Preparing America's food 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?

Food and Drug Law Journal

Volumn 52, Issue 1, 1997, Pages 13-30

  Taylor, Michael R ^a  

^a RESOURCES FOR THE FUTURE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONSUMER; ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; FOOD HANDLING; FOOD SAFETY; MORBIDITY; REVIEW; RISK ASSESSMENT;

CONSUMER PRODUCT SAFETY; FOOD CONTAMINATION; FOOD INDUSTRY; FOOD MICROBIOLOGY; FOOD POISONING; FOOD TECHNOLOGY; FOODBORNE DISEASES; HUMANS; INTERNATIONAL COOPERATION; LEGISLATION, FOOD; MEAT; QUALITY CONTROL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030895493     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (60)

1. In 1993, American consumers spent $617.1 billion on food, $511 billion of which was spent on foods originating on U.S. farms. U.S. DEP'T OF AGRIC., AGRICULTURE FACT BOOK 1996, at 7-9 (1996). The employment estimate includes people employed on farms, in food processing, and at retail. Id. at 23; U.S. DEP'T OF COMMERCE, STATISTICAL ABSTRACT OF THE UNITED STATES 1996, at 762, 862-63 (1996). The export figure is USDA's widely reported estimate for 1996, which is up sharply from the 1994 figure of $45.7 billion. Id. at 673.
2. In 1993, American consumers spent $617.1 billion on food, $511 billion of which was spent on foods originating on U.S. farms. U.S. DEP'T OF AGRIC., AGRICULTURE FACT BOOK 1996, at 7-9 (1996). The employment estimate includes people employed on farms, in food processing, and at retail. Id. at 23; U.S. DEP'T OF COMMERCE, STATISTICAL ABSTRACT OF THE UNITED STATES 1996, at 762, 862-63 (1996). The export figure is USDA's widely reported estimate for 1996, which is up sharply from the 1994 figure of $45.7 billion. Id. at 673.
3. This is evidenced by the continuing problems of Salmonella enteriditis in eggs, Vibrio vulnificus in raw oysters, and Salmonella and Campylobacter contamination of meat and poultry; the recent outbreaks of illness associated with Cryptosporidium in drinking water and Cyclospora on imported fruit; and the continued emergence around the world of E. coli 0157:H7 and related strains of toxin-producing bacteria as dangerous foodborne pathogens.
4. Recent examples include food irradiation to kill harmful bacteria, the noncaloric fat substitute Olestra, and genetic modification of food crops.
5. An illustration of this are the obstacles raised recently in Europe to American exports of genetically modified corn and soybeans, and beef from cows treated with hormones.
6. The information concerning food safety risks that consumers would need to make safety-based purchase decisions often is not available or useful to most consumers, and post-hoc remedies through the private liability system generally are insufficient, due in part to the complex and difficult-to-prove chain of causation commonly associated with cases of foodborne illness. See generally JOHN M. ANTLE, CHOICE AND EFFICIENCY IN FOOD SAFETY POLICY (AEI Press 1995).
7. Pure Food and Drugs Act of 1906, Pub. L. No. 59-384, 34 Stat. 768.
8. 60 Fed. Reg. 65,096 (Dec. 18, 1995).
9. 61 Fed. Reg. 38,806 (July 25, 1996).
10. The Codex Alimentarius Commission of the United Nations, whose food safety standards are deemed by the Sanitary and Phytosanitary Agreement (S&P Agreement) within the General Agreement on Tariffs and Trade to be presumptively valid for purposes of complying with the S&P Agreement, has endorsed HACCP. The European Union has adopted HACCP principles for seafood and is considering HACCP for meat and poultry.
11. For a more detailed description of FDA's approach to food safety regulation, see Michael R. Taylor, Food Safety Regulation, in FOOD AND DRUG LAW 182 (FDLI 1991).
12. Pub. L. No. 75-717, § 402, 52 Stat, 1040, 1046 (1938) (codified as amended 21 U.S.C. § 342 (1994)).
13. This does not include the approximately 750,000 restaurants, grocery stores, and other retail outlets, most of which fall within FDA's jurisdiction as a legal matter but are overseen primarily by state and local food safety authorities. See U.S. DEP'T OF COMMERCE, supra note 2, at 763.
14. FDA also can seek court injunctions to prevent future adulteration violations or criminally prosecute those responsible for adulterating food, but the agency rarely resorts to these remedies.
15. See also the preamble to USDA's proposed rules on HACCP, which provides an overview and history of the USDA food safety program. 60 Fed. Reg. 6774 (Feb. 3, 1995).
16. Pub. L. No. 59-242, 34 Stat. 1260 (1907) (codified at 21 US.C. §§ 601 et seq.).
17. Pub. L. No. 85-172,71 StaT. 441 (1957) (codified at 21 U.S.C. §§ 451 et seq.).
18. In 1994, USDA inspectors individually examined approximately 130,000,000 head of livestock (mostly cattle and swine) and 7.5 billion chickens, turkeys, and other poultry. U.S. DEP'T OF ACRIC., MEAT AND POULTRY INSPECTION - 1994 REPORT OF THE SECRETARY OF AGRJCULTURE TO THE U.S. CONGRESS 39-40 (1995).
19. 60 Fed. Reg. at 6780.
20. This policy was changed in October 1994 with the determination by USDA that the presence of any amount of E. coli 0157:H7 in raw ground beef legally adulterates that product. The policy change was upheld in court. See Texas Food Industry Ass'n v. Espy, 870 F. Supp. 143 (W.D. Tex. 1994).
21. In connection with its HACCP rulemaking, USDA estimated that the four microbial pathogens most commonly occurring in meat and poultry plants could contribute annually to as many as 5000 deaths and 4,000,000 cases of foodborne illness. 61 Fed. Reg. at 38,964-95. See also ECONOMIC RESEARCH SERV., USDA, BACTERIAL FOOOBORNE DISEASE: MEDICAL COSTS AND PRODUCTIVITY LOSSES (Agric. Econ. Rep. No. 741) (1996). Through a combination of steps, including the prevention and removal of contamination, effective cooling during transportation and storage, and proper handling and cooking at retail and in the home, these deaths and illnesses are largely preventable.
22. FOOD SAFETY & INSPECTION SERV., USDA, REPORT ON THE ESCHARICHIA COLI 0157:H7 OUTBREAK IN THE WESTERN STATES 1, 21 (1993).
23. 21 U.S.C. §§ 453(e), 601(j); 9 C.F.R. §§ 301.2(qq), (rr), 381.1(b)(40) (1996).
24. Pub. L. No. 91-597, §§ 4(f), 5(a), 23(c), 84 Stat. 1620 (1970) (codified at 21 U.S.C. §§ 1033(f), 1034(a), 1052(c)). 7 C.F.R. § 59.5 (1996) (definition of "egg product").
25. Food Quality Protection Act of 1996, Pub. L. No. 104-170, 110 Stat. 1489.
26. FDA sets "action levels," which express the amount of a pesticide residue on a nontarget crop or commodity that may trigger FDA enforcement action. 21 C.F.R. pt. 109 (1996).
27. Of these, FDA, the National Institutes of Health, and USDA's Agricultural Research Service have the largest research budgets. See generally FEDERAL COORDINATING COUNCIL FOR SCIENCE, ENG'G, AND TECH., AN OVERVIEW OF FEDERAL FOOD SAFETY RESEARCH - INCLUDING RESEARCH NEEDS FOR THE FUTURE (1993).
28. FOOD & DRUG ADMIN., U.S. PUBLIC HEALTH SERV., FOOD CODE - 1995 RECOMMENDATIONS OF THE UNITED STATES PUBLIC HEALTH SERVICE (Sept. 1995).
29. VICE PRESIDENT AL GORE, CREATING A GOVERNMENT THAT WORKS BETTER AND COSTS LESS - REPORT OF THE NATIONAL PERFORMANCE REVIEW 101 (1993).
30. NATIONAL RESEARCH COUNCIL/NATIONAL ACADEMY OF SCIENCES, MEAT AND POULTRY INSPECTION - THE SCIENTIFIC BASIS OF THE NATION'S PROGRAM 8-9, 124-37 (1985).
31. 60 Fed. Reg. 6774 (Feb. 3, 1995).
32. 59 Fed. Reg. 4142 (Jan. 28, 1994).
33. USDA's HACCP rules require that HACCP plans address all significant hazards, including any microbial pathogens likely to pose a significant hazard. 21 C.F.R. § 417.2; 61 Fed. Reg. at 38,869. USDA also established specific performance standards for reducing Salmonella contamination in slaughter plants. 9 C.F.R. §§ 31025(b), 381.94(b); 61 Fed. Reg. at 38,865, 38,867.
34. USDA's HACCP rules require that HACCP plans address all significant hazards, including any microbial pathogens likely to pose a significant hazard. 21 C.F.R. § 417.2; 61 Fed. Reg. at 38,869. USDA also established specific performance standards for reducing Salmonella contamination in slaughter plants. 9 C.F.R. §§ 31025(b), 381.94(b); 61 Fed. Reg. at 38,865, 38,867.
35. 21 U.S.C. §§ 455(b), 604, 606.
36. As part of its regulatory reform strategy to support HACCP and improve the allocation of responsibilities between FSIS and the industry, FSIS has published rulemaking proposals to eliminate its prior approval systems for facility blueprints and equipment. 61 Fed. Reg. 19,578 (May 2, 1996). USDA also intends to rely more heavily on plant managers to decide when a plant has been properly cleaned in accordance with the plant's own sanitation standard operating procedure and is ready to commence daily operations. 61 Fed. Reg. at 38,829-35.
37. As part of its regulatory reform strategy to support HACCP and improve the allocation of responsibilities between FSIS and the industry, FSIS has published rulemaking proposals to eliminate its prior approval systems for facility blueprints and equipment. 61 Fed. Reg. 19,578 (May 2, 1996). USDA also intends to rely more heavily on plant managers to decide when a plant has been properly cleaned in accordance with the plant's own sanitation standard operating procedure and is ready to commence daily operations. 61 Fed. Reg. at 38,829-35.
38. Id. at 38,835-54.
39. To support implementation of HACCP, President Clinton also is seeking additional resources as part of his fiscal year 1998 budget to increase the frequency of inspection in seafood establishments. The White House, Office of the Press Secretary, transcript of Radio Address of the President to the Nation (Jan. 25, 1997) (transcript and accompanying material on file with author).
40. The current mode of slaughter inspection is labor-intensive, consumes approximately half of USDA'S inspection resources, and devotes substantial attention to carcass conditions that do not relate to food safety. See generally NATIONAL RESEARCH COUNCIL/NATIONAL ACADEMY OF SCIENCES, POULTRY INSPECTION - THE BASIS FOR A RISK-ASSESSMENT APPROACH (1987). USDA plans to develop and test alternative inspection models that would make better use of the agency's resources to improve food safety and implement HACCP.
41. Pilot Project to Evaluate Inspector Redeployment, FOOD CHEM. NEWS, Aug, 1996, at 26.
42. 61 Fed. Reg. at 38,810-11.
43. 61 Fed. Reg. 57,790 (Nov. 8, 1996).
44. 61 Fed. Reg. at 38,807.
45. DEP'T OF HEALTH AND HUMAN SERVS., HEALTHY PEOPLE 2000 - NATIONAL HEALTH PROMOTION AND DISEASE PREVENTION OBJECTIVES (U.S. Gov't Printing Off. 1990).
46. JEAN C. BUZBY, ET AL., BACTERIAL FOODBORNE DISEASE - MEDICAL COSTS AND PRODUCTIVITY LOSSES I (USDA Agric. Econ. Report No. 741, 1996).
47. 9 C.F.R. §§ 317.2(1), 381.125.
48. In the case of food additives, for example, approval depends on a finding of safety and a showing that the additive will accomplish its intended effect, but the statute does not permit any showing of benefits to offset potential safety risks. 21 U.S.C. § 348(c).
49. Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784 (codified at 21 U.S.C. § 348).
50. See H.R. REP. No. 2284, 85th Cong., 2d Sess. (1958).
51. Agreement on the Application of Sanitary and Phytosanitary Measures, in Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, opened for signature Apr. 15, 1994, at 69, reprinted in Uruguay Round Trade Agreements, Text of Agreements, Implementing Bill, Statement of Administrative Action, and Required Supporting Statements, H.R. Doc. No. 316, 103d Cong., 2d Sess. 1381 (1994).
52. See, e.g., GENERAL ACCOUNTING OFFICE, FDA CAN IMPROVE MONITORING OF IMPORTED CHEESE (GAO/RCED-92-21O, 1992); GENERAL ACCOUNTING OFFICE, IMPORTED FOODS: OPPORTUNITIES TO IMPROVE FDA's INSPECTION PROGRAM (GAO/HRD-89-88, 1989).
53. See, e.g., GENERAL ACCOUNTING OFFICE, FDA CAN IMPROVE MONITORING OF IMPORTED CHEESE (GAO/RCED-92-21O, 1992); GENERAL ACCOUNTING OFFICE, IMPORTED FOODS: OPPORTUNITIES TO IMPROVE FDA's INSPECTION PROGRAM (GAO/HRD-89-88, 1989).
54. Riley E. Dunlap & Curtis E. Beus, Understanding Public Concerns About Pesticides: An Empirical Examination, 26 J. CONSUMER AFF. 418 (1992).
55. John Darton, The Logic of the "Mad Cow" Scare, N.Y. TIMES (late edition), Mar. 31, 1996, § 4, at 1.
56. In a recent survey for the Food Marketing Institute, 84% of shoppers said they were completely or mostly confident that supermarket food is safe. FOOD MARKETING INST., TRENDS IN THE UNITED STATES -CONSUMER ATTITUDES AND THE SUPERMARKET, 1996, at 29 (1996).
57. FDA conducted about 16,000 food inspections in 1980, compared to about 5000 food inspections in 1996. Personal conversation with Dr. Karen Hulebak, Office of Policy, FDA (Feb. 18 1997).
58. See, e.g., FSIS Budget Request Would be Funded by Industry User Fees, FOOD CHEM. NEWS, Feb. 10, 1997, at 31; FDA Budget Indicates Food and Animal Drug User Fees, FOOD CHEM. NEWS, Feb. 10, 1997, at 44.
59. See, e.g., FSIS Budget Request Would be Funded by Industry User Fees, FOOD CHEM. NEWS, Feb. 10, 1997, at 31; FDA Budget Indicates Food and Animal Drug User Fees, FOOD CHEM. NEWS, Feb. 10, 1997, at 44.
60. See The White House, Office of the Press Secretary, supra note 36.