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:


Some excerpts:

Background:

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.



TK: Whew! And we are just getting started… Here are just a few of the 60 frequently asked questions…
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Q. Will the Reportable Food electronic portal allow partial submissions to be saved and will it save them automatically? Will I be able to review a report that I previously submitted?

FDA: No, release 1.0 of the Reportable Food electronic portal will not allow partial submissions to be saved, and it will not have an automatic save feature (in case you end your session before submitting your report). Also, you will not be able to use release 1.0 of the Reportable Food electronic portal to retrieve and review previously submitted reports.
Enhanced features, such as the ability to save partial reports, the ability to retrieve previously submitted reports, and the ability to make edits to previously submitted information are planned for future versions of the Reportable Food electronic portal.


Q. Is a food that presents a Class I recall situation a reportable food?

FDA: Yes. FDA interprets the definition of reportable food to include those foods that would meet the definition of a Class I recall situation. A Class I recall situation is one in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Q. I received a positive microbiological test result indicating the presence of a pathogen in food. Based on this test result, the food would be "reportable." However, I retested the food for the pathogen and the second test result did not indicate the presence of the pathogen. Should I still consider the food to be reportable?

FDA: Yes. There are a number of explanations why a food may test positive for a pathogen in one test and negative in one or more additional tests although the food continues to be contaminated. For example, the distribution of a pathogen in the food may not be homogeneous. Therefore, absent other circumstances clearly demonstrating the inaccuracy of the first test result, the first test result upon which the reportable food determination was made should be considered valid.

Q. When is a responsible party not required to submit a reportable food report to FDA for food that would otherwise be reportable?

FDA: A responsible party is not required to submit a reportable food report when all of the following criteria are met:
The adulteration originated with the responsible party; AND
The responsible party detected the adulteration prior to any transfer to another person of such article of food; AND
The responsible party corrected such adulteration; or
destroyed or caused the destruction of such article of food.




TK: The mere technical aspects of the portal are challenging enough, not to mention the attention to detail that it will demand of produce companies who wish to stay on the right side of this ambitious law.