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The Codex Alimentarius Commission, Corporate Influence, and International Trade: A Perspective on FDA's Global Role

Published online by Cambridge University Press:  06 January 2021

Sam F. Halabi*
Affiliation:
University of Tulsa College of Law, O'Neill Institute for National and Global Health Law, Georgetown University Law Center, Harvard Law School, Oxford University, Kansas State University

Extract

The FDA Food Safety Modernization Act (FSMA) is by all accounts the most sweeping and comprehensive update to U.S. food laws in seventy years, aiming to confront the reality that the nation's food supply has undergone fundamental shifts in its sources, distribution channels, and intermediate handlers. The law's intent is to prevent problems that can cause foodborne illness and enable the Food and Drug Administration (FDA) to keep a record of facilities processing food for sale in the United States, a mandate that expands FDA's already global regulatory activities. FSMA gives FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods. Because the law specifically aims to update FDA authority in light of the reality of global food and food additive markets, Section 305 FSMA calls for FDA to develop a comprehensive plan to expand the “technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States.”

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

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References

1 FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified as amended at 7 U.S.C. § 7625 and in scattered sections of 21 U.S.C.).

2 See FDA, FDA's International Food Safety Capacity Building Plan 5 (2013), http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM341440.pdf; Food Safety Modernization Act, Vt. Agency of Agric. Food & Mkts., http://agriculture.vermont.gov/food_safety_consumer_protection/fsma.

3 See Vt. Agency of Agric. Food & Markets, supra note 2.

4 FDA, supra note 2, at v.

5 Report to Congress on the FDA Foreign Offices, FDA (Feb. 2012), http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm291803.htm#summary.

6 FDA, supra note 2, at 3.

7 FDA Food Safety Modernization Act, Pub. L. No 111-353, § 305(c)(5), 124 Stat. 3885, 3958 (2011); FDA, supra note 2, at 21.

8 For a list of the standards Codex covers, see Codex Standards, Codex Alimentarius, http://www.codexalimentarius.org/standards/en/ (last updated Mar. 3, 2015).

9 Id.

10 FDA, supra note 2, at 21.

11 See About Codex, Codex Alimentarius, http://www.codexalimentarius.org/codex-home/en/ (last updated Apr. 8, 2015).

12 Codex Timeline from 1945 to the Present, Codex Alimentarius, http://www.codexalimentarius.org/about-codex/codex-timeline/en/ (last visited May 5, 2015).

13 The term “Codex Alimentarius” derives from the Codex Alimentarius Austracius, a collection of food standards developed by the former Austrian-Hungarian empire, which originated as early as 1891 and was completed in 1917. Rep. of the Joint FAO/WHO Codex Alimentarius Comm'n, 19th Sess., July 1-10, 1991, ALINORM 91/40 app. 2 (1991), available at http://www.fao.org/docrep/meeting/005/t0490e/T0490E04.htm.

14 Codex Timeline from 1945 to the Present, supra note 12.

15 See Scientific Basis for Codex Work, Codex Alimentarius, http://www.codexalimentarius.org/scientific-basis/en/ (last updated Mar. 3, 2015).

16 Codex Members and Observers, Codex Alimentarius, http://www.codexalimentarius.org/members-observers/en/ (last updated Mar. 3, 2015).

18 Codex Members and Observers, supra note 16.

19 Consumers Int'l, supra note 17.

20 Codex Members and Observers, supra note 16.

21 Id. The IGO application for observer status is available online. Codex Alimentarius Comm'n, Information Required from International Governmental Organizations Requesting “Observer Status” (2013), available at ftp://ftp.fao.org/codex/forms/Observer_Application_Form_IGO_2013e.pdf (last visited May 5, 2015).

22 See Principles Concerning the Participation of International Non-Governmental Organizations in the Work of the Codex Alimentarius Commission, Codex Alimentarius, http://www.codexalimentarius.org/members-observers/ngo-participation/en/ (last updated Mar. 3, 2015). The application for observer status for NGOs is available online. Codex Alimentarius Comm'n, Information Required from International Non-Governmental Organizations Requesting “Observer Status” (2013), available at ftp://ftp.fao.org/codex/forms/Observer_Application_Form_NGO_2013e.pdf (last visited May 5, 2015).

23 Consumers Int'l, supra note 17.

24 Id. at 19.

25 See U.S. Codex & Codex Alimentarius, USDA, http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius (last updated Mar. 24, 2015).

26 See CVM's Participation in the Codex Committee on Residues of Veterinary Drugs in Foods and the Ad Hoc Intergovernmental Task Force on Antimicrobial Resistance, FDA, http://www.fda.gov/aboutfda/centersoffices/officeoffoods/cvm/whatwedo/ucm282088.htm (last updated Aug. 25, 2014); FDA's Participation in Codex, FDA, http://www.fda.gov/food/internationalinteragencycoordination/internationalcooperation/ucm106250.htm (last updated Dec. 12, 2014).

27 FDA's Participation in Codex, supra note 25.

28 Codex Alimentarius Comm'n, FAO/Who Codex Training Package: Module 2.3 3, ftp://ftp.fao.org/es/esn/food/capacity_building/2_3.pdf.

29 Codex Alimentarius Comm'n, Codex Alimentarius Commission: Procedural Manual 9 (12th ed. 2001), ftp://ftp.fao.org/docrep/fao/005/Y2200E/Y2200E00.pdf.

30 Id. at 19-21.

31 Id. at 9.

32 The Codex has clarified that consensus does not require unanimity, but rather alludes to a standard less than unanimity but more than supermajority. See Consumers Int'l, supra note 17, at 15.

33 Id. at 11.

34 See id. at 19-21.

35 For an organization chart, see Codex Alimentarius Comm'n, Guidelines for Codex Contact Points and National Codex Committees (Asia) 8, CAC GL/57-1999 (1999), available at www.codexalimentarius.org/input/download/standards/.../cxg_057Re.pdf.

36 See Codex Alimentarius Comm'n, Understanding the Codex Alimentarius 16-19 (3d ed. 2006), ftp://ftp.fao.org/codex/Publications/understanding/Understanding_EN.pdf.

37 Id. at 16-17.

38 See id. at 19.

39 Id. at 17-18.

40 Food & Agric. Org. of the U.N. [FAO], Lesson 2.1 – How Codex is Organized: The General Subject Committees, IMark Group, http://www.imarkgroup.org/projects/course/moduleX/EN/downloadresource.asp?filelocation=pdf/GeneralSubjectCommittees.pdf (last visited May 5, 2015).

41 Codex Alimentarius Comm'n, supra note 36, at 17.

42 See id. at 22-24. Expert scientific bodies include: Joint FAO/WHO Expert Committee on Food Additives (JECFA); Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA); Joint FAO/WHO Meetings on Pesticide Residues (JMPR). Id.at 23; see also FAO, supra note 50.

43 Codex Alimentarius Comm'n, supra note 36, at 18.

44 Id. at 9.

45 Id. at 18.

46 See id. Previously assembled Ad Hoc Task Forces include: Task Force on Animal Feeding (1999-2004) and Task Force on Fruits and Vegetable Juices (1999-2005). Id. at 19.

47 Id. at 18.

48 Codex Members and Observers, supra note 16.

49 Id. Codex's documented Members, Observers, and invitees currently account for over 600 delegates. Codex Alimentarius Comm'n, supra note 36, at 15.

50 Consumers Int'l, supra note 17, at 16.

51 Codex Alimentarius Comm'n, supra note 36, at 15.

52 Id. at 15-16.

53 Id. at 16.

54 See Consumers Int'l, supra note 17, at 16.

55 FAQs – General Questions, Codex Alimentarius, http://www.codexalimentarius.org/faqs/general-questions/en/ (last visited May 5, 2015).

56 Id.

57 See Codex Timeline from 1945 to the Present, supra note 12.

58 The WTO's SPS Agreement was established in 1995 to regulate food, plant, and animal safety and health regulations. Id. The adjudicatory arm (“Panels”) of the WTO resolves trade disputes regarding such issues, and can impose or permit trade-based punitive measures for violations of the SPS Agreement. See Understanding the WTO Agreement on Sanitary and Phytosanitary Measures, WTO, http://www.wto.org/english/tratop_e/sps_e/spsund_e.htm (last visited Mar. 16, 2015).

59 See Livermore, Michael A., Authority and Legitimacy in Global Governance: Deliberation, Institutional Differentiation, and the Codex Alimentarius, 81 N.Y.U. L. Rev. 766, 768 (2006)Google Scholar.

60 Id. at 768-69. The WTOs near codification of Codex Alimentarius standards regarding sanitary and phytosanitary measures likely casts Codex's SPS-related actions as the organization's most significant activity. See Randell, A.W. & Whitehead, A.J., Codex Alimentarius: Food Quality and Safety Standards for International Trade, 16 Revue Scientifique et Technique De L'Office International des Épizooties 313, 316-17 (1997)Google ScholarPubMed.

61 The SPS Agreement instructs its Members “to base their sanitary or phytosanitary measures on international standards” (Article 3.1.) and presumes those international standards to “be consistent with the relevant portions of this Agreement and of GATT [General Agreement on Tariffs and Trade] 1994” (Article 3.2). The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), WTO, https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm (last visited May 5, 2015); see also Wirth, David A., The Transatlantic GMO Dispute Against the European Communities: Some Preliminary Thoughts, in EU and WTO Law: How Tight Is the Legal Straightjacket for Environmental Product Regulation? 175, 183 (Marc Pallemaerts ed., 2006)Google Scholar.

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67 Beacham, L.M., Ten Years of Codex Alimentarius—A Progress Report, Foreign Agric. 10, 10 (1973)Google Scholar, available at http://legacy.library.ucsf.edu/tid/odj92a99/pdf.

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69 See International Harmonization of Food Safety and Labeling Standards: Threats and Opportunities for the U.S. Food and Drug Administration and the U.S. Department of Agriculture, Ctr. for Sci. Pub. Interest (June 1997), http://www.cspinet.org/reports/codex.htm.

70 See Linhai Wu & Dian Zhu, Food Safety in China: A Comprehensive Review 239 (2015); List of Active Codex Committees, Codex Alimentarius, http://www.codexalimentarius.org/committees-and-task-forces/en/ (last updated Mar. 3, 2015).

71 Codex Standard 72-1981 § 9.6 (Codex Alimentarius Comm'n 2011).

72 See Edward Scarbrough, F., Codex—What's All the Fuss?, 65 Food & Drug L.J. 631, 631-33 (2010)Google Scholar.

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74 See Lee, supra note 63, at 577-78.

75 Id. at 578-79.

76 Dietary Guidelines for Americans, USDA, http://www.cnpp.usda.gov/DietaryGuidelines (last visited May 5, 2015).

77 See Lee, supra note 63, at 580.

78 Codex Standard 1-1985 § 4.2.1.3 (Codex Alimentarius Comm'n 2010).

79 Codex Alimentarius Comm'n, Guidelines for the Use of Flavourings, CAC/GL66-2008 (2008), available at www.codexalimentarius.org/input/download/standards/.../cxg_066e.pdf.

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81 Smythe, supra note 64, at 98.

82 Id.

83 Otho D. Easterday & Julia C. Howell, Report of the International Food Laws Committee 1 (1989), available at http://legacy.library.ucsf.edu/tid/rrh14d00/pdf (“The activities of the ad hoc FEMA [Flavor and Extract Manufacturers Association]/FDA/USDA group that developed a system for prioritization of flavorings was of particular interest to the committee members… JECFA has commenced using the system by selecting high priority compounds from the list of prioritized flavorings. One substance, quinine hydrochloride, is being evaluated by JECFA in June 1989.”).

84 See Food Standards Austl. N.Z., Draft Assessment Report: Proposal P237: Country of Origin Labelling [sic] of Food 18-33 (2004).

85 See, e.g., Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, 78 Fed. Reg. 45,782 (proposed July 29, 2013) (to be codified at 21 C.F.R. pts. 1, 16).

86 McDaniel, Patricia A. et al., Commentary, The Tobacco Industry and Pesticide Regulations: Case Studies from Tobacco Industry Archives, 113 Envtl. Health Perspectives 1659, 1661 (2005)Google ScholarPubMed.

87 Id.

88 Consultancy Agreement Between Vettorazzi Associates and CORESTA (Sept. 30, 1993), available at http://legacy.library.ucsf.edu/tid/cwb24e00.

89 Vettorazzi Assocs., Pamphlet, http://legacy.library.ucsf.edu/tid/zhq25c00/pdf (pamphlet describing Vettorazzi Associates operating principles, services, and credentials of Director Gaston Vetorrazi); see also The ITIC in [sic] now an NGO, ITIC Newsletter (Int'l Toxicology Information Ctr., San Sebastian, Spain) Dec. 1992, at 1, available at http://legacy.library.ucsf.edu/tid/suo24a99.

90 Id. at 4.

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94 Minutes of the Joint Meeting of the ILSI and ILSI-NF Boards of Members 1 (Jan. 21, 1989), available at http://legacy.library.ucsf.edu/tid/pyu56a00/pdf.

95 Robert Verkerk, The International Food Code of Codex Alimentarius, Ethical Consumer, http://www.ethicalconsumer.org/commentanalysis/factsvgreenwash/codexalimentarius.aspx (last visited May 5, 2015).

96 See generally Eur. Food Safety Auth., EFSA Meeting Summary Report: EFSA/WHO International Conference with Support of ILSI Europe on Risk Assessment of Compounds that Are Both Genotoxic and Cytotoxic (2006), available at http://www.efsa.europa.eu/en/home/publication/efsawho2006.pdf.

97 See RJR Interoffice Memorandum from John C. Kirschman to A. Wallace Hayes (July 31, 1987), available at http://legacy.library.ucsf.edu/tid/pct75a00/pdf.

98 See RJR Nabisco, Inc., Corporate Center of Excellence in Toxicology, http://legacy.library.ucsf.edu/tid/hmp15d00/pdf?search=%22kirschman%20excellence%20research%22.

99 Sixty-Ninth Meeting of the Joint FAO/WHO Expert Committee on Food Additives, Rome, Italy, June 17-26, 2008, Evaluation of Certain Food Additives, at 1, WHO Technical Rep. Series No. 952 (2009)Google Scholar.

101 Review of Codex Alimentarius Food Standards, 21 CFR § 130.6(c) (2012).

102 See id.

103 Codex Alimentarius: FAO/WHO Trust Fund for Participation in Codex, Codex Alimentarius, http://www.codexalimentarius.org/faowho-trust-fund/en/ (last updated Mar. 3, 2015). Dr. Gro Harlem Brundtland (WHO) and Dr. Jacques Diouf (FAO) launched the fund during the 25th session of Codex. Id.

104 Id.

105 Codex Trust Fund: Donor Contributions, WHO, http://www.who.int/foodsafety/areas_work/food-standard/codextrustfund/en/index1.html (last visited May 5, 2015). The list of donating countries and organizations were as follows: Australia, Canada, European Commission, Finland, France, Germany, India, Ireland, Japan, Malaysia, Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United States. Id. India and Malaysia have transitioned to become donor countries. Id.

106 See Codex Trust Fund: Background, WHO, http://www.who.int/foodsafety/areas_work/food-standard/codextrustfund/en/ (last visited May 5, 2015).

107 Gumisai Mutume, New Barriers Hinder African Trade, Afr. Renewal, http://www.un.org/africarenewal/magazine/january-2006/new-barriers-hinder-african-trade (last visited May 5, 2015).

108 Beacham, supra note 67, at 11.

109 Mutume, supra note 107 (“The EU, however, frequently chooses to ignore Codex recommendations and is often much stricter ….” (internal quotation marks omitted)).

110 Lin, Ching-Fu, Global Food Safety: Exploring Key Elements for an International Regulatory Strategy, 51 Va. J. Int'l L. 637, 661-62 (2011)Google Scholar.

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112 See FDA's International Posts: Improving the Safety of Imported Food and Medical Products, FDA, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm185769.htm (last updated Apr. 29, 2015).

113 Id.

114 See FDA, supra note 2, at 21.

115 See FDA, supra note 112.

116 FDA Food Safety Modernization Act, Pub. L. No 111-353, § 305(a), 124 Stat. 3885, 3958 (2011).

117 See FDA, supra note 2, at 21.

118 Dispute Settlement, United States—Measures Affecting the Production and Sale of Clove, WT/DS406 (Oct. 3, 2014).