TPA.1 How will the third-party certificationprogram work?
第三方认证计划如何运作？
The final rule establishes a system for the FDA to recognize accreditationbodies that in turn accredit third-party certification bodies to perform foodsafety audits and issue certifications for foreign food facilities and thefoods they produce. Such certifications will be required for participation inthe Voluntary Qualified Importer Program (VQIP), which will allow for expeditedreview and entry of foods from importers in the program. In addition, toprevent potentially harmful food from reaching U.S. consumers, the FDA canrequire in specific circumstances that a food offered for import be accompaniedby a certification from an accredited third-party certification body.
最终的规定建立了一个系统，以便FDA认可认证机构，这些机构反过来认证第三方认证机构进行食品安全审核并颁发外国食品设施及其生产食品的认证。这种认证将需要参加自愿合格进口商计划（VQIP），这将允许进口商快速检查和进入食品进口计划。此外，为了防止潜在的有害食物抵达美国消费者，FDA可以在特定情况下要求提供进口的食品附有认证的第三方认证机构的认证。
TPA.2 What are thekey features of the program?
该计划的主要特点是什么？
More information about the final rule can be found in the Third PartyAccreditation At-a-Glance fact sheet.
有关最终规则的更多信息，请参见第三方认证概览。
TPA.3 Willcertification bodies have to submit their audit reports to FDA?
认证机构必须向FDA提交审核报告吗？
For regulatory audits, in which a facility is examined for compliance with FDAfood safety requirements for purposes of certification, an accreditedthird-party certification body must routinely submit an audit report to theFDA. For consultative audits, which are performed in preparation for regulatoryaudits and do not result in issuance of a certification, the audit report isgenerally intended for internal use. The FDA must be notified if a potentialserious risk to public health is identified during a regulatory or consultativeaudit.
对于监管审核，其中检查工厂是否符合FDA食品安全要求的认证目的，经认证的第三方认证机构必须定期向FDA提交审核报告。对于进行监管审核而进行的协商审计，不会颁发认证，审计报告一般用于内部使用。如果在监管或协商审核期间发现潜在的公共卫生严重风险，则必须通知FDA。
TPA.4 Can a foreigngovernment serve as a third-party certification body?
国外政府能否担任第三方认证机构？
Yes. Public and private agencies and organizations are eligible foraccreditation as third-party certification bodies.
可以。公共和私人机构和组织有资格获得认证作为第三方认证机构。
TPA.5 Can reportsand notifications from participants in this program be submitted in theirnative language?
该计划参与者的报告和通知可以用其母语提交吗？
No, all reports and notifications required to be submitted to the FDA must besubmitted in English to be properly and efficiently reviewed.
不可以，所有提交给FDA的报告和通知必须用英文提交，才能正确有效地审查。
TPA.6 How long doesrecognition (i.e., qualification) last for recognized accreditation bodies?
认证机构获得认可（即资格）的时间有多久？
The FDA may grant a period of recognition for an accreditation body of up tofive years. The length of recognition granted will be determined on acase-by-case basis, depending on a number of factors, including theaccreditation body’s experience conducting accreditation work in the foodsafety area.
FDA可授予认证机构长达五年的认可期限。获得认可的时间将根据具体情况确定，具体取决于许多因素，包括认证机构在食品安全领域进行认证工作的经验。
TPA.7 How long doesthe accreditation last for certification bodies?
认证机构认证持续时间多长？
The maximum duration of accreditation for certification bodies is four yearsunder the rule.
认证机构认证的最长期限为四年。
TPA.8 Can bothforeign and domestic food entities receive food safety audits conducted underthe Accredited Third-Party Certification program?
外国和国内的食品实体都可以接受认证第三方认证计划下的食品安全审核吗？
Only foreign food entities can receive food safety audits under the third-partycertification program. The program does not apply to audits of domestic firms.
只有国外食品实体可以根据第三方认证计划获得食品安全审核。该计划不适用于国内企业的审核。
TPA.9 Where do Isubmit an application to participate in this program?
在哪里提交参加此计划的申请？
The Accredited Third-Party Certification rule that FDA issued on November 27,2015 establishes the framework, procedures, and requirements for the program.
FDA于2015年11月27日发布的认证第三方认证规则确定了该方案的框架，程序和要求。
An accreditation body recognized by FDA under this programcould be a foreign government/agency or a private third party. Accreditationbodies assess third-party certification bodies for accreditation and monitortheir performance.
FDA根据本计划认可的认证机构可以是外国政府/机构或私人第三方。认证机构评估第三方认证机构的认证和监督其绩效。
Third-party certification bodies will be accredited underthis program to conduct food safety audits and to certify that foreign foodfacilities, and the foods they produce, meet FDA food safety standards.
第三方认证机构将根据本计划进行认证，进行食品安全审核，并证明国外食品工厂及其生产的食品符合FDA食品安全标准。
FDA issued two companion documents in December 2016. First,FDA issued a guidance to industry entitled, “Third-Party Certification BodyAccreditation for Food Safety Audits: Model Accreditation Standards,” whichcontains FDA recommendations on third-party certification body qualifications.Second, FDA issued a final rule entitled, “Amendments to Accreditation ofThird-Party Certification Bodies to Conduct Food Safety Audits and to IssueCertifications to Provide for the User Fee Program,” which provides for auser-fee program to assess fees and require reimbursement for the work theagency performs to establish and administer the third-party certificationprogram.
FDA于2016年12月份发布了两份配套文件。首先，FDA对“食品安全审核第三方认证机构认证标准”进行了指导，其中载有FDA对第三方认证机构资质的建议。第二，FDA发布了一项最终规则，题为“第三方认证机构进行食品安全审核的认证修订和颁发用户费用计划的认证”，该规定规定了用户费用计划来评估费用和要求，报销该机构负责建立和管理第三方认证计划的工作。
In June 2017 FDA launched a website where organizationscan apply to be recognized as an Accreditation Body. Third-party certificationbodies can seek accreditation after one or more FDA-recognized accreditationbodies begin accepting applications.
2017年6月，FDA发起了一个网站，组织可以申请认可为认证机构。第三方认证机构可以在一个或多个FDA认可的认证机构开始接受申请后寻求认证。
TPA.10 Where do I find a list ofaccreditation bodies?
在哪里可以找到认证机构的名单？
Once recognized by FDA, an accreditation body may begin accrediting third-partycertification bodies that meet our program requirements. We will maintain aregistry of recognized accreditation bodies and accredited third-partycertification bodies on our website.
一旦被FDA认可，认证机构可以开始认证符合我们计划要求的第三方认证机构。我们将在我们的网站上维护认可的认证机构和认可的第三方认证机构的注册。
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