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FSMA Updates and resources

FSMA Updates and resources. CASA Yearly Educational Conference May 13, 2014. Since Niagara Falls…. http:// www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm Progress Report on Oct-Dec 13 accomplishments E subscriptions for updates Three proposed rules out

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FSMA Updates and resources

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  1. FSMA Updates and resources CASA Yearly Educational Conference May 13, 2014

  2. Since Niagara Falls… • http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm • Progress Report on Oct-Dec 13 accomplishments • E subscriptions for updates • Three proposed rules out • FDA used some new regulatory tools • CORE integral part of outbreak response

  3. FSMA Mandate Areas • International capacity building • Federal/State/Local integration • Inspection & Compliance • Imports • Preventative Controls • Produce Safety • Fees • Reports & Studies • Small business

  4. Specific Productions Since • http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm • April – F/R and two guidance docs on records (establishment, maintenance, availability) • March – progress report/statement on all proposed rules (produce and PC-H) • March – P/R PC-A comment period ended and not extended (10/13) • March – ANPRM on RFR information • Jan/Feb – P/R on sanitary transportation • 2nd 2013 – P/R’s for FSVP & 3rd Party

  5. Predictions and Guesses • PC-A leapfrogs Produce & PC-H • Summer 14 – F/R’s for Produce and PC-H; those two probably last • User Fees – still being reviewed • Second comment period??? • FSMA delays  DQSA • Funding • FSMA as a statute and its implementation

  6. Firm Registration • Inspection & Compliance mandate area • October – December each year • Grace periods granted early have expired! • Refinement/expansion of previous BT Act registration but doesn’t supersede • Some exemptions still may apply (“qualified firms”)

  7. Accomplishments • Administrative Detention – executed followed by destructions and recalls • Mandatory Recall – type of product steers governing regulations / oversight • Re-inspections fees – thusfar no challenge or stiff • DWPE of foreign firms refusing to permit inspection • Immense capacity building on several fronts, particularly domestically • Never better communication*

  8. Interesting / Novel • Recourse for employees fired for reporting violations – update for first year • Third party consultancy on preventative controls • Foreign Supplier Verification Program & accreditation • Social media comments & use

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