FSMA Strategy for Engaging Stakeholders
Sharon Natanblut (above left and top right), director of Communications and Stakeholder Engagement in FDA’s Foods and Veterinary Medicine program, and Kari Barrett, leader of the program’s stakeholder engagement team.
A Conversation with Sharon Natanblut and Kari Barrett
Since its inception, the leaders of FDA’s Foods and Veterinary Medicine (FVM) program have made stakeholder engagement a top priority. (FVM includes the Office of the Deputy Commissioner for Foods and Veterinary Medicine, as well as the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine.) This robust commitment to engagement was particularly evident as the foundational rules implementing the FDA Food Safety Modernization Act (FSMA) took shape. FDA was involved in more than 600 engagements between FSMA’s enactment in 2011 and the finalization of the rules in 2015-16.
Sharon Natanblut heads up communications and stakeholder engagement for the program, with Kari Barrett and her team focusing specifically on stakeholder engagement. They talk about the program’s approach to having meaningful engagement with consumers, industry, professional associations, and other government agencies in FDA’s oversight and initiatives to protect human and animal health.
Q: To start at the beginning, what do you mean by stakeholder engagement?
Natanblut: Engagement is about building relationships with the people whose lives intersect with FDA, whether they’re producing or consuming products regulated by the agency. We have both formal and informal ways of doing that. Most notably, the formal ways include holding public meetings and soliciting public comment in response to draft guidances and regulations. Less formal ways include listening sessions with stakeholder groups on specific safety or nutrition issues.
Barrett: The key to engagement is that it’s a two-way street. We can communicate information out to stakeholders, but engagement also brings knowledge back to the agency. As Sharon said, it can take different forms, depending on what works best for the situation. In addition to the larger venues like public meetings, we have webinars and conference calls and facilitate meetings with FDA leadership. We tour farms and food facilities to get first-hand production knowledge. The method we use is tailored to the audience we’re trying to reach.
Q: What have you been able to accomplish by actively engaging stakeholders in this way?
Natanblut: Meaningful stakeholder engagement has helped shape our thinking and our actions. That’s really been a hallmark of the program’s efforts as we have developed sound, effective and workable solutions to public health challenges. Through this ongoing engagement, we have gained invaluable insights into stakeholders’ concerns and experiences, thereby enabling us to craft better policy and regulatory solutions to public health problems. We believe that such engagement will contribute to enhanced stakeholder acceptance, higher levels of compliance, and greater public understanding and confidence in what we do.
Barrett: Unparalleled engagement with farmers, producers, state officials, and consumers has played a major role in how we implement FSMA. Similar strategic engagement has also played a critical role in shaping FDA’s response to a variety of issues beyond food safety.
Q: What started this focus on stakeholder engagement?
Natanblut: FDA has always been interested in hearing from the public, and in engaging with stakeholders. However, the program’s current focus in this area really started when Michael Taylor became the first Deputy Commissioner for Foods and Veterinary Medicine in 2009, and has continued under the leadership of Stephen Ostroff. When FSMA became law in 2011, we were required to develop regulations that would affect, among others, farmers. Mike realized how uneasy farmers were about this prospect and he looked for a way to build a bridge, reaching out to them on their own turf. FDA recognizes that we have to give people a voice in the decisions that will affect them and make those voices really count for something.
Q: How were those early efforts to engage on FSMA implementation received?
Natanblut: Honestly, not well! The first farmers we reached out to didn’t want FDA stepping foot on their farms. We actually had to work through others who were known and trusted to “vouch” for us. We were fortunate that a highly regarded extension agent in Delaware and others in the produce industry did just that. Soon after, North Carolina Agriculture Commissioner Steve Troxler hosted a listening session for us with farmers, along with some farm visits. And when we saw that farmers were more familiar with the U.S. Department of Agriculture, we invited USDA to come along and that worked well. From there, state agriculture commissioners and others from across the country started inviting us to visit. That’s when we really started making connections.
Q: Do specific examples come to mind?
Natanblut: We were very moved by an Amish farmer who came up to us after a listening session in Pennsylvania. Recognizing the impact that these produce safety requirements would have in his community, he arranged for visits to his and other farms in Pennsylvania. He explained to us that farming was not just a livelihood, it was their way of life, and he said he wanted to work with us to find a way to ensure we developed rules that ensured safe food but didn’t threaten the way in which they farmed. And after a listening session and farm tours in North Carolina, a woman with the North Carolina farm bureau took it upon herself to travel across the state in her own car, holding 30 listening sessions of her own and reporting back to us what she heard. Around the same time, we also heard from parents who lost children to foodborne illness and channeled their sorrow into activism, working to prevent these tragedies from happening to other families. These experiences stayed with us and deepened our determination to protect consumers but to do so in ways that address the real challenges that farmers and other food producers face.
Q: How did stakeholder engagement affect how the FSMA rules took shape?
Barrett: Meeting with the people on the front lines who would be covered by FSMA rules definitely helped educate our staff. The issues that face each region of the country are unique. We received a lot of useful information during our outreach, including local, regional, and commodity-specific concerns. I think we got such valuable input because farmers, manufacturers, importers and other stakeholders felt that they were really connecting with the agency and their input shaped the rules, four of which were revised and re-proposed based in part on that feedback. We want to dispel the belief that we’re driving people to a single solution.
Q: Kari, you’ve been a regular on those road trips to discuss FSMA. What was that like?
Barrett: They gave me such an appreciation of what people are doing throughout the food chain to keep food safe. From small farms to large processing facilities, the levels of care, of pride and of the desire to do what’s right are impressive. Many of the farms we saw had been in families for generations. It would have been easy for them to be defensive about protecting their interests, and easy for us to be defensive about what we need to accomplish. But if you can work past that, the dynamic changes and a real sense of community develops. We look for common ground. People want to engage and, in the right circumstances, will open up. It’s very powerful when you’re actually with the stakeholders whose partnership you need.
Q: You focused on FSMA, but can you each describe another area of stakeholder engagement?
Natanblut: Yes, take the issue of arsenic in rice, for example. We heard from and worked with people on all sides of this issue, including industry trade associations and consumers. It also included states with significant rice production. We appreciated how they approached this issue in a problem-solving manner. In fact, a leading manufacturer of infant rice cereal worked to reduce the level of inorganic arsenic well in advance of a limit we proposed in a draft guidance to industry. And the American Academy of Pediatrics and the American Congress of Obstetricians and Gynecologists played an invaluable role in lending their support to our efforts to protect babies from the developmental problems tied to exposure to inorganic arsenic. Soon after we announced the draft limits, these medical groups reached out to their members, who helped communicate effectively to patients. Even on sensitive issues, we try to find a way to work reasonably with all concerned.
Barrett: Defining the term “healthy” as a nutrient content claim on food labels is an issue that’s been on a lot of people’s minds. We had a public meeting on the subject in March and we had six breakout sessions so that FDA could hear different perspectives and ideas. What we saw was that there is a wide variety of opinions on this subject. And that’s one of the benefits of an interactive meeting like that. Participants get the opportunity to not only hear from FDA but also to hear what others are saying. It gives them a perspective on FDA’s task ¬– determining a direction against the backdrop of very different views.
Q: What are some of the principles that guide your work?
Natanblut: They include making sure that we hear from all sides, including the industries we oversee, the health professionals who have specialized expertise, and the consumers we protect. Balance is key. Engaging early is another principle. It ensures that even before we “put pen to paper,” we get insights from those who will be directly affected. Other principles are: Being open and respectful of other perspectives, searching for areas of commonality and building on them. Being honest about the points on which we may disagree. Having the involvement of FDA’s leaders and experts. And recognizing that for engagement to be effective, it takes sustained involvement.
Barrett: I agree with that but we also recognize that we’ve got limited resources, limited time, and many demands. We try to be very strategic and to maximize our resources. For example, we often work with stakeholder groups that form consortiums to include other stakeholder groups and keep the conversation going across a diverse landscape of farmers, manufacturers, retailers, importers and others. We regularly participate in events that stakeholders organize. If they set up a webinar, we’ll often work to provide an expert. We’re always trying to find different and efficient ways to communicate what we’re doing, but we recognize that we can’t be everywhere. That’s why we often write about these outreach experiences in blogs or other communications to widen the audience of people we’re reaching.
Q: What do you find most interesting about stakeholder engagement?
Natanblut: Unexpected outcomes. People, both within and outside of FDA, might start off with their opinions already set. If you can get them to really hear what another person is saying, they sometimes have a kind of “ah ha” moment that turns into a solution no one may have even considered beforehand. That’s the point I like getting to.
Barrett: For me, it’s getting a sense of the diversity of our stakeholders. Everyone brings such different perspectives and experiences to the table.
Q: You mentioned working with USDA. How do you reach out to other government agencies? Does stakeholder engagement include them?
Natanblut: It absolutely does. We not only reach out to them, but they reach out to us. Our road tours were often prompted by state public health and agriculture leaders. We toured the Oneida Nation’s farm and food distribution system. We have traveled around the world to meet with foreign leaders on food safety. We don’t know everything and we can’t do this work alone. Our regulatory partners in the states, on tribal lands, and in other countries open a window for us on how FDA actions will truly affect the communities in their jurisdictions. On the federal level, we also work with the Centers for Disease Control and Prevention, the National Institutes of Health and the Environmental Protection Agency because they, too, have a role in food safety, especially in the identification and control of potential hazards.
Q: What’s the bottom line?
Barrett: The more we get to know different groups, the more we realize the importance of considering the diversity of the food industry in our work. What’s so important, no matter what the issue, is to hear the range of needs, concerns and possibilities. Good policy-making, in fact good decision making, involves understanding an issue from a variety of perspectives and factoring that into the actions we take.
Natanblut: If the first time you do stakeholder engagement is when there’s a crisis, you’re in trouble. Real stakeholder engagement is a long-term commitment. These are ongoing relationships that go beyond policy-making to encompass the short and long-term challenges of keeping FDA-regulated products safe for consumers. Our partnerships with leading industry, farm, medical and consumer groups are thus focused, not just on a single issue, but on our overarching public health mission. And, as in all things, we can always improve – and we will. How we reach out, how we receive input, and how we form partnerships with stakeholders are works in progress.