In a piece titled, Science-based Or Emotion-based? As Food Safety Modernization Act Soon Goes Into Effect, Industry Looks At Extra Costs And Little Return To Public Health,we discussed — with the help of a crack legal team from Jones Day— some of the implications of new food safety rules being proposed by the FDA to implement the Food Safety Modernization Act.
The legal team includes some produce royalty in the form of Harold Gordon, son of Myra Gordon, Executive Administrative Director of the Hunts Point Market in the Bronx. So the team not only is widely respected for legal acumen but actually cares about the produce trade.
On April 17, 2013, in response to a question by Senator Roy Blunt (R-MO) at a Senate Agricultural Appropriations Subcommittee hearing, Commissioner Margaret Hamburg announced that the FDA would be extending by 120 days the comment period which had originally been due to close on May 16, 2013. So now the industry has time to study the rules and submit comments.
The trade associations play an important role here but, very often, they don’t have the detail of knowledge about how, precisely, the rules will affect, say, rutabaga farmers, to give all the detail that could lead to a change in the rules. It is also true that bureaucrats are not unmindful of politics, and a swelling of critiques of the new proposals from particular states or congressional districts can rouse the interests of Senators or Representatives who have their own way of weighing in on the process.
Over the years, though, we have found that many industry members comment in such a way that they can’t have much effect. The comments deal with broad policy decisions that are made by Congress and the President, not the rule-making based on specific legislation that the FDA officers have to develop.
So how does one write an effective comment? We asked the team from Jones Day to make an encore appearance and provide some specific suggestions on how to comment in a way that makes a difference.
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 justified. If not, a court may strike down the rule, refuse to enforce it, or make the FDA start over.
So, here are a few simple tips for how your comments can have an impact on the final shape of the rules.
Details Matter. You could tell the FDA rule-makers that they shouldn’t impose requirements that cost a lot of money but do nothing to improve safety. But they already know that. In fact, they think their proposed rules already reflect this principle. If you disagree, you need to show them where they have fallen short. Let them know which requirement is unnecessary or unduly costly. If a particular part of a rule is ambiguous, tell the FDA exactly which provision troubles you, why it has more than one meaning or reflects a misunderstanding of how your business operates, and how the rule can be reworded.
Mastering the Details Matters. The two new proposed FSMA rules, taken together along with their preambles and appendices, cover hundreds of pages in the Federal Register with dense prose and technical jargon. Who reads all this stuff? Well, the people you’re talking to did. In fact, they wrote it!
You don’t need to read every word in order to provide effective comments. But you will need to find the portion of the rule that causes you concern. And the preamble is where you can find the FDA’s explanation for why they wrote the rules the way they did, which regulations they viewed as compelled by Congress and which reflect their judgment, and what choices and trade-offs were part of the rule-making process. It’s not very effective to simply ask the FDA to reach a conclusion that the rule-makers already rejected. It is much more effective to explain why the conclusion doesn’t fit the facts, and to do that you need to first understand what they had in mind.
Facts Matter. If you want to grab the rule-makers’ attention, tell them something they don’t know. The regulators are acutely aware that the “real world” is larger and more complex than the view from their desks. This is doubly true regarding farm operations, since to date the FDA has far less experience with farms than with other portions of the food supply chain.
The FDA officials said as much at the recent public meeting, and emphasized that they view public comments as an important learning tool. And, they have emphasized repeatedly that they want the final rule to be “risk-based” and “flexible.” This means that although the FDA will make businesses spend real money to prevent food-borne illness, the FDA does not want to burden operations that do not present such risks. So, one of the best ways to convince the regulators is to give them the information that they currently lack, so that they understand why a particular proposal does not make sense in a real-world situation.
Evidence Matters. At the public meeting and elsewhere, FDA officials repeatedly invoked the mantra that their rules are “science-based.” To shake their faith in the scientific nature of the proposed regulations, confront the FDA with evidence. This evidence can come in many forms: scientific studies regarding the transmission of pathogens, industry studies regarding best practices, actual costs incurred for a task that the FDA wants to see repeated across all facilities, etc. The assertions in your comments may point the FDA toward issues that should be further explored, but assertions backed by studies or data are much harder to ignore.
Comments on both rules have been extended and are now due by September 16, 2013. To submit your comments, go to www.regulations.gov, search for docket number FDA-2011-N-0921 (for the Produce Standards rule) or FDA-2011-N-0920 (for the Preventative Controls rule), and follow the on-screen directions.
Although it is certainly not essential, individuals and organizations submitting comments in response to proposed regulations frequently enlist lawyers to help shape and draft their input. If you have questions about these articles we’ve written for the “Pundit” or would simply like to discuss the proposed regulations or your participation in the comment process please feel free to get in touch with any of the authors.
June K. Ghezzi
Harold K. Gordon
New York, New York
Many thanks to Jonathan, June and Harold for helping the industry become more effective in dealing with this process. Our sense is that this round is a rare opportunity. The FDA knows little about farming and knows this, so they are more open to learning than they typically are. So here is the opportunity for the industry to state its case or forever hold its peace.