Testimonies and Speeches
FSIS Policy on E. Coli O157:H7:
Reviewing the Role of Pathogen Testing in HACCP

Remarks of Caroline Smith DeWaal
Director of Food Safety
Center for Science in the Public Interest

Washington, D.C.
February 29, 2000

   Good afternoon. I am Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest. I am speaking today on behalf of the Safe Food Coalition. Like Nancy, I am not an scientist. CSPI represents nearly one million consumers in the US and Canada on food safety and nutrition issues.


   Pathogen testing is an essential weapon in the government’s arsenal against food borne illness. Testing at many levels is needed to maximize consumer and public health protections.

   Microbial testing at multiple levels was built into the Pathogen Reduction/HACCP regulation, which utilizes both industry and government testing. USDA requires all beef, pork and poultry slaughter plants to test their own products for generic E. coli and the government tests these slaughter operations and some beef, pork and poultry processors for Salmonella.

   This program has had a marked improvement on Salmonella contamination levels across the meat and poultry industry, with reductions in many meat products ranging from one-half to one-quarter of previous contamination levels. Unfortunately, it has also shown that control of one hazard does not result in control of all hazards. In fact, recalls for other hazards in meat continued at a high level last year. Listeria-contaminated meat and poultry products were recalled 33 times and products containing E. coli O157:H7 were recalled 10 times. In addition, consumers suffered one of the most deadly outbreaks ever linked to meat products in 1998-99 when Listeria monocytogenes in a processed meat product sickened 100 and killed 21.

   The lessons of HACCP implementation show clearly that systematic pathogen testing of meat and poultry products is an essential adjunct to HACCP systems. Testing provides both the food industry and the government an objective measure for evaluating HACCP’s effectiveness. Recent improvements in Salmonella contamination rates show that testing and performance standards provide incentives for meat and poultry processors to improve. It is time to expand this testing to cover more products and more pathogens, especially those that trigger adulteration standards.

   The government has another model for pathogen testing that differs from the model used in the HACCP regulation. It is being used for two pathogens, Listeria monocytogenes and E. coli O157:H7, which are legal adulterants in certain meat products. This system utilizes limited random government testing for a pathogen of concern, and when it is found in food, the products are subject to a voluntary recall. This model has been used by the government to address serious hazards in certain foods which have not been adequately controlled.

   The E. coli adulteration policy and ground beef testing program was announced in 1994, over one year after a major fast-food outlet sold contaminated meat that sickened over 700 consumers and was linked to the deaths of four children. In situations like this, the government must act promptly to address serious safety hazards and restore consumer confidence.

   However, nearly six years later, there are many criticisms that can be leveled at the limited approach to testing. It is reactive, instead of prevention-oriented. The number of tests conducted each year is highly inadequate. The program is not systematic, and provides inadequate coverage. Like throwing darts at a dart board, although the government hits the target occasionally, it is clearly missing a lot of the problem. The same is true for the government’s Listeria testing program currently in place for ready-to-eat products. CSPI recently petitioned USDA to change this program, and I believe that our analysis here is applicable to both hazards.

   We support changing the E. coli O157:H7 testing system to one that is more systematic, more prevention-oriented, and one that gives consumers greater assurance that it is actually catching the hazards in the food supply.

Bringing E. coli O157:H7 Testing into the HACCP Era

   In 1994, Michael R. Taylor, the Administrator of FSIS, announced the E. coli policy that we have today. In a speech to the American Meat Institute Annual Convention, Taylor said, "In the case of O157:H7 and raw ground beef, the only satisfactory public health goal is to eliminate contamination... . We must look for ways to reduce the likelihood that contaminated animals will enter the stream of commerce, the risk that any pathogenic bacteria present in the intestinal track will contaminate meat during the slaughter process, and the potential for subsequent growth of any organism that may be present. In short, technological innovation in production, slaughter and processing must be harnessed and applied aggressively if we are to move effectively toward our public health goal." Taylor’s words provide an important reminder of the challenges that continue to face the beef industry.

   We strongly support FSIS in expanding the adulteration policy to non-intact meat. This step is essential if all segments of the beef industry are to share the responsibility for meeting these challenges.

   Some things have changed since the original testing program for E. coli O157:H7 was announced. We now know that this hazard is much more prevalent in the live animals than was assumed in 1994. Also, the annual burden of human illnesses estimate by CDC has greatly increased. Obviously, previous efforts to control the pathogen have not worked. It is time to bring this problem into the HACCP era.

   First, E. coli O157:H7 should be considered a hazard reasonably likely to occur for beef slaughter and processing operations, which should include this hazard in their HACCP plans and institute technological controls that address it. If a company has evidence that indicates that E. coli is not a hazard for the particular type of cattle that it slaughters, the burden should be on the company to seek an exemption from the general policy and make supporting data available to FSIS.

   Second, government testing for E. coli O157:H7 should be continued and industry testing should be mandated. When Mike Taylor announced the original policy on E. coli, consumers believed that government testing would provide greater incentive for the industry to test their own products. Unfortunately, as with Listeria, food lawyers advised the industry that it is better not to know if their product contains a deadly hazard. The government must counter this "hide your head in the sand" approach to product safety with a testing mandate.

HACCP Verification and Consumer Protection

   Microbial testing for E. coli O157:H7 should achieve the following objectives. First and foremost, it should verify that plants’ HACCP systems are effective in controlling E. coli O157:H7 and also identify problems so that corrective actions can be taken. Second, testing should improve the likelihood that contaminated products are detected and either further processed to eliminate pathogens, recalled if the product is already in commerce or destroyed. It can also provide incentives for companies to implement effective interventions against E. coli O157:H7, both on the farm and during the slaughter process, and to conduct their own thorough testing. Finally, testing can facilitate the acquisition of data concerning: (I) the seasonal and geographic prevalence of the pathogen; (ii) the effectiveness of various intervention measures implemented by industry; and (iii) the relative utility of carcass sampling versus bin sampling versus finished-raw-product sampling.

   Neither government sampling nor industry sampling alone would achieve those objectives. Instead, FSIS should develop a comprehensive E. coli O157:H7 strategy that includes systematic microbial testing by both the government and the industry.

   At a minimum, USDA should consider the following elements for a sampling program:

1. Mandatory industry testing of carcasses and trimmings in slaughterhouses

   Slaughterhouses should be required to test both carcasses and trimmings for the presence of E. coli O157:H7, at least until sufficient data exist to demonstrate that thorough carcass testing obviates the need to test trimmings. It may be appropriate to allow plants that conduct more frequent carcass testing to reduce their testing of trimmings.

   As part of its rulemaking, FSIS should consult an independent, expert body regarding how lot size for carcass testing should be determined. Consumer protection must be maximized in determining lot size. Actual carcasses that are sampled should be held pending test results.

   Any positive test results should trigger appropriate corrective actions, including stepped-up sampling in the plant. Repeated positives should trigger re-validation of interventions and possibly changes in slaughter processes. All positives must be reported to FSIS immediately, and the agency should take appropriate action, including asking for product recalls.

2. Random FSIS testing based on risk

   FSIS should significantly increase the number of E. coli O157:H7 tests conducted annually, and establish a protocol for conducting the tests in order to evaluate a plant’s process controls.

   FSIS should target establishments that do not conduct their own testing and/or do not employ validated interventions against E. coli O157:H7 initially, but once the entire industry is required to perform its own testing, FSIS sampling should be focused on those plants and raw-meat products that historically have posed the greatest risk. Until sufficient O157:H7 data are obtained from plants, FSIS should consider, among other things, results from Salmonella and generic E. coli testing in determining where to sample.

   Once industry testing is fully implemented, all plants should be subject to random government testing, in a pooled system similar to the one used for Salmonella testing today.

The trade offs currently reflected in FSIS Directive 10,010.1 should be eliminated, as all beef slaughter and most processing plants will be required to conduct systematic testing.

   FSIS’s program should be dynamic, not static. The agency should alter its testing program based on data derived from both government and industry testing. The focus should be on identifying the riskiest plants and products and taking appropriate measures to assure their safety.

Other issues posed by USDA

Retail versus slaughterhouse sampling

   FSIS should continue to conduct tests at both the plant and retail levels. Retail testing can help the agency detect problems that fall through the cracks of plant testing. But testing earlier in the process (at plants) should be the focus of FSIS’s program, because it is far more efficient -- and protective of public health -- to detect and eliminate microbial contamination before products are widely distributed.

Expansion of the sampling program to Listeria monocytogenes and Campylobacter

   Absent findings of actual risk to the public from Listeria or Campylobacter in raw beef products, we don’t support increased testing of these hazards in raw beef products.

   FSIS is already conducting random testing for Listeria to enforce the zero tolerance policy in ready-to-eat meat products. CSPI has petitioned FSIS to require the processed meat and poultry industry to conduct testing for Listeria both in the plants and in ready-to-eat products. In addition, the poultry industry should be required to test their products for pathogens like Salmonella and Campylobacter as well, as a mechanism to evaluate the ongoing effectiveness of HACCP.

Consumers’ responsibility for food safety

   Industry commenters have asserted that consumers should assume more responsibility for their own safety, an assertion that both USDA and consumers strongly reject. Clearly, consumers can and should take precautions to protect themselves from food-borne illness. However, food hazards like E. coli O157:H7 can cause such severe illnesses that precautions must be taken at every step of the food chain. Relying on consumers to bear of the responsibility for the risk associated with this deadly food hazard is no more acceptable today than in 1994, when FSIS’s adulteration policy withstood a federal court challenge. FSIS should continue to reject any backward attempts by the meat industry to shift the burden for food safety solely onto consumers.


   USDA should take this opportunity to devise a new testing policy for E. coli O157:H7 that is more systematic, more prevention-oriented, and one that gives consumers greater assurance that it is actually catching the hazards in the food supply. In addition, the new policy should utilize the lessons learned from the HACCP implementation, including the importance of testing at several levels to maximize public health protections. Combining both government and industry testing for E. coli O157:H7 would significantly improve consumer protection from this deadly bacterium.

   It is important that FSIS bring the E. coli policy into the HACCP era. First, E. coli O157:H7 should be considered a hazard reasonably likely to occur for beef slaughter and most processing operation. This means it would be included in the HACCP plans and companies would have to institute technologies to address it. Industry testing should be mandated to help verify that controls are working to eliminate the hazard and government testing should be expanded. Finally, as FSIS modernizes this policy, it should also mandate pathogen testing in other areas, such as Listeria in ready-to-eat meat and poultry products, and Campylobacter in poultry products.

   These are the next logical steps for FSIS to "bring the science of microbiology" both to modernize its regulatory program and to improve food safety. These steps are essential if the government and the industry want to continue the work begun in 1994 to improve consumer confidence in meat and poultry products.