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What is your position on genetically-modified foods? Construct your argument based on your personal ethical architecture? What is important to you in agreeing to support GMOs and would you use those products to feed yourself and your family? Case Studies in Ethics a t D u k e U n i v e r s i t y dukeethics.org This work is licensed under the Creative Commons Attribution - Noncommercial - No Derivative Works 3.0 Unported License. To view a copy of this license, visit http://creativecom- mons.org/licenses/by-nc-nd/3.0/. You may reproduce this work for non-commercial use if you use the entire document and attribute the source: The Kenan Institute for Ethics at Duke University. On September 19, 2010, 13 members in a special Veterinary Medicine Advisory Committee (VMAC) of the Food and Drug Administration (FDA) convened for public hearings to discuss the approval for biotechnology company AquaBounty Technologies’ AquAdvantage salmon. This particular salmon is genetically modifi ed (GM) to grow twice as fast as conventional Atlantic salmon. If authorized, the product would mark the fi rst FDA-approved GM animal for human consumption. To AquaBounty, the AquAdvantage salmon would be a profi table solution to meet increasing fi sh demand in the coming years. Critics of the GM salmon, however, pointed to the fl awed FDA approval process—the public was only given 14 days to review all documents before the public hearing, and several organizations questioned the makeup of VMAC and whether the studies provided by AquaBounty adequately addressed ecological and human health concerns. This case considers the FDA approval process for genetically modifi ed animals in light of AquaBounty Technologies’ push to bring AquAdvantage salmon to the market. Issues of effective governance, transparency, and antiquated policies highlight challenges for the FDA in regulating biotechnology enhancements. The case and teaching notes for this case were completed under the direction of Dr. Rebecca Dunning, the Kenan Institute for Ethics. Institutions in Crisis FISHY BUSINESS? AquaBounty Technologies, the FDA, and Genetically Modifi ed Foods Jessie Tang Case Studies in Ethics dukeethics.org2 Introduction In 2006, approximately 110.4 million metric tons of fi sh were consumed, with almost half of that from aquaculture, the commercial farming of fi sh. Seventy percent of salmon consumed are from farmed sources. The Food and Agricultural Organization (FAO) of the United Nations has estimated that by 2030, annual commercial production will need to increase by an additional 28.8 million metric tons in order to maintain per capita fi sh consumption at current levels.1 Biotechnology company AquaBounty Technologies’ hopes to meet this demand through the production of a genetically engineered fi sh that grows twice as fast as conventional Atlantic salmon, an advantage that would signifi cantly cut production costs for fi sh farmers while providing a potentially large source of revenue for the company.2 AquaBounty Technologies fi rst fi led for U.S. approval of its AquAdvantage salmon in 1995. In 2010, the FDA announced that there was enough information available to review the GM salmon. However, criticisms of the FDA approval process have brought up issues of transparency and accountability. The FDA released 255 pages of technical information regarding the GM salmon on Sept 5, 2010, giving the public only 14 days to review the document before the public hearings would begin September 19. The Consumer Union, the nonprofi t watchdog group and publisher of Consumer Reports, formally submitted comments noting the shortened time frame for public comments, the questionable composition of the review board, and lack of data rigor present in AquaBounty’s research.3 This case considers the FDA approval process for genetically modifi ed animals in light of AquaBounty Technologies’ push to bring AquAdvantage salmon to the market. Issues of effective governance, transparency, and antiquated policies highlight challenges for the FDA in regulating biotechnology advancements. This case also highlights how accountability frameworks within public institutions are reacting to rapid scientifi c innovations that may pose threats to human and environmental safety. “The Magician’s Wand”: AHistory of Agricultural Science and Genetics The process of modifying crops through agricultural science has been occurring for several centuries. In the late 1840s, Justus von Liebig published Organic Chemistry and Its Applications in Agriculture and Physiology. Thousands of copies of the book were sold in America, and his letters were published in newspapers around the world, making Liebig a better known international fi gure than Abraham Lincoln by the start of the Civil War in 1861.4 The publication discussed soil fertilizer and its implications for agriculture, and the fi rst application of agricultural science was coincidentally in fertilizer by James Murray in 1842. His treatment of fertilizer was further investigated by other scientists, which led to the advent of the modern nitrogen fertilizer industry, which has produced both greater yields and environmental problems.5 Concerted scientifi c research on genetics can be traceed back to the work of evolutionary biologist Charles Darwin, who in 1859 brought to light the laws of heredity and natural selection in The Origins of Species. Darwin’s research was infl uenced by William Youatt, an agriculturalist who understood the principle of selection as a tool that one could use to “not only modify the character of the fl ock, but to change it altogether.”6 In this sense, the laws of heredity were a “magician’s wand” that enabled agriculturalists to alter their stock. 1 From www.fao.org/newsroom/en/news/2008/1000930/index.html, accessed 11/10/2010. 2 From http://www.aquabounty.com/products/aquadvantage-295.aspx, accessed 10/25/2010. 3 From http://www.consumersunion.org/pub/core_food_safety/016884.html, accessed 10/25/2010 4 Fedoroff, Nina and Nancy Marie Brown. Mendel in the Kitchen. Washington, D.C.: Joseph Henry Press, 2004. Page 49. 5 Ibid. Page 50. See Modern Applications of Genetics in Food section of this case for more information 6 Fedoroff, Nina and Nancy Marie Brown. 2004. Mendel in the Kitchen. Washington, D.C.: Joseph Henry Press. Page 51. Case Studies in Ethics dukeethics.org3 It was not until Gregor Mendel, the Moravian monk, that the signifi cance of the hereditary factors, or genes, was established as he examined the breeding of two types of peas in his monastery garden. He mathematically documented the outcomes of crossbreeding round, yellow peas with wrinkled, green peas. His observations led to the development of Mendel’s laws of genetic inheritance, which was published in 1866. His work was mostly forgotten until 1886, when Dutch botanist Hugo De Vries recovered Mendel’s publication while Vries himself was developing his theories of plant heredity and mutation. Mendel’s work has been cited as the groundwork for contemporary molecular techniques for plant improvement.7 Traditional methods of crossbreeding and hybridizations as employed by Mendel involve artifi cial selection, which is the genetic improvement of cultivated plants and domesticated animals by way of direct human interference.8 Genetic modifi cation, which began in the 1990s, is an extension of artifi cial selection, whereby new genetic material is created and directly inserted in plants and animals, a method not seen in traditional methods of hybridization and cloning.9 There are various names for foods that contain genetic modifi cation, the most popular being “genetically modifi ed,” “genetically engineered,” “genetically altered,” “transgenic,” or “advance-hybrid.” The FDA defi nes genetically engineered (GE) animals as “those animals modifi ed by recombinant DNA (rDNA) techniques, including the entire lineage of animals that contain the modifi cation.”10 Modern Applications of Genetics in Food The application of Mendel’s laws of plant breeding spurred the creation of high-yielding hybrid seed varieties that resulted in the dramatic increase in crop yields from 1950 to 1984. This period is known as the “Green Revolution,” and was particularly promising in the developing world. For example, wheat and rice production increased by about 75 percent between 1965 and 1980.11 In America, the hybrid seed varieties led to a 242\% increase in production of the 17 most important domestic crops, while area only increased by 3 percent between 1940 and 1980.12 Today, applications of biotechnology in foods are abundant. According to the International Service for the Acquisition of Agri-biotech Applications, a non-profi t international organization that supports biotechnology as a means of helping farmers in developing nations, 14 million farmers in 25 countries planted 134 million hectors (i.e. 330 million acres) of biotech crops in 2009, a 80-fold increase from 1996.13 In addition to biotech crops, the genetic modifi cation of animals and fi sh is becoming a growing area of research. Transgenic cattle, sheep, pigs, chickens and other animals have been used in biomedical research, and show potential for farming. These animals have faster growth rates, lower fat levels and increased disease resistance.14 The genes transferred to the animals are generally ones that regulate the production of growth hormones, or chemicals that regulate growth, thus making the process of growing animals more economical. 7 Ibid. Page 56. 8 Nottingham, Stephen. 2003. Eat Your Genes: How Genetically Modifi ed Food is Entering Our Diet, Second Edition. New York: Zed Books. 9 Biologist Stephen Nottingham differentiates the distinction between cross breeding and genetic modifi cation as such: “[Traditional plant breed- ing] is constrained by limitations in sexual compatibility, which prevents cross-fertilization between species. This limits the potential gene pool, that is the total number of genes and their different alleles, available for crop improvements. Genetic engineering extends this potential by creat- ing new genetic material for breeders to work on. Once a foreign gene has been engineered into a variety, it can be passed into hybrids like any other gene using traditional breeding methods.” Further reading can be found in : Nottingham, Stephen. 2003. Eat Your Genes: How genetically modifi ed food is entering our diet, Second Edition. New York: Zed Books. 10 From http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf, accessed 10/20/2010. 11 Nottingham, Stephen. 2003. Eat Your Genes: How Genetically Modifi ed Food is Entering Our Diet, Second Edition. New York: Zed Books. 12 Ibid. Page 4. 13 From http://www.isaaa.org/resources/publications/briefs/41/executivesummary/default.asp, accessed 11/15/2010. 14 Nottingham. Stephen. 2003. Eat Your Genes: How Genetically Modifi ed Food is Entering Our Diet, Second Edition. New York: Zed Books. Page 9. Case Studies in Ethics dukeethics.org4 The benefi ts of biotech foods have been established on several fronts. Proponents recognize biotechnological advancements as a way to increase crop yield, create herbicide- and insect-resistant crops, and design crops that are tolerant to various conditions, including droughts and frost.15 Supporters of biotechnology see biotech crops as an innovative approach to world hunger. One example is the “Golden Rice” initiative, begun in 1984 by Dr. Peter Jennings. The goal of the venture was to alleviate Vitamin A defi ciency by inserting beta-carotene into rice.16 Others, such as philanthropist Bill Gates and the Director-General of the FAO, endorse biotech advancements as an important method to tackle the problem of resource constraints. At the 2009 World Summit on Food Security, world leaders discussed key challenges facing the world, including the increase to a world population of 9 billion inhabitants by 2050. The goal of eradicating world hunger is paired with an emphasis on international development. A declaration stemming from the World Summit on Food Security, states, We recognize that increasing agricultural productivity is the main means to meet the increasing demand for food given the constraints on expanding land and water used for food production. […] We will seek to mobilize the resources needed to increase productivity, including the review, approval, and adoption of biotechnology and other new technologies and innovations that are safe, effective, and environmentally sustainable.17 However, not all outcomes of biotech food production have been positive. Following the “Green Revolution,” the yield outputs after 1984 leveled off and declined due to the high levels of expensive agrochemicals, high water volumes for irrigation, and the increase in farm machinery. These new crops favored large farms, and poorer farmers could not benefi t from new seed varieties. It was also found that agrochemicals degraded the environment and polluted water, and an overuse of pesticides created resistance in pests.18 Critics point to issues of resource effi ciency, resource allocation, and ecological risks as downfalls of biotech advancements. There are also several notable ecological concerns with regards to GM crops. For example, genetically modifi ed crops may become weeds to agricultural or natural habitats, diverting nutrients from the crops in the soil. The new genes may also be transferred from the GM plants to the wild population, whose hybrid offspring could have an effect on the existing environmental landscape. For transgenic fi sh, there is also the potential for reproduction between GM and wild species.19 Additionally, opponents have cited GM foods as having negative impacts on human health. Biologist Dr. Stephen Nottingham notes the possibility of food allergies to GM foods and bacterial buildup in the human gut that could lead to antibiotic resistance.20 Critics also bring up the lack of labeling for genetically modifi ed foods as another cause for concern. Consumer advocates believe the public should have the right to information about their food. Currently, genetically modifi ed crops do not require labeling, and the issue of labeling has been brought up again with regards to the potential of GM animals for human consumption. Further, Carol Tucker Foreman, director of the Food Policy Institute at the Consumer Federation of America, a consumer advocacy group in Washington, D.C., feels that when it comes to animals, labeling may not appease consumers—many individuals object to the genetic engineering of animals on humane or ethical grounds more so than on concerns for human safety. 21 15 Ibid.. 16 Pringle, Peter. 2003. Food, Inc. New York: Simon & Schuster. Page 19. 17 From http://www.fao.org/fi leadmin/templates/wsfs/Summit/Docs/Final_Declaration/WSFS09_Declaration.pdf, accessed 12/4/2010. 18 Nottingham, Stephen. 2003. Eat Your Genes: How Genetically Modifi ed Food is Entering Our Diet. Second Edition. New York: Zed Books. Pages 4-5. 19 Ibid. Page 88. 20 Ibid. Page 91. 21 Pollack, Andrew. “Without U.S. Rules, Biotech Food Lacks Investors. “ The New York Times (July 30, 2007). Case Studies in Ethics dukeethics.org5 The Genetic Era and U.S. Regulations The Genetic Era dawned when the U.S. Department of Agriculture approved Petition No. 92-196-01P on October 19, 1992, which approved the commercialization of the Flavr Savr Tomato by Calgene Incorporated.22 In 1994, the Flavr Savr tomato was the fi rst genetically modifi ed product to reach U.S. supermarkets. The tomato was supposed to soften at a slower speed compared to conventional tomatoes. The Flavr Savr tomato was not a success with the public, however, given its (ironic) lack of fl avor. The fi rst profi table genetically modifi ed plant was Monsanto Company’s Roundup Ready soybean, which was approved by the Department of Agriculture on May 19, 1994. This spurred subsequent government approval for GM corn, potatoes, cotton, squash, papaya, radicchio, and tomatoes. In 1996, the fi rst GMO crops were grown commercially. These crops generally included two new gene traits. One was herbicide tolerance, mostly using the Monsanto-created Roundup formulation; the other was insect resistance, in which a bacterium, Bacillus thuringienis, would cause plants to produce a protein fatal to pests.23 The United States leads all other countries in the production of genetically modifi ed crops, planting 64.0 million hectares of GM crops. In 2009, over 75\% of the 90 million hectares of soybeans and almost 50\% of the 33 million hectares of cotton were biotech.24 An additional 32 countries granted regular approvals for biotech crops between 1996 and 2009.25 With regards to consumption, it is estimated that 70\% of processed foods sold in the USA and Canada contain approved GM ingredients. The Regulatory Framework of Genetically Engineered Foods in America Coordinated Framework for Regulation of Biotechnology Federal policy fi rst addressed biotechnology in 1986. The “Coordinated Framework for Regulation of Biotechnology” stated that no new laws were needed to regulate the products of biotechnology. This piece of policy was based upon the assumption that “upon examination of the existing laws available for the regulation of products developed by traditional genetic manipulation techniques, the working group concluded that, for the most part, these laws as currently implemented would address regulatory needs adequately.”26 Under the “Coordinated Framework,” three lead federal agencies— the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA/APHIS), the Department of Health and Human Services’ Food and Drug Administration (HHS/FDA), and the Environmental Protection Agency (EPA)—have the responsibility for implementing the nation’s biotechnology regulatory framework.27 Furthermore, the policy stated that a commercial product should be regulated based on the product’s composition and intended use, regardless of its manner of production—essentially implying that biotech food would be regulated 22 Lambrecht, Bill. 2001. Dinner at the New Gene Café: How Genetic Engineering is Changing How We Eat, How We Live, and the Global Politics of Food. New York: Thomas Dunne Books. Page 6. 23 Ibid. Page 7. 24 Nottingham, Stephen. 2003. Eat Your Genes: How Genetically Modifi ed Foods ars Entering Our Diet, Second Edition. New York: Zed Books. Page 3. 25 Ibid. Page 15. 26 From http://usbiotechreg.nbii.gov/CoordinatedFrameworkForRegulationOfBiotechnology1986.pdf, accessed 11/10/2010. 27 From http://usa.usembassy.de/etexts/tech/biotechreg.pdf, accessed 11/10/2010 Case Studies in Ethics dukeethics.org6 in the same manner as other foods produced through conventional processes.28 The result is that no single statute and or single federal agency specifi cally governs the regulation of biotechnology products.29 The FDA, CVM, and Transgenic Animal Regulation The FDA is the oldest comprehensive consumer protection agency in the U.S. federal government, and its modern regulatory framework was established under the 1906 Pure Food and Drugs Act.30 Below is the stated mission statement of the agency as provided on the FDA website: The FDA is responsible for protecting the public health by assuring the safety, effi cacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. One of the major pieces of legislation related to the regulation of the United States Food Safety system is the Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938. It was passed after a legally marketed toxic elixir killed 107 people. This incident led the FFDCA to overhaul the public health system. The law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.31 Specifi c to genetically modifi ed animals, in January 2009 the FDA issued a fi nal version of “Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs.”32 Within the FDA, the Center for Veterinary Medicine (CVM) oversees the application process and works with developers of genetically engineered (GE) animals. The agency issued the industry guidance for the following reasons: As GE animals approach commercialization, we think it is important to issue guidance to clarify our regulatory process, and to gather input from the public and the regulated industry. In addition, we think publishing the guidance is timely in light of the recent adoption of the Codex Alimentarius guideline on assessing the safety of food from GE animals.33 The 26-page document outlines new regulatory steps scientists and companies need to take in order to seek approval for GE animals, which is regulated under the “new animal drug provision” of the FFDCA (see Appendix A for reasons for approval). A drug, in section 201(g) of the FFDCA (21 U.S. 321 et seq.), is defi ned as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;” and “articles (other than 28 Pew Initiative on Food and Biotechnology. “Guide to U.S. Regulation of Genetically Modifi ed Food and Agricultural Biotechnology Prod- ucts.” The full document is available at http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/hhs_bio- tech_0901.pdf, 29 It should be noted that the lack of differentiation between process and product has signifi cant implications for the topic of food labeling. The United States does not currently have a mandate for the agribusiness industry to label GM foods. In 2001, the FDA proposed voluntary label- ing guidelines for both non-genetically modifi ed and genetically modifi ed foods (for more information, see the FDA’s “Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering.” In Europe, public pressure pushed the European Commission to establish mandatory GM food labeling in foods with higher than 0.9\% of genetically modifi ed ingredients. 30 From http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm, accessed 11/27/2010. 31 From http://www.fda.gov/RegulatoryInformation/Legislation/default.htm, accessed 11/27/2010. 32 For the complete 26-page document, visit http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidancefo- rIndustry/UCM052463.pdf. 33 From http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm113660. htm, accessed 11/27/2010. The Codex Alimentarius Commission was formed in 1963 as a joint venture between the World Health Organization and the Food and Agriculture Organization of the United Nations. The goals of the Commission are to promote fair trade practices in the food industry and promote coordination of all food standards undertaken by international governmental and non-governmental organizations. For more information, visit http://www.codexalimentarius.net/web/index_en.jsp. Case Studies in Ethics dukeethics.org7 food) intended to affect the structure or any function of the body of man or other animals.” A new animal drug is defi ned as “any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed.”34 The rDNA construct used to create a transgenic animal affects the structure or function of the body of the GE animal, and thus qualifi es as an animal drug that requires FDA approval under the new animal drug defi nition. 35 In the FDA Veterinarian Newsletter 2008, the oversight goals of the CVM were as follows: “As with any review of a new animal drug, CVM will be considering the safety of the gene construct to the animal, the safety of any food derived from the animal (if it is intended to enter the food supply), the effectiveness of the construct, and any possible threat to the environment.”36 It has been noted that FDA offi cials have said that treating a gene inserted into an animal’s DNA as a drug was “the best approach, because it was unlikely Congress would pass entirely new laws governing genetically engineered livestock.”37 AquaBounty Technologies Originally incorporated in 1991, AquaBounty Technologies is a biotechnology company focused on the commercial aquaculture industry. Executive Director, CEO, and President of AquaBounty stated the following as the company’s mission: Our mission is to play a signifi cant part in “The Blue Revolution” – bringing together biological sciences and molecular technology to enable an aquaculture industry capable of large-scale, effi cient, and environmentally sustainable production of high quality seafood. Increased growth rates, enhanced resistance to disease, better food-conversion rates, manageable breeding cycles, and more effi cient use of aquatic production systems are all important components of the sustainable aquaculture industry of the future.38 The company fi rst originated as A/F Protein, through which they sought to pursue the commercial development of antifreeze protein-based technology under license from the University of California at Berkeley.39 In 1996, they acquired a license for AquAdvantage technology from the University of Toronto and Memorial University of Newfoundland. The company then reorganized itself into two separate entities in 2000, one remaining A/F Proteins, the other named AquaBounty Farms, and in 2004 owners offi cially changed the name to AquaBounty Technology. AquAdvantage Salmon AquaBounty is working toward developing “advanced-hybrid” salmon, trout, and tilapia. The AquAdvantage salmon is the fi sh that the company is seeking FDA approval for currently. According to the company’s web site, 34 From http://www.FDA.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitle- andDefi nitions/ucm086297.htm, accessed 11/27/2010. 35 From http://www.FDA.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitle- andDefi nitions/ucm086297.htm, accessed 11/27/2010 36 http://www.FDA.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm109295.htm 37 Pollack, Andrew. “Rules Near for Animals’ Engineering.” The New York Times (September 17, 2008). 38 From http://www.prnewswire.com/news-releases/aquabountys-response-to-the-press-release-titled-coalition-demands-fda-deny-approval-of- fi rst-genetically-engineered-food-animal-101927263.html, accessed 11/27/2010. 39 From http://www.aquabounty.com/company/company-history-292.aspx, accessed 10/20/2010. Case Studies in Ethics dukeethics.org8 AquAdvantage® Salmon (AAS) reach market size twice as fast as traditional salmon. This advancement provides a compelling economic benefi t to farmers (reduced growing cycle) as well as enhancing the economic viability of inland operations, thereby diminishing the need for ocean pens. AAS are also reproductively sterile, which eliminates the threat of interbreeding amongst themselves or with native populations, a major recent concern in dealing with fi sh escaping from salmon farms.40 The AAS is an Atlantic salmon that contains a growth hormone gene from a Chinook salmon, in addition to a genetic on-switch from the ocean pout, a distant relative of the salmon.41 The genetic on-switch allows the salmon to grow year-round, rather than just during the warmer months. AAS can reach market weight in about 18 months, versus the 30 months of conventional Atlantic salmon, though the company states that the GM salmon will not end up any bigger than a conventional fi sh. In addition to the shortened growth time frame, the fi sh produced are also reproductively sterile, according to the company, which addresses certain environmental concerns about the threat of inbreeding among the genetically modifi ed and wild salmon population. The FDA and AquaBounty’s AAS AquaBounty fi rst fi led for FDA approval of its AquAdvantage salmon in 1995. According to Elliot Entis, the company’s chief executive, by 2007 the company had already given the agency studies showing that the fi sh were healthy and that implanted genes remained stable over several life cycles. Additionally, the company affi rmed that it had conducted tests revealing that the GM salmon were essentially identical to other farmed salmon, containing the same levels of fats, proteins and other nutrients, and would not set off allergic reactions.42 However, at that point, the FDA was still seeking more data from the biotech company on safety and environmental risks on the wild salmon population.43 According to news reports from June 2010, AquAdvantage Salmon seemed on a path to becoming approved by the FDA. This announcement was important, because the approval of AAS would set a precedent for other GM animals. For example, cattle resistant to mad cow disease or pigs that could supply healthier bacon may be next in line for possible approval.44 On September 3, 2010, the VMAC informed the public that it was hosting a …