On Friday, July 26, 2013, the U.S. Food and Drug Administration (FDA) released two more proposed rules as part of the ongoing implementation of the Food Safety Modernization Act (FSMA). Today, FDA published its proposed rules on 1) Foreign Supplier Verification Programs (FSVP) and 2) Accreditation of Third-Party Auditors. These rules are the 3rd and 4th proposed rules that are cornerstones of the preventive food safety approach established under FSMA. Our previous blog posting on the first two proposed rules on preventive controls and produce standards released back in January can be found here.
The proposed FSVP rule requires importers to perform certain risk-based verification activities that ensure that food imported into the U.S. has been produced in a manner that is on par with public health standards applicable to domestic food producers. Under the FSVP requirements, importers must develop, maintain and follow a FSVP for each food it imports, which would include a compliance status review, hazard analysis, verification activities (e.g., onsite auditing or periodic sampling), corrective actions, periodic reassessment of the FSVP, importer identification, and recordkeeping obligations.
The proposed rule on Third-Party Accreditation establishes a program for accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities. Unlike the FSVP program, this would not apply to importers, but instead contains requirements for accreditation bodies and third-party auditors, and FDA would recognize these bodies based on certain criteria such as competency and impartiality. Although importers will generally not be required to obtain certifications, FDA may nonetheless use certifications from accredited auditors in order to make decisions as to whether to admit certain imported foods into the U.S. that pose food safety risks.
These sweeping changes to food safety represent expansive new enforcement authorities that will require food manufacturers, distributors, and importers to take visible steps to prevent or mitigate liability as they make management, production, and handling decisions. With food safety at the forefront, these decisions can not only help to protect consumers from unsafe food, but could help shield producers from potential liability. In order to mitigate the risk of FDA enforcement activity, product liability claims and recalls, food manufacturers should familiarize themselves with these proposed rules and understand the implications to their business once these rules are finalized.
The two proposed will be published in the Federal Register on Monday, July 29, 2013 and the Comment Period will last for 120 days—until the end of November. Although the FSVP proposed rule states that the regulations would become effective 60 days after the final rule is published in the Federal Register, FDA is proposing additional time—up to 18 months—for importers to come in to compliance. Since the FSVP proposed rule is closely tied to the proposed rules on preventive controls and produce safety, compliance dates will hinge heavily on the dates that are established for these earlier proposed rules.