United States General Accounting Office
441 G Street, NW
Washington, DC 20548
Report Number GAO-02-47T Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food
The Association of Food and Drug Officials (AFDO) was organized in 1896 to support uniformity in food and drug regulation between and among the states. Although Harvey W. Wiley, known as the “Father of the Pure Food and Drugs Act”, was an active participant during those first years of AFDO, at that time there was no federal law until the passage of that Act in 1906.
AFDO would like to comment on the recent October 10, 2001 testimony provided by Robert A. Robinson, Managing Director, Natural Resources and Environment, which was published by the GAO. This testimony, "Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food", was provided before the Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia, Committee on Governmental Affairs, U.S. Senate.
AFDO wishes to provide comments relating to state and local food safety programs as first responders to public health issues in dealing with contaminated foods, both domestic and imported, and from farm-to-table. The food safety roles of these programs are critical and essential in ensuring and improving the level of food safety and security that is provided to consumers in the United States. As an example of the criticality of these roles, states currently have embargo authority over all food sold or distributed in the state, regardless of whether such food is processed in state. Additionally, state and local food safety programs account for most of the enforcement actions against contaminated foods. States' enforcement authority covers all foods manufactured, processed, stored, or sold within its jurisdiction, whether or not the food originates within the jurisdiction. State and local field inspectors operate in plants, warehouses and retail facilities, right at the consumer level, with authority to examine and if necessary detain any foods suspected of being in violation of food safety standards. Most state laws substantively model the Federal Food, Drug and Cosmetic Act and most states adopt the food safety standards found in the applicable Code of Federal Regulations. Additionally, many food safety standards are found in federal action levels and guidance documents. Many states utilize these federal action levels and guidance documents in support of their enforcement actions, and some states, such as Florida, even use their own rule-making authority to adopt these key federal food safety guidelines as state regulations.
AFDO testified in 1998 before the Institute Of Medicine (IOM), National Research Council regarding the nation’s food safety system. A copy of that testimony is attached. AFDO did not take a position then, nor does it now, in regard to a single federal food safety agency, as there are valid issues on both sides of the current debate. However, we did articulate the critical role of the first responders at the state and local level and proposed an integrated food safety system in which each jurisdiction would bring its resources to bear in a coordinated manner to maximize efficiency and effectiveness of the available resources. Elements of that testimony were included in the final report issued by the IOM in 1998 (Committee to Ensure Safe Food from Production to Consumption, Institute of Medicine, National Research Council; Ensuring Safe Food From Production to Consumption; National Academy Press, Washington, DC; 1998.)
As a result of that report, President Clinton organized a "Food Safety Initiative" with a directive to federal agencies to better coordinate resources with state and local agencies. Correspondingly, state and local government programs provided personnel and resources to work with the federal agencies to identify and address issues that had hindered an effective system; this endeavor has become known as the National Food Safety System (NFSS) project. As a consequence of that project, numerous joint working groups have produced strategies and solutions to many of the impediments to a coordinated food safety system. The following are examples of significant NFSS accomplishments that have been achieved in the short time since 1998:
• eLEXNET - a secure electronic data sharing system for food safety laboratory data (By the end of the year, 28 states will be sharing data)
• ISO Accreditation - an internationally recognized laboratory accreditation program aimed at assuring uniform methodologies for federal, state and local laboratories
• Directory of Laboratory Capabilities - a compilation that identifies federal, state and local laboratory capabilities in preparation for emergency needs
• AFDO Recall Workgroup - an effort involving state and federal (FDA and FSIS) officials to streamline and better coordinate recalls for increased effectiveness in removal of contaminated product from the market place
• Validation of Laboratory Methodologies - a joint federal/state effort to standardize and develop national rapid detection methods
• Foodborne Illness Outbreak Coordination Guidelines - developed to provide uniform investigational procedures and information-sharing protocols
• ORA-U - development of a comprehensive national training and certification system to better facilitate uniform food safety activities among all federal, state and local field inspectors
• Uniform Criteria Workgroup - development of uniform national regulatory standards
• Integrated Food Safety Partnership - provides a pilot program that integrates the food safety functions of a state and the FDA. A pilot of this partnership is currently in its early stages of application
Unfortunately, recent federal support to furthering these initiatives has been notably sluggish. Currently Congress and the federal agencies have only given tacit support to continuing these efforts, although verbally they have assured us that these efforts will not "die on the vine." Why is this important? In a recent GAO Report issued in February 2001, the GAO reported that state programs alone (excluding local food safety program resources) in 1999 provided more that $300 million in resources to food safety programs. Most of these resources were field directed and accounted for almost 2 million food safety inspections, of which 44% were at the processor level. In comparison, FDA's budget for field activities provided $145 million in resources that same year. FDA’s establishment inventory accounts for 57,000 food establishments while the states’ (no locals) account for 1,075,124. The 2 million inspections provided by the states annually have an establishment frequency of quarterly to annually. These figures are not meant to imply that FDA is not doing its job; on the contrary, they demonstrate the significantly large component of food safety inspection and enforcement activities at the state program level. Because of the enormity of the state component to food safety inspections, states account for most food safety enforcement actions, including recalls and embargoes of contaminated product. Clearly, state and local programs are doing the vast majority of the field "front line work" in food safety.
What is distressing is that these very significant contributions, both from their role as first responders and from the percentages of total food safety resources committed, are largely ignored at the federal level, especially in Congress. As recently as the last Congress, legislation was almost passed that would have stripped states of rule-making authority in food safety, thereby destroying their jurisdictional and enforcement authorities. This legislation would have prevented state regulatory actions in the area of adulterated foods, including those foods contaminated with microbes, with illegal food additives, with pesticide residues, and with unsafe dietary supplements. One major mid-western state determined that 9 of its 13 food protection laws would have been invalidated, as well as the rules adopted under the authority of those laws. Not a single state or local food safety program representative was called to testify on what was needed to preserve and enhance the resource and workload component from the first responder level.
State and local programs have the flexibility to react quickly to emerging food safety and security issues. Illustrating that point is the recent finalization of the egg safety regulations. By the time the federal rules became final, the incidence of Salmonellosis associated with eggs had declined 40%, largely because states had already implemented time/temperature requirements for eggs at the retail level.
States having to work with the many agencies at the federal level do encounter frustration in dealing with different agency regulatory frameworks and philosophies. States do, however, work within the parameters of each agency's framework, and when those efforts become problematic, states seek solutions through cooperative efforts. A recent example is that of recalls in which AFDO formed two working groups, one with the FDA, the other with USDA/FSIS. Accomplishments that have currently been achieved through the efforts of those working groups include:
• The development and delivery of the AFDO Food Recall Workshop on November 16, 2000. This workshop included participants from federal, state and local government agencies, the food industry, consumers and the media
• Reconvening of a combined AFDO Recall Workgroup to address the numerous issues and questions that were raised during the November 2000 workshop
• Development of draft AFDO model guidelines for the handling of recalls to promote uniformity among the states
• Ongoing efforts to coordinate recall activities among federal, state and local food safety agencies to continue to reduce duplicative efforts and efficiently utilize each agency’s limited resources
As referenced in our testimony, what state and local agencies need from the federal level is:
• Leadership and uniformity - the federal agencies should assume a major leadership and oversight role to facilitate uniformity among federal, state and local food safety agencies nationwide
• Standard setting - A lack of federal standards leads to non-uniformity which is used to refer to states as "protectionists" because of "non-uniformity"
• Training - There should be uniform training and standards for food safety
inspectors regardless of jurisdiction
• Improved Import Inspections – Although import activities are predominantly the responsibility of the federal government, States, in cooperation with the federal agencies, must have inspection and testing of imported foods as a major component of their programs in order to enhance federal efforts within the import arena. Historically, state programs have identified most problems with imported foods.
While AFDO is not commenting on the need for a single food safety agency, the list of former federal officials who support this concept is impressive. Over the years, we have worked with most of these officials, and most of these officials have supported AFDO's contention that state and local governments play a key role on the front line of food safety inspection. State and local programs have the field force (nearly 6,000 state inspectors alone, according to GAO) and the role of being in the market place. Because of this role as first responder and the large resource commitment, no national system solution discussion should exclude participation by state and local regulatory agencies or their representatives. The current infrastructure would have a huge and expensive-to-fill hole absent this state and local component. Care must be taken that legislation does not unnecessarily impede its first responder from fulfilling that role in any food safety crisis. It is the absence of attention to this role by the federal government that we find the most frustrating. The interface of federal/state/local roles is absolutely critical to the success of any national food safety strategy--it simply cannot continue to be overlooked or treated as an after thought.
Clearly, if we are to have a comprehensive, uniform, seamless, and risk-based food safety system for the nation, a myopic approach that only examines the federal component, in isolation from the state and local components, cannot be utilized. If such an approach is utilized, any attempt to correct the deficiencies in the current system, to provide strategic plans for addressing emerging food safety issues, and to develop a truly effective national food safety system is doomed to failure.
We appreciate this opportunity to provide comments on such an extremely important issue.
Sincerely,
Doug Saunders
President
Association of Food and Drug Officials
cc: Denise Rooney
AFDO Board of Directors
AFDO Regional Affiliate Presidents
AFDO Committee Chairs
