The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR), is announcing the availability of cooperative agreements for equipment, supplies, personnel, training, and facility upgrades to Food Emergency Response Laboratory Network (FERN) radiological
laboratories of State, local, and tribal governments.
The cooperative agreements are to enable the analyses of foods and food products in the event that redundancy and/or additional laboratory surge capacity is needed by FERN for analyses related to radiological terrorism or other emergency situations.
These cooperative agreements are also intended to expand participation in networks to enhance Federal, State, local, and tribal governmental food safety and security efforts.
The goal of ORA's cooperative agreement program is to complement, develop, and improve State, local, and Indian tribal food safety and security testing programs.
This will be accomplished through the provision of equipment, supplies, personnel, facility upgrades, training in current food testing methodologies, participation in proficiency testing to establish additional reliable laboratory sample analysis capacity, analysis of surveillance samples, and, in cooperation with FDA, participation in method enhancement activities designed to extend analytical capabilities.
In the event of a large-scale radiological terrorism event affecting foods or food products, the recipient may be required to perform selected radiological analyses of domestic and imported food samples collected and supplied to the laboratory by FDA or other Federal agencies through FDA.
These samples may consist of, but are not limited to, the following:
Vegetables and fruits (fresh and packaged), juices (concentrate and diluted), grains and grain products, seafood and other fish products, milk and other dairy products, infant formula, baby foods, bottled water, condiments, and alcoholic products (beer, wine, scotch).All grant application projects that are developed at State, local, and tribal levels must have national implications or application that can enhance Federal food safety and security programs.
There are two key project areas identified for this effort:
1. The use of gamma spectrometry analysis for the screening and identification of gamma-emitting radionuclides in foods, and 2. The use of beta spectrometry analysis for the screening and identification of beta-emitting radionuclides in foods.It should be emphasized that in all of the projects, there is a particular desire to promote a continuing, reliable capability and capacity for laboratory sample analyses of foods and food products for the rapid detection and identification of radionuclides.
With this in mind, it is desirable that sample analyses will be completed within 2 weeks of receipt, and the results will be reported to FERN.
The format and reporting media will be established by FERN.
Shorter timeframes may be sought for special testing such as proficiency tests or special assignments.FDA will support the projects covered by this notice under the authority of section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188).
This program is described in the Catalog of Federal Domestic Assistance under number 9 3. 44 8. ORA is the primary inspection and analysis component of FDA and has approximately 1,600 investigators, inspectors, and analysts who cover the country's approximately 95,000 FDA-regulated businesses.
These investigators inspect more than 15,000 facilities per year and ORA laboratories analyze several thousand samples per year.
ORA conducts special investigations, conducts food inspection recall audits, performs consumer complaint inspections, and collects samples of regulated products.
Increasingly, ORA has been called upon to expand the testing program that addresses the increasing threat to food safety and security through intentional radiological terrorism events.
Toward this end, ORA has developed radiological screening and analysis methodologies that are used to evaluate foods and food products in such situations.
However, in the event of a large-scale emergent incident, analytical sample capacity in ORA field laboratories has a finite limit.
Information from ongoing relationships with State partners indicates limited redundancy in State food testing laboratories; both in terms of analytical capabilities and analytical sample capacity.
Several State food testing laboratories lack the specialized equipment and/or the specific methodological expertise required to perform analyses for screening foods and food products involving radiological terrorism events.The events of September 11, 2001, reinforced the need to enhance the security of the U. S. food supply.
Congress responded by passing the Bioterrorism Act, which President George W.
Bush signed into law on June 12, 200 2. The Bioterrorism Act is divided into the following five titles:Title I-National Preparedness for Bioterrorism and Other Public Health Emergencies, Title II -Enhancing Controls on Dangerous Biological Agents and Toxins, Title III -Protecting Safety and Security of Food and Drug Supply, Title IV-Drinking Water Security and Safety, and Title V-Additional Provisions.
Subtitle A of the Bioterrorism Act, "Protection of Food Supply," section 312, "Surveillance and Information Grants and Authorities," amends part B of Title 111 of the Public Health Service Act to authorize the Secretary of Health and Human Services to award grants to States and Indian tribes to expand participation in networks to enhance Federal, State, and local food safety efforts.
This may include meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation.See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.