Oversight of Food Safety Activities: Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better Leverage Resources
Released: 2005-05-17T00:00:00

Letter

Background

Many federal agencies, as well as state and local entities, play a part in the U.S. food safety regulatory system. While the federal agencies regulate the food production chain from farms to food manufacturers, state and local agencies primarily regulate food safety in retail food establishments. Table 1 summarizes the food safety responsibilities of the federal agencies. In addition to their established food safety and quality responsibilities, following the events of September 11, 2001, these agencies began to address the potential for deliberate contamination of agriculture and food products, with the Department of Homeland Security providing overall coordination on how to protect the food supply from deliberate contamination.

The agencies’ food safety authorities stem from 30 principal laws related to food safety. For a listing of the principal food safety laws, see appendix IV. As a result of this division of responsibility, the federal food safety system is fragmented. In some instances, agencies perform nearly identical activities—both USDA and FDA inspect food-processing facilities that produce foods under the regulatory responsibility of each agency, referred to as dual jurisdiction establishments (DJE). DJEs are those that manufacture or process food products that contain ingredients regulated by more than one federal agency. For example, both USDA and FDA inspect facilities that make canned baked beans with 2 percent or more bacon (a USDA-regulated food) and canned baked beans without meat (an FDA-regulated food). While these agencies each perform food safety inspections, the frequency of their inspections varies. Generally, USDA inspectors have a more regular presence at DJEs. As another example, both FDA and NMFS inspect seafood-processing facilities, although NMFS’s inspections are conducted at the request of the facility through a contract between the facility and NMFS.

Four agencies—USDA, FDA, EPA, and NMFS—are involved in key program functions related to food safety—including inspection and enforcement, research, risk assessment, education and outreach, rulemaking and standard setting, surveillance and monitoring, food security, and administration. Examples of activities under these functions include: inspecting domestic food-processing facilities and imported food items at U.S. ports of entry; researching foodborne chemical and biological contaminants, as well as conducting risk assessments of foodborne physical, chemical, and biological contaminants to inform rulemaking, allocation of agency resources, or risk communication; developing and distributing guidance to consumers and industry related to food safety topics such as appropriate food temperatures; and issuing/promulgating HACCP, sanitation, and good manufacturing practices regulations.

In fiscal year 2003, the four federal agencies spent nearly $1.7 billion on food safety-related activities. USDA and FDA are responsible for most federal food safety resources (as fig. 1 shows).

These agencies spent about $921 million (55 percent) in fiscal year 2003 on inspection/enforcement functions, including inspections of domestic and imported food (as fig. 2 shows).

Risk assessment - $149,402,717 USDA’s Food Safety and Inspection Service did not provide Surveillance expenditure data.

The agencies’ expenditures vary by program function (as shown in fig. 3). For example, USDA’s inspection/enforcement expenditures made up almost three-quarters of the total spent by these agencies for that program function. That is, the majority of federal food safety inspection expenditures are directed toward USDA’s programs for ensuring the safety of meat, poultry, and egg products. In contrast, FDA accounts for more than half of the agencies’ expenditures for food safety education/outreach programs.

National Research Council and Institute of Medicine, Ensuring Safe Food: From Production to Consumption (Washington, D.C.: 1998).

Federal Food Safety Agencies Spend Resources on Overlapping Food Safety Activities

As a result of the multiple laws and regulations governing food safety, several federal agencies conduct activities—inspections of domestic and foreign foods, training, research, risk assessment, education, and rulemaking—that can serve overlapping, if not identical, purposes. As a result, federal agencies spend resources on similar food safety activities. Table 2 illustrates similar activities conducted by the four federal agencies we examined. These activities, such as laboratory analysis and risk assessment, may be product specific.

Agencies Conduct Overlapping Inspections at Jointly Regulated Food- Processing Facilities

USDA and FDA spent $884 million in fiscal year 2003 on inspection and enforcement activities—roughly 60 percent of their total food safety expenditures. Neither USDA nor FDA has estimated the total costs associated with inspecting jointly regulated facilities. FDA estimated that it spends about $4,000 per inspection. As figure 4 shows, USDA and FDA both inspect 1,451 known DJEs located across the country. USDA and FDA inspect these establishments with different frequencies. For example, USDA inspects a canning facility at least daily if it produces food containing meat and poultry. If the facility also produces canned soups containing beans or seafood, FDA inspects it every 1 to 5 years.

Because of their split jurisdiction, each agency is responsible for inspecting different food products at these facilities; but the agencies’ inspections have common key elements, including verifying the facilities’ compliance with sanitation standards (as defined by USDA) or good manufacturing practices (as defined by FDA). For example, both agencies’ inspectors verify that facilities do not have rodent or insect infestations. Figure 5 summarizes some of the common elements of USDA and FDA inspections.

At jointly regulated facilities, USDA and FDA inspectors also verify that HACCP systems are in place. In these instances, each agency verifies that the facility has created and implemented a HACCP plan specific to the products that the agency regulates. The regulations require the facility to maintain separate HACCP plans for each product and to develop separate analyses of critical control points and separate strategies to mitigate or eliminate food contaminants. For example, at a facility we visited that produces both crab cakes and breaded chicken, the manager is required to maintain a seafood HACCP plan and a poultry HACCP plan. The manager said that although both plans have similar elements, each agency’s inspectors expect different levels of detail for the plans—something the manager finds confusing and difficult to comply with.

USDA and FDA have new tools that could help reduce overlaps in inspections. Under the Bioterrorism Act, FDA could allow USDA inspectors, who are present every day at these jointly regulated facilities, to inspect FDA-regulated food. In doing so, FDA could reduce overlapping inspections and redirect resources to other facilities for which it has sole jurisdiction. While they did not disagree in principle with the benefits of such an arrangement, FDA officials said that the savings would be somewhat offset because FDA would likely have to reimburse USDA for the costs of those inspections. FDA officials said that they do not currently plan to pursue this option and have not conducted any analyses of the costs or savings associated with authorizing USDA officials to conduct FDA inspections at these facilities. USDA officials commented that their inspectors are fully occupied and that they would need to be trained before conducting joint inspections.

Overlaps also occur at seafood-processing facilities that both FDA and NMFS inspect. NMFS currently inspects approximately 275 domestic seafood facilities that FDA also inspects. NMFS safety and sanitation inspections, as well as other product quality inspections are conducted on a fee-for-service basis. NMFS inspectors verify sanitation procedures, HACCP compliance, and good manufacturing practices—many of the same components of an FDA inspection. Although NMFS and FDA seafood safety inspections are similar, FDA does not take into account whether NMFS has already inspected a particular facility when determining how frequently its inspectors should visit that same facility.

FDA officials said they do not rely on NMFS inspections for two reasons. First, FDA officials believe that NMFS has a potential conflict of interest because companies pay NMFS for these inspections; and therefore, as a regulatory agency, FDA should not rely on them. NMFS officials disagree with FDA’s viewpoint, stating that their fee-for-service structure does not affect their ability to conduct objective inspections. NMFS officials said that, when NMFS inspectors find noncompliance with FDA regulations, they refer companies to FDA and/or to state regulatory authorities. NMFS officials stated that companies that contract with NMFS need the agency’s certification in order to satisfy their customers. Second, it is difficult for FDA to determine which facilities NMFS inspects at any given time because NMFS inspection schedules fluctuate often, according to changes in NMFS’s contracts with individual companies. If FDA were to recognize the results of NMFS inspection findings in targeting its resources, it could decrease or eliminate inspections at facilities that NMFS inspectors find are in compliance with sanitation and HACCP regulations.

USDA and FDA Conduct Inspections of Food Imports

Both USDA and FDA maintain inspectors at 18 U.S. ports of entry to inspect imported food products. In fiscal year 2003, USDA spent almost $16 million on these inspections, and FDA spent more than $115 million. FDA spends about 7 times as much on import inspections because the agency is responsible for about 80 percent of the U.S. food supply, including imports from about 250 countries, compared with USDA’s responsibility for inspecting imports that come from 34 countries. However, the agencies are not leveraging inspection resources at these ports. USDA officials told us that FDA-regulated, imported foods are sometimes stored in USDA- approved inspection facilities at these ports. USDA inspectors have no authority to inspect FDA-regulated products, although USDA inspectors are present at these ports more often than FDA inspectors. As a result, some FDA-regulated products may remain at the facility for some time awaiting inspection. FDA has the authority to commission federal officials to conduct inspections at jointly regulated facilities. In 2003, FDA exercised this authority to conduct inspections by entering into an agreement with the Department of Homeland Security’s Customs and Border Protection (CBP) so Customs’ officials can help FDA inspect products at ports and other facilities subject to CBP jurisdiction.

FDA could also leverage USDA’s efforts to ensure the safety of imported food by using information that USDA compiles in its determinations that exporting countries’ food safety systems are equivalent to the U.S. system. Under the Meat and Poultry Products Inspection Acts, the Secretary of Agriculture is required to certify that countries exporting meat and poultry to the United States have equivalent food safety systems for producing meat and poultry products that are exported to the United States. That information could inform FDA’s decision making about which countries to visit for its overseas inspections. Currently, FDA visits foreign countries to inspect individual food-processing firms. In 2004, USDA determined that the food safety systems of 34 countries it evaluated were equivalent to that of the United States. A substantial portion of what USDA evaluates— sanitation procedures and compliance with HACCP rules—could be useful to FDA in deciding what countries to visit when conducting inspections of foreign firms that export products under its jurisdiction. FDA officials told us, however, that the agency does not use that information when deciding which countries to visit. As a result, FDA at times conducts inspections in the same countries that USDA has evaluated. For example, USDA and FDA each visited Brazil, Costa Rica, Germany, Hungary, Mexico, and Canada last year. USDA spent almost $500,000, and FDA spent almost $5 million, on its foreign country visits in fiscal year 2003. USDA and FDA officials said these agencies do not share information from their overseas visits because their different statutory responsibilities make such information of little advantage. That is, USDA’s focus during foreign country visits is to evaluate the meat and poultry inspection systems to determine if they are equivalent to that of the United States, whereas FDA focuses its visits on specific companies that produce food under the agency’s jurisdiction.

Agencies Maintain Similar Inspection Training Programs

USDA and FDA provide similar training to their inspectors. For example, both agencies train inspectors on sanitation requirements, good manufacturing practices, and HACCP. Agency officials agreed that the training programs have a common foundation but pointed out that there are differences, as each agency applies these principles to the specific foods it regulates. USDA spent $7.8 million, while FDA spent about $1.5 million, during fiscal year 2003 to train their food inspection personnel. FDA’s comparatively lower training costs reflect a contractual agreement with a private firm that has produced an online curriculum. This curriculum includes over 106 courses that address topics common to both USDA and FDA—ranging from foodborne pathogens, HACCP requirements, and good manufacturing practices, to courses that are specific to FDA’s regulations and enforcement authorities. Another agency—NMFS—uses 74 of these online courses to train its own seafood inspectors. The benefits NMFS officials cited include accessibility to training materials at times other than when inspectors are “on duty” and no charge to NMFS for the training materials. USDA officials said they are exploring the possibility of entering into an agreement with the company that developed FDA’s online curriculum to allow USDA inspectors access to some of this training. In addition to the costs associated with developing inspector training programs, USDA estimates that it spends an average of about $900,000 per year on training-related travel, not including other costs related to replacing inspectors in food-processing facilities while they participate in the training. A joint USDA-FDA training program could reduce duplication in developing training materials and in providing instruction, and potentially achieve some savings.

Other federal agencies have consolidated training activities that have a common purpose and similar content. For example, in 1970, the Consolidated Federal Law Enforcement Training Center (the Center) brought together the training programs of 75 federal law enforcement agencies that had maintained separate training programs. Specifically, the Center provides standardized programs for criminal investigators and uniformed police officers across the federal government. While standardizing basic training, the Center also offers specialized courses for individual agencies to address their particular needs. In addition, according to the Center, the interaction with students from other agencies promotes greater understanding of other agencies’ missions and duties, and therefore provides for a more cooperative federal law enforcement system.

Agencies Conduct Other Activities That Overlap

We identified overlapping activities in the areas of food safety research and risk assessment, consumer and industry education, and rulemaking.

Food Safety Research and Risk- Assessment Efforts

USDA and FDA participate in similar food safety research efforts; that is, both agencies collect and analyze food samples for chemical and biological contaminants. During fiscal year 2003, the agencies spent over $245 million on these types of activities. For example, because of the agencies’ split jurisdiction, both USDA and FDA maintain separate laboratory capability to sample and analyze the foods that they regulate for chemical contaminants such as pesticides and dioxins. EPA uses USDA and FDA data to inform EPA’s risk assessments on human exposure to pesticides. Specifically, in 2003, FDA analyzed 11,331 food samples for pesticides and chemical contaminants to help estimate the dietary intake of pesticide residues. In 2000, the most recent year for which data are available, USDA’s Food Safety and Inspection Service (FSIS) analyzed over 33,000 samples of meat, poultry, and egg products. In addition, USDA’s Agricultural Marketing Service’s (AMS) Pesticide Data Program samples and tests commodities across the food spectrum to help inform EPA in making decisions on acceptable levels of pesticide residues (tolerances). According to EPA officials, USDA data are their primary source of information. However, FDA provides additional information on a greater range of foods and chemicals that EPA also uses to form its decisions. EPA officials said that the overlap in data collection and analysis adds value because USDA’s data comes from a well-controlled survey of food samples taken at the wholesale level, and FDA’s data helps fill in the gaps with samples of food at different points in the distribution chain.

USDA and FDA also both conduct risk assessments of foodborne pathogens that can contaminate food products under their respective jurisdictions. For example, in 2000, USDA released a draft risk assessment for Escherichia coli ( E. coli) O157:H7 in ground beef and, FDA released a draft risk assessment for Vibrio parahaemolyticus in raw molluscan shellfish. The agencies also conduct joint risk assessments when addressing the same pathogen or the same food product. In the case of eggs, regulatory responsibility shifts as eggs make their way from the farm to the table, with FDA being primarily responsible for the safe production and processing of eggs still in the shell (known as shell eggs), and USDA being responsible for food safety at the processing plants where eggs are broken to produce egg products. In 1996, the agencies began work on a joint risk assessment for salmonella in eggs to evaluate the risk to human health of salmonella in shell eggs and in liquid egg products and to identify potential risk reduction strategies. In 1998, USDA and FDA jointly published an advance notice of proposed rulemaking, based on this risk assessment, to identify farm-to-table actions that would decrease the food safety risks associated with eggs. However, the agencies have not issued a joint rule to help eliminate foodborne illnesses caused by salmonella in eggs. In 2004, FDA issued a proposed rule that would require shell egg producers to implement measures to help prevent salmonella from contaminating eggs on the farm. Although USDA released a new draft risk assessment in 2004, the department has not yet issued a proposed rule to help prevent salmonella from contaminating egg products. Both agencies have also committed personnel resources to a World Health Organization effort to conduct a risk assessment of salmonella in eggs and broiler chickens.

Consumer and Industry Education

USDA, FDA, and EPA conduct education and outreach on food safety—and spent more than $107 million in fiscal year 2003. In some cases, these agencies’ efforts overlap. For example, these agencies create and distribute educational materials to consumers, or host hotlines or other forums that address food safety issues. In some cases, these efforts target the same food safety topic. For example, USDA, FDA, and EPA each develop consumer guidance on chemical food contaminants such as pesticides, dioxin, and mercury. In addition, USDA and FDA each develop similar food safety guidance for (1) consumers on general topics, such as cooking and chilling food, and safe handling practices, such as using a food thermometer and (2) industry, on their HACCP regulations and sanitation and good manufacturing practices. These overlapping efforts, caused in part by the agencies’ divisions in jurisdiction, can be confusing to both consumers and industry representatives. For example, USDA officials said they receive calls from consumers and industry representatives to their consumer hotline about FDA-regulated food products. These agencies have made some efforts to reduce overlaps in their consumer education activities. For example, USDA and FDA developed the “Fight Bac” program to educate the public about safe food handling to help reduce foodborne illness. In addition, for the first time in 2004, FDA and EPA issued a joint consumer advisory about mercury in fish and shellfish for women who might become pregnant, who are pregnant, who are nursing, as well as for young children. However, the joint advisory recommends different consumption levels, depending on whether the fish is commercially caught (regulated by FDA) or recreationally caught (regulated by EPA). Specifically, for fish purchased from a store, the guidance recommends up to 12 ounces per week. However, if the fish is recreationally caught, the guidance recommends that women consume up to 6 ounces per week. EPA said that the consumption guidance differs due to different mercury levels in recreationally and commercially caught fish.

Rule-Making Activities Vary but Share Some Similarities

As the principal agencies responsible for food safety, both USDA and FDA engage in rule-making and standard-setting activities under their respective statutes. While the rulemakings USDA and FDA undertake vary under those statutes, there are some similarities. For example, USDA and FDA promulgated separate HACCP regulations for industry, but both agencies’ regulations require food processors to incorporate certain sanitation processes into their HACCP systems. The HACCP rules are based on the same model, though applied to the different food products each agency regulates. For example, FDA requires seafood-processing facilities to address contaminants that are likely to be found in seafood, such as Vibrio vulnificus (a bacteria found in raw seafood, particularly in oysters). USDA requires all meat and poultry processing facilities to address contaminants, such as E. coli and salmonella, which are likely to be found in these products. While quantifying the resources dedicated to rule-making activities is difficult for the agencies, the costs are significant. FDA estimates that it spent between $650,000 and almost $1 million to issue its seafood HACCP rule in 1995. NMFS officials said they spent $5 million to support the FDA rule by developing a model seafood surveillance project. USDA was unable to calculate how much it spent to develop its meat and poultry HACCP rule.

In some cases, the agencies collaborate in the early stages of rulemaking. For example, USDA and FDA participated in a joint Listeria monocytogenes (listeria) risk analysis of ready-to-eat foods. However, the agencies will promulgate separate listeria rules for the products under their jurisdiction.

Agencies Have Numerous Interagency Agreements to Coordinate Food Safety Activities, but Tracking Mechanisms and Implementation Are Weak

The principal food safety agencies—USDA, FDA, EPA, and NMFS—have entered into 71 interagency agreements to coordinate the full range of their food safety activities and to support their mission to protect the public health. About one-third of the agreements include as objectives, the coordination of activities, reductions in overlaps, and/or leveraging of resources. The agencies’ ability to take full advantage of these agreements is hampered by the absence of adequate mechanisms for tracking them and, in some cases, by ineffective implementation of the provisions of these agreements.

Many Interagency Agreements Address Inspection and Enforcement and One-Third Highlight the Need to Reduce Duplication and Overlap

Of the 71 interagency agreements we identified, the largest proportion (43 percent) reflect the agencies agreement to increase cooperation on inspection and enforcement activities. The agencies also spent the largest share of their food safety resources on these activities (as fig. 2 showed). Other agreements address activities such as education/outreach, food security, and monitoring/surveillance related to food safety and quality (as shown in fig. 6). Furthermore, 24 agreements specifically highlight the need to reduce duplication of effort by clarifying responsibilities, reducing overlaps, and/or making efficient and effective use of resources. Appendix III provides additional information about the 71 agreements.

In some instances, the agencies entered into multiple agreements to coordinate and ensure the safety of a single type of food. For example, we identified seven agreements that focus on seafood inspection and enforcement activities; signatories to one or more of these agreements include USDA, FDA, NMFS, the Department of Defense, and the Interstate Shellfish Sanitation Conference (ISSC).

In addition to these formal interagency agreements, the agencies cooperate through other mechanisms such as the Foodborne Diseases Active Surveillance Network (also known as FoodNet) that USDA, FDA, and the Centers for Disease Control and Prevention use to help track the incidence of foodborne illness and track the effectiveness of food safety programs in reducing foodborne illness. Agency officials also noted that they informally cooperate and collaborate with one another on a regular basis.

Controls for Tracking Food Safety Agreements Are Weak

USDA, FDA, EPA, and NMFS do not have adequate mechanisms to track interagency food safety agreements. Consequently, the agencies could not readily identify the agreements that they have entered into, could not determine which agreements are still in effect, and were unable to determine which are still needed. As a result, we could not determine which agreements are currently being used by the agencies. Agency officials did not agree on the number of food safety-related agreements they have entered into, and only 7 of the 71 agreements that we ultimately compiled were identified to us by all signatory agencies. For example, FDA and EPA provided a copy of an agreement they had entered into with USDA about residues in drugs, pesticides, and environmental contaminants in foods; however, USDA officials said the agency is not party to any agreement on residues. Forty-one additional agreements were identified to us by only one of the multiple signatories. In addition, we found three agreements—through our prior work or Internet searches—that none of the agencies had identified to us.

Of the agencies we reviewed, only USDA’s Animal and Plant Health Inspection Service maintained a database that allowed it to readily identify all the agreements it was party to. The other agencies did not have such databases. During the course of our review, EPA officials said that, without such tools, they had difficulty identifying the agreements they have entered into. Officials also said they are planning to develop an electronic system to identify and track these agreements. EPA said that, if developed, this system could offer one means of tracking and managing information related to, and contained in, interagency agreements.

The weaknesses in tracking agreements may also affect the agencies’ ability to determine whether these agreements are still needed and whether specific provisions are still in effect. First, about one-third of the agreements we identified were created decades ago and may no longer be relevant to current needs. Technological and scientific advances have made some provisions of these agreements obsolete. Second, some agencies that were party to the agreements have ceased to exist because of internal reorganizations; but the agreements have not been modified to reflect such changes, indicating that the agencies may not be actively monitoring the status and relevance of these agreements. For example, a 1978 agreement between USDA and FDA on education programs to assist livestock and poultry producers in using animal drugs has not been modified to reflect the fact that USDA’s Science and Education Administration no longer exists. Also, we found that some agreements have not been updated to account for changes in a signatory’s responsibilities since they were signed. For example, NMFS officials said that the ISSC has taken on some responsibilities that once belonged to NMFS and that the 1985 agreement on shellfish-growing waters signed by FDA, EPA, NMFS, and the U.S. Department of the Interior’s Fish and Wildlife Service should be updated to reflect this change.

Agencies Are Not Fully Implementing Two Comprehensive Interagency Agreements That Could Eliminate Duplication of Effort and Leverage Resources

Because the agencies spend most of their food safety resources on inspection and enforcement, we evaluated the implementation of two comprehensive inspection and enforcement agreements: one that pertains to DJEs and one that pertains to inspections of fishery products. These agreements were established to make more efficient and effective use of agency resources through improved coordination and information sharing. Although the agencies are exchanging some information as called for in the agreements, they are generally missing opportunities to make more effective and efficient use of their resources, such as leveraging inspection and enforcement resources.

USDA and FDA Agreement to Exchange Information About Establishments That Are Subject to the Jurisdiction of Both Agencies and to Permit More Efficient Use of Resources

In 1999, USDA and FDA signed an interagency agreement to facilitate the exchange of information between the agencies about food-processing facilities that they both inspect. The agreement stated that the exchange of information will permit more efficient use of both agencies’ resources and contribute to improved public health protection. The agreement was to be the first step toward allowing USDA’s FSIS inspectors to conduct FDA’s inspections at DJEs, according to a former USDA senior food safety official who signed the agreement. The agreement was developed in response to a 1997 report by the President’s Food Safety Council, which recommended increased cooperation among agencies. Specifically, the report recommended that USDA and FDA take steps to ensure that the resources and experience of FDA and USDA’s FSIS be used as efficiently as possible to avoid duplication of effort and that the agencies consider using FSIS inspectors to conduct FDA inspections at DJEs. The report stated that because FSIS inspectors are already in these plants, they could be used to maximize use of federal resources without loss of inspection coverage for FSIS-regulated foods.

In 2000, USDA and FDA evaluated the agreement’s implementation and concluded that the experience had been largely successful because the agencies learned about each other’s operations and about ways to cooperate more effectively. However, the evaluation also included recommendations to strengthen, clarify, or otherwise improve the agreement’s implementation. Among other things, the evaluation recommended that FDA provide FSIS with access to FDA’s inspection database, ensure more frequent updates to the list of jointly regulated facilities, and train inspectors on the provisions of the agreement. The evaluation cited the potential for significant resource savings over time as the agreement is implemented, particularly in personnel, administrative, and travel costs. Since the 2000 evaluation, officials at USDA and FDA said they have not again monitored the agreement’s effectiveness, nor have they implemented their own recommendations to realize resource savings.

We found that the agencies are not systematically exchanging information about DJEs, as called for in the agreement. First, the agreement called for USDA and FDA to develop, maintain, and annually update a list of such establishments. We found that although the agencies created such a list in 1999 when the agreement was signed, they had not updated it until 2004, when we brought the matter to their attention. As a result, the agencies had great difficulty identifying the current number of DJEs to which this agreement pertains. For example, during the course of our review, USDA and FDA provided several different lists of jointly regulated establishments. The number of establishments that were listed ranged from 1,152 to 1,867. In December 2004, FDA headquarters officials provided us a list of 1,451 known DJEs, and the agency is verifying approximately 400 establishments that may be added to the list.

Second, the agreement calls for the district offices of each agency to share certain findings with their counterpart district offices and for the agency receiving a finding of noncompliance to track and use that information in its program evaluation, work planning, and consideration of whether action against the facility is warranted. The agreement also calls for the receiving agency to inform the notifying agency of the disposition of the notification, including any actions that it plans or takes, within 30 days. During field visits to three USDA and FDA district offices that, together, are responsible for food safety in 13 states, we found that USDA and FDA field inspection personnel are not routinely communicating these findings of mutual concern, such as sanitation problems at facilities they jointly regulate. Nor have USDA and FDA explored the feasibility of developing a system to track and exchange information when each agency finds instances of noncompliance. As a result, work planning by each agency cannot take advantage of the other agency’s inspection findings.

Because FDA inspectors visit DJEs less frequently than USDA inspectors, we believe that FDA staff could benefit from the compliance information that USDA inspectors collect. Generally, problems with a facility’s manufacturing processes or sanitation procedures affect all products produced at the establishment. As a USDA district official told us, “a rodent doesn’t distinguish between FDA-regulated products and USDA-regulated products, so a problem affecting one agency’s product is likely to affect the other agency’s product.”

Third, the agreement calls for the agencies to explore the feasibility of granting each other access to appropriate computer-monitoring systems so each agency can track inspection findings. However, the agencies maintain separate databases, and the inspectors with whom we spoke continue to be largely unaware of a facility’s past history of compliance with the other agency’s regulations. Inspectors told us that compliance information might be helpful when inspecting DJEs so that they could focus attention on past violations.

Fourth, the agreement calls for the agencies to develop and provide appropriate training in the inspectional techniques and processes of each agency to ensure that the contacts for each agency have an appropriate understanding of the working of the other agency. In addition, the 2000 evaluation found that more training was needed, particularly at the field level, to achieve the results of the agreement. Although USDA and FDA held 28 joint training sessions during the first year of the agreement’s implementation, no additional training has been provided since then. Because USDA and FDA on-site inspectors are often the first agency staff to become aware of deficiencies at a plant, effective sharing of this type of information depends upon those inspectors being adequately trained.

According to agency officials, the agreement has helped agency coordination and communication, particularly when major public health concerns arise. USDA and FDA headquarters officials identified instances of major enforcement actions resulting from FDA’s notification to USDA of problems with products under its jurisdiction. For example, in one case, FDA investigators learned that a sample of chicken salad tested positive for listeria and alerted USDA, resulting in a voluntary recall. In a second case, USDA and FDA cooperated by exchanging information on a severe rodent infestation at a DJE, resulting in the seizure of millions of pounds of USDA- and FDA-regulated product. In addition, USDA and FDA district managers were able to assist each other during the recall of beef and beef products, after the December 2003 discovery of a cow infected with bovine spongiform encephalopathy (BSE, also known as mad cow disease).

However, we found that the stated purpose of the agreement—which is to facilitate an exchange of information permitting more efficient use of both agencies’ resources and contributing to improved public health protection—has not been maximized. USDA and FDA are not making better use of each other’s inspection resources to reduce overlap and duplication of effort, particularly at establishments that both agencies inspect. Depending on the type and layout of the facility, a USDA inspector may have a more regular presence in an area where FDA-regulated products are maintained. For example, at a plant that produces both meat and seafood products, a USDA inspector told us that as part of his daily routine inspections he walks through the seafood processing and storage section of the plant. (See fig. 7). However, because FDA regulates seafood, the USDA inspector does not monitor or inspect the seafood storage section. The inspector noted that, with minimum training on seafood temperature controls, he could inspect this section of the plant as well. USDA officials at headquarters said the agency’s inspectors are capable of taking on FDA’s inspection responsibilities at jointly regulated facilities, given the proper resources and training.

A 1974 agreement between FDA and NMFS recognizes the two agencies’ related responsibilities for inspecting seafood facilities and standardization activities, and it details actions the agencies can take to enable each agency to discharge its responsibilities as effectively as possible. The agreement states that these actions should minimize FDA inspections in the approximately 275 domestic seafood facilities that NMFS inspects under contract, as long as FDA’s inspection requirements are followed. Among other items in the agreement: FDA is to (1) request information about NMFS-inspected products when FDA is considering an enforcement action, (2) provide timely notification to NMFS of any products seized from NMFS-inspected plants, (3) inform NMFS of FDA industry guidelines and its standards for establishing compliance action levels, and (4) invite NMFS inspectors to observe FDA inspections of companies under contract to NMFS.

NMFS is to (1) supply FDA headquarters with a list of all NMFS- inspected processing and packing establishments; (2) apply FDA requirements to NMFS-inspected products and establishments and decline to inspect, grade, or certify products that FDA would consider adulterated or misbranded; (3) upon request, provide FDA with information on NMFS-inspected products when FDA is taking or considering compliance action; and (4) cooperate with FDA in investigations of food poisoning, product recalls, and problems concerning food contamination caused by disasters or other phenomena.

FDA and NMFS may meet periodically and, when appropriate, with industry to promote better communication and understanding of regulations, policy, and statutory responsibilities. If either agency believes that a particular violation is occurring in several seafood- processing plants, it may request a meeting with the other agency to consider investigative steps and, when necessary, mutually agreeable remedial action.

We found that FDA is not using the agreement to minimize its inspections in seafood plants that NMFS has inspected and certified as meeting FDA’s safety standards. FDA officials said the agency does not recognize the NMFS inspections as aiding FDA in enforcing pertinent statutes. As a result, FDA is missing opportunities to leverage inspection resources and possibly avoid duplication of effort.

In addition, we found that FDA is not carrying out provisions in the agreement. For example, FDA rarely provides notification of seizure actions it takes against NMFS-inspected plants, as outlined in the agreement. Furthermore, according to a senior NMFS official, NMFS communicates its inspection results to FDA, but FDA does not share its results with NMFS.

FDA officials recently said they do not rely on NMFS’ inspection information for two reasons. First, NMFS conducts a fee-for-service inspection, and therefore, FDA officials believe that NMFS could have a conflict of interest because, as a nonregulatory body, it is paid for its services by the industry that it inspects. Second, FDA does not know which firms NMFS is inspecting at any given time. FDA officials said the list of firms NMFS inspects changes, depending on market fluctuations that affect each company’s need for NMFS’ services. Furthermore, FDA officials said that they already have a risk-based system in place to determine which firms to inspect, and at what frequencies, and that NMFS’ inspections are not a factor in its determination of risk.

NMFS officials disagreed with FDA’s reasons for not using NMFS inspection results. First, they pointed out that NMFS’s relationship to industry is similar to USDA’s Agricultural Marketing Service, which also conducts fee-for-service grading and certification of poultry, meat, eggs, and other agricultural commodities. Second, NMFS officials said they maintain an up-to-date list of firms that the agency inspects and post this information on its Web site, most recently revised in January 2005. NMFS readily provided us with a list of the firms it was inspecting when we spoke with officials during the course of our review.

Although FDA is not implementing the agreement, the agency has recognized the potential benefits of working with NMFS to leverage resources. In a January 2004 letter to the Under Secretary of Commerce for Oceans and Atmosphere, the then-Commissioner of Food and Drugs proposed ways that the two agencies could enhance coordination, including commissioning NMFS inspectors to help FDA meet its public health responsibilities. The Commissioner noted that using NMFS inspectors could be cost effective because the NMFS inspectors may already be on-site and the FDA inspector therefore would not have to travel to conduct an inspection.

FDA has not used NMFS inspection resources under the terms of the fishery products agreement, nor has the agency used its authority under the Bioterrorism Act to commission NMFS officials. However, FDA used this authority to commission CBP officers to assist FDA at ports of entry. FDA officials said the agency has not yet considered using the act to enter into similar agreements with other federal agencies. NMFS officials said the agency would be willing to enter into such an agreement with FDA, thereby assisting FDA in reaching its goal of conducting annual inspections at all high-risk facilities.

Industry and Other Stakeholders Disagree on the Significance of Overlap in the Federal Food Safety System and on How to Improve It

Industry associations, food-processing companies, consumer groups, and academic experts we contacted disagree on the significance of overlapping activities in the federal food safety system. However, most of these stakeholders agree that the laws and regulations governing the system should be modernized so that science and technological advancements can be used to more effectively and efficiently control current and emerging food safety hazards. While we found agreement among the stakeholders about the need for modernization, they differed about whether food safety functions should be consolidated into a single federal agency.

Stakeholders Disagree about Overlaps in the Federal Food Safety System

The stakeholders we contacted disagree on whether federal agencies’ food safety functions overlap, specifically with regard to inspections. Industry associations that we spoke with, such as the Food Products Association, National Fisheries Institute, American Frozen Food Institute, and Grocery Manufacturers of America, told us that overlaps occur but do not harm the safety of food and therefore are not significant. These overlaps, they noted, occur primarily in dual jurisdiction establishments—those regulated by both USDA and FDA—or facilities inspected by both FDA and NMFS. However, some overlaps occur outside these establishments. For example, although the United Fresh Fruit and Vegetable Association’s (UFFVA) member companies are primarily inspected and regulated by FDA, companies that sell fruit and vegetables to the school meals programs are also inspected by USDA. UFFVA officials pointed out that USDA inspects fruits and vegetables to be included in school lunches; and the companies, already subject to FDA inspections, incur additional expenses for these USDA inspections. UFFVA also cited overlaps in USDA’s and FDA’s sampling and testing for pesticides and microbiological contaminants on fruits and vegetables. Other stakeholders, including the U.S. Tuna Foundation and the American Meat Institute, reported that they do not think the federal agencies’ programs overlap because USDA and FDA have specific, defined areas of responsibility for their industries. The U.S. Poultry and Egg Association added that the regulatory delineations do not always make sense, citing the split jurisdiction between USDA and FDA over the regulation of eggs. Specifically, FDA regulates an egg farm as a “food factory” within its area of jurisdiction, and USDA regulates plants that process eggs into products such as powdered eggs.

Other stakeholders—generally food companies that are regulated by both USDA and FDA—told us that overlaps can be burdensome. These stakeholders did not see the added value of FDA’s once-a-year (or less) inspections, because USDA inspectors already visit their plants daily. For example, managers at these facilities told us the following: At an egg- and potato-processing company, each agency uses different frequencies for monitoring and ensuring food safety, with USDA inspecting the physical plant, usually daily, while FDA’s inspections usually take place annually. According to a senior plant manager, FDA’s inspections place more responsibility for food safety on the company. From the manager’s perspective, the most effective inspection strategy would be to combine elements of both agencies’ inspections into a single inspection program.

At a facility that produces USDA- and FDA-regulated foods on three different production lines, the facility must maintain different sets of paperwork for each food that the company processes in order to meet USDA and FDA HACCP and sanitation requirements. Since the USDA inspector is at the facility every day, the manager said he does not see any value added by FDA’s inspection because that inspector examines the same areas of the facility—the processing lines and the refrigerated storage area—which are covered by the USDA inspector.

A facility that cans a variety of soups and bean products experienced contradictory instructions from USDA and FDA during overlapping inspections. USDA inspectors did not want the company to paint its sterilization equipment because they determined that paint chips could contaminate the food. Subsequently, an FDA inspector told the company to paint the same equipment because he determined that it would be easier to identify sanitation problems on lightly painted equipment than on the dark-colored metal. The manager of the facility said the company had to paint and then remove the paint from equipment in order to satisfy both the USDA and FDA inspectors.

In addition, at a seafood-processing plant that is inspected by both NMFS and FDA, the manager said that when FDA collects product samples for testing, it does not report test results in a timely fashion. According to the manager, NMFS inspections are preferable because the agency is able to provide test results more rapidly than FDA, which, according to the manager, allows the company to know its products are safe before they enter the market.

A few stakeholders also saw value in some of the overlapping activities. For example: The American Frozen Food Institute noted that USDA and FDA inspections and their complementary expertise—independent scientific assessment, research, and education—provide value in addressing food safety issues.

The quality assurance manager at a dual jurisdiction establishment with whom we spoke said he liked having a “second pair of eyes” inspecting the facilities for food safety. The company produces smoked salmon—a high-risk food—and the manager noted that having inspections by FDA and NMFS helps to ensure that products are safe and of high quality.

Most Stakeholders Recognize the Need to Modernize the Food Safety System but Differ on What Approach to Take

The majority of stakeholders we contacted said they believed that the federal food safety system needs to be modernized, though they did not agree on what direction this modernization should take. Stakeholders’ views included (1) minor changes to improve coordination among the food safety agencies, (2) statutory changes to make the system more science and risk based, and (3) consolidating federal food safety functions into a single agency.

Some large industry associations (e.g., the Grocery Manufacturers of America, the Food Products Association, the American Frozen Food Institute, the National Fisheries Institute, and the United Fresh Fruit and Vegetable Association) saw the need for only minor changes within the existing regulatory framework to enhance communication and coordination among the existing agencies. Some industry officials said that the current food safety system protects consumers, and they cited decreases in illnesses caused by foodborne bacteria, such as salmonella and listeria. The Grocery Manufacturers of America said that the food safety system must be flexible enough to allow resources to be directed toward identifying and addressing serious food safety problems but that this alteration would not require changing the food safety structure. The Grocery Manufacturers of America also reported that the current food safety system could be enhanced, and perhaps made more efficient, through enhanced interagency coordination.

Other stakeholders—including representatives from industry associations, academia, consumer groups, public policy organizations, and individual food companies—believe that the system needs to be modernized through statutory changes to make it more science and risk based. According to the Consumer Federation of America, a science- or risk-based system should consider not only the risk posed by the food but also the history of the plant—whether is has a track record for producing high quality, safe food. Resources for the Future stated that the current food safety laws undermine a successful food safety system. That is, the laws do not build prevention into the farm-to-table continuum and divide responsibility and accountability for food safety among federal agencies. Further, the laws prevent risk-based allocation of resources across the federal food safety agencies. Further, USDA’s carcass-by-carcass organoleptic inspections exemplify the outmoded requirements of the current food safety system and cannot identify and control the microbiological hazards associated with meat and poultry products, such as E. coli O157:H7. Additionally, such inspections waste resources because new technologies are more efficient and effective. For example, the manager at a jointly regulated canned- goods company told us that daily inspections of meat and poultry products is wasteful and inefficient for most, if not all, heat-processed meat and poultry products, such as canned chicken or pork, since the canning process kills all the bacteria. Some stakeholders, including the Institute for Food Technologists, believe that modernizing the food safety system could be accomplished by rewriting the food safety statutes.

Finally, some of the stakeholders that cited the need for modernization also believe that these changes should be accompanied by consolidation of federal food safety programs into a single agency for the following reasons: Consolidation of functions could allow a single food agency to manage the safety of the whole food chain, not just its parts, according to food safety experts at the Center for Science in the Public Interest, the Consumer Federation of America, and the University of Illinois.

Consolidation would eliminate overlap between the agencies, especially at DJEs, according to several individual companies, and could generate substantial savings in terms of administrative efficiency and overall consistency in the application of policy, according to the Food Marketing Institute and food safety experts at Kansas State University and the University of Georgia.

The legislative changes needed to accomplish consolidation could also be used as the vehicle for modernizing the food safety statutes or establish a scientific basis for distributing food safety resources, according to several individual food companies and food safety experts at the Center for Science at the Public Interest and Resources for the Future.

The stakeholders we contacted also identified a number of roadblocks to changing the system, whether or not they supported such consolidation. First, industry is reluctant to change from a familiar regulatory framework to one that is untested. According to the Food Marketing Institute, food companies tend to prefer the inspection process that is known to them. Second, according to some industry associations, a transition to a single agency could create a period of uncertainty, as limited resources are diverted from the existing programs, and could therefore cause vulnerabilities in the food supply. Third, the transition costs to a single agency would be higher in the short term, according to food safety experts at the University of Illinois and the University of California. Fourth, current agency employees would be concerned that a consolidation would adversely change their working lives and that institutional knowledge would be lost. Finally, some stakeholders, including the Consumer Federation of America, said that some congressional committees may be reluctant to lose jurisdiction over food safety functions.

Conclusions

We recognize that current statutory authorities require the food safety agencies to carry out regulatory activities that have resulted in some overlapping or duplicative activities. We have recommended in the past that federal food safety statutes be streamlined and that food safety functions be consolidated into a single agency to ensure the logical and most effective use of government resources and to protect consumers.

Even within the current statutory framework, the agencies can take practical steps to reduce overlap and duplication and thereby free resources for more effective oversight of food safety. The Congress has recognized this possibility in the Bioterrorism Act by authorizing FDA to commission other agencies’ officials to conduct FDA’s inspection activities. Other avenues are open to the agencies as well. For example, the two interagency agreements that we examined in detail, could address problems in duplicative inspections if they were more effectively implemented. Other interagency agreements designed to reduce overlap might also prove fruitful. By not effectively implementing these agreements and by not exercising the new authorities under the Bioterrorism Act, the agencies are missing opportunities to make the system more efficient and effective.

Recommendations for Executive Action

We are making seven recommendations designed to reduce or eliminate duplication and overlaps, leverage existing resources, and enhance coordination efforts among the principal federal food safety agencies.

We recommend that the Secretary of Agriculture and the Commissioner of the Food and Drug Administration work together to ensure the implementation of the interagency agreement that calls for, among other things, sharing inspection- and enforcement-related information at food-processing facilities that are under the jurisdiction of both agencies; examine the feasibility of establishing a joint training program for food consider the findings of USDA’s foreign country equivalency evaluations when determining which countries to visit.

To better use FDA’s limited inspection resources and leverage USDA’s resources, we recommend that, if appropriate and cost effective, the Commissioner of the Food and Drug Administration, as authorized under the Pubic Health Security and Bioterrorism Preparedness and Response Act of 2002, enter into an agreement to commission USDA inspectors to carry out FDA’s inspection responsibilities for food establishments that are under the jurisdiction of both agencies.

To better use FDA’s limited inspection resources and leverage NMFS’s resources, we recommend that the Commissioner of the Food and Drug Administration and the Under Secretary of Commerce for Oceans and Atmosphere ensure the implementation of the interagency agreement that calls for FDA to recognize the results of NMFS inspections when determining the frequency of its seafood inspections.

To strengthen management controls and maximize the effectiveness of interagency agreements that are designed to reduce overlap, increase coordination, and leverage resources, we recommend that the Secretary of Agriculture, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, and the Under Secretary of Commerce for Oceans and Atmosphere identify and inventory all active interagency food safety-related evaluate the need for these agreements and, where necessary, update the agreements to reflect recent legislative changes, new technological advances, and current needs.

Agency Comments and Our Response

We provided USDA, HHS, EPA, and NOAA with a draft of this report for their review and comment. We received written comments on the report and its recommendations from USDA, HHS, and NOAA. EPA provided minor technical comments.

In commenting on a draft of this report, USDA expressed serious reservations about the report, asserting that it oversimplifies food safety regulatory functions within USDA and FDA and that it exaggerates the extent of regulatory overlap. USDA appears to have misinterpreted the focus of this report, and we disagree with USDA’s characterization. This report examines overlapping activities rather than the regulatory framework that allows these activities. Nevertheless, the report contains a clear and accurate acknowledgment that the agencies operate under a statutory framework that gives them different authorities and responsibilities to regulate different segments of the food supply. While we recognize that the agencies operate under different authorities, the activities they perform under these authorities are similar in nature, leading us to question why the federal agencies must continue to spend resources on overlapping, and sometimes duplicative, food safety activities. For example, we disagree with USDA’s assertion that the agencies’ inspection activities are vastly different. As we identify in the report, these inspections have sufficiently common features, including the verification of sanitation procedures and good manufacturing practices at food processing facilities that make them candidates for consolidation within one agency. USDA’s comments and our detailed response are contained in appendix V.

In commenting on a draft of this report, HHS raised concerns about our terminology regarding overlapping activities. We disagree with HHS comment that our report’s title should substitute the word duplication for overlap. That is, our report distinguishes between “overlap”—which we define as those similar activities being performed by more than one agency and “duplication”—which we define as essentially identical activities performed by more than one agency. Given the definitions we lay out in the report, if we modified the title as HHS suggests, we would risk implying that the agencies are literally duplicating efforts in every instance, even though we are fully aware that, under the current statutory framework, the agencies do not exactly replicate food safety activities. We also disagree with HHS’s comment that our report overstates similarities in USDA and FDA inspections because, as our report clearly states, USDA and FDA inspections have similar key elements: sanitation, good manufacturing practices, and HACCP compliance oversight. It also makes it clear that USDA and FDA inspections vary depending on whether the product is a USDA- or FDA-regulated food product. Furthermore, we disagree with HHS’s comment that the training programs are vastly different. As our report discusses, FDA’s training curriculum includes dozens of courses that address topics common to USDA and FDA. Overall, HHS agreed with three of the report’s seven recommendations, including (1) the usefulness of USDA’s foreign country evaluations, (2) identifying and inventoring all interagency agreements, and (3) the need to evaluate and update the agreements. HHS disagreed with our recommendation regarding joint training of USDA and FDA food inspectors. HHS took no position on our recommendation for using the Bioterrorism Act authorities. Finally, HHS partially concurred with two other recommendations dealing with the implementation of two interagency agreements. HHS also provided technical comments which we incorporated in our report, as appropriate. HHS’s comments and our detailed response are contained in appendix VI.

EPA did not provide official comments, but it provided minor technical comments that we incorporated as appropriate. The technical comments noted that EPA will consider GAO’s recommendation for better tracking of interagency agreements when the agency sets priorities for future investments in information technology.

NOAA provided written comments and agreed with the report’s recommendations that pertain to NMFS. NOAA also commented that our report does a fair and thorough job of describing the food safety activities of NMFS. NOAA stated that the positions expressed in GAO’s previous work continue to be germane to the issue of coordination with FDA on inspections of seafood. NOAA’s comments are contained in appendix VII.

As agreed with your offices, unless you publicly release the contents of this report earlier, we plan no further distribution until 30 days from the report date. We are sending copies of this report to the Secretary of Agriculture, the Acting Commissioner of the Food and Drug Administration, the Acting Administrator of the Environmental Protection Agency, and the Under Secretary of Commerce for Oceans and Atmosphere. In addition, this report will be available at no charge on the GAO Web site at http://www.gao.gov.

If you or your staffs have any questions concerning this report, I can be reached at (202) 512-3841, or robinsonr@gao.gov. Major contributors to this report are included is appendix VIII.

Scope and Methodology

To identify overlaps that may exist in the federal food safety system, we collected fiscal year 2003 budget data for food safety-related activities from the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the National Marine Fisheries Service (NMFS). We selected these agencies because they have broad food safety-related inspection and enforcement related responsibilities, the function to which most federal food safety funding is dedicated. We defined overlaps as similar activities being performed by more than one agency, such as training food inspectors. In contrast, we defined duplication as essentially identical activities performed by more than one agency, such as inspecting the same food- processing facility for compliance with sanitation and good manufacturing practices requirements. We used categories of food safety activities contained in the National Academy of Science’s 1998 report Ensuring Safe Food to group the agencies’ food safety activities. These categories include: monitoring/surveillance, inspection/enforcement, education/outreach, research, and risk assessment. We included three additional categories—food security, administration, and rulemaking/standard setting—to capture other relevant activities. We defined the categories of food safety activities into the following program functions: Monitoring/Surveillance: activities related to the monitoring of foodborne illness or disease, as well as monitoring the agents of illness in the food supply, including the collection of baseline data for contaminants; Inspection/Enforcement: activities related to ensuring compliance with agency food safety regulations, including premarket application or petition approval; Education/Outreach: activities related to communicating food safety- related information or guidance to the public, industry, or agencies’ other clients; Research: activities related to the study of food safety-related topics, which support agency policy decisions; Risk assessment: activities related to evaluation of the likelihood and severity of an adverse event (e.g., illness or death) on the public health as a result of the likelihood of exposure to a particular hazard; Food security: activities related to preparing for and responding to deliberate attacks on the food supply; Administration: supporting activities that enable the agencies to perform their food safety responsibilities. Examples of administrative activities include: procurement, human resources support, financial management, travel management, and information technology support; and Rulemaking/Standard setting: activities related to food safety policy decisions, development of regulations, and administration of regulatory review processes.

Specifically, we obtained actual expenditures and staffing level data in full- time equivalents (FTE) from the following USDA units: Agricultural Marketing Service; Agricultural Research Service; Animal and Plant Health Inspection Service; Cooperative State Research, Education, and Extension Service; Economic Research Service; Grain Inspection, Packers and Stockyards Administration; Food Safety and Inspection Service; and National Agricultural Statistics Service. We also obtained data from the following FDA units: Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, National Center for Toxicological Research, and Office of Regulatory Affairs. EPA’s Office of Pesticide Prevention and Office of Water, as well as the NMFS’s Seafood Inspection Program and Office of Sustainable Fisheries also provided data. To assess the reliability of the staffing and expenditure data, we questioned knowledgeable agency officials and reviewed existing documentation regarding the data and the systems that produced them. We determined that the data were sufficiently reliable for the purposes of identifying overlaps.

After the agencies provided budget data, we contacted agency budget and program officials to determine what activities were linked to the expenditure and staffing data. We categorized expenditures and staffing and asked agency officials if they considered our categorizations to be appropriate. We adjusted our categorization when agency officials told us it was inaccurate. In some cases, the agencies’ preferred categorization of the same activity varied. For example, FDA considered inspector training as an education/outreach activity, whereas USDA considered it an inspection- related activity. These discrepancies are noted in appendix II. After we categorized the budget and staffing level data, we identified cases in which more than one agency performed similar activities. In some instances, the agencies estimated budget and staffing levels, or they were unable to separate budget data into specific categories. As a result, some agencies did not provide expenditures and staffing data for categories such as administration, food security, and rulemaking. The agencies’ officials explained that these expenditures are distributed among more than one of the other categories.

To examine the extent to which federal food safety agencies are using interagency agreements to leverage existing resources to reduce any such overlaps, we requested that agencies provide copies of all active interagency food safety-related agreements, and we selected two agreements to analyze their implementation. We compared the agreements that the agencies provided to determine where there were differences. In the cases where agency signatories provided us an agreement, and one or more agency signatories did not, we followed up with those agencies to reconcile the discrepancies. In some cases, we provided the agreement to an agency to obtain confirmation that it was a signatory to the agreement. We asked the agencies to categorize the agreements according to primary program function. We also independently categorized the agreements using information from their introduction and/or background to ensure consistent categorization across the agencies. If the agencies’ categorization differed with ours, we considered their rationale and changed the categorization as appropriate.

We selected two inspection-related interagency agreements for in-depth review because the agencies spend most of their resources on inspection activities; one agreement that pertains to dual jurisdiction establishments (DJE) and one that pertains to inspections of fishery products. In addition, these agreements encompassed a broad range of intended coordination efforts between the agencies involved. We conducted site visits to three USDA and FDA field offices to obtain information related to implementation of the agreements. The site visits included USDA district offices in Philadelphia, Pennsylvania and Boulder, Colorado; and FDA district offices in Philadelphia, Pennsylvania; Denver, Colorado; and Seattle, Washington, which are responsible for food safety in a total of 13 states. We met with USDA and FDA district managers, inspectors, and other staff to discuss the agreement’s implementation. We also selected two to four DJEs at each location and visited them to discuss implementation of the agreements with plant managers and, in some cases, with USDA or FDA inspectors assigned to these facilities. In some cases, we accompanied inspectors as they conducted inspections of the facilities.

To obtain the views of regulated industry and other stakeholders regarding opportunities to reduce overlap by consolidating federal food safety functions, we contacted a total of 35 stakeholders from food industry associations, food manufacturers, consumer groups, and academic experts using a structured interview format consisting of 22 questions. In selecting associations, organizations, and experts, we included contacts from our previous reports and testimonies and considered recommendations from USDA, FDA, EPA, and NMFS. In selecting which food manufacturers to interview, we used Food Processing’s Top 100 Companies to identify the largest food manufacturers. Of those companies, we selected and contacted food manufacturers that have facilities that produce food regulated by both USDA and FDA.

We conducted our review from May 2004 through March 2005 in accordance with generally accepted government auditing standards.

Food Safety Expenditures and Staffing Levels for Fiscal Year 2003

We asked agencies within USDA, FDA, EPA, and NMFS to provide all expenditures and staffing levels, in FTEs, related to food safety activities they conducted in fiscal year 2003. Tables 3 and 4 categorize these expenditures and staffing levels according to program function. Though most agencies were able to identify expenditures and staffing levels related to inspection and enforcement, research, risk assessment, education and outreach, and monitoring and surveillance—many were unable to provide expenditures linked to rulemaking and standard setting, food security, and administration. For this reason, table 4 containing this data is included separately. As table 3 shows, inspection and enforcement-related spending accounts for most of these agencies’ food safety-related spending in fiscal year 2003.

Food Safety-Related Interagency Agreements

We solicited all active food safety-related interagency agreements from USDA, FDA, EPA, and NMFS. Table 5 categorizes the 71 agreements by program function. Twenty-four agreements state the need to reduce duplication of effort, reduce or clarify overlaps, or increase the efficient or effective use of resources between agencies. Table 5 also provides the year each agreement became effective and indicates the signatory agencies. The bolded agreements are the two that were analyzed in-depth.

Principal Federal Laws Related to Food Safety

As we have noted in this and other reports, the federal framework for food safety is based on a patchwork of numerous laws. Table 6 lists the 30 laws that we have identified as the principal federal laws related to food safety in order of their enactment, along with the agency or agencies that have food safety responsibilities under each law and a brief discussion or example of each law’s food safety-related provisions. Included in the table are several laws that primarily deal with health claims or labeling, which we consider to be food-safety related, as well as some laws that are largely amendments of the Federal Food, Drug and Cosmetic Act. This table does not provide an exhaustive list of all food safety-related laws and amendments, nor does it detail all of the food safety provisions for those laws listed.

Comments from the U.S. Department of Agriculture

The following are GAO’s comments on the U.S. Department of Agriculture’s letter dated March 10, 2005.

GAO Comments

1. We disagree with USDA’s assertion that our report overly simplifies the food safety regulatory functions within USDA and FDA and that it exaggerates the extent of regulatory overlap. USDA has misinterpreted the focus of this report. This report examines overlapping activities rather than the regulatory framework that allows these activities. Nevertheless, the report contains a clear and accurate acknowledgment that the agencies operate under a statutory framework that gives them different authorities and responsibilities to regulate different segments of the food supply. While we recognize that the agencies operate under different authorities, the activities they perform under these authorities are similar in nature, leading us to question why the federal agencies must continue to spend resources on overlapping, and sometimes duplicative, food safety activities.

We also disagree with USDA’s assertion that the agencies activities are vastly different. For example, we find that the agencies’ inspection activities to ensure that food manufacturers comply with regulatory requirements are quite similar. As we document in our report, these inspections have sufficiently common features, such as verifying proper sanitation procedures at food processing facilities, that make these inspections activities candidates for consolidation under one agency.

We further disagree with USDA’s comment that the report’s recommendations rely upon overly simplistic interpretations of food safety authorities, regulations, inspection requirements, and training needs. To the contrary, our recommendations address specific areas where the agencies could improve coordination to better leverage resources. USDA did not comment directly on these recommendations. 2. We believe that USDA mischaracterizes our report in noting that it states that a “significant” overlap in inspection authorities exists. Specifically, our report examines inspection activities, not inspection authorities, and certainly does not identify “significant” overlaps in authorities. In fact, the report clearly states that, because of the agencies’ split jurisdiction, they are each responsible for inspecting different food products at jointly regulated facilities. As a result, both agencies send inspectors into these facilities—USDA on a daily basis and FDA less regularly.

While we agree with USDA that the number of jointly regulated establishments may be a relatively small portion of all regulated food establishments, USDA and FDA had great difficulty identifying the current number of jointly regulated facilities. Consequently, the magnitude of potential savings is difficult to calculate. We continue to believe that, because USDA maintains a daily presence at hundreds of these facilities, FDA could make more effective use of its resources— an average cost of $4,000 per inspection—if it redirected its inspectors to other facilities for which FDA has sole jurisdiction. 3. Contrary to USDA’s assertion, our report does not suggest that USDA (FSIS) and FDA have comparable HACCP regulations. Instead, our report clearly distinguishes between the elements of the agencies’ HACCP regulations that are comparable and those that are not. For example, the report acknowledges that, given the agencies’ different statutory authorities, both require jointly regulated facilities to maintain separate HACCP plans and states that the contents of these plans differ because the agencies regulate different products. However, as USDA itself notes, the two sets of HACCP regulations (USDA and FDA) are quite similar, and as we point out, they have certain features in common, such as certain sanitation and manufacturing processes. Therefore, we continue to believe that USDA and FDA could consolidate HACCP-based inspections at these jointly regulated facilities. To provide further clarification on what commodities are currently subject to HACCP regulations, we modified our report to indicate, as USDA suggests, that FDA currently requires HACCP plans for seafood and juice products only. 4. We disagree that our report oversimplifies or inaccurately describes federal food safety functions at ports of entry. For example, USDA noted that in order for meat and poultry and egg products to be eligible for import to the United States, foreign food safety regulatory systems must employ equivalent sanitary measures that provide the same level of protection against food safety hazards as is achieved domestically under USDA regulations. We disagree with USDA’s comment, because our report clearly and accurately describes the requirement for certification of those countries wishing to export meat and poultry into the United States, including a finding by the Secretary of Agriculture that the countries have equivalent food safety systems. The main point of our report is that the agencies are not leveraging inspection resources at ports of entry, especially regarding FDA-regulated imported foods that, according to USDA officials, are being stored at USDA-approved inspection facilities. Therefore, we continue to believe that there are opportunities to leverage inspection resources, as we are recommending.

Furthermore, USDA’s comment that it shares the results of its overseas equivalency determinations contradicts what USDA and FDA officials told us during the course of our review. However, we note that USDA is now sharing this information. Indeed, FDA commented that it would consider the results of USDA’s foreign country equivalency determinations. 5. Any successful consolidation of inspectors’ training would of course require work. However, we continue to believe that, as USDA’s comments note, there is merit in examining the feasibility of conducting joint training activities when workable commonalities can be found. Our report identifies more than 100 courses in FDA’s inspector training curriculum that include topics common to both USDA and FDA. 6. We disagree with USDA’s assertion that implementation of the 1999 interagency agreement has been largely successful. Our report highlights several deficiencies, even as it gives the agencies credit for improved communication in times of crisis, such as during major recalls. These deficiencies include agencies’ (1) difficulty identifying the establishments to which this agreement pertains, (2) lack of routine communication on inspection findings between agencies’ inspection personnel on such findings of mutual concern as sanitation problems at jointly regulated facilities, and (3) lack of a system to track and exchange information when each agency finds instances of noncompliance. Finally, we also found that the agencies’ efforts to develop and provide training on each other’s inspection techniques and processes did not continue past the first year of the agreement’s implementation. As a result, we continue to believe that the stated purpose of the agreement—to facilitate an exchange of information permitting more efficient use of both agencies’ resources—has not been maximized.

We further disagree with USDA’s comment that our report inaccurately characterizes the Bioterrorism Act. As we state in the report, FDA is authorized under the act to enter into an agreement to commission other agency officials, including USDA officials, to carry out inspections on its behalf—for FDA-regulated foods—at establishments under the jurisdiction of both agencies.

Comments from the Department of Health and Human Services (FDA)

The following are GAO’s comments on the U.S. Department of Health and Human Services’ (HHS) letter, dated March 11, 2005.

GAO Comments

1. We disagree with HHS’s comment that our report’s title should substitute the word duplication for overlap. Given the definitions we lay out in the report, if we modified the title as HHS suggests, we would risk implying that the agencies are undertaking many duplicative efforts, even though we are fully aware that under the current statutory framework the agencies do not exactly replicate food safety activities. That is, our report distinguishes between “overlap”—which we define as those similar activities being performed by more than one agency and “duplication”—which we define as essentially identical activities performed by more than one agency.

We also disagree with HHS’s comment that our report overstates similarities in USDA and FDA inspections. First, our report clearly states that USDA and FDA inspections have common key elements: sanitation, good manufacturing practices, and HACCP compliance oversight. Second, the report makes it clear that USDA and FDA inspections vary, depending on whether the product is a USDA- or FDA- regulated food product.

Furthermore, we disagree with HHS’s comment that the training programs are vastly different. As our report discusses, FDA’s training curriculum includes dozens of courses that address topics common to USDA and FDA. Despite HHS’s disagreement with our recommendation that the agencies examine the feasibility of establishing a joint training program for food inspectors, we continue to believe that such an examination has merit. In its comments, USDA agreed that there is merit in examining the feasibility of conducting joint training activities when commonalities can be found. 2. We agree with HHS’s comment that, if a single agency were to be responsible for the safety of all food products, different organization units within that agency may need to coordinate their activities. However, we believe that some economies of scale would be derived from combining overlapping activities, including those that our report highlights. For example, with a single food safety agency, the federal government would not need to have two separate food inspection workforces or two separate training programs. 3. We acknowledge that some elements of the 1999 interagency agreement on dual jurisdiction establishments have been implemented and that the agreement has enhanced coordination. However, we continue to believe that the agreement could be better implemented. We further disagree that the report does not identify the distinct difference between FDA interagency agreements and memoranda of understanding. We acknowledge that, as used in our report, the term interagency agreement refers generally to memoranda of understanding, memoranda of agreement, and interagency agreements identified by USDA, FDA, EPA, and NMFS. The report includes a footnote to indicate that FDA makes a distinction, which the other agencies do not, between interagency agreements and memoranda of understanding. The footnote explains that, according to FDA, FDA memoranda of understanding do not provide for exchanges of funds. FDA refers to agreements that involve exchanges of funds, personnel, or property as interagency agreements. We did not consider this type of agreement in our analysis. 4. We understand the differences between HACCP principles and plans.

Our report acknowledges that while HACCP principles are the same for both FDA and USDA, the HACCP plans are different as they address different risks associated with different products (i.e., seafood, juice, meat, or poultry). Our report’s identification of HACCP requirements as another area of overlap between the two agencies refers to the fact that both agencies have issued HACCP regulations that are based on a similar HACCP model. We have modified our report to indicate that, short of consolidating all inspection functions, consolidating inspections of the similar elements in the agencies’ HACCP plans would reduce overlap. We further note that USDA’s HACCP rule applies to both meat and poultry products, although these products present different hazards. Thus, we believe it is possible to issue broad regulations based on common principles that can then be applied to specific products. We have made minor modifications in the report to avoid confusion regarding HACCP principles and HACCP plans and to indicate that different risks are associated with different food products and, therefore, require different HACCP plans.

Comments from the U.S. Department of Commerce (NOAA)

GAO Contacts and Staff Acknowledgments

GAO Contacts

Staff Acknowledgments

In addition to those named above Lawrence J. Dyckman, Katheryn Hubbell, Jane Kim, Sara Margraf, Carol Herrnstadt Shulman, Michele Fejfar, Amy Webbink, and Katherine Raheb made key contributions to this report.