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Enactment of the Food Safety Modernization Act

The US FDA within the Context of Interacting Public-Private Governance Processes

Published online by Cambridge University Press:  20 January 2017

Michaela Tarr Oldfield
Michaela Tarr Oldfield*
Affiliation:
Michigan State University's College of Law
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Abstract

The United States’ Food Safety Modernization Act (FSMA) revises the US Food and Drug Administration's regulatory authority. While expanding FDA's authority, the legislation replicates and relies on private systems of standards and third party audits, albeit with modifications. This article argues that public and private actors develop food safety regulations within multiple types of institutional venues, including private standards regimes, courts, congresses, and government regulatory agencies. It examines how interactions within each of these venues are shaped by stakeholders’ interests, and how the relevant subset of interactions within these venues ultimately shaped the FSMA. The article concludes by offering insights into what consequences these interactions and outcomes may have on the roles and capacities of affected stakeholders in food safety governance.

Type
Special Issue on the Patterns of Interplay between Public and Private Food Regulation
Information
European Journal of Risk Regulation , Volume 6 , Issue 4 , December 2015 , pp. 488 - 501
Copyright
Copyright © Cambridge University Press 2015

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References

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7 FDA Food Safety Modernization Act (FSMA), Pub. L. No. 111-353, 124 Stat. 3885 (2011), Amending the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (1938).

8 Food, Drug and Cosmetic Act, 21 U.S.C. § 303, prohibiting inter-state shipments of adulterated food.

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10 See e.g. the California and Arizona Leafy Greens Agreements, discussed in more detail infra section II.1.b. Marketing orders are public-private regulatory mechanisms developed in the 1930's to coordinate production and marketing of perishable crops.

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16 Havinga, “Conceptualizing Regulatory Arrangements”, supra note 15.

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19 Gallup polls during this time period showed little change in consumer perceptions regarding food safety. Gallup, “Nutrition and Food”, available on the Internet at: http://www.gallup.com/poll/6424/Nutrition-Food.aspx (last visited 2 Feb. 2015). However, industry and consumer group publications were widely reporting declining consumer confidence in the US food supply. See, e.g., Peter D. Hart Research Associates and Public Opinion Strategies, “Results Of A National Survey On Produce Safety”, available on the Internet at: http://www.pewtrusts.org/∼/media/legacy/uploadedfiles/phg/content_level_pages/reports/PSPRPTHartResearchSurveypdf.pdf (last visited 2 Feb. 2015), Rory Harrington, “Bill bids to strengthen ‘dangerous’ US food safety regimes”, Food Navigator USA, 29 May 2009, available on the Internet at http://www.foodnavigator-usa.com/Regulation/Bill-bids-to-strengthen-dangerous-US-food-safety-regime (last visited 2 Feb. 2015), Jenny McTaggart, “Food Safety: Safety Dance”, Progressive Grocer, 15 Oct. 2007, available on the Internet at: http://business.highbeam.com/4122/article-1G1-170296861/cover-story-food-safety-safety-dance (citing FMI research showing consumer confidence at 18 year low.)

20 The LGMA is not technically a private regulatory regime. Instead, it is a regulatory tool that was developed under state-level marketing agreement laws. Since it was industry initiated and driven, but overseen by public process, it is a quasi-public-private regulatory arrangement.

21 GFSI, “What Is GFSI”, available on the Internet at: http://www.mygfsi.com/about-us/about-gfsi/what-is-gfsi.html (last accessed on 17 October 2014).

22 John G. Surak and Kathy L. Gombas, “GFSI's Role in Harmonizing Food Safety Standards”, Food Safety Magazine, June/July 2009.

23 Wal-Mart, “Wal-Mart Becomes First Nationwide U.S. Grocer to Adopt Global Food Safety Initiative Standards,” 4 February 2008, available on the Internet at: <http://news.walmart.com/news-archive/2008/02/04/wal-mart-becomes-first-nationwide-us-grocer-to-adopt-global-food-safety-initiative-standards> (last accessed on 17 October 2014).

24 Jim Prevor, “Buyer Led Food Safety Initiative Recap”, Perishable Pundit, available on the Internet at: http://www.perishablepundit.com/index.php?hot=buyer-led (last accessed on 13 October 2014).

25 See, e.g., “United Fresh Statement on Introduction of the FDA Food Safety Modernization Act of 2009”, 9 March 2009, available on the Internet at: http://www.unitedfresh.org/food-safety/food-safety-modernization-act/ (last accessed on 17 October 2014), “Grocery Manufacturers Association And Food Marketing Institute Call For Passage Of Food Safety Bill”, 24 November 2010, available on the Internet at: http://www.gmaonline.org/news-events/newsroom/grocery-manufacturers-association-and-food-marketing-institute-call-for-pas/ (last accessed on 17 October 2014).

26 See Patricia Sabatini, “Calls Grow For Tougher Food Safety Regulations,” Pittsburgh Post-Gazette , 7 October 2009, at FOOD p. A1, (quoting CSPI attorney Sarah Klein saying “the FDA needs tough, 21st-century tools to deal with centralized, modern production…we cannot rely on the good will of the food industry.“)

27 See Timothy Lytton and Lesley Mcallister, “Oversight In Private Food Safety Auditing: Addressing Auditor Conflict Of Interest” 2014 Wisconsin Law Review (2014), pp. 290 et sqq.

28 The Peanut Corporation of America and Decoster Farms had both received “superior” ratings from AIB shortly before their products sickened hundreds. See The Outbreak of Salmonella in Eggs, Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 111th Congress (2010) (statements by Peter DeCoster, co-owner of DeCoster Farms; statement by DeGette, vice-chairman, H. Comm. on Energy and Commerce) at p. 82. See also Andrew Martin, “Peanut Plant Says Audits Declared it in Top Shape”, New York Times, 5 February 2009, at p. B10, Michael Booth and Jennifer Brown, “Producers Seldom Hear of Food Safety Issues from their Private Auditor”, The Denver Post, 30 October 2011, at p. A1.

29 Alan Judd, “Peanut Scare Exposes Flaws in Inspections; Food Safety Net: Regulation Gaps Found at Georgia Processing Plant Will Likely Come Under Scrutiny In Upcoming Congressional Hearings”, Atlanta Constitution Journal, 30 January 2009, at p. 1A.

30 See, e.g., How Do We Fix Our Ailing Food Safety System? before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 111th Congress (2009) (statement of Tom Stenzel, President and CEO, United Fresh Produce Association), Keeping America’s Families Safe: Reforming the Food Safety System, before the S. Comm. on Health, Education, Labor, and Pensions, 111th Congress (2009) (statement by Michael Roberson, Director of Corporate Quality Assurance Publix Markets Inc., on behalf of the Food Marketing Institute).

31 Anonymous interviews conducted by the author with civil society, government, and industry representatives between October 2013 and September 2014. Interview subjects were initially identified using news stories and legislative testimony from the FSMA; further interview subjects were identified through snowball sampling by asking initial subjects for other important actors to speak with.

32 See Caroline Smith-Dewaal and David W. Plunkett, “Building A Modern Food Safety System For FDA Regulated Foods”, (Center For Science In The Public Interest, 2009), “Food Protection Plan: An Integrated Strategy for Protecting the Nation's Food Supply” (Food And Drug Administration, 2007); “A Commitment to Consumers to Ensure the Safety of Imported Foods: Four Pillars of Public-Private Partnership” (Grocery Manufacturers of America).

33 See Luis A. Ribera et al., “Costs of Foodborne Illness Outbreaks for Vegetable Producers”, EHT-027 Texas A&M Agrilife Extension (December 2013).

34 See Vanessa Wong, “Rotten Tomatoes: Farmers Pay the Price for A False Food Safety Warning”, Bloomberg Business Week, 29 September 2014.

35 Jesse Mckinley, “Center Of E. Coli Outbreak Is Also Center Of Anxiety”, New York Times, 25 September 2006, at p. A14.

36 Each state technically has a separate LGMA, because they are developed under state law. However, it is common to refer to them jointly as the LGMA.

37 California Marketing Act of 1937, 21 Food & Agric. § 58601-58624 et seq., 3 Ariz. Rev. Stat. § 3-401 et seq.

38 Scott Horsfall, “California Leafy Greens Marketing Agreement Emerges as a Model Program for Food Safety”, Food Safety Magazine, August/September 2008.

39 See Stuart, “Science, Standards, and Power”, supra note 13 for an in-depth discussion of the motivations and controversies involving the LGMA. Efforts have since been underway to address some of these issues. See, e.g., Karen Lowell, Jeffrey Langholz, and Diana Stuart, “Safe and Sustainable: Co-Managing for Food Safety and Ecological Health in California's Central Coast Region” (The Nature Conservancy of California and the Georgetown University Produce Safety Project, 2010).

40 See Jim Prevor, “Is the California Marketing Agreement a Triumph or a Failure?”, Perishable Pundit, 9 February 2007.

41 See Rong-Gong Lin II, “Senator Seeks New Oversight of Greens”, Los Angeles Times, 12 October 2006, available on the Internet at: < http://articles.latimes.com/2006/oct/12/local/me-spinach12> (last accessed on 31 October 2014).

42 California Leafy Greens Products Handler Marketing Agreement, “About Us”, available on the Internet at: http://www.lgma.ca.gov/about-us/ (last accessed on 17 October 2014).

43 National Marketing Agreement Regulating Leafy Green Vegetables; Termination of Proceeding on Proposed Marketing Agreement, 78 Fed. Reg. 234 at 73111.

44 See Jim Prevor, “PMA and United Fresh Agree on Federal Food Safety Regulation”, Perishable Pundit, 24 May 2007.

45 See Bill Marler, “Once GOP Is In Kitchen, Food Safety Is Toast”, Food Safety News, 3 December 2010.

46 Food Drug and Cosmetic Act, 21 U.S.C. § 331 et seq. (2009).

47 Dan Flynn, “Reprieve from Criminal Prosecutions May Be Ended For Food Execs”, Food Safety News, 4 May 2012.

48 See David Acheson, “FDA FSMA Facility Suspension Powers – Appropriate or Abusive?”, 20 March 2014, available on the Internet at: <http://achesongroup.com/2014/03/fda-fsma-facility-suspension-powers/> (last accessed on 12 October 2014).

49 Dan Flynn, “Top Food Safety Stories Of 2011: No. 5”, Food Safety News, 27 December 2011, Dan Flynn, “Tomato Growers Lose ‘Takings’ Lawsuit against FDA”, Food Safety News, 22 September 2014.

50 Mary Clare Jalonick, “Suit Could Chill Government Efforts To Keep Food Safe”, Bloomberg Businessweek, 31 August 2011.

51 See, e.g., Hearing to Review Current Issues in Food Safety, Hearing Before the H. Committee On Agriculture, 111th Cong. (2009) (Statement of Rep. Bob Goodlatte, Member, House Comm. On Agriculture). “That incident [the PCA outbreak] was not the result of inadequate legal authority or even inadequate regulation. It was the result of intentional disregard of food safety standards by the food processor and a complete failure of the FDA to enforce its own regulations.”

52 Linda Fulponi, “Private Voluntary Standards In The Food System: The Perspective Of Major Food Retailers In OECD Countries” 31 Food Policy (2006), pp. 1 et sqq., Hatanaka, Bain and Busch, “Third-Party Certification In The Global Agrifood System”, supra note 4.

53 See Bill Marler, “Why Food Retailers Really Don't Care”, 14 June 2013, available on the Internet at: http://www.marlerblog.com/lawyer-oped/why-food-retailers-really-dont-care/#.u2z4c_ldwso (last accessed on 4 May 2014), Bill Marler, “What Do Cantaloupe and Baseball Have In Common? At Least a Baseball Won't Kill You”, Food Safety News, 17 August 2013.

54 Uruguay Round of Multilateral Trade Negotiations (1986- 1994) , Agreement on the Application of Sanitary and Phytosanitary Measures (WTO- GATT 1994), 15 April 1994, in force 01 Jan. 1995, Art. 12.3.

55 GFSI Guidance Document, 6th ed. (The Global Food Safety Initiative, 2011).

56 Lytton And Mcallister “Oversight In Private Food Safety Auditing”, supra note 21.

57 Discussed supra section II.1.

58 See Dewaal and Plunkett, “Building a Modern Food Safety System”, supra note 32, at p. 2 for a list of other outbreaks.

59 See Patricia Sullivan, “Another Pet Food Ingredient is Contaminated by Chemical”, 20 April 2007, at p. A8, Gardiner Harris and Andrew Martin, “U.S. Blocks Products with Milk from China”, New York Times, 14 November 2008, at p. A18.

60 See, e.g., Peter D. Hart Research Associates and Public Opinion Strategies, “Results Of A National Survey On Produce Safety”, Rory Harrington, “Bill bids to strengthen ‘dangerous’ US food safety regimes”, Jenny McTaggart, “Food Safety: Safety Dance” supra note 19.

61 See Smith-DeWaal and Plunkett, “Building a Modern Food Safety System”, “Food Protection Plan”, “A Commitment to Consumers to Ensure the Safety of Imported Foods “ supra note 32. The FDA specifically created the position of Association Commissioner of Food Protection and appointed David Acheson to conduct an internal assessment what resources and authorities FDA would need to more effectively govern food safety. FDA News Release, “FDA Commissioner Announces New Food Safety Protection Position,” 1 May 2007, available on the internet at: http://www.fda.gov/newsevents/newsroom/pressannouncements/2007/ucm108903.htm (last accessed on 07 January 2015).

62 See, e.g., Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply?”, Hearing before H. Comm. on Energy and Commerce, 111th Congress (2010).

63 According to one interview, “GMA also brought on a lobbyist who had good relations with the consumer groups, and that was Scott Faber. Scott's very effective lobbyist, very good, very knowledgeable, and strong personality with good relations on the hill, but at the same time he had a very good reputation with our groups because he came out of the environmental working group.”

64 See Bill Marler, “FSMA: The End of My 20-Year Law Practice? Let's Hope So!”, 19 March 2014, available on the Internet at: http://www.marlerblog.com/case-news/fsma-the-end-of-my-20-year-law-practice-lets-hope-so/#.u1a7r_ldwgc (last accessed on 17 April 2014).

65 See Marler, “Once GOP is in Kitchen”, supra note 38.

66 Helena Bottemiller, “Food and Ag Groups Rally Against Tester Amendment”, Food Safety News, 16 November 2010.

67 Bill Marler, “FSMA: The End of My 20-Year Law Practice? Let’s Hope So!”, supra note 64.

68 Food and Drug Administration, “Background on the Food Safety Modernization Act (FSMA)”, available on the Internet at: http://www.fda.gov/food/guidanceregulation/fsma/ucm239907.htm (last accessed on 12 October 2014). For a more in depth discussion of the key provisions, and discretion left to FDA for fleshing out the rules, see Kristin Eads and Jennifer Zwagerman, “In Focus: Examining The New FDA Food Safety Modernization Act” 33 Hamline Journal of Public Law and Policy (2011) , pp. 123 et sqq.; Debra Strauss, “An Analysis Of The FDA Food Safety Modernization Act: Protection For Consumers And Boon For Business” 66 Food And Drug Law Journal (2011), pp. 353 et. sqq.

69 FSMA, supra note 7, § 103 (to be codified at 21 U.S.C. § 350(G)).

70 FSMA, supra note 7, § 103(N)(5).

71 FSMA, supra note 7, § 105 (to be codified at 21 U.S.C. § 350(H)).

72 See FDA, “FDA Issues Draft Guidances for Tomatoes, Leafy Greens and Melons”, available on the Internet at: <http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm174639.htm> (last accessed on 12 October 2014).

73 See National Sustainable Agriculture Coalition, “Food Safety Action Alert”, 10 November 2010, available on the Internet at: <http://sustainableagriculture.net/blog/food-safety-action-alert-2/> (last accessed on 12 October 2014), National Sustainable Agriculture Coalition, “Senate Passes Food Safety Modernization Act”, 30 November 2010, available on the Internet at: <http://sustainableagriculture.net/blog/senate-passes-food-safety-bill/> (last accessed on 12 October 2014).

74 See Kelly Damewood, “FSMA's Small Farm Exemption Has Its Limits”, Food Safety News, 17 December 2013.

75 See Food and Drug Administration, “FDA Answers Farmers' Questions: Answers to Questions about the Original FSMA Produce Safety Proposed Rule from Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine”, available on the Internet at: <http://www.fda.gov/food/guidanceregulation/fsma/ucm358090.htm> (last accessed on 17 October 2014).

76 See “FDA Oversight Of State Food Inspection Programs: A Call For Greater Accountability”, OEI-01-98-00400 (Department of Health and Human Services, Office of Inspector General, June 2000), “Vulnerabilities In FDA's Oversight Of State Food Facility Inspections”, OEI-02-09-00430, (Department of Health and Human Services, Office of Inspector General, December 2011), Dewaal and Plunkett, “Building A Modern Food Safety” supra note 32.

77 FSMA, supra note 7, § 101 (To Be Codified at 21 U.S.C. 350c(A))).

78 FSMA, supra note 7, § 206 (To Be Codified At 21 U.S.C. 341 Et Seq.).

79 FSMA, supra note 7, § 102(B) (To Be Codified at 21 U.S.C. 350d(A))).

80 See Ted Agres, “‘Doing the Right Thing’ to Ensure Food Safety: Incorporate Food Safety into all Aspects of Your Business or Risk Becoming a Target of FDA's New Enforcement Powers”, Food Quality and Safety Magazine, June/July 2014. See also Acheson, “FDA FSMA Facility Suspension Power”, supra note 41.

81 See Jessica Dye, “Experts Predict More Criminal Scrutiny for Food Safety in 2014”, Reuters Legal, 26 December 2013.

82 FSMA, supra note 7, § 301 et sqq.

83 FSMA, supra note 7, § 303

84 FSMA, supra note 7, § 307

85 See Helena Bottemiller, “Senate Holds Hearing on Food Safety Reform”, Food Safety News, 23 October 2009, stating “many experts expect that the house's fee provision will survive conference if the senate does not add a fee provision to help fund the bill, but it is an issue that will be watched very closely.”

86 Helena Bottemiller, “Historic Food Safety Bill Signed Into Law”, Food Safety News, 5 January 2011.

87 See, e.g., Marian Garcia Martinez et al., “Co-regulation as a possible model for food safety governance: Opportunities for public–private partnerships,” 32 Food Policy (2007), 299 et sqq., Paul Verbruggen and Tetty Havinga, “Food Safety Meta-controls in the Netherlands”, in this Special Issue.

88 For example, forestry has seen the emergence of private standard that are increasingly mandatory due to public adoption of the standards. Errol Meidinger, “The Administrative Law of Global Private-Public Regulation: the Case of Forestry,” 17 European Journal of International Law (2006) 47 et sqq.

89 Sorensen, Eva and Torfing, Jacob, “Making governance networks effective and democratic through metagovernance,” 87 Public Administration (2009) 234 et sqq CrossRefGoogle Scholar.

90 See OIG oversight reports, supra note 75.

91 Government Accountability Office, Federal Food Safety Oversight: Additional Actions needed to improve planning and collaboration, GAO-15-180, Dec. 2014.

92 http://www.foodquality.com/details/article/6166181/Staffing_Reductions_Curtail_Prevention_Investigation_of_Foodborne_Illness_Outbre.html

93 21 C.F.R. § 120.1 (2014)

94 21 C.F.R. § 123.6 (2014)

95 See e.g. Examining the Implementation of the Food Safety Modernization Act, before the H. Comm. on Energy and Commerce, Subcomm. on Health, 113th Congress (February 5, 2014).

96 Tacy Katherine Hass, “New Governance: Can User-Promulgated Certification Schemes Provides Safer, Higher Quality Food?”, 68 Food and Drug Law Journal (2013) 77 et sqq.; Jason Solomon, “New governance, preemptive self-regulation, and the blurring of boundaries in regulatory theory and practice,” Wisconsin Law Review (2010) 591 et sqq.; Lesley K. McAllister, “Harnessing Private Regulation,” U-C Davis Legal Studies Research Paper (2013).

97 For instance, the agency must conduct rulemaking through the traditional “ossified” notice and comment process, rather a more flexible process such as negotiated rulemaking whereby the agency convenes the stakeholder groups to negotiate a set of rules. Jody Freeman, “Collaborative governance in the administrative state,” 45 UCLA Law Revew (1997) 1 et sqq..

98 See, e.g., Sorensen and Torfing, supra note 89; Erik-Hans Klijn, Bram Steijn & Jurian Edelenbos, “The impact of network management on outcomes in governance networks”, 88 Public Administration (2010) for discussions of how network managers might be evaluated.

99 Lars H. Gulbrandsen, “Dynamic governance interactions: Evolutionary effects of state responses to non-state certification programs,” 8 Regulation & Governance (2014) 74 et sqq.

100 The importance of education for successful implementation of self-regulatory programs is key. Martinez et al., supra note 87 at 308.

101 See Discussion, Supra Section II.1. See also Jim Prevor, “Buyer Led Food Safety Initiative Recap”, supra note 18, Jim Prevor, “The Cantaloupe Crisis: The Truth That Dare Not Speak Its Name: The Priority can be Safe or the Priority can be Local, but it cannot be Both”, Perishable Pundit, available on the Internet at: <http://www.perishablepundit.com/index.php?date=10/04/2011&pundit=1> (last accessed on 13 October 2014).

102 Scholars have questioned this independence. See Maki Hatanaka And Lawrence Busch, “Third-Party Certification In The Global Agrifood System: An Objective Or Socially Mediated Governance Mechanism?” 48 Sociologia Ruralis (2008) , pp. 73 et sqq.

103 Lawrence Busch & Carmen Bain, “New! Improved? The Transformation of the Global Agrifood System,” 69 Rural Sociology (2004) 321 et sqq.

104 See, e.g., Gottlieb, Robert, Forcing the spring: The transformation of the American environmental movement (Island Press: Washington DC, 2005)Google Scholar for a discussion of the diverse roots and conflicts that have played out in the environmental movement in the United States.

105 Kingdon, Agendas, Alternatives and Public Policies, supra note 13.