Reporting a safety problem

For any petfood manufacturer with brands being made in the US, the issue of how, when and whether to report a potential safety or quality problem just got simpler--sort of.

Starting September 8, all food manufacturing facilities must now report any serious safety problem directly to the US Food and Drug Administration (FDA) through its new Reportable Food Registry portal.

FDA says: "Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the FD&C Act (21 U.S.C. 350d) are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals."

This is an outcome of the FDA Amendments Act of 2007, directly linked to the melamine-related petfood recalls of that year. While some manufacturers might view this new requirement as onerous, at least it clears up any questions about when you need to report. Or does it?

In his monthly "Petfood Insights" column in Petfood Industry, Dr. Dave Dzanis does his usual stellar job of explaining the whys and hows of this new regulation. He also points out some ambiguity, though a new guidance document from FDA may help clear that up. Or not.

As Dr. Dzanis says, "The impression given by FDA is, if in doubt, the responsible party should err on the safe side and report the incident. FDA would then determine if the food was a reportable food."