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FDA Registration -FAQs for Food

Posted Date:2017/8/2 9

R.1 Does FSMA require a food facility to submit additional registration information to FDA in order for the facility to receive a food facility registration number?

Yes. Section 102 of FSMA amends section 415(a)(2) of the FD&C Act by requiring food facilities to submit registrations to FDA containing additional information. Specifically, a registration for a domestic facility is required to contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the United States agent for the facility. All food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured/processed, packed, or held at registering facilities.

R.2 Will food facilities already registered with FDA under section 415 of the FD&C Act be required to renew their registrations? 

Yes. All food facilities that are required to register with FDA under section 415 of the FD&C Act must renew their registrations with FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year.

R.3 Has the scope of who is required to register under section 415 of the FD&C Act changed?

At this time, the same types of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations. Those facilities are domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 103(c) of FSMA directs FDA to conduct a rulemaking to “clarify the activities that are included as part of the definition of the term ‘facility’ under such section 415 [of the FD&C Act].” A clarification of activities included as part of the definition of the term “facility” is included in the rulemaking for preventive controls, as provided by section 103(c) of FSMA. For more information on preventive controls, please visit FDA’s Preventive Standards page.

R.4 Does the FSMA amendments final rule change who is subject to food facility registration?

Yes. The final rule amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register. The expanded definition of a retail food establishment allows establishments located on a farm and “farm-operated businesses” may consider sales directly to consumers via roadside stands, farmers markets, Community Supported Agriculture (CSAs), and other such direct-to-consumer platforms in determining their primary function and whether they would meet the requirements to be considered retail food establishments. By “farm-operated business,” we mean a business that is managed by one or more farms and that conducts manufacturing/processing not on the farm(s). Entities that meet this expanded definition are exempt from food facility registration requirements.

R.5 When do I have to register or renew registration for my food facility?

The owner, operator, or agent in charge of a food facility that begins to manufacture, process, pack, or hold food for consumption in the United States must register before the facility begins such activities. Registration expires at the end of a two-year renewal cycle and renewal is required each even-numbered year between October 1 and December 31. The next registration renewal period will be October through December of 2016. The requirement for mandatory electronic registration will begin January 4, 2020, and the requirement for providing a unique facility identifier (UFI) will begin October 1, 2020.

R.6 If a foreign facility is already registered with FDA will it need to renew its registration? 

Under FSMA, all food facilities that are required to register with FDA under section 415 of the FD&C Act, including foreign facilities, are required to submit registration renewals to FDA during the registration renewal period.

R.7 How can I complete registration for my food facility?

Beginning January 4, 2020, facilities must submit registrations, registration renewals, updates, and cancellations to the FDA electronically, unless the FDA has granted a waiver. To obtain a waiver, facilities must submit a written request to the FDA that explains why it is not reasonable to use the electronic registration system (e.g., lack of Internet access). Facilities that have been granted waivers may submit registration through mail or fax.

R.8 What form do I use to renew a food facility registration?

Registrants must use Form 3537 to register, update, or renew a registration. Facilities may register online via the Internet at www.fda.gov/furls, which operates during business hours from 7:00 am to 11:00 pm U.S. Eastern Time. Facilities may also register by mail or fax or for multiple submissions, by CD-ROM.  

· Registration by Paper (Mail or FAX) or CD-ROM

· Step by Step Instructions

R.9 What information is required for food facility registration renewal?

All mandatory fields on the Form 3537 must be complete in order to renew a food facility registration. This includes new or updated fields described in question IC.3.1. If using the online renewal process, existing registration information will be displayed for review and can be edited as necessary. All information submitted, in both mandatory and optional fields, must be true and accurate, and the registrant will be required to certify that all information submitted is true and accurate at the end of the registration process. 

R.10 Am I required to renew a food facility registration online?

No. Registrants can renew food facility registrations online or submit the paper Form 3537 by mail or fax. A business with multiple facilities may also renew a registration on a CD-ROM by mail. FDA encourages online registration renewal as a cost-effective, quick, and efficient means for food facility registration renewal. With online registration renewal, a registrant may review and edit existing registration information and add information. All of the mandatory data fields are required for the system to accept the renewal submission.  After all required information has been entered, a registrant will receive confirmation of registration renewal.

Paper registration renewal likely will be a more costly and less efficient process to supply FDA with registration information and to provide food facilities with their registration renewal confirmations than online registration. As with online submissions, for paper submissions, all mandatory data fields must be completed. However, if your paper registration form contains errors or omissions, FDA will return it for corrections, which may require additional time to complete the registration process. As a result it may take longer to receive confirmation for paper registration renewals. 

R.11 Is there a fee for registration, updating a registration, or renewal of registration?

No. There is no fee associated with initial registration, updating a registration, or renewing a registration. 

R.12 Do new food facilities need to wait until October 1st to register?

No. The owner, operator, or agent in charge of a facility that begins to manufacture/process, pack, or hold food for consumption in the U.S. on or after December 12, 2003 must register before the facility begins such activities (21 C.F.R. 1.230). An owner, operator, or agent in charge of a facility may authorize 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 the registration renewal period. 

R.13 I have changes to my registration information now. Must I amend or update it now, or can I wait until the beginning of the first biennial registration renewal period?

The owner, operator, or agent in charge of a facility is required to submit an update to a facility’s registration to FDA within 60 calendar days of a change to any of the required registration information previously submitted under 21 CFR 1.232, except for a change of the owner (21 CFR 1.234(a)).  If a facility has a new owner, the former owner must cancel the facility’s registration within 60 calendar days of the change and the new owner must re-register the facility (21 CFR 1.234(b)). If a change occurs to a facility’s previously submitted required registration information before the start of or during the next biennial registration renewal period, a registrant may submit an update for such change as part of the facility’s registration renewal by including the update information in the registration renewal, provided that such update is submitted within 60 calendar days of the change.  If a facility submits an update to FDA before the start of the next biennial registration renewal period, the facility will still be required to submit a registration renewal to FDA during the biennial registration renewal period.

R.14 Do I have to use a third-party registrar for the initial, update, renewal or cancellation of registration for my food facility?

No. FDA does not require a food facility to use a third-party registrar to submit an initial registration, update, renewal, or cancellation of a food facility registration to FDA. A food facility owner, operator, or agent in charge 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). The owner, operator, or agent in charge may authorize an individual to register, update, or cancel a registration on his or her behalf (except for cancellations caused by changes of ownership) (21 CFR 1.225, 1.234). The authorized individual may be, but is not required to be, the U.S. agent for a foreign facility. Foreign facilities should note that U.S. agents may charge a fee for their services, but this is solely controlled by the third-party, and there is no fee assessed by FDA for the initial, update, renewal or cancellation of registration of a food facility.

If a facility is cancelling its registration because it has a new 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 CFR 1.234). 

R.15 What happens if a facility fails to register?

The failure to register your facility, update required elements, or cancel a registration in accordance with 21 CFR Part 1, Subpart H  is a prohibited act under the FD&C Act (see 21 C.F.R. 1.241).  If a foreign food facility is required to register with FDA, but fails to do so, food from that facility that is being imported or offered for import into the U.S. is subject to refusal under section 801(l) of the FD&C Act.  

R.16 Will a food facility be issued a new registration number during the biennial registration renewal process?

No. A food facility will not be issued a new registration number when it renews a current registration under the biennial registration renewal process.

R.17 When may FDA suspend the registration of a facility registered under section 415 of the FD&C Act? 

Under section 415(b) of the FD&C Act, if FDA determines that food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:

· Created, caused or was otherwise responsible for such reasonable probability; OR

· Knew of or had reason to know of such reasonable probability AND packed, received or held such food.

R.18 When are registered facilities subject to the suspension of registration provisions? 

Registered facilities became subject to the suspension of registration provisions in section 415(b) of the Federal Food Drug and Cosmetic Act on July 3, 2011; 180 days after the date of enactment of FSMA (January 4, 2011).

R.19 What is the effect of such a suspension? 

If the registration of a facility is suspended, no person can import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food into interstate or intrastate commerce in the 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 security of our nation’s food supply.

R.20 Who may issue an order to suspend a facility’s registration?

The authority to issue an order to suspend a registration or to vacate an order of suspension may not be delegated by the Secretary of Health and Human Services to any officer or employee other than the FDA Commissioner (section 415(b)(7) of the FD&C Act).

R.21 Is there an opportunity for an informal hearing on suspension of registration?

FDA will provide a registrant subject to a suspension 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 the issuance of the suspension of registration order, unless an alternate time period is agreed upon by FDA and registrant. The registrant will have an opportunity for an informal hearing on actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. FDA will reinstate a registration if it determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration (section 415(b)(2) of the FD&C Act).

R.22 What happens if it is determined that suspension remains necessary after the opportunity for the informal hearing?

If, after providing opportunity for an informal hearing, FDA determines that a suspension of registration remains necessary, FDA will require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by FDA (section 415(b)(3) of the FD&C Act).

R.23 How may a suspension of registration order be vacated or modified?

Upon a determination by FDA that adequate grounds do not exist to continue the suspension actions required by a suspension of registration order, or that such actions should be modified, FDA will vacate the order and reinstate the registration of the facility subject to the order, or modify the order, as appropriate (section 415(b)(3) of the FD&C Act).

R.24 Is FDA going to promulgate regulations on suspension of registration?

Yes. Section 415(b)(5) of the FD&C Act requires that FDA issue regulations to implement section 415(b) of the FD&C Act. However, food facilities became subject to the requirements of  section 415(b) of the FD&C Act, including the suspension of registration provisions, on July 3, 2011 (180 days after the date of enactment of FSMA).

R.25 What changes were made to the “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”? 

FDA updated this guidance document to specify additional food product categories to be included as mandatory fields in the food facility registration form. The updated guidance notes that the list of additional food product categories includes food categories that were previously included on the food facility registration form as optional fields, including food product categories for animal consumption. This guidance also describes certain FSMA amendments to section 415(a) of the FD&C Act, which provide that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3 or any other food categories, as determined appropriate by FDA, including by guidance) of any food manufactured, processed, packed, or held at such facility. FDA believes that the additional food product categories are necessary and appropriate for food facility registration and has included such categories as mandatory fields in the food facility registration form.

R.26 Why did FDA make changes to “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”?

FDA believes that information about the food product categories of foods manufactured, processed, packed or held at food facilities is a key element to allow for rapid communications between FDA and facilities directly impacted by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents. Information about the categories of food a facility handles currently assists FDA in conducting investigations and surveillance operations in response to food-related emergencies. These categories also enable FDA to quickly alert facilities potentially affected by such an incident if FDA receives information indicating the type of food affected. The additional food product categories enhance the agency’s ability to respond quickly and accurately to an actual or potential bioterrorist incident or other food-related emergency. See the updated guidance, Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories, for more information.

R.27 Will FDA provide further outreach or guidance on how FSMA changed food facility registration? 

Yes. FDA anticipates releasing updated registration guidance materials after a rule published in April 2015 to amend and update FDA’s registration regulation is finalized. Additionally, FDA intends to conduct outreach with stakeholders and make technical assistance available as this renewal period takes place.

R.28 If I create a new registration, will I retain my compliance history or shipping history associated with my facility?

Some facilities may create new registrations rather than renew existing registrations because they no longer have the PIN numbers that are needed to access their existing registrations in the online registration system. For such a facility, the Agency does not anticipate a loss of compliance history or shipping history, provided that the facility’s new registration includes the same information such as facility name and facility address. 

R.29 If my farm is registered with FDA but I am not required to register it, how do I cancel the registration, or will FDA cancel the registration?

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)). In addition, as specified in 21 CFR 1.241(c), we will cancel registrations if we independently verify that a facility is not required to register.