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FDA Seeks Comment On Reportable Food Registry Document

Public comment is being sought after by the FDA regarding the reporting of adulterated foods by manufacturers.

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The U.S. Food and Drug Administration (FDA) is seeking input on a document created to assist the food industry in complying with new requirements that pertain to the reporting of adulterated food.

The Reportable Food Registry (RFR) requires a responsible party to file a report through an FDA Internet portal when there is reason to believe that an adulterated food will cause serious adverse health consequences or death to humans and animals. The FDA’s “draft guidance,” provides questions and answers pertaining to the registry.

The RFR applies to all FDA-regulated categories of food, including pet food. Only infant formula and dietary supplements are exempt from RFR requirements. “Responsible party” is defined as the person who submits the registration information to FDA for a food facility that manufacturers, processes, packs or holds food for human or animal consumption in the United States. Federal, state and local government officials would also be able to use the portal to report information that may come to them about such foods.

The establishment of the registry is mandated in the Food and Drug Administration (FDA) Amendments Act of 2007. The Congressional intent for the RFR, according to the FDA, is to provide a “reliable mechanism to track patterns of adulteration in food [which] would support efforts by FDA to target limited inspection resources to protect the public health.”

The RFR and electric portal are slated for implementation on Sept. 8.

The FDA’s draft guidance explains:

• Who must submit RFR reports of adulterated foods to the FDA
• How, when and where RFR reports may be submitted
• What information the RFR reports must include
• What steps must be taken to notify others in the supply chain of the adulterated food

Interested persons may submit written comments on or before July 27 to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Click here to submit electronic comments.

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