FDA Network Takes a New Approach to Produce Safety
When the Produce Safety Rule became final in November 2015, the U.S. Food and Drug Administration (FDA) began building the Produce Safety Network (PSN) to support the efforts of farmers, state regulators and other key stakeholders to implement the rule, which is aimed at preventing foodborne illnesses associated with produce.
The challenges of successful implementation include regional differences in growing conditions and practices across the country, and that the produce industry has never before had this kind of FDA oversight.
The PSN does two things:
- It establishes regionally based policy and regulatory experts throughout the country, making them uniquely suited to address the issues specific to the states they’re supporting.
- It also places these experts, from two very different FDA offices, within one team. The network combines the regulatory expertise from the FDA’s Office of Regulatory Affairs (ORA) with the policy and science expertise from the Center for Food Safety and Applied Nutrition (CFSAN).
In an interview, Stephen Hughes, the PSN’s Team Lead from CFSAN and Brittany Laymon, one of two Branch Chiefs leading the investigators from ORA, discuss the PSN’s goals, the work their teams are doing, and how this team allows for better coordination within FDA as its experts work with farmers, state partners and other key stakeholders to support implementation of the Produce Safety Rule.
Q: What is the Produce Safety Network?
Laymon: Given the challenges of implementing the Produce Safety Rule, which include differences in growing practices and conditions across the country and the newness of this kind of federal oversight, we recognized that a specialized group of individuals based in each region could better support farmers and state regulators. Our job includes providing technical assistance, conducting outreach and training, participating in work planning, participating in outbreak investigations, and conducting foreign inspections and inspections in states that don’t have their own inspection programs in place.
Hughes: I want to add that we have been really fortunate to have been able to bring on staff with experience from cooperative extension, industry, state departments of agriculture, and from FDA. Collectively, our PSN staff has a broad range of knowledge and experience in areas that include agricultural science, produce production, international produce safety, outbreak response related to produce, and produce inspections and investigations.
Q: Why is it so important to bring these two parts of the FDA, ORA and CFSAN, together in the Produce Safety Network?
Laymon: It’s important to bring these two parts of the FDA together because when you are developing a food safety program you need both the policy and regulatory expertise. So in general, ORA is the lead office for all agency inspectional activities. Our investigators have routinely conducted regulatory activities, including surveillance inspections, for-cause inspections, investigations and sample collections. The PSN investigators will also be involved with education, outreach, and training.
Hughes: The staff from CFSAN is generally focused on policy, education, training, and research. When you think about the Produce Safety Rule, you might think about guidance. Staff members at CFSAN are the ones who are writing guidance and responding to inquiries received through the FDA FSMA Technical Assistance Network (TAN).
What we have done with the PSN is bring these two groups together so that there is better coordination between those working on policy and those doing inspections. We have preserved our roles as staff from CFSAN or ORA, but with some changes that enable us to be more responsive to farmers and external stakeholders. For one, before the PSN the produce safety experts from CFSAN would have typically been based out of the Washington, D.C. area. Today we have them located in places like Minnesota or North Carolina, where they can visit farms, learn more about the specific growing conditions in their regions, and work with ORA during investigational activities.
The PSN investigators from ORA remain responsible for inspection and investigation activities, but within this network they work with the CFSAN produce safety experts on education, outreach, and training. Having one team with both policy and inspectional perspectives is important so that we are providing farmers and external stakeholders the best information we can based on where they are located, what commodities they are growing, and more.
Q: How large is the PSN team and why are team members located throughout the country?
Laymon: Currently, we have seven produce safety experts and one team leader from CFSAN and 14 investigators and two branch chiefs from ORA. We generally based the number of PSN staff assigned to the southern, western, north central, and northeast regions on the volume of covered produce production in those regions. We anticipate hiring additional PSN staff in the future.
Hughes: Growing practices and growing conditions vary substantially throughout the United States. We felt it was important to have the staff located throughout the country so they could get an in-depth understanding of the growing practices and conditions in their area. Conditions, practices, and compliance challenges that someone may experience in the northeast may be very different from what’s experienced in the west, in places such as California, so that makes implementing a rule that applies to all these regions particularly challenging. We realized very quickly how important it was going to be to have regional experts on the ground.
Q: What is the specific role of the produce safety experts from CFSAN?
Hughes: We have a few different roles, one of which is providing technical assistance. Technical assistance is a very broad term, so we are talking about things like addressing questions about the produce safety rule, policy and rule interpretation, as well as providing real-time support for regulators, both FDA and state, as they conduct inspections on farms. For instance, we are setting up a system in which any regulator conducting an on-farm inspection can call the network for assistance if questions arise.
Our produce safety experts also bring information about their regions or specific commodities back to CFSAN, and that information can be used to help us develop guidance and training curricula, or respond to inquiries.
With respect to training, both CFSAN and ORA PSN staff are involved with developing the training curriculum for state and federal regulators, including investigators who will be visiting farms. Some of our staff will be working as trainers for those courses, and we are supporting the development of other materials through our course advisory groups.
We are also doing outreach. At this point we are out there sharing information about the network itself because it’s a new concept, but as we develop relationships we’ll be able to identify new opportunities to share information about the Produce Safety Rule and to address information gaps.
Q: What is the role of the investigators from ORA?
Laymon: Our outreach is very similar to what Stephen described for the produce safety experts. We are supporting our state partners and are also involved in training. Part of this training is foundational regulatory training on produce inspections and investigations. Another piece is through field experience and educational farm tours so that we can learn more about the growing practices and conditions within our assigned regions.
We will also be involved with domestic and foreign inspections. Domestically, in states that do not have a produce safety program under the State Produce Implementation Cooperative Agreement Program (CAP), we will conduct routine and for-cause inspections. In states that do develop a produce safety program, we may accompany state inspectors during for-cause and routine inspections upon request.
Q: Will you be conducting foreign inspections as well?
Laymon: Yes, PSN investigators will be conducting regulatory activities, including inspections and investigations, under the Produce Safety Rule in foreign countries. FDA already has a routine presence on foreign farms, conducting inspections under the Federal Food, Drug, and Cosmetic Act, so this is not unfamiliar territory for us. We hold produce that is imported and sold in the United States to the same standard as produce grown, harvested and sold domestically. So, having the PSN investigators who are conducting or supporting domestic inspections also conducting foreign inspections is a key part of ensuring that the same standards are applied to both domestic and international farms.
Q: How do the roles of the produce safety experts from CFSAN and the investigators from ORA intersect? How do you all work together?
Hughes: In addition to outreach, there are a few specific areas in which the investigators and produce safety experts work closely together. One good example is our educational farm visits to learn more about the different growing conditions and practices that exist within our assigned regions and throughout the country. The farm visits allow us to get out and interact with farmers and our state partners, and to see some of the unique conditions and growing practices firsthand. For the produce safety experts, these visits help us not only as CFSAN develops guidance, but also provide us with a regional perspective and increased knowledge as we develop answers for the inquiries we receive about the Produce Safety Rule. For the ORA staff, these visits are helpful because we are able to really understand how these operations work.
Laymon: We are also working together in the development of the On-Farm Readiness Review (OFRR) program. We are working closely with the National Association of State Departments of Agriculture (NASDA) and state partners to develop these reviews as a resource for farmers preparing to comply with the Produce Safety Rule.
The goal of the OFRR program is to provide farmers with specific feedback on how well they are prepared to meet the requirements of the Produce Safety Rule. The OFRR tool will be available to farmers to use as a self-assessment. If the farmer chooses, a team of state regulators, FDA regulators, and other educational partners may visit the farm to offer observations, advice, and resources. These are another educational opportunity for the farms.
We are also working together to build a Regulator Technical Assistance Network for produce that will be a resource for FDA investigators and state inspectors to receive support from our subject matter experts during inspectional activities. This assistance might present itself in the form of policy, regulation interpretation, inspectional, investigational, or sampling technical assistance.
Q: The Produce Safety Network has been operational for a few months now, what has the experience been like so far?
Hughes: I would say it has been a good experience so far, and a challenging one. It’s challenging because we are standing up a new team, so we have to establish norms and expectations that enable us to work together effectively and consistently. At the same time, we are working closely with our state partners as they develop their produce safety programs. We are also working with industry partners who are learning about the rule and asking questions. So there are a lot of different things going on at the same time.
That being said, one of the positive things that we have seen so far with our state, industry, cooperative extension and academic partners is that they are receptive of the PSN concept. I think folks are starting to recognize that we are a resource they can rely on so if they have questions about the rule or what the agency is doing in the area of produce safety, we have folks located nearby who they can talk with.
Laymon: I have to agree with that, and I want to add that the produce safety experts from CFSAN and the PSN investigators from ORA all continuously communicate with each other. We have received a lot of positive feedback about our staff and their interactions and engagement with external stakeholders. I think a lot of that is because of that constant communication we have internally, and we are really excited to continue these efforts. We have also had a lot of support from FDA upper management to get out and get involved with external stakeholders so we are really looking forward to continuing to build this network.
Q: How do people contact the Produce Safety Network?
Hughes: We have a directory on the Produce Safety Network webpage. On the webpage, the produce safety experts from CFSAN are listed separately from the investigators from ORA. The produce safety experts from CFSAN serve as the primary point of contact for engagement with farmers and external stakeholders. The PSN investigators from ORA serve as the primary point of contact for activities involving coordination with our state counterparts in conducting OFRRs, sharing of work plan/assignment information, and the coordination of regulatory activities, such as inspections and investigations. We know that, especially in this virtual world, communication will take place through emails, telephone, virtual meetings, as well as face-to-face meetings and trainings, and we are open to working with stakeholders in all of these ways.
The first step is to contact the produce safety expert listed in the directory as representing your state. We encourage folks to reach out to us. If anyone is unsure of whom to contact, just reach out to any one of us. We are all available to help in any way we can and have internal processes for getting the question or information to the correct person.
Q: Before we wrap up, Brittany you are in uniform. Can you explain how your role in the U.S. Public Health Service informs your work?
Laymon: As a Commissioned Corps officer in USPHS, I am supporting both the USPHS and FDA parallel missions to protect the public’s health. When folks see me and other USPHS Commissioned Corps officers on produce farms representing the FDA, we are working in a capacity equivalent to all other FDA investigators who are in civilian clothes. We wear our uniform to display our respect for our country, our service, and ourselves. The uniform I’m wearing is the Operational Dress Uniform, which is a normal work uniform for USPHS Officers conducting regulatory activities on farms.
Q: To close, what do you want growers to know about the network? If you’re a farmer, how are you likely to be affected by this work?
Hughes: The PSN is a resource for farmers and other stakeholders to help them achieve compliance with the Produce Safety Rule. In order to be successful with prevention you have to empower folks with the information they need to make the right decision at the right moment. The network is a resource for folks to get that information. So when our regulatory partners or farmers have a question or they are unsure about the rule, the network offers them someone they can call who is familiar with the region, and familiar with the conditions and practices there. We hope folks take advantage of this resource.