The FDA Food Safety Modernization Act (FSMA) heralded a new era of enhanced collaboration between the U.S. Food and Drug Administration and its counterparts in state governments across the country. State officials were instrumental in providing comments to help FDA create regulations that take into account the complexities of food production and are designed to be flexible and practical while meeting the agency’s public health goals.

As FDA passes from FSMA rulemaking to implementation, the states continue to have an important role in bringing to life the FSMA mandate that the prevention of illnesses, rather than response to outbreaks, should be the cornerstone of the nation’s food safety system. This is especially true when it comes to helping FDA implement FSMA’s produce safety rule, which, for the first time, establishes enforceable safety standards for the production and harvesting of produce.

In September 2016, FDA awarded 42 states a total of $21.8 million in cooperative agreements to develop produce safety programs that will enable them to deliver education and technical assistance to farmers and provide ongoing inspection, compliance and oversight.

Why is this collaboration so important in protecting the safety of the food supply?

Why does FDA need the states, and vice versa?

Erik Mettler, FDA’s acting deputy commissioner for foods and veterinary medicine, Richard Ball, New York’s commissioner of agriculture and markets, and Joseph Corby, executive director of the Association of Food and Drug Officials, talk about the evolution of this federal-state partnership.

Q: Why are the cooperative agreements with the states so important in implementing the produce safety rule?

Mettler: FDA cannot effectively and efficiently implement the produce safety rule alone. There are local, state and federal government roles to be played to be successful. We knew this from the start. Establishing these cooperative agreements helps leverage federal resources to provide the states the funding that they need to establish or expand their produce safety programs and ultimately make the food safety system work as a whole.

Ball: We’re going to rely heavily on our collaboration with FDA. Certainly, this funding to do the work, and collaboration to make sure the work is done the right way, is critical to the success of the program. So the states very much like the cooperative agreement approach to getting the job done and achieving the goal of enhanced produce safety for consumers.

Corby: It’s worth noting that produce safety may be the largest cooperative agreement between FDA and the states on food safety, but it’s not the only one. There are agreements to improve state laboratory efforts and FDA funding of Rapid Response Teams to respond to food emergencies. All of these agreements are part of building a successful food protection program and have been very useful to the states in building capacity.

Q: When FDA was establishing the produce safety cooperative-agreement framework, what was it hearing from the states? What drove this decision to award this funding?

Mettler: FDA knows that the states have already built long-term relationships with the growers; they understand their local circumstances better than FDA does.  FDA does not intend to conduct regular inspections of all of the farms covered by the produce rule. We can only accomplish the level of compliance needed to protect public health by partnering with the states to build on their established relationships and help farmers understand how to comply with this rule.  This will also allow FDA to deploy our resources to states that are not part of the cooperative agreement and to address imported produce.  At the end of the day we’re about protecting public health and public safety, and we felt it was best that this begin at the local level.

Ball: I really like the tone you used to express that.  We value our relationship with the growers every day.  We’re on the farms and we regularly meet with all of our commodity groups.  If we’re going to have success, it will ultimately depend on making it achievable for the grower community.  I’m a farmer myself – a vegetable grower, so I can appreciate both sides.  Being involved with the industry, I understood very quickly that food safety needs to be everybody’s business, not just the end user or the retailer or the wholesaler but the whole food system needs to have ownership of food safety.

Q: Could the states protect the health of their citizens without this kind of FDA involvement?

Corby: The states already do the overwhelming amount of food safety work, whether it’s inspections or surveillance. Local and state agencies are often first responders in food-related emergencies. When someone believes something they ate made them sick, they don’t usually call the FDA. They call someone local. That said, many food safety problems are multi-state in nature; recalls are often national; and many times imported foods are implicated. So we recognize that FDA has to be engaged in all of those circumstances.

Ball: And I would agree 100 percent with Joe.  State health and agriculture departments have been ensuring the quality and safety of food for a long time.  We’ve always had a strong relationship with FDA and we’ve always looked to FDA for guidance, as Joe mentioned, on large-scale challenges.  So even before FSMA, we had a partnership with FDA but now we can grow that partnership even more to achieve our goals.

Q: What challenges and critical issues do you see ahead, especially as it relates to the produce rule?

Mettler: Sustained funding through this cooperative agreement to build and maintain the program will always be key.  But I would like to emphasize that a key issue is continuing to do what we promised during the rulemaking, which is to educate while we regulate. At the local, state and federal levels, this is a learning process as we go along.  We really needed to sit down and listen to everyone as we developed the rule, but it’s just as important as we implement it.  Again, the key outcome here is public health and public safety and we need to make sure we can adjust when needed and also make sure that we’re not being an undue burden or hindrance to industry’s economic vitality.

Ball: As a farmer, I make a list for myself every day of things to do on the farm.  I do the same thing as Commissioner.  At the top of my list every day I write down the words “long view.”  As Erik said, for us the long view is public health and safety, and I agree that we must be able to rely on federal resources.  We need to stay on the same page and make sure we’re communicating and collaborating and making sure we understand what our goal is and that it’s a mutual goal.  I think that the farm community already recognizes that food safety needs to be a big part of its world every day.  I think they get it but again the notion of educating while we regulate just needs to be first and foremost in our minds.  I think the farm community wants to achieve this, they want to get it right, and they want to partner with us.  The challenge will be: How do we do that?  How do we communicate that?  How do we bring them along and raise the bar in a way that’s achievable?

Corby: I do look at this somewhat broadly because I think our big challenge is continuing to build out the effort to integrate the nation’s food safety system.  I would add that the states have been committed to an integrated system for about two decades now, ever since 1997-98 when AFDO first offered the vision for an Integrated Food Safety System.  Education while you regulate is something that state and local agencies have done for many years now and FDA’s commitment to do this is essential to our ability to coordinate our efforts.  I think we have to coordinate outreach and education efforts by all stakeholders because that can be done by government, by academia, and it can be done by cooperative extension.  I think that will be a challenge as we go forward.

Q: Is there anything that has surprised you about this FDA-state partnership?

Corby: I’ve worked in government for over 30 years and I’ve worked a lot with FDA and quite frankly I did not believe that FDA would be so receptive to this concept of educating while regulating.  That was the biggest surprise to me, and a very welcome one, I might add.

Mettler: I think our partnership has developed smoothly.  I’m sure there will be surprises along the way, but I don’t see them as challenges.

Q: How do you see the federal-state partnership evolving?

Mettler: This is a bright future and what we’re after at the end of the day is a fully integrated food safety system at all levels.  We have been using the concept of “educate while we regulate,” but I really think it’s more than that.  It’s really “educate before, during, and after we regulate” so we really do this at each step of the way.  Education through the entire process is key.

Ball: As we move forward, the notion of us as co-regulators, partners and collaborators is so vital to our success here. I think that when you value a relationship you nurture it, and we just need to be mindful of that.  We’ve got to recognize that we’re all trying to accomplish a common goal and continue working in that direction.  We all want this to be a success and the best possibility of achieving that is working together.

Corby: I think the relationship between the state and federal governments will keep getting better and better.  based on what I’ve seen, there is clearly a much fuller respect and trust between agencies, whether it’s between state and local or between state and federal. There just is clearly more trust.