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

FSMA 人类食品预防控制实施扩展对 RFA-FD-18-001 的补充（不允许进行 U18 临床试验）

• 批准号: 10176121
• 负责人: Dan McCarthy
• 金额: $ 15万
• 依托单位: NY STATE DEPT OF AGRICULTURE/ MARKETS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10176121
• 关键词: FSMA; Human; Foods; Preventive; Controls

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.

1项目概要/摘要： 2.纽约州农业和市场部（NYSAGM）有一个昂贵的食物 3.安全检查和监管实验室检测计划。NYSAGM食品安全部 4和检查（FSI）的主要使命是确保纽约的食品供应是安全和适当的 5标签 6如果由FSMA资助，人类食品预防控制（PCHF）实施扩展 7 RFA-FD-18-001（不允许进行U18临床试验）的补充，FSI将对多达33%的 8.检查人员进行人类食品预防控制（PCHF）检查。在 2016年9月，NYSAGM采用了PCHF规则21 CFR 117，以便在检查员接受培训时， 有10个国家能够在纽约州权力下进行这种检查， 11我们的FDA年度检查合同。如获拨款，财政司司长法团会制订全面的培训计划， 12跟踪每个检查员的培训直到完成。本培训计划将包括但不限于 13限于：完成预防控制合格人员（PCQI）培训，FD-190 14良好生产规范，FD-254人类食品监管培训的预防控制 15（取决于座位的可用性），以及通过FDA的在职经验 16经验（OJE）或州同等课程。 17自通过PCHF规则以来，FSI通过国家管理的面对面调查， 18与食品制造商在我们的国家，以了解他们遵守这一新的 19条规定。这些调查的结果表明， 20扩大了对规则的基本理解及其对我们食品制造商的适用性， 21.增加预防控制合格人员培训的可及性。我们的关闭计划 22知识差距，并与FDA的口头禅保持一致，在我们 23监管，将举办网络研讨会，定期提供一个基本的概述PCHF 24通过利用这笔资金与康奈尔大学签订分包合同， 25.大学协助开设更多的PCQI培训班。这些资源将 26个开放给食品制造业代表和FSI督察。我们看到这种类型 27.协调外联与标准7直接相关。(See分离康奈尔 28大学，食品安全研究所预算）。 29 NYSAGM FSI完全支持综合食品安全系统，并很高兴参与其中。 30资金的机会，旨在改善和优化国家的食品安全体系。