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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
Speeches
Remarks prepared for delivery by Dr. Elsa Murano, Under Secretary for Food Safety, at the 63rd American Convention of Meat Processors & Suppliers' Exhibition, July 26, 2002, Reno, Nevada.
Good morning. It's a pleasure to join you this morning in Reno for your annual convention. I really do appreciate the opportunity to participate in this important meeting because I believe this is a perfect time to review our accomplishments and clarify where we are headed to ensure a safer meat and poultry supply for the nation.
Just one week ago, USDA announced that ConAgra Beef Company was voluntarily recalling approximately 19 million pounds of beef trim and ground beef products due to possible contamination with E. coli O157:H7. Even before this recall, we were seeing heightened interest on the part of Congress, the media, and consumer groups regarding performance standards, microbial testing, and HACCP. This Administration has been accused of acquiescing to the Supreme Beef decision, trying to do away with zero tolerance standards for pathogens, and ineffectively implementing HACCP.
It's time to set the record straight on each of these key issues. In particular, I am concerned that the volume of this publicity is interfering with our ability to pursue our science-based, food-safety strategy. Public discourse on these issues is healthy and I welcome it. But I also have a responsibility to intervene when I believe the public is being misinformed, as is the case in recent weeks.
At the same time, the events of the past week have been a learning experience for both government and industry. Our food safety system as it is designed and operated today is not perfect. Have we arrived at a place where we can say we are doing everything we possibly can to reduce pathogens to the lowest level possible? The answer is probably “no” because there remains a significant amount of preventable illnesses, and the illnesses associated with ConAgra product are evidence of this. Raw meat presents special problems that I admit are difficult to solve. This means we have to approach the problem on many levels and work together to find constructive solutions.
Every person regardless of role or operation within the farm-to-table continuum is accountable for ensuring a safer food supply. This morning I want to illustrate to you how USDA/FSIS is integrating accountability into its programs to build a stronger, safer meat supply.
As you have probably heard recently, media reports have focused on microbiological testing as a primary risk management strategy. There is a limit to what testing can accomplish however. It cannot, for one, ensure zero risk.
Testing is important as a verification tool and, in the case of E. coli O157:H7 where the pathogen has been declared an adulterant in ground beef, testing also helps to remove adulterated products from commerce. However, laboratory sampling is not the silver bullet that some would like it to be.
This Administration is committed to taking a holistic—not a piecemeal—approach to pathogen reduction. I believe it is helpful to discuss this approach using a risk analysis framework—that is, risk assessment, risk management, and risk communication.
First, we have to assess the risks associated with the consumption of meat, poultry, and egg products to determine where our resources and efforts are best spent. This includes conducting surveillance of the food supply to determine current pathogen levels, but it goes much farther than that. We must gather more information through basic research to determine dose response—that is, how much of certain pathogens it takes to make people sick—so we can in turn determine potential risks to the public.
That is why we are devoting considerable resources to risk assessment. A farm-to-table risk assessment on Salmonella Enteritidis in eggs conducted in 1998 is being used by both FSIS and FDA to develop risk management strategies. A recent risk assessment conducted for USDA by Harvard and Tuskegee universities on bovine spongiform encephalopathy has shown that the risk of BSE entering and spreading in the United States is low, and the study is guiding numerous risk management strategies.
In a perfect world, risk assessments would be completed before risk management strategies are developed. But in the real world, both activities occur together. We must design risk management strategies based on what we know today and improve them as more information becomes available. I want to talk more about several of these risk management strategies to illustrate the holistic approach we are taking.
Let me begin with inspection, because this is a risk management strategy that I believe is under appreciated by many. Over the past century FSIS, and its forerunners within USDA, have developed a strong 7,600-member inspection force who serve as our eyes and ears on the front lines in plants each day. Without them, we cannot implement new requirements and programs that work. We are continuously focusing on ways to improve our inspection force's effectiveness and accountability.
For instance when we conduct an in-depth review, the IDV should reveal inadequacies within the establishment's HACCP plan – not reveal any missing basic information that our inspectors should have caught in the first place. Over the last several years, our Workforce of the Future initiative has raised the level of expertise on the front lines. Our new Consumer Safety Officer (CSO) initiative is a step in this direction. These individuals are highly trained in HACCP and are an essential component of our in-depth review teams. Their assignments are focused on in-plant inspection activities, and an important part of their role is to help establishments find the technical resources that they need to achieve regulatory compliance.
Twenty FSIS employees just completed CSO training last month, bringing the total number of CSOs in the field now to 55. We contracted with the Texas Agricultural Experiment Station at Texas A&M University in May to provide training on CSO methodology to 75 employees this fiscal year. This training includes regulatory requirements, administrative enforcement strategies, scientific applications, and interpersonal skills. We continue to monitor the progress of this new CSO program and will make any necessary adjustments along the way.
HACCP is another risk management strategy and I am including in this category intervention steps that can be incorporated into industry HACCP plans. Recently, a draft report from the General Accounting Office was prematurely released, outlining numerous implementation problems having to do with training and enforcement prior to when the Bush Administration took office. While the GAO report has not yet been formally released, the GAO's conclusions confirm many of our own assessments conducted this fall concerning HACCP implementation.
However, one important point to remember is that despite the fact that HACCP remains a work in progress, the Centers for Disease Control and Prevention have documented reductions in foodborne illness that they have attributed in part to HACCP, and we expect additional public health benefits as HACCP is further improved.
In fact, we have taken some recent steps to do just that. An example is a ground beef directive designed to promote the use of intervention strategies at grinding operations and their suppliers. Under this directive inspectors will determine whether plants have specifically addressed Salmonella and E. coli O157:H7 in their Pathogen Reduction/HACCP plans to have effective control measures for these pathogens.
Ground beef plants that do not employ effective decontamination strategies, or that do not require their suppliers to do so as part of their PR/HACCP systems, will be targeted for increased verification testing by FSIS, above that which is already conducted. These directives are an example of how we can better tap HACCP's potential. If we are going to continue to drive down the incidence of pathogens in raw ground beef, it is crucial that we increase our efforts and resources on those establishments where microbial control may be insufficient.
Performance standards are another risk management strategy, and I believe there has been much confusion regarding FSIS' use of performance standards, particularly in light of the Supreme Beef decision. For example, recent legislation proposed by Senator Harkin would, in part, provide the Secretary with the authority to set, and later revise, pathogen reduction performance standards for meat and poultry. What this bill does not take into account is that even after the Supreme Beef decision, USDA still has the authority to set performance standards and continues to maintain these standards in plants. In fact, we are successfully using pathogen reduction performance standards every day as one way to verify that a plant's food safety program is working to reduce pathogens. USDA continues to take regulatory action when plants fail to control hazards through HACCP and SSOPs, sometimes indicated by having exceeded Salmonella performance standards.
I am pleased to announce today new procedures for responding to establishments that fail to meet standards for Salmonella in raw products, and you can find more information on these new procedures on our web site at www.fsis.usda.gov. Companies must take immediate steps to correct the problem. The new procedures accelerate the review of a plant's HACCP plan and involve higher level supervisors at an earlier stage. Comprehensive reviews are necessary to ensure that all four components of the Pathogen Reduction and HACCP rule are working together as originally intended. In addition to the steps we will take within plants that fail to meet the standards, FSIS may conduct in-depth verification reviews at some or all suppliers of a grinding plant that repeatedly fail the performance standard.
While I am on the subject of performance standards, I want to make clear that USDA is not changing its policy on zero tolerance for E. coli O157:H7 in raw ground beef or Listeria monocytogenes and Salmonella in ready-to-eat products. I made a statement at an April 30, 2002 hearing on Federal school lunches that "….zero tolerance, which is what we have with E. coli O157:H7 in ground beef, does not equal zero risk, because you can say you have zero tolerance, you can test, but you cannot test the problem away."
This means that simply having a zero tolerance policy in place and testing for the pathogen are not enough to ensure safety. You can never reduce the risk to zero without introducing a step that kills pathogens. Rather, the production process must be under control, and testing is most appropriately used to verify that such control exists within a HACCP framework.
Unfortunately, this statement was taken out of context by some to indicate that USDA is changing its policy to back off on zero tolerance. Nothing could be further from the truth.
In fact, the recent outbreak of foodborne illness associated with ground beef from a ConAgra plant in Colorado has prompted us to cast a wider net to enhance rapid response to positive E. coli O157:H7 results. In order to expedite recalls even more, FSIS will now inform the suppliers to a further processing facility, both verbally and in writing, when a positive E. coli O157:H7 sample is discovered in ground beef supplied to that facility. This will allow all the suppliers to take proactive steps without waiting for results from the FSIS investigation of their customers.
This is an important step, but I believe that more can be done to prevent contamination in the first place. As I said earlier, the illnesses associated with product from ConAgra show us that more needs to be done. That is why I'd like to issue a challenge to the industry to introduce interventions that are aimed specifically at achieving at least a 3 log reduction in E. coli O157:H7 in raw product, at the grinding step or when trimmings are introduced. Testing for an adulterant in raw product cannot make it go away, but validated interventions certainly can achieve that result.
Microbial testing is another risk management tool used by USDA. But I believe many misconceptions exist about what microbial testing can do and cannot do. Microbial testing is useful for some purposes, but not for others. For example, it is useful to verify whether an establishment's food safety programs are able to control contamination. Testing can serve as a flag that points inspectors to conduct an in-depth review of the establishment's food safety programs. If failures are found in those programs then the establishment can be shut down.
But by itself, microbial testing cannot ensure food safety. This is because pathogenic bacteria are not evenly distributed in food and are found in a relatively small percent of samples. So finding them is a "hit" or "miss" situation. Thus, a negative sample can give us the false impression that the entire lot is safe when in fact it may not be.
Microbial testing certainly has a place in our pathogen reduction strategy, but food safety experts agree that the best way to ensure food safety to the greatest extent possible is to control the process that goes on at an establishment.
These risk management strategies—inspection, HACCP, performance standards, and microbial testing—when combined, form a multi-faceted approach to pathogen reduction that I firmly believe is the right way to go. None of these strategies by itself is sufficient. Their strength lies in the total package.
I haven't yet addressed the third component of the risk analysis framework—risk communication. Risk communication is often an afterthought to the risk analysis process, and in the coming months you will see a greater emphasis on getting our message out to all our key audiences.
No matter how many improvements we can make from a regulatory standpoint, food safety education will continue to be a critical part of our effort. But we must look for new and creative ways to provide this information. For example, I recently visited Miami to promote the expansion of the USDA Meat and Poultry Hotline to include services for Spanish-speaking individuals.
Risk communication, while it focuses on message development, is much broader than that. I believe that good risk communication involves ensuring that our policies and procedures are sound and have been developed with the full input of our constituents, and that our risk assessment and risk management activities are well coordinated. I look forward to seeing the risk communication function more fully develop within FSIS.
What I have just talked about all fits in the context of the five major goals I outlined for FSIS to improve food safety. They are:
I'd like to briefly give you a few examples of the progress made by FSIS in each of these areas.
The first goal is to base food safety policies on science, and we have made quite a bit of progress here. As you might know, we are hosting a series of scientific symposia on specific issues. Our first symposium on pathogen reduction was held in May, and most recent one on animal production food safety was held two weeks ago in Puerto Rico. These symposia offer an opportunity to hear from experts in academia and government. It also allows for a dialogue on how we can improve the scientific basis for our food safety programs and policies.
Our science-driven policies have led to the need for more frontline personnel with scientific and technical expertise. We are exploring new roles for our veterinary force and established a new veterinary presence in the field – the District Veterinary Medical Specialist or DVMS. One DVMS has been assigned to each district office. The DVMS is the primary contact to ensure that all plants, regardless of size, receive appropriate guidelines, inspection oversight, and information on humane handling responsibilities and other slaughter issues.
The second goal—protecting the food supply from a bioterrorist attack—has generated much activity as well. We are working closely with other agencies, including FDA, EPA, CDC, DOD, and APHIS through the Food Threat Preparedness Network, or PrepNet. And we are working with the Association of Food and Drug Officials, FDA and the states to revitalize our laboratory network that enables us to identify quickly isolated cases, as well as outbreaks of foodborne illness.
At the agency level, the Food Biosecurity Action Team is serving as the "arms and legs" of food biosecurity at FSIS and has been instrumental in several initiatives to improve food safety and security. These include: (1) assessing potential vulnerabilities along the farm-to-table continuum; (2) strengthening FSIS coordination and cooperation with law enforcement agencies; (3) enhancing security features at all FSIS laboratories, (4) increasing the capacity of the agency's laboratories to test for additional food safety hazards and biological agents; and (5) providing guidelines to industry on food security and increased plant security.
We have utilized the same outreach strategy to reach small and very small plants in distributing these security guidelines that we did with HACCP implementation materials. There should be copies of these security guidelines here at FSIS' exhibit booth. We also have the guidelines available in Spanish on our Web site: www.fsis.usda.gov/oa/topics/SecurityGuide.pdf)
My third goal, improving the management of agency programs, is critical to the success of our programs. That is why I have made changes in key leadership positions within FSIS. Earlier this week, Secretary Veneman announced the selection of Dr.Gary McKee as the new FSIS Administrator. Dr. McKee brings more than 30 years of public health experience and a solid track record in managing public health programs and personnel. He will begin his new job in September, and I want to thank Bill Hudnall who stepped in as acting administrator during the past three months.
In recent months, I have announced other key personnel changes in FSIS to strengthen agency performance. Linda Swacina is the new Associate Administrator, and Bill Smith is now Deputy Administrator for Field Operations. And I am pleased to announce that Dr. Karen Hulebak has just been selected as the new deputy administrator for the Office of Public Health and Science.
In addition to these leadership changes, a planned reorganization is underway that will include an independent program review function, among other changes. These changes will better enable FSIS to meet its food safety goals.
We also are enhancing communication with our sister agencies. I already mentioned our activities involving PrepNet in the biosecurity area. FSIS' interaction with FDA on issues of mutual concern has increased significantly in recent months.
States are also an integral part of the U.S. food safety system as they have prime jurisdiction at the retail level. We are continuing to take steps to improve Federal-State cooperation on State Meat and Poultry Inspection (MPI) Programs. For example we are working in close cooperation with state program directors on the National Criteria for Meat and Poultry Inspection Program – a project to update, clarify, and simplify requirements for cooperative state meat and poultry inspection programs.
Another area where we are making major strides in cooperation with states is sharing recall information. Several months ago, FSIS published a final rule allowing FSIS to share a firm's distribution list with state and federal agencies in the event of a meat or poultry recall. This rule will take effect on July 31st, and it will allow for better communication and coordination between FSIS and the numerous state and federal agencies that are involved in product recalls.
And, regarding the interstate shipment provision of the Farm Bill, last month, FSIS sought advice from the National Advisory Committee on Meat and Poultry Inspection on how to implement the Farm Bill provision requiring a review of the State inspection systems. The committee suggested that we complete comprehensive reviews by March 2003 of all States not reviewed since 2000, and it recommended that we request all States to adopt current Federal food safety regulations and FSIS Notices, Directives, and memoranda, to prepare for the authorization of interstate shipment of State-inspected products.
Goal number 5 is to engage in proactive education programs. We are seeking to develop an aggressive education and risk communication campaign within USDA to ensure that our efforts are recognized, and that consumers have confidence in our system.
As an example of how we are meeting this goal, we are cosponsoring with the Department of Health and Human Services and the Partnership for Food Safety Education a food safety education conference on September 18-20, in Orlando, Florida. This conference will provide an opportunity for food safety education and communication leaders from across this country to present and share projects, assess current trends, and plan for the future.
The National Food Safety Education Month SM 2002 Planning Guide for Food Safety Educators is being offered this year online and on CD-ROM. You can view the National Food Safety Education Month Web site at: www.FoodSafety.gov/September
A few years ago FSIS launched a food thermometer education campaign, popularly known as The Thermy™ Campaign, to communicate to consumers the importance of using a food thermometer when cooking meat, poultry, and egg products. Our next step in this campaign is to take Thermy™ into food service and retail. Thermy™ for food service will have a little different look, will emphasize time/temperature relationships, and will reflect the 2001 Food Code temperatures.
Regardless of what changes lie ahead with regard to food safety, we need to remember that everyone is accountable when it comes to ensuring food safety – industry, government, and consumers. Industry is responsible for establishing validated and verifiable systems that successfully control hazards. Government is responsible for establishing science-based policies that ensure hazards are controlled and are verified through proper inspection. And consumers have a responsibility to follow safe food handling and preparation practices.
I have enjoyed the opportunity to talk to you today, and hope that I have given you a clear indication of where we are headed. I invite you to participate in the process that guides us to achieve a stronger food safety system.
For Further Information:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-3897
Fax: (202) 720-5704