FDA Gives One-Month Grace Period for Food Facility Registrations
Foreign and domestic food facilities are getting a little more time to make sure they are properly registered with the Food and Drug Administration. FDA had previously set a Dec. 31 deadline for facilities that manufacture, process, pack or hold food for human or animal consumption to register or renew their existing registrations, which must be done every other year. However, FDA is now extending that deadline for a month in light of delays in this year’s registration process and the substantive changes to this process that were included in the Food Safety Modernization Act.
Specifically, FDA intends to exercise until Jan. 31 enforcement discretion with respect to registration renewals submitted after Dec. 31. As a result, FDA will not suspend the registration number for facilities that submit a registration or renewal during this one-month period. Nevertheless, the agency is encouraging facilities to renew their registrations as early as possible.
FDA has also issued two new guidance documents to further assist facilities that must comply with this registration requirement. “What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide” contains information regarding who is required to register and who may be exempt, how often facilities must register and renew registrations, when FDA may suspend a registration, and how facilities may submit their registrations and registration renewals to FDA. Among other things this guidance highlights the additional information that must be provided in a facility’s registration pursuant to the Food Safety Modernization Act, which includes the email address of the U.S. agent for the foreign facility and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act. “Questions and Answers Regarding Food Facility Registration (Fifth Edition)” contains updated answers to questions regarding food facility registration that are based on the FSMA amendments.
Those affected by the new registration requirements are reminded that FSMA also imposes new burdens and potential liabilities on entities designated as U.S. agents to foreign food facilities. One of these liabilities stems from FSMA §107 concerning re-inspection fees. It is believed that in 2013 FDA will begin charging $289 per hour for the time it devotes to re-inspecting foreign food facilities, resulting in the potential for invoices to reach several thousands of dollars per re-inspection. The FDA will hold the U.S. agent responsible for paying all re-inspection invoices. Accordingly, brokers, forwarders and importers of record will likely want to find alternatives to becoming U.S. agents themselves and foreign food facilities will need to seek out entities to become U.S. agents.
FDA Solutions Group LLC, a consulting company affiliated with the customs and international trade law firm Sandler, Travis & Rosenberg, assists foreign and domestic clients with the registration and compliance requirements affecting FDA-regulated industry. FDA Solutions Group makes it easy for food facilities to protect against suspension and costly business interruptions through its turn-key registration and U.S. agent services. To learn more about these services or submit your registration renewal today, please visit our Web site at www.fdasolutionsgroup.comor send us an e-mail at firstname.lastname@example.org.