Testimonies and Speeches
Testimony of Caroline Smith DeWaal
Director of Food Safety
before the
Senate Agriculture, Nutrition and Forestry Committee
Hearing on “How Our Food Safety System
Should Address Microbial Contamination”

September 20, 2000 Washington, DC

   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, DC. Since 1971, CSPI has been working to improve the public’s health, largely through its work on nutrition, food-safety and alcohol issues. CSPI is supported primarily by 850,000 subscribers to its Nutrition Action Healthletter, the largest circulation health newsletter in North America.

   Food-safety experts believe that contaminated food causes up to 75 million illnesses, 325,000 hospitalizations and 5,000 deaths each year.(1) These estimates underline the fact that food safety is a significant public health burden. For many consumers, the aggregate numbers mean less than the specific cases of illness involving themselves, their friends or family members. For example, just last year, I testified before the Senate Governmental Affairs Committee and Senator Voinovich mentioned during the hearing that his wife had recently had a bout of food poisoning so serious that she was taken from their home in an ambulance. And it is a rare visit to Capitol Hill where a staff member doesn’t share with me a food poisoning experience. Clearly, this is a problem that can hit perilously close to home.

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

   Furthermore, foodborne pathogens have become increasingly virulent,(2) while the public has grown increasingly 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. One area of oversight that needs improving is surveillance. Foodborne-disease outbreak investigations tell the stories of who gets sick and why. Today, while headline after headline alert 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 and the food industry to monitor trends, issue public-health alerts and change production practices. For the public, that ultimately would mean fewer illnesses and deaths caused by contaminated food.

   The Centers for Disease Control and Prevention (CDC) is well-situated to collect, analyze, and publish comprehensive and timely information on foodborne-illness outbreaks. It published an annual listing of foodborne-illness outbreaks in the 1980s, but stopped due to funding deficiencies.(3) To help fill that gap, CSPI has been maintaining a database of foodborne-illness outbreaks that have occurred from 1990 to the present. We have documented 865 food poisoning outbreaks over the last decade.(4) This list is the only one of its kind available, but even it includes only a small fraction of the outbreaks that are actually occurring, because foodborne illnesses are significantly underreported.(5)

Outbreak Alert!

   Outbreaks are defined generally as two or more illnesses from a single source.(6) The outbreak information listed in CSPI’s report Outbreak Alert! Closing the Gaps in Our Federal Food Safety Net (Acrobat 953k) was obtained from CDC, other government agencies, and medical journal articles.

   These data suggest some striking gaps in our regulatory system. For example, nearly four 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 1.) FDA regulates all foods other than meat, poultry, and some processed egg products. Of course, that doesn’t mean that meat and poultry products are safe. In fact, data collected by CDC’s FoodNet system on individual illnesses clearly demonstrate that Campylobacter and Salmonella, two pathogens commonly found on chicken, are the principle cause of individual cases of food poisoning.(7) Instead, the outbreak data clearly show that FDA-regulated foods pose a significant public-health problem that is not being addressed adequately. Here are some of our findings:

  • 682 outbreaks were linked to FDA-regulated foods, as compared to 179 outbreaks linked to USDA-regulated foods.
  • 237 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, 41 were linked to shellfish, including oysters, clams, and mussels.
  • 170 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.
  • 91 outbreaks were linked to beef, including at least 40 to ground beef. Other types of beef were prime rib, roast beef, corned beef, raw beef, and beef jerky.
  • 82 outbreaks were linked to produce, including cantaloupe, tomatoes, strawberries, watermelon, potatoes, scallions, lettuce, raspberries, sprouts, basil, and parsley.
  • 52 outbreaks were linked to poultry. Campylobacter is the leading bacterial cause of foodborne diarrhea and current data suggest that more individual cases are linked to poultry than to any other food. However, reported outbreaks linked to poultry are not as common as those linked to beef, probably because 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.(8)
  • 39 outbreaks were linked to dairy products, including cheese, pasteurized and raw milk, and ice cream.
  • 31 outbreaks were linked to pork, including ham and pork sausage.
  • 14 outbreaks were linked to game, including venison, bear meat, and cougar meat.
  • Ten outbreaks were linked to juices, including apple cider, apple juice, and orange juice.
  • Five outbreaks were linked to luncheon meats, such as hot dogs and bologna.
  • 130 outbreaks were linked to FDA-regulated foods with multiple ingredients. Those include salads, baked goods, and soups.

   Our outbreak tracking shows that FDA’s foods clearly pose a significant risk of causing a food poisoning outbreak. However, FDA’s budget for regulating foods is only about one-third of USDA’s food inspection budget.(9) (See Appendix 2) In essence, FDA regulates more food with less money. If food-safety resources could be applied on the basis of risk rather than on the basis of historical precedent, it is clear that the food categories regulated by FDA would receive a much greater share of the budget.(10) This imbalance led CSPI and other consumer organizations to call for Congress to create a single independent food safety agency, so that the government could apply food safety resources to the food safety hazards that are causing the greatest risk to the public.

The HACCP Solution

   To keep up with the changing hazards in our food supply, it is time to change some of the regulatory tools as well. The advent of new systems of preventative controls — so called “HACCP” systems (for Hazard Analysis/Critical Controls Points) — coupled with the expanded use of new technologies have the potential to significantly enhance the safety of food. But these benefits will not be fully realized until the underlying regulatory systems for inspection and technology approvals are modernized as well.

   HACCP focuses on preventing foodborne illnesses by applying science-based controls to food production and has been endorsed by many scientific groups. However, HACCP implementation in the seafood, meat and poultry industries has graphically highlighted the weakness in the fragmented regulatory system.

HACCP Implementation Inconsistent Between USDA and FDA

   Due to the different regulatory approaches at FDA and USDA, the meat, poultry and seafood HACCP systems share almost as many differences as similarities. For example, while USDA requires both frequent inspection and product testing for meat and poultry products, FDA requires neither for seafood products.(11) That makes seafood HACCP an industry honor system of dubious value and unworthy of public support.

   HACCP became a mandatory program for seafood processors in December 1997 when FDA implemented a HACCP rule applicable to approximately 4,000 seafood plants nationwide.(12) The following month, in January 1998, the USDA’s Food Safety and Inspection Service (FSIS) implemented HACCP in the 300 largest meat and poultry slaughter and processing plants.(13) Another 2,300 small and medium-sized meat and poultry plants started using the new system in January 1999, and the final group, 3,100 very small meat and poultry plants, in January 2000.(14) Although both FDA and FSIS began to implement their HACCP programs at about the same time, the results have been very dissimilar.

   There have been few surprises with respect to implementing HACCP in meat and poultry plants. Six months after the large plants were brought into the HACCP program, the industry had a 93 percent compliance rate.(15) This past year, even after small plants were brought into the system, compliance increased to 96 percent.(16)

   In comparison with meat and poultry plants, the seafood industry has done a dismal job in implementing HACCP. FDA required all seafood processors, both large and small, to develop and implement HACCP plans in December 1997.(17) But data from FDA inspections in 1999 — the second year of implementation — showed that only 24 percent of all seafood firms had fully implemented HACCP plans deemed adequate by FDA.(18) Thirty percent of the seafood firms inspected in 1999 had inadequate HACCP plans or were failing to properly implement their plans (or both). Sixteen percent of the firms inspected in 1999 failed to have any HACCP plan in place, even though FDA inspectors believed they needed an HACCP plan. The remaining 30 percent of the seafood firms had no HACCP plan, but FDA inspectors did not think that a plan was necessary. (See Appendix 3.) (FDA’s de facto exemption of nearly one-third of the seafood industry from HACCP requirements stands in stark contrast to FSIS’s position. In its HACCP final rule, FSIS stated: “FSIS is currently unaware of any meat or poultry production process that can be deemed categorically to pose no likely hazards.”(19))

   FDA and FSIS differ on more than just the applicability of their HACCP programs. Unlike meat and poultry plants, which have statutorily-mandated daily on-site inspections by FSIS, FDA’s inspections of seafood plants are infrequent — dropping from 3,146 inspections in 1998 to 2,796 inspections in 1999. That’s equivalent to one inspection per year in approximately 70 percent of seafood firms.(20)

   FDA’s failure to enforce implementation of the seafood HACCP regulation obscures another critical weakness in the program. FDA failed to mandate any government or industry testing for verification of the HACCP program. While FSIS requires HACCP verification testing of food samples both by the government and the industry,(21) the FDA made product testing optional. As a result, in many seafood plants, pathogens are not adequately controlled. For example, the FDA’s 1999 inspection data showed that 71 percent of the smoked fish processors, 69 percent of the vacuum-packed fish industry, and 63 percent of the cooked, ready-to-eat seafood firms lacked adequate pathogen controls in their HACCP plans.(22) (See Appendix 4.)

   The meat and poultry HACCP rule, by contrast, has clear tools to evaluate its success. After two years of product testing in large plants, Salmonella contamination has been cut in half in chicken and pork products and has declined substantially in ground beef and ground turkey as well.(23) HACCP performance in small plants has been equally impressive. After one year of testing in small meat and poultry plants, Salmonella contamination in ground beef has been reduced by more than 40 percent, and contamination in chicken by nearly 20 percent.(24) (See Appendix 4.)

   This success is further supported by FoodNet data collected by CDC. In the years 1996-1998, the rate of Salmonella illness declined from 14.5 cases per 100,000 people to 12.3 cases per 100,000.(25) CDC concluded that this decline “may also reflect disease prevention efforts, particularly for campylobacteriosis and salmonellosis. These efforts include changes in meat and poultry processing in the United States mandated by the USDA HACCP rule.”(26) While this evidence is promising, it is too early to tell for sure whether this is a continuing trend.(27)

Improving HACCP Means More, Not Less, Testing

   The lessons of HACCP are clear. Without government-enforced performance standards, it is impossible to measure either the relative performance of different processors’ HACCP plans or the overall success of the HACCP system to control food-safety hazards. Consumers can be much more confident in the meat and poultry HACCP system, because the industry has complied with the regulation and the government is monitoring its effectiveness using performance standards. In contrast, the seafood industry has a very poor record of compliance with FDA’s HACCP regulation, and there is no government testing to monitor its success. Consumers will not continue to support HACCP if the weak FDA model prevails. Performance standards enforced by government testing are essential to ensure that HACCP is not just an industry honor system.

   It is a well-known management concept that “You manage what you measure.” USDA’s meat and poultry regulation was the first effort to manage food safety hazards using a HACCP system, which included regular microbial testing. A recent report by USDA’s Office of the Inspector General (OIG) recommended that USDA expand pathogen testing in order to increase food-safety protections offered by the HACCP rule. The OIG investigative report said, “One of the keys to the success of HACCP is microbial testing, and sound management practices dictate that known harmful pathogens should be monitored through an effective testing program.”(28)

   Now that we have seen the success of a pathogen-based performance standard, it is time to expand this concept to cover additional hazards in food. This year, CSPI petitioned USDA to require ready-to-eat processed meat products to be tested for Listeria monocytogenes and also urged the agency to require slaughterhouses to test beef carcasses for the harmful E. coli O157:H7.(29) We have also urged FDA to mandate product testing to improve its seafood HACCP rule.(30)

   It is clear that consumers would benefit from increased testing by both industry and the government to monitor for food-safety hazards. Congress should require USDA and FDA to establish performance standards to demonstrate that their HACCP programs actually reduce food safety hazards.

The Big Fix: An Independent Food Safety Agency

   Inconsistent HACCP implementation is just one of numerous problems that arise from having several agencies with separate responsibilities for food safety regulation. Other problems include gaps in consumer protections, conflicting public health standards, regulatory redundancies, and slow approvals of new technologies. In addition, gaps in food safety oversight mean that few resources are aimed at preventing hazards at the farm and animal production level, in part because neither agency is exercising farm-to-table food safety responsibility.

    A National Academy of Sciences (NAS) committee completed a report two years ago, called Ensuring Safe Food From Production to Consumption, that determined that the “current fragmented regulatory structure is not well equipped to meet the current challenges.”(31) In its report, the NAS found glaring disparities that result 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.(32)

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

   In response to the NAS report, President Clinton appointed a Food Safety Council that promised to coordinate its way out of these problems,(33) but the experience with HACCP implementation shows that coordination isn’t enough. More fundamental reform is needed.

   Over the last thirty years, many policy makers — from congressional committees to White House councils — have reached similar conclusions. Most recently, a major industry trade association, the Food Marketing Institute (FMI), issued a paper calling for Congress and the President to create a single food safety agency. In its position paper, the FMI says “new challenges have arisen that, taken together, threaten to overwhelm the ability of our current regulatory system to respond effectively. We believe that designating a single agency responsible for the safety of our food is essential if we are to maintain a food supply that remains the envy of the world”(34) Many other organizations, including the National Cattleman’s Beef Association, S.T.O.P.— Safe Tables Our Priority (a food poisoning victims support and advocacy organization), Consumer Federation of America, American Society for Microbiology, Institute for Food Technologists, and the American Meat Institute, have signaled an interest in moving to a single food safety agency to achieve a more rational system of food safety regulation. (See Appendix 5.)

   Legislation has been pending in Congress since 1997 that would establish a single, independent food-safety agency.(35) Senator Richard Durbin 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 Tom Latham, an Iowa Republican, and Rosa DeLauro, a Connecticut Democrat. That bill represents the most important improvement to the federal food-safety system that has been proposed in the last several decades.(36)

   Senator Tom Harkin has also sponsored many other important food safety changes pending before Congress, including mandatory recall and civil penalty authority for USDA; a significant expansion of FDA’s food safety mandates; and improved FDA oversight of produce.(37) These bills provide for incremental changes that could easily fit with a single food safety agency; they deserve your support and speedy action by the Senate Agriculture Committee.

   While it is clear that a 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 resolve their competing agendas. The current system is highly inefficient, and that inefficiency is putting consumers at risk. It is time for Congress to make a more coherent food-safety system a reality. It is time for Congress to respond with concrete actions, and not mere words.

(For appendices, please contact CSPI at 202-332-9110.)


Appendix 1: contact CSPI at 202-332-9110.
Appendix 2: contact CSPI at 202-332-9110.
Appendix 3: contact CSPI at 202-332-9110.
Appendix 4: contact CSPI at 202-332-9110.
Appendix 5: contact CSPI at 202-332-9110.

1. Paul S. Mead, et al., “Food-Related Illness and Death in the United States” Emerging Infectious Diseases, Vol. 5, No. 5 (Sept.-Oct. 1999), p. 607.

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

3. 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; e.g., Centers for Disease Control and Prevention, “Line Listing of Foodborne Disease Outbreaks, 1982” Foodborne Disease Surveillance, Annual Summary 1982, (Atlanta, GA: Centers for Disease Control and Prevention, September 1985), pp. 19-24.

4. 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 2000).

5. Centers for Disease Control and Prevention, “Surveillance for Foodborne-Disease Outbreaks — United States, 1993-1997” CDC Surveillance Summaries, Morbidity and Mortality Weekly Report, Vol. 49, No. SS-1 (2000), pp. 5-6.

6. 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.

7. Centers for Disease Control and Prevention, FoodNet Surveillance Report for 1998 (Final Report), March, 2000, p. 9 [hereinafter cited as 1998 FoodNet Final Report]; see also, Centers for Disease Control and Prevention, “Preliminary FoodNet Data on the Incidence of Foodborne Illnesses — Selected Sites, United States, 1999” Morbidity and Mortality Weekly Report, Vol. 49, No. 10 (2000), p. 203 [hereinafter cited as Preliminary 1999 FoodNet Data].

8. 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.

9. US Department of Agriculture, Office of Budget and Program Analysis, “U.S. Department of Agriculture 2001 Budget Summary” available here; Food and Drug Administration, “FY 2001 Congressional Budget Request Table of Contents” available at here [hereinafter cited as FDA Budget].

10. The National Academy of Sciences (NAS) has warned that FDA “appears to have insufficient resources to meet its statutory obligations” Institute of Medicine, National Research Council, Ensuring Safe Food From Production to Consumption, (Washington, DC: National Academy Press, 1998), p. 87 [hereinafter cited as Ensuring Safe Foods]. NAS concludes: “Congress must provide appropriate resources for the tasks demanded of FDA” Id.

11. 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.

12. Department of Health and Human Services, Food and Drug Administration, “Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products; Final Rule” Federal Register, Vol. 60, No. 242 (1995), pp. 65096-65202 [hereinafter cited as FDA Seafood HACCP Rule].

13. 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, pp. 38806-38989 [hereinafter cited as FSIS Meat and Poultry HACCP Rule].

14. US Department of Agriculture, Food Safety and Inspection Service, “Very Small Plants Successfully Implement HACCP” News Release, March 21, 2000.

15. “HACCP Implementation in Small Plants — The Role of FSIS” Remarks prepared for delivery by Thomas J. Billy, Administrator, Food Safety and Inspection Service, US Department of Agriculture, before the Small Plant HACCP Implementation Meeting, September 19, 1998, Raleigh, NC, available here.

16. “FSIS Experiences With HACCP” Remarks prepared for delivery by Thomas J. Billy, Administrator, Food Safety and Inspection Service, US Department of Agriculture, before the Fisheries Council of Canada, October 6, 1999, Halifax, Nova Scotia, available here.

17. FDA Seafood HACCP Rule.

18. Mary Losikoff, “Compliance with Food and Drug Administration’s Seafood HACCP Regulations” Presentation Before the International Association for Food Protection , August 2000, Atlanta, GA. The data were drawn from forms filled out by FDA inspectors and sent to the FDA Office of Seafood [hereinafter cited as FDA Seafood Data].

19. FSIS Meat and Poultry HACCP Rule, p. 38824.

20. FDA Seafood Data. In general, FDA inspects food processing plants under its jurisdiction only once every ten years. Government Accounting Office, Food Safety: Opportunities to Redirect Federal Resources and Funds can Enhance Effectiveness, (Washington, DC: Government Accounting Office, 1998), p. 8.

21. FSIS Meat and Poultry HACCP Rule.

22. FDA Seafood Data.

23. US Department of Agriculture, Food Safety and Inspection Service, “FSIS Reports Continued Decline of Salmonella” News Release, March 21, 2000.

24. Id. The only exception to the downward trend in Salmonella contamination was the performance of small swine plants. Id.

25. 1998 FoodNet Final Report, p. 9.

26. 1998 FoodNet Final Report, p. 4.

27. Preliminary 1999 FoodNet Data, p. 203.

28. US Department of Agriculture, Office of the Inspector General, Food Safety and Inspection Service: Implementation of the Hazard Analysis and Critical Control Point System, Report No. 24001-3-At, June 2000, Section I, p. 33.

29. Center for Science in the Public Interest, “Petition for Regulatory Action to Require Microbial Testing By Industry for Listeria monocytogenes in Ready-To-Eat Meat and Poultry Products” January 13, 2000; Center for Science in the Public Interest, Comments on Recent Developments Regarding Beef Products Contaminated With Escherichia coli O157:H7; Public Meeting (Docket No. 99-060N), (April 11, 2000).

30. Center for Science in the Public Interest, Comments on Performance Standard for Vibrio vulnificus (Docket No. 98P-0504), (Jan. 21. 1999), pp. 9-13; Center for Science in the Public Interest, Comments on Program Priorities in the Center for Food Safety and Applied Nutrition (Docket No. 98N-0359), (Sept. 30, 1999), pp. 1-3; Center for Science in the Public Interest, Comments on Program Priorities in the Center for Food Safety and Applied Nutrition (Docket No. 98N-0359), (Aug. 25, 2000), pp. 3, 5-6.

31. Ensuring Safe Foods, p. 12.

32. Id., p. 13.

33. 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 here.

34. Food Marketing Institute, “It’s Time to Designate A Single Food Safety Agency” Food Marketing Institute Board Approved Policy, May 6, 2000.

35. H.R. 2801, “Safe Food Act of 1997” 105th Cong., 1st Sess.; S. 1465 “Safe Food Act of 1997” 105th Cong., 1st Sess.

36. H.R. 2345, “Safe Food Act of 1999” 106th Cong., 1st Sess.; S. 908, “Consumer Food Safety Act of 1999” 106th Cong., 1st Sess; S. 1281, “Safe Food Act of 1999” 106th Cong., 1st Sess.

37. S. 18, “Safer Meat and Poultry Act of 1999” 106th Cong., 1st Sess.; S. 823, “Fruit and Vegetable Safety Act of 1999” 106th Cong., 1st Sess.