Two more FSMA rules proposed

Two more FSMA rules proposed

- Foreign supplier rule meant to ease FDA border inspection burden. - Accreditation rule forms system to recognize third-party auditors.

THE Food & Drug Administration released two more proposed food safety rules under the Food Safety Modernization Act (FSMA) of 2011.

The proposed regulations — the Foreign Supplier Verification Programs for Importers of Food for Humans & Animals and the Accreditation of Third-Party Auditors — join two previously released draft rules under FSMA that address produce safety at the farm level and food processing and storage facilities.

"Initially, we don't see any surprises in FDA's draft rules on imported foods and third-party auditor accreditation," said Dr. David Gombas, senior vice president for food safety and technology at United Fresh.

He added that the group will conduct a thorough review of the rules, including an analysis of their interaction with other FSMA draft rules, to "ensure that they advance food safety and are workable for the industry."

The Foreign Supplier Verification Program (FSVP) rule would establish guidelines by which importers must verify that food products imported from their foreign suppliers meet U.S. food safety standards.

FDA explained that this program will alleviate the burden of border inspection on FDA and allow for a more preventive approach to food safety, a key aim of FSMA. All non-exempt importers would be required to develop, maintain and follow an FSVP for each food it imports.

All FSVPs must be reassessed within three years, or when significant changes have been made.

The importer must also conduct verification activities to ensure that the foreign supplier: (1) has controlled each of the hazards identified in the importer's hazard analysis and (2) is in compliance with relevant FDA regulations.

Instead of an on-site audit, an importer may use an FDA inspection or an inspection of the foreign operation by an officially recognized food safety authority in the supplier's country, if performed within the past 12 months.

The rule also provides modified provisions (no exemptions) for "very small importers" or for importing from a "very small supplier," defined as annual food sales of $500,000 or less.

The third-party accreditation rule would establish a program to recognize certification bodies that provide accreditation to third-party auditors that conduct food safety audits and issue certifications of foreign food facilities.

The rule sets eligibility requirements for recognition as an accreditation body as well as for accreditation as a third-party auditor, according to an update from law firm Faegre Baker Daniels.

Comments on the proposed rules on foreign supplier verification and third-party auditor accreditation are due within 120 days of the July 29 publication in the Federal Register. FDA also indicated that the comment period for the draft preventive controls and produce safety rules will be extended 60 days past the current Sept. 16 deadline.

In the Faegre Baker Daniels update, Steven Toeniskoetter and Bradley McKinney said FSVP compliance would not be required until 18 months after the publication date. "Given the comment period and implementation timeline, compliance is unlikely to be required prior to 2015," they wrote.

For the third-party accreditation rule, Faegre Baker Daniels said FDA indicated only that it intends to implement the program as soon as possible after publication of the final rule and the final model accreditation standards. The latter will be published separately and will specify what qualifications a certification body must have to qualify for accreditation.

Volume:85 Issue:31

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