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

> **NIH FDA U19** · MICHIGAN STATE DEPT OF AGRICULTURE · 2024 · $845,000

## 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 organization:** MICHIGAN STATE DEPT OF AGRICULTURE
- **Principal Investigator:** Jordan Polaskey
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $845,000
- **Award type:** 5
- **Project period:** 2020-09-01 → 2025-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10877702

## Citation

> US National Institutes of Health, RePORTER application 10877702, Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed (5U19FD007092-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10877702. Licensed CC0.

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