Your 2 Cents Worth Could Be Priceless

It is too easy to assume that federal bureaucrats propose new regulations, such as the ones recently released implementing the Food Safety Modernization Act, without harboring any possibility of alteration. The cynics say, “comment if you wish, but your views will bounce off FDA like spitballs off a submarine.”
But that view may not hold much water.
It is true that FDA is not required to follow the suggestions contained in comments from the industry. The agency is, after all, bound by the mandate given to it by Congress to overhaul the nation’s food safety apparatus.
For right now, however, the main thing to remember is that the proposed rules are just that: proposals.
“What FDA has released is what its current thinking is,” said Bob Whitaker, chief scientific officer of the Produce Marketing Association (PMA). “So we have a chance to inform and to educate. We can provide constructive comments, provide alternatives and help shape the rules.”
While attending a webinar on the new rules hosted by PMA, I was struck by the number of times both Whitaker and PMA Washington, D.C., representative Tom O’Brien mentioned that FDA was seeking industry guidance in comments on specific areas. The reason for this is simple: regulators and inspectors can’t possibly know more about the realities of the produce industry than those who are on its front lines every day.
That’s why veteran observers of the regulatory system will tell you that comments have a history of influencing change between proposed rules and final rules.
“The comments are the most important way we can have influence on the final rule,” said Ray Gilmer, vice president of issues management and communications for United Fresh. “When United puts together its comments, it’s going to the lengthy deliberative process involving working groups for each of the proposed rules. People will come together, either by phone or in person, and hash out line by line every bit of that proposed language.”
FDA will take comments from organizations, but also from individuals. Whatever the source, the comments need to be respectful and constructive — something diametrically opposed to what you see on the average Internet comment board or cable news channel.
Even better, the comment period gives the industry a chance to be proactive.
“Often, we let food safety happen to us. We wait for somebody to give us a rule or requirement we have got to follow,” said Whitaker. “This is one of those times we have to actively engage in the process. FDA wants to do this right, and they need industry input in order to do this right.”

Lee Dean, editorial director


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