FSMA：果蔬最终法规.pptVIP

Final Rule on Produce Safety果蔬安全最终法规 /fsma Jeffrey Read Policy Analyst, International Affairs Staff, Center for Food Safety and Applied Nutrition (CFSAN), FDA 杰夫·雷德 FDA食品安全与应用营养中心(CFSAN)国际事务部国际政策分析官员 * Regulatory Framework法规框架 Framework considers a broad range of crops and practices within the farming community 框架中考虑了农业种植的众多作物和操作 Integrated approach that draws on current scientific information, outbreak data, past experiences 依据当前科学信息、疫情爆发数据和过往经验形成综合方法 Focuses on identified routes of contamination, rather than commodity-based (except for sprouts) 关注已识别的污染途径，而非基于具体作物（芽菜除外） Includes Current Good Manufacturing Practice-like provisions; numerical criteria; and monitoring provisions 包括类似现行良好操作规范（cGMP)的内容；量化标准；及监控的条款 * * Coverage of Rule法规监管范围 Covers 包括: Domestic and imported produce 美国国内以及进口果蔬 Produce for human consumption 供人食用的果蔬 Does not cover 不包括: Produce for personal or on-farm consumption 供个人或农场内食用的果蔬 Produce not a “raw agricultural commodity” 果蔬不是美国法律中定义的“初级农产品” Certain specified produce rarely consumed raw 具体列明的极少用于生食的果蔬 Farms with produce sales of ≤ $25,000 per year 果蔬年销售值≤ $25,000 美金的农场 * * Flexibility Provided Under the Rule法规赋予的灵活性 Eligible for exemption (with modified requirements) 有豁免资格 (符合变更要求） Produce that will receive commercial processing (“kill-step” or other process that adequately minimizes hazards) 用于商业加工的果蔬 ( 进行”灭菌加工”或其他足以使危害最小化的加工） Qualified exemption for smaller farms selling more locally 主要在本地销售的较小型农场符合豁免资格 A state, tribe, or foreign country may petition FDA for a variance from some or all provisions if necessary in light of local growing conditions 如果必要，州 （state)，部落(tribe)或其他国家(foreign country) 可根据当地种植条件向FDA申请与法规某些或全部条文相异的条款 Farms may establish alternatives to certain, specified requirements only 农场可建立与法规中某些具体要求对应且仅与这些要求对应的替代要求 Both variances and alternatives must provide the same level of public health protection as the rule and not increase the risk that produce is adulterated 这些相异条款和替代要求能提供的公众健康保护必须达到和法规中的要求同等水平，并且不增加