F.D.A. seeks more info through food registry
June 5, 2012
by Jay Sjerven
WASHINGTON — The Food and Drug Administration on June 4 brought on-line a new Reportable Food Registry (R.F.R.) Rational Questionnaire that it said incorporates additional data elements as part of an effort to improve the R.F.R.’s information-gathering capability.
The R.F.R. is an electronic portal to which the food industry must, and public health officials may, report when they have information about a reportable food. A reportable food is an article of food or feed 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 F.D.A. said by gathering and analyzing the new data, it will improve its ability to track patterns of adulteration in human food and animal feed (including pet food) and to target its inspection resources.
The additional elements are:
1 — The reason the food has been determined to be reportable (agent).
2 — A description of the root cause of the reportable food, if applicable.
3 — A brief justification of the process used to determine which product(s), lot(s), or batch(es) were affected.
4 — Whether or not the submitter believes all of the reportable food has been removed from commerce.
5 — A brief description of the corrective actions taken to avoid repeating the reportable event.
6 — The commodity type of the reportable food.
7 — The dates that the product was manufactured.
8 — Whether or not the reportable food underwent treatment to reduce microorganisms.
9 — A brief description of the microbial reduction treatment.
10 — Whether or not a bacterial isolate is available for F.D.A. collection.
11 — For reportable foods intended for animal consumption, the animal species for which the reportable food was intended.
12 — For reportable foods intended for animal consumption, the life stage of the animal for which the reportable food was intended.
13 — Whether the responsible party has notified all of its immediate previous sources or suppliers of the reportable food, if applicable.
14 — Whether the responsible party has notified all of its immediate subsequent recipients or customers for the reportable food, if applicable.
The F.D.A. said providing information in response to the new data elements was voluntary for the time being; however, later this year, responses to these elements will become mandatory.