Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed

NIH RePORTER · FDA · U19 · $845,000 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY (OVERALL): The Michigan Department of Agriculture and Rural Development (MDARD) intends use this opportunity to support activities to meet regulatory requirements, and improve its efficacy, accuracy, and defensibility on a continuous basis and to maintain and enhance our current level of services with our federal, state, and local partners. This funding opportunity also allows for the risk-based development of metrics to base objectives upon, allowing MDARD to better forecast emerging issues and hazard. This funding will allow MDARD to work with our regulatory partners to develop plans and processes to facilitate the increase sample volumes across our human and animal food microbiology and chemistry sections to work with our regulatory partners in the process of increasing the types of analysis across the two section by allowing for new advanced technologies and methodologies to be explored such as Whole Genome Sequencing, allergens, food adulteration, toxic elements, and economic fraud. The lab will maintain its ISO 17025 accreditation providing confidence and defensibility in the labs results. MDARD will continue to work with the Emergency Rapids Response Team and the MDARD Food and Dairy Division and FDA to build a more robust and effective food defense program. The Michigan Department of Agriculture and Rural Development (MDARD) Chemistry Laboratory intends to continue its basic scope which of testing for human and animal food; mycotoxins, veterinary drugs, nutrient and heavy metals, crude fat content, crude fiber content, and protein (Nitrogen) content, acid detergent fiber, neutral detergent fiber, filth, fish speciation, histamine, cannabidiol potency in food products and foreign materials in feed products whilst increasing sample volumes and participating in any food defense outbreaks, investigations, exercises, and trainings, Chemistry will participate in Track 4 building the section's allergen testing program. The Michigan Department of Agriculture and Rural Development (MDARD) Microbiology Laboratory emphasizes food safety for human food through surveillance testing for foodborne pathogens. Testing is performed using validated and verified test methods. The lab routinely tests samples for Salmonella, Listeria monocytogenes and pathogenic E. coli (Shiga-toxin producing E. coli, or STEC) Surveillance manufactured food samples and fresh produce samples are tested for the presence of the foodborne pathogens. Samples found to be contaminated with foodborne pathogens will be reported to the Regulatory Division and FDA for possible regulatory action. The Microbiology Laboratory has recently committed to a multi-lab validation (MLV) through test tattoo ink for Mycobacterium spp.

Key facts

NIH application ID
10877702
Project number
5U19FD007092-05
Recipient
MICHIGAN STATE DEPT OF AGRICULTURE
Principal Investigator
Jordan Polaskey
Activity code
U19
Funding institute
FDA
Fiscal year
2024
Award amount
$845,000
Award type
5
Project period
2020-09-01 → 2025-09-30