FDA to revise safety rules based on comments

09/03/2013 04:47:00 PM
Coral Beach

Federal officials say they will revise proposed rules for foreign supplier verification programs and the accreditation of third-party auditors based on industry and public comments, which are due Nov. 26.

Officials from the Food and Drug Administration presented information on both proposed rules during an Aug. 19 Web seminar sponsored by the Produce Marketing Association, Newark, Del., and a group of other interested entities, including U.S. commodity groups and produce groups from foreign countries.

More than 400 people from 29 U.S. states and 15 countries registered for the seminar, said moderator Bob Whitaker, PMA’s chief science and technology officer. The free program will be repeated Sept. 10 by PMA and FDA presenters who speak Spanish. Registration details are available on the PMA website.

Condensed versions of the proposed regulations, as well as links to the full rules and directions on how to file comments with FDA are all available on the PMA’s website on the “resources” tab: www.pma.com/recources. The proposed rules are required by the Food Safety Modernization Act.

Brian Pendleton, attorney/senior policy advisor at FDA, said during the seminar the fact that the U.S. imports 50% of its fresh fruits and 20% of its fresh vegetables makes the proposed rule on foreign supplier verification programs important to the entire industry, not just importers.

After the online session, Whitaker said he thought the number of questions asked about “Options 1 and 2” in the foreign supplier verification program proposed rule showed the agency has some revision work to do. The options have to do with who has the responsibility to control identified hazards and what importers have to do to verify proper actions have been taken.

Pendleton repeatedly said FDA does not consider the proposed rule to be the final version and encouraged participants to file comments.

Several seminar participants asked Pendleton who the FDA considers to be the responsible party when retailers buy fresh produce from a supplier who imports it. Pendleton said the person or entity that owns the food at the time it comes into the U.S. is the responsible party.

As for the proposed rule on accreditation of third-party auditors, another attorney/senior policy advisor from FDA, Charlotte Christin said FDA officials studied existing regulations before drafting the accreditation proposal.

“We are trying to build on what already works,” she said.

Christin said the agency is particularly interested in receiving comments about its proposal to have certification by a third-party auditor satisfy some requirements in the foreign supplier verification program. She stressed that FDA does not want to impose duplicate requirements.



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