What exactly is a guidance document and what is its role?
A guidance document can serve many purposes but is almost always designed in one way or another to assist the regulated industry or the public or even the regulators themselves by describing “the agency’s interpretation of or policy on a regulatory issue,” to quote an FDA description. They aren’t mandatory as such, as are the laws or regulations they refer to or are based on.
When FDA recently marked the start of the effectiveness of new requirements due to the Food Safety Modernization Act, it issued a written interview with Joann Givens, co-chair of the agency’s FSMA Operations Team Steering Committee, who said that many companies had to begin to comply with key requirements under FSMA on September 19, 2016, notably the new preventive controls and current Good Manufacturing Practices requirements. She offered some insights into the agency’s approach to enforcement.
FSMA requires food companies to undertake important new steps relating to their processes, personnel, and recordkeeping. An important aspect of the agency’s implementation of these requirements is education of the regulated industry, as both the regulators and the businesses feel their way forward with the many new regulations under FSMA.
And here’s the thing: FDA’s website lists 14 final and proposed regulations it’s been making due to the law, but 20 final and draft guidance documents. That’s no surprise, perhaps, because guidance documents are an important player in the regulatory world, and seem to be of growing importance recently for FDA in particular. In FSMA, Congress specifically instructed FDA to make guidance documents on some topics, and to make regulations on others. Some years ago FDA actually made a regulation about guidance documents. At 21 CFR 10.115, FDA sets out its ‘good guidance practices’ aimed at enhancing transparency and consistency in guidance processes.
There are several important roles to be played by government-issued advice as opposed to government-issued requirements, and one is morale. By helping show the regulated industry what the regulators are thinking and how industry can be sure to comply with new requirements, agencies help blunt criticism that regulations are inscrutable, overly burdensome, or cumbersome.
Guidance documents give agencies a chance to communicate more freely with industry and are quicker and easier to make than regulations. They aren’t subject to the legal challenges that regulations are that can sometimes prevent regulations from going into effect at all.
And best of all from the regulators’ perspective, guidance documents might be just as effective as regulations. Yes, it’s true, many regulated businesses are quite conscientious and try to do what the regulators recommend they do.
When a new law or regulation calls for businesses to take one or another action or achieve one or another result, but there are multiple possible ways to do so and it’s not clear which would meet FDA’s strictures, I often tell clients there are two important points to keep in mind.
First, if you choose to do something—manufacture a component, sanitize equipment, whatever—in a manner different from how the agency recommends you do it, you bear the burden of proving your method achieves the desired result. The regulators will even tell you so. Here’s what FDA says about its many guidance documents: “Guidance documents represent FDA’s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.”
Second, there’s this very practical advice: the fastest way to a regulator’s heart is to follow the recommendations in its guidance document. That’s the one action you know for sure the agency will find compliant with the law and regulation; anything else you’ll have to prove. Now of course there are many situations in which your way is better or cheaper or both and worth fighting for, but if you need a quick answer as to how to comply, following the agency’s guidance is a good road map.
The most common path that regulatory agencies take for making regulations is provided for by a federal law, the Administrative Procedure Act. That law requires the regulators to publish the rules in proposed form, receive comments and other input from the public, mull those over, then publish final regulations taking due account of substantive comments, explaining its reactions to them.
Over the years, Congress and the President have added a series of requirements for analyses of various kinds to accompany rulemaking procedures, such as cost-benefit analyses and evaluation of the regulation’s effects on small businesses, and those chores make the process more of a headache for regulators. Also, once a regulation is final and being enforced by the agency, regulated industry or members of the public can challenge it on one or more substantive grounds, claiming for example that it was made without due attention to specified facts or Congress’ instructions, or that it is arbitrary or capricious. A challenged regulation can be prevented from going into effect by being tied up in court for years.
In the case of FSMA, there are so many new and changed requirements built into the law that industry and FDA are both feeling their way through its implementation, so guidance documents play an even more crucial role than in the past.