FDA proposed rule for FSMA to support importers

This proposal includes who would be subject to a fee; how fees would be computed; how FDA would notify the public about annual rates; how it would be collected; and consequences for not paying a user fee.

It forms part of the Accreditation of Third-Party Auditors proposed rule, for which a comment period closed on January 27, 2014 and the agency is scheduled to make it final soon.

FSMA proposed rule​

The program under the Food Safety Modernization Act (FSMA) will help eligible foreign firms demonstrate imported food meets safety requirements.

It would provide for accreditation of third-party auditors/certification bodies (CBs) to do food safety audits of eligible foreign entities (including registered foreign food facilities), and to issue food and facility certifications.

Under this program, FDA would recognize accreditation bodies (ABs) to accredit CBs, except for circumstances in which it may directly accredit CBs.

FDA will use certifications from accredited CBs in deciding whether to allow certain imported food into the country.

They will also decide whether an importer is eligible to participate in the Voluntary Qualified Importer Program (VQIP).

Participation in the program is voluntary for third-party auditors/certification bodies and the accreditation bodies that accredit them to audit food facilities.

FDA tentatively concluded there are four groups for charging fees: ABs submitting or renewing applications for recognition in the third-party accreditation program and recognized ABs participating in the program subject to FDA monitoring activities.

CBs submitting or renewing applications for direct accreditation; and accredited CBs (whether accredited by recognized ABs or by FDA through direct accreditation) participating in the program subject to FDA monitoring activities.

One example of proposed fees was based on the estimated average cost of the work FDA performs in reviewing and evaluating an application for renewal of recognition for an AB would be $16,413 ($202/hour × (40 hours + 41.25 hours)) plus $2,440 ($305/hour × 8 hours), which is $18,853 total), according to the notice in the Federal Register.

The proposed rule and draft guidance will be available for public comment until 7 October​.

Food Safety Challenge​

Meanwhile, the agency has announced the winners of the 2014 FDA Food Safety Challenge.

The competition advances breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.

Purdue University’s “Physical method for concentrating Salmonella to detectable levels using automated microfiltration” was the grand prize winner.

It uses miniscule filters to capture small numbers of foodborne pathogens in large volumes of liquid suspensions.

Pronucleotein’s “DNA aptamer-magnetic bead sandwich assays to detect foodborne pathogens with a handheld fluorescence reader” was runner-up.

It uses small strands of DNA bound to magnets to capture pathogens, which are then tagged with pigments that can light up and be detected.

The grand prize winner and runner-up received $300,000 and $100,000.

FDA intends to continue working with winners to refine the technologies for potential use in testing processes.

Salmonella is the leading cause of deaths and of hospitalizations related to foodborne illness, estimated to cause 380 deaths and 19,000 hospitalizations each year.