ARLINGTON, VIRGINIA, U.S. — The American Feed Industry Association (AFIA) on July 26 called on the Food and Drug Administration (FDA) to revise its draft guidance for industry on its Reportable Food Registry to ensure the registry legally recognizes standard commercial feed industry practices for ensuring the ingredients it uses are safe. Further, FDA needs to establish — based on best available science — when actions taken to ensure human food safety should be applied to animal feeds, AFIA said.
Under requirements of the FDA Amendments Act of 2007 (FDAAA), the Reportable Food Registry requires reporting any food, feed, ingredient or pet food deemed reasonably likely to cause serious adverse health effects or death in humans or animals. When a "registered facility" — the same "food producers," which register under the Bioterrorism Act — makes such determination, it has 24 hours to report the finding to FDA. FDA has solicited public comment on its question/answer document on how the registry operates.
In July 21 formal comments to the agency, AFIA Vice-President Richard Sellers focused FDA’s attention on the need to revise its proposed interpretation of a "responsible party" and to recognize a "transfer" of a food must include legal transfer of ownership before it becomes a "reportable food" for the purposes of the Reportable Food Registry.
"Today, the agency says if an ingredient company’s truck trailer containing a feed ingredient is left at a feed mill for quality and safety sampling — which may result in rejection of the load before ownership is transferred — the feed company is ‘holding’ the ingredient for purposes of the registry and if a problem is found during testing, it’s the feed company’s responsibility to report the contaminated load," Sellers said. "FDA is wrong."
FDA’s definition of "transfer" must be clarified for purposes of the registry to make clear no transfer occurs as long the responsible party has continuous physical possession of the food, AFIA said.
"FDA needs to change its thinking on what ‘transfer’ means when it comes to legal ownership and responsibility for the food in question.
"The feed industry, as well as other parts of the food industry, routinely sample and test ingredients prior to taking ownership. To contend a trailer left by the ingredient supplier for testing shifts responsibility for reporting a contaminated load doesn’t recognize common industry quality/safety assurance practices and is inconsistent with earlier FDA statements."
AFIA asked FDA to revise its draft guidance to include the following: "No reportable food report is required if a load of incoming product has been sampled, but legal transfer has not occurred, provided the trailer is on the premises of your facility only for as long as is necessary to sample, test and reject the shipment, and no longer. Your facility has not ‘held’ the reportable food. Therefore, you are not a ‘responsible party’ with regard to such food."
Sellers also called for clarification of FDA’s definition of "reportable food." The definition turns on the phrase "…will cause serious adverse health consequences to humans or animals" — as in a Class I recall — but FDA’s attempts to explain the definition "leave many questions unanswered and may be subject to misinterpretation."
Needing particular clarification is microbial contamination of animal feeds and raw materials, AFIA said. The draft guidance implies any positive test result makes the feed or ingredient a reportable food, but it’s well known salmonella found in feed "generally do not make the animals sick and pose little risk to livestock owners."
Sellers points out there isn’t enough information about the mere presence of salmonella in feed to conclude a risk rises to the level of having to report the food, and cites a Food and Agriculture Organization (FAO)/World Health Organization (WHO) 2007 report to support the association’s call for clarification that the presence of a human pathogen in a raw ingredient or finished livestock or poultry feed does not cause them to be a reportable food. Sellers acknowledged this would not apply to pet foods.