Regulatory Comments
Submitted by the National Restaurant Association
To: U.S. Department of Agriculture, Food Safety & Inspection Service
Date: March 18, 1999
Topic: E. coli Sampling

March 18, 1999

FSIS Docket Clerk
U.S. Department of Agriculture, Food Safety and Inspection Service
Room 102, Cotton Annex
300 12th Street, SW
Washington, DC 20250-3700

Re: Docket No. 97-068N

Dear Sir or Madam:

The National Restaurant Association, representing more than 37,000 members and 175,000 restaurant outlets, would like to comment on the agency's proposed expanded policy on raw beef products contaminated with E. coli 0157:H7. The National Restaurant Association shares the concern expressed in the past by FSIS regarding the illnesses caused by this bacterial contaminant, and sincerely wishes to help the agency evolve an effective, rational and science-based methodology to prevent future E. coli 0157:H7 outbreaks associated with beef.

At the outset, we generally encourage FSIS to work closely with affected industry groups to focus on prevention rather than the identification after product release or an outbreak. We feel that the primary duty is to prevent people from becoming ill, and to that end we encourage others in industry and government to assist through maintaining the focus on reduction or elimination of pathogens in food system. The practice of random sampling of raw beef products for E. coli 0157:H7 at points where the product is generally consumed before the results are obtained, is logically flawed from a prevention standpoint and should generally be avoided. Furthermore, science-based technologies and procedures, which can be shown to eliminate E. coli 0157:H7, should be investigated and rapidly approved by FSIS.

Bacteria are a normal part of most raw foods, including beef. However, FSIS has taken the public position that the presence of anything other than zero levels of E. coli 0157:H7 in ground beef will result in the food being declared adulterated. Unfortunately, rather than absolutely assuring a safe food supply, this policy has caused confusion and a tremendous waste of resources at all levels. We fear that this policy was set without an adequate risk assessment or the identification of a reasonable means for compliance.

Our specific concerns with the proposed E. coli 0157: H7 sampling policy are as follows:

1. It appears the FSIS is attempting to expand the sampling program without full consideration of input from affected industries and consumers. The beef industry and consumers, such as ourselves, have shown a great willingness to work at various levels toward the elimination of this pathogen. In fact, more industry and consumer education, and focused testing for E. coli 0157:H7 takes place today than at any other time. We encourage FSIS to work with all sectors to address this concern in a more cooperative manner.

2. The FSIS proposal to expand random sampling and the zero tolerance level set for beef is problematic. The concept of random sampling and zero tolerance for E. coli 0157:H7 in raw beef products is currently not supported by statistical validation or scientific findings. Furthermore, FSIS did not anticipate the negative reactions by meat manufacturers seeking to avoid the severe sampling liability of an expanded unscientific rule. From a prevention and HACCP standpoint, FSIS should develop a science-based risk assessment for E. coli 0157: H7 at various levels in production. FSIS should then work with industry to identify critical control point strategies and technologies to be employed at the most effective points to prevent contamination. Finally, cooperative sampling should be used primarily to determine the effectiveness of the hazard control measures and not for punitive actions.

3. Finally, we hope that FSIS will not continue to delay the implementation of promising new technologies such as, thermal carcass washing and cold pasteurization (irradiation), which can eliminate E. coli 0157: H7 bacteria from beef. Preventing illness and eliminating E. coli 0157:H7 from the food system must be the goal. Sampling may not bring us any closer to our common goal, but new procedures, focus and technologies like cold pasteurization have a much better chance than simply increasing sampling.

In conclusion, we hope to avoid the perception that federal mandates can somehow provide raw food products that are free from all bacteria. While that is an admirable food safety goal, it may not be reasonable or even possible in the real world. Furthermore, random sampling and after- the-fact destruction of contaminated products, should not be our main line of defense. We understand that a coalition of beef manufacturing leaders have offered an innovative science-based plan to address the E. coli 0157:H7 contamination in all beef products. We encourage FSIS to fully consider the plan and advantages of moving to a more statistically valid, prevention-focused and science-based sampling system.

We believe that the ultimate solution to E. coli 0157:H7 contamination will involve a cooperative and comprehensive approach to food safety, which encourages new technologies and procedures for beef processing and expanded education of consumers and industry. We are deeply committed to assuring food safety and will continuously strive to provide the safest food products possible to our customers. To this end, we have taken substantive steps to improve food safety regulations, education and the safety of foods served in restaurants. We look forward to working with FSIS in the future towards our common goal of improved food safety.

Sincerely,

Steven F. Grover, R.E.H.S.
Vice President for Technical Services, Public Health and Safety

Cc:
Herman Cain
Stephen Caldeira
John Farquharson
Peter Kilgore