 |
Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
|
Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
Remarks prepared for delivery by Thomas J. Billy, Administrator, Food Safety and Inspection Service, before a symposium entitled Food Safety Policy, Science and Risk Assessment: Strengthening the Connection, before the Food Forum of the National Academy of Sciences, July 13, 1999, Washington, DC.
Thank you for the opportunity to talk about meat and poultry HACCP and the impact it has had on food safety. As Under Secretary for Food Safety Catherine Woteki discussed this morning, food safety agencies make many different types of decisions, from major policy changes, which can take years, to specific enforcement actions, which sometimes have to be carried out very quickly. HACCP for meat and poultry products is the result of a major policy change that was made about five years ago, to focus our efforts more heavily on the risks posed by pathogenic microorganisms.
The need for such a change was well documented and well accepted by the scientific community. First, studies conducted over the past 15 years by the National Academy of Sciences, the U.S. General Accounting Office, and FSIS itself established the need to focus more heavily on pathogenic microorganisms on raw meat and poultry products. And they established the need to implement preventive approaches to improving food safety.
Data on foodborne illness also supported the need for change. Data from the Council for Agricultural Science and Technology from 1994 estimated that 6.5 to 33 million cases of foodborne illness and up to 9,000 deaths occur each year in the United States due to microbial pathogens in all foods. Our 1995 estimates for the meat and poultry share of these illnesses and deaths were 5 million and 4,000, respectively.
The real public impetus for change, however, was a 1993 outbreak of foodborne illness attributed to E. coli O157:H7 in undercooked hamburgers. This tragic outbreak permitted FSIS to take the expert advice it already had and set in motion a strategy for change that garnered broad support.
When we began to develop our food safety strategy, we knew that it was not enough to make a few select changes, and leave it at that. That had been done in the past, and those changes had not reached the root of the problem. We needed a comprehensive strategy that would address all of the weaknesses in the traditional inspection system for meat and poultry.
I emphasize the need for a comprehensive strategy, because today, I will focus on our Pathogen Reduction and HACCP rule, which we published in July 1996. HACCP is the centerpiece of our strategy, but by no means is it the sole element, and I will address the other elements after discussing HACCP.
The Pathogen Reduction and HACCP rule has four mandatory key provisions. First, it requires all plants to have in place standard operating procedures for sanitation. Second, the rule requires slaughter plants to test for generic E. coli, an indicator of fecal contamination. Third, it requires all plants that slaughter and process meat and poultry to implement HACCP systems as a means of preventing or controlling contamination from pathogens and other hazards. Under HACCP, plants identify and evaluate the food safety hazards that could affect the safety of their products and institute controls necessary to prevent those hazards from occurring or to keep them within acceptable limits. And fourth, to make sure HACCP systems are working as intended, the rule also sets in-plant performance standards for Salmonella, and we conduct the testing to ensure those standards are met.
The HACCP approach, a system of preventive process controls, is widely recognized nationally and internationally by scientific authorities and is used extensively in the food industry to produce products in compliance with health and safety requirements. In fact, as we implemented HACCP, Codex was embracing HACCP as an international strategy for food safety as well. We also made these changes all within our current statutory authority, which illustrates the flexibility we have under the meat and poultry inspection laws.
HACCP was a good idea for many reasons, but one of the key guiding principles was the importance of clarifying the respective roles of industry and FSIS in ensuring the safety of meat and poultry products. Our rule makes it clear that industry is responsible for producing and marketing products that are safe, unadulterated, and properly packaged and labeled. This is a very important distinction, because by clearly placing responsibility for the production of products that meet food safety requirements on the industry, government is better able to use its limited resources more efficiently and effectively. This is preferable to our traditional inspection and detection approach, which, without process control, is neither effective nor efficient. I cannot overstate the significance of this change in the roles and cultures of the agency and the industry. This culture change is a work in progress.
The combination of HACCP and performance standards for pathogen reduction also was a key concept. FSIS believed that HACCP-based process control had to be combined with objective means of verifying that meat and poultry plants are achieving acceptable levels of food safety performance. FSIS had in place microbiological performance standards for ready-to-eat and other processed products, but such standards for raw products, with the exception of E. coli O157:H7 in ground beef, did not exist.
A third concept that served us very well was the need to make these changes through a thoroughly public process. We held countless public meetings during which our constituents had the opportunity to provide input, and that input not only improved the end result, but also led to a regulation that had broad support.
Implementation of the rule began in January 1997 and will be complete in January 2000. Implementation is being phased in based on plant size. This phased implementation has worked very well, because of the logistical effort required for such a fundamental change in both industry and FSIS responsibilities and practices. For example, FSIS’ inspection strategy has been changed completely, requiring extensive training of our personnel. And it has provided us with the time to provide extra technical assistance to the small and very small plants, which we recognized would have less experience with HACCP and very limited means to meet these new requirements.
Our technical assistance program has included:
We also established a Technical Services Center in Omaha, Nebraska, to serve as the Agency’s center for technical assistance, advice, and guidance for the implementation of national policies, programs and systems—including HACCP. The Center has been well received and used extensively by our inspectors as well as by industry.
The implementation of HACCP is still underway, but we have some preliminary data that support the direction we have taken. Salmonella prevalence in broilers, swine, ground beef, and ground turkey was significantly lower after HACCP implementation than in baseline studies conducted before HACCP implementation.
In addition, data released this year from the FoodNet Active Surveillance System for foodborne illness show that during 1998, the rate of Campylobacter, Salmonella, and Cryptosporidium infections declined nationwide, and Salmonella Enteritidis infections declined in all states but Oregon. These data provide hope that improvements industry and we are making through new food safety regulations, research, the introduction of new technologies, and education are helping to reduce the incidence of foodborne illness.
As I said earlier, while this presentation focuses on HACCP, our food safety strategy is much broader. We recognized that the hazard identification and prevention steps inherent in HACCP had to reach the entire farm-to-table chain, not just federally inspected establishments. That is why, concurrent with improvements within meat and poultry slaughter and processing establishments, our strategy had to address every step in the process of producing the animals on the farm, converting them into food products through slaughter and processing steps, distributing the products to the consumer, and preparing these products for consumption.
For example, at the animal production level and intermediate stages before the slaughter plant, FSIS is working with producer groups and the states to develop and encourage measures to reduce food safety hazards associated with animals presented for slaughter. We believe that the voluntary application of food safety assurance programs, based on HACCP principles, has a role in reducing risks at this level of the farm-to-table chain.
At the transportation to retail level of the farm-to-table chain, we are working with FDA and the states to develop government standards for the safety of foods during distribution.
At the retail level, we are working again with FDA and with state officials to ensure the adoption of science-based standards and to foster HACCP-type approaches –largely through the Food Code process.
And we also are working through the Partnership for Food Safety Education and the Fight BAC! campaign to ensure that consumers know how to properly prepare and handle foods. In fact, education is needed all along the farm-to-table chain.
In addition to our farm-to-table strategy, we also saw the need to significantly reform our existing regulations, to be consistent with HACCP principles. Traditional regulatory requirements have been very detailed and prescriptive, specifying, for example, precise, step-wise cooking time-and-temperature combinations for many products, to be verified in detail by our inspectors. We are in the process of converting our command-and-control regulations to performance standards, to clarify responsibilities and allow industry the flexibility to innovate.
We have learned many lessons so far from the process we have followed in implementing our food safety strategy.
First, of course, is the need to base changes in science. Science is not an absolute, but we can base our policies on the best science available and then make adjustments as new information becomes available. The advantage of HACCP is that is lends itself to just this type of adjustment.
Second is the importance of making HACCP mandatory, which was our intention from the beginning. While most comments on our original proposal supported making HACCP mandatory, some commenters requested that HACCP be voluntary to alleviate economic burdens to small plants. FSIS determined that mandatory HACCP was the only viable option. From the consumer’s viewpoint, it would be difficult to explain why we are not requiring establishments to implement HACCP if we know that it is a widely-accepted method of improving food safety. We also determined that HACCP should be mandatory for all plants, regardless of size. While there were concerns about the economic burden to small plants, our position was that consumers expect their food to be safe regardless of whether it comes from a large or small establishment. Added phase-in time, extensive technical assistance, and regulatory flexibility are cushioning the impact.
The third lesson learned is the need to implement HACCP in the context of a broad, farm-to-table strategy. Addressing only what was going on within federally inspected establishments would not enable us to make the far-reaching changes we believe are necessary to reduce the number of illnesses attributable to foodborne diseases.
Fourth is the importance of a public process in allowing us to achieve our food safety goals. Public policy that is made without the input of all interested parties is doomed to fail. This does not mean that everyone gets what he or she wants. The public process ensures that common ground is reached, and that policies are scientifically sound.
For the future, science is the key to continual progress. For example, in the past, we had not established performance standards with respect to pathogenic microorganisms in raw meat and poultry because we were constrained by lack of a scientific basis for determining the levels at which specific pathogens do or do not present a safety hazard. In setting the pathogen reduction performance standards for Salmonella in the HACCP rule, we based our standards on the current nationwide baseline prevalence for each major species and product class. We recognize there are still many gaps in the science preventing us from setting pure public health standards. We have signaled, however, that we expect to revise the standards periodically as new data become available.
For the future, we also need to do a better job of determining quantitatively the public health risks associated with certain pathogens and foods. Hazard identification is the first step in developing a HACCP plan, and it is important that we, as regulators, design our policies and focus our resources on what we know are the most significant public health risks. For example, last year we completed with FDA and others a risk assessment for Salmonella Enteritidis in eggs and processed egg products to help us determine, where, along the farm-to-table chain, contamination is most likely to occur and what steps—regulatory, educational, and voluntary—we can take to best address this public health problem. This risk assessment will be extremely helpful as we proceed with this strategy. Such risk assessments must become an integral part of our public health strategies.
Also, for the future, we need to be sure that research is ongoing to provide us with enough, and the right type, of information on which to base regulatory decisions and develop new preventive approaches.
In closing, I believe HACCP, as part of a broad-based strategy, is working as intended to reduce the incidence of foodborne illness. And the lessons learned from HACCP implementation will serve us well as we pursue additional initiatives to meet our common goal of improving the safety of meat, poultry, and egg products.
For Further Information:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-3897
Fax: (202) 720-5704