As previously covered on this blog post, FSMA Final Rule Follow-Up, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017 (for a summary of which importers are covered by the general compliance date, see FDA Issues New Guidance on Food Safety Modernization Act’s Foreign Supplier Verification Program Rule). The U.S. Food and Drug Administration recently issued additional guidance for importers on FSVP compliance.

In the new guidance, issued in a question and answer format, FDA noted that the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system will now require filers to provide an “entity role code” to indicate whether the importer is subject to the May 30 compliance date. If so, the entity should enter “FSV,” which will prompt the ACE system to ask for the importer’s name, email address, and unique facility identifier.  If the food is exempt from FSVP because it will be used for research or evaluation in accordance with 21 CFR 1.501(c), the filer should enter code “RNE”; if the food is exempt from FSVP for any other reason, or if compliance with FSVP is not yet required, the filer should enter code “FSX.”

FDA indicated that it will focus on education, training, and technical assistance as regulated entities work to understand and comply with the new regulations.  The Agency stated that, at this time, its priority is to support compliance, but cautioned that “when appropriate, the agency will act swiftly” in response to “problems that pose a danger to health or reflect intentional disregard for legal responsibilities.”

We will continue to monitor and report on FDA’s activities to implement the FSVP rule and other FSMA related activities.