The FDA Food Safety Modernization Act (FSMA) outlines a new approach to animal food safety that is risk-informed and preventive in focus. Recognizing that sample testing can play a greater role in helping the Agency and their regulatory partners prevent contaminated product from reaching consumers, understand risks, and assess the value of strategies to control those risks, the Food and Drug Administration has implemented processes to deploy its resources using risk-based decision making that is founded in science and available data.
Donor Name: Food and Drug Administration (FDA)
State: All States
County: All Counties
Type of Grant: Grant
Deadline (mm/dd/yyyy): 04/04/2022
Grant Size: $100,000
Grant Duration: 1 year
Details:
The objectives of this cooperative agreement are to assist state animal food regulatory programs to enhance regulatory and compliance response when a potential violative sample is identified by labs participating in the LFFM. This objective is classified into several broad activities to enhance and support analogous cooperative agreements and other human and animal food related laboratory and response activities:
- Training
- Program Improvement and Infrastructure Development
- Compliance Implementation Strategies
The goals of this funding opportunity are as follows:
- Awardees will apply their Animal Food Regulatory Program Standards (AFRPS) inspection, sampling, and regulatory framework to collect samples needed to support the LFFM cooperative agreement. Awardees will collect samples at the manufacturer, and other locations, in accordance with the collection instructions for each hazard-commodity pair on the approved LFFM sample plan, as needed. LFFM laboratories and state regulatory programs must develop workplans together to ensure that the LFFM hazard/commodity pairs can be collected from the state’s available inventory, samples are collected in an appropriate manner to maintain sample integrity, and chain of custody can be documented.
- Awardees will apply their AFRPS response, enforcement and regulatory framework to conduct follow-up inspections, investigations (including traceback/forward), and enforcement actions (such as embargos, recalls, warning letters, and closures) to positive and violative samples identified as part of the LFFM cooperative agreement. Coordination with the RRT and activation, if applicable, is required for grantees also awarded the RRT track.
- Awardees will commit to coordinating response and compliance follow-up on LFFM samples with the FDA in a timely manner, to include sharing findings and compliance actions or other follow-up activities, and discussing regulatory and compliance strategy with the FDA.
- If a potentially violative LFFM sample comes to an AFRPS program but is outside of the program’s regulatory authority/jurisdiction, the applicant AFRPS program will identify and notify the appropriate state and federal agencies with jurisdiction, and to notify the FDA.
- Potentially violative LFFM samples may be referred to the AFRPS program from any laboratory participating in the LFFM Animal Food Product Testing track for microbiology or chemistry. This includes samples collected by LFFM laboratories outside of the grantee’s state and which may not be the primary servicing laboratory designated for the applicant. Additionally, it may include samples collected by other states where the source of the violation or the responsible party is traced back to the applicant program’s state.
- Animal food regulatory agencies will have training and auditing programs necessary to ensure a sufficient number of staff are qualified to conduct regulatory and compliance activities in response to violative laboratory samples.
- Awardees will expand upon the LFFM goals to participate in IT-data exchange development and implementation with the FDA to enable necessary information exchange between the FDA and state. This includes collaborating with LFFM laboratories to ensure all sample collection information is complete and meets ORA DX requirements, for LFFM samples to be submitted via ORA DX. This will set best practices for enhanced coordination between the FDA and state for information sharing coordination and leveraging of resources for regulatory work.
- To increase the use of best practices for enhanced coordination between the FDA and state for information sharing, coordination, and leveraging of resources for regulatory work, awardees will participate in IT-data exchange development and implementation with the FDA to enable information exchange between FDA and state.
Funding Information
- The FDA/ORA intends to commit up to $1,500,000 in FY 2022 to fund 15 awards.
- Applicants may request support for 1 year, not to exceed the remaining number of years on the parent grant.
Eligibility Criteria
- State governments
- Native American tribal governments (Federally recognized)
- State Governments – Indian/Native American Tribal Governments (Federally Recognized) – U.S. Territory or Possession – Currently holds an award under PAR-20-132 “Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18)” and is satisfactorily meeting the conditions of the award; and-Currently is conducting animal food inspections under contract with the FDA and maintains an animal food compliance inspection contract in good standing for the duration of the award project period; and-Collaborates with one or more human food testing laboratories currently holding an award under PAR-20-105 “Laboratory Flexible Funding Model (LFFM) and participating in the Feed/Animal Food Product Testing Track(s) – Micro or Chem” with the LFFM lab in the same state as the FFM CAP program.
For more information, visit Grants.gov.
