Contributed by The Acheson Group
The Acheson Group, LLC (TAG), led by Dr. David Acheson, is a strategic consulting firm for food and beverage companies and those providing technical support to the food industry.
The obvious answer to the question of “what is the role of the regulator” is to regulate, but what exactly does that mean? In the ideal world, the regulator actually has a much more complex role than simply to enforce rules and regulations. If we focus on the world of food safety, we can consider regulators at the local, state and federal level. Each plays a different role and, yet, there are overlaps in the approach.
If we examine this from a federal perspective in the U.S., it may help to look at the role of the regulator through the lens of the Food Safety Modernization Act (FSMA). As FSMA was developed, the regulators, in this case FDA, played a key role in developing what was in the legislation. Recognizing that Congress, and ultimately the President, has the final voice, regulators still have a significant say in the final act. But sometimes regulators want to gain new authorities beyond what Congress and the White House are comfortable with, as happened with FSMA.
Once a law is signed, the FDA swing into action and start to develop new regulations and new guidance documents based on their new authority. Their role is to protect the public and, sometimes, implementing the new legislation leads to a point when the economic burden is too high. In other words, there is not a balance with regard to the cost benefit analysis. Again, the White House, in this case the Office of Management and Budget, will enter the picture and will delete sections or propose new regulations if the economics don’t pan out.
Finally, we get to a point when the regulations are final. Industry has to comply and the regulators have to enforce them. This gets into a potential gray zone of “enforcement discretion”. Enforcement discretion gives the regulators some latitude on a case by case basis, and while it is often good for the industry, it is not necessarily easy to understand exactly what is behind any given decision. For example, the way in which the FDA will interpret different food safety plan implementation strategies or supply chain control systems may be somewhat loose and not overly prescriptive.
As noted in the opening paragraph, the ideal role of the regulator is more than just regulation. A good regulator wears two hats. The first is that of the enforcer and the second is that of the educator. The challenge is that not all inspectors charged with enforcement see the education component as part of their job. Yet the system works best when industry understands the ground rules and, in order for that to happen, there has to be an educational step. Then the regulators can hold the industry accountable based on that mutual understanding of the rules.
Often when one thinks of regulators we equate that with inspectors. Yet, we should not forget that in the U.S. food world of both FDA and USDA, there is a significant cadre of scientists behind the scenes. The role of these scientist is to ensure that policy and regulations are based on current science and are not the whim of a lawyer or a political figure to drive policy. Thankfully, this system generally works well; yet there are obvious tensions that exist. Often due to the very slow nature of change in the government, the rules that we have to follow have not kept up with the science. When this happens we end up with obvious and frustrating disconnections in the system. As a recent example, the issue of bisphenol-A (BPA) has been tough for FDA. The Agency has been under huge pressure to ban this from food – yet have taken a methodical and scientific approach to the problem and have continued to allow its use.
Another section of the regulatory community are the risk assessors. This group at FDA sits in the Center for Food Safety and Applied Nutrition (CFSAN). They are led by a small team who specialize in this work but typically bring in appropriate subject matter experts from the rest of CFSAN to address specific issues. They are charged with assessing risk in any given situation. Sometimes this is a long and complex process, such as the FDA/FSIS Listeria monocytogenes risk assessment undertaken several years ago. Sometimes it is quick, as in the case of a recall decision or when the situation poses a significant risk to health.
Regulators also play an important role when it comes to outbreaks of foodborne illness. This process typically starts with the local and/or the state regulators. They are usually the first to know of an outbreak and, based on the situation, may undertake an investigation. In the U.S., sometimes the Centers for Disease Control, who are not regulators, get involved and then, ultimately, the regulatory agencies get involved. Again, this is the regulator taking the role of protecting public health to take whatever immediate action is necessary to prevent further exposure in the community. Then the regulators take on the question of “how did it happen” at which point you can expect them to show up at your facility, if you were the subject of the recall, to take a very serious look at things.
Overall, the regulator is often seen as the enforcer, but in reality their role is much broader than that. Regulators rely on information flowing to them from the private sector in order to better understand food production and risks. If one takes an arms-length attitude to regulators you are not doing yourself any favors. The best strategy is for industry to engage with the regulators before you have a crisis. Get to know them, have them understand your commitment to producing safe products, get involved with data sharing when they ask for it – after all, they want this data to better inform risk decisions and those decisions drive regulatory policy. Logical, scientific regulatory policy helps us all.