Comments to The Committee on Energy and Commerce Regarding Bioterrorism
November 8, 2001
John Ford
Amit Sachdal
Brent Delmonte
Bruce Gwinn
Earl Seeley
The Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, DC 20515
Gentlemen:
The Association of Food and Drug Officials (AFDO) was very honored and sincerely appreciates your request to meet with us regarding state food safety programs and particularly their role as it relates to an approach in dealing with bioterriorism and our interface with the federal agencies. AFDO has for our 105 year existence represented state and local government program officials dealing with the regulation of foods, drugs and medical devices within their respective jurisdictions. Our Board of Directors has advisors from industry, the FDA, USDA/FSIS, CDC, and Canada. We are also pleased to have been asked to discuss and comment on the proposed amendments to the Food, Drug, and Cosmetic Act that would enhance the authorities and resources of the Food and Drug Administration.
In our opinion, any response to bioterrorist incidents that affect this country's food supply must include the coordinated efforts of state and local government officials, because it is these officials who serve as first responders in issues of food safety and security.
We view the current state of heightened alert in this country as an opportune time to transition to a concept of a nationally integrated food safety system. This is an idea that AFDO has promoted for many years, especially the last 5 years. Our activity resulted in the formation of the National Food Safety System (NFSS) project that involves USDA, CDC, EPA, state and local program officials, in addition to FDA. Among the projects developed to enhance the integrated concept of NFSS that are currently being piloted are the following:
* 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 aimed at assuring uniform methodologies for federal and state laboratories
* Directory of Laboratory Capabilities - a compilation to identify state and federal capabilities in event of 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 for 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
* Food Net - participation and sharing of foodborne illness information from state and local government
* Pulse Net - development and sharing of information related to DNA fingerprinting of pathogens associated with disease outbreaks to identify clusters of outbreaks
Clearly AFDO supports the goals of resource management at all levels of government to provide synergistic and effective response to all food safety emergencies, including bioterrorism. We strongly support the need to enhance FDA's authority, capacity and expertise and urge you to consider these NFSS efforts to integrate the food safety and security system as you propose current and future legislative actions enhancing FDA's activities. FDA and the states have a tradition of working very closely in public health issues. Any improvement toward integrating the states with their federal counter parts will literally add thousands of food safety "foot soldiers" to what is clearly a national effort.
Our specific comments to the proposed Bill provided to us during our meeting are as follows:
1. We strongly support bill provisions that would enhance FDA authorities in such areas as embargo and recalls. However, we do not believe the enhanced authorities should be limited to periods that have been declared a public health emergency by the Secretary of Health and Human Services. Embargo authority, in particular, is an exposure prevention measure that should be used proactively. Denying use of the authority until an emergency has been declared denotes that an incident resulting in harm may have already occurred that otherwise could have been prevented with an unencumbered embargo authority. AFDO would like to see this authority granted in a manner to be used proactively to prevent such an incident and not reactively. If there is a single large scale incident, with no prior emergency declaration by the Secretary, this authority would not be available to the FDA to prevent the tragedy even in light of circumstantial evidence suggesting a contamination was possible.
2. Debarment authority for food imports should be extended to circumstances where state food safety programs have established credible evidence that an importer has repeatedly or deliberately imported an adulterated or misbranded product.
3. Section 414; Maintenance; and Inspection of Records, is weakened considerably and made too subjective through the repeated use of the term, "reasonably". This is an important inspection authority and needs to be definitive.
4. In many instances, records are not required to be kept and provision for regulations will have to be developed to require retention of important records such as those which facilitate trace back.
5. Food safety inspection records (government and third party) should be required to be maintained and made available to the FDA for review.
6. The commissioning of agents should be expanded to include certified state officials. This would be an added mechanism for advancing the integrated concept of NFSS. Similarly, the state grants proposal is an excellent method for resource synergy in assuring equivalency and coordination needed to realize the full benefits of maximizing all available resources to handle food safety and security issues.
7. Finally we strongly support the additional appropriations for the FDA to better handle imports. As documented by GAO and through our experience at the state level with frequent findings of adulterated and misbranded imports in commerce, this is an area of federal responsibility that desperately needs additional resources, particularly in light of today's threats.
In addition to these remarks, we are mailing a copy of the Uniform State Food, Drug and Cosmetic Bill for your information, as requested. In the interim, I have attached a file that provides the embargo language in that bill. While states may be slightly different in their embargo authority language, 48 states (excluding SD and Utah) have embargo authority similar to this model.
We again thank you for the invitation to meet and look forward to further dialogue on this and other issues.
Sincerely,
R. Douglas Saunders, President
Steve Steinhoff, Past President
Joseph Corby, Director of Public Policy
Betsy Woodward, Advisor
