On April 9, 2015, the U.S. Food and Drug Administration (FDA) published a proposed rule that would add verification measures to its regulation for the registration of food facilities. The proposal is part of FDA’s implementation of the Food Safety Modernization Act (FSMA).
U.S. Agent Verification and Access to Registration Information
When a foreign facility registers with FDA, the facility is required to designate a U.S. Agent for FDA communications. FDA contacts the U.S. Agent with information about shipments and to schedule inspections. FDA is proposing that when a foreign facility designates a U.S. Agent on its registration, FDA would ask the designated agent to confirm they have agreed to the responsibility via the e-mail address provided by the foreign facility. FDA would not confirm a foreign facility’s registration or renewal or provide the facility with a registration number until the designated agent confirmed. When a foreign facility updates its U.S. Agent information, FDA would not confirm the update until the agent confirmed.
Currently when a facility designates a U.S. Agent, FDA e-mails a notice of designation to the agent, who then has 15 days to deny the position. If they do not deny, they automatically become the U.S. Agent for the foreign facility. The U.S. Agent is often unaware of their position as a facility’s U.S. Agent. For example, if a foreign facility uses an incorrect e-mail address, the agent never sees the e-mail and gets no chance to deny responsibility. This is a bigger issue now that FSMA has granted FDA the right to charge U.S. Agents re-inspection fees for their foreign facilities.
FDA also proposed to allow a foreign facility’s U.S. Agent to view the information submitted in the facility’s registration so that the U.S. Agent would have up-to-date contact information. FDA does not consider this public disclosure of registration records because the agency believes that “allowing U.S. agents to view foreign facilities’ registration information is the equivalent to allowing foreign facilities to view that information.”
FDA proposed that both domestic and foreign facilities be required to include their D-U-N-S number in their registration. FDA would use the D-U-N-S number as a verification tactic, as they would check to ensure the address associated with the D-U-N-S number matched the address associated with the facility’s FDA registration. FDA would not confirm a facility’s registration or renewal or provide the facility with a registration number until the agency confirmed that both documents used the same address. FDA would provide a direct link to obtain a free D-U-N-S number in its registration system for food facilities that do not currently have one.
Registration Authorization Verification
A food facility’s registration must be completed by the facility’s owner, operator, or agent in charge, or by an authorized individual. FDA is proposing that when a registration is completed by an authorized individual, they would be required to include the e-mail address of the individual who authorized them to do so. FDA would then email the individual identified as the authorizer to verify that the individual truly did authorize the submission. FDA would not confirm a facility’s registration or renewal or provide the facility with a registration number until the authorizer confirmed.
Registrar Corp published a previous article regarding additional proposals in the rule pertaining to retail food establishments, electronic registration requirements, and other registration requirements that became effective upon the enactment of FSMA. FDA is taking comments on the proposed rule until June 8, 2015.
Registrar Corp is an FDA consulting firm that helps food and beverage facilities comply with FDA regulations. Registrar Corp can register a facility with FDA, help a facility obtain a D-U-N-S number, and act as a facility’s U.S. Agent. If the U.S. Agent verification procedures are finalized, it will be more important than ever to have a reliable U.S. Agent. If a facility’s designated agent does not respond to FDA’s proposed e-mail, the facility’s registration would be invalid and FDA would consider its shipments to the U.S. to be misbranded. Contact +1-757-224-0177 to learn about the benefits of Registrar Corp’s U.S. Agent service, including FDA compliance monitoring, FDA inspection and detention assistance, and more. Registrar Corp offers 24-hour live help with FDA regulations at https://www.registrarcorp.com/livehelp.
This blog was originally published as a press release.