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Published byValentine Kelley Modified over 8 years ago
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CASA Yearly Educational Conference May 13, 2014
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http://www.fda.gov/Food/GuidanceRegulati on/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
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International capacity building Federal/State/Local integration Inspection & Compliance Imports Preventative Controls Produce Safety Fees Reports & Studies Small business
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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 2 nd 2013 – P/R’s for FSVP & 3 rd Party
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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
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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”)
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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*
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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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