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FDA Issues Guidance on Registry Reporting for Multiple Facilities

Mar 26, 2010

The Food and Drug Administration has issued new guidance to industry to help companies comply with some of the requirements of its Reportable Food Registry, which went into effect last year. The guidance clarifies that companies only need to submit one report to the registry for a reportable food incident that involves more than one of the company's facilities.

The registry, included as a provision in the FDA Amendments Act of 2007, imposes new reporting responsibilities on food industry manufacturers and suppliers, including IDFA members. It is intended to improve FDA's ability to ensure the safety of the domestic food supply.

A reportable food is any food product or ingredient for which there is a reasonable probability that the use of or exposure to the product will cause serious harm or death to humans or animals. Companies are required to file with the registry within 24 hours of the company making a determination that the food product has a reasonable probability of presenting this kind of risk.

The guidance, entitled "Guidance for Industry: Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007," supplements previous industry guidance issued by FDA last September.

At this time, IDFA still anticipates that FDA will issue revised guidance for industry related to the transfer issue that has concerned a number of companies. (See "FDA Reportable Food Registry Now in Effect" for details.)

Members with questions may contact Clay Detlefsen, IDFA vice president of regulatory affairs, at


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