APHL Update – FDA Cooperative agreement

1. APHL Update – FDA Cooperative agreement

2. The Association of Public Health Laboratories (APHL) has been actively working towards meeting the deliverables of the $1.5 Million/year 5‐year cooperative agreement from the FDA to support food and feed programs in regulatory agencies. • This cooperative agreement is a collaboration with AFDO and AAFCO and is strengthening the food and feed testing regulatory communities.

3. The APHL created a Food and Feed Testing Subcommittee housed within the Food Safety Committee. Dan Rice and Yvonne Salfinger co‐Chair this Subcommittee. The Subcommittee is charged with strengthening and building the food and feed laboratory community and assisting with meeting the deliverables of the recently awarded FDA cooperative agreement.

4. Additional efforts include: • developing informatics tools and resources • gathering information on accreditation related training and identifying training gaps • gathering mentoring best practices from laboratories that are accredited to the ISO 17025 standard.

5. Specific Aim 1: • Design, develop, document, deliver, manage, and implement support programs for ISO/IEC 17025:2005 accreditation of food and animal feed regulatory laboratories.

6. Activities: • A Food/Feed Safety Sub-committee has been convened and is comprised of representatives from APHL, AAFCO and AFDO. Monthly conference calls and one in-person meeting have been held. Charges and Action Items have been developed.

7. Activities: • In the process of identifying the best platform for sharing documents and other information relevant to accreditation of food and feed laboratories to the ISO/IEC 17025:2005 standard.

8. Specific Aim 2: • Identify, pilot test, and implement nationally the policies and procedures necessary to establish equivalency between federal, state, and local food and feed testing laboratories.

9. Activities: • Sampling and sample handling working group has been convened and is comprised of representatives from AAFCO, AFDO, APHL and FDA. • Established as a FoodShield workgroup “FDA CoAg Sampling and Sample Handling Workgroup”

10. Specific Aim 3: • Establish nationally accepted models for the rapid sharing and acceptance of laboratory data by FDA (and partnering regulatory agencies) in order that those agencies may pursue regulatory action and advance public and animal health.

11. Activities: • In the “Discovery” phase. • Two exceptional consultants with J. Michael Consulting brought on board. Melanie Kourbage - research specialist, will focus efforts on collating information necessary for the discovery document and creating the document outline. Jeff Sellers – informatician, responsible for conducting detailed interviews with lab personnel, technical staff, and identified FDA points of contact. • APHL has begun gathering data from the PFP IT Work Group to integrate into our report and research.

12. Specific Aim 4: • Facilitate the implementation of a national framework for a unified laboratory response to emerging food or animal feed safety emergencies or other issues of public health significance based on the Manufactured Food Regulatory Program Standards (MFRPS), the guidelines published by the Council to Improve Foodborne Outbreak Response and other standards recognized by the Secretary.

13. Activities: • Primarily AFDO led initiatives at this point.

14. Specific Aim 5: • Provide forums, including national and international meetings, to improve communication and collaboration between federal, state, and local food and animal feed testing laboratories and their associated regulatory and public health programs.

15. Activities: • Several sessions at last week’s APHL meeting on accreditation and food safety • APHL has convened an Associations CoAg Steering Committee • Several AFDO and AAFCO led initiatives

16. Specific Aim 6: • Provide educational opportunities, resources, tools, and mentoring for laboratories seeking to achieve, maintain, and enhancing the scope of their ISO/IEC 17025:2005 accreditation. Working in concert with the International Food Protection Training Institute (IFPTI), expertise will be applied to assess laboratory needs, develop course content, and conduct laboratory training using a multitude of in-person and distance learning.

17. Activities: • Offered free access to A2LA webinar series on ISO 17025 management requirements • Accreditation Training Steering Committee formed • Available Accreditation Training Subcommittee • Training Needs Subcommittee • Evaluation and determination of needs of laboratories providing mentoring (accredited lab)/being mentored (lab seeking accreditation).

18. Specific Aim 7: • Form national consensus with Federal and State regulatory officials on the acceptance of laboratory data and for the coordination of laboratory resources in response to emerging food and animal feed issues of public and animal health significance.

19. Activities: • No APHL activity to report

20. Specific Aim 8: • Use association infrastructure to develop an integrated approach to assist food and animal testing laboratories to achieve, maintain, and enhance the scope of laboratory accreditation and achieve conformance with applicable program standards as established by the Secretary.

21. Activities: • No APHL activity to report

22. Specific Aim 9: • Advance the efforts of FDA to achieve specific goals of FSMA related to laboratory analysis, including the rapid shipment of clinical isolates related to foodborne illnesses to public health laboratories for submission to PulseNet.

23. Activities: • Convened a Clinical Isolates workgroup toidentify and resolve challenges to shipment of clinical specimens or isolates to public health laboratories and submission to PulseNet.