How To Make Effective Comments On The FDA's New 'FSMA' Regulations

If You Want Your Opinion to Count, Think Like a Bureaucrat

As we've previously written, the most sweeping changes to food regulation in decades are underway. To implement the 2011 FDA Food Safety Modernization Act, (which is known by its acronym, FSMA), the FDA has proposed two major sets of regulations. The first, the Produce Standards, imposes a new and pervasive regulatory regime upon farms. The second, the Preventive Controls rule, will affect most facilities that are registered with the FDA, most notably by broadly imposing regulations comparable to the "HACCP" regulations that are currently mandatory only for seafood, juice, meat, and poultry facilities. (If you want to see the official texts of FSMA and the two regulations, follow the embedded hyperlinks above.)

These regulations are not in their final form. The FDA is actively seeking comments about the regulations, and it promises to carefully consider the comments before finalizing the rules. The FDA is doing this, in part, because it has to. In addition, at a recent public meeting, top FDA officials insisted that they genuinely want to receive comments, and that quality input will help them write a better rule. But even taking these sentiments at face value—and the FDA officials did sound sincere—not all comments are created equal. If you want your comment to be persuasive, and not just considered and rejected, you need to think like a bureaucrat.

We don't mean that you should surrender to the worst stereotypes of how Washington operates. Rather, to persuade the bureaucrats, you need to put yourself in their shoes. Keep in mind, first of all, that the FDA does not operate with a free hand. While it does have a lot of discretion on some issues, the FDA must always follow Congress' mandates regarding which problems should be addressed, which ones should not be, who can and cannot be regulated, and how they can be regulated. Second, within the mandate provided, the FDA has a job it wants to accomplish. It wants to make America's food supply safer. Even if you think our food is plenty safe already, you won't get anywhere by saying so.

Third, drafting regulations is difficult work. A rule must be clear and understandable, or no one will know how to comply. It must be strong enough to accomplish its goals but not so blunt that it imposes unnecessary burdens, all the while being flexible enough to accommodate varying circumstances. And every decision made while crafting a rule must be...