FDA-State Partnership Propels FSMA Implementation

By: Michael R. Taylor and Stephen Ostroff, M.D.

Ever since the FDA Food Safety Modernization Act (FSMA) was enacted in 2011, we’ve said that successful implementation is not possible without a meaningful partnership between FDA and its counterparts in state government. This is especially critical in the new area of produce safety regulation.

Michael R. Taylor

Michael R. Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine

After years of rulemaking – of planning, discussing and revising – this partnership is no longer just an aspiration. Instead, it’s evolving into a real union of public health and regulatory colleagues at the state and federal levels who together are taking concrete steps to make the produce safety protections envisioned by FSMA a reality.

An example of this forward movement is a conference we both attended on March 22 in Orlando, Florida, where the National Association of State Departments of Agriculture (NASDA) unveiled its proposed framework for state participation in the implementation of FDA’s new produce safety rule. This rule—for the first time—establishes enforceable federal safety standards for the production and harvesting of produce on farms.

In 2014, FDA entered into a five-year cooperative agreement with NASDA to work with state partners to collaboratively plan implementation of the produce rule. The NASDA framework will help guide and inform states that are working to develop a state produce safety regulatory program that is aligned with the FSMA rule.

The NASDA framework was developed with the active involvement of 24 state departments of agriculture and five national public health organizations. Key areas addressed include education and compliance, information sharing, regulator training, accessing laboratory resources, technical assistance, and infrastructure.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1

All 50 states were represented at the Orlando meeting to review and discuss the proposed framework, which is intended by NASDA to be a living document that can be refined and improved over time as experience is gained with implementation of the produce safety rule. The level of alignment and energy among participants at the conference – which included 46 agriculture departments and 19 public health departments – was inspiring and demonstrates that we are very much on the right path toward a sustained partnership with our state colleagues.

The states have always been clear in conversations with us, and we have been clear in conversations with Congress, that federal funding is necessary for the work ahead. State agriculture and public health personnel are the ones who have built relationships with and knowledge of local farming communities and practices and can often deliver oversight most efficiently. But almost all states will have to build produce safety programs largely or completely from scratch. We want to rely on them, not only to deliver education and technical assistance, but also to provide ongoing compliance support and oversight.

But this requires resources.

The President’s Fiscal Year 2017 budget request includes $11.3 million in new funds for the National Integrated Food Safety System. We have been building this system to fully integrate the more than 3,000 state, local and tribal government agencies involved in food safety in FDA’s work to meet the FSMA mandate. The FY 2017 funding, which Congress is considering, will be used primarily to support state produce safety programs through cooperative agreements and grants.

The FY 2017 funding builds upon resources for states that Congress provided for FSMA implementation in FY 2016. Earlier this month we took an important step toward distributing these funds – $19 million – to support state produce safety programs by soliciting applications for cooperative agreements with state regulatory agencies. These funds will make an important down payment on the capacity states need to be our full FSMA partners in produce safety. The FY 2017 funding request recognizes that more will be needed – both next year and beyond — to realize this goal.

There is a great diversity in where states are right now in planning and developing their produce safety programs. Some may already have developed multi-tiered plans and are ready to begin implementing. Others may just be starting to consider what’s ahead. This program is designed to give states the support they need at whatever stage they’re in.

Our goal is to get the initial funding to a number of states before the end of this fiscal year.

This has been a long road. But we are gaining real momentum toward the ultimate goal of having a food safety system in place in which government agencies at all levels are working in partnership with each other – and collaboratively with farmers – to ensure that we are doing everything we can to prevent or reduce the risk of foodborne illness. Safe and widely available produce is good for consumers, good for public health, and good for growers. That’s why we’re all in this together.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1.