Not only does Cohen provide an extensive series of comments about the rule, he also provides an executive summary.
From his summary:
The comment begins with “The proposed rule is a mess...” and ends with “The Secretary would be a fool to sign it.” In between I criticize the justifications given for the proposed rule, its structure and some key parts of its content.
A central concept behind the critique is that the rules developed for leafy greens in California, and for other commodities with a persistent record of outbreaks, appear to be the models for this proposed rule. Ripped out of their original contexts, they are not appropriate for a national rule for all produce. However, the analysis given for the proposed rule appears to have been distorted to achieve this result.
“Only a fool would grow fresh produce without considering food safety” especially when it is going to be eaten as a raw fresh vegetable without a kill step. The question is the balance, what is reasonable, and what is actually known. To some extent it also involves what the FDA is capable of doing well. Separating out fresh-cut and sprouts, I give some alternatives to the proposed rule, one from a fresh-cut processor that takes four sentences, and one based on my own conclusions. These could be considered different approaches to take in a revised rule. .
Although I interviewed a number of people to get some perspective of my own, both for attribution and for background, none of them are responsible for the use I make of their information or any other judgments or assertions in this Comment. Their approved interview notes or statements, are part of the Comment. In Jim Prevor’s case I use part of a recent column with his approval. I would have liked to include more people who disagreed with me.
Much of the original work that informs this comment was done in 2008 and resulted in the CAFF Guide to food safety issues and their politics. The basic idea in the Guide was that a new type of pathogen O157:H7 affected a new type of processing without a kill step, fresh-cut. At the time fresh-cut was not even recognized as processing.
The CAFF Guide and my 2010 written comments to the proposed Preventative Controls for Fresh Produce, Request for Comment are incorporated by reference and attached as separate pdf’s.
I was encouraged to do a 20,000 foot overview of the proposed Rule, how it fits together and with other rules and laws. It does not look good from 20,000 feet and it looks worse up close.
TK: I would encourage everyone to check out Cohen’s exhaustive comments, which are particularly tough on FDA’s approach to regulating farmers in contrast to FDA’s treatment of fresh cut processing facilities.
Here is the gist, from a 75-page comment:
Farmers are made to pay the price for others’ failures and for systemic failure. The rule treats all food safety as the consequence of individual actions on a farm.There are sufficient hazards to look at on-farm. But there is not a clear outbreak record saying planting to harvest has actually caused many outbreaks. How the FDA ended up in this position is part of the analysis. The short version is: all produce farms in the country are treated as part of HACCP for fresh-cut processing.