Testimonies and Speeches
 
Testimony of Caroline Smith DeWaal
Director of Food Safety
before the
Senate Committee on Governmental Affairs
on
“Overlap and Duplication in the Federal Food Safety System”

Washington, D.C.
August 4, 1999


   My name is Caroline Smith DeWaal and I am director of food safety for the Center for Science in the Public Interest (CSPI). CSPI is a non-profit organization based in Washington, D.C. Since 1971, CSPI has been working to improve the public’s health, largely through its work on nutrition and food-safety issues. CSPI is supported primarily by the one million subscribers to its Nutrition Action Healthletter, the largest circulation health newsletter in North America.

   Food-safety experts believe that contaminated food causes up to 33 million illnesses and 9,000 deaths each year.(1) These estimates illuminate the magnitude of the problem with food-borne illness in the US. For many consumers, the aggregate numbers mean less than the specific outbreaks and recalls, which have awakened them to the fact that the risk from contaminated food is greater than they thought. Parents shouldn’t have to fear the consequences of serving their children apple cider or a meal out at a local restaurant. Yet, food poisoning outbreaks have taught us that today we must.(2)

   In the last thirty years, the US consumer has seen many changes in the way food is produced that impact food safety. Food production has evolved from a local industry to one where production and processing is centralized in different regions of the country. Improved transportation also has given consumers greater access to foods from around the world, with both their benefits and the potential hazards. The increase in imported foods presents new challenges because it is especially difficult to police the safety of food grown and processed in foreign countries.

   Other changes are affecting US consumers as well. Foodborne pathogens have developed increased virulence,(3) while the public has grown more vulnerable to foodborne illnesses due to the aging of the population.

   While the food marketplace has changed dramatically, the regulatory tools available to the federal government to prevent food poisoning have changed only minimally. The advent of new systems of preventive controls — so called “HACCP” systems — coupled with the expanded use of new technologies have the potential to enhance the safety of food.(4) But these benefits will not be fully realized until the underlying regulatory systems are modernized as well.

   One area of food-safety oversight that needs improving is the area of surveillance. Foodborne-disease outbreak investigations tell the stories of who gets sick from food and why. Today, while headline after headline alerts consumers to food-poisoning outbreaks, no agency in the federal government maintains a comprehensive and current inventory of these outbreaks. Such an inventory would allow policy makers, the food industry and the public to monitor trends, issue public-health alerts, change production practices, and, ultimately, reduce the number of illnesses and deaths caused by contaminated food.

   The Centers for Disease Control and Prevention (CDC) is the only entity that would be capable of releasing comprehensive and timely information on foodborne-illness outbreaks, but it discontinued its annual listing of foodborne-illness outbreaks in the 1980s.(5) To fill this gap, CSPI has been maintaining its own list of foodborne-illness outbreaks that have occurred from 1990 to the present. Today we are releasing an updated version of this list with over 350 outbreaks.(6) This list is the only one of its kind available, but even it includes only a small fraction of the outbreaks being reported to CDC and the other federal agencies.(7)

   Outbreaks are defined generally as two or more illnesses from a single source.(8) The outbreaks on CSPI’s list were those that could be relatively easily identified, such as highly publicized, novel, or large outbreaks. We also used CDC lists for Salmonella enteritidis (SE) and E. coli O157:H7. Here are our most recent findings:

   First, looking at the data in the context of our current regulatory system, over three times as many outbreaks were linked to Food and Drug Administration (FDA)-regulated foods as were linked to US Department of Agriculture (USDA)-regulated foods (See Appendix A). FDA regulates all foods other than meat, poultry, and some processed egg products. This doesn’t mean that meat and poultry products are safer than we thought. In fact, data on individual illnesses that is collected by CDC’s FoodNet system clearly demonstrates that Campylobacter and Salmonella, two pathogens commonly found on chicken, are the principle cause of individual cases of food poisoning.(9) Instead, the outbreak data make it clear that FDA-regulated foods represent a significant public-health problem that is not being addressed adequately.

   Out of 277 outbreaks linked to FDA-regulated foods:

  • 123 outbreaks were linked to eggs and egg dishes. Most of the egg-related outbreaks were caused by Salmonella enteritidis, a bacterium that can survive in raw or undercooked eggs and egg dishes. Egg dishes involved in several outbreaks include pudding, stuffing, baked ziti, and ice cream made with shell eggs
  • 42 outbreaks were linked to produce, including cantaloupe, tomatoes, strawberries, watermelon, potatoes, scallions, lettuce, raspberries, sprouts, basil, and parsley
  • 39 outbreaks were linked to seafood, including mahi mahi, salted whitefish, tuna, buffalo fish, blue marlin, surgeon, grouper, ahi, crab, and shrimp. Of the seafood outbreaks, 19 were linked to shellfish, including oysters, clams, and mussels.
  • 14 outbreaks were linked to game, including venison, bear meat, and cougar meat.
  • 12 outbreaks were linked to dairy products, including cheese, pasteurized and raw milk, and ice cream
  • Eight outbreaks were linked to juices, including apple cider, apple juice, and orange juice.
  • 39 outbreaks were linked to FDA-regulated foods with multiple ingredients. These include salads, baked goods, and soups.

   Out of 78 outbreaks linked to USDA-regulated foods:

  • 50 outbreaks were linked to beef, including 38 to ground beef. Other types of beef were prime rib, roast beef, corned beef, raw beef, sliced beef, and beef jerky.
  • 27 outbreaks were linked to meats other than beef, including chicken, pork, turkey, and multiple-meat products. Poultry products caused 14 of these outbreaks and pork caused 10. Although Campylobacter is the leading bacterial cause of foodborne diarrhea and current data suggest that more cases are linked to poultry than to any other food, outbreaks linked to poultry are rarely recognized. The illnesses resulting from poultry products are more likely to occur individually or as part of a family outbreak that is never reported, according to CDC.(10)

   Contrary to our findings, FDA’s foods are generally, but erroneously, thought to pose a lower risk than the meat and poultry products regulated by USDA, and Congress appropriates accordingly. FDA’s budget for regulating foods is approximately one-third of USDA’s food inspection budget (See Appendix B).(11) In essence, FDA regulates more food with less money.

   FDA’s food program also doesn’t fare well when compared with other priorities at FDA. When you compare funding of the food program to that of the programs that approve drugs, biologics, and medical devices, the food-safety office at FDA only received 27% of the total program budget (See Appendix C).(12) This is despite the fact that food represents more than 50% of FDA’s mission area.(13)

   These data show that there is a big imbalance in the way Washington directs food safety resources. If food-safety resources were applied either equitably or on the basis of risk, FDA’s food program would receive a much bigger budget.

   While CSPI has broken down the data on foodborne illness outbreaks into nice, neat little categories, let’s not forget the impact that each outbreak has on consumer perceptions of food safety. Consumers have to eat and feed their families several times a day. They want to know that everything is being done both by the food industry and by the government to assure the safety of that food.

   Public concern about the safety of the food supply has increased, especially following the Jack in the Box outbreak in which fast-food hamburgers were linked to over 700 illnesses and 4 deaths.(14) In poll after poll, food safety ranks high on the list of things that consumers would like to see improved. Consumers’ concerns are registering with the White House and with many in the government who are promoting new programs that will enhance food safety. Over the last three years, a national initiative on food safety has resulted in over $110 million in new federal dollars going to the food-safety programs, and we are urging Congress to add another $75 million this year. In addition, the Clinton administration has racked up an impressive number of food-safety accomplishments, including new regulatory, research and education programs. There has also been great emphasis on improving communication between the multiple departments with food-safety responsibilities.

   While these initiatives are good, they are not enough. The National Academy of Sciences (NAS) completed a report last August, called Ensuring Safe Food From Production to Consumption, that concluded that the “current fragmented regulatory structure is not well equipped to meet the current challenges.”(15)

   Last year, I enumerated CSPI’s concerns about the current structure for the NAS panel. One year later, little has changed. CSPI remains concerned that:

    Under the current structure, food-safety problems fall through the cracks of agency jurisdiction. Lettuce and other fresh vegetables and fruits are essentially unregulated for safety. Last year, FDA proposed a number of guidelines for farmers,(16) but they are entirely unenforceable. The use of animal manure on food crops is also not controlled. These are some of the problems that fall through the cracks of the current jurisdictional systems.

   Under the current structure, multiple agencies fail to address glaring public health problems. Eggs are regulated both by FDA and USDA, but neither agency has developed an effective containment strategy to prevent the spread of Salmonella enteritidis (SE) in shell eggs. Instead, the agencies have acted like keystone cops, tripping over each other and bungling each attempt to control SE in eggs.(17) Today, over twelve years since SE inside eggs was first identified as a public-health concern by the Centers for Disease Control and Prevention, consumers still await an effective strategy to eradicate SE in shell eggs.

   Under the current structure, the same food-processing plant may get two entirely different food-safety inspections. The classic example is a processing plant that produces both pepperoni and cheese frozen pizzas. The pepperoni line will get daily visits from a USDA inspector to check on conditions in the plant as workers slice the pepperoni and apply it to the pizza.(18) The cheese line will be subject to FDA inspection on average once every 10 years.(19) The minimal difference in hazard between the processing of cheese and pepperoni pizzas is not enough to justify the vast disparity in government inspection.

   Under the current structure, some food-processing plants may get no federal food- safety inspections. Due to resource constraints, FDA has turned some portions of its regulatory responsibility over to the states. The best example of this is in the area of shellfish production, where FDA relies totally on state inspectors. In other instances, FDA simply is unaware of plants that it is supposed to regulate. A 1991 Inspector General investigation documented that FDA’s identifies food firms “by reviewing newspapers, magazines, phone books, industry publications, trade periodicals, surveillance reports and consumer complaints. Inspectors may also walk through stores looking for new products.”(20) The Inspector General reported that, under this system, some food plants escape detection for long periods of time.

    Under the current structure, quality inspections occur more frequently than safety inspections. There are many shell-egg plants that receive regular inspections from US government inspectors, but the inspections are for quality, not for safety. All plants shipping eggs between states are visited by the Agricultural Marketing Service (AMS) each quarter and many plants also participate in a voluntary grading program where they receive continuous inspection by AMS.(21) Under the voluntary AMS program, our government ensures that each has a yolk of the proper diameter, but nothing in the program checks for the presence of SE.(22) Nor does FDA, the agency charged with food-safety oversight of shell eggs, check for SE during its infrequent inspections.(23)

   Under the current structure, HACCP is a different system at FDA and at USDA. The new HACCP systems for seafood, meat, and poultry share almost as many differences as similarities. For example, both frequent inspection and laboratory verification of product samples are essential to give the government appropriate oversight over plants utilizing HACCP. Otherwise, the HACCP program is little more than an industry honor system. While USDA requires both on-site inspection by government inspectors and two levels of laboratory verification of meat and poultry products, FDA requires neither for seafood products. FDA inspects seafood plants once every one to five years and made laboratory testing for HACCP verification optional for seafood processors.(24)

   Multiple agencies may prolong the time it takes to bring the benefits of new technologies to the consumer. For example, last year, Agriculture Secretary Dan Glickman announced the commercial availability of a biological inoculation for young chicks against Salmonella.(25) This product was developed by the USDA’s Agricultural Research Service and then spent years being considered for approval at the Food and Drug Administration.(26) For several other heralded technologies, like trisodium phosphate for poultry and irradiation for poultry and red meat, FDA approval is just the first step in implementation; there is often a public rulemaking process at USDA before products can be used in meat and poultry plants. This bifurated process can take years to get through.(27)

   Under the current structure, imported products are treated differently at FDA and USDA. Imported meat and poultry products are subject to a two-stage approval process by USDA. First, the exporting country’s meat or poultry inspection safety system must be approved by USDA; then, the individual plant must be inspected by USDA before it can ship meat to the U.S. Even then, the meat is subject to random verification checks at the border. FDA meanwhile only has the authority to inspect food at the border but has the staff to check less than two percent of import shipments.(28) FDA can’t send inspectors to foreign countries except by invitation, even when they are checking the source of food involved in an outbreak in the U.S.

   Under the current structure, we risk exporting our irrational food-safety system. There is increasing international pressure to “harmonize” our food safety systems with the systems used in foreign countries. “Harmonization” is the process of assuring that the systems in use in foreign countries provide an equally safe food product.(29) With international trade in food products expanding rapidly, tremendous energy is being devoted to identifying and eliminating unnecessary barriers to trade and simplifying standard setting internationally, using organizations like Codex and the World Trade Organization.(30) We shouldn’t harmonize internationally before we have harmonized our systems domestically, and this alone should provide some urgency to developing a more rational basis for our food safety system today.

   In the year since CSPI first enumerated our concerns to the National Academy of Sciences, little has changed. In addition, we have documented other examples:

   Coordination with the state agencies that handle food safety is a nightmare. For example, state laboratories that analyze food samples for chemical or microbial contamination have complained about the lack of uniform testing methods and reporting requirements required by the federal agencies, including USDA, FDA, CDC, and the Environmental Protection Agency (EPA). This means that state labs may have to run multiple tests on a single food simply to meet the varying requirements of the federal agencies. In addition, they waste valuable staff time transmitting the same information to different agencies, which each have their own customized system for reporting lab results. The lack of common data requirements for foods discourages many states from sharing their laboratory data with the federal agencies.(31)

   In addition, there are not common laboratory certification standards for state laboratories that test food for contamination. This means that in many outbreak and recall situations, a state lab test result will have to be repeated by a federal agency. This can result in a several day delay in recalling food or informing the public, with the continuing risk to public health.

   Confusing food-safety standards exist because agencies can’t agree. FDA and EPA have different public health standards for the permissible methylmercury content of fish. Methylmercury is a potent developmental toxin that accumulates in fish from environmental sources.(32) It can accumulate to toxic levels both in fresh water and ocean dwelling species. EPA has established a standard for recreationally caught fish that is more protective of public health than the standard that FDA applies to commercially caught fish. Efforts to set a single standard have resulted in a logjam, with Congress finally asking the National Research Council to mediate the squabble and set its own standard. Meanwhile, the public and the states are left to wonder what is the safe level for methylmercury in fish.

   New technologies can completely escape government review for food safety, because of the complicated system of multiple reviews. For genetically modified foods, approval responsibilities for new plant varieties is done by three different federal agencies. USDA’s Animal and Plant Health Inspection Service (APHIS) has a mandatory review process to protect against plant diseases and pests that might emerge from genetically modified seed stock. The EPA has a mandatory review process for genetically modified seeds with pesticidal qualities. FDA, meanwhile, utilizes a voluntary review process to address food-safety problems that might emerge from genetically modified foods. Under this system, FDA relies on an industry honor system that allows the biotech companies to decide whether and when they should consult with FDA prior to putting a product on the market.

   This scheme certainly demonstrates that with respect to genetically modified foods, issues other than human-health issues have been the principle focus of government agencies so far. While every plant species using genetically modified techniques has to go through a review at APHIS to determine the impact on plant health, some of these species could escape any government review for food safety. Clearly, FDA has let resource deficiencies drive some policy issues. The agency simply has not had the staff to police emerging food issues properly. Given FDA’s other priorities, it is unclear if it ever will.

   In its report last summer, the NAS found similar glaring disparities resulting from the multiple agency system of food-safety regulation and concluded that:    

“[A]n identifiable, high-ranking, presidentially-appointed head, [is needed] who would direct and coordinate federal activities and speak to the nation, giving federal food safety efforts a single voice. The structure created, and the person heading it, should have control over the resources Congress allocates to the food safety efforts; [and] the structure should have a firm foundation in statute ... Many members of the committee are of the view that the most viable means of achieving these goals would be to create a single unified agency headed by a single administrator — an agency that would incorporate the several relevant functions now dispersed ... among three departments and a department level agency.”(33)

   The NAS also issued a call for new federal food-safety statutes so that resources could be better allocated according to assessments of risk to public health.

   The NAS has provided further documentation of the problems that drove CSPI and other consumer organizations to call on President Clinton in April 1997 to form a single independent food-safety agency.(34) But NAS was hardly the first major advisory body to call for fundamental reform of our food-safety agencies.

   In 1969, the White House Conference on Food recommended that there be one federal regulatory policy with respect to the safety, sanitation, identity, and labeling of food and advised consideration of the establishment of a single federal regulatory agency for foods.(35)

   In 1972, Ralph Nader published a report, Sowing the Wind, that found that food inspection “remains embarrassed by department conflicts of interest and overlapping jurisdictions in USDA and FDA.” The report recommended the creation of a food safety agency to enhance the protection of public health.(36)

   In 1977, the Senate Government Affairs Committee issued a report that said, “We believe the bifurcated food regulatory system should be unified in a single agency.”(37)

   The United States General Accounting Office (GAO), which advises Congress, has consistently documented problems with the current food-safety structure and has recommended that Congress evaluate options for revamping the federal food-safety and quality system. In 1993, the GAO concluded that:    

“[C]reating a single food safety agency is the most effective way for the federal government to overcome long-standing problems, deal with emerging food safety issues, and guarantee the safety of our nation’s food.”(38)

   The GAO has reiterated this finding in numerous reports and testimonies before Congress since the early 1990’s.

   Two years ago, legislation calling on the President to establish a single, independent food-safety agency at the federal level was introduced in Congress by Senator Richard Durbin and Representative Vic Fazio.(39) Senator Durbin has played a leading role in examining the effectiveness of our current food-safety system and initiating this legislation, which is called the Safe Food Act. The Safe Food Act also was introduced in the House by Representatives Rosa DeLauro, a Connecticut Democrat, and Tom Latham, an Iowa Republican. This bill represents the most far-reaching change to the federal food-safety system that have been proposed in the last several decades.(40)

   Last August, President Clinton appointed a Food Safety Council, which is charged with responding to the findings of the National Academy of Sciences. The agencies have responded by promising to coordinate their way out of these problems.(41) Despite their best efforts, however, coordination does not seem to be working. Following a multi-year effort at solving the SE problem in eggs, neither agency had proposed on-farm controls for SE.(42) In addition, a Memorandum of Understanding between FSIS and FDA on inspection issues failed to net any meaningful change.(43) USDA is statutorily limited to conducting only meat and poultry inspections, and can not expand their inspection scope to cover FDA-regulated foods. These examples show that coordination cannot ultimately address many of the problems with the current system.

   Others have expressed concerns that the agencies currently are in the process of implementing HACCP and cannot adapt to the other changes at this time. However, the fact that HACCP systems are being implemented at both FDA and USDA for seafood, meat, and poultry should be a driving force for making the shift to a single food-safety agency. FDA’s weak regulatory program may jeopardize the credibility of HACCP with the American public. Seafood plants inspected last year showed a distressingly low level of compliance with the new HACCP regulation. Approximately 70% of seafood plants inspected by FDA were not fully in compliance with FDA’s seafood HACCP rule.(44)

   While FDA’s recent failure at HACCP implementation is troubling, many hope that the widespread use of regulatory HACCP can and will fundamentally change government’s role in food-safety oversight. It won’t happen without more uniform enforcement.

   HACCP may also help to free up some USDA inspectors to do other jobs. For example, technological innovation may make our current system of inspecting poultry obsolete within the next few years. Those inspectors are urgently needed to provide inspections at the tens of thousands of food plants under FDA’s jurisdiction. However, given the agency split, you cannot simply transfer inspection resources across agencies to the areas of greatest risk. Appropriate, efficient, and flexible utilization of this inspection resource in the next century requires the reorganization of the government structure.

   Another driving force to change our current inspection program is the increase in imported food products. Imports have increased dramatically in the last few years due to several trade agreements that have expanded food trade with our closest neighbors.(45) This is creating a tremendous problem, especially for the Food and Drug Administration, because of the acute lack of resources directed towards food safety at that agency. For example, FDA inspects fewer than 2% of food products coming into the US, not including meat and poultry.(46) Several major outbreaks in the last few years have demonstrated the weaknesses in FDA’s system of inspecting imports.(47) Clearly, the increasing number of food imports demands a more systematic and uniform approach to import inspection than we have today.

   While it is clear that creating a single food-safety agency must be done thoughtfully, it is also clear it should be done soon. Consumers can’t afford to wait years and even decades for the agencies to work out policies on every food-safety question. The current system is highly inefficient, and that inefficiency is putting consumers at risk.

   The Committee asked us to answer the questions: If the federal government were to create a food-safety system from scratch, would it resemble the current system? Is this the best and most logical organization for the federal food-safety agencies? As this testimony has amply demonstrated, the answer to both questions is a resounding NO.

   In Vermont, where I grew up, there is a joke about a city slicker who asks directions from an old Vermont farmer. The punch line is: You can’t get there from here. Today we must ask whether we can achieve a safer food supply in the 21st century without radically redesigning the current food-safety regulatory system? Like that old Yankee farmer, I am afraid that you can’t get there from here.

   Thirty years ago, the White House Conference on Food first recognized the need for a single food-safety agency. We are hopeful that now Congress will lead the way to a more coherent food-safety system. It is time to respond with actions and not mere words.

References:

1. Council for Agricultural Science and Technology, Foodborne Pathogens: Risks and Consequences, (Ames, IA: Council for Agricultural Science and Technology, 1994), p. 4.

2. Eg., Centers for Disease Control and Prevention, "Outbreaks of Escherichia coli O157:H7 Infection and Cryptosporidiosis Associated with Drinking Unpasteurized Apple Cider — Connecticut and New York, October 1996," Morbidity and Mortality Weekly Report, Vol. 46, No. 1 (1997), pp. 4-9; Centers for Disease Control and Prevention, "Outbreaks of Shigella sonnei Infection Associated with Eating Fresh Parsley — United States and Canada, July-August, 1998," Morbidity and Mortality Weekly Report, Vol. 48, No. 14 (1999), pp. 285-289.

3. Robert V. Tauxe, "Strategies for Surveillance and Prevention," The Lancet, End of Year Review, Vol. 352 (1998), p. 10.

4. US Department of Agriculture, Food Safety and Inspection Service, "Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule," Federal Register, Vol. 61, No. 144 (1996), pp. 38806-38989.

5. Telephone conversation with Dr. Patricia Griffin, Chief of Foodborne Diseases, Foodborne and Diarrheal Branch, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, January 14, 1999; eg. Centers for Disease Control, "Line Listing of Foodborne Disease Outbreaks, 1982," Foodborne Disease Surveillance, Annual Summary 1982, (Atlanta, GA: Centers for Disease Control, September 1985), pp. 19-24.

6. Center for Science in the Public Interest, Outbreak Alert! Closing the Gaps in Our Federal Food Safety Net (Acrobat 953k), (Washington, DC: Center for Science in the Public Interest, Updated August 1999).

7. Ibid., p. 3.

8. Centers for Disease Control and Prevention, "Surveillance for Foodborne-Disease Outbreaks — United States, 1988-1992," CDC Surveillance Summaries, Morbidity and Mortality Weekly Report, Vol. 45, No. SS-5 (1996), p. 1.

9. Centers for Disease Control and Prevention, "Incidence of Foodborne Illnesses: Preliminary Data from the Foodborne Diseases Active Surveillance Network (FoodNet) — United States, 1998," Morbidity and Mortality Weekly Report, Vol. 48, No. 9 (1999), p. 191.

10 Telephone conversation with Dr. Patricia Griffin, Chief of Foodborne Diseases, Foodborne and Diarrheal Branch, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, January 14, 1999.

11. US Department of Agriculture, "U.S. Department of Agriculture 1999 Budget Summary," available at <http://www.usda.gov/agency/obpa...-Summary/1999/text.html#funding>; US Food and Drug Administration, "FY 2000 Budget Request Table of Contents," available at <http://www.fda.gov/oc/oms/ofm/budget/BudgetTOC.htm> [hereinafter cited as FDA Budget].

12. FDA Budget.

13. The FDA Food Additive Review Process: Backlog and Failure to Observe Statutory Deadline, Fourth Report by the Committee on Government Reform and Oversight, December 21, 1995, p. 8.

14. Suzanne Marks and Tanya Roberts, "E. coli O157:H7 Ranks as the Fourth Most Costly Foodborne Disease," Food Review, Vol. 16, No. 3 (1993), p. 1; Centers for Disease Control and Prevention, "Outbreaks of E. coli O157:H7 Infections Reported to CDC for 1993," (unpublished).

15. Institute of Medicine, National Research Council, Ensuring Safe Food From Production to Consumption, (Washington, DC: National Academy Press, 1998), p. 12 [hereinafter cited as Ensuring Safe Food].

16. US Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Guidance for Industry. Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, (Washington, DC: US Food and Drug Administration, October, 1998).

17. US General Accounting Office, Food Safety and Quality: Salmonella Control Efforts Show Need for More Coordination, (Washington, DC: US General Accounting Office, April 1992).

18. Michael R. Taylor, "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, Vol. 52, No. 1 (1997), p. 18 [hereinafter cited as Preparing for the Twenty-First Century].

19. US Department of Agriculture, US Department of Health and Human Services, US Environmental Protection Agency, Food Safety From Farm to Table: A National Food Safety Initiative. A Report to the President. May 1997, p. 37 [hereinafter cited as Food Safety from Farm to Table], Preparing for the Twenty-First Century, p. 18.

20. Department of Health and Human Services, Office of the Inspector General, FDA Food Safety Inspection, August 1991.

21. 7 C.F.R. 59.28; Poultry Division, AMS, USDA, "Quality Eggs for Volume Buyers," Brochure No. AMS-627, August, 1996.

22. Ibid.

23. Elizabeth Dahl and Caroline Smith DeWaal, Scrambled Eggs: How a Broken Food Safety System Let Contaminated Eggs Become a National Food Poisoning Epidemic (Washington, DC: Center for Science in the Public Interest, 1997), p. 11 [hereinafter cited as Scrambled Eggs].

24. Caroline Smith DeWaal, "Delivering on HACCP’s Promise to Improve Food Safety: A Comparison of Three HACCP Regulations," Food and Drug Law Journal, Vol. 52, No. 3 (1997), pp. 331-335.

25. US Department of Agriculture, "USDA Researchers Create New Product That Reduces Salmonella in Chickens," USDA Release No. 0121.98, March 19, 1998.

26. Telephone conversation with John DeLoach, MS BioScience, Inc., Dundee, IL, April 1998.

27. Rosanna Mentzer Morrison, Jean Buzby, and C. T. Jordan Lin, "Irradiating Ground Beef to Enhance Food Safety," Food Review, Vol. 20, No. 1 (1997), p. 34; US Department of Health and Human Services, Food and Drug Administration, "Irradiation in the Production, Processing, and Handling of Food; Final Rules," Federal Register, Vol. 62, No. 232 (1997), pp. 64102-64121; Memo from Robert Sindt, Burditt & Radzius, to Caroline Smith DeWaal, April 1, 1998; Meeting with Robert Sindt, Burditt & Radzius, James Elfstrum, Rhodia, and Jerry Carosella, Consultant, Regulatory Microbiology, Washington, D.C., April 3, 1998.

28. US General Accounting Office, "Food Safety: Federal Efforts to Ensure the Safety of Imported Foods are Inconsistent and Unreliable," (Washington, DC: US General Accounting Office, April 1998), p. 5 [hereinafter cited as Safety of Imported Foods].

29. Agreement on the Application of Sanitary and Phytosanitary Measures, Article 3, GATT Doc. MTN/FA II-A1A-4 (Dec. 15, 1993) in Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, GATT Doc. MTN/FA (Dec. 15, 1993) 33 I.L.M. 9 (1994).

30. Preparing for the Twenty-First Century, pp. 26-27.

31. "National Integrated Food Safety System. An Update on Work Group Activities: Laboratory Operations and Coordination," session at the 103rd Annual Educational Conference of the Association of Food and Drug Officials, June 5-9, 1999, San Antonio, TX; Association of Food and Drug Officials 1999 Resolution Number 99-09 Concerning National Standards for Computer-based Laboratory, Inspection and Surveillance Data Standards, June 7, 1999.

32. Institute of Medicine, Seafood Safety, (Washington, DC: National Academy Press, 1991), pp. 12, 116-117.

33. Ensuring Safe Food, p. 13.

34. Memorandum from S.T.O.P.—Safe Tables Our Priority, Center for Science in the Public Interest, Consumer Federation of America, Public Voice for Food and Health Policy, Government Accountability Project, and the United States Humane Society to President Bill Clinton on the President’s Food Safety Initiative, April 2, 1997.

35. White House Conference on Food, Nutrition, and Health. Final Report, (Washington, DC: White House, 1969), pp. 118-119.

36. Harrison Wellford, Sowing the Wind: A Report from Ralph Nader’s Center for Study of Responsive Law on Food Safety and the Chemical Harvest, (New York: Grossman Publishers, 1972), p. 354.

37. Senate Committee on Governmental Affairs, "V. Regulatory Organization," Study on Federal Regulation, 95th Cong., 2d sess., December 1977, S.Rept. 95-91, p. 140.

38. General Accounting Office, "Food Safety: A Unified, Risk-Based System Needed to Enhance Food Safety," (Washington, DC: US General Accounting Office, 1993).

39. H.R. 2801, "Safe Food Act of 1997," 105th Cong., 1st Sess.; S. 1465 "Safe Food Act of 1997," 105th Cong., 1st Sess.

40. H.R. 2345, "Safe Food Act of 1999," 106th Cong., 1st Sess.; S. 1281, "Safe Food Act of 1999," 106th Cong., 1st Sess.

41. President’s Council on Food Safety, "President’s Council on Food Safety Assessment of the NAS Report: Ensuring Safe Food from Production to Consumption," last updated on March 19, 1999, available at <http://www.foodsafety.gov/~fsg/creport2.html>.

42. US Department of Agriculture , "New Egg Safety Steps Announced, Safe Handling Labels and Refrigeration Will be Required," USDA Release No. 0271.99, July 1, 1999, US Department of Health and Human Services, "New Egg Safety Steps Announced, Safe Handling Labels and Refrigeration Will be Required," HHS News No. P99-11, July 1, 1999; Scrambled Eggs, pp. 8-9.

43. US Department of Agriculture, Food Safety and Inspection Service, U.S. Department of Health and Human Services, Food and Drug Administration, Memorandum of Understanding, Feb. 23, 1999.

44. Testimony of Jane Henney, Commissioner, US Food and Drug Administration, before the Committee on Agriculture, Rural Development, and Related Agencies, US Senate, March 16, 1999 in response to a question from Senator Durbin.

45. Preparing for the Twenty-First Century, pp. 26-27; Food Safety from Farm to Table, p. 41.

46. Safety of Imported Foods, p. 5.

47. Ibid., p. 47.