Hostname: page-component-848d4c4894-nr4z6 Total loading time: 0 Render date: 2024-05-19T18:14:28.124Z Has data issue: false hasContentIssue false

If FDA Does Not Regulate Food, Who Will? A Study of Hormones and Antibiotics in Meat Production

Published online by Cambridge University Press:  06 January 2021

Christine Donovan*
Affiliation:
Boston University School of Law, State University of New York at Geneseo
*

Abstract

Approximately 128,000 Americans are hospitalized and 3000 die each year from foodborne illness. A ten-year study of 4589 foodborne outbreaks attributed 46% of these hospitalizations and 43% of the deaths to meat. The Food and Drug Administration (FDA), the primary federal agency tasked with regulating food, is aware of these statistics, and characterizes them as “largely preventable.” It is becoming clear that modern meat production methods allow pathogens to spread with ease, creating great food safety risks. Startling numbers of people continue to get sick each year from food, even though regulators believe the harms are preventable, and know the source of many of the risks. This Note explores why the United States under-regulates its food as compared to other nations, and suggests improvements to the domestic regulatory structure that would facilitate better regulation.

Type
Notes
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2015

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 These illnesses and deaths are conservatively estimated to cost the United States $14.1 billion per year. U.S. Gov't Accountability Office, GAO-15-180, Federal Food Safety Oversight: Additional Actions Needed to Improve Planning and Collaboration 1 (2014), available at http://www.gao.gov/assets/670/667656.pdf; Preventive Standards, U.S. Food & Drug Admin., http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm256826.htm (last updated Sept. 19, 2014).

2 These percentages do not include illnesses and deaths caused by seafood. See Painter, John A. et al., Attribution of Foodborne Illnesses, Hospitalizations, and Deaths to Food Commodities by Using Outbreak Data, United States, 1998-2008, 19 Emerging Infectious Diseases 407, 407-09, 412 (2013)CrossRefGoogle ScholarPubMed, available at http://wwwnc.cdc.gov/eid/article/19/3/11-1866_article.

3 Preventive Standards, supra note 1.

4 Marion Nestle, Safe Food: The Politics of Food Safety 42-43 (2010).

5 What We Do, U.S. Food & Drug Admin., http://www.fda.gov/AboutFDA/WhatWeDo/ (last updated Aug. 5, 2014).

6 About the Center for Veterinary Medicine (CVM), U.S. Food & Drug Admin., http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/default.htm (last updated Mar. 27, 2015).

7 Id.

8 Mission Statement, U.S. Department Agric., http://www.usda.gov/wps/portal/usda/usdahome?navid=MISSION_STATEMENT (Apr. 15, 2014).

9 Nestle, supra note 4, at 63.

10 Id.

11 Our Mission and What We Do, U.S. Envtl. Protection Agency, http://www2.epa.gov/aboutepa/our-mission-and-what-we-do (last updated Oct. 6, 2014).

12 For example, in regulating pesticides, EPA decides whether to approve a pesticide and determines its maximum permissible level in food. U.S. Food & Drug Admin., Pesticide Monitoring Program: 2011 Pesticide Report 5 (n.d.), available at http://www.fda.gov/downloads/Food/FoodborneIllnessContaminants/Pesticides/UCM382443.pdf. USDA is tasked with enforcing these maximum tolerance levels in “meat, poultry, and certain egg products,” while FDA enforces the levels in all other foods. Id.

14 Nestle, supra note 4, at 28.

15 See, e.g., id. at 45.

16 Id.

17 Id. at 30.

18 Id. at 58 (“[O]nly five flocks … have been identified in Sweden, for example, since 1987.”).

19 Id. at 44.

20 See id.

21 “Proponents of the drug use the scientific term bovine somatotropin (bST), whereas critics tend to use the more recognizable bovine growth hormone (BGH). Both put an r in front to distinguish the genetically engineered drug from the natural hormone in cows.” Id. at 197. Simply for consistency, I will refer to the growth hormone as rBST throughout this paper.

22 Suzanne J. Sechen et al., Bovine Somatotropin (bST) – Possible Increased Use of Antibiotics to Treat Mastitis in Cows 1 (2013), available at http://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/UCM383073.pdf.

23 See, e.g., European Comm'n, Review of Specific Documents Relating to the SCVPH Opinion of 30 April 99 on the Potential Risks to Human Health from Hormone Residues in Bovine Meat and Meat Products (2000), available at http://ec.europa.eu/food/fs/sc/scv/out33_en.pdf (expressing the Commission's concern that exposure to certain hormones could increase the risk of cancer); rBGH: What the Research Shows, Food & Water Watch (Sept. 10, 2007), http://www.foodandwaterwatch.org/factsheet/what-research-shows/ (collecting studies); Recombinant Bovine Growth Hormone, Am. Cancer Soc'y (Sept. 10, 2014), http://www.cancer.org/cancer/cancercauses/othercarcinogens/athome/recombinant-bovine-growth-hormone (identifying various review committees that have researched these possible health effects).

24 Renée Johnson, Cong. Research Serv., R40449, The U.S.-EU Beef Hormone Dispute 2 (2015), available at http://fas.org/sgp/crs/row/R40449.pdf.

25 See Sechen et al., supra note 22, at 3-4.

26 Id. at 3.

27 Id.

28 Id. at 4. The rate decreased to 17.2% in 2007. Id.

29 Id.

30 Id.

31 Id. at 5.

32 Mastitis in Dairy Cows, DairyCo, http://www.dairyco.org.uk/technical-information/animal-health-welfare/mastitis/#.VEq1WYvF9jB (last visited Apr. 8, 2015).

33 Sechen et al., supra note 22, at 4.

34 Id. at 4-5.

35 Id. at 5.

36 For instance, there is some concern that drinking milk from cows treated with rBST may cause various cancers, and studies have reached conflicting conclusions on the topic. Sources cited supra note 23.

37 See Sechen et al., supra note 22, at 5.

38 Id.

39 U.S. Food & Drug Admin., Phasing out Certain Antibiotic Use in Farm Animals 1 (2013), available at http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM378197.pdf.

40 See, e.g., Antibiotic Resistance Questions & Answers, Centers for Disease Control & Prevention, http://www.cdc.gov/getsmart/antibiotic-use/antibiotic-resistance-faqs.html (last updated Dec. 18, 2013) (explaining antibiotic resistance); Antimicrobial resistance, World Health Org., http://www.who.int/mediacentre/factsheets/fs194/en/ (last updated Apr. 2014) (same).

41 U.S. Food & Drug Admin., supra note 39, at 1.

42 Press Release, European Food Safety Auth., Antimicrobial Resistance Remains Commonly Detected in Bacteria in Humans, Animals and Food: ESFA –ECDC Report (Mar. 25, 2014) (on file with author), available at http://www.efsa.europa.eu/en/press/news/140325.htm.

43 Id.

44 Nestle, supra note 4, at 47.

45 Id. at 46.

46 Eliza Barclay, In Meat Tests, More Data Tying Human Illness to Farm Antibiotics, NPR (Apr. 17, 2013), http://www.npr.org/blogs/thesalt/2013/04/17/177601237/in-meat-tests-more-evidence-of-human-illness-tied-to-farm-antibiotics.

47 Envtl. Working Grp., Superbugs Invade American Supermarkets 3 (2013), available at http://www.ewg.org/meateatersguide/superbugs/.

48 Ctrs. for Disease Control & Prevention, U.S. Dep't of Health & Human Servs., Antibiotic Resistance Threats in the United States, 2013, at 6 (2013), available at http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf#page=13.

49 Id. at 31.

50 David Kesmodel at al., Meat Companies Go Antibiotics-Free as More Consumers Demand It, Wall St. J. (Nov. 3, 2014), http://online.wsj.com/articles/meat-companies-go-antibiotics-free-as-more-consumers-demand-it-1415071802.

51 Maria Godoy, Americans Want Antibiotic-Free Chicken, And The Industry Is Listening, NPR (Feb. 19, 2014), http://www.npr.org/blogs/thesalt/2014/02/14/276976353/americans-want-antibiotic-free-chicken-and-the-industry-is-listening.

52 See id.

53 Nestle, supra note 4, at 198-99.

54 See Sechen et al., supra note 22, at 1-2.

55 Richard Raymond et al., Recombinant Bovine Somatotropin (rBST): A Safety Assessment 8 (2010), available at http://www.naiaonline.org/uploads/WhitePapers/RecombinantSomatotropinASafetyAssessment2010.pdf.

56 Sechen et al., supra note 22, at 1 (citing U.S. Food and Drug Administration, Freedom of Information Summary: Polisac (1993), available at http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm050022.pdf); see also Report on the Food and Drug Administration's Review of the Safety of Recombinant Bovine Somatotropin, U.S. Food & Drug Admin., http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm130321.htm (last updated July 28, 2014) [hereinafter FDA's Somatotropin Review].

57 Sechen et al., supra note 22, at 1.

58 Id. at 5.

59 Animal & Plant Health Inspection Serv., U.S. Dep't of Agric., Determining U.S. Milk Quality Using Bulk-tank Somatic Cell Counts, 2011, at 1 (2012), available at http://www.aphis.usda.gov/animal_health/nahms/dairy/downloads/dairy_monitoring/BTSCC_2011infosheet.pdf. Producing milk with a shorter shelf life seems to undercut the value of using hormones to increase milk production. As discussed below however, FDA regulations allow for relatively high somatic cell counts in milk, which may help explain how milk remains profitable. See infra Part IV.

60 See id.

61 Pamela L. Ruegg, Antimicrobial Residues and Resistance: Understanding and Managing Drug Usage on Dairy Farms, U. of Wis., http://milkquality.wisc.edu/wp-content/uploads/2011/09/Antimicrobial-Residues-and-Resistance-2013.pdf (last visited Apr. 8, 2015).

62 Animal & Plant Health Inspection Serv., supra note 59, at 1. Federal Milk Market Order Areas each represent a region of the country; the remaining six do not provide this milk quality information. Id.

63 Id. at 3.

64 Id. at 4.

65 Andrea S. Wiley, Milk Intake and Total Dairy Consumption: Associations with Early Menarche in NHANES 1999-2004, PLoS One (Feb. 14, 2011), http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0014685.

66 Id.

67 FDA's Somatotropin Review, supra note 56.

68 Nestle, supra note 4, at 199-200; Wiley, supra note 67.

69 Nestle, supra note 4, at 199-200.

70 Wiley, supra note 65.

71 Raymond et al., supra note 55, at 3-4.

72 Dohoo, I.R. et al., A Meta-Analysis Review of the Effects of Recombinant Bovine Somatotropin, 67 Canadian J. Veterinary Res. 252, 257 (2003)Google ScholarPubMed, available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC280709/pdf/20031000s00002p252.pdf.

73 Id. at 261.

74 European Comm'n, supra note 23, at 3.

75 Id.

76 U.S. Food & Drug Admin., Guidance for Industry: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals 3 (2012), available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf.

77 Id. at 5.

78 Id. at 6.

79 Id. at 15-17.

80 European Food Safety Auth. et al., The European Union Summary Report on Antimicrobial Resistance in Zoonotic and Indicator Bacteria from Humans, Animals and Food in 2011 (2013), available at http://www.efsa.europa.eu/en/efsajournal/doc/3196.pdf.

81 Antibiotic Debate Overview, PBS Frontline, http://www.pbs.org/wgbh/pages/frontline/shows/meat/safe/overview.html (last visited May 7, 2015).

82 Nestle, supra note 4, at 30.

83 What does FDA regulate?, U.S. Food & Drug Admin., http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm (last updated Apr. 6, 2015); Food Safety, U.S. Department of Agric., http://www.usda.gov/wps/portal/usda/usdahome?navid=food-safety (last updated Mar. 27, 2015).

84 Nestle, supra note 4, 55-57. In an area that regularly causes human illness, “FDA is generally responsible for ensuring that eggs in their shells—referred to as shell eggs … are safe, wholesome, and properly labeled. [USDA], on the other hand, is responsible for the safety of eggs processed into egg products. In addition, USDA's Agricultural Marketing Service sets quality and grade standards for shell eggs, such as Grade A, but does not test the eggs for bacteria such as Salmonella. Further, while USDA's Animal and Plant Health Inspection Service manages the program that helps ensure laying hens are free from Salmonella at birth, FDA oversees the safety of the feed they eat.” GAO-15-180, Federal Food Safety Oversight: Additional Actions Needed to Improve Planning and Collaboration 2 (2014).

85 FSIS History, U.S. Department of Agric., http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/history/history (last updated Mar. 24, 2015); The Story of the Laws Behind the Labels, U.S. Food & Drug Admin., http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm (last updated Mar. 11, 2014); Background, U.S. Food & Drug Admin., http://www.fda.gov/AboutFDA/WhatWeDo/History/ResearchTools/Background/default.htm (last updated Feb. 27, 2009).

86 FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011); see also Preventive Standards, supra note 1.

87 About the Center for Veterinary Medicine (CVM), supra note 6.

88 Id.

89 Dohoo et al., supra note 72, at 260-61.

90 Id. at 263.

91 Nestle, supra note 4, at 27.

92 Id. at 200-01.

94 Sechen et al., supra note 22, at 5.

95 Animal & Plant Health Inspection Serv., supra note 62, at 1.

96 Id.

97 Id.

98 Id. Grade A milk is milk that can be sold for direct consumption, as opposed to milk that is sold to be further manufactured, for butter, cheese, or other products. Ralph M. Chite, Cong. Research Serv. 91-589, Milk Standards: Grade A vs. Grade B 1 (1991), available at http://dairy.wisc.edu/PubPod/Reference/Library/Chite.8.1991.pdf.

99 See Animal & Plant Health Inspection Serv., supra note 62, at 1.

100 Get Smart About Antibiotics Week, Centers for Disease Control & Prevention, http://www.cdc.gov/getsmart/week/overview.html (last updated Oct. 21, 2014).

101 See Press Release, The White House, Executive Order -- Combating Antibiotic-Resistant Bacteria § 3(a) (Sept. 18, 2014) (on file with author), available at http://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria.

102 Id. at § 3(c).

103 Id. at § 8.

104 Id. at § 5(f).

106 Id.

107 Sechen et al., supra note 22, at 5.

108 See Food & Drug Admin., Grade “A” Pasteurized Milk Ordinance, at iii (2009); Ralph M. Chite, Cong. Research Serv. 91-589, Milk Standards: Grade A vs. Grade B 1 (1991), available at http://dairy.wisc.edu/PubPod/Reference/Library/Chite.8.1991.pdf.

109 Sechen et al., supra note 22, at 5.

110 U.S. Department of Agric., Bulk Tank Milk Somatic Cell Counts and Your Milk Quality Assurance Program 1 (1994), available at http://www.aphis.usda.gov/animal_health/nahms/dairy/downloads/dairy_monitoring/dryscc.pdf.

111 Sechen et al., supra note 22, at 8.

112 U.S. Food & Drug Admin., supra note 76, at 1-2.

113 Id. at 2.

114 Id.

115 Press Release, U.S. Food & Drug Admin., FDA Receives Strong Industry Commitment for its Antibiotic Resistance Strategy (Mar. 26, 2014) (on file with author), available at http://www.fda.gov/animalveterinary/newsevents/cvmupdates/ucm390736.htm.

116 Ben Elgin & Andrew Martin, Animal Antibiotics: FDA Rules Criticized as Weak as McDonald's, Bloomberg Bus. (Jan. 2, 2014), http://www.bloomberg.com/bw/articles/2014-01-02/animal-antibiotics-fda-rules-criticized-as-weak-as-mcdonalds.

117 Id.

118 Natural Res. Def. Council, Playing Chicken with Antibiotics: Previously Undisclosed FDA Documents Show Antibiotic Feed Additives Don't Meet the Agency's Own Safety Standards 6 (2014), available at http://www.nrdc.org/food/saving-antibiotics/files/antibiotic-feed-fda-documents-IB.pdf.

119 See id.

120 About EFSA, Eur. Food Safety Authority, http://www.efsa.europa.eu/en/aboutefsa.htm (last visited May 7, 2015).

121 Id.

122 See id.

123 Risk Assessment, Eur. Food Safety Auth., http://www.efsa.europa.eu/en/efsawhat/riskassessment.htm (last visited May 7, 2015).

124 Nestle, supra note 4, at 113.

125 Hormones in Meat – Introduction, Eur. Commission, http://ec.europa.eu/food/food/chemicalsafety/contaminants/hormones/index_en.htm (last updated Dec. 4, 2007).

126 Id.

127 Id.

128 Renée Johnson, Cong. Research Serv., R40449, The U.S.-EU Beef Hormone Dispute 3 (2015), available at http://fas.org/sgp/crs/row/R40449.pdf.

129 Id. at 4-5.

130 Hormones in Meat – International Aspects, Eur. Commission, http://ec.europa.eu/food/food/chemicalsafety/contaminants/hormones/aspects_en.htm (last visited Apr. 8, 2015). The Agreement on the Application of Sanitary and Phytosanitary Measures is an international treaty of the WTO, under which member-states are given policy guidance relating to food, animal, and plant safety. Sanitary and Phytosanitary Meaures: Text of the Agreement, World Trade Org., https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm.

131 Renée Johnson, Cong. Research Serv., R40449, The U.S.-EU Beef Hormone Dispute 4 (2015), available at http://fas.org/sgp/crs/row/R40449.pdf.

132 Id. Interestingly, under this international agreement, it appears that the European Union could successfully base its ban on the protection of animals, given the wealth of evidence that hormones harm farm animals; further, because use of hormones requires greater antibiotic administration, the European Union could likely successfully oppose the use of hormones for that reason, as it has taken a strong position against the use of antibiotics in raising animals.

133 Id.

134 Id. at 2, 4-5, 8.

135 Id. at 8-9.

136 Id. (quoting Michael K. Hoffman, U.S. Dep't of Agric. Foreign Agric. Serv., European Union Trade Policy Monitoring: EU Presentation on Hormone Ban Directive (2003), available at http://apps.fas.usda.gov/gainfiles/200311/145986807.pdf).

137 Renée Johnson, Cong. Research Serv., R40449, The U.S.-EU Beef Hormone Dispute 6-7 (2015), http://fas.org/sgp/crs/row/R40449.pdf.

138 Id. at 15.

139 Id. at summary, 14-15.

140 Id. at 18.

141 Id. at 19.

142 Id.

143 See Press Release, U.S. Department of Agric., U.S. Trade Representative Froman, Secretary of Agriculture Vilsack Announce Continued EU Market Access for American Producers of High-Quality Beef (Aug. 1, 2013) (on file with author), available at http://www.usda.gov/wps/portal/usda/usdahome?contentid=2013/08/0152.xml&contentidonly=true.

144 Antimicrobial Resistance, Eur. Food Safety Authority, http://www.efsa.europa.eu/en/topics/topic/amr.htm (last updated Feb. 27, 2015).

145 Id.

146 European Meds. Agency, CVMP Strategy on Antimicrobials 2011-2015, at 9 (2011), available at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109137.pdf.

147 Antimicrobial Resistance, supra note 145.

148 See generally Eur. Food Safety Auth., Foodborne Antimicrobial Resistance as a Biological Hazard (2008), available at http://www.efsa.europa.eu/en/efsajournal/doc/765.pdf. (recommending different methods for prevention of the spread of antibiotic resistance bacteria).

149 Id.

150 About TATFAR, Centers for Disease Control & Prevention, http://www.cdc.gov/drugresistance/tatfar/about.html (last updated Apr. 7, 2015).

151 Nils Daulaire & John F. Ryan, Transatlantic Taskforce on Antimicrobial Resistance: Progress Report 2, 31 (2014), available at http://www.cdc.gov/drugresistance/pdf/TATFAR-Progress_report_2014.pdf.

152 Id. at 15.

153 Id. at 17.

154 Cross, Frank B., Paradoxical Perils of the Precautionary Principle, 53 Wash. & Lee L. Rev. 851, 851 (1996)Google Scholar.

155 Trade Topics: The “Precautionary Principle”, World Trade Org., http://www.wto.org/english/tratop_e/sps_e/sps_agreement_cbt_e/c8s2p1_e.htm (last visited May 7, 2015).

156 Nestle, supra note 4, at 23.

158 See Neonicotinoid pesticides are a huge risk – so ban is welcome, says EEA, Eur. Env't Agency (May 2, 2013), http://www.eea.europa.eu/highlights/neonicotinoid-pesticides-are-a-huge (last visited Oct. 24, 2014). Interestingly, the European Environment Agency stated that “scientific evidence ha[d] been systematically suppressed for many years and early warning [sic] were ignored.” Id.

159 See id.

160 About EFSA, supra note 120.

161 Id.

162 See Nestle, supra note 4, at 28-29.

163 For example, chicken producer Tyson had $856 million of net income for 2014. Annual Income Statement, Tyson, http://apps.indigotools.com/IR/IAC/?Ticker=TSN&Exchange=NYSE# (last updated Feb. 2, 2015).

164 See Nestle, supra note 4, at 62.

165 Id. at 65.

166 Id. at 60.

167 Id. at 64.

168 Committee Membership, U.S. Senate Committee on Agric. Nutrition & Forestry, http://www.ag.senate.gov/about (last visited May 7, 2015); FAQs, U.S. Department of Agric., http://www.ers.usda.gov/faqs.aspx#10 (last updated Feb. 10, 2015).

169 Committee Members, House Committee on Agric., https://agriculture.house.gov/about/membership (last visited May 7, 2015); FAQs, supra note 168.

170 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, U.S. House of Representatives Committee on Appropriations, http://appropriations.house.gov/subcommittees/subcommittee/?IssueID=43419 (last visited May 7, 2015).

171 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, U.S. Senate Committee on Appropriations, http://www.appropriations.senate.gov/subcommittee/agriculture-rural-development-food-and-drug-administration-and-related-agencies (last visited May 7, 2015).

172 Nestle, supra note 4, at 46; see also Marian Burros, F.D.A. Proposal on Meat Safety Draws Criticism, N.Y. Times (June 8, 1983), http://www.nytimes.com/1983/06/08/garden/fda-proposal-on-meat-safety-draws-criticism.html.

173 Nestle, supra note 4, at 201.

174 Id. at 202.

175 U.S. Gov't Accountability Office, GAO-15-180, Federal Food Safety Oversight: Additional Actions Needed to Improve Planning and Collaboration 1 (2014), available at http://www.gao.gov/assets/670/667656.pdf

176 Id. at 2. FSIS responded to this report, writing that food safety should no longer be listed as high risk. It argues that the food safety structure need not be altered, that food safety is currently being handled properly, and that listing food safety as high risk misleads consumers and trade partners. Id. at 39-40.

177 Id. at 30.

178 Id. at 8-13.

179 Id. at 18-19.

180 Id. at 23.

181 See, e.g., Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 844 (1984).

182 Stauber v. Shalala, 895 F. Supp. 1178 (W.D. Wis. 1995).

183 Id. at 1182.

184 Id. at 1191-92. Unrelated to this point, but discussing the problem of transparency in food regulation, the court states that “in the future it would be helpful to reviewing courts for the FDA to set out the factors it looks at in determining whether a particular risk is a manageable one.” Id. at 1192.

185 When and why was FDA formed?, U.S. Food & Drug Admin., http://www.fda.gov/AboutFDA/Transparency/Basics/ucm214403.htm (last updated Apr. 30, 2015).

186 Lydia Zuraw, Lawmakers Introduce Bills to Create Single Food Safety Agency, Food Safety News (Jan. 28, 2015), http://www.foodsafetynews.com/2015/01/lawmakers-introduce-legislation-to-create-single-food-safety-agency/#.VM-cbWTF9at.

187 Id.

188 Id.

189 Dick Durbin & Rosa L. DeLauro, Food safety is a matter of national security, Hill (Jan. 20, 2015), http://thehill.com/opinion/op-ed/229987-food-safety-is-a-matter-of-national-security.

190 Id.

191 Id.

192 Id.

193 Safe Food Act of 2015, S. 287, 114th Cong. §§ 402-404 (2015).

194 Id. §§ 205, 208, 210, 303.

195 Office of Mgmt. & Budget, Exec. Office of the President, Fiscal Year 2016 Budget of the U.S. Government 82 (2015), available at http://www.whitehouse.gov/sites/default/files/omb/budget/fy2016/assets/budget.pdf.

196 Id. at 82.

197 Id.

198 See S. 287, § 101.

199 U.S. Gov't Accountability Office, GAO-15-180, Federal Food Safety Oversight: Additional Actions Needed to Improve Planning and Collaboration 1 (2014), available at http://www.gao.gov/assets/670/667656.pdf.

200 Id. (“FDA and [USDA] officials told us that the [Food Safety Working Group] is no longer meeting because, they believe, it served its purpose of improving interagency coordination.”).

201 Office of Mgmt. & Budget, supra note 195, at 82.