On July 14, 2016, the U.S. Food and Drug Administration published a final rule to amend the registration of domestic and foreign food facilities. Part of FDA’s Food Safety Modernization Act (FSMA), the rule is intended to improve the accuracy of FDA’s registration database and improve efficiency with regard to FDA’s use of inspection resources.
The final rule codifies some of the self-implementing regulations that became effective upon the enactment of FSMA. These include:
- E-Mail Addresses: Domestic facilities must list an e-mail address for the contact person at the facility. Foreign facilities must list an e-mail address for their U.S. Agent for FDA communications.
- Inspections: All registrations must contain assurance that FDA will be permitted to inspect the registered facility.
- Registration Renewal: Food facilities must renew their FDA registrations between October 1 and December 31 of every even numbered year. FDA offers an abbreviated renewal process for facilities that have no information to update from their previous registration. FDA will consider non-renewed registrations to be expired.
- Registration Suspension: FDA may suspend a food facility registration if the agency has reasonable belief that food manufactured, processed, packed, or stored at the facility may cause serious adverse health consequences or death to humans or animals.
The final rule also mandates new amendments to update FDA food facility registration:
- US. Agents: A facility’s designated U.S. Agent will be able to view information submitted in the facility’s FDA registration.
- Third-Party Submitters: Food facilities may authorize a third-party individual to complete their FDA registration on their behalf. Under the final rule, an individual submitting a food facility registration that is not the owner, operator, or agent in charge of that facility must identify the name, address, and phone number of the individual who authorized the third-party submitter to submit the registration. The submitter must also identify himself in the registration. FDA will not confirm a registration until the owner, operator, or agent in charge of the facility confirms with FDA that it has authorized the third-party submitter to manage the facility’s registration.
- Product Categories and Activities: The Agency plans to add four new food product categories and revised three existing food product categories for animal food. FDA will update the Food Product Categories Guidance if it makes changes to those for human food. Facilities must now identify the type of activity conducted at the facility for each food product category identified. FDA plans to update the Types of Activity categories in Form FDA 3537, replacing the current “Acidified and Low Acid Canned Food Processor” category with separate categories for Acidified and Low Acid foods. Facilities that engage in holding or storing products must identify the type of storage provided at a facility (Ambient, Refrigerated or Frozen). FDA plans to add a new category for Farm Mixed-Type facilities that engage in both activities that are exempt from registration under section 415 of the Food, Drug and Cosmetics Act and activities that require the establishment to be registered. The agency plans to update Molluscan Shellfish to a Food Product Category instead of an Activity Type.
- Electronic Registration: Beginning January 4, 2020, food facilities will be required to submit food facility registrations (including renewals, updates, and cancellations) electronically. A facility may request a waiver from FDA if it is unable to submit electronically.
- Retail Food Establishment: The rule updates the definition of a retail food establishment to include (1) The sale of food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.
- Unique Facility Identifiers: FDA will require food facilities to list a Unique Facility Identifier (UFI) in their registration in order to verify the information provided in the registration. In the proposed rule, FDA specifically proposed to require Data Universal Numbering System (DUNS) numbers. The agency did not finalize this requirement. FDA will publish additional information regarding what UFIs will be recognized as acceptable for use in food facility registrations. While DUNS numbers are not required, the final rule does state that FDA expects to recognize DUNS numbers as acceptable UFIs. FDA expects to initiate the UFI requirement on October 1, 2020.
- Registration Cancellations: FDA updated the circumstances under which the agency will cancel registrations. According to the final rule, FDA will cancel a registration if:
- FDA independently verifies that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration;
- FDA determines that the registration is for a facility that does not exist, is not required to register, or where the information about the facility’s address was not updated in a timely manner in accordance with § 1.234(a);
- The registration was submitted by an unauthorized individual;
- The facility’s registration has expired due to failure to renew in accordance with § 1.230(b).
In addition to updating the reasons for cancellation, FDA also finalized the proposal to accept corrective action if it is submitted within 30 days of a cancellation confirmation. If circumstances meriting possible cancellation are corrected within 30 days after notice is provided, when appropriate, FDA will not cancel the registration.
It is prudent for food facilities to stay up-to-date on U.S. FDA registration requirements in order to avoid having their registration expired, suspended, or cancelled by FDA. Marketing food from a facility with an expired, suspended, cancelled, or otherwise invalid FDA food facility registration in the United States is a prohibited act. Food from a facility without a valid FDA registration may be stopped at the border when being imported into the United States.
Registrar Corp can quickly and properly register a facility with FDA as well as renew or update a facility’s registration as required by FDA. Registrar Corp can also act as a foreign facility’s required U.S. Agent. Registrar Corp’s U.S. Agent service provides numerous benefits, including:
- Required registration updates and biennial registration renewal.
- Three free Prior Notice filings each year
- Detention and inspection assistance
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- And more
For more information about FDA registration requirements or Registrar Corp’s services, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.