The Hang-Up with HACCP: The Resistance to Translating Science into Food Safety Law

Food and Drug Law Journal

Volumn 58, Issue 4, 2003, Pages 565-593

  Fortin, Neal D ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ESCHERICHIA COLI; FOOD CONTAMINATION; FOOD INDUSTRY; FOOD POISONING; FOOD SAFETY; HEALTH CARE COST; HUMAN; INFECTION CONTROL; INFECTION RISK; LAW; LEGAL LIABILITY; NONHUMAN; REVIEW; RISK ASSESSMENT; SALMONELLA; SANITATION; STAPHYLOCOCCUS AUREUS; UNITED STATES;

CONSUMER PRODUCT SAFETY; FOOD CONTAMINATION; FOOD MICROBIOLOGY; FOOD POISONING; FOOD-PROCESSING INDUSTRY; GOVERNMENT; HISTORY, 20TH CENTURY; HUMANS; INFORMATION MANAGEMENT; LEGISLATION, FOOD; RISK ASSESSMENT; RISK MANAGEMENT; SAFETY MANAGEMENT; SCIENCE; UNITED STATES; UNITED STATES DEPARTMENT OF AGRICULTURE; UNITED STATES FOOD AND DRUG ADMINISTRATION;

ESCHERICHIA COLI; SALMONELLA; STAPHYLOCOCCUS; STAPHYLOCOCCUS AUREUS;

EID: 1442302311     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (209)

1. See, e.g., Margie Russell, HACCP: What's the Hang-Up? (Hazard Analysis Critical Control Point System), CHILTON'S FOOD ENG'G, Dec. 1, 1995, available at 481995 WL 12141218 ("The Hazard Analysis Critical Control Point System has been around since 1959. Even though this scientific-based system can prevent food safety hazards, its implementation has been slow.")
2. See, e.g., About the National Conference on Emerging Foodborne Pathogens: Implications and Controls, 3 EMERGING INFECTIOUS DISEASES 415 (1997) ("Infectious diseases transmitted by food have become a major public health concern in recent years."); Stephen R. Crutchfield & Tanya Roberts, Food Safety Efforts Accelerate in the 1990's, 23 FOODREVIEW 44 (2000) (awareness of the health risks from foodborne disease has increased over the past ten years).
3. See, e.g., About the National Conference on Emerging Foodborne Pathogens: Implications and Controls, 3 EMERGING INFECTIOUS DISEASES 415 (1997) ("Infectious diseases transmitted by food have become a major public health concern in recent years."); Stephen R. Crutchfield & Tanya Roberts, Food Safety Efforts Accelerate in the 1990's, 23 FOODREVIEW 44 (2000) (awareness of the health risks from foodborne disease has increased over the past ten years).
4. See, e.g., Crutchfield & Roberts, supra note 2, at 44.
5. I b i d.
6. See, e.g., FOOD AND DRUG ADMIN., FOOD CODE 2001, RECOMMENDATIONS OF THE UNITED STATES PUBLIC HEALTH SERVICE, FOOD AND DRUG ADMINISTRATION 424 (2001) [hereinafter FDA 2001 FOOD CODE] ("FDA is recommending the implementation of HACCP in food establishments because it is a system of preventive controls that is the most effective and efficient way to ensure that food products are safe."); NAT'L RESEARCH COUNCIL, NAT'L ACAD. OF SCIENCE, AN EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA FOR FOODS AND FOOD INGREDIENTS 329 (1985) [hereinafter NAS REPORT, THE ROLE OF MICROBIOLOGICAL CRITERIA].
7. See, e.g., FOOD AND DRUG ADMIN., FOOD CODE 2001, RECOMMENDATIONS OF THE UNITED STATES PUBLIC HEALTH SERVICE, FOOD AND DRUG ADMINISTRATION 424 (2001) [hereinafter FDA 2001 FOOD CODE] ("FDA is recommending the implementation of HACCP in food establishments because it is a system of preventive controls that is the most effective and efficient way to ensure that food products are safe."); NAT'L RESEARCH COUNCIL, NAT'L ACAD. OF SCIENCE, AN EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA FOR FOODS AND FOOD INGREDIENTS 329 (1985) [hereinafter NAS REPORT, THE ROLE OF MICROBIOLOGICAL CRITERIA].
8. See Paul S. Mead et al., Food-Related Illness and Death in the United States, 5 EMERGING INFECTIOUS DISEASES 607 (1999).
9. See also CDC, Preliminary FoodNet Data on the Incidence of Foodborne Illness-Selected Sites, United States, 2001, 51 MORBIDITY & MORTALITY WKLY. REP. (MMWR), Apr. 19, 2002, at 325-29, available at http: //www.cdc.gov/mmwr/preview/mmwrhtml/mm5115a3.htm (last visited Nov. 12, 2003).
10. The seven principles are variously described, but the International Commission on Microbiological Specifications for Food (ICMSF), the National Advisory Committee on Microbiological Criteria of Foods (NACMCF), and the U.S. Food and Drug Administration (FDA) define HACCP as consisting of these seven principles. FDA 2001 FOOD CODE, supra note 5, at 421-57.
11. See, e.g., Russell, supra note 1.
12. See FDA 2001 FOOD CODE, supra note 5, at 423.
13. I b i d.
14. See Douglas L. Archer, The Need for Flexibility in HACCP, 44(5) FOOD TECH. 174 (1990).
15. See id. See also A.V. Riswadkar, An Introduction to HACCP: The Hazard Analysis & Critical Control Point System for Food Processors, PROFESSIONAL SAFETY, June 2000, at 33-36.
16. See, e.g., INST. OF MED., NAT'L RESEARCH COUNCIL, NAT'L ACAD. OF SCIENCE, ENSURING SAFE FOOD: FROM PRODUCTION TO CONSUMPTION 29-30 (1998) ("It is widely accepted by the scientific community that use of HACCP systems in food production, processing, distribution, and preparation is the best known approach to enhancing the safety of foods.").
17. NAS REPORT, THE ROLE OF MICROBIOLOGICAL CRITERIA, supra note 5, at 329.
18. NAT'L ADVISORY COMM. ON THE MICROBIOLOGICAL CRITERIA FOR FOODs, U.S. DEP'T OF AGRICULTURE, HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEM (1990).
19. INTERNATIONAL COMMISSION ON MICROBIOLOGICAL SPECIFICATIONS FOR FOOD, MICROORGANISMS IN FOODS 2, SAMPLING FOR MICROBIOLOGICAL ANALYSIS: PRINCIPLES AND SPECIFIC APPLICATIONS (Univ. of Toronto Press 2d ed. 1986).
20. FDA 2001 FOOD CODE, supra note 5, at 424.
21. See Michael R. Taylor, Preparing America's Safety System 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. 13-14 (1997).
22. See Riswadkar, supra note 12, at 33-36.
23. See id.; JAMES M. JAY, MODERN FOOD MICROBIOLOGY 408 (5th ed. 1996).
24. FDA 2001 FOOD CODE, supra note 5, at 424 ("Traditional inspection is relatively resource-intensive and inefficient and is reactive rather than preventative compared to the HACCP approach for ensuring food safety.").
25. Charles E. Morris, HACCP Under the Microscope, FOOD ENG'G, Oct. 2000, at 74 (quoting Dr. Timothy Freier, Director of Educational Services for the Siliker Laboratory Group).
26. See Jean C. Buzby et al., Product Liability and Microbial Foodborne Illness /AER-799, at 3-4 (Economic Research Service/USDA 2001).
27. FDA 2001 FOOD CODE, supra note 5, at 424.
28. 21 C.F.R. § 113 (2000).
29. See Archer, supra note 11, at 174; Riswadkar, supra note 12, at 33-36.
30. See Mead et al., supra note 6, at 607 (citing F.L. BRIAN, DISEASES TRANSMITTED BY FOOD (Centers for Disease Control 1982)).
31. See Mead et al., supra note 6, at 607 (citing F.L. BRIAN, DISEASES TRANSMITTED BY FOOD (Centers for Disease Control 1982)).
32. A sequela is an aftereffect of disease or injury, or a secondary result of a disease.
33. See James A. Lindsay, Chronic Sequelae of Foodborne Disease, 3(4) EMERGING INFECTIOUS DISEASES 1 (1997), available at http://www.cdc.gov/ncidod/eid/vol3no4/lindsay.htm (last visited Nov. 10, 2003).
34. I b i d.
35. I b i d.
36. Id. See also U.S. GENERAL ACCOUNTING OFFICE (GAO), FOOD SAFETY, INFORMATION ON FOODBORNE ILLNESSES, GAO/RCED-96-96, at 8 (May 1996).
37. See Chryssa V. Deliganis, Death by Apple Juice: The Problem of Foodborne Illness, the Regulatory Response, and Further Suggestions for Reform, 53 FOOD & DRUG L.J. 681, 695 (1998) (citing E.J. Mundell, Food-Borne Illness on the Rise, REUTERS, Dec. 2, 1997, with the statements of Michael Osterholm, Epidemiologist, Minnesota Dep't of Health, at American Medical Ass'n press conference on public health (Dec. 2, 1997)).
38. See Chryssa V. Deliganis, Death by Apple Juice: The Problem of Foodborne Illness, the Regulatory Response, and Further Suggestions for Reform, 53 FOOD & DRUG L.J. 681, 695 (1998) (citing E.J. Mundell, Food-Borne Illness on the Rise, REUTERS, Dec. 2, 1997, with the statements of Michael Osterholm, Epidemiologist, Minnesota Dep't of Health, at American Medical Ass'n press conference on public health (Dec. 2, 1997)).
39. See Sanford A. Miller, The Saga of Chicken Little and Rambo, 51 J. ASS'N OF FOOD & DRUG OFFICIALS 196 (1987); Jean C. Buzby & Tanya Roberts, Economic Costs and Trade Impacts of Microbial Foodborne Illness, 50(1/2) WORLD HEALTH STAT. Q. 57 (1997).
40. See Sanford A. Miller, The Saga of Chicken Little and Rambo, 51 J. ASS'N OF FOOD & DRUG OFFICIALS 196 (1987); Jean C. Buzby & Tanya Roberts, Economic Costs and Trade Impacts of Microbial Foodborne Illness, 50(1/2) WORLD HEALTH STAT. Q. 57 (1997).
41. "Illness" as used here means that the disease is serious enough to require medical treatment.
42. CDC, FOODNET SURVEILLANCE REPORT FOR 1999 (FINAL REPORT) 6, 19 (Nov. 2000) (citing P. Mead et al., Food-Related Illness and Death in the United States, 5 EMERGING INFECTIOUS DISEASES 607 (1999)).
43. CDC, FOODNET SURVEILLANCE REPORT FOR 1999 (FINAL REPORT) 6, 19 (Nov. 2000) (citing P. Mead et al., Food-Related Illness and Death in the United States, 5 EMERGING INFECTIOUS DISEASES 607 (1999)).
44. See Buzby et al., supra note 23, at 3.
45. Miller, supra note 34, at 196.
46. JACK GUZEWICH & MARIANNE P. ROSS, FOOD AND DRUG ADMINISTRATION, EVALUATION OF RISKS RELATED TO MICROBIOLOGICAL CONTAMINATION OF READY-TO-EAT FOOD BY FOOD PREPARATION WORKERS AND THE EFFECTIVENESS OF INTERVENTIONS TO MINIMIZE THOSE RISKS 3 (citing J.C. Buzby & T. Roberts, Economic Costs and Trade Impacts of Microbial Foodborne Illness, 50(1/2) WORLD HEALTH STAT. Q. 57 (1997)).
47. JACK GUZEWICH & MARIANNE P. ROSS, FOOD AND DRUG ADMINISTRATION, EVALUATION OF RISKS RELATED TO MICROBIOLOGICAL CONTAMINATION OF READY-TO-EAT FOOD BY FOOD PREPARATION WORKERS AND THE EFFECTIVENESS OF INTERVENTIONS TO MINIMIZE THOSE RISKS 3 (citing J.C. Buzby & T. Roberts, Economic Costs and Trade Impacts of Microbial Foodborne Illness, 50(1/2) WORLD HEALTH STAT. Q. 57 (1997)).
48. See also GAO, FOOD SAFETY, INFORMATION ON FOODBORNE ILLNESSES, GAO/RCED-96-96, at 9 (May 1996).
49. GAO, FOOD SAFETY, INFORMATION ON FOODBORNE ILLNESSES, supra note 39, at 9.
50. See Lindsay, supra note 29, at 2.
51. See, e.g., Morris, supra note 22, at 74.
52. See, e.g., Russell, supra note 1.
53. See, e.g., ERIC SCHLOSSER, FAST FOOD NATION 197 (1st perennial ed. 2002) ("[T]he nation's leading agribusiness firms have resolutely opposed any further regulation of their food safety practices.")
54. See infra Figure 2, Escherichia coli O157:H7 Chronology.
55. I b i d.
56. 21 C.F.R. § 120.1(b)(2).
57. See Morris, supra note 22, at 74.
58. I b i d.
59. Id. ("[P]roduct is released despite critical control point (CCP) violations.")
60. I b i d.
61. See Richard S. Silverman, The Liability of HACCP Risk Assessment, in FOOD PROTECTION REPORT, 2A (1997).
62. See, e.g., John Cady, FDA Reform: The Need for a Sound Science-Based Approach, 51 FOOD & DRUG L.J. 407 (1996) ("HACCP requires a mindset change from distrustful enforcement to scientific cooperation.").
63. See, e.g., Silverman, supra note 52.
64. See, e.g., Cady, supra note 53.
65. CDC, FOODNET SURVEILLANCE REPORT FOR 1999, supra note 36, at 6.
66. See Lindsay, supra note 29, at 2.
67. See, e.g., GROCERY MANUFACTURERS OF AMERICA, FOOD SAFETY 1 (Sept. 24, 2001), available at http:/ /www.gmabrands.com/news/docs/WhitePaper.cfm?DocID= 290 (last visited Nov. 26, 2003) ("The FDA's and USDA's current authority to regulate food products is ample. There should be more emphasis on research and establishing science-based standards .... They must also be able to identify and fight the true causes of foodborne illnesses with the right scientific weapons. These weapons can only be discovered through laboratory research and practical testing.") See also Deliganis, supra note 33, at 727 ("Foodborne illness is a problem not because of widespread fraud or abuse in the food processing industry, but rather for numerous other reasons, some of which are not completely understood.").
68. See, e.g., id.; Cady, supra note 53.
69. GUZEWICH & ROSS, supra note 39, at 3.
70. Epidemiology is a field of medical science that deals with the incidence, distribution, and cause of disease in a population. By quantifying the occurrence of illness and statistically relating the occurrence to characteristics of the people and their environment (e.g., meal patterns), epidemiology can pinpoint disease causation.
71. The author suspects that both the food industry and government regulators are less likely to rely on scientific determinations based on epidemiology rather than determinations based on microbiology. Underutilization of epidemiology may be due to a cultural skepticism of statistics. See generally DARRELL HUFF, HOW TO LIE WITH STATISTICS (paperback reissue 1994).
72. Efficient in the sense of being the most cost-effective control system. HACCP is preventative, whereas traditional controls are relatively resource-intensive and inefficient because they are reactive. See subsection I. B., supra. In addition, food processing and packaging firms can reduce their cost of raw material inspections and qualitative testing, and redundant food safety testing may be eliminated. See Michael A. Mazzocco, HACCP as a Business Management Tool, 78 AM. J. AGRIC. ECON. 770, 771 (1996).
73. Jesse D. Lyon, Coordinated Food Systems and Accountability Mechanisms for Food Safety: A Law and Economics Approach, 53 FOOD & DRUG L.J. 729, 750 (1998) (quoting Jean Buzby & Tanya Roberts, Microbial Foodborne Illness: The Costs of Being Sick and the Benefits of New Prevention Policy, CHOICES 14, 15 (First Quarter 1996).
74. Jesse D. Lyon, Coordinated Food Systems and Accountability Mechanisms for Food Safety: A Law and Economics Approach, 53 FOOD & DRUG L.J. 729, 750 (1998) (quoting Jean Buzby & Tanya Roberts, Microbial Foodborne Illness: The Costs of Being Sick and the Benefits of New Prevention Policy, CHOICES 14, 15 (First Quarter 1996).
75. SCHLOSSER, supra note 44, at 210 (noting that the cost of the firm's complete HACCP system raised the cost of the chain's ground beef by about one penny per pound).
76. See, e.g., Russell, supra note 1, at 4 ("And safe products are everyone's business.").
77. See, e.g., JOHN M. ANTLE, CHOICE AND EFFICIENCY IN FOOD SAFETY POLICY 44-45, 54-55 (AEI Press 1995) ("If perfect information was available and consumers knowledgeable, then market controls are efficient. Post-hoc remedies are also efficient if perfect information is available after purchase.").
78. W. PAGE KEETON ET AL., PROSSER AND KEETON ON THE LAW OF TORTS 255 (5th ed. 1984).
79. Buzby et al., supra note 23, at 27.
80. See generally id. at 11; Taylor, supra note 18, at 13-14 ("Market mechanisms work reasonably well to satisfy consumer demands for economy, convenience, and choice in the food supply, but they cannot fully satisfy the very high consumer expectations for food safety.").
81. See Buzby et al., supra note 23, at 11 ("High transaction costs and information costs dissuade food-poisoning victims from filing lawsuits ... limit feedback to firms to produce safer food ... the result is a level of food safety that is less than the socially optimal level provided by a perfectly competitive market.").
82. See generally id.; Taylor, supra note 18, at 13-14.
83. Dion Casey, Agency Capture: The USDA's Struggle to Pass Food Safety Regulations, 7 KAN. J.L. & PUB. POL'Y 142, 144 (1998).
84. CDC, FOODNET SURVEILLANCE REPORT FOR 1999, supra note 36, at 6.
85. CDC, Update: Multistate Outbreak of Escherichia coli 0157:H7 Infections from Hamburgers-Western United States, 1992-1993, 42(14) MORBIDITY & MORTALITY WKLY. REP. (MMWR), Apr. 16, 1993, at 258 [hereinafter CDC, Multistate Outbreak-Western U.S.].
86. Id. (noting that foodborne illness outbreaks of 14 ill in Idaho, 34 ill in California, and 58 ill in Nevada may not have been recognized if the epidemiological link to 477 illnesses in Washington had not been established).
87. The incubation period is the time between ingestion of the infecting pathogen and the first appearance of symptoms of the consequent disease.
88. GUZEWICH & ROSS, supra note 39, at 5-6.
89. Id. at 6 (citing A.R. Walburton et al., Hepatitis A Outbreak Involving Bread, 106 EPIDEMIOL. INFECT. 199-202 (1991)).
90. O See Buzby et al., supra note 23, at 24.
91. See generally id.; Richard Merrill & Jeffrey Francer, Organizing Federal Food Safety Regulation, 31 SETON HALL L. REV. 61, 64 (2000).
92. In addition, many small businesses, particularly retail establishments, are judgment proof because they lack sufficient insurance or assets to remedy the injuries.
93. See Buzby et al., supra note 23, at 1.
94. CENTER FOR FOOD SAFETY & APPLIED NUTRITION, FOOD AND DRUG ADMIN., FOODBORNE PATHOGENIC MICROORGANISMS AND NATURAL TOXINS (BAD BUG BOOK), at http://www.cfsan.fda.gov/~mow/chap3.html (last visited Nov. 10, 2003); INT'L ASS'N OF MILK, FOOD AND ENVIRONMENTAL SANITARIAN, PROCEDURES TO INVESTIGATE FOODBORNE ILLNESS 102 (5th ed. 1999).
95. CENTER FOR FOOD SAFETY & APPLIED NUTRITION, FOOD AND DRUG ADMIN., FOODBORNE PATHOGENIC MICROORGANISMS AND NATURAL TOXINS (BAD BUG BOOK), at http://www.cfsan.fda.gov/~mow/chap3.html (last visited Nov. 10, 2003); INT'L ASS'N OF MILK, FOOD AND ENVIRONMENTAL SANITARIAN, PROCEDURES TO INVESTIGATE FOODBORNE ILLNESS 102 (5th ed. 1999).
96. Incubation period is the time between ingestion of the infecting pathogen and the first appearance of symptoms of the consequent disease. Latency period is the time between exposure to a toxin or other harmful agent and the first manifestation of reaction.
97. See CDC, Surveillance for Foodborne Disease Outbreaks-United States, 1990-1992, 45 MORBIDITY & MORTALITY WKLY. REP. (MMWR), Oct. 25, 1996, at 56; Economic Research Serv., USDA, Consumer Food Safety Behavior: Restaurants the Chief Target of Foodborne Illness Lawsuits, available at http://www.ers.usda.gov/briefing/consumerfoodsafety/feature.htm (last visited Nov. 10, 2003).
98. See CDC, Surveillance for Foodborne Disease Outbreaks-United States, 1990-1992, 45 MORBIDITY & MORTALITY WKLY. REP. (MMWR), Oct. 25, 1996, at 56; Economic Research Serv., USDA, Consumer Food Safety Behavior: Restaurants the Chief Target of Foodborne Illness Lawsuits, available at http://www.ers.usda.gov/briefing/consumerfoodsafety/feature.htm (last visited Nov. 10, 2003).
99. See Figure 1.
100. The CDC estimates that each year foodborne illness causes 76 million illnesses, 320,000 hospitalizations, and 5,000 deaths in the United States. See CDC, FOODNET SURVEILLANCE REPORT FOR 1999, supra note 36, at 6, 19 (citing P. Mead et al., Food-Related Illness and Death in the United States, 5 EMERGING INFECTIOUS DISEASES 607 (1999)).
101. The CDC estimates that each year foodborne illness causes 76 million illnesses, 320,000 hospitalizations, and 5,000 deaths in the United States. See CDC, FOODNET SURVEILLANCE REPORT FOR 1999, supra note 36, at 6, 19 (citing P. Mead et al., Food-Related Illness and Death in the United States, 5 EMERGING INFECTIOUS DISEASES 607 (1999)).
102. GUZEWICH & Ross, supra note 39, at 3 (citing C.B. Dalton et al., The Cost of Food-Borne Outbreak of Hepatitis A in Denver, Colo., 156 ARCH. INTERN. MED. 1013 (1996) (this study estimated the total societal cost of a particular outbreak of Hepatitis A at $809,706)); Jean C. Buzby & Tanya Roberts, Economic Costs and Trade Impacts of Microbial Foodborne Illness, 50(1/2) WORLD HEALTH STAT. Q. 57 (1997) (estimates of the annual cost of medical treatment and lost productivity from five major foodborne pathogens range from $6. 6 billion to $37.1 billion).
103. GUZEWICH & Ross, supra note 39, at 3 (citing C.B. Dalton et al., The Cost of Food-Borne Outbreak of Hepatitis A in Denver, Colo., 156 ARCH. INTERN. MED. 1013 (1996) (this study estimated the total societal cost of a particular outbreak of Hepatitis A at $809,706)); Jean C. Buzby & Tanya Roberts, Economic Costs and Trade Impacts of Microbial Foodborne Illness, 50(1/2) WORLD HEALTH STAT. Q. 57 (1997) (estimates of the annual cost of medical treatment and lost productivity from five major foodborne pathogens range from $6. 6 billion to $37.1 billion).
104. GUZEWICH & Ross, supra note 39, at 3 (citing C.B. Dalton et al., The Cost of Food-Borne Outbreak of Hepatitis A in Denver, Colo., 156 ARCH. INTERN. MED. 1013 (1996) (this study estimated the total societal cost of a particular outbreak of Hepatitis A at $809,706)); Jean C. Buzby & Tanya Roberts, Economic Costs and Trade Impacts of Microbial Foodborne Illness, 50(1/2) WORLD HEALTH STAT. Q. 57 (1997) (estimates of the annual cost of medical treatment and lost productivity from five major foodborne pathogens range from $6. 6 billion to $37.1 billion).
105. See Buzby et al., supra note 23, at 1.
106. Consumers cannot determine the safety before purchase because food pathogens are generally invisible, usually odorless, and tasteless. After an illness strikes, consumers rarely can identify the food that caused the illness. See Section II for a more thorough discussion of foodborne illness investigation and the difficulties in establishing causation.
107. Other factors may contribute to industry resistance to HACCP; however, without scientific risk controls for pathogens, there can be no HACCP. Step one of HACCP begins with the identification of the risk, and the next six steps involve controlling identified risks. This article focuses on the implementation of science-based risk controls because this step is foundational for all other aspects of HACCP.
108. See Figure 2, Escherichia coli O157:H7 Chronology.
109. JAY, MODERN FOOD MICROBIOLOGY 527-34 (5th ed. 1996).
110. Casey, supra note 73, at 142.
111. See Figure 2, Escherichia coli O157:H7 Chronology.
112. JAY, supra note 94, at 527.
113. Casey, supra note 73, at 147-49 ("[A]ccording to Carol Foreman, an Assistant Secretary of Agriculture under President Carter, USDA and FSIS officials generally ignored the NAS report. Agency officials also failed to pay heed to a 1987 report that urged the FSIS to change to a science-based inspection system and predicted that more food-poisoning illnesses and deaths would occur if the agency failed to do so.")
114. CDC, Multistate Outbreak-Western U.S., supra note 75, at 258; CDC, Outbreak of Escherichia coli O157:H7 Infection-Georgia and Tennessee, 1992-1993, 45(12) MORBIDITY & MORTALITY WKLY. REP. (MMWR), Mar. 29, 1996, at 249.
115. CDC, Multistate Outbreak-Western U.S., supra note 75, at 258; CDC, Outbreak of Escherichia coli O157:H7 Infection-Georgia and Tennessee, 1992-1993, 45(12) MORBIDITY & MORTALITY WKLY. REP. (MMWR), Mar. 29, 1996, at 249.
116. See CDC, E. coli O157:H7 (chronology) (1997), at http://phil.cdc.gov/phil/detail.asp?id=107 (last visited Feb. 13, 2002).
117. JAY, supra note 94, at 527.
118. I b i d.
119. I b i d.
120. I b i d.
121. CDC, Multistate Outbreak-Western U.S., supra note 75, at 258.
122. Casey, supra note 73, at 147.
123. I b i d.
124. CDC, E. coli O157:H7 (chronology), supra note 100.
125. I b i d.
126. U.S. GENERAL ACCOUNTING OFFICE (GAO), FOOD SAFETY: RISK-BASED INSPECTION AND MICROBIAL MONITORING NEEDED FOR MEAT AND POULTRY, GAO-94-110, at 4 (1994) [hereinafter GAO REPORT, FOOD SAFETY: RISK-BASED INSPECTION].
127. CDC, E. coli O157:H7 (chronology), supra note 100.
128. I b i d.
129. I b i d.
130. I b i d.
131. CDC, Multistate Outbreak-Western U.S., supra note 75, at 258; Casey, supra note 73, at 148.
132. CDC, E. coli O157:H7 (chronology), supra note 100.
133. 60 Fed. Reg. 6774 (1995).
134. SCHLOSSER, supra note 44, at 194 (citing Steve Kay, Hudson Recall Was Larger Than Reported CATTLE BUYERS WKLY., Sept. 29, 1997).
135. SCHLOSSER, supra note 44, at 194 (citing Steve Kay, Hudson Recall Was Larger Than Reported CATTLE BUYERS WKLY., Sept. 29, 1997).
136. Pathogen Reduction: Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule, 61 Fed. Reg. 38,806 (1996) (codified as 9 C.F.R. pts. 304, 308, 310, 320, 327, 381, 416, and 417).
137. CDC, E. coli O157:H7 (chronology), supra note 100. See also U.S. Health and Human Services News Release, FDA Publishes Final Rule to Increase Safety of Fruit and Vegetable Juices (Jan. 18, 2001).
138. CDC, E. coli O157:H7 (chronology), supra note 100. See also U.S. Health and Human Services News Release, FDA Publishes Final Rule to Increase Safety of Fruit and Vegetable Juices (Jan. 18, 2001).
139. Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice; Final Rule, 66 Fed. Reg. 6137 (2001) (codified as 21 C.ER. pt. 120).
140. I b i d.
141. SCHLOSSER, supra note 44, at 194 (citing Steve Kay, Hudson Recall Was Larger Than Reported, CATTLE BUYERS WKLY., Sept. 29, 1997).
142. SCHLOSSER, supra note 44, at 194 (citing Steve Kay, Hudson Recall Was Larger Than Reported, CATTLE BUYERS WKLY., Sept. 29, 1997).
143. See, e.g., Casey, supra note 73, at 142, 148.
144. Janis Sowerby, The Human Face of Foodborne Disease, in FOOD PROTECTION REPORT 2A (Dec. 1993).
145. 60 Fed. Reg. 6774 (1995).
146. GAO REPORT, FOOD SAFETY: RISK-BASED INSPECTION, supra note 110, at 4.
147. SCHLOSSER, supra note 44, at 215 (e.g., unlike government inspections reports, the records compiled by firms are unavailable to the public, firms are not required to test for known lethal pathogens (e.g., E. coli O157:H7), and meat containing pathogens could still be sold to the public) (citing OFFICE OF INSPECTOR GENERAL, USDA, FOOD SAFETY AND INSPECTION SERVICE: IMPLEMENTATION OF THE HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEM, Report No. 24001-3-AT (June 2000.)
148. SCHLOSSER, supra note 44, at 215 (e.g., unlike government inspections reports, the records compiled by firms are unavailable to the public, firms are not required to test for known lethal pathogens (e.g., E. coli O157:H7), and meat containing pathogens could still be sold to the public) (citing OFFICE OF INSPECTOR GENERAL, USDA, FOOD SAFETY AND INSPECTION SERVICE: IMPLEMENTATION OF THE HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEM, Report No. 24001-3-AT (June 2000.)
149. SCHLOSSER, supra note 44, at 197.
150. E.g., James A. Albert, A History of Attempts by the Department of Agriculture to Reduce Federal Inspection of Poultry Processing Plants- A Return to the Jungle, 51 LA. L. REV. 1183 (1991); THE CENTER FOR PUBLIC INTEGRITY, SAFETY LAST, THE POLITICS OF E. COLI AND OTHER FOOD-BORNE KILLERS (1998); SCHLOSSER, supra note 44, at 197; Casey, supra note 73, at 141.
151. E.g., James A. Albert, A History of Attempts by the Department of Agriculture to Reduce Federal Inspection of Poultry Processing Plants- A Return to the Jungle, 51 LA. L. REV. 1183 (1991); THE CENTER FOR PUBLIC INTEGRITY, SAFETY LAST, THE POLITICS OF E. COLI AND OTHER FOOD-BORNE KILLERS (1998); SCHLOSSER, supra note 44, at 197; Casey, supra note 73, at 141.
152. E.g., James A. Albert, A History of Attempts by the Department of Agriculture to Reduce Federal Inspection of Poultry Processing Plants- A Return to the Jungle, 51 LA. L. REV. 1183 (1991); THE CENTER FOR PUBLIC INTEGRITY, SAFETY LAST, THE POLITICS OF E. COLI AND OTHER FOOD-BORNE KILLERS (1998); SCHLOSSER, supra note 44, at 197; Casey, supra note 73, at 141.
153. SCHLOSSER, supra note 44, at 199 (citing Paul S. Mead et al., Food-Related Illness and Death in the United States, 5 EMERGING INFECTIOUS DISEASES 607 (1999) (noting 73,480 illnesses, 2,168 hospitalizations, and 61 deaths-multiplied by 8)).
154. SCHLOSSER, supra note 44, at 199 (citing Paul S. Mead et al., Food-Related Illness and Death in the United States, 5 EMERGING INFECTIOUS DISEASES 607 (1999) (noting 73,480 illnesses, 2,168 hospitalizations, and 61 deaths-multiplied by 8)).
155. MICHAEL E. PORTER, THE COMPETITIVE ADVANTAGE OF NATIONS 648-49 (1990).
156. I b i d.
157. See, e.g., Taylor, supra note 18, at 13-14 ("The importance of proper food safety regulation to protect public health and maintain public confidence in the food supply is widely accepted."). See generally IAN AYRES & JOHN BRAITHWAITE, RESPONSIVE REGULATION: TRANSCENDING THE DEREGULATION DEBATE 63 (1992) (A strong government state helps create strong markets. Historically, advanced capitalism did not appear until central states acquired considerable authority to enforce contract law, impose antitrust law, and build an infrastructure to support communication and travel.).
158. See, e.g., Taylor, supra note 18, at 13-14 ("The importance of proper food safety regulation to protect public health and maintain public confidence in the food supply is widely accepted."). See generally IAN AYRES & JOHN BRAITHWAITE, RESPONSIVE REGULATION: TRANSCENDING THE DEREGULATION DEBATE 63 (1992) (A strong government state helps create strong markets. Historically, advanced capitalism did not appear until central states acquired considerable authority to enforce contract law, impose antitrust law, and build an infrastructure to support communication and travel.).
159. Casey, supra note 73, at 142 (quoting John Sheppard Wiley, Jr., A Capture Theory of Antitrust Federalism, 99 HARV. L. REV. 713, 722 (1986)).
160. Casey, supra note 73, at 142 (quoting John Sheppard Wiley, Jr., A Capture Theory of Antitrust Federalism, 99 HARV. L. REV. 713, 722 (1986)).
161. AYRES & BRAITHWAITE, supra note 134, at 63.
162. Matthew D. Zinn, Policing Environmental Regulatory Enforcement: Cooperation, Capture, and Citizen Suits, 21 STAN. ENVTL. L.J. 81, 107 (2002).
163. See AYRES & BRAITHWAITE, supra note 134, at 63.
164. See, e.g., Mark Seidenfeld, Bending the Rules: Flexible Regulation and Constraints on Agency Discretion, 51 ADMIN. L. REV. 429, 462 (1999).
165. See, e.g., Casey, supra note 73, at 142, 143 (1) Limits on an agency's resources can create reliance on the regulated industries; 2) a regulated firm has much more at stake than each individual member of the public; 3) the transaction costs of organizing taxpayers are much higher than for small groups, such as industry trade associations; 4) industry know the "ins and outs" of an agency's structure and operations (and have an edge over public interest groups); 5) a "revolving door," where regulated firms hire former agency employees; and 6) regulated industries lobby not only the regulators, but also the political masters of the agency).
166. SCHLOSSER, supra note 44, at 3 (citing the National Restaurant Ass'n).
167. HACCP emphasizes industry's role in continuous quality, problem solving, and prevention, rather than relying on periodic government regulatory inspections to identify and solve problems by ordering specific corrective measures.
168. See, e.g., Casey, supra note 73, at 141.
169. ROBERT V. PERCIVAL ET AL., ENVIRONMENTAL REGULATION 182 (2d ed. 1996) (citing JOE SAX, DEFENDING THE ENVIRONMENT 60-61 (1970)).
170. ROBERT V. PERCIVAL ET AL., ENVIRONMENTAL REGULATION 182 (2d ed. 1996) (citing JOE SAX, DEFENDING THE ENVIRONMENT 60-61 (1970)).
171. See, e.g., AYRES & BRAITHWAITE, supra note 134, at 80 ("Most of us regularly conciliate in circumstances where we could achieve a better result by fighting; we do this because fighting is nasty and unpleasant ...little wonder they [regulators] seek to minimize their exposure to conflict even when it is in the public interest.")
172. Barry Boyer & Errol Meidinger, Privatizing Regulatory Enforcement, 34 BUFF. L. REV. 833, 880 (1985).
173. See Albert, supra note 130, at 1183-92.
174. JOSEPH L. SAX, DEFENDING THE ENVIRONMENT 53 (1970).
175. I b i d.
176. I b i d.
177. I b i d.
178. I b i d.
179. Id. at 56.
180. See, e.g., Casey, supra note 73, at 148.
181. Lyon, supra note 64, at 750.
182. Id. at 753.
183. NAS, ENSURING SAFE FOOD, supra note 13, at 3.
184. Casey, supra note 73, at 148.
185. Lyon, supra note 64, at 750.
186. Robert Pestronk, Ward Lindsay, Neal Fortin, Brendon Kearney & Robert Eadie, Protecting Our Vulnerable Food Supply, 30(Supp.) J.L. MED. & ETHICS 101 (Fall 2002).
187. See e.g., id.
188. See generally AYRES & BRAITHWAITE, supra note 134, at 31.
189. Buzby et al., supra note 23, at 27.
190. Raymond Formanek, Jr., An Interview With Joseph A. Levitt: Food for Thought, FDA CONSUMER, Sept.-Oct. 2001, at 13.
191. See, e.g., MICHIGAN DEP'T OF AGRICULTURE, APPROPRIATIONS REPORTING REQUIREMENT: LOCAL HEALTH DEPARTMENT CONFORMANCE WITH FOOD SERVICE SANITATION REGULATORY PROGRAM MINIMUM REQUIREMENTS, MARCH 1998 THROUGH SEPTEMBER 2001, at 18 (Nov. 2001) (23% of Michigan's food service regulatory programs failed to implement minimum foodborne illness investigation and surveillance systems) available at http://www.michigan.gov/documents/MDA_ LHD_MPR_Conformance_2001_15768_7.pdf (last visited Nov. 10, 2003).
192. Daniel A. Farber & Phillip P. Frickey, In the Shadow of the Legislature: The Common Law in the Age of the New Public Law, 89 MICH. L. REV. 875, 879 (1991).
193. CARL W. HALL & G. MALCOLM TROUT, MILK PASTEURIZATION 2-4 (1968).
194. Id. at 9-11.
195. Id. at 11.
196. Public Citizen v. Heckler, 602 F. Supp. 611, 612, 614 (1985); Public Citizen v. Heckler, 653 F. Supp. 1229, 1241 (D.D.C. 1986).
197. Public Citizen v. Heckler, 602 F. Supp. 611, 612, 614 (1985); Public Citizen v. Heckler, 653 F. Supp. 1229, 1241 (D.D.C. 1986).
198. Lars Noah, Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability, 88 GEO. L.J. 2147, 2155 (2000) (citing successful judicial challenges to FDA's failure to act on petitions filed by Public Citizen that had requested rulemaking to require warnings of Reye's syndrome, Public Citizen Health Research Group v. Food & Drug Admin., 740 F.2d 21, 34-35 (D.C. Cir. 1984); toxic shock syndrome, Public Citizen Health Research Group v. Food & Drug Admin., 724 F. Supp. 1013, 1019-22 (D.D.C. 1989); and a ban on interstate sale of raw milk, Public Citizen v. Heckler, 653 F. Supp. 1229, 1241 (D.D.C. 1986)).
199. Lars Noah, Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability, 88 GEO. L.J. 2147, 2155 (2000) (citing successful judicial challenges to FDA's failure to act on petitions filed by Public Citizen that had requested rulemaking to require warnings of Reye's syndrome, Public Citizen Health Research Group v. Food & Drug Admin., 740 F.2d 21, 34-35 (D.C. Cir. 1984); toxic shock syndrome, Public Citizen Health Research Group v. Food & Drug Admin., 724 F. Supp. 1013, 1019-22 (D.D.C. 1989); and a ban on interstate sale of raw milk, Public Citizen v. Heckler, 653 F. Supp. 1229, 1241 (D.D.C. 1986)).
200. Lars Noah, Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability, 88 GEO. L.J. 2147, 2155 (2000) (citing successful judicial challenges to FDA's failure to act on petitions filed by Public Citizen that had requested rulemaking to require warnings of Reye's syndrome, Public Citizen Health Research Group v. Food & Drug Admin., 740 F.2d 21, 34-35 (D.C. Cir. 1984); toxic shock syndrome, Public Citizen Health Research Group v. Food & Drug Admin., 724 F. Supp. 1013, 1019-22 (D.D.C. 1989); and a ban on interstate sale of raw milk, Public Citizen v. Heckler, 653 F. Supp. 1229, 1241 (D.D.C. 1986)).
201. The model draws heavily from the Michigan Environmental Protection Act originally drafted by Joseph Sax and enacted as 1970 Mich. Pub. Acts 127.
202. Cf. SAX, supra note 148, at 248.
203. SAX, supra note 148, at 56.
204. Phillip M. Bender, Slowing the Net Loss of Wetlands: Citizen Suit Enforcement of Clean Water Act S 404 Permit Violations, 27 ENVTL. L. 245, 263 (1997).
205. E.g., the Clean Water Act, 42 U.S.C. § 7604 (1994), Federal Water Pollution Control Act, 33 U.S.C. 1365 (1994); and Endangered Species Act, 16 U.S.C. § 1540(g) (1994). The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is one exception.
206. E.g., the Clean Water Act, 42 U.S.C. § 7604 (1994), Federal Water Pollution Control Act, 33 U.S.C. 1365 (1994); and Endangered Species Act, 16 U.S.C. § 1540(g) (1994). The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is one exception.
207. Before the industrialization and centralization of food production, traditional tort law offered this right, because producers and consumers generally knew each other (so causation was not as problematic as today) and scientific and technological change was less rapid.
208. See generally PORTER, supra note 132.
209. SAX, supra note 148, at xviii.