Senior Science Advisor Aims to Build Bridges to Advance Produce Safety

A Conversation with Jim Gorny

Jim Gorny has returned to the U.S. Food and Drug Administration, where he was a food safety expert at a critical time in the agency’s efforts to enhance produce safety. He left the agency five years ago to work on food safety from another perspective, as vice president of food safety and technology at the Produce Marketing Association, a trade organization representing the entire produce supply chain.

Dr. Gorny is back at the FDA to, among other responsibilities, work alongside a dedicated team of produce safety experts on the implementation of new science and risk-based requirements created to help prevent illnesses caused by contaminated produce.

From 2009 to 2013, Dr. Gorny was a senior advisor in FDA’s Office of Food Safety. He was involved in the initial development of the FDA Food Safety Modernization Act (FSMA) draft regulations after the law was enacted in 2011. He had key roles in the agency’s response to serious outbreaks of foodborne illness, including the 2011 listeriosis outbreak tied to cantaloupe in which 33 people died.

And now Dr. Gorny is taking on a newly created position at FDA – Senior Science Advisor for Produce Safety at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). He shares his thoughts here on his new role and the opportunities ahead as the requirements of the FSMA Produce Safety Rule transition from theory to practice.

Q: What is this new job exactly?

I will be the chief advisor to CFSAN director Dr. Susan Mayne on policies and programs related to the safety of produce. There will be a lot of parts to this job, including working on outreach and engagement with stakeholders, investigations and recalls, research, and training activities.

At the heart of it all is FSMA. I’ll be helping develop strategies to implement the Produce Safety Rule. I’ll be working closely with the Division of Produce Safety, which has been on the frontlines of FSMA rulemaking and implementation, and FDA’s Produce Safety Network that has stationed experts across the country to support farmers and state regulators. I will be working with state regulatory partners and other government agencies at home and abroad to build support for implementation of the produce rule, as well as with industry to help further compliance. Most importantly, I’ll be working with the farming community.

And as a senior advisor to Dr. Mayne, I’ll be working to make sure that the people in senior-level management and the field staff, including those conducting foreign inspections, are speaking the same language. This level of coordination extends to stakeholders, and there are so many of them – growers of all types and sizes, packinghouse operations, state and federal regulators, consumers, cooperative extension agents and others. We’ve all got to be pushing in the same direction.

It’s all about building bridges, both within and outside of the agency.

Q: How will your experiences in working with the produce industry shape how you approach your role at FDA?

I have a broader understanding now of how the produce rule impacts businesses. I saw first-hand how hard people are working in the produce industry to understand the new requirements and be prepared to meet them. We’re all in this together. FDA has created a good framework to implement the Produce Safety Rule. Has every question about how it should work in practice been answered yet? No. Part of the challenge for FDA is that there’s no one-size-fits-all when it comes to produce safety, and applying a flexible approach to implementation takes time. There are people of good will in both the produce industry and the FDA, and we need to work collaboratively to achieve success.

Q: You will be working with our state partners, who will be doing the heavy lifting when it comes to implementing the Produce Safety Rule domestically. How do you see the evolution of FDA’s relationship with the states?

I think FDA has to continue to look for ways to deepen and strengthen our relationship with state public health and agriculture departments. FDA can learn a lot from state agriculture and public health officials; they are keenly attuned to the unique regional, seasonal and crop-specific business issues that produce growers in their state face every day. FDA and state partners share a common goal of protecting public health, and working together will be critical for a successful, smooth rollout of Produce Safety Rule compliance and enforcement efforts.

Fresh produce is a nutritionally important component of a healthy diet and improved nutrition is an important part of CFSAN’s mission. Therefore, we want to ensure that produce farmers can provide consumers with nutritious, fresh and abundant produce.

Q: What do you see as a priority for FDA in implementing the produce rule?

One priority is to develop and release the guidance documents that will help provide clarity for farmers preparing for compliance and make sure they know what’s expected. We’re close to releasing a comprehensive Produce Safety Rule draft guidance. Going forward, I hope to bring some momentum and to provide insights on how best to facilitate getting our key guidance documents across the finish line. We’re down to the nitty gritty now, and I want to offer some pragmatic solutions to complex problems that we’re working so hard to get right.

Another priority is using the tools that FSMA provided to ensure that both imported and domestic produce meet U.S. food safety standards. It’s important to note that produce grown in other countries is also subject to the applicable requirements of the Produce Safety Rule if that produce is imported, or offered for import, into the United States. Another FSMA rule, the Foreign Supplier Verification Programs rule plays a central role, making importers responsible for ensuring that their suppliers are producing food in a manner that provides the same level of public health protection required of domestic growers.

In addition, importers of produce may choose to participate in our Voluntary Qualified Importer Program (VQIP), which requires that produce come from farms that have been certified under FDA’s Accredited Third-Party Certification Program. We will also continue to engage with our foreign regulatory counterparts to help ensure that safety standards are met. And, of course, we have our tools at the border, which allow us to sample and test products and deny entry to products that pose a risk to public health.

If I can help move the ball forward in these areas, I’ll feel that I’m making a significant contribution.

Q: On a personal note, what brought you to the produce field, so to speak? Did you grow up on a farm?

No, I was not raised on a farm but my wife was and I’ve spent many a day with my in-laws on their farm working alongside them, as there never seems to be a shortage of things to do. I’ve always been interested in food safety. I trained as a food scientist, worked in food processing, and then earned an advanced degree related to fresh produce handling. The recurring outbreaks of foodborne illness reinforced my desire to help find solutions to produce-associated outbreaks caused by E.coli, Listeria and other pathogens in foods that are the very fabric of our diet.

Q: What do you want stakeholders, whether they’re farmers or consumers, or part of the supply chain, to know about you?

To the entire farm-to-fork supply chain, I’d say: I want to talk to people before a spark becomes a bonfire. If you have an issue, bring it forward. I will always listen because your perspective is important and likely shared by many in your community. And consumers should know that farmers really want to produce safe food. It’s in their interest as business people; it’s in their interest as consumers.