Amidst the pending food safety debate in the Senate, the health care reform brouhaha and the climate change debate, there is the matter of the Food and Drug Administration’ Reportable Food Registry.
I visited today with Kathy Means and David Gombas about the RFR, and what they said was not exactly reassuring for the trade.
Gombas believes there are a great many in the industry that are unaware of the requirements of this law.
More from those two in coverage for The Packerr….
Here are some questions about the RFR:
Will the FDA have a period of soft enforcement for the electronic portal?
Will the effect of the law be to discourage product testing by produce marketers?
How realistic is the process of electronically filing a report on the portal? Gombas said the questionnaire associated with the registry is lengthy in the extreme.
Here is the link to the FDA’s guidance to the industry:
On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). This law amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by creating a new section 417, Reportable Food Registry. Section 417 requires the Secretary of Health and Human Services (the Secretary) to establish within the Food and Drug Administration (FDA) a Reportable Food Registry.
The congressionally-identified purpose of the Reportable Food Registry is to provide a "reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health" (Pub. L. 110-085, section 1005(a)(4)). The Secretary has delegated to the Commissioner of the Food and Drug Administration the responsibility for administering the FD&C Act, including section 417. To further the development of the Reportable Food Registry, section 417 of the FD&C Act requires FDA to establish an electronic portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials.
After receipt of reports through the electronic portal, FDA is required to review and assess the information submitted for purposes of identifying reportable food, submitting entries to the Reportable Food Registry, issuing an alert or notification as FDA deems necessary, and exercising other existing food safety authorities under this Act to protect the public health.