Description
1. Research Objectives The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) in coordination with the Center for Veterinary Medicine (CVM), is announcing the availability of cooperative agreements to further enhance the infrastructure of State, territorial, and tribal animal feed safety and bovine spongiform encephalopathy (BSE) prevention programs. These cooperative agreements are intended to fund additional personnel, equipment, supplies, and training to support activities related to the FDA ruminant feed ban (21 CFR parts 589.2000 - 2001, referred to as the BSE/ruminant feed ban) as well as other activities related to feed safety, in State, territory, and tribal governments. The goal of FDAs ORA Cooperative Agreement Program is to enhance, complement, develop and improve State/territory/tribal animal feed safety and surveillance programs. This will be accomplished through the provision of funding for additional equipment, supplies, funding for personnel, training in current feed testing methodologies recognized by FDA, participation in proficiency testing to establish additional reliable laboratory sample analysis capacity, and analysis of surveillance samples as well as State/territorial/tribal government compliance inspections. This will also require extensive cooperation and coordination with FDA District Offices to minimize duplication of inspections. Under these cooperative agreements, the State, territory, and tribal governments would enhance their feed safety and/or BSE/ruminant feed ban programs to increase the ability to locate and visit firms involved in the manufacture, distribution, and transportation of animal feed and operations feeding livestock in their jurisdiction. Verification of compliance with the BSE/ruminant feed ban as well as other regulations related to feed safety will be conducted. In addition, funds could be used to increase State, territory, and tribal personnel dedicated to conducting these inspections. Funds could be used for supplies, training, and laboratory equipment for feed sample testing using analytical methods recognized by FDA. Funds could also be used to conduct educational outreach activities and to develop materials needed to further and enhance the industries' knowledge of and compliance with feed safety regulations and the BSE/ruminant feed ban. As a result of enhancing their feed safety and/or BSE/ruminant feed ban programs, an increase in State, territory, and tribal inspections under section 702 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 372) of renderers, protein blenders, feed mills that manufacture animal feeds, feed ingredient manufacturers, feed distributors an d transporters, salvagers of food and feed, and livestock feeders is expected. Animal feed and feed ingredients utilizing materials prohibited under the BSE/ruminant feed ban are of significant interest, although other work related to feed safety may also be conducted. Finally, the Feed Safety and BSE/Ruminant Feed Ban Support Project funds are intended to supplement, not replace, State funding for program improvement. All cooperative agreement projects that are developed at State, territorial, and tribal levels must have existing feed inspection and surveillance programs or propose in detail the development of a State/territory/tribal feed regulatory program. There are eight key project areas identified for this effort that must be addressed: (1) Hire and/or train State/territory/tribal personnel to conduct inspections. Training of State/territory/tribal personnel may be accomplished through the ORA University, training sponsored by the Association of American Feed Control Officials, or other training that meets State/territory/tribal and FDA requirements. New hires for this program must meet the State/territory/tribal agencys qualifications for feed inspections and sampling techniques. (2) Hire and/or train laboratory personnel to conduct laboratory analyses of feed samples. Laboratory analyses of samples collected under this program must utilize methodologies recognized by the FDA, or other professional groups, such as the Association of Official Analytical Chemists International (AOACI). (3) Identify animal feed and feed ingredient manufacturers, including renderers, protein blenders, feed mills, ingredient manufacturers, feed salvagers, distributors (including retailers), transporters of animal feed and feed ingredients, and on-farm animal feed mixers, as well as ruminant feeders within the State/territory/tribal jurisdiction where such firms have not already been identified and/or inspected for compliance with feed safety requirements, such as the BSE/ruminant feed ban. (4) Inspect animal feed and feed ingredient manufacturers, including renderers, protein blenders, feed mills, ingredient manufacturers, feed salvagers, distributors (including retailers), transporters of animal feed and feed ingredients, and on-farm animal feed mixers, as well as ruminant feeders within the State/territory/tribal jurisdiction where such firms have not already been identified and/or inspected for compliance with feed safety requirements, such as the BSE/ruminant feed ban. These inspections would be conducted under section 702 of the FD&C Act, using and completing the appropriate inspection forms and following the appropriate guidance to verify compliance. For example, the FDA Ruminant Feed Ban Inspection Checklist and Ruminant Feed Ban Compliance Program would be used to verify compliance with the BSE/ruminant feed ban. These inspections would be conducted by officers and employees duly commissioned by FDA in accordance with section 702 of the FD&C Act. (5) Conduct surveillance sampling at establishments supplying ingredients or finished feed into the feed supply, including manufacturers, distributors, and livestock feeders. Samples should be tested for the presence of materials prohibited under the BSE/ruminant feed ban or other contaminants, such as drug and pesticide residues, mycotoxins, heavy metals or the presence of pathogenic microorganisms. This surveillance sampling would be conducted under section 702 of the FD&C Act and would be conducted by officers and employees duly commissioned by FDA in accor dance with section 702 of the FD&C Act. (6) Provide copies of all completed inspection reports, including any FDA Ruminant Feed Ban Inspection Checklists, analytical results for surveillance sampling, and reports of any other inspection work as a part of the mid-year program progress report to the FDA Project officer or designated office, as well as provide completed checklists and sample results in accordance with section 702 of the FD&C Act. (7) Be able to identify and quantify improvements to the existing State/territory/tribal feed safety and/or BSE/ruminant feed ban program or developing new programs (i.e., personnel hiring, personnel training, equipment upgrades, increase in inspections conducted) in the mi d-year report as a result of the cooperative agreement. (8) Conduct educational outreach activities and develop materials needed to further and enhance the industries' knowledge of and compliance with feed safety requirements, such as but not limited to the BSE/ruminant feed ban and medicated feed good manufacturing practice regulations, for example. FDA will support the projects covered by this notice under the authority of section 311 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188), which amends the FD&C Act by adding section 909 (21 U.S.C. 399). This program is described in the Catalog of Federal Domestic Assistance under number 93.449.