The Vermont Department of Health Laboratory (VDHL) is applying for funding to obtain ISO/IEC 17025:2005accreditation. Funding is being sought to expand the VDHL quality system management, informationmanagement and testing resource capabilities so as to advance the Vermont and National food safety systemsin protecting the food supply. The VDHL plans to work in collaboration with the VDH Food and LodgingProgram which has a contract with the U.S. Food and Drug Administration (FDA) and has been enrolled in theManufactured Food Regulatory Program Standards (MFRPS) since 2008. The VDHL will be the sole servicinglaboratory for Vermont's Manufactured Food Regulatory Program (MFRP). The VDHL has been a member ofthe Food Emergency Response Network (FERN) since 2005 and is the sole Vermont laboratory dedicated toresponding to public health foodborne emergencies. In order to comply with the MFRPS and to provide FDAwith data generated during response to foodborne outbreaks through eLEXNET, the VDHL must achieve andmaintain ISO/IEC 17025:2005 accreditation as mandated by the Food Safety Modernization Act signed intolaw on January 4, 2011.VDHL is requesting funding for 3.25 positions to address the need to obtain and maintain ISO/IEC 17025accreditation: a Quality Systems Specialist, a Food Microbiologist, a Laboratory Information Specialist and .25FTE Laboratory Technician II. The Quality Systems Specialist will train in ISO/IEC practices; will coordinatewith FDA, VDH MFRP and an accreditation body; will ensure that the VDHL quality system manual andnecessary documents to achieve accreditation are established and maintained; and will provide continuedguidance to staff. The Food Microbiologist will coordinate with the Quality Systems Specialist, FDA and VDHMFRP and will be responsible for updating and implementing procedures, validating assays, attendingtrainings, responding to findings from internal quality audits and testing food samples from the MFRP program,outbreaks or biothreat emergencies. The Laboratory Information Specialist will coordinate with FDA, VDHInformation Technology staff and the Quality Systems Specialist to implement a new Food Microbiologymodule in the VDHL Laboratory Information Management System (LIMS), assist with the implementation ofother food modules as needed and integrate each LIMS module with the automated data exchange reportingnetwork, eLEXNET. The .25 FTE Laboratory Technician will perform support duties such as sample andreagent preparation. VDHL is requesting additional equipment and supplies to improve the capacity andefficiency of the Food Microbiology laboratory with additional improvements to be made in other test areas(e.g. Chemistry) as expansion of the accreditation to other areas occurs.

Public Health Relevance

The FDA Food Safety Modernization Act (FSMA) contains many key reforms of US food safety laws but there are two primary mechanisms for ensuring the safety of the U.S. food supply that will be the focus of this project: shifting the focus from responding to contamination to preventing it and strengthening collaboration between federal and state agencies to achieve overall public health goals. This project addresses the critical need to enact these two mechanisms at the local level in order to protect the public health from unsafe food supplies. The establishment of standard guidelines through ISO/IEC 17025:2005 accreditation requirements and the implementation of the State Manufactured Food Regulatory Program Standards (MFRPS) is a way to meet FSMA's stated goals of developing and implementing a national agriculture and food defense strategy, establishing an integrated consortium of laboratory networks, and improving foodborne illness surveillance.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
1U18FD004458-01
Application #
8461393
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2012-09-01
Project End
2017-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
1
Fiscal Year
2012
Total Cost
Indirect Cost
Name
Vermont State Agency of Human Services
Department
Type
DUNS #
809376155
City
Williston
State
VT
Country
United States
Zip Code
05495