|Food Safety and Inspection
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 the World Congress on Meat and Poultry Inspection, June 10, 1997, Sint Michielsgestel, The Netherlands.
It's a pleasure to have the opportunity to join you to discuss Hazard Analysis and Critical Control Point (HACCP) systems and food safety. I have been asked to discuss HACCP in terms of how the United States has applied HACCP in a mandatory regulatory environment.
I would like to begin by reviewing the steps that led to a mandatory HACCP system for meat and poultry products. One of the greatest strengths of the U.S. inspection system is that it is constantly being analyzed and critiqued by lawmakers, consumer groups, scientists, and industry, and we listen to these criticisms and respond in a positive manner. Our food supply is extremely safe, but we know that to keep it that way, we must welcome the challenge of making it even better, regardless of how difficult those challenges may be.
We have known for some time of the need to make changes in our inspection program. Studies conducted over the past decade by the National Academy of Sciences, the U.S. General Accounting Office, and FSIS itself have established the need to implement preventive approaches to improving food safety. And they have established the need to better address the problem of pathogenic microorganisms on raw meat and poultry products.
While these studies addressed shortcomings in the U.S. food safety system for meat and poultry, by no means are these problems confined to the U.S. system. The need to implement preventive approaches to food safety and to better target current food safety risks are concepts that have application world-wide. No country is immune to foodborne illness, nor to the need for food safety improvements.
We recognized, in developing our food safety strategy, that no single technological or procedural solution existed for the problem of foodborne illness. Rather, the Agency's food safety goal would be achieved only through continuous efforts to improve hazard identification and prevention.
We also recognized that this hazard identification and prevention had to reach the entire farm-to-table chain, not just federally inspected establishments. That is why, concurrent with improvements in food safety within establishments, our strategy had to address the identification and prevention of hazards at virtually every step in the process of producing meat and poultry on the farm, converting it into a food product through slaughter and other processing steps, distributing the product to the consumer, and preparing product for consumption.
While our food safety strategy encompasses the entire farm-to-table continuum, we had the responsibility to focus most heavily on federally inspected establishments, where the majority of our regulatory authority--and responsibility--lies. The centerpiece of our in-plant strategy is our final regulation on Pathogen Reduction and HACCP systems, which was published on July 25, 1996. The Pathogen Reduction and HACCP rule has four mandatory key provisions: (1) Sanitation Standard Operating Procedures (SSOPs), (2) HACCP, (3) testing for generic E. coli, and (4) performance standards for Salmonella.
The Pathogen Reduction and HACCP rule provides a framework for carrying out a scientific and risk-based strategy to improve food safety. It substantially improves the ability of meat and poultry establishments and FSIS to target and systematically prevent and reduce food safety hazards and to continually improve food safety as science and technology improve.
It also clarifies the respective roles of industry and FSIS in ensuring the safety of meat and poultry products. The rule makes it clear that the industry is responsible for producing and marketing products that are safe, unadulterated, and properly packaged and labeled. This is a very important concept, because by 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. We can focus our resources on inspecting products and facilities to verify that the statutory requirements are being met and for taking appropriate compliance and enforcement actions when the requirements are not being met. This is preferable to the traditional inspection and detection approach, which, without process control, is neither effective nor efficient.
I now will discuss the HACCP provision of the rule in more detail. The final rule requires establishments to develop and adopt a HACCP program to ensure that they have in place science-based controls to prevent and reduce food safety hazards. Establishments are required to develop HACCP plans based on the seven principles established by the U.S. National Advisory Committee on Microbiological Criteria for Foods and adopted by the Codex Alimentarius Commission in 1993 as a benchmark for countries to incorporate HACCP principles into their food industries. The principles are: (1) hazard analysis, (2) critical control point identification, (3) establishment of critical limits, (4) monitoring procedures, (5) corrective actions, (6) recordkeeping, and (7) verification, including validation. HACCP systems are required to have critical control points that address product safety hazards, as opposed to control measures related to economic adulteration and quality.
We will not approve HACCP plans in advance, but our inspection personnel will review them for conformance with the final rule and continually verify their effectiveness through records review, visual process verification, and product sampling.
We are now preparing to implement HACCP. Implementation is being phased in based on establishment size, with the largest establishments required to put HACCP in place by January 26, 1998. Small plants have until January 25, 1999 to implement HACCP, and very small plants have until January 25, 2000 to meet this requirement.
In developing our food safety strategy, it was our intention to make HACCP mandatory from the very 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 is the only viable option that will result in improvements in food safety throughout the meat and poultry industries. Mandatory HACCP was supported by several prominent organizations in the United States, including the International Meat and Poultry HACCP Alliance and the American Meat Institute. From the consumer's viewpoint, it is difficult to explain why we would not require 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. To accommodate the needs of small plants, we are allowing them more time for implementation, and we have a number of ongoing activities to help them implement HACCP.
HACCP provides a framework for making food safety improvements, but it must be combined with food safety performance standards to make it an effective means of controlling and reducing pathogenic microorganisms. A key part of our strategy is the need to clearly define the minimum requirements all plants must meet to produce safe meat and poultry products and to make establishments readily accountable for meeting them. We believe that setting performance standards is the most powerful and effective tool available for bringing about change.
Performance standards tell establishments what degree of effectiveness their HACCP plans will be expected to achieve. Science-based process control, as embodied in HACCP, and appropriate performance standards are inextricably intertwined. Neither is sufficient by itself, but, when combined, they will allow us to achieve significant reductions in the incidence and levels of harmful bacteria.
We have not taken this approach in the past with respect to pathogenic microorganisms on raw meat and poultry because we have been constrained by the lack of a scientific basis for determining the levels at which specific pathogens do or do not present a safety hazard. We recognize there are still many gaps in this information, and we intend to continue to work with the scientific and public health communities and the industry toward determining what levels of specific pathogens on specific products pose public health concerns requiring regulatory action.
For the present, we are basing the performance standards for Salmonella on what we believe is achievable today with current science and technology. We have based our standards on the current national baseline prevalence for each major species and product class. We expect to revise the standards periodically as new baseline prevalence data become available that reflect progress in pathogen reduction.
FSIS will conduct extensive Salmonella testing to ensure compliance with the pathogen reduction performance standards. We have invested heavily in renovating and automating our laboratories to meet the demands of the microbial testing portions of the final rule. We expect to collect and analyze about 1,000 samples per day once the performance standards for Salmonella become effective and expect by the end of 1998 to have analyzed a quarter of a million samples.
While FSIS cannot quantify the reduction in disease incidence that will occur with specific reductions in pathogens on raw products, we know that reducing the percentage of product containing a pathogen should result in a reduction in disease incidence.
Our experience with Listeria monocytogenes in the 1980's tells us this strategy will work. USDA and FDA worked with plants to improve procedures and established a "zero" tolerance for Listeria monocytogenes in finished, ready-to-eat products.
Between 1989, when the "zero" tolerance policy was established, and 1993, the incidence of illness from Listeria monocytogenes declined 44 percent, and the incidence of deaths declined by 49 percent. Our experience with Listeria monocytogenes is a very dramatic indication of how a regulatory change can have a significant impact on rates of human disease.
Because our ultimate measure of effectiveness of food safety programs is a reduction in foodborne illness, good data on the incidence of foodborne illness is a critical tool for evaluating effectiveness. In 1995, the U.S. government began an active surveillance program in five states to collect more precise information about the incidence of foodborne illness, especially illness caused by Salmonella and E. coli O157:H7. The program, now called FoodNet, will provide us with more precise information that will enable us to better determine the effectiveness of food safety initiatives.
For the future, we need to do a better job at 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. Under this approach, we would determine, based on risk assessment, the levels of specific pathogens on raw meat and poultry products that do not pose a significant risk of illness, and prohibit distribution of products exceeding such levels.
Knowing the risks is not enough, however, to make public health decisions. We must integrate the results from the risk assessments with other factors, such as costs, benefits, and technical feasibility considerations, and then weigh the risk management alternatives available to us. Only then can we select appropriate regulatory and non-regulatory options.
Transparency is very important to the risk management process. We must be able to demonstrate the rationale for our decisions to all interested parties and allow opportunity for input throughout the process. This involvement is necessary to ensure that the public has confidence in our risk management decisions.
HACCP will help us to achieve our most important goal--that is, reducing the risk of foodborne illness associated with meat and poultry to the extent possible. But it provides us with many other advantages as well.
As I mentioned previously, it will allow us to focus our resources in such a way as to extend the greatest protection to consumers. By placing responsibility for producing safe food on industry's shoulders, where it belongs, we can focus our resources on setting standards and ensuring that industry is meeting those standards. I don't believe that any of us are immune from tightened budgets, and being able to do our job more efficiently is important.
HACCP also provides a solid foundation for facilitating international trade. On a very basic level, HACCP, and the remaining provisions of the final rule, are consistent with the GATT agreement, which requires countries to ensure that their sanitary or phytosanitary measures are based on science and risk assessment principles.
But the HACCP rule does much more than just conform to the GATT principles. Through performance standards, we have established a level of protection that is based on science. And through HACCP, we have established a system of process control, with documentation, for meeting those standards. The two together set what I believe will be a standard for international meat and poultry trade in the future. The combination of performance standards and HACCP will enable us to objectively demonstrate that the level of protection the U.S. system provides is science-based, addresses likely hazards, and is equivalent to foreign requirements.
HACCP combined with performance standards will also allow us to better evaluate whether inspection systems in countries that export meat and poultry to the United States are equivalent from a food safety perspective. We will focus our equivalency determinations for food safety on whether countries have process control requirements verifiable through records, have adequate Federal inspection, and can meet our performance standards--not on the steps taken to meet those standards. And we believe other countries should consider this same approach. Greater reliance on science-based standards will allow countries the flexibility to meet those standards in a number of ways. The more we can focus on the end result--the performance standard--the more we will avoid trade disputes, particularly those that are not really about food safety but are about protecting national trade interests.
In closing, mandatory HACCP is the cornerstone of our strategy to improve food safety in the United States. It provides a framework for carrying out a scientific and risk-based strategy to improve food safety, and when combined with performance standards, provides an effective means of controlling and reducing pathogenic microorganisms.
As we make progress on conducting risk assessments, HACCP plans can be more directly focused on known public health risks, making HACCP an even more effective food safety tool. And we will be able to tell whether or not we have succeeded by looking at data from our active foodborne disease surveillance system.
For the future, HACCP, combined with performance standards, will provide a solid foundation for facilitating trade because it will enable us to objectively demonstrate that the level of protection provided by the U.S. system is equivalent to foreign requirements. And it will enable us to evaluate the equivalency of foreign inspection systems in the same manner.
I appreciate the opportunity to share our food safety strategy with you, and we look forward to working with all of our trading partners to improve the safety of food worldwide.
For Further Information Contact:
FSIS Food Safety Education and Communications Staff
Public Outreach and Communications
Phone: (202) 720-9352
Fax: (202) 720-9063
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