The United States Food Safety Modernization Act 食品安全现代法案 Compliance by Foreign Suppliers 适用于国外供应商 Source: www.fda.gov

Background of the FSMA 食品安全现代法案的产生背景 FSMA Signed into Law by President Obama on January 4, 2011 食品安全现代法案由奥巴马总统于2011年1月4日签署通过 FSMA shifts the focus of the FDA from that of response to prevention 食品安全现代法案将食品及药物管理局的工作重点由后期的反馈转向前期的预防

FSMA Mandates to FDA 食品安全现代法案授权于食品及药物管理局 The FSMA directs the FDA to create two new programs for foreign food and drug companies: Foreign Supplier Verification Program (FSVP) and Voluntary Qualified Importer Program (VQIP).  在食品安全现代法案的指导下，食品及药物管理局为外国食品及医药公司制定了两个新计划： --外国供应商检验计划 --合格进口商自愿计划

The FSVP – Generally 外国供应商检验计划-概要 By January 4, 2012, the U.S. FDA must issue specific FSVP regulations issue a guidance document to assist importers in developing FSV programs.  截止至2012年1月4日，美国食品及药物管理局必须： --发布具体的检验计划条例 --发布指导性文件，以便在计划中协助进口商的相关事务

The FSVP – Generally 外国供应商检验计划-概要 FSVP requires importers to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported is produced safely, unadulterated, and not mis-branded.  检验计划要求进口商在风险控制的基础上对外国供应商进行检验，目的是为了确保所进口的食品生产是安全和纯正的，而并非仅仅是根据产品的品牌来引进。

The FSVP – Generally 外国供应商检验计划-概要 Verification activities: monitoring shipping records for shipments lot-by-lot certification compliance annual on-site inspections checking the hazard analysis and risk-based preventative control plan of the FS periodically testing and sampling shipments.  检验内容： 监控货物运输记录  对每披货物进行检验  每年现场视察  核查食品安全中的危险性分析和以风险防范为基础的预防控制计划定期测试和取样的检查

The FSVP – Generally 外国供应商检验计划-概要 Importers are required to maintain records for two years and are required to allow a U.S. FDA inspector to review these records  U.S. FDA is required to publish and maintain a list of FSVP participants which includes the name and location of suppliers  All of the new FSMA requirements for this program are required to be in place and functional by January 4, 2013. 进口商必须保存两年的进货记录，并且配合美国食品与药物管理局的检查员审查这些记录 美国食品药品管理局需要公布并且维护FSVP的与会者名单，应该列出供应商的名称和位置 新的食品安全现代法案关于检验计划的规定都需要在2013年1月4日前完成并且生效。

The VQIP – Generally 合格进口商自愿计划-概要 VQIP is entirely voluntary.  U.S. FDA must, in conjunction with the Secretary of the Department of Homeland Security (DHS), establish this program to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate. 合格进口商自愿计划是完全自愿性质的 美国食品与药物管理局必须与美国国土安全部秘书部（DHS）合作完成本计划，以便加快对已经自愿参加该计划的进口商的商品的审查和进口程序。

The VQIP – Generally 合格进口商自愿计划-概要 VQIP will include a process for facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in the program.  An “importer” is defined as the person that brings food, or causes the food to be brought, from a foreign country into the United States.   This is an important distinction from the definition of an importer under FSVP because it could mean that foreign manufacturers may be allowed to participate in this program.  VQPI还将增加一个厂商认证过程，以此来配合已经自愿参加该计划的进口商的进口产品检验。 根据这项计划，“进口商”的定义是带来食品的人，或促使食品从国外带来并进入美国的人。 这个定义与FSVP中对“进口商”的定义有重要的区别，因为这表明国外制造商可能被允许参加这一计划。

The VQIP – Generally 合格进口商自愿计划-概要 As with all new requirements under FSMA, the rules will not be known until the final regulations are issued.   FSMA does not define details of entities that are or are not allowed to participate in VQIP, nor does it outline the specific benefits and advantages of participating.  因为有食品安全现代法案的新规定，因此所有的决定因素在最终的法规颁布前都不能被敲定。 事实上，食品安全现代法案并没有定义哪些主体能够或不能够参与到VQIP中，并且也没有列出计划参与者能够获得的具体好处和优势。

The VQIP – Generally 合格进口商自愿计划-概要 FSMA merely states that importers may request to participate and that participation will provide an expedited review process.  VQIP regulations are not required to be finalized by the U.S. FDA until July 4, 2013. 食品安全现代法案只说明进口商可以要求参加该计划，并通过参与计划可以加快检验程序。 VQIP法规在2013年7月4日前无需提交给美国食品及药物管理局定稿。

FDA Inspections 美国食品与药物检验管理局检查 “The FSMA establishes a mandated inspection frequency, based on risk, for food facilities and requires the frequency of inspection to increase immediately.  Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years!” “食品安全现代法案明文规定了对食品厂商设备的检查频率，基于对风险的防范，要求立即增加检查的次数。在颁布的第一年，在食品安全现代法案的指导下，美国FDA需要检查超过600的外国厂商设备，并且在未来五年将检查的数量翻倍！”

Exports to America 出口到美国 Importer accountability:  For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment) Third Party Certification:  The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards.  This certification may be used to facilitate the entry of imports. (Establishment of a system for FDA to recognize accreditation bodies is due 2 years after enactment) 进口商责任：对于第一次，进口商有明确的责任去验证他们的外国供应商有适当的预防控制，以确保他们生产的食品是安全的。（最终的法规和指导意见在通过后的一年内有效） 第三方认证：食品安全现代法案建立第一个项目，可以通过合格的第三方证明外国食品厂商符合美国食品安全标准，这个认证可以使进口的程序更加便利。 （美国食品及药物管理局对认可认证机构的系统，在通过后2年内有效）

Exports to America、 出口到美国 Certification for high risk foods:  FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S.  Voluntary qualified importer program:  FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers.  Eligibility is limited to, among other things, importers offering food from certified facilities.  (Implementation due 18 months after enactment) Authority to deny entry:  FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located. 高风险食品认证：FDA有权要求高风险进口食品必须通过可信的第三方认证或有其他的确保措施，作为进入美国的条件。 合格进口商自愿计划：FDA必须为进口商建立一个自愿性计划，以便为参与计划着提供更快的审查和和进口程序。资格仅限于从验证过的厂商进口食品的进口商。（颁布实施后18个月有效期） 拒绝入境的权利：如果FDA被某一国外厂商拒绝或者该厂商所在的国家拒绝过，那么FDA可以拒绝该厂商进口食品到美国境内的要求。

Enhanced Partnerships 增强合作关系 “Foreign capacity building: The law directs FDA to develop a comprehensive plan to expand the capacity of foreign governments and their industries.  One component of the plan is to address training of foreign governments and food producers on U.S. food safety requirements.” “外国​​能力建设：在法案指导下，FDA为提高外国政府与其产业的能力制定了一项全面计划。计划的一部分是为了解决外国政府和粮食生产者要求对美国食品安全方面进行培训的请求。”

“Reliance on inspections by other agencies: FDA is explicitly authorized to rely on  inspections of other Federal, State and local agencies to meet its increased inspection mandate for domestic facilities. The FSMA also allows FDA to enter into interagency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.”    “依靠其他机构进行检查：FDA明确被授权依靠其他联邦，州和地方机构对国内厂商进行。 食品安全现代法案还允许FDA跨机构去协调关于国内外海鲜厂商、设施以及海产品进口资源的协议。”