Public Affairs Specialist Krysten Carrera in the FDA Office of Regulatory Affairs (ORA) Office of Communications and Project Management recently caught up with ORA Human and Animal Food State Liaison Julie Vosilus and Chief of the Food and Consumer Safety Bureau Mark Speltz in the Iowa Department of Inspections and Appeals (DIA) to discuss domestic mutual reliance in Iowa.
What is domestic mutual reliance?
JULIE: At its core, domestic mutual reliance is a partnership that enables the FDA and states with comparable regulatory public health systems to rely on and coordinate with one another to achieve a safer national food supply and prevent foodborne illness outbreaks. Protecting consumers across the country is our ultimate goal.
MARK: In July 2022, DIA signed a domestic mutual reliance partnership agreement with the FDA. Through this agreement, we share inspectional information through spreadsheets, calls, and other means – and this minimizes duplication of work and leverages resources.
JULIE: You can read more about the FDA’s agreement with DIA in the recent Food Safety Magazine article written by FDA Associate Commissioner for Regulatory Affairs, Dr. Judy McMeekin.
In 2020, as part of domestic mutual reliance, the FDA created the non-contract inspection program to obtain manufactured food data from states for inspections that meet certain criteria. Can you tell us a bit about this program?
MARK: Well, if we both have the same approach regarding inspections, there’s no reason for DIA to visit a facility that the FDA has already visited; the reverse is also true. That’s where non-contract inspections are useful. A non-contract inspection is a non-high-risk inspection conducted by the state under its own authority in which no other regulatory action was required.
JULIE: A non-contract inspection of a manufactured food product facility enables the FDA and the state to count on one another so that we don’t duplicate efforts. They also make working with industry more effective because they don’t have to address multiple inspections at different times. We recognize the importance of using taxpayer dollars responsibly and spend resources where they need to be. If a state has the authority and resources to take on certain domestic inspectional duties, then the FDA can focus on firms a state may not be able to cover that year, as well as foreign food safety and other areas.
MARK: We perform our own inspections at many facilities the FDA also inspects. Over the last several years, we’ve worked hard in Iowa to meet our regulatory program standards. The FDA trusts our data and inspections, and vice versa, so non-contract inspections just felt like a natural next step. They already trust our contract inspections, so why not our non-contract ones? We use the same standards. By meeting these standards, we showed the FDA that the impact of our work is equivalent to what they would do. This really captures the essence of domestic mutual reliance: the fact that leveraging each other’s resources and knowledge, that cooperate with and trust in each other, results in faster and more timely food safety oversight.
JULIE: We’re excited about the progress we’re making with the non-contract inspection program. Iowa has been sharing these inspections with us since 2020, and to date, we’ve been able to use 20 non-contract inspections to count towards our inspection frequency mandate under the Food Safety Modernization Act. It truly is mutual because Iowa also uses FDA inspections to count towards their inspection frequency as well.
In addition to Iowa, Virginia, Florida, Utah, and Wisconsin have initiated non-contract inspection programs, and the FDA is working to get additional states to participate.
How have domestic mutual reliance and non-contract inspections changed the workflow between the FDA and states?
JULIE: We spend a bit more time on work planning, but in the long run, it’s much more efficient because it provides another safeguard to ensure we’re all using our time wisely.
MARK: Yes, it’s been a huge efficiency gain for everyone. Fifteen or 20 years ago, it was not uncommon for Iowa to inspect a facility and do our state inspection just days after the FDA did the same thing. That doesn’t happen anymore. Our work planning is where that really shakes out. Every year, we sit down with the FDA and discuss with Julie what we’re planning to do in Iowa. We coordinate our resources and work plans to each other’s benefit in these work planning sessions.
And in some cases, we can act more quickly due to our close connections to and relationships with local firms. The non-contract inspection program has helped us enormously with completing inspectional work. Non-contract inspections enable us to reallocate our resources and concentrate on firms that present the greatest risks.
How has domestic mutual reliance helped Iowa advance food safety?
JULIE: Coming out of the pandemic, we’ve recognized the significant amount of work and limited resources we all have. Non-contract inspections and domestic mutual reliance definitely have helped us stay on top of our game.
Due to the relationships that we’ve established through domestic mutual reliance, we were able to divert resources to address the Salmonella outbreak in melons a few months ago. DIA pulled in inspectors that would have been doing contract work, and they then initiated traceback, onsite investigations, and sample collection and analysis. With non-contract inspections, it’s not just the inspections, it’s the data that enables us to update our operations and clean up our inventory.
MARK: If there’s an outbreak or complaint that needs to be investigated quickly, when time is of the essence, the more likely we’re able to effectively intervene. When something has led to, or could potentially lead to, an illness or injury, domestic mutual reliance helps us tap into the FDA’s resources and expertise, and the other way around. We have the same goal: identify and address food safety risks before they materialize or magnify.
For example, in early November 2022, we were out doing a non-contract inspection and noticed that certain allergens were not listed on a granola label. When we reached out to the ORA compliance branch, we were able to speak with the recall coordinator at the FDA while we were onsite – which enabled us to reach a decision about the recall in real-time. Domestic mutual reliance has helped strengthen the trust between the FDA and Iowa so we can more swiftly address food safety issues.
Can you expand on how industry has reacted to domestic mutual reliance?
JULIE: Our Iowa partners have done a lot of outreach to industry through its food protection taskforce. We’ve had many opportunities to discuss work planning and how we train our investigators. Industry is recognizing that because of domestic mutual reliance and non-contract inspections, they haven’t needed to see us as often. We’re acting as one voice, one face: a unified front between the federal and state governments.
MARK: From the people we’ve spoken to, they’re very supportive of domestic mutual reliance because they’re not getting inspected back-to-back. When they do get an inspection from either state or federal, they know what to expect. More consistency in the application of laws and regulations is good for everyone, because inconsistency can cause confusion.
What’s next for NCIs and domestic mutual reliance in Iowa?
JULIE: The FDA is looking at potential ways to evaluate non-contract inspections and expand to animal foods.
MARK: We’ve recently started doing joint compliance meetings with the firm where Iowa and the FDA are in the same room, or at least the same virtual space, speaking with representatives of the company. For example, an infant formula ingredient supplier was in such a meeting recently with Iowa and the FDA.
Any closing thoughts about domestic mutual reliance and federal-state partnerships?
MARK: I believe our collaboration between DIA and the FDA has been successful. Domestic mutual reliance is key for us to achieve as much as possible together to advance public health and strengthen our integrated food safety system.
JULIE: I really see domestic mutual reliance as the future. In the spirit of the Food Safety Modernization Act, we have spent a lot of time, energy, and funding to build capacity at the state level and integrate our regulatory efforts over the last decade. This is how we meet this moment of coming out of the pandemic. This is how we step into the New Era of Smarter Food Safety, of which domestic mutual reliance is a core element. It’s completely worth the investment and effort to ensure it continues. Our partners in Iowa have fostered an environment of trust, respect, and willingness to share opportunities for improvement. The FDA greatly appreciates and values this relationship as we work together toward our shared goal of a food supply that’s safe for everyone.
For more information about domestic mutual reliance, visit fda.gov.