April 23, 2009

Chairman Scott, Ranking Member Neugebauer, and members of the Subcommittee, thank you for inviting me to appear before you today at this hearing to review Federal food safety systems at the U.S. Department of Agriculture (USDA).

Food safety is a priority for this Administration and this Agency. I commend the President and Secretary Vilsack for taking on this difficult issue and making review of the current state of our food safety system a top priority. I also appreciate this Subcommittee and the full House Agriculture Committee exploring how FSIS regulates products under its jurisdiction and the larger issue of the nation's food safety system.

There is much we can draw from as we engage in this food safety dialogue. Many experts have studied our current system in the U.S. and that of other countries. We don't need to start from scratch; there are many lessons learned that can and should be considered as part of this open discussion.

As we embark on this dialogue, we all need to look at the various levels of risk posed by different food products, and the different performance of the establishments that manufacture those food products, for the entire food supply. We also need to ask hard questions about what level of inspection is appropriate for different kinds of foods, what roles are appropriate for the different agencies involved in food safety, and how we approach uniformity in import safety. These questions should be viewed through the prism of public health protection and risk assessment and management.

We will support Secretary Vilsack's pledge to strengthen and enhance our nation's food safety system. He has tasked us to look at all of our regulations and administrative actions, inter-agency coordination, the way we work with State and local partners, and our coordination with foreign governments. In addition, we will review our strengths and weaknesses and provide suggestions on areas needing enhancement. We welcome your interest and this hearing today and look forward to working with you and all of our stakeholders.

Who We Are and What We Do to Ensure Food Safety
FSIS is the inspection agency within the U.S. Department of Agriculture with a focus on public health. It is responsible for ensuring that the Nation's commercial supply of meat, poultry, and processed egg products is safe, secure, wholesome, and accurately labeled and packaged, whether those products are domestic or imported. We administer and enforce the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, portions of the Agricultural Marketing Act, the Humane Methods of Slaughter Act, and the regulations that implement these laws.

Our mission is to protect the public health. Since our long-standing statutes were established, our inspection process has evolved into a dynamic preventative system designed to address problems before they occur. However, there is always room for enhancement and we are always open to improvement. Mindful of our finite resources, we have to measure and attack risk, hazards, or inadequate performance to know where we can best focus our attention. In order to efficiently and effectively protect the public health, we at FSIS recognize that all food doesn't necessarily carry the same risk, and all plants do not operate the same way.

The high volume and the high-risk nature of the products that FSIS inspects demand an in-plant inspection presence, which is not only required by law, but is necessary to protect consumers. For this reason, the agency employs over 9,500 people, including around 7,800 full-time in-plant and other front-line personnel protecting the public health in approximately 6,200 federally-regulated establishments nationwide. Our statutes require us to be present for all slaughter operations and we inspect each processing establishment once per shift per day. Inspection personnel perform approximately 9 million food safety and 1.5 million food defense verification procedures annually at these plants. In fiscal year (FY) 2008, FSIS personnel inspected about 50 billion pounds of livestock carcasses, about 59 billion pounds of poultry carcasses, and about 4.3 billion pounds of processed egg products. Additionally, FSIS personnel inspected 3.3 billion pounds of imported meat and poultry products at our borders.

In addition to in-plant personnel in Federally-inspected establishments, FSIS employs a number of other field personnel, such as laboratory technicians and investigators. Program investigators conduct surveillance, investigations, and other oversight activities at food warehouses, distribution centers, retail stores, and other businesses operating in commerce that store, handle, distribute, transport, and sell meat, poultry, and processed egg products to the consuming public. These in-commerce businesses do not operate under grants of inspection and are not inspected on a daily basis by FSIS. However, the agency verifies that FSIS-regulated products moving in consumer distribution channels continue to be safe and wholesome.

Since 2000, the Hazard Analysis and Critical Control Point (HACCP) system, an internationally recognized method for the identification and control of hazards, has been required for all meat and poultry plants. Plants are responsible for identifying the hazards in the products they produce and determining how to minimize contamination at each step of their process. Our responsibility is to verify that plants are following their own food safety or HACCP plans.

In late 2001, FSIS began an additional level of surveillance through food safety assessments (FSAs), further strengthening public health. These FSAs, carried out by highly trained scientific personnel, look thoroughly at the design of the plant's food safety plan as verification that an establishment has fully assessed the relevant hazards and put in place controls or preventive measures that are effective. This more intensive review, now to be done on a routine basis, provides valuable data for the Agency to analyze and can lead to major changes or refinements in Agency policy. FSIS has committed to conducting routine FSAs in every plant every 4 years. Additional FSAs will be conducted as needed, for example, following positive pathogen sample results or products implicated in foodborne illness outbreaks.

Our policies at FSIS are rooted in science and based on data. Through science-based initiatives and efforts to continue to strengthen our infrastructure, FSIS works to prevent adulterated food from reaching the consumer. In 2008, FSIS personnel tested about 21,300 ready-to-eat product and environmental samples using risk-based criteria for Listeria and approximately 49,000 raw product samples for E. coli O157:H7 in ground beef and Salmonella in raw meat and poultry. To analyze these samples, FSIS has three labs, and supports 25 Food Emergency Response Network (FERN) labs. FERN consists of Federal, State, and local governmental laboratories, which are responsible for protecting the U.S. food supply from intentional biological, chemical, and radiological contamination.

All products under FSIS' jurisdiction receive the USDA mark of inspection after inspectors confirm its safety and wholesomeness. This is one of our most powerful tools in protecting the public health. Denying the mark of inspection due to insanitation or a lack of process control, for example, closes down a regulated establishment and effectively prevents the production of potentially adulterated food.

Making the Best Use of Our Data
In order to improve upon our preventative system of identifying the inherent risks of different food products and establishments, we must continue to evolve towards an even more science-based, data driven inspection system. This depends on building a comprehensive and integrated strategic approach to managing data. FSIS has long recognized this need, which has also been recognized by the Office of the Inspector General (OIG), the Government Accountability Office (GAO), Congress and our stakeholders. Before and since its December 2007 audit, we have been working closely with the OIG to strengthen our data collection and analysis capabilities.

FSIS has enhanced data integration through data sharing, mining, reporting, and analysis within and across FSIS programs and other agencies. FSIS' improvements include forming the Data Analysis and Integration Group (DAIG) and the Data Coordinating Committee (DCC). The DAIG is a staff dedicated to conducting data analysis and ensuring that Agency data analyses are consistent, of high quality, relevant to FSIS' mission and business processes, and fully integrated into ongoing decision-making. The DCC has members from each FSIS program office who serve as liaisons between the DAIG and the program offices. More specifically, DCC members coordinate the analysis of data to ensure that data is not duplicated, that data is used efficiently, and that analysis done in one part of the Agency is available to inform the work done in other parts of the Agency and other food safety partners.

FSIS works closely with other Federal, State, and local agencies, which have a role in keeping the U.S food supply safe, to coordinate food safety and food defense activities, including risk assessment and risk management. For example, the agency has a liaison to the Centers for Disease Control and Prevention (CDC) and uses data from the PulseNet system to monitor foodborne illness-causing bacteria; coordinates with Custom and Border Protection (CBP) to monitor product imported to the United States; and frequently interacts with the U.S. Food and Drug Administration (FDA) on mutual food safety and food defense issues. These are only a few examples. We also recognize the importance of uniform and consistent federal food safety requirements for our State and local partners.

In addition, FSIS utilizes AssuranceNet, a Web-based system of management controls that pull inspection and laboratory data from the Agency's data warehouse. We have been creating analysis plans for directives and notices, conducting peer reviews of data analyses, soliciting input from stakeholders, and developing a consistent set of tools for conducting data analysis. In all these efforts to evolve our data management system, we are pleased with the support we've been given by the Administration and Congress in recognition of providing support for our information technology infrastructure enhancements.

Public Health Information System
FSIS has been working on a number of actions related to data integration and analysis and enhancements to the Agency's inspection program and many are nearing completion. The most significant initiative is the development of a Public Health Information System (PHIS) which will integrate the Agency's data systems to provide a comprehensive, fully automated system that will allow FSIS to more quickly and accurately identify trends, including vulnerabilities in food safety systems, and thus allow us to more efficiently and effectively protect public health.

In order to satisfy the OIG's recommendation for external review, FSIS asked the National Academy of Sciences (NAS) to review FSIS data initiatives in order to ensure that Agency decisions are science-based and data driven. Three studies have already been undertaken by NAS. FSIS will review the input from NAS and determine whether and how to incorporate appropriate changes into PHIS.

PHIS will integrate FSIS data sources, improve data quality and reporting consistency, enhance management controls, and ensure more efficient and effective use of FSIS data to inform inspection activities and develop policies that protect public health. This enhanced dynamic system will be a flexible, user friendly, and Web-based application that replaces many of FSIS' legacy systems built with older technology (e.g., the Performance-Based Inspection System), automates paper-based business processes (e.g., export certification), and can be modified to accommodate changing needs.

PHIS will also revolutionize how FSIS collects and analyzes information about domestic and international food safety systems that produce FSIS-regulated products so that the Agency can better identify food safety risks before they result in outbreaks or recalls. Using multiple FSIS data sources, analysts will be able to identify trends and anomalies from test results and inspection findings.

Further, using the Predictive Analytics component of the Public Health Information System, FSIS will be able to monitor all establishment and import/export data points in near real time and alert the Agency to anomalies, such as a large number of incomplete inspection activities or high rates of noncompliance in an establishment. In addition, PHIS will support automated algorithms and decision criteria for consistent direction of inspection activities and reporting of inspection results.

PHIS will streamline the Agency's export program by automating paper-based processes, including establishment applications for approval for export, applications for export certificates, and the issuance of export certificates. The system will enable an automated edit-check capability to ensure certificates properly reflect a foreign country's import requirements. The new system will allow FSIS to verify the effectiveness of foreign food safety systems and enable the advance receipt and verification of electronic foreign health certificates associated with arriving foreign shipments certified by a foreign government.

PHIS will also automate FSIS processes for auditing the inspection programs of foreign countries exporting meat, poultry, and processed egg products to the United States. This will also serve to allow the Agency to provide greater oversight to countries that stand out because of import findings or inconsistencies in their programs, allowing us to spend less time and resources performing our annual audits of countries that consistently meet our regulatory requirements and more time auditing those that do not.

Since 2002, FSIS has actively participated in the International Trade Data System initiative, and is working closely with the Department of Homeland Security's (DHS) CBP to ensure an electronic interface between PHIS and CBP's Automated Commercial Environment. This long overdue initiative, when completed, will give us a greater level of confidence in the safety of imports and the food safety systems of foreign countries deemed equivalent by providing real-time exchange of import data between the importing community, CBP, and FSIS to ensure that appropriate inspections are performed and enforcement actions are taken.

We have also provided broadband computer connections to most inspection program personnel in the field so that they are linked to a near real-time data communications infrastructure. This improved access is vital for Agency personnel who are collecting data in the field, because it will allow them to spend more of their time on inspection activities.

FSIS is leveraging USDA enterprise data centers to host the new PHIS and other major systems to ensure that they are readily available and are using current data. In addition to using a primary USDA enterprise data center, a second, geographically separate, failsafe enterprise data center will be used to ensure a consistently reliable system in case of disaster or disruptions in the primary facility. The Agency is also continuing to further secure its infrastructure to protect its data and systems.

Imports
FSIS ensures the safety of imported meat, poultry and processed egg products through a three-part approach. First, FSIS establishes the initial equivalence of the meat, poultry, or processed egg inspection system of a country that wishes to export to the United States. Second, as I mentioned, we verify continuing equivalence of the foreign system through annual audits. Finally, FSIS import inspectors perform re-inspection of shipments of meat, poultry, and processed egg products at the border, including statistically-based random sampling that is intended to verify the effectiveness of the foreign inspection system.

This country-to-country approach to food safety is an efficient and effective means to ensure the safety of imported products and illustrates that our trading partners' governments have appropriately invested in and exercised control of their food safety infrastructure. PHIS will also connect with participating foreign governments, which will enable electronic certification of shipments to the United States. This is an important additional control for import safety.

Equivalence is the foundation for our system of import safety. The equivalence principle recognizes that an exporting country can employ different sanitary measures than the U.S. to address food safety hazards if the country can objectively demonstrate that its safety measures achieve the same level of public health protection as the measures used by the United States for its meat, poultry, and processed egg products.

Once the imported product enters this country, FSIS' field force of program investigators provide ongoing surveillance of product in commerce to protect the public from illegally imported and smuggled meat, poultry, and processed egg products.

We take great pride in FSIS' equivalence system for imported food under its jurisdiction. By working with the government of each foreign trading partner, rather than individual establishments, we can ensure that imported products under FSIS' jurisdiction meet standards that provide the same level of protection as that provided by FSIS inspection of domestic products. Further, we can use resources more efficiently and effectively when working with our counterparts in other countries.

Fighting Foodborne Pathogens
Earlier, I hinted at some of the steps that FSIS has taken to tackle foodborne pathogens, and I'd like to elaborate on that a little. FSIS works in collaboration with CDC, FDA and state and local public health partners to investigate foodborne illness cases and outbreaks. One specific collaborative effort is FoodNet (the Foodborne Diseases Active Surveillance Network), a part of the Emerging Infections Program at the Centers for Disease Control. FSIS worked in conjunction with CDC, FDA, and epidemiologists and public health laboratories in several States to establish FoodNet in 1996. FoodNet conducts active surveillance of foodborne diseases, case-control studies to identify risk factors for acquiring foodborne illness, and surveys to assess medical and laboratory practices related to foodborne illness diagnosis. It also provides estimates of foodborne illness and sources of specific diseases that are usually found in the United States and interprets these trends over time. FSIS uses the data that are generated to analyze the effectiveness of its Pathogen Reduction/Hazard Analysis and Critical Control Point (PR/HACCP) rule and other regulatory actions, as well as to develop public education initiatives.

FoodNet data are used by the agencies that are involved to evaluate progress toward meeting the Healthy People 2010 and Healthy People 2020 national objectives for foodborne infections. FSIS and FDA are co-lead agencies responsible for the HP 2010 food safety objectives. Of the infections tracked in this category, most, but not all, are transmitted by food vehicles, including drinking water, and many are transmitted by foods not regulated by FSIS. We recognize that the most recent surveillance data on foodborne disease outbreaks from the Centers for Disease Control shows that progress toward Healthy People 2010 objectives has plateaued, and that the incidence of the most common foodborne illnesses has changed very little over the past three years. This is troubling to us, and we believe the report points to the need for better information about which foods contain pathogens that are sources of infection.

We have taken many aggressive actions to combat E. coli O157:H7. For example, we now have more targeted routine testing, we are testing more ground beef components, we refined the testing method, and we have released draft compliance guidelines for industry. We have also held several public meetings to discuss the challenges posed by E. coli O157:H7 and to work on solutions with industry, including small plants, consumers, and other public health partners. Those discussions have helped us begin developing directives and policies to address our new steps for the future.

We are also pleased to report that we have seen improvement in the data trends as a result of the Salmonella initiative and verification testing programs. Furthermore, FSIS is analyzing the data on Salmonella and Campylobacter contamination from a recently completed microbiological baseline study of broiler carcasses and deciding how to proceed based on that data.

We have implemented policies to control Listeria monocytogenes (Lm) in ready-to-eat (RTE) products. The Agency has a zero tolerance policy for this pathogen in RTE products and FSIS requires that establishments producing RTE products address Lm through a written program, such as their HACCP plan or Sanitation Standard Operating Procedures, or other prerequisite programs.

FSIS scientists continue to stay abreast of new developments in the area of microbial food safety and inform Agency management of potential policy implications. I do want to be clear that our routine Salmonella testing data is not a measure of true national prevalence — that is why we conduct periodic baseline studies. We have completed a new broiler baseline study, from which we plan to estimate national prevalence data. Our intent is to continue to drive down human illness rates, to drive down percent positive rates in verification samples, and to reduce the national prevalence of Salmonella as estimated by baseline studies. However, without accurate data attributing illness to specific foods, defining meaningful performance objectives remains challenging for regulators. Attribution is absolutely critical.

Recalls
Recalls are the last weapon that FSIS uses to combat foodborne illness and protect public health. The purpose of a recall is to remove meat or poultry from commerce as quickly as possible when FSIS has reason to believe it is adulterated or misbranded. Just as we approach preventing a recall in a proactive way, FSIS is also proactive in overseeing recalls once they become necessary.

I cannot stress enough that, even though recalls are voluntary actions, they are the result of active oversight and intervention by our Agency. Moreover, we are open to any ideas that will strengthen our food safety system recall process.

The Agency issues recall information as quickly as possible to the public, stakeholders and public health partners. Also, we have begun translating more of the recall releases into Spanish. Individuals can subscribe to receive automatic e-mail notification of recall updates, including press releases, directly from FSIS' Web site at www.fsis.usda.gov, as well as RSS (Really Simple Syndication) feeds.

After the recall occurs, FSIS conducts effectiveness checks to ensure that consignees have received notice of the recall and are making reasonable efforts to retrieve and destroy the recalled product or return it to the recalling firm. Upon compliance, the recalling firm is officially notified by letter that the recall is completed, and no further action is expected.

Last year, in order to improve the effectiveness of a recall, FSIS also began to make available to the public a list of retail establishments that have likely received products subject to the recall. FSIS believes this information helps consumers lower their risk of foodborne illness by providing more information that may assist them in identifying recalled products. Interested individuals can also subscribe on the FSIS Web site to get e-mail alerts about the retail distribution lists.

Training and Education
FSIS can only achieve its public health, food safety, and food defense missions with a well-prepared workforce; therefore, training is one of our top priorities. Through scientific and technical training that reflects the agency's science-based approach to food safety and food defense, we can accomplish this. FSIS has made a number of improvements in employee training, thereby increasing workforce capability and advancing our public health goals. In addition, FSIS training is accredited by the International Association for Continuing Education and Training, qualifying our training programs to award continuing education units (CEUs) to participants who successfully complete courses.

FSIS has made substantial progress in improving its workforce training program. Some key milestones demonstrating improvement include establishing a new curriculum based on food safety and public health; implementing training as a condition of employment; launching a comprehensive management, leadership and development program based on the Office of Personnel Management's competencies to meet the need for succession planning; introducing a regular process to provide training that coincides with the issuance of key agency policies; building capacity for follow up training and education through distance learning; achieving greater flexibility with training contracts; establishing regional training bringing courses closer the worksite; and evaluating the effectiveness of training through pre and post testing.

We also recognize the importance of partnering with industry by sharing our training materials and conducting training and education sessions for industry and inspection personnel in the same room together. This approach keeps industry current on our training methods and materials and leads to greater compliance by industry through a better understanding of the federal requirements.

The best asset that FSIS has is a dedicated workforce. With FSIS being the largest federal employer of veterinarians, the Agency has developed new recruitment and retention strategies to retain those employees who have a passion for food safety and public health and to attract others to join us in protecting the public health. As a result of our efforts, Agency in-plant personnel vacancy rates are declining. At the end of FY 2008, FSIS had more in-plant inspection personnel than at any time since 2001. Even with these strategies, the future of the workforce will need a high degree of technical and analytical skills in order to address emerging pathogens and problems.

Where We Go from Here
Mr. Chairman and Members of the Subcommittee, President Barack Obama and Secretary Tom Vilsack have clearly expressed a willingness to tackle food safety and they are to be commended again for taking on this difficult and challenging issue. This is a priority from the top, and FSIS is up to the challenge.

For its part, FSIS will continue along the lines I've described here today - to improve its public health infrastructure designed to address problems before they occur.

But that is not enough. The President and the Secretary have laid a challenge before us, and we need to engage in the dialogue now opened to take a look at the risk posed by different food products, and the performance of the establishments that manufacture those food products, for the entire food supply. We also need to ask hard questions about what level of inspection is appropriate for different kinds of foods, what roles are appropriate for the different agencies involved in food safety, and if a uniform approach on import safety is needed. The President has established a Food Safety Working Group to conduct a thorough review of food safety systems.

There has been much written about our current system, as well as those of other countries. The GAO has repeatedly studied how our trading partners ensure food safety, most recently in 2008. It is clear that GAO believes that the experiences of nations such as Canada, the European Union, Germany, Ireland, Japan, the Netherlands, and the United Kingdom can provide insight on how to improve our own food safety system.

FSIS recognizes the keen interest of Congress, our stakeholders, and the public in food safety. We support the President's pledge to strengthen and enhance our nation's food safety system. Based on my more than 30 years serving out in the field for FSIS, I believe this Agency is up for the challenge.

Chairman Scott, Ranking Member Neugebauer, and members of the Subcommittee, thank you again for allowing me the opportunity to be here today to discuss our current food safety system and future enhancements. I look forward to your questions.