Statement of Dane Bernard

on behalf of

The National Food Processors Association

Before the Committee on Agriculture, Nutrition and Forestry

United States Senate

"How Should Our Food Safety System Address Microbial Contamination?"

September 20, 2000

Mr. Chairman and Members of the Committee: My name is Dane Bernard, and I serve as Vice President of Food Safety Programs for the National Food Processors Association (NFPA). I am pleased to join the Committee today to discuss the important issue of food safety and how our nation's food safety system addresses those threats posed by microbial contamination. I am a microbiologist by training, and, in my position at NFPA, I oversee the Association's food safety-related technical and regulatory affairs activities.

NFPA serves as the scientific and technical trade association for the $460 billion U.S. food processing industry. We operate three laboratory centers and employ approximately 75 scientific and regulatory experts. NFPA's primary mission focuses on food science and food safety. Our strong scientific and technical base gives us unique expertise on food safety issues, and we are pleased to have the opportunity to participate in today's hearing.

The Food Supply is Safe

American consumers continue to enjoy a safe and abundant food supply. Actual data of food-related illnesses compiled by the Centers for Disease Control and Prevention (CDC) indicate that the greatest risk to consumers appears to be that presented by microbial pathogens that may occasionally contaminate food products

Food Safety is a Shared Responsibility

In this day of farm-to-table food safety, it has become increasingly obvious that food safety is a responsibility shared by all stakeholders. It is the responsibility of the food industry to provide foods that meet the safety expectations of our consumers. Toward meeting this goal, the

food industry implements hazard control programs; conducts testing of ingredients, products during processing, and finished food products; provides assistance to foreign producers who provide ingredients and raw materials; conducts audits of suppliers; and carries out many other activities on a voluntary basis to help assure that foods are safe and wholesome.

The total efforts of the food industry in assuring the safety of food through self-inspection and testing amount to significantly more than those of the collective government agencies who claim responsibility for food safety. At the same time, however, the industry mission is most successfully fulfilled within an environment of fair, science-based laws and regulations that facilitate the production of safe foods. In order to ensure that the regulatory inspection system is fair and science-based, NFPA feels there are issues that deserve attention. These will be discussed later.

HACCP Is an Integral Component of Food Safety Management Systems

The current paradigm for addressing food safety issues is the implementation by industry of the Hazard Analysis and Critical Control Points (HACCP) concept. While it is widely accepted that HACCP is the best system for assuring safety of foods, it is not a magic wand that will fix all food safety problems. HACCP can successfully allow the government and industry to address food safety issues, as long as it is understood what HACCP is and what its limitations are.

HACCP is a management tool that facilitates the focusing of resources and control measures on those hazards that pose a risk to consumers. HACCP can only be effective in controlling those risks if adequate and appropriate control measures are applied. In certain situations, few control measures are available that can eliminate microbial hazards that may be associated with some foods or ingredients. Unfortunately this is the situation with most raw products. Thus, without application of some globally effective process like irradiation to raw products, the best that can be achieved is a reduction in the level of the hazard.

HACCP has been adopted by the Food and Drug Administration (FDA) for the regulation of the seafood industry and by the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) for the regulation of the meat and poultry industry. While recent information indicates these programs are enjoying success in reducing levels of hazards associated with raw and processed products, HACCP, as a regulatory tool, is still a work in progress. Some have begun to criticize these efforts, but NFPA continues to believe that HACCP offers the best approach to assure the safety of our food supply.

In our view, successful implementation of HACCP involves basic changes in the nature of the industry-regulatory agency relationship. After 90+ years of regulation in one mode, certain habits are difficult to change, but change is necessary for any contemporary food safety system to be able to address new challenges. Toward this end, the agencies involved have recognized a need for ongoing flexibility. In late 1999, many organizations from the food industry collectively petitioned the FSIS to consider certain changes to the Pathogen Reduction HACCP Rule. This "friendly" petition was aimed at sharpening the focus of application of HACCP in the meat and poultry industry and at reducing some of the factors observed in the field to have been confusing. In our estimation, addressing these issues will promote a more complete understanding of HACCP and will help to achieve its full potential as a food safety assurance tool.

The Appropriate Role of Microbiological Testing in a Regulated HACCP System Must be Determined

One controversial item related to the responsibilities of government and industry within a HACCP framework is the role and utility of microbiological testing. This topic has been the subject of debate for both FDA- and FSIS-regulated products. In particular, several questions have arisen about the application of microbiological standards in a regulated HACCP system.

To the heart of the matter, FSIS, in its combined Pathogen Reduction HACCP Rule, established mandatory microbiological standards for Salmonella. Microbiological standards are not a new concept, as they have been applied for decades in the processed food area. For example, canned goods and products that are cooked and ready-to-eat are expected to be free of pathogenic microorganisms capable of causing illness when the foods are properly handled by the consumer. These criteria have been a regular part of our food safety system and they work. Further, microbiological criteria focused mainly on indicator organisms have been used routinely by the food industry on a voluntary basis for both raw and processed products as a guidepost to indicate that there may be operational or production problems deserving further investigation.

What is unique about the Salmonella standards contained in the FSIS Pathogen Reduction HACCP Rule is that for the first time bright-line, pass/fail standards based on frequency of finding Salmonella were broadly applied to products that are not ready-to-eat. While NFPA believes that the goal of providing more focus on microbiological quality is laudable, such standards are simply not appropriate when used as a pass/fail regulatory tool. These standards do not measure whether a product is safe or whether the operation that produced the product is sanitary. Such microbiological measurements are a very useful tool as an operational or production quality control indicator, but are not reliable as a definitive regulatory measure.

Quite simply, a tool that works well as a guidepost to indicate that there may be operational or production problems deserving further investigation is not necessarily appropriate as a bright-line, pass/fail microbiological standard for raw commodities

Application of such microbiological criteria as bright line standards will, sometimes arbitrarily and unfairly, discriminate against and result in closure of some establishments. This is the nature of mandatory microbiological standards, especially those that are not strictly tied to achieving a specific public health goal, where the pass/fail level is somewhat arbitrary. In addition, smaller firms will have a more difficult time in meeting these criteria, as they may lack the technical and financial resources needed to consistently meet the criteria, resulting in more and more plant closures and consolidation.

NFPA feels that there are opportunities to utilize results of microbiological testing of raw products to achieve the desired result of improvement in the food supply within a HACCP system, but without arbitrarily and unfairly discriminating against certain facilities. The approach we suggest is one where results of microbiological testing are used to indicate that an in-depth investigation is warranted rather than a determination that product or an establishment is non-conforming solely on the basis of the test results. We also note here that FDA has taken a somewhat different, and we feel a more scientific approach from FSIS on certain raw foods by issuing growing and production guidelines that will lead to better controls rather than an over reliance on microbial testing with its inherent variability.

Support Is Needed for The Development and Implementation of

New Food Safety Technologies

NFPA feels that, eventually, there must be other questions addressed by all stakeholders: What is a fair criterion, (or standard) for raw products, and what is our ultimate goal in terms of hazards associated with raw foods? As we continually strive for "zero," we must either make quantum leaps in technology or submit to eating only foods that are canned, irradiated, or treated in some other way to sterilize them

New and innovative ways to address hazards is our most important need relative to advances in food safety. To meet this demand for new technologies and innovations, barriers will have to be overcome. Time, money and fresh ideas are clearly the chief barriers to development and implementation of new technologies.

However, even for those technologies that have been fully developed, scientifically well-documented, and proven safe, regulatory approvals for use have taken far too long. For example, an extensive petition was filed with FDA in July of 1994 for pre-market approval of irradiation for red meat. It was not until December, 1997 that FDA granted the petition, and not until December of 1999 that the final rule making this food safety technology available was issued by FSIS. A petition for use of ultraviolet light for the reduction of pathogens in juice products is still under review by FDA more than a year later.

To overcome these barriers, resources need to be allocated to provide the appropriate but expedited review of food safety enhancements. In addition, funding must be provided to organizations such as the Agricultural Research Service and the Joint Institute for Food Safety Research, for academia, and to private concerns to assist in the development and validation of new technologies and technological innovations. To assure sustained progress Congress must provide appropriate advocacy for technological innovation and frequent oversight of government appropriations to assure that funds allocated for this purpose are being effectively used.

Some Issues in the Food Safety System Must Be Addressed

As noted earlier, it is NFPA's opinion that if progress on food safety issues is to continue, some issues and concerns need to be resolved. One of the key issues is training and management of our food inspection force. Full utilization of HACCP will require a higher level of understanding of potential food safety problems and their resolution by inspection personnel, as well as a shift in attitude.

Thus, in the longer term, there must be a transition to an inspection force more attuned to hazards and their controls and to the potential for certain actions to result in food safety problems. There will be a need to differentiate minor infractions from those that can have a significant adverse impact on the safety of a product. In addition, the system must find a way to provide assistance to those food operations that are eager to do the right thing, if they only knew what the right thing is. All of this will require specialized training, and the ability to actually work together with industry. Regulatory agencies, in particular FSIS, will need flexibility to make changes in inspection modes and make adjustments in inspection tasks. Toward this end, we applaud the FSIS efforts to modernize its inspection practices through pilot testing inspection changes during the HACCP Implementation Models Project.

In addition, NFPA continues to advocate better coordination between FDA and USDA on food safety policy. We also call the Committee's attention to the Association of Food and Drug Officials estimate that as much as 80% of food-related inspections and regulatory activities are conducted by State and local authorities. Coordination of Federal, State and Local efforts is essential to a uniform and effective inspection system without duplication and unnecessary overlap . We urge Congress to support better coordination of these efforts through funding and oversight of the National Food Safety System and increased uniformity in our federal and state food laws.

Conclusion

We recognize that increased focus on microbiological quality of raw commodities can be of benefit. However we foresee the need for well-based, scientifically accurate criteria applied in a non-punitive way as the vehicle for progress. Thus, we recommend that this area receive the attention of an expert body to more fully explore appropriate establishment and use of microbiological criteria within contemporary food safety assurance programs. In this context, the U.S. National Advisory Committee on Microbiological Criteria for Foods can provide some review of specific items or scientific information. Congress may also wish to request a comprehensive review of this entire topic by an institution such as the National Academy of Sciences.

Thank you for your time and thank you for the opportunity to testify before this Committee.