May 17, 2005
In your letter of invitation, you asked FDA to respond to the recent report by the Government Accountability Office (GAO) entitled “Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better Leverage Resources.” I would like to take this opportunity to assure you that FDA is committed to using our resources as effectively as possible. Both FDA and our colleagues at USDA work cooperatively to leverage each other’s resources when appropriate. However, we recognize that one can always do more and welcome your suggestions. Although HHS does not agree with the GAO report’s overall assessment, we do agree with some of its recommendations and are implementing them.
Your letter of invitation mentioned that this hearing will also examine the need for reorganizing. The current system of interagency coordination is helping improve the safety of the food supply, and we will continue to look for ways to further this coordination.
The American food supply continues to be among the safest in the world. The current Federal food safety system is working well, and food safety agencies are working more closely together than ever before. Just last month, the Centers for Disease Control and Prevention (CDC) in HHS, in collaboration with FDA and USDA, released a report with preliminary surveillance data that show important declines in foodborne infections due to common pathogens in 2004 when compared against baseline data for the period 1996 through 1998. We will continue to strive to reduce the incidence of foodborne illness to the lowest level possible. This report shows that FDA’s and USDA’s efforts are working, and we are making progress.
Reductions in foodborne infections are a result of numerous measures taken by FDA, USDA, and others. For example, in the fall of 2003, HHS and USDA released the “Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Food.” This assessment identified clear measures that industry, retailers, and consumers can take to dramatically reduce the risk of illness from this foodborne pathogen. HHS also released the Listeria Action Plan that identified additional measures to reduce the risk of listeriosis.
In October 2004, FDA released the Produce Action Plan, which will aid in reducing the incidence of foodborne illness attributed to the consumption of produce. In 2001, FDA issued its Juice Hazard Analysis and Critical Control Point (HACCP) regulation, which provided control measures to prevent, reduce, or eliminate hazards from fruit and vegetable juice and juice products. This regulation was promulgated in response to a number of foodborne illness outbreaks associated with these products. After raw sprouts were associated with several outbreaks, FDA issued guidance documents in 1999 for the sprout industry. The guidance documents contain steps that the sprout industry can take to reduce microbial hazards common to sprout production to ensure that sprouts are not a cause of foodborne illness. These are just a few examples of the many activities that have contributed to a decline in the incidence of foodborne illness.
In my testimony today, I will first describe HHS’ food safety and defense responsibilities. Then, I will discuss some of the issues raised in the GAO report. I will also describe a few of our many cooperative activities with USDA and our other partners.
HHS’ Food Safety and Defense Responsibilities
FDA has many roles in the food inspection system. For example, FDA conducts investigations into foodborne illness outbreaks along with CDC and our Federal and state partners. FDA utilizes a risk-based approach for inspections of food manufacturing facilities, inspecting high-risk facilities with greater frequency than low-risk facilities. We have 39 contract and 37 partnership agreements with states to assist with these domestic inspection activities. In addition, FDA works closely with state and local food safety officials on food safety inspections at the retail level. For foreign producers, FDA conducts a limited number of compliance inspections, with the permission of the foreign country, of high-risk food facilities, such as firms that manufacture low-acid canned foods or infant formula. FDA also works through international organizations such as Codex Alimentarius to establish international standards. Through this mechanism, we extend technical assistance and science-based inspectional standards worldwide.
To manage the ever-increasing volume of imported food shipments, we also utilize risk-management strategies in the review of foods that are being imported or offered for import into the United States. Working with information submitted to Customs and Border Protection (CBP) in the Department of Homeland Security (DHS), FDA screens shipments electronically to determine if the shipment meets identified criteria for physical examination or sampling and analysis or warrants other review by FDA personnel. This electronic screening allows FDA to concentrate its resources on high-risk shipments while allowing low-risk shipments to proceed into commerce. FDA personnel conduct examinations and collect and analyze samples as necessary to determine compliance with FDA food safety requirements. For any products found to be in violation of the Federal Food, Drug, and Cosmetic Act, we take appropriate enforcement action, working closely with CBP.
By way of background, while FDA has the lead responsibility within HHS for ensuring the safety of food products, CDC in HHS has an important complementary and non-regulatory public health role. As the lead Federal agency for conducting disease surveillance, CDC monitors the occurrence of illness in the U.S. attributable to the entire food supply. The disease surveillance systems coordinated by CDC provide an essential early-information network to detect dangers in the food supply and to reduce foodborne illness. In addition, these systems can be used to indicate new or changing patterns of foodborne illness. Because CDC also detects and investigates outbreaks of foodborne illness through its networks, CDC is able to alert FDA and USDA about implicated food products associated with foodborne illness and works closely with the agencies to take protective public health action. In keeping with its agency mission, CDC also identifies, evaluates, and provides expert scientific opinion on the effectiveness of foodborne disease prevention strategies.
FDA contributes financially and scientifically to the Foodborne Diseases Active Surveillance Network (FoodNet), the principal foodborne disease component of CDC’s Emerging Infections Program (EIP). FoodNet is a collaborative activity of CDC, FDA, the Food Safety and Inspection Service (FSIS) of USDA, and ten EIP sites (California, Colorado, Connecticut, Georgia, New York, Maryland, Minnesota, Oregon, Tennessee, and New Mexico). Through this active surveillance system, these sites actively seek out information on foodborne illnesses identified by clinical laboratories, collect information from patients about their illnesses, and conduct investigations to determine which foods are linked to specific pathogens. This surveillance system provides important information about changes over time in the burden of foodborne diseases. For example, the CDC foodborne illness report I mentioned earlier, which shows a decline in the incidence of foodborne illness, used data from FoodNet. These data help public health and food safety agencies evaluate the effectiveness of current food safety initiatives and develop and plan future food safety activities to prevent and reduce emerging foodborne illnesses.
In addition, just as FDA works with state and local food safety counterparts, CDC works extensively with state and local health departments to build their epidemiology, laboratory, and environmental health expertise in foodborne disease surveillance and outbreak response. All of these collaborations draw on and apply the unique expertise within HHS to address significant and emerging challenges to our food supply.
GAO’s report cites the inspection of dual jurisdiction establishments (DJEs) as a primary example of overlap and inefficiency. DJEs are facilities that are regulated by both FDA and USDA because the establishment processes some food products that fall under FDA’s jurisdiction and other food products that fall under USDA’s jurisdiction. First, let us be clear on the scope of GAO’s focus. DJEs comprise less than two percent of the total food processing or manufacturing facilities in the U.S. This is a very small percentage of food facilities and, in many cases, these are facilities at which FDA has assessed the risks to be low. At DJEs, each agency is responsible for products and processes within its own area of expertise and jurisdiction. We do not agree with GAO’s characterization of these inspections as examples of overlap. We also do not agree with GAO’s emphasis on DJE inspections as a significant way to save resources and achieve efficiencies. The report did not seem to take into account the fact that many of these facilities are low-risk facilities such as warehouses or other establishments that do not require a high inspection frequency by either agency. Of the 1,451 DJEs, more than a third (539) are warehouses, which are considered low-risk. Of the 772 food manufacturers, FDA considers 284 of these to be low-risk. The remaining DJEs include 140 other types of establishments such as retailers, importers, packers, and labelers. We believe the report’s findings are flawed. The report did not take into account the fact that more than half of the DJEs are low-risk facilities that, under FDA’s risk-based strategy, do not require frequent inspections; thus, the opportunity for achieving efficiencies through the leveraging of resources is quite small.
As noted in the report, FDA and USDA’s FSIS have signed a Memorandum of Understanding (MOU) to facilitate the sharing of information between the agencies about establishments that are subject to the jurisdiction of both agencies. This exchange of information is to permit more efficient use of both agencies’ resources and to contribute to improved public health protection. The primary application for this shared information is for enforcement collaboration when inspections find unsanitary conditions that cut across the regulatory authority of both agencies. FDA and FSIS coordinate these activities at the local level on a regular basis. We believe this MOU has been quite productive and has been successful in enhancing collaborative activities to improve public health protection. For example, the sharing of information through this MOU has led to a number of recalls of both FDA- and USDA-regulated products and has led to joint enforcement activities by the agencies.
An example of a joint enforcement action that occurred as a result of the MOU involved a large warehouse in Illinois. In March of this year, the U.S. Attorney’s Office charged the company and a former company executive with two felony counts of improperly storing USDA-regulated meat and poultry products and one misdemeanor count of improperly storing FDA-regulated food products. This action began with a joint FDA/USDA inspection after USDA reported, pursuant to the MOU, extensive rodent infestation in the perishable meat and produce section, as well as the dry goods section. FDA pursued the prosecution in conjunction with the local FSIS district office and the U.S. Attorney’s Office of the Northern District of Illinois. During the course of the GAO study, FDA supplied other examples in which FDA and FSIS notified each other under the MOU after determining that the conditions found in the facility required enforcement action for all products in the warehouse, regardless of which agency was regulating the product.
The MOU calls for the local FDA and FSIS offices to meet on an annual basis to share information. It also called for an evaluation after the first year to confirm that it was implemented. Although no further evaluation was required under the agreement, we believe that this annual information-sharing of local FDA and FSIS offices has generally occurred. This is evident based on the annual changes in the number of dual jurisdiction firms, as well as the joint enforcement actions taken over the past years. Through this MOU, FDA and FSIS have significantly increased the effectiveness of communications between the two agencies, heightened awareness of each other’s responsibilities and operations, and initiated more frequent and more effective cooperative efforts. We recognize that there are additional actions that may be taken to further strengthen and enhance our collaboration with FSIS. Therefore, FDA and FSIS have agreed to conduct some additional joint training to further the implementation of this MOU. In addition, we are following up on the GAO report’s recommendations to identify and inventory all active interagency agreements and to evaluate and update them as necessary.
With regard to training, the GAO report recommends that FDA and USDA examine the feasibility of establishing a joint training program for food inspectors. HHS agrees that USDA and FDA should collaborate in developing training where both agencies can benefit. However, the report implies that FDA and USDA are not collaborating, which is incorrect. We have collaborated and will continue to do so.
For example, as recently as February 2005, FDA posted and presently hosts a web-based training course on food defense. FDA and USDA’s FSIS and Agricultural Marketing Service jointly developed this food defense awareness training program to help reduce the risk of an attack on the food supply. The training is intended for individuals who play an important role in defending our nation’s food from attack: federal, state, local, and tribal regulators; school food authorities; and nutrition assistance program operators and administrators. Representatives from the food industry and individuals essential in responding to an attack on the food supply, such as law enforcement, public health, and homeland security officials, are also encouraged to participate. The program is available free of charge in three formats: via FDA’s website, via face-to-face training courses offered across the country, and via a CD-ROM for limited distribution.
Over the years, FDA and USDA have collaborated on numerous satellite downlinks that have benefited the staff of both agencies. These joint downlinks have covered such topics as retail meat and poultry processing; personal safety training for field personnel; multi-agency import controls to prevent bovine spongiform encephalopathy (BSE); the FDA/FSIS MOU; food microbiological control; foodborne illness investigations; traceback of fresh produce and other commodities; and communication skills. FDA and USDA have also collaborated on training related to epidemiology, tissue residue, retail food safety, and laboratory science.
The training director of FSIS and the training director of FDA’s Office of Regulatory Affairs regularly meet to discuss best practices and opportunities to collaborate. Further, USDA and FDA training staffs regularly provide support for each other. For example, in the fall of 2004, FDA staff trained school lunch officials on the HACCP process. The training was held at FDA’s training facility.
We agree that FDA and USDA should continue to identify additional opportunities to collaborate on training issues when sufficient commonalities can be found. However, we do not agree with GAO’s recommendation to pursue the establishment of a joint training program for FDA investigators and USDA inspectors. The two agencies enforce different laws and regulations using different procedures. The foods regulated by the two agencies are different. In addition, our staffs have different educational backgrounds as well as experience. By suggesting a unified program, the report suggests that, for example, HACCP is the same for all products and should be taught jointly. Although the seven principles of HACCP are the same, the practical application of HACCP is significantly different for each food. Therefore, the practical application of HACCP that is taught to FDA staff is different than what is taught to USDA staff. However, as we have described above, FDA and USDA regularly collaborate on joint training programs when appropriate.
The Secretary of DHS is responsible for coordinating the overall national effort to enhance the protection of the critical infrastructure and key resources of the nation, including food and agriculture defense. The White House has issued Homeland Security Presidential Directives HSPD-7, -8, and –9, which identify critical infrastructures, improve response planning, and establish a national policy to defend the agriculture and food systems against terrorist attacks, major disasters, and other emergencies. The USDA Secretary, the HHS Secretary, and the EPA Administrator exercise key responsibilities as sector-specific agencies. DHS serves as the coordinator of the Food and Agriculture Sector with FDA in HHS as the lead for the food sector and the Homeland Security Office in USDA as the lead for the agriculture sector. This collaborative effort combines expertise from several Federal agencies (FDA, USDA, EPA, Department of Defense [DoD], DOC, Department of the Interior, and the Department of Justice) as well as that of state and local officials (representing agriculture, public health, and veterinary services), and the private sector (more than 100 trade associations and individual firms participate). As part of the HSPD-7 National Infrastructure Protection Plan (NIPP) development, FDA and USDA have drafted sector-specific plans, which will be finalized after obtaining additional input from states and the private sector. Using these plans as components, DHS has formulated the Interim NIPP for all sectors. The Interim NIPP is now being reviewed by sector members who are obtaining input from industry and state and local government participants. With the close working relationship of FDA and USDA and the other government and industry collaborators, the Food and Agriculture Sector activities to protect critical infrastructure have set the organizational and operational standard for 13 of the critical infrastructure sectors. DHS has applauded the Food and Agriculture Sector’s organizational structure, consensus building, and the steps it has taken to improve food defense.
In April 2003, FDA began using the CARVER+Shock analytical tool to perform vulnerability assessments to identify what a party, intent on doing damage, could do based on their capability, intent, and past history. The CARVER+Shock methodology was developed under Homeland Security Council leadership by FDA, USDA, and DoD with coordination by DHS, the Central Intelligence Agency, and the Federal Bureau of Investigation. FDA’s approach has been to seek voluntary, mutually-beneficial partnerships with various segments of the food industry. We have completed such cooperative assessments with two segments of the regulated industry that involve bottled water and dairy products. FDA is in the process of collaborating and providing technical assistance in assessments to a number of other food product industries using this tool. FDA also has collaborated with USDA to provide assistance to the USDA Food and Nutrition Service on the use of this analytical tool on specific commodities in the school lunch program.
A critical component of controlling threats from deliberate foodborne contamination is the ability to rapidly test large numbers of samples of potentially contaminated foods for a broad array of biological, chemical, and radiological agents. HHS has worked in close collaboration with USDA’s FSIS to establish the Food Emergency Response Network (FERN). FERN will increase our laboratory surge capacity through a nationwide network of Federal and state laboratories capable of testing the safety of thousands of food samples, thereby enhancing the nation’s ability to respond swiftly to a terrorist attack.
FDA is also collaborating with CDC, USDA, EPA and many other Federal agencies to create a Memorandum of Agreement for an Integrated Consortium of Laboratory Networks (ICLN). The ICLN will be an integrated system of laboratory networks to provide for early detection and effective consequence management of acts of terrorism and other events involving a variety of agents and more than one section or segment of the nation (i.e., humans, animals, plants, food, the environment). ICLN will include FERN for food-related information and assistance. It will use other networks to address the other segments.
FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. To address these concerns, FDA collaborates extensively with USDA’s Animal and Plant Health Inspection Service (APHIS) and FSIS, CBP, EPA, the U.S. Department of State, our HHS colleagues at CDC and the National Institutes of Health, other Federal agencies, state and local jurisdictions, affected industries and consumer groups, and the World Trade Organization. Both FDA and USDA closely coordinated the Federal government’s actions in response to the finding of a BSE-positive cow in the state of Washington in December 2003. This coordinated response was successful in quickly containing adulterated food and feed products and limiting food safety concerns in the general public.
On July 14, 2004, FDA published an Interim Final Rule, which became effective immediately, that banned the use of specified risk materials (SRMs) and other prohibited cattle materials in all FDA-regulated foods and cosmetics. Prohibited cattle materials include SRMs from cattle 30 months of age and older, small intestine of all cattle, materials from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated beef. These are the cattle materials at highest risk of containing the BSE agent. FDA’s regulation parallels USDA’s Interim Final Rule for meats and meat products. The agencies cooperated in the development of these documents and continue to cooperate to maintain a harmonized U.S. food safety policy for BSE.
Both the FDA regulation covering foods and cosmetics and the USDA regulation covering meat and meat products augment the preventive measures already in place to reduce or eliminate the threat of BSE in the U.S. and in the U.S. food supply. These measures include FDA’s 1997 regulation that prohibits, with some exceptions, the use of protein derived from mammalian tissues in feed for cattle and other ruminant animals. This is the basis of FDA’s efforts to prevent the spread of BSE in U.S. cattle. The import controls imposed by FDA and APHIS in USDA are other preventive measures.
Most of the examples above have focused on our collaborations with USDA. I would also like to describe some of our collaborations with the two other agencies represented on the panel today, DOC and EPA. For example, FDA, NMFS, and USDA jointly sponsor the National Advisory Committee on Microbiological Standards for Foods. NMFS, FDA, and the International Atomic Energy Commission are cooperating on a study to develop an alternative method for the detection of paralytic shellfish poisoning. To address the issue of contaminants, including methylmercury, in seafood, FDA is working closely with the National Oceanic and Atmospheric Administration on a study being conducted by the National Academy of Sciences entitled “Nutrient Relationships in Seafood: Selections to Balance Benefits and Risks.” The outcome of this study will provide useful information for the development of public health policy on contaminants in seafood. In addition, NMFS and FDA jointly support the executive office of the Interstate Shellfish Sanitation Conference, the standards-setting body for a Federal/state cooperative program to ensure the safety of raw molluscan shellfish. To validate a risk assessment on Vibrio parahaemolyticus, FDA and NMFS have been jointly funding a study on the levels of this organism in raw molluscan shellfish at the retail level.
For several decades, EPA and FDA have collaborated on food safety and other public health issues. For example, in the regulation of pesticides, EPA sets tolerances, and FDA monitors the food supply for illegal pesticide residues and takes enforcement action. Similar collaboration occurs for bottled water contaminants. Recently, FDA and EPA collaborated on a joint consumer advisory on methylmercury in fish and shellfish. It provides advice for reducing the exposure to high levels of mercury in women who may become pregnant, pregnant women, nursing mothers, and young children. FDA and EPA are also working closely together on the issue of perchlorate. EPA has developed a risk assessment, and FDA is providing data on the levels and occurrence in food.
Thank you for this opportunity to discuss HHS’ role in the Federal food safety system. I would be pleased to respond to any questions.
Last Revised: May 19, 2005