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Why FDA Needs FSMA Resources Now

Deputy Commissioner for Foods and Veterinary Medicine responds to funding questions

Opinion

(Editor’s note: The following is in response to “Experts Debate Whether Food Safety Funding is Adequate,” published April 24, 2014, on Food Safety News.)

Two questions regarding the adequacy of food safety funding for the Food and Drug Administration were asked at last week’s National Food Policy Conference.

Michael Taylor

I would like to answer both of them.

First, the question was raised whether FDA really needed more money when it had spent only $7 million of the “extra $40 million” Congress gave FDA in 2013 in a special, one-time appropriation.

The actual amount FDA received in June 2013 was $37 million, due to $3 million in rescission cuts. Congress appropriated this one-time funding without restriction as to when it could be spent. It has played a crucial role in maintaining the momentum of implementation for the Food Safety Modernization Act (FSMA), including essential support for the FSMA rulemaking process and guidance development, outreach to our stakeholders, the Produce Safety Alliance and other education and technical assistance infrastructure, state capacity building, and risk-based decision-making tools and data.

By September 2013 (the end of FY 13), we had spent the $7 million to which the question refers. Since that time, we have committed an additional $23 million, and, in the next several months, the remaining $7 million likely will be dedicated toward additional outreach and guidance development, technical assistance to stakeholders, and data collection to support development and implementation of the FSMA rules.

Second, the question was asked: “Why does FDA need money to implement FSMA when we don’t even know what FSMA is yet?”

Congress was quite clear about what FSMA was intended to achieve, and it is much more than new regulations. The mandate includes:

  • Shifting the focus of FDA’s food safety oversight from reaction and after-the-fact enforcement to risk-based prevention of food safety problems;
  • Creating a national, integrated food safety system that leverages state, local and tribal food safety efforts, and ensures nationwide consistency in oversight, and,
  • Implementing an entirely new import oversight program that includes importers taking greater care of the foods they bring into the U.S., greater FDA presence overseas, and facilitation of trade in safe food.

Thus, the modern food safety system envisioned by Congress requires a true transformation in how FDA approaches its day-to-day food safety work and how it works with its government partners and the food industry to achieve high rates of compliance with the new FSMA rules. This includes a new compliance strategy focused on public health outcomes and based on clear guidance, education, and technical assistance to help industry understand and voluntarily comply with the new requirements, minimizing the need for FDA to take enforcement measures.

Investment in this transformation cannot wait until the produce and preventive controls rules become final in late 2015. We are actively planning the transformation now, but, to implement it on a timely basis, we must make serious investments in 2015 and 2016 in FDA training and expertise, state training and capacity building, technical assistance infrastructure, and the new import oversight system.

Training in the details of the final rules will come after the rules are finalized in late 2015 and before implementation in food facilities begins in late 2016, but this is just one part of the larger investment needed for FSMA to be successfully implemented and avoid unwanted delays and disruptions in implementation.

© Food Safety News
  • Catherine Musgrave

    I am so happy to see that they are taking a common sense approach. I work with numerous small and medium businesses and they receive different requirements (often contradictory) from their inspectors now in local, state, and federal requirements. It is close to impossible for businesses to comply to each of these entities. There is a disconnect on how the FDA regulations are interpreted by other agencies that inspect and audit, there needs to be one clear regulations that is adhered to by all the agencies that audit and inspect our food producing facilities. This will also help the overburdened local, state, and federal agencies if their guidelines are all the same, are clear cut, and a consistent set of regulations and inspect and audit procedures are put forth.

  • Rob Stuart

    Why does FDA have so many attorneys? It didn’t use to be that way.