THE ASSOCIATION OF FOOD AND DRUG OFFICIALS

COMMENTS TO THE U.S. HOUSE OF REPRESENTATIVES

ENERGY AND COMMERCE COMMITTEE

JUNE 25, 2004

R. Douglas Saunders

Chair, AFDO Food Security Task Force

Betsy Woodward

Special Advisor to the AFDO Board of Directors

Mr. Chairman, and members of the Committee, I am here today as a representative of the Board of Directors and a past president of the Association of Food and Drug Officials (AFDO), to provide testimony on the importance of the Bioterrorism Preparedness and Response Act of 2002 (hereinafter referred to as the Bioterrorism Act).  I would like to thank you for this opportunity to share the perspective of AFDO on an issue that is so vital to the protection of the food and agriculture critical infrastructure of our nation.

For 108 years, AFDO has served as a major voice for food safety officials in the United States and Canada.  AFDO proudly represents state and local government food safety officials at public meetings or briefings where consensus opinions or official comments are presented on a host of food safety and security issues.  Today, more than ever, there is a call for unity among health officials in government at all levels and the need to coordinate all available food safety and security resources, particularly those at the sentinel nodes of our detection system.  From that perspective, we would like to offer the following comments relative to the Bioterrorism Act.

With respect to the four major issues addressed by the Bioterrorism Act, AFDO fully supports the U.S. Food and Drug Administration (FDA) as they implement regulations to address those provisions.  Specifically, those provisions include:

• Prior notification of imported foods coming into the United States;
• Registration of food establishments;
• Record keeping to ensure effectiveness of tracebacks, traceforwards and recall activities; and
• Administrative detention of food products.

Prior notification of incoming shipments of imported foods and registration of food establishments are absolutely imperative if we are to have any ability at all to effectively control the movement or distribution of foods that are suspected of being compromised through acts of terrorism.  We believe that such requirements provide the basis for having greater control of suspect foods and will enhance the capability to more quickly detect non-intentional or intentional adulteration and facilitate immediate removal of suspect foods from the channels of commerce.  Early detection and rapid response are essential elements to defend the integrity of our food supply.  Prior notification and establishment registration can only improve those elements.  However, we also believe that these components of the bioterrorism act must be augmented by additional measures.  With imported foods, FDA must do more.  The concept of evaluating the safety of imported foods solely at one of the 400 border points is inadequate, in our view.  FDA needs to move back the borders to the manufacturing site and perform inspections of these food establishments to significantly enhance our ability to detect, detain, and ultimately remove from commerce intentionally adulterated foods.  Currently, such inspections only take place with respect to low-acid canned foods.  This authority must be expanded to cover all food manufacturers located outside of our borders that ship food products into the United States.

In addition, FDA must work closer with State and Local government agencies relative to imported foods that are distributed domestically.  Some may suggest that imported foods are a regulatory concern for federal agencies alone.  These individuals would be wrong.  Once imported foods get through the scrutiny of our federal partners, they become primarily the concern of State and Local regulatory agencies.  Many states report recalls, and food seizures or embargoes are commonplace for issues that include undeclared allergens, unapproved color additives, undeclared preservatives, and pathogens.  FDA must develop a means for obtaining this information and utilizing it, where appropriate, to institute import alerts.  FDA must also consider how to best use State and Local laboratory resources, as well.

The recordkeeping requirements provided by the Bioterrorism Act certainly improve the likelihood that effective tracebacks, traceforwards, or recalls will be facilitated in the event of a terrorist act against our food supply.  Improved traceback, traceforward, or recall capabilities will significantly enhance the expeditious tracking and removal activities of the FDA when adulteration is detected.  It must be noted, however, that historically, traceback or traceforward activities are usually performed by State food safety agencies.  It is safe to assume that with the limited resources that are available to the FDA, most traceback and traceforward activities will continue to be performed by the States, in cooperation with the FDA.

Administrative detention is a tool that FDA has needed for many years, and a tool that will provide immediate results when it becomes necessary to prevent further distribution of suspect food products.  Prior to granting of this authority by Congress, FDA had to request States to detain, seize or embargo food products when suspect food products were encountered.  Through cooperative agreements, FDA has utilized the States’ detention authority for many years.  Because the Bioterrorism Act contains specific requirements that define when FDA can utilize administrative detention, it will still be necessary for FDA to maintain these cooperative agreements with the States to ensure that suspect foods that do not meet the Federal definition but are still of considerable concern relative to adulteration, continue to be legally restrained.  Consequently, through the FDA’s new detention authority, and through continuing cooperative agreements between FDA and the States, the nationwide network of detention capabilities will be substantially strengthened.

For as long as FDA has existed, the cooperative relationships between the FDA and State and Local food safety agencies have worked very effectively in protecting our nation’s food supply.  These coordinated activities have led to a maximized utilization of Federal, State and Local food safety and security resources, while eliminating the duplication of food protection activities.  Through these cooperative efforts, State and Local food safety agencies have been able to supplement the food safety and security activities of the FDA.  In 2002, AFDO conducted a survey of state activities which showed that during 2001, state programs performed:

• More than 2.5 million inspections of food establishments;
• More than 3,000 foodborne illness investigations;
• Investigation of over 46,000 consumer complaints;
• Response to over 2,800 emergencies or disasters involving food products;
• More than 128,000 enforcement actions, including, but not limited to, embargos, seizures and stop sales; injunctions; criminal prosecutions; warning letters; informal hearings; and food recalls; and,
• Collection and analyses of over 328,000 food samples, including more than 252,000 microbiological samples.

Based on these figures, more than 80% of the food safety and security activities in the United States are performed at the State or Local levels.  Consequently, it is clear that State and Local food safety programs provide the major portion of the shields that must be in place to detect any sort of terrorist act.  With the increasing threat of terrorist activities against our food supply, it is paramount that this cooperative and highly integrated Federal, State and Local food safety and security system be maintained and strengthened for the deterrence, prevention and detection of terrorist activities.  With that focus in mind, AFDO would like to call attention to a piece of Federal legislation that threatens to eviscerate this system.  The ramifications of this bill, intended or not, will dissolve our nation’s biodefense capabilities.

H.R. 2699, the National Uniformity for Food Act of 2003, as presently cast, undermines our nation’s whole biosurveillance system by preempting and invalidating many of the State and Local food safety laws and regulations that provide the necessary authority for State and Local agencies to operate food safety and security programs.  The pre-9/11 concept embodied in this bill is very much out of line with current threats that confront our food safety and security system.  Preempting and invalidating State and Local food safety and security activities will lead to serious ramifications that will be difficult, if not impossible, for our nation to recover from.  Specifically, FDA’s ability to detect, much less respond, to acts of terrorism will be severely hampered.  The cost to the FDA to replace the infrastructure and food safety and security activities currently accomplished at the State and Local levels is estimated to exceed $500,000,000.  Our current food safety and security system will be significantly disrupted for many years to come, and our inability to track suspected acts of intentional adulteration will be exploited by those who seek to do harm to our nation.  Passage of H.R. 2699, in its current form, which would invalidate State and Local food safety laws and regulations, will effectively eliminate our nation’s food biosecurity shields, and will undermine our whole, food safety and biosurveillance capability.

In conclusion, the Bioterrorism Preparedness and Response Act of 2002 is an immeasurably  important and necessary law that further solidifies our nation’s food safety and security system by providing FDA with much needed, and long overdue authorities, and it ensures the continuing, cooperative efforts of State and Local agencies.  However, these new FDA authorities can only remain effective if these cooperative relationships between the FDA and State and Local food safety and security programs can be maintained and improved.  Consequently, for the effectiveness of the Bioterrorism Act to be fully realized, it is absolutely imperative that our current food safety and security programs at all levels remain fully functional and active, and that we continue to seek ways in which we can strengthen this highly integrated and cooperative system.

Once again, thank you for this opportunity to provide our comments.