Casting a global safety net - A framework for food safety in the age of globalization

Food and Drug Law Journal

Volumn 64, Issue 2, 2009, Pages 313-334

  Chyau, James ^a  

^a Southwestern Law School and the Biederman Entertainment and Media Law Institute   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; CERTIFICATION; CONCEPTUAL FRAMEWORK; DEVELOPING COUNTRY; FOOD AND DRUG ADMINISTRATION; FOOD SAFETY; GOVERNMENT; HEALTH CARE ORGANIZATION; HUMAN; LAW; REVIEW; UNITED STATES;

ANIMAL FEED; ANIMALS; CERTIFICATION; COMMERCE; CONSUMER PRODUCT SAFETY; FOOD CONTAMINATION; FOOD INSPECTION; FOOD SUPPLY; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; INFANT FORMULA; INFANT, NEWBORN; INTERNATIONAL AGENCIES; INTERNATIONAL COOPERATION; INTERNATIONALITY; UNITED STATES; UNITED STATES DEPARTMENT OF AGRICULTURE; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 66749123645     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (146)

1. Zamiska, Nicholas, Who's Monitoring Chinese Food Exports?, YALEGLOBAL ONLINE, (Apr. 13, 2007), http://yaleglobal.yale.edu/display.article?id=9053.
2. Id.
3. See FDA, Consumer Health Info., FDA's Ongoing Pet Food Investigation, (Apr. 16, 2007), available at http://www.fda.gov/consumer/updates/ petfoodrecallup.html. See also id.
4. FDA., IMPORT ALERT #99-29 (IA9929), Detention without Physical Examination of All Vegetable Protein Products from China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs, (Apr. 27, 2007), available at http://www.fda.gov/ora/fiars/ora-import-ia9929.html.
5. See Barboza, David & Barrionuevo, Alexei, Filler in Animal Feed Is Open Secret in China, N.Y. TIMES, (Apr. 30, 2007), at A1.
6. Transcript of FDA Press Conference on the Pet Food Recall, FDA, (May 1, 2007), available at http://www.fda.gov/bbs/transcripts/transcript050107.pdf.
7. See Feds: Millions have eaten chickens fed tainted pet food, HEALTH, (May 02, 2007), http://www.cnn.com/2007/HEALTH/05/02/pet.food.poultry/index.html. FDA stressed that there was minimal danger for human.
8. See FDA/USDA Joint News Release: Scientists Conclude Very Low Risk to Humans from Food Containing Melamine, FDA NEWS, (May 7, 2007), available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01629.html.
9. Timeline: China Milk Scandal, BBC, (Nov. 14, 2008), http://news.bbc.co. uk/2/hi/asia-pacific/7720404.stm.
10. Id.
11. Id.
12. See FDA, Domestic Infant Formula Testing Results, (Nov. 26, 2008), available at http://www.fda.gov/oc/opacom/hottopics/melamine/testresults.html.
13. See also Martin, Andrew, Melamine Traces Found in U.S. Infant Formula, N.Y. TIMES, (NOV. 25, 2008). http://www.nytimes.eom/2008/11/26/us/26formula. html.
14. Calls for national infant formula recall spread, ASSOC. PRESS, (NOV. 26, 2008), http://www.msnbc.msn.com/id/27914218/. FDA announced that the levels of melamine found in the infant formula were not high enough to raise health concerns.
15. See FDA, CFSAN, Update: Interim Safety and Risk Assessment of Melamine and its Analogs in Food for Humans, (Nov. 28, 2008), available at http://www.cfsan.fda.gov/~dms/melamra4.html.
16. Customers at Albert Hein of the Netherlands, the largest Dutch grocery chain, can find bananas from Guatemala, shrimps from Ecuador, coffee from Columbia, grapes from Chile, Oranges from California, noodles from Asia, and virtually any other imaginable imported foods. DeWaal, Caroline S. & Brito, Gonzalo R. Guerrero, Safe Food Internationl: A Blueprint For Better Global Food Safety, 60 FOOD & DRUG L.J. 393, 393 (2005) [hereinafter DeWaal & Brito].
17. Taylor, Michael R., Preparing America's Safety Syetem For The Twenty-First Century - Who Is Responsible For What When It Comes To Meeting The Food Safety Challenges Of The Consumer-Driven Global Economy, 52 FOOD & DRUG L.J. 13, 28 n.1 (1997).
18. Office of Commc'ns, USDA, AGRICULTURE FACT BOOK 2001-2002 at 20, (2003) (in 2002 dollar and not adjusted for inflation), available at http://www.usda.gov/factbook/2002factbook.pdf.
19. See, e.g., DeWaal & Brito, supra note 11, at 393.
20. Taylor, supra note 12, at 24.
21. Id. at 13.
22. See, e.g., id. at 24.
23. See id.
24. The U. S. Constitution gives Congress the power to regulate interstate commerce. U.S. CONST. art. I § 8 cl. 3 ("To regulate commerce with foreign nations, and among the several States, and with the Indian tribes."). Imported foods, as a part of the interstate commerce, are under the same federal regulations as domestically produced foods. Federal Food, Drug, and Cosmetic Act (FDCA) prohibits: a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded. b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce. c) The receipt in interstate commerce any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise. FDCA, 21 U.S.C. § 331(a)-(c) (2006). See FASONLINE, Food and Agricultural Import Regulation and Standards Report, (Feb. 1999), available at http://www.fas.usda.gov/itp/ofsts/us.html.
25. See, e.g., Agreement on the Application of Sanitary and Phytosanitary Measures pmbl., (Apr. 15, 1994), Marrakesh Agreement Establishing the World Trade Organization (WTO), Annex 1A, 1867 U.N.T.S. 493 [hereinafter SPS Agreement].
26. The use of food safety standards as trade barrier benchmarks is not without its critics. It is feared that such an use of food safety standard can hinder the effort to improve the standard itself. For example, one author opined "[T]he globalization of the food industry necessitates an international food safety agreement, not just an international trade agreement on food safety." (emphasis original). See Silverglade, Bruce, Director of Legal Affairs, Center for Science for the Public Interest (CSPI), The WTO Agreement on Sanitary and Phytosanitary Measures - Weakening Food Safety Regulation to Facilitate Trade, Address Before WTO: Linking with Development (May 25, 2000), available at http://www.cspinet.org/reports/codex/dutch-wto.html.
27. See U.S. CONST. art. I § 8.
28. DeWaal, Caroline Smith, Food Safety Inspections: A Call For Rational Reorganization, 54 FOOD & DRUG L.J. 453, 454 (1999).
29. Pure Food and Drugs (Wiley) Act of 1906, Pub. L. No. 59-384, 34 Stat. 768 (repealed 1938) [hereinafter PFDA];
30. Federal Meat Inspection Act, 21 U.S.C. §§ 601 et seq. (2006) [hereinafter FMIA].
31. See Note, Reforming The Food Safety System: What If Consolidation Isn't Enough?, 120 HARV. L. REV. 1345, 1346 (2007).
32. Note, supra note 24.
33. Taylor, supra note 12, at 14.
34. See, e.g., 21 U.S.C. § 603(a) (2006) (requiring "an examination and inspection of all amenable species before they shall be allowed to enter into any slaughtering, packing, meat-canning, rendering or similar establishment...."); Egg Products Inspection Act, 21 U.S.C. § 1034(a) (2006) (requiring continuous inspection to be made of the processing of egg products in each plant processing egg products for commerce.); FASONLINE, Supra note 14.
35. See What FDA Regulates, http://www.fda.gov/comments/regs.html (last visited Mar. 30, 2009); FASONLINE, Supra note 14.
36. For legal definitions for food safety terminology, see 21 U.S.C. § 321 (2006); 21 U.S.C. § 601 (2006). See also Taylor, supra note 12, at 15.
37. FDA regulates about 124,000 business establishments and its Consumer Safety Officers (CSO) and inspectors conduct about 22,000 domestic and foreign inspections a year. See FDA's Sentinel of Public Health: Field Staff Safeguards High Standards, http://www.fda.gov/opacom/factsheets/justthefacts/7ora.html (last visited Mar. 30, 2009) [hereinafter Sentinel]; DeWaal, supra note 23, at 454.
38. FDA has the authority to seize "any article of food, drug or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce." 21 U.S.C. § 334(a) (2006). See DeWaal, supra note 23, at 455.
39. DeWaal, supra note 23, at 455.
40. See generally FDCA, supra note 19; FASONLINE, supra note 19.
41. See 21 U.S.C. § 331(g) (2006) (prohibiting "[t]he manufacture within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded."); Taylor, supra note 12, at 16.
42. See, e.g., Lyon, Jesse D., Coordinated Food Systems And Accountability Mechanisms For Food Safety: A Law And Economic Approach, 53 FOOD & DRUG L.J. 729, 746 (1998).
43. Escola v. Coca-Cola Bottling Co. of Fresno, 150 P.2d 436 (Cal. (1944)) (Traynor, J. concurring).
44. See Sentinel, supra note 30; Taylor, supra note 12, at 16.
45. Taylor, supra note 12, at 16, 28 n. 12.
46. Congress has authority to regulate channels and instrumentalities of interstate commerce. Local restaurants and food establishments are often participants of interstate commerce. See DeWaal, supra note 23, at 454.
47. Taylor, supra note 12, at 28 n. 12.
48. Id. at 16.
49. FMIA, supra note 24; PPIA, 21 U.S.C. §§ 451 et seq. (2006). See FASONLINE, supra note 19.
50. 21 U.S.C. § 603(a) (2006); 21 U.S.C. § 455(a)-(b) (2006) (requiring ante mortem inspection of all poultry and post mortem inspection of the carcass of each bird processed.). See Taylor, supra note 12, at 16.
51. 21 U.S.C. § 603(a) (2006); 21 U.S.C. § 455(a)-(b) (2006).
52. 21 U.S.C. § 604 (2006) (requiring "all such animals found to be not adulterated shall be marked, stamped, tagged or labeled as 'Inspected and passed'...."); 21 U.S.C. § 457(a) (2006) (requiring "[a]ll poultry products inspected at any official establishment ... and found to be not adulterated, shall at the time they leave the establishment bear ... the information required under [PPIA]....")
53. Taylor, supra note 12, at 17.
54. FASONLINE, supra note 19.
55. 21 U.S.C. § 620(a) (2006) ("No carcasses, parts of carcasses, meat or meat food products... shall be imported into the United States if such articles are adulterated or misbranded and unless they comply with all the inspection, building, construction standards, and all other provisions ... applicable to such articles in commerce within the United States."); 21 U.S.A. § 466(a) (2006) ("No slaughtered poultry, or parts or products thereof, of any kind shall be imported into the United States unless they are healthful, wholesome, fit for human food, not adulterated, and ... comply with the standards provided for in PPIA.")
56. 21 U.S.C. § 620(f) (2006) ("Each foreign country from which such meat articles are offered for importation into the United States shall obtain a certification issued by the Secretary (USDA) stating that the country maintains a program using reliable analytical methods to ensure compliance with the United States standards....")
57. Id. ("the review of any such certification...shall include the inspection of individual establishments to ensure that the inspection program of the foreign country involved is meeting such United States standards.")
58. Id. ("The Secretary...shall revoke any certification if...the country involved is not maintaining a program that uses reliable analytical methods to ensure compliance with United States standards.")
59. 21 U.S.C. § 620(a) (2006) ("The Secretary shall enforce the provision through (1) the imposition of random inspections for such species verification and for residues....")
60. Codex Alimentarius Comm'n, World Health Org., Understanding the Codex Alimentarius preface (3d ed. 2006) (CODEX).
61. DeWaal & Brito, supra note 11, at 395.
62. Id.
63. Id.
64. Id.
65. Codex Alimentarius Comm'n, World Health Org., Food Import & Export preface (2d ed. 2006) [hereinafter FOOD IMPORT].
66. Id.
67. 6(1 CODEX, supra note 53, at 10-11.
68. See id. at 11, 16.
69. Id. at preface.
70. Id. at 3.
71. Id. at 17.
72. DeWaal & Brito, supra note 11, at 395.
73. CODEX, supra note 53, at 16.
74. Id. at 21.
75. See Silverglade, supra note 21.
76. CODEX, supra note 53, at 7.
77. Id. at 8.
78. Id. at 29-30.
79. Id.
80. WORLD TRADE ORG., UNDERSTANDING THE WTO 9 (3d ed. 2007), available at http://www.wto.org/english/thewto-e/whatis-e/tif-e/understanding-e.pdf.
81. See, e.g., id. at 30; CODEX, supra note 53, at 30.
82. WORLD TRADE ORG., supra note 73, at 30.
83. SPS Agreement, supra note 20, art. 2.2.
84. Id. art. 3.1.
85. Id. pmbl.
86. Id. art. 4.1.
87. WORLD TRADE ORG., supra note 73, at 30.
88. Id. at 31.
89. Agreement on Technical Barriers to Trade art. 2.4, (Apr. 15, 1994), Marrakesh Agreement Establishing the WTO, Annex 1A, 1868 U.N.T.S. 120 [hereinafter TBT Agreement].
90. See id. art. 2.5.
91. CODEX, supra note 53, at 11.
92. The Univ. of Ariz. Cooperative Extension: About HACCP, http://cals.arizona.edu/maricopa/fcs/haccp/about.htm (last visited Sept. 15, 2007) [hereinafter About HACCP].
93. DeWaal & Brito, supra note 11, at 399.
94. About HACCP, supra note 85. The seven steps of the HACCP include: 1) analyze hazards and the measures to control them: Hazards can be biological, such as a microbe; chemical, such as a toxin; or physical, such as metal fragments; 2) identify critical control points: These are the points in the processing, shipping, and consumption continuum during which the potential hazards to the food can be controlled or eliminated; 3) establish preventive measures with critical limits for each control point: For example, establish the minimum cooking temperature to ensure the elimination of certain microbe; 4) establish procedures to monitor the critical control points: For example, specify how and by whom the measures for the critical control point should be carried out; 5) establish corrective actions to be taken when monitoring shows that a critical limit has not been met: For example, reprocess the food using the correct temperature to ensure the elimination of a biological hazard; 6) establish procedures to verify that the system is working properly: For example, implement regular re-calibration of the food processing devices; and 7) establish effective record keeping to document the HACCP system: The record should reflect the hazards and their control methods, monitoring of the control points and action taken to correct potential or actual problems, etc.
95. See Buzby, Jean C. & Crutchfield, Stephen R., USDA Modernizes Meat and Poultry Inspection, Food Review, (Jan.-Apr., 1997), available at http://www.ers.usda.gov/publications/foodreview/jan1997/jan97b.pdf.
96. FDA, FDA will require the seafood industry to establish safety controls - HACCP, HHS NEWS, (Jan. 21, 1994), available at http://www.cfsan.fda.gov/~lrd/ haccp-re.html.
97. See generally FDA, HACCP, http://www.cfsan.fda.gov/~lrd/haccp.html (last visited Sept. 1, 2007).
98. Taylor, supra note 12, at 12.
99. For example, the World Health Organization (WHO) estimated that contaminated food contributed to 1.5 billion annual episodes of diarrhea in children below the age of five and at least 1.8 million deaths. See FOOD SAFETY AND FOODBORNE ILLNESS, WORLD HEALTH ORGANIZATION, (Mar. 2007), available at http://www.who.int/mediacenter/factsheets/fs237/en; DeWaal & Brito, supra note 11, at 394.
100. Food and Agriculture Organization of the United Nations, THE IMPORTANCE OF FOOD QUALITY AND SAFETY FOR DEVELOPING COUNTRIES, http://www.fao.org/trade/ docs/LDC-Foodqual-en.htm (last visited Sept. 14, 2007) [hereinafter FOOD QUALITY].
101. Window of China, Full Text: China's Food Quality and Safety, http://news.xinhuanet.com/english/2007-08/17/content-6553424.htm (last visited Aug. 27, 2007).
102. Id.
103. China food safety head executed, http://news.bbc.co.Uk/l/hi/world/asia- pacific/6286698.stm (last visited Nov. 5, 2007).
104. See FOOD QUALITY, supra note 93. (explaining "Lack of resources and infrastructure for post-harvest handling, processing and storage leads to severe diminishing of quality and avoidable contamination and food losses.")
105. Id.
106. Id.
107. SPS Agreement, supra note 20, art. 9.
108. See FOOD QUALITY, supra note 93.
109. Id.
110. See CODEX, supra note 53, at preface.
111. FOOD IMPORT, supra, note 58, at 4 ("Inspection is the examination of food or systems for control of food, raw materials, processing, and distribution including in-process and finished product testing, in order to verify that they conform to requirements.")
112. Id. ("Certification is the procedure by which official certification bodies or officially recognized certification bodies provide written assurance that foods or food control systems conform to requirements.")
113. Id. ("Officially recognized inspection system and officially recognized certification are systems which have been formally approved or recognized by a government agency having jurisdiction to perform the inspection and certification tasks.")
114. Id. at 8 ("Official accreditation is the procedure by which a government agency having jurisdiction formally recognizes the competence of an inspection and/or certification body to provide inspection and certification services.")
115. See e.g., Taylor, supra note 12, at 20-21; About HACCP, supra note 85.
116. U.S. FOOD AND DRUG ADMIN., FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDANCE 16-50 (3rd ed. 2001) [hereinafter FISH AND FISHERY], available at http://www.cfsan.fda.gov/~comm/haccp4.html.
117. About HACCP, supra note 85 (explaining between 1973 and 1988 certain bacteria not previously recognized as important causes of food-borne illness became more widespread).
118. See id.
119. ISO, ISO 9000 essentials, http://www.iso.org/iso/iso-catalogue/ management-standards/iso-9000-iso-14000/iso-9000-essentials.htm (last visited Sept. 16, 2007)
120. See generally id.
121. See ISO9000Council.org: Information and Advice to facilitate your ISO 9000 Implementation, http://www.iso9000council.org (last visited Sept. 16, 2007).
122. It identifies hazards and devices procedures to remove them. It promotes the safety of the food products. But it does relatively little to ensure the total quality of the final food products. See generally FISH AND FISHERY, supra note 109.
123. See generally ISO9000Council, supra note 114.
124. See generally FOOD IMPORT, supra note 58.
125. See SPS Agreement, supra note 20, art. 9.
126. See FOOD QUALITY, supra note 93.
127. Id.
128. Id. It was suggested that financing be available from World Bank, regional development bank, bilateral donors, etc. However, IFSIO would be in the best position to offer cost estimates, risk-benefit analysis, etc.
129. See generally WORLD TRADE ORG., supra note 73; CODEX, supra note 53.
130. See generally WORLD TRADE ORG., supra note 73.
131. See generally id.
132. See FOOD QUALITY, supra note 93. It was suggested that the financial institutions such as World Bank, regional development banks, and bilateral donors be involved.
133. The Codex eight-step procedure includes: 1) A project proposal is reviewed by the Executive Committee and compared against the criteria and priorities established by the Commission. 2) A draft text is prepared. 3) The draft is circulated to member countries and all interested parties for comments. 4) The draft and comments are reviewed at the Committee level and, if necessary, a new draft is prepared. 5) The Commission reviews the progress made and agrees that the draft should go to finalization. 6) The approved is again sent to governments and interested parties for comment and finalized by the relevant committee. 7) The draft is submitted to the Commission for adoption. 8) Following a final round of comments, the Commission adopts the draft as a formal Codex text. The standard, guideline or other text is then published by the Codex Secretariat. See CODEX, supra note 53, at 17.
134. See SPS Agreement, supra note 20, art. 4 (equivalence).
135. Id. art. 9.
136. Air Navigation Bureau, ICAO, Making an ICAO Standard, http://www.icao.int/icao/en/anb/mais/index.html (discussing how SARPs are formed and adopted by ICAO) (last visited Nov. 29, 2007).
137. INT'L CIVIL AVIATION ORG., ANNUAL REPORT OF THE COUNCIL 2006, at 1 (2006), available at http://www.icao.int/icao/en/pub/rp06-en.pdf.
138. Office of the Secretary General, ICAO, Safety and Security Audits Branch, http://www.icao.int/icao/en/osg/ssa/ (describing the functions of the Safety Oversight Audit Section) (last visited Feb. 9, 2008).
139. JOSE E. ALVAREZ, INTERNATIONAL ORGANIZATIONS AS LAW-MAKERS 222 (2005).
140. Id. at 223.
141. Barboza, David, China Food Mislabeled, U.S. Says, N.Y. TIMES, (May 3, 2007), at C1.
142. Lyon, supra note 35, at 733.
143. Id. at 756-757 (stating by examples that United States alone lost 5.6 billion in medical charges and lost productivity due to foodborne illnesses).
144. See FOOD QUALITY, supra note 93.
145. See generally Lyon, supra note 35 at 751-752. Vertical coordination in food industries has been viewed as an important mechanism in improving food safety.
146. See CODEX, supra note 53, at 2.