Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their U.S. Food and Drug Administration (FDA) registrations every even-numbered year between October 1 and December 31. Facilities have just one month left to renew their registrations for 2017.
FDA recently published a draft guidance to help food facilities better understand FDA’s registration and renewal requirements. Entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry,” the guidance aims to provide answers to frequently asked questions received from stakeholders regarding FDA registration regulations and the final rule titled “Amendments to Registration of Food Facilities” that was issued in July 2016.
The seventh edition builds upon former versions of FDA’s food facility registration guidance. Several new questions were added regarding FDA’s renewal period since the sixth edition. Some examples include:
Q: “Do new food facilities need to wait until October 1 of a biennial renewal year to register?”
A: No. A facility can register with FDA initially any time throughout the year. The operator, owner or agent must register the facility before beginning to manufacture, process, pack or store food for consumption in the U.S. If the initial registration occurs prior to October 1 of a biennial renewal period, the facility must renew their registration. This is true even if the registration is only months, or even days, old.
Q: “Will a food facility be issued a new registration number during the registration renewal process?”
A: No, a facility will keep its original registration number as long as its registration is renewed by the deadline. In the event that a facility misses the renewal period it would be required to re-register, resulting in a new registration number.
Q: “How will FDA conduct the verification process for U.S. agents?”
A: FDA will send an email to the individual listed as a facility’s U.S. Agent. The individual must confirm that they accept responsibility as the U.S. agent for the specified facility. The identified individual has 30 days to respond to FDA verification request. A registration is not valid until FDA receives confirmation from the U.S. Agent. If the individual denies responsibility or if FDA receives no response within the 30 days, the agency will remove the registration from its database. FDA’s new verification step makes it more important than ever to designate a reliable U.S. Agent. Learn about the benefits of designating Registrar Corp as your U.S. Agent here.
Q: “Is a foreign facility required to provide assurance that FDA will be permitted to inspect the facility?”
A: Yes, foreign food facilities are required to assure that FDA will be permitted to inspect their facility in ways outlined by the Food, Drug, & Cosmetic Act (FD&C Act.) Registrar Corp can provide a mock inspection service to ensure that foreign food facilities meet all FDA inspection requirements.
Q: “If a foreign facility has not renewed its registration by December 31 of a biennial renewal period, will the facility still be able to import food into the United States?”
A: If a food facility does not renew its registration by December 31, its registration will be deemed expired and FDA will cancel the registration. Food exported to the US by a foreign facility with a canceled registration is subject to being held at the port of entry.
Q: “If I am the owner, operator, or agent in charge of a facility, may I authorize another individual to update the facility’s registration?”
A: Yes, the owner, operator, or agent may authorize another individual to update a facility’s registration. This person may or may not be the facility’s U.S. agent. As a facility’s U.S. Agent, Registrar Corp will update and renew a facility’s registration at no additional cost.
FDA also added many questions regarding the Unique Facility Identifiers (UFIs) finalized in the July 2016 rule. Examples of some new UFI questions include:
Q: “When will I be required to submit a UFI in my registration submission?”
A: A UFI will be required in registration submissions beginning on October 1, 2020.
Q: “Which UFI or UFIs are recognized as acceptable to FDA for food facility registration purposes?”
A: FDA recognizes Data Universal Numbering System (DUNS) numbers as acceptable UFIs. Though FDA’s UFI requirement does not come into effect until 2020, it is prudent to apply for a DUNS number for your facility in advance, as it may take some time to obtain. Registrar Corp can assist a facility in obtaining a DUNS number free of charge.
FDA has opened up the draft guidance for public comment. You may submit your comments for here. Submit by February 6, 2017 to ensure your comments are considered before FDA begins working on its final draft.
Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including registration, registration renewal, and new requirements under the Food Safety Modernization Act (FSMA). Registrar Corp’s Regulatory Specialists register and renew thousands of food facilities each year and act as the U.S. Agent for over 13,000 facilities around the world. Contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp for assistance.