U.S . Food and Drug Administration Pacific Region Retail Food Seminar September 22 – 24, 2015

1. U.S. Food and Drug Administration Pacific Region Retail Food Seminar September 22 – 24, 2015 Helena, Montana Luis Solorzano Director, State Cooperatives Program FDA, Pacific Region September 22, 2015

2. Welcome • Good morning! • Lets celebrate the good work we do • Who is in the room? • States • Local tribal governments • Federal regulators • Academia • Industry

3. FDA Re-Organization Update • Program Alignment (PAG) will refocus the nature of the Regions within FDA’s Office of Regulatory Affairs. • PAG will have no impact on your current relationship and work with the FDA Retail Food Specialists. It will remain the same, just a different reporting structure. • PAG will have no impact of the Regional Seminar.

4. Current RFFD Dr. William B. Marin • Former RFDD Mark Roh and his Deputy Judy Strojny retired in the Spring of 2015 • Currently Dr. William B. Martin is the Acting Regional Food and Drug Director for FDA’s Pacific Region. • He is in full support of the Regions Cooperative Programs

5. About Program Alignment On September 6, 2013, former U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D. charged a group of senior leaders with identifying and developing plans to modify functions, processes and structures to meet greater agency demands by facilitating increased operational and program alignment.

6. ORA’s Approach to Increased Specialization • ORA’s current district structure will remain the same, but align to commodity areas with operational management and staff specializing in a program. • The current Regional Food and Drug Director positions will become Program Executives responsible for each commodity area.

7. Specializing ORA’s Operational Staff Movement from our geographically-based management to a program-based management. Investigators, compliance officers and operational managers will specialize in a single program area. Cooperative Program Specialists are currently doing this and provided ORA a model to specialize.

8. Risk Factor Study • Analysis and drafting report for the last study in restaurants still needs to be vetted through agency before its distributed • Coming year FY-2016 Risk Factor study will continue in another leg of a study that began in 1998. • Starting in October FDA Retail Food Specialists will collect data within Health Care (Hospitals and Long-Term Care Facilities); Schools (K-12); and Retail Food Store facilities.

9. Risk Factor Study • This data collection period is scheduled for 15 months and will continue through December 16. • In advance I would like to thank you all in advance for assisting the FDA specialists with verifying establishment lists and helping them gain access to the establishments through out 2016.

10. CFP 2016 • Conference for Food Protection which will be held in Boise, Idaho in April 2016.

11. Year 3 Funding of AFDO Administered Retail Program Standards Grant Program • http://afdo.org/retailstandards • This program will open on Tuesday, September 1, 2015 and applications will be accepted through Friday, October 9, 2015. • Funding will be available for the completion of projects and training to enhance conformance with the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards).

12. MEHA! • Thank you to the Montana Environmental Health Association and WAFDO for hosing the seminar this year • Enjoy your Seminar and stay in Helena.