U.S. Food and Drug AdministrationPacific Region Retail Food SeminarSeptember 22 – 24, 2015Helena, Montana

Luis SolorzanoDirector, State Cooperatives Program

FDA, Pacific RegionSeptember 22, 2015

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Welcome• Good morning!Good morning!• Lets celebrate the good work we doLets celebrate the good work we do• Who is in the room? Who is in the room? • StatesStates• Local tribal governmentsLocal tribal governments• Federal regulatorsFederal regulators• AcademiaAcademia• IndustryIndustry

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FDA Re-Organization Update

• Program Alignment (PAG) will refocus the Program Alignment (PAG) will refocus the nature of the Regions within FDA’s Office of nature of the Regions within FDA’s Office of Regulatory Affairs. Regulatory Affairs.

• PAG will have no impact on your current PAG will have no impact on your current relationship and work with the FDA Retail relationship and work with the FDA Retail Food Specialists. It will remain the same, just Food Specialists. It will remain the same, just a different reporting structure. a different reporting structure.

• PAG will have no impact of the Regional PAG will have no impact of the Regional Seminar.Seminar.

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Current RFFD Dr. William B. Marin

• Former RFDD Mark Roh and his Deputy Judy Former RFDD Mark Roh and his Deputy Judy Strojny retired in the Spring of 2015Strojny retired in the Spring of 2015

• Currently Dr. William B. Martin is the Acting Currently Dr. William B. Martin is the Acting Regional Food and Drug Director for FDA’s Regional Food and Drug Director for FDA’s Pacific Region. Pacific Region.

• He is in full support of the Regions He is in full support of the Regions Cooperative ProgramsCooperative Programs

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

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ORA’s Approach to Increased Specialization

• ORA’s current district structure will remain the ORA’s current district structure will remain the same, but align to commodity areas with same, but align to commodity areas with operational management and staff specializing operational management and staff specializing in a program.in a program.

• The current Regional Food and Drug Director The current Regional Food and Drug Director positions will become Program Executives positions will become Program Executives responsible for each commodity area.responsible for each commodity area.

Specializing ORA’s Operational Staff

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Movement from our Movement from our geographically-based geographically-based management to a program-management to a program-based management.based management.

Investigators, compliance Investigators, compliance officers and operational officers and operational managers will specialize in a managers will specialize in a single program area. single program area. Cooperative Program Cooperative Program Specialists are currently Specialists are currently doing this and provided ORA doing this and provided ORA a model to specialize.a model to specialize.

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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.

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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.

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CFP 2016• Conference for Food Protection which will

be held in Boise, Idaho in April 2016.

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).

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MEHA!• Thank you to the Montana Environmental

Health Association and WAFDO for hosing the seminar this year

• Enjoy your Seminar and stay in Helena.

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