Description
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) Office of Research Veterinary Laboratory Investigation and Response Network (Vet-LIRN) is announcing the availability of cooperative agreements for equipment, supplies, personnel, and training to Vet-LIRN laboratories in the United States. The cooperative agreements are to enable the analyses of animal diagnostic samples and animal food/drug products in the event that laboratory investigations or surge capacity are needed by Vet-LIRN and the FDA for analyses related to microbiological or chemical contamination, either through intentional or unintentional means. These cooperative agreements are also intended to expand participation in networks to enhance Federal, State, local, and tribal food safety and security efforts. The Vet-LIRN cooperative agreements are intended to fulfill requirements put forth in the Food Safety Modernization Act (FSMA) - Title 1 SEC. 110, SEC E, Building Domestic Capacity via development and enhancement of “surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks.”This program will increase capability for laboratory analysis as outlined in Title 1 SEC. 110, SEC E to build food defense capabilities by “identifying new and rapid analytical techniques” and “to provide for well-equipped and staffed laboratory facilities” and Title 1 SEC. 205. SEC D. to “Improve the effectiveness of Federal, State, and local partnerships to coordinate food safety and defense resources and reduce the incidence of foodborne illness.” The outcomes will result in increased Vet-LIRN laboratory capabilities and capacity to investigate potential animal foodborne illness outbreaks by fostering training, the use of new technologies, and improving the effectiveness of collaborative partnerships.CVM is the FDA Center that regulates animal food and animal drugs. During the 2007 pet food recall due to melamine adulteration of animal food ingredients the FDA realized the need to establish rapid communication with veterinary diagnostic laboratories and increase the government’s ability to examine samples from animals adversely affected by contaminated or adulterated products. While FDA’s Office of Regulatory Affairs (ORA) is the primary inspection and analysis component of FDA, the Vet-LIRN program adds an essential component that is outside of ORA's usual investigations and testing programs, the examination of veterinary diagnostic samples. Examination of such samples has greatly facilitated early detection of animal food/drug adulteration or contamination. These efforts can contribute to overall food safety as animal food events could signal potential issues in the human food system.Increasingly, FDA has been called upon to expand the testing programs addressing the threats to food safety and security through both naturally occurring pathogen outbreaks and intentional terrorism events. This mission has been expanded even more with the Food Safety Modernization Act (FSMA). Vet-LIRN’s investigations into reports of illness caused by animal food have led to recalls of contaminated products. Additional testing capabilities and matrix expansion to diagnostic samples have been used in such situations. Vet-LIRN laboratories provide an additional resource in the case of large-scale outbreak or threat incident, which could exceed the analytical sample capacity of FDA’s ORA laboratories. Vet-LIRN laboratories provide additional capabilities and capacity to FDA’s response to animal food/drug related contamination. This system of university, state, and federal veterinary diagnostic laboratories leverages their expertise and integrates resources to obtain needed veterinary diagnostic information. This cooperative agreement will facilitate methods standardization, training and proficiency testing of the partner laboratories. Such activities strengthen the overall food safety system by developing increased capacity and capabilities to detect adulteration which could affect animals raised for human consumption or companion animals consuming ingredients used in both animal and human food products. Veterinary diagnostic laboratories have limited redundancy, both in terms of analytical capabilities and analytical sample capacity. Some veterinary diagnostic laboratories lack the specialized equipment to perform the analyses and/or the specific methodological expertise in the types of analyses performed for rapid screening of samples from animals which have been sickened by foods and food products involving microbiological terrorism events or natural pathogenic organism contamination. Even fewer laboratories have sophisticated chemical contamination analytic capabilities. Funding offered by this program can provide laboratories with the infrastructure to enhance their testing capabilities for both microbiological and chemical methodologies.The pet food recall of 2007 was followed by the melamine infant formula event in 2008, demonstrating the close ties that animal food ingredients can have with human food. These events also serve to highlight the need for rapid communication, coordination and testing by veterinary diagnostic laboratories and FDA laboratories during contamination events and make readily apparent the need for surge capabilities by Vet-LIRN in the event of a large scale outbreak or adulteration incident.The goal of CVM's cooperative agreement program is to complement, develop, improve and use university, state, and federal veterinary diagnostic laboratories testing programs. It is anticipated that the program's funding will accomplish these goals through the provision of equipment, supplies, and personnel; training in standardized testing methodologies; participation in proficiency testing in those methodologies; participation in method enhancement activities to extend analysis capability; and analysis of surveillance and emergency outbreak samples. In the event of large-scale microbiological or chemical contamination events affecting animal food/drug products, the Vet-LIRN laboratory may be asked to perform selected analyses of diagnostic samples collected and supplied to the laboratory by FDA or other government agencies through FDA, or from other Vet-LIRN laboratories. Some clinical samples may be directly sent to the laboratory, via Vet-LIRN Program Office (VPO) coordination, from a veterinarian working with the VPO on a case investigation. These samples may consist of, but are not limited to, the following: diagnostic animal clinical or post mortem samples from sickened animals, environmental samples from food or drug production facilities, vermin sampled from food production facilities or suppliers and food ingredients including grains, meats, fish products, dairy products and water. Surveillance samples obtained by FDA or collaborating diagnostic laboratories will also be tested. Numbers of samples and scheduling will be determined by the VPO) in coordination with the grantees. FDA estimates that the analysis of up to 300 samples may be needed. In addition, bacterial isolates from test samples may be submitted to other Vet-LIRN laboratories for further characterization.Grantees will conduct testing to investigate animal food or drug related illnesses or other large-scale animal food/feed emergency events requiring surge capacity testing of implicated diagnostic or animal food samples. Grantees may also be involved with small scale, short-term projects as directed by the Vet-LIRN Program Office (VPO).There are three key project areas that will need to be addressed if a cooperative agreement award is to be made:(1) Participation in FDA/Vet-LIRN sample analysis. Samples could be collected by Federal, State, or local entities. Sample sources include:a. Surveillance assignments as designated by the VPO.b. Animal food/drug emergency outbreak testing (in coordination with Federal and State analytical requirements).c. Large-scale animal food/drug emergency event surge capacity (in coordination with Federal and State analytical requirements).(2) Providing analytical data to support potential regulatory use through:a. Use of standardized methods, equipment platforms, and reporting methods (standardized analytical worksheets and electronic results reporting).b. Participation in proficiency testing and method training provided by the VPO.c. Investigating consumer report cases requested by VPOd. Implementation of standardized quality management systems for laboratories as determined by the VPO(3) Participation in additional projects such as small-scale method development and/or method validation and matrix extension work as determined by the VPO. Post Award Supplemental Project funding may be available for projects. These projects are designed to address new developments in emerging regulatory science as well as urgent, novel or unmet needs. FDA anticipates additional projects to be conducted in collaboration with other Vet-LIRN laboratories or Federal Networks in response to public health needs that may not yet be known or identified at the time of the original Vet-LIRN award. In some cases these projects may be conducted by Vet-LIRN laboratories in collaboration with investigators from the Agency. In this case, internal support for the FDA portion will be provided separately from the external support.