On September 19-20, 2013, the U.S. Food and Drug Administration (FDA) conducted a public meeting on Proposed Rules published in July to implement the Food Safety Modernization Act (FSMA). The proposed rules are Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) and Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.

The FSVP rule lays out requirements which U.S. importers of food from suppliers outside of the U.S. must follow to ensure that imported food products meet U.S. food safety standards. The third-party accreditation rule sets requirements which accreditation and certification bodies must meet to become third-party auditors of foreign food facilities or accreditors of such entities. Each of the rules is key to the implementation of FSMA.

Nearly 375 people attended the meetings, including representatives from stakeholder associations and international and domestic companies interested in food safety. For each rule, FDA staff reported on the regulation parameters, the intent of the agency regarding key details, and economic analyses and global outreach.

For the FSVP rule, public comment focused on supplier verification provisions and whether on-site audits of foreign suppliers should be required, foreign food safety systems recognition, and how existing accreditation programs would work under the new law. The FDA proposed two options for verification procedures – one with on-site audits and one without. The former would be required for food or production process with a higher likelihood of serious harm to consumers. Several of the public commenters suggested every establishment should be subject to on-site inspection, without exception, although a number also endorsed the two-option approach.

The period for public comment on each of the rules ends November 26, 2013. Those interested in commenting can do so at www.regulations.gov. Enter docket number FDA-2011-N-0143 to view and comment on the FSVP rule, and number FDA-2011-N-0146 for the third-party rule. All submitted comments are public. The normal process is for FDA to take several months to consider comments and publish final rules.

 Click here to view materials from the public meeting.