The Vermont Department of Health Laboratory (VDHL) is applying for funding to obtain ISO/IEC 17025:2005 accreditation. Funding is being sought to expand the VDHL quality system management, information management and testing resource capabilities so as to advance the Vermont and National food safety systems in protecting the food supply. The VDHL plans to work in collaboration with the VDH Food and Lodging Program which has a contract with the U.S. Food and Drug Administration (FDA) and has been enrolled in the Manufactured Food Regulatory Program Standards (MFRPS) since 2008. The VDHL will be the sole servicing laboratory for Vermont's Manufactured Food Regulatory Program (MFRP). The VDHL has been a member of the Food Emergency Response Network (FERN) since 2005 and is the sole Vermont laboratory dedicated to responding to public health foodborne emergencies. In order to comply with the MFRPS and to provide FDA with data generated during response to foodborne outbreaks through eLEXNET, the VDHL must achieve and maintain ISO/IEC 17025:2005 accreditation as mandated by the Food Safety Modernization Act signed into law on January 4, 2011. VDHL is requesting funding for 3.25 positions to address the need to obtain and maintain ISO/IEC 17025 accreditation: a Quality Systems Specialist, a Food Microbiologist, a Laboratory Information Specialist and .25 FTE Laboratory Technician II. The Quality Systems Specialist will train in ISO/IEC practices;will coordinate with FDA, VDH MFRP and an accreditation body;will ensure that the VDHL quality system manual and necessary documents to achieve accreditation are established and maintained;and will provide continued guidance to staff. The Food Microbiologist will coordinate with the Quality Systems Specialist, FDA and VDH MFRP and will be responsible for updating and implementing procedures, validating assays, attending trainings, 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, VDH Information Technology staff and the Quality Systems Specialist to implement a new Food Microbiology module in the VDHL Laboratory Information Management System (LIMS), assist with the implementation of other food modules as needed and integrate each LIMS module with the automated data exchange reporting network, eLEXNET. The .25 FTE Laboratory Technician will perform support duties such as sample and reagent preparation. VDHL is requesting additional equipment and supplies to improve the capacity and efficiency 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)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
5U18FD004458-03
Application #
8798446
Study Section
Special Emphasis Panel (ZFD1)
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Vermont State Agency of Human Services
Department
Type
DUNS #
City
Williston
State
VT
Country
United States
Zip Code
05495