FDA Reviewing Info Collection on Disclosure, Recordkeeping for Reportable Food
The Food and Drug Administration is accepting comments through Sept. 24 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.