Stenzel reaction

Tom Stenzel passed on these comments in an email responding to my blog post earlier about Donna Garren' s remarks about produce safety and the NRA's position going forward.

Here is what Tom says:

"I want to be careful that we don't confuse readers with semantics of what constitutes "guidance" vs. "regulation." It's quite clear that FDA's 1999 "guidance" document for fresh sprouts has the legal power to enforce compliance -- it says so right there in the legal language -- and that meets the definition of regulation in most dictionaries I know.

There's amazing consensus among FDA, expert scientists, industry, and many leaders in Congress that we need to put our regulatory attention and resources directly on those few commodities that have a history of connection to outbreaks. FDA published the data for this hearing -- only five commodities have been linked to 80% of the produce outbreaks in the past 10 years. That's where commodity specific "guidance" issued by FDA, with the legal and regulatory power to be enforced, is not only the quickest response, it is the most scientifically sound response."