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FDA- Laboratory Flexible Funding Model (MICROBIOLOGY)

Objective

Project summary/Abstract
The Michigan Department of Health and Human Services, Bureau of Laboratories (MDHHS-BOL) Infectious
Disease Division, Microbiology Section has built a strong working relationship with USDA FERN for more than
15 years. The MDHHS Microbiology section is the Midwest regional laboratory for the CDC PulseNet program
with enhanced capacity and capabilities for Whole Genome sequencing (WGS). BOL is accredited to ISO 17025
standard by the American Industrial Hygiene Association Laboratory Accreditation Program (AIHA-LAP, LLC)
in their Food Laboratory Accreditation Program (Food LAP); has a Certificate of Registration with the CDC
Federal Select Agent Program (FSAP) and a USDA APHIS permit; has been designated as an Tier-1 Biological
lab within the Laboratory Response Network (LRN) performing testing associated with foodborne outbreak
investigations; and has experience with and facilities for the agents of bioterrorism. The objectives proposed here
are intended to enhance the capacity and capabilities in the detection of bacterial pathogens in food products,
thereby, supporting and improving the laboratory capacities for food defense assignments and outbreak response
in State of Michigan.
Objective 1: The primary goal is to provide surge capacity testing for the analysis of food products for BSL3
bacterial select agents and participate in FDA surveillance and special event activities.
Objective 2: To study the genomic diversity of enteric pathogens associated with food borne illness collected
from human food by WGS as a member of the GenomeTrakr network. This increased capability will allow
MDHHS access to improved comparison and analysis of sequencing, which in turn, will improve outbreak
investigations and food safety.
Objective 3: To develop the capacity and capability for detecting Cyclospora in human food products. Following
training and competency this would increase the lab’s ability to detect Cyclospora in the event of an outbreak.
MDHHS would also be able to assist FDA in special events in testing for Cyclospora.

Investigators
Soehnlen, Marty
Institution
Michigan State Department of Health and Human Services
Start date
2020
End date
2025
Project number
5U19FD007116-02