International Standards Organization (ISO)/International Electrotechnical Commission (IEC) 17025:2005 Accreditation for State Food Testing Laboratories Nebraska Department of Agriculture (NDA) Application for Funding Opportunity Announcement (FOA) Number- RFA-FD-12-008 Project Summary NDA would like to apply for FOA Number RFA-FD-12-008 to achieve ISO 17025:2005 Lab Accreditation for the Dairy and Food Laboratory. The long-term objectives of this Project are to achieve ISO Laboratory Accreditation within the five years defined by the funding announcement, and maintain it beyond the five-year scope of the grant agreement. The NDA Laboratory proposes to hire a Quality Assurance (QA) Manager, Chemist III, and a Chemist II in year one of the grant and begin to implement the ISO 17025:205 Lab Accreditation process over the five-year timeframe specified in the funding opportunity announcement. With support from the Food and Drug Administration (FDA), NDA would host an ISO 17025 workshop on-site at the NDA Laboratory in 2012-2013. We would also obtain a cost estimate in the first year for future expansion of our BSL II facilities that would be used to enforce FDA/Manufactured Foods Regulatory Program Standards. S: BAF_WP Rich RFA-FD-12-008 ISO_Accreditation_ProjSum- 042012.doc

Public Health Relevance

FOA Number- RFA-FD-12-008 The Nebraska Department of Agriculture (NDA), Food Laboratory qualifies for the FOA by meeting the requirement of being the only state laboratory in Nebraska with the capabilities to analyze regulatory food samples on behalf of the Nebraska MFRPS program. The NDA Food Laboratory is also a member of the FERN network and is prepared to begin the ISO 17025:2005 Laboratory Accreditation program. The Food Laboratory is currently participating in Food and Drug Administration (FDA) Food Contract # HHSF223200940012C. As a result of participation in this contract, we have, with FDA's assistance, identified gaps and deficiencies to ISO 17025 Laboratory Accreditation that need to be addressed through defined changes. The chief change needed to begin the process of ISO Lab Accreditation is to hire additional personnel with FDA's assistance to achieve these objectives. We also intend to purchase the USALIMS software that integrates with the USAFoodSafety software that will be purchased through the Conformance with the recent Manufacturer Food Regulatory Program Standards (RFA-FD-12-007) FOA submission. The impact on public health in terms of food safety, will be positive for citizens of Nebraska and the nation as a whole, as NDA becomes integrated into the national food-safety system. The President's Food Safety Working Group (FSWG), National Integrated Food System, and particularly the Food Safety Modernization Act (FSMA) highlight the need for the State of Nebraska to be a part of this widespread effort. These initiatives and the FSMA law indicate the need for a state-federal cooperative and fully-integrated effort. The NDA Food Laboratory has been a Food Emergency Response Network (FERN) laboratory since the inception of FERN in 2005, with the goal to create a network of laboratories to respond to a bioterror event. Up to this point, the Food Laboratory has been funded by grants from the USDA for FERN participation. During this time period, the Food Laboratory has been fully compliant and has participated in numerous multi-laboratory validation studies, proficiency tests, FERN-sponsored training classes, and a Southwest Region Table-Top Exercise simulating a multi-state foodborne illness event. Due to a reduction in USDA funding, the Food Laboratory is currently staffed with a Chemist III and a Chemist II. One year ago, there was an additional Chemist III working in the Food Laboratory. NDA would like to staff an independent Quality Assurance (QA) Manager to achieve ISO lab accreditation, as well as another Chemist to provide analytical instrument expertise in addition to being capable of analyzing microbiological pathogens. Both new FDA-funded hires would be capable of performing microbiological and chemical analysis. FERN-sponsored activities and equipment upgrades have allowed the NDA Food Laboratory to make significant gains in pathogen detection capability and have also added additional analytical capacity to the FERN network. In this FOA, NDA also asks for additional equipment upgrades, Data Center support, and travel to implement the project. In addition, March 2012 marks the beginning of the same ISO 17025 Lab Accreditation process for the NDA's Residue Laboratory under FDA/FERN Chemical Laboratory grant (2U18FD003652-03). This timely occurrence will allow staff and management mentoring and familiarity as we move forward in the process. L: ADM For Dirk ISO_Accreditation_ProjNarr_042012.doc

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Research Demonstration--Cooperative Agreements (U18)
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Nebraska St Department of Agriculture
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