To answer the question of whether the Food Safety Modernization Act (FSMA) will make a difference, I want to take a look historically at why FSMA ever got passed by Congress. To do this, I have to wind the clock back almost 10 years.
The only thing that got FSMA through Congress — and those who remember back to the end of 2010 will recall it was only by a squeak that it got through — was an unlikely alliance of stakeholders. So what created that alliance?
There were three major events that drove FSMA. The first was in 2006 with the large E. coli O157:H7 outbreak linked to spinach. This event drove the produce industry to push for regulatory change. I remember getting calls in 2006 from the produce industry almost pleading with FDA to set regulatory standards for growers of fresh produce.
The second event was in 2007, with the deliberate contamination of wheat gluten with melamine, which resulted in a lot of sick and dead pets. This event really got the attention of the Bush administration due to three factors: It was deliberate, it was in imported food, and it involved China.
The third event was, of course, the 2008-09 outbreak involving the Peanut Corporation of America, which, as we all know, has now resulted in some major jail time for those found guilty.
What these three events did was to cause the food industry — both growers and manufacturers, along with consumers, Congress and regulators — to all pull together in 2009 and 2010 and push for a set of regulatory standards to which the industry could be held accountable.
Back in 2007, when melamine hit, I had the fortune to lead a group at FDA tasked with writing the Food Protection Plan. This was a three-pronged approach to food safety that would shift FDA from a reactive organization to a prevention-focused agency. Our approach for this plan was to concentrate on risk-based preventive controls, targeted risk-based inspections and rapid response. The plan also requested a number of new regulatory authorities around preventive controls and imports that would allow FDA to follow through on this new plan. In my view, this was important policy and regulatory thinking at FDA that paved the way for FSMA from a FDA perspective.
So fast-forward to 2015, and we have FDA with a host of new authorities and an agency publishing new and major rules related to many aspects of food safety. These new rules will literally impact hundreds of thousands of entities globally when one considers all seven new rules due out in the coming months and in the early part of 2016.
My view is that the stakeholders who supported the passage of FSMA still believe it is both needed and a good idea. But, as with all new regulatory authorities, the devil is in the details, and there are some devils buried in FSMA for sure. Some stakeholders are really not happy — they feel that they are being over-regulated and that there will be no benefit to public health with some aspects of FSMA. Why? Because FDA had to essentially write a one-size-fits-all set of rules and the food industry is anything but one size.
So how should FDA proceed in a way that will have that positive public health impact that we all want and which, let’s not forget, was the original driver for the passage of FSMA in the first place? My answer is: with a major dose of enforcement discretion.
FDA always has the capacity to use discretion when it comes to enforcing regulations. What is really important is that, in the FSMA regulations, we have a clear regulatory bar that applies to high-risk entities. But it also applies to low-risk entities. Thus, FDA now has the authority to make a difference. However, the agency needs to focus its efforts where they will get the biggest bang for the buck. And, since the bucks are in very short supply, that approach is all the more important.
All FDA-registered facilities now have to have preventive controls in place. Some, such as seafood and juice facilities, will stick to the old HACCP approach, while others will have to embrace the more comprehensive and risk-based HARPC approach. That is a good thing since it will raise the standards for those who are somewhat asleep at the switch when it comes to food safety.
What I hope FDA will do is to focus its inspectors on those facilities that are not up to speed on food safety in ways that create real risks for public health. FDA has the power to make a lot of people miserable, and the agency shouldn’t do that. FDA can demand to see food safety plans and all the records that go with it. This gives the agency a lot of power to dig very deeply into a facility’s food safety system.
The reality is that the regulatory bar is now set with the publication of two new preventive control rules for human and animal foods. Whether these rules drive toward an improvement in public health will be heavily dependent on how FDA acts.
FDA has a major shortage of funds, and I want them to have more, but that is unlikely to happen in the short term. So FDA must focus its new authorities on food companies that really do represent a risk to public health. At the same time, I hope that FDA recognizes that it has three roles to play. The first is to set the bar to make the food industry accountable to good preventive controls — the agency has done that with the new rules. The second is to provide the tools for the food industry to understand what it needs to do to meet that new standard — there is a lot more needed here. The third is to hold accountable the parts of the food industry that create public health risks. This latter point is critical and I worry that, without good governance, we will see FDA wielding a new and very large stick that will create resentment and anger and, unfortunately, not result in the public health gains that this is all about.
So will FSMA make a difference? The answer is that it will if we manage all these moving parts correctly. The ball is very much in FDA’s court, and while writing the rules was difficult, what will be really tough for the agency will be enforcing them in a way that will drive down foodborne illness and not simply drive up the number of 483s and warning letters.