FDA Registration -FAQs for Food
R.1 Does FSMA require a food facility tosubmit additional registration information to FDA in order for the facility toreceive a food facility registration number?
为了获得食品工厂登记号码FSMA要求食品机构向FDA提交其他注册信息吗？
Yes. Section 102 of FSMA amends section415(a)(2) of the FD&C Act by requiring food facilities to submitregistrations to FDA containing additional information. Specifically, aregistration for a domestic facility is required to contain the e-mail addressfor the contact person of the facility, or for a foreign facility, the emailaddress of the United States agent for the facility. All food facilityregistrations are required to contain an assurance that FDA will be permittedto inspect the facility at the times and in the manner permitted by the FD&CAct. Additionally, if determined necessary by FDA, registrations are requiredto contain information regarding other applicable food categories, asdetermined appropriate by FDA, for foods manufactured/processed, packed, orheld at registering facilities.
是的。FSMA第102节修改FD＆C法案第415（a）（2）条要求食品工厂向FDA提交含有附加信息来注册。具体来说，国内工厂的注册必须包含工厂联系人的电子邮件地址，或国外的工厂需要美国代理人的电子邮件地址。所有食品工厂注册都必须包含一项保证，FDA将允许按照FD＆C法允许的时间和方式检查工厂。此外，如果FDA认为有必要，注册必须包含FDA所适用的其他适用食品类别的信息，用于在注册工厂生产/加工，包装或持有的食品。
R.2 Will food facilities already registeredwith FDA under section 415 of the FD&C Act be required to renew theirregistrations?
已经根据FD＆C法第415条登记的FDA食品工厂是否需要更新注册？
Yes. All food facilities that are required to register with FDA under section415 of the FD&C Act must renew their registrations with FDA, every otheryear, during the period of time beginning on October 1 and ending on December31 of each even-numbered year.
是的。所有根据FD＆C法第415条向FDA注册的食品工厂必须更新其FDA注册，每隔一年，从10月1日开始到每个偶数年12月31日的时间段。
R.3 Has the scope of who is required toregister under section 415 of the FD&C Act changed?
根据FD＆C法第415条要求注册的范围是否发生变化？
At this time, the same types of food facilities that were required to registerwith FDA under section 415 of the FD&C Act before FSMA are required toregister with FDA and renew such registrations. Those facilities are domesticand foreign facilities that manufacture, process, pack, or hold food for humanor animal consumption in the United States. Section 103(c) of FSMA directs FDAto conduct a rulemaking to “clarify the activities that are included as part ofthe definition of the term ‘facility’ under such section 415 [of the FD&CAct].” A clarification of activities included as part of the definition of theterm “facility” is included in the rulemaking for preventive controls, asprovided by section 103(c) of FSMA. For more information on preventivecontrols, please visit FDA’sPreventive Standards page.
目前，在FSMA之前，根据FD＆C法第415节要求向FDA注册的相同类型的食品工厂必须向FDA注册并更新此类注册。这些工厂是在美国制造，加工，包装或饲养人类或动物消费食品的国内和国外工厂。FSMA第103（c）条指示FDA进行规则制定以澄清活动，根据“FD＆C法案”第415条，将其作为“工厂”一词的定义的一部分。根据FSMA第103（c）条的规定，作为“工厂”一词定义的一部分的活动的澄清包含在预防性控制规则中。有关预防性控制的更多信息，请访问FDA的“预防性标准”页面。
R.4 Does the FSMA amendments final rulechange who is subject to food facility registration?
FSMA修改最终规则是否改变了谁接受食品工厂注册？
Yes. The final rule amends the definition of a retail food establishment in away that expands the number of establishments that are considered retail foodestablishments, and that are therefore not required to register. The expandeddefinition of a retail food establishment allows establishments located on afarm and “farm-operated businesses” may consider sales directly to consumersvia roadside stands, farmers markets, Community Supported Agriculture (CSAs),and other such direct-to-consumer platforms in determining their primaryfunction and whether they would meet the requirements to be considered retailfood establishments. By “farm-operated business,” we mean a business that ismanaged by one or more farms and that conducts manufacturing/processing not onthe farm(s). Entities that meet this expanded definition are exempt from foodfacility registration requirements.
是的。最终规则修改了零售食品业的定义，从而扩大了被视为零售食品企业的企业数量，因此不需要注册。扩大零售食品企业的定义允许位于农场的企业和“农场经营的企业”可以通过路边摊位，农民市场，社区支持农业（CSA）和其他直接到消费者平台来确定消费者的主要功能，以及是否将满足被视为零售食品企业的要求。“农业经营”是指由一个或多个农场管理的，不在农场进行生产/加工的企业。符合这一扩大定义的实体免于食品工厂注册要求。
R.5When do I have to register or renew registration for my food facility?
我什么时候需要为我的食品工厂注册或续订注册？
The owner, operator, or agent in charge of a food facility that begins tomanufacture, process, pack, or hold food for consumption in the United Statesmust register before the facility begins such activities. Registration expiresat the end of a two-year renewal cycle and renewal is required eacheven-numbered year between October 1 and December 31. The next registrationrenewal period will be October through December of 2016. The requirement formandatory electronic registration will begin January 4, 2020, and therequirement for providing a unique facility identifier (UFI) will begin October1, 2020.
负责开始制造，加工，包装或持有在美国消费的食品的食品工厂的所有者，经营者或代理商必须在工厂开始此类活动之前进行注册。注册在两年更新周期结束时届满，在每个偶数年份的10月1日至12月31日期间需要更新。下一个注册续期日期为2016年10月至12月。强制性电子注册的要求将于2020年1月4日起施行，提供独特的设备标识符（UFI）的要求将于2020年10月1日起施行。
R.6 If a foreign facility is alreadyregistered with FDA will it need to renew its registration?
如果外国工厂已经进行FDA注册，它需要更新注册吗？
Under FSMA, all food facilities that are required to register with FDA undersection 415 of the FD&C Act, including foreign facilities, are required tosubmit registration renewals to FDA during the registration renewal period.
根据FSMA，所有根据FD＆C法案第415条（包括国外工厂）向FDA注册的所有食品工厂必须在注册续期期间向FDA提交注册续期。
R.7 How can I complete registration for myfood facility?
如何完成我的食品工厂注册？
Beginning January 4, 2020, facilities must submit registrations, registrationrenewals, updates, and cancellations to the FDA electronically, unless the FDAhas granted a waiver. To obtain a waiver, facilities must submit a writtenrequest to the FDA that explains why it is not reasonable to use the electronicregistration system (e.g., lack of Internet access). Facilities that have beengranted waivers may submit registration through mail or fax.
从2020年1月4日起，设施必须以电子方式向FDA提交注册，注册续展，更新和取消注册，除非FDA豁免。为了获得豁免，工厂必须向FDA提交书面请求，解释为什么使用电子注册系统是不合理的（例如，缺乏互联网接入）。被豁免的工厂可以通过邮件或传真提交注册。
R.8 What form do Iuse to renew a food facility registration?
我用什么格式来更新食品工厂注册？
Registrants must use Form 3537 to register, update, or renew a registration.Facilities may register online via the Internet at www.fda.gov/furls, whichoperates during business hours from 7:00 am to 11:00 pm U.S. EasternTime. Facilities may also register by mail or fax or for multiplesubmissions, by CD-ROM.
注册人必须使用表格3537注册，更新或续订注册。工厂可以通过互联网在www.fda.gov/furls进行在线注册，该服务时间为美国东部时间早上7:00至晚上11:00。工厂也可以通过邮寄或传真或通过CD-ROM进行多次提交。
· Registration by Paper (Mail or FAX) or CD-ROM
· 纸张注册（邮件或传真）或CD-ROM
· Step by Step Instructions
· 步骤说明
R.9 What information is required for foodfacility registration renewal?
食品工厂注册更新需要什么信息？
All mandatory fields on the Form 3537 must be complete in order to renew a foodfacility registration. This includes new or updated fields described inquestion IC.3.1. If using the online renewal process, existing registrationinformation will be displayed for review and can be edited as necessary. Allinformation submitted, in both mandatory and optional fields, must be true andaccurate, and the registrant will be required to certify that all informationsubmitted is true and accurate at the end of the registration process.
表格3537上的所有强制性字段必须完整，以便更新食品工厂注册。这包括问题IC.3.1中描述的新的或更新的字段。如果使用在线更新过程，现有的注册信息将被显示以供审核，并可根据需要进行编辑。在强制性和可选字段中提交的所有信息必须是真实和准确的，并且注册人将被要求证明在注册过程结束时提交的所有信息都是真实准确的。
R.10 Am I required to renew a food facilityregistration online?
我是否被要求在线更新食品工厂注册？
No. Registrants can renew food facility registrations online or submit thepaper Form 3537 by mail or fax. A business with multiple facilities mayalso renew a registration on a CD-ROM by mail. FDA encourages onlineregistration renewal as a cost-effective, quick, and efficient means for foodfacility registration renewal. With online registration renewal, a registrantmay review and edit existing registration information and addinformation. All of the mandatory data fields are required for the systemto accept the renewal submission. After all required information has beenentered, a registrant will receive confirmation of registration renewal.
不用。注册人可以在线更新食品工厂注册，或通过邮件或传真提交表格3537。具有多个工厂的业务也可以通过邮件更新光盘上的注册。FDA鼓励在线注册更新，作为更新食品工厂注册的成本效益，快速，高效的手段。通过在线注册更新，注册人可以查看和编辑现有的注册信息并添加信息。所有必需的数据字段是系统接受更新提交所必需的。在输入所有必需的信息后，注册人将收到注册更新的确认。
Paper registration renewal likely will be a more costly andless efficient process to supply FDA with registration information and toprovide food facilities with their registration renewal confirmations thanonline registration. As with online submissions, for paper submissions,all mandatory data fields must be completed. However, if your paperregistration form contains errors or omissions, FDA will return it forcorrections, which may require additional time to complete the registrationprocess. As a result it may take longer to receive confirmation for paperregistration renewals.
纸张注册更新可能是向FDA提供注册信息并为食品工厂提供注册续订确认是比在线注册的成本更高，效率更低的过程。与在线提交一样，对于提交的纸张，必须完成所有强制性数据字段。但是，如果您的纸质注册表格包含错误或遗漏，FDA将退还其更正，这可能需要额外的时间才能完成注册过程。因此，可能需要更长时间才能收到纸张注册续订的确认。
R.11 Is there a fee for registration,updating a registration, or renewal of registration?
是否有注册费，更新注册费或注册续期费？
No. There is no fee associated with initial registration, updating aregistration, or renewing a registration.
没有。与初次注册相关的更新注册或续订注册费用不存在。
R.12 Do new food facilities need to waituntil October 1st to register?
新的食品工厂需要等到10月1日才能注册吗？
No. The owner, operator, or agent in charge of a facility that begins tomanufacture/process, pack, or hold food for consumption in the U.S. on or afterDecember 12, 2003 must register before the facility begins such activities (21C.F.R. 1.230). An owner, operator, or agent in charge of a facility mayauthorize an individual to register the facility on its behalf (21 C.F.R.1.230). If a facility registers before October 1 during an even-numbered year,the facility will still be required to renew its registration during theregistration renewal period.
不是。在2003年12月12日当天或之后开始制造/加工，包装或持有食品消费的工厂的所有者，经营者或代理人必须在工厂开始此类活动之前进行注册（21 CFR 1.230）。负责工厂的业主，经营人或代理人可以授权个人代表其注册工厂（21 C.F.R. 1.230）。如果一个工厂在偶数年的10月1日之前进行登记，那么工厂仍将被要求在注册续期期间续订注册。
R.13 I have changes to my registrationinformation now. Must I amend or update it now, or can I wait until thebeginning of the first biennial registration renewal period?
我现在更改了我的注册信息。那我必须现在修改或更新，还是等到第一个两年一次的注册续期时间开始？
The owner, operator, or agent in charge of a facility is required to submit anupdate to a facility’s registration to FDA within 60 calendar days of a changeto any of the required registration information previously submitted under 21CFR 1.232, except for a change of the owner (21 CFR 1.234(a)). If afacility has a new owner, the former owner must cancel the facility’sregistration within 60 calendar days of the change and the new owner mustre-register the facility (21 CFR 1.234(b)). If a change occurs to afacility’s previously submitted required registration information before thestart of or during the next biennial registration renewal period, a registrantmay submit an update for such change as part of the facility’sregistration renewal by including the update information in the registrationrenewal, provided that such update is submitted within 60 calendar days of thechange. If a facility submits an update to FDA before the start of thenext biennial registration renewal period, the facility will still be requiredto submit a registration renewal to FDA during the biennial registrationrenewal period.
负责工厂的所有者，经营者或代理人必须在更改以前根据21 CFR 1.232提交的任何所需注册信息的60个日历日内向FDA提交工厂更新，除了所有者的变更（21 CFR 1.234（a））。如果工厂有新的所有者，则前业主必须在更改后的60天内取消工厂的注册，新的所有者必须重新注册该工厂（21 CFR 1.234（b））。如果在下一个两年期注册续期期间之前或期间，工厂之前提交的所需注册信息发生变化，注册人可以通过在注册续期中包含更新信息，将该更改的更新提交为工厂注册续订的一部分，条件是此更新在更改后的60天内提交。如果工厂在下一个两年期注册更新期开始前向FDA提交更新，该工厂仍将被要求在两年期注册续期期间向FDA提交注册续期。
R.14 Do I have to use a third-partyregistrar for the initial, update, renewal or cancellation of registration formy food facility?
我必须使用第三方注册商进行食品工厂的初始注册，更新，续订或取消注册吗？
No. FDA does not require a food facility to use a third-party registrar tosubmit an initial registration, update, renewal, or cancellation of a foodfacility registration to FDA. A food facility owner, operator, or agent incharge of the facility must register, update, renew, or cancel a registration(see section 415(a) of the FD&C Act; and 21 CFR 1.225, 1.234). Theowner, operator, or agent in charge may authorize an individual to register,update, or cancel a registration on his or her behalf (except for cancellationscaused by changes of ownership) (21 CFR 1.225, 1.234). The authorizedindividual may be, but is not required to be, the U.S. agent for a foreignfacility. Foreign facilities should note that U.S. agents may charge a feefor their services, but this is solely controlled by the third-party, and thereis no fee assessed by FDA for the initial, update, renewal or cancellation ofregistration of a food facility.
If a facility is cancelling its registration because it has anew owner, the former owner, or an individual authorized by the former owner,must cancel the facility’s registration as specified in 21 CFR 1.235 (21 CFR1.234).
不需要。FDA不要求食品机构使用第三方注册商向FDA提交食品工厂初始注册，更新，续订或取消。负责食品工厂的所有者，经营者或代理人的变更必须注册，更新，许多或取消注册（见FD＆C法案第415（a）条; 21 CFR 1.225,1.234）。所有者，经营者或负责人可以授权个人代表他们注册，更新或取消注册（除所有权变更引起的取消之外）（21 CFR 1.225,1.234）。授权的个人可能是但不是必须是美国驻外机构的代理人。外国工厂应注意，美国代理商可能会收取其服务费用，但这完全由第三方控制，FDA不会对食品工厂的初始注册，更新，续订或取消进行评估。如果工厂由于拥有新的所有者而取消注册，则前所有者或授权的个人必须按照21 CFR 1.235（21 CFR 1.234）中的规定取消该工厂的注册。
R.15 What happens if a facility fails toregister?
如果工厂注册失败会怎么样？
The failure to register your facility, update required elements, or cancel aregistration in accordance with 21 CFR Part 1, Subpart H is a prohibitedact under the FD&C Act (see 21 C.F.R. 1.241). If a foreign foodfacility is required to register with FDA, but fails to do so, food from thatfacility that is being imported or offered for import into the U.S. is subjectto refusal under section 801(l) of the FD&C Act.
根据21 CFR第1部分子部分H注册您的工厂，更新所需元素或取消注册是根据FD＆C法案禁止的行为（见21 C.F.R. 1.241）。如果外国食品工厂需要向FDA注册，但没有这样做，则从该工厂进口或提供进口到美国的食品将根据FD＆C法案第801（l）节被拒绝。
R.16 Will a food facility be issued a newregistration number during the biennial registration renewal process?
在两年期注册续订过程中，食品工厂是否会发放新的注册号码？
No. A food facility will not be issued a new registration number when it renewsa current registration under the biennial registration renewal process.
不会。在两年期注册续订过程中更新当前注册时，食品工厂将不会发行新的注册号。
R.17 When may FDA suspend the registrationof a facility registered under section 415 of the FD&C Act?
FDA何时可以根据FD＆C法第415条暂停工厂的注册？
Under section 415(b) of the FD&C Act,if FDA determines that food manufactured, processed, packed, received, or heldby a facility has a reasonable probability of causing serious adverse healthconsequences or death to humans or animals, FDA may by order suspend theregistration of a facility that:
根据“FD＆C法”第415（b）条，如果FDA确定工厂制造，加工，包装，接收或持有的食品有合理的可能对人类或动物造成严重的不良健康后果或死亡的，FDA可以通过命令暂停工厂注册：
· Created, caused or was otherwise responsible for suchreasonable probability; OR
· 创造，造成或以其他方式负责此类合理的概率；或
· Knew of or had reason to know of such reasonable probabilityAND packed, received or held such food.
· 知道或有理由知道这种合理的概率和包装，接收或持有这样的食品。
R.18 When are registered facilities subjectto the suspension of registration provisions?
注册工厂什么时候受制于暂停注册规定？
Registered facilities became subject to thesuspension of registration provisions in section 415(b) of the Federal FoodDrug and Cosmetic Act on July 3, 2011; 180 days after the date of enactment ofFSMA (January 4, 2011).
2011年7月3日，“联邦食品药品和化妆品法”第415（b）条注册工厂受到暂停注册规定；FSMA颁布之日起180天（2011年1月4日）。
R.19 What is the effect of such asuspension?
这种暂停的影响是什么？
If the registration of a facility issuspended, no person can import or export food into the United States from suchfacility, offer to import or export food into the United States from suchfacility, or otherwise introduce food into interstate or intrastate commerce inthe United States from such facility (section 415(b)(4) of the FD&C Act).This important authority will further help FDA ensure the safety and securityof our nation’s food supply.
如果工厂的注册被暂停，任何人不得从该工厂进口或出口食品进入美国，从该工厂提供进口或出口食品到美国，或以其他方式引入美国州际或州际商业来自该工厂的食品（FD＆C法案第415（b）（4）条））。这一重要机构将进一步帮助FDA确保我国食品供应的安全和保障。
R.20 Who may issue an order to suspend afacility’s registration?
谁可以发出指令中止工厂的注册？
The authority to issue an order to suspenda registration or to vacate an order of suspension may not be delegated by theSecretary of Health and Human Services to any officer or employee other thanthe FDA Commissioner (section 415(b)(7) of the FD&C Act).
发出指令暂停注册或撤销暂停令的权力不得由卫生和人类服务部秘书任命给FDA专员以外的任何官员或雇员（第415（b）（7）条） FD＆C法）。
R.21 Is there an opportunity for aninformal hearing on suspension of registration?
有暂停注册的非正式听证会的机会吗？
FDA will provide a registrant subject to asuspension of registration order with an opportunity for an informal hearing,to be held as soon as possible but not later than 2 business days after theissuance of the suspension of registration order, unless an alternate timeperiod is agreed upon by FDA and registrant. The registrant will have anopportunity for an informal hearing on actions required for reinstatement ofregistration and why the registration that is subject to suspension should bereinstated. FDA will reinstate a registration if it determines, based onevidence presented, that adequate grounds do not exist to continue thesuspension of the registration (section 415(b)(2) of the FD&C Act).
FDA将提供注册人暂停注册订单，并提供非正式听证会的机会，尽快但不迟于发布暂停注册订单后的2个工作日内举行，除非交替的时间段由FDA和注册人同意。注册人将有机会对恢复注册所需的行动进行非正式听证会，以及为什么应该恢复注册。如果根据提供的证据确定不存在适当理由继续暂停注册（FD＆C法案第415（b）（2）条）），FDA将恢复注册。
R.22 What happens if it is determined thatsuspension remains necessary after the opportunity for the informal hearing?
如果确定在非正式听证会的机会之后仍然需要暂停，会怎么样？
If, after providing opportunity for aninformal hearing, FDA determines that a suspension of registration remainsnecessary, FDA will require the registrant to submit a corrective action planto demonstrate how the registrant plans to correct the conditions found by FDA(section 415(b)(3) of the FD&C Act).
如果在提供非正式听证会的机会之后，FDA决定暂停注册仍然是必要的，FDA将要求注册人提交纠正措施计划，以说明注册人如何计划更正FDA发现的问题（第415（b）条）（3））。
R.23 How may a suspension of registrationorder be vacated or modified?
如何撤销或修改注册令的暂停？
Upon a determination by FDA that adequategrounds do not exist to continue the suspension actions required by asuspension of registration order, or that such actions should be modified, FDAwill vacate the order and reinstate the registration of the facility subject tothe order, or modify the order, as appropriate (section 415(b)(3) of theFD&C Act).
当FDA决定不存在足够的理由继续停止注册订单所要求的暂停诉讼，或者这种行为应被修改的情况下，FDA将撤销该命令，并恢复受该命令的设施的注册，或适当修改订单（FD＆C法案第415（b）（3）条）。
R.24 Is FDA going to promulgate regulationson suspension of registration?
FDA是否会颁布暂停注册的规定？
Yes. Section 415(b)(5) of the FD&CAct requires that FDA issue regulations to implement section 415(b) of theFD&C Act. However, food facilities became subject to the requirementsof section 415(b) of the FD&C Act, including the suspension ofregistration provisions, on July 3, 2011 (180 days after the date of enactmentof FSMA).
是的。FD＆C法案第415（b）（5）条要求FDA颁布条例以实施FD＆C法案第415（b）条。但是，2011年7月3日（FSMA颁布之日起180天），食品工厂符合“FD＆C法”第415（b）条的要求，包括暂停注册规定。
R.25 What changes were made to the “Guidance for Industry: Necessity of the Use of FoodProduct Categories in Registration of Food Facilities”?
“产业指导意见：食品生产类别在食品工厂注册中的应用”做了什么改变？
FDA updated this guidance document to specify additional food productcategories to be included as mandatory fields in the food facility registrationform. The updated guidance notes that the list of additional food productcategories includes food categories that were previously included on the foodfacility registration form as optional fields, including food productcategories for animal consumption. This guidance also describes certain FSMAamendments to section 415(a) of the FD&C Act, which provide that, when determinednecessary by FDA “through guidance,” a registrant must submit a registration toFDA containing information necessary to notify FDA of the general food category(as identified in 21 CFR 170.3 or any other food categories, as determinedappropriate by FDA, including by guidance) of any food manufactured, processed,packed, or held at such facility. FDA believes that the additional food productcategories are necessary and appropriate for food facility registration and hasincluded such categories as mandatory fields in the food facility registrationform.
FDA更新了本指导文件，以指定在食品工厂注册表格中列入作为强制性领域的其他食品类别。更新的指导意见指出，其他食品类别列表包括以前作为可选领域包括在食品工厂注册表中的食品类别，包括动物消费的食品类别。该指南还描述了对FD＆C法案第415（a）条的某些FSMA修正案，其中规定，当FDA通过指导确定必要时，注册人必须向FDA提交注册，其中包含通知FDA通用食品所必需的信息在该工厂制造，加工，包装或持有的任何食品类别（根据21 CFR 170.3或通过FDA确定的任何其他食品类别（包括通过指导）确定）。FDA认为，食品添加剂类别对于食品工厂的注册是必要和适当的，并且在食品工厂注册表中列出了强制性领域。
R.26 Why did FDA make changes to “Guidance for Industry: Necessity of the Use of FoodProduct Categories in Registration of Food Facilities”?
为什么FDA要对 “产业指导意见：食品生产类别在食品工厂注册中的应用”进行更改？
FDA believes that information about the food product categories of foodsmanufactured, processed, packed or held at food facilities is a key element toallow for rapid communications between FDA and facilities directly impacted byactual or potential bioterrorist attacks, other food-related emergencies, orfood safety incidents. Information about the categories of food a facilityhandles currently assists FDA in conducting investigations and surveillanceoperations in response to food-related emergencies. These categories alsoenable FDA to quickly alert facilities potentially affected by such an incidentif FDA receives information indicating the type of food affected. Theadditional food product categories enhance the agency’s ability to respondquickly and accurately to an actual or potential bioterrorist incident or otherfood-related emergency. See the updated guidance, Guidance forIndustry: Necessity of the Use of Food Product Categories in Food FacilityRegistrations and Updates to Food Product Categories, for moreinformation.
FDA认为，关于食品生产，加工，包装或持有的食品的食品类别的信息，受实际或潜在的生物恐怖袭击，其他与粮食有关的紧急情况或食品安全事件的影响，是允许FDA和工厂直接快速通信的关键因素。关于工厂处理食品类别的信息目前有助于FDA对食品相关紧急情况进行调查和监视。如果FDA收到指示受影响食物类型的信息，这些类别也可以使FDA能够快速预警可能受到此类事件影响的工厂。额外的食品类别增强了该机构快速准确地对实际或潜在的生物恐怖活动或其他与食品有关的紧急情况作出反应的能力。有关更多信息，请参阅更新指南，行业指南：食品工厂注册中食品类别使用的必要性和食品类别更新。
R.27 Will FDA provide further outreach orguidance on how FSMA changed food facility registration?
FDA会进一步推广或指导改变食品工厂的注册方式？
Yes. FDA anticipates releasing updated registration guidance materials after arule published in April 2015 to amend and update FDA’s registration regulationis finalized. Additionally, FDA intends to conduct outreach with stakeholdersand make technical assistance available as this renewal period takes place.
是的。FDA预计在2015年4月发布的规则之后发布更新的注册指导资料，以修订和更新FDA的注册管理。此外，FDA打算与利益相关者进行沟通，并在此更新期间提供技术援助。
R.28 If I create a new registration, will Iretain my compliance history or shipping history associated with my facility?
如果我创建一个新的注册，会保留与我的工厂相关的履历历史或货运历史吗？
Some facilities may create newregistrations rather than renew existing registrations because they no longerhave the PIN numbers that are needed to access their existing registrations inthe online registration system. For such a facility, the Agency does notanticipate a loss of compliance history or shipping history, provided that thefacility’s new registration includes the same information such as facility nameand facility address.
某些工厂可能会创建新的注册，而不是续订现有的注册，因为它们不再具有访问在线注册系统中现有注册所需的PIN码。对于这样的工厂，如果工厂的新注册包括相同的信息，例如工厂名称和工厂地址，代理机构不会预期履行合同历史或货运历史的损失。
R.29If my farm is registered with FDA but I am not required to register it, how doI cancel the registration, or will FDA cancel the registration?
如果我的农场在FDA注册，但我不需要注册，如何取消注册，还是FDA取消注册？
Cancellations of registrations must follow the requirements in 21 CFR 1.235.For example, cancellations must include the required information (e.g.,registration number, facility name and address) (see 21 CFR 1.235(b)). Inaddition, as specified in 21 CFR 1.241(c), we will cancel registrations if weindependently verify that a facility is not required to register.
取消注册必须符合21 CFR 1.235中的要求。例如，取消必须包括所需的信息（例如注册号码，工厂名称和地址）（见21 CFR 1.235（b））。另外，如21 CFR 1.241（c）所述，如果我们独立核实工厂不需要注册，我们将取消注册。
声明：以上内容为临安科达认证技术咨询服务有限公司原创内容，如需转载，请标明出处，谢谢！
