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FDA Reviewing Info Collection on Disclosure, Recordkeeping for Reportable Food

Tuesday, June 03, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting comments through Aug. 4 on the proposed extension of an information collection regarding third-party disclosure and recordkeeping requirements for reportable food. Mandatory respondents to this collection are the owners, operators or agents in charge of a domestic or foreign facility engaged in manufacturing, processing, packing or holding food for consumption in the United States who have information on a reportable food.

The Federal Food, Drug and Cosmetic Act, as amended by the FDA Amendments Act of 2007, requires the establishment of a reportable food registry by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. A reportable food is an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

The FD&C Act also establishes third-party disclosure and recordkeeping burdens. Specifically, the FDA may require the responsible party to notify the immediate previous source(s) and/or immediate subsequent recipient(s) of a reportable food, and may also require the responsible party that is notified to notify their own immediate previous source(s) and/or immediate subsequent recipient(s). Notification may be accomplished by electronic communication methods such as email, fax or text messaging, by telegrams, mailgrams or first-class letters, or by telephone call or other personal contacts. The FDA may require that the notification include any or all of the following data elements: (1) the date on which the article of food was determined to be reportable; (2) a description of the article of food, including the quantity or amount; (3) the extent and nature of the adulteration; (4) the results of any investigation of the cause of the adulteration if it may have originated with the responsible party, if known; (5) the disposition of the article of food, when known; (6) product information typically found on packaging, including product codes, use-by dates, and the names of manufacturers, packers or distributors sufficient to identify the article of food; (7) contact information for the responsible party; (8) contact information for parties directly linked in the supply chain and notified, as applicable; (9) the information required to be included in the notification provided by the responsible party involved; and (10) the unique number described in section 417(d)(4) of the FD&C Act. The FDA may also require that the notification provide information about the actions that the recipient will perform.

Responsible persons must maintain records related to reportable foods for two years.

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