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Whole Foods: The FSMA and the Challenges of Defragmenting Food Safety Regulation

Published online by Cambridge University Press:  06 January 2021

Stephanie Tai
Stephanie Tai*
Affiliation:
University of Wisconsin Law School
*
Email: tai2@wisc.edu
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Abstract

With respect to addressing food safety—and food system issues in a more general sense—coordination in regulatory approaches can be critical. As a recent Washington Post article stated,

Diet-related chronic disease, food safety, marketing to children, labor conditions, wages for farm and food-chain workers, immigration, water and air quality, greenhouse gas emissions, and support for farmers: These issues are all connected to the food system. Yet they are overseen by eight federal agencies. Amid this incoherence, special interests thrive and the public good suffers.

Type
Articles
Information
American Journal of Law & Medicine , Volume 41 , Issue 2-3: The Iron Triangle of Food Policy , May 2015 , pp. 447 - 458
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2015

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References

1 Mark Bittman et al., Op-Ed., How a national food policy could save millions of american lives, Wash. Post (Nov. 7, 2014), http://www.washingtonpost.com/opinions/how-a-national-food-policy-could-save-millions-of-american-lives/2014/11/07/89c55e16-637f-11e4-836c-83bc4f26eb67_story.html.

2 U.S. Gov't Accountability Office, GAO-07-449T, Federal Oversight of Food Safety: High-Risk Designation Can Bring Needed Attention to Fragmented System (2007), available at http://www.gao.gov/new.items/d07449t.pdf.

3 Id. at 1.

4 Id. at 4-5.

5 Id. at 5.

6 Id.

7 Renee Johnson, Cong. Research Serv., RS22600, The Federal Food Safety System: A Primer 2 (2014), available at http://fas.org/sgp/crs/misc/RS22600.pdf.

8 Id.

9 Id.

10 Id. at 6.

11 About FSIS, U.S. Department Agric., http://www.fsis.usda.gov/wps/portal/informational/aboutfsis (last modified Oct. 1, 2014).

12 Renee Johnson, Cong. Research Serv., RS22600, The Federal Food Safety System: A Primer 2 (2014).

13 Id.

14 Id.

15 Id.

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21 Renee Johnson, Cong. Research Serv., RS22600, The Federal Food Safety System: A Primer 1 (2014).

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28 FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified as amended in scattered sections of 21 U.S.C.).

29 About the President's Food Safety Working Group (FSWG), supra note 27.

30 Id.

31 U.S. Gov't Accountability Office, GAO-11-289, Federal Food Safety Oversight: Food Safety Working Group is a Positive First Step but Governmentwide Planning is Needed to Address Fragmentation (2011), available at http://www.gao.gov/assets/320/316742.pdf.

32 Id.

33 Id. at 5-6.

34 Id. at 6-7.

35 Id. at 7-11.

36 Id. at 7-8.

37 FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified as amended in scattered sections of 21 U.S.C.).

38 21 U.S.C. § 350j (2012).

39 Id. § 350j(c)(1).

40 Id. § 350j(c)(2).

41 Id. § 350j(d).

42 Id. § 2203.

43 Id. §§ 2221, 2222.

44 Id. § 2224(b)(1)(A)-(B).

45 Id. § 399c(a).

46 Id. § 2203(1).

47 Id. § 2223(a)(1).

48 See What's New: Actions implemented under the FSMA, U.S. Food & Drug Admin., http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm257986.htm (last updated Apr. 16, 2015).

49 Sanitary Transportation of Human and Animal Food, 79 Fed. Reg. 7006, 7016 (Feb. 5, 2014) (to be codified at 21 C.F.R. pt. 1) (“Communication and coordination between carriers, shippers and receivers is a critical element in properly carrying out such transport.”).

50 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 78 Fed. Reg. 3504, 3511 (Jan. 16, 2013) (to be codified at 21 C.F.R. pts. 16 and 112) (“Recurring comments included: The importance of activities to promote or enhance rapid, accurate traceback; strengthened coordination and communication between all sectors (i.e., researchers, regulators, and industry) on available science and current unpublished data; and an integrated, multidisciplinary approach to identify best practices not currently incorporated by industry.”); id. at 3511-13 (discussing partnerships and collaborations); id. at 3513 (“FDA regularly consults and coordinates with other Federal agencies in the area of produce safety. Examples of these efforts can be found throughout this document and include collecting samples, sharing data, providing training and technical assistance to industry, and research. Our partnerships with USDA and CDC have been particularly valuable to our efforts.”); id. at 3514 (discussing welcoming of input on “[c]oordination of produce food safety practices and Federal, state, local and tribal government statutes and regulations”).

51 Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, 78 Fed. Reg. 3646 (Jan. 16, 2013) (to be codified at 21 C.F.R. pts. 1, 16, 106, 110, 114, 117, 120, 123, 129, 179 and 211) (discussing the role of industry throughout).

52 U.S. Gov't Accountability Office, GAO-13-283, High-Risk Series: An Update (2013), available at http://www.gao.gov/assets/660/652133.pdf.

53 See generally id. (stating that the “fragmented federal oversight of food safety has caused inconsistent oversight, ineffective coordination, and inefficient use of resources” within the federal government.).

54 Id. at 198.

55 Id. at 197.

56 Id.

57 See supra Part III.

58 U.S. Gov't Accountability Office, GAO-13-283, High-Risk Series: An Update 199 (2013).

59 Id.

60 Dan Flynn, U.S. Catfish Farmers Emerge As Big Winners in 2014 Farm Bill, Food Safety News (Jan. 31, 2014), http://www.foodsafetynews.com/2014/01/u-s-catfish-farmers-emerge-as-big-winners-in-2014-farm-bill/#.VF9P0fTF_zk.

61 Dan Flynn, Agencies Reach Catfish Inspection Agreement Required by Farm Bill, Food Safety News (May 14, 2014), http://www.foodsafetynews.com/2014/05/catfish-agreement-called-for-in-farm-bill-reached-by-agencies/#.VF9QHfTF_zk.

62 U.S. Gov't Accountability Office, GAO-13-283, High-Risk Series: An Update 199 (2013).

63 Id. at 199-200.

64 See discussion supra Part III.

65 See discussion supra Part III.

66 See 21 U.S.C. §§ 2221-2222, 2224(b)(1)(A)-(B) (2012).

67 See discussion supra Part III.

68 Id.

69 See, e.g., 21 U.S.C. §§ 399c(a), 2224(b)(1)(A)-(B).

70 Id. § 399c(a).

71 See, e.g., id. §§ 2221-2222, 2224(b)(1)(A)-(B).

72 Endangered Species Act of 1973 § 7, 16 U.S.C. § 1536(a)(2) (2012).

73 See, e.g., Memoranda of Understanding (MOU), U.S. Department Agric., http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/food-safety-agencies/mou (last modified Mar. 24, 2014) (listing the various memoranda of understanding signed by the FSIS with other agencies).

74 See 28 U.S.C. §§ 620-629.

75 Id. § 621(a)(2).

76 Schwarzer, William W., The Federal Judicial Center and the Administration of Justice in the Federal Courts, 28 U.C. Davis L. Rev. 1129, 1134 (1995)Google Scholar.

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78 Schwarzer, supra note 76, at 1143 (describing how the FJC provided criticisms of existing judicial policies to provide an independent, yet collaborative, assessment).

79 See 42 U.S.C. §§ 4342-4347 (2012).

80 Id. § 4342.

81 See Albert I. Herson, Environmental Permitting: Expediting the NEPA Process, Nat. Resources & Env't, Winter 1987, at 13.

82 Toni Clarke, Lawmakers propose bill to create single food safety agency, Reuters (Jan. 28, 2015), http://www.reuters.com/article/2015/01/28/us-usa-congress-food-safety-idUSKBN0L12I720150128.

83 Safe Food Act of 2015, S. 287, 114th Cong. §§ 101-102 (2015).

84 Dodd-Frank Wall Street Reform and Consumer Protection Act § 1011(a), 12 U.S.C. § 5491(a) (2012).

85 12 U.S.C. § 5511(a).

86 About Us, Consumer Fin. Protection Bureau, http://www.consumerfinance.gov/the-bureau/ (last updated Dec. 4, 2014).

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89 Kruly, supra note 88, at 1736.

90 See U.S. Gov't Accountability Office, GAO-11-289, Federal Food Safety Oversight: Food Safety Working Group is a Positive First Step but Governmentwide Planning is Needed to Address Fragmentation (2011); U.S. Gov't Accountability Office, GAO-07-449T, Federal Oversight of Food Safety: High-Risk Designation Can Bring Needed Attention to Fragmented System (2007).