APHIS to declare that a GE plant is not a plant pest and therefore should be given “non-regulated status.”42 Once the petition is granted, the plant is no longer subject to any APHIS oversight.43 Thus, there is no post-market surveillance to monitor how the GE plant will fare over time.
Since APHIS is required to carry out its regulatory mandates while promoting agriculture, including the biotech industry, critics have argued that this conflict of interest would prevent APHIS from objectively assessing the safety of new biotech products.44 This criticism is particularly valid as the next generation of GE products comes online with significant profit outlooks for the biotech industry, but potentially even greater impact to human health and the environment. Field-testing, for example, of transgenic pharmaceutical-producing plants can pose significant risks to humans if the plants contaminate other food plants, and the approval and release of transgenic insects for pest management on farmland can have widespread ecological consequences and impact to food sources. The current regulatory framework for the USDA to regulate GE plants and products is wholly insufficient in managing these types of risks. In fact, contamination from pollen “drift” has already proven to be economically devastating.45 It is estimated that GE contamination to U.S. corn crops alone could lead to lost income of over ninety million dollars for organic farmers.46 An example was Terra Prima, a small organic tortilla chips producer who suffered a loss of $150,000 and was forced to recall 87,000 bags of chips it exported to Europe after scientific testing detected GE corn in the chips, which was unacceptable under European Union (EU) regulations.47

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41. See 7 C.F.R. § 340.4. 42. 7 C.F.R. § 340.6. 43. Id. 44. BD. ON AGRIC. & NATURAL RES., NAT’L RESEARCH COUNCIL, ENVIRONMENTAL EFFECTS OF TRANSGENIC PLANTS: THE SCOPE AND ADEQUACY OF REGULATION 19 (2002). 45. See generally K.L. HEWLETT & G.S.E. AZEEZ, THE ECONOMIC IMPACTS OF GM CONTAMINATION INCIDENTS ON THE ORGANIC SECTOR (2008), available at http://orgprints.org/ 12027/1/The_Economic_Impacts_of_GM_Contamination_Incidents_on_the_Organic_Sector.pdf (highlighting the economic costs of GM contamination on organic production). 46. Id. 47. Id.; see also Sarah L. Kirby, Genetically Modified Foods: More Reasons to Label than Not, 6 DRAKE J. AGRIC. L. 342, 358 (2001) (discussing instances of problems with genetic drift).

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2. FDA
The FDA is responsible for the safety of all food products and animal feeds in the United States, with the exception of meat and poultry.48 Meat and poultry are regulated by the USDA.49 The Center for Food Safety and Applied Nutrition within the FDA is charged with overseeing the safety of food created from GE crops.50 The primary statutory authority is the Federal Food, Drug, and Cosmetic Act (FFDCA), even though no provisions expressly cover GE foods.51 The FFDCA simply authorizes the FDA to regulate “adulterated foods” and “food additives.”52 Pursuant to FDA regulations, GE plants are not treated any differently from conventionally modified plants.53 The FDA has determined that “[i]n most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or substantially similar to substances commonly found in food, such as proteins, fats and oils, and carbohydrates,” and therefore will be generally recognized as safe (GRAS) by experts.54 This regulatory policy is based solely on chemical similarity, with no risk assessments or safety reviews, and “no biological, toxicological, or immunological data to back up the assumption of safety.”55
Further, it is the manufacturer, not the FDA, which makes the initial determination whether a food or food additive is GRAS.56 The manufacturer does
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48. What Does FDA Regulate?, FOOD & DRUG ADMIN. (June 21, 2012), http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm.
49. See Poultry Products Inspection Act, 21 U.S.C. §§ 451–472 (2006); Federal Meat Inspection Act, 21 U.S.C. §§ 601–695 (2006); Egg Products Inspection Act, 21 U.S.C. §§ 1031– 1056 (2006).
50. PEW INITIATIVE ON FOOD & BIOTECHNOLOGY, ISSUES IN REGULATION, supra note 7, at 7.
51. See Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301–399d (2006); see also Mandel, Gaps, Inexperience, Inconsistencies, and Overlaps, supra note 15, at 2218 (noting that FFDCA does not specifically address GE foods).
52. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 342, 348. Adulterated food is defined as food that “bears or contains any poisonous or deleterious substance which may render it injurious to health.” Id. § 342(a). Food additives are defined as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.” Id. § 321(s).
53. Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22,984, 22,984–85 (May 29, 1992).
54. Id. at 22,985. 55. Rebecca Bratspies, Some Thoughts on the American Approach to Regulating Genetically Modified Organisms, 16 KAN. J.L. & PUB. POL’Y 393, 409 (2007) [hereinafter Bratspies, Some Thoughts]. 56. See Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. at 22,989.
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