FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed)

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1 Project Summary/Abstract: 2 The New York State Department of Agriculture and Markets (NYSAGM) has an expansive food 3 safety inspection and regulatory laboratory testing program. NYSAGM’s Division of Food Safety 4 and Inspection (FSI) primary mission is to ensure New York’s food supply is safe and properly 5 labeled. 6 If funded by FSMA Human Foods Preventive Controls (PCHF) Implementation Expansion 7 Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed), FSI will fully train up to 33% of 8 the inspection staff to conduct Preventive Controls for Human Foods (PCHF) inspections. In 9 2016, NYSAGM adopted the PCHF Rule 21 CFR 117 so that when inspectors are trained, they 10 were be able to conduct such inspections both under New York State authority and as part of 11 our FDA annual inspection contract. If funded, FSI will devise a comprehensive training plan to 12 track each inspector’s training through to completion. This training plan will include, but not be 13 limited to: completion of the Preventive Controls Qualified Individual (PCQI) training, FD-190 14 Good Manufacturing Practices, FD-254 Preventive Controls for Human Foods regulator training 15 (depending on seat availability), as well as hands on experience through FDA’s On-the Job 16 Experience (OJE) or state equivalent program. 17 Since adoption of the PCHF rule FSI has, through a state administered in-person survey, been 18 working with food manufacturers in our state to understand their compliance to this new 19 regulation. As a result of these surveys, it has become apparent that there is a need for an 20 expanded basic understanding of the rule and its applicability to our food manufacturers, as well 21 as increased accessibility to Preventive Controls Qualified Individual training. Our plan to close 22 the knowledge gap and in keeping with FDA’s mantra to truly regulate before and while we 23 regulate, will be to host webinars on a recurring basis that provide a basic overview of the PCHF 24 rule and expand PCQI training availability by utilizing this funding to sub-contract with Cornell 25 University to facilitate the creation of additional PCQI training classes. These resources will be 26 open to both manufactured food industry representatives and FSI inspectors. We see this type 27 of coordinated outreach as being in direct correlation with Standard 7. (See separate Cornell 28 University, Institute for Food Safety budget). 29 NYSAGM FSI fully supports an integrated food safety system and is excited to engage in this 30 funding opportunity that aims to improve and optimize the nation’s food safety system.