With a number of the proposed rules covering portions of the Food Safety Modernization Act released, pace of the rule making work will increase, said Michael R. Taylor, deputy commissioner for food and veterinary medicine, U.S. Food and Drug Administration. “The industries and consumer groups are with us in publishing these rules,” Taylor said at the International Association of Food Protection convention in Charlotte, N.C. “This FSMA development has been a collaborative effort across the food community.”


“How these rules are implemented are what really determines the improvement in the safety of food,” Taylor said.  “The development of the rules and the implementation strategies all have to come together in a coherent way. We want to do outreach on some of these implementation strategies.”

Taylor characterized the writing of the proposed rule for produce as being particularly complex. “The produce rule is one of the most challenging rule making activities that I have been involved in,” he said. Because of this complexity, he said that the FDA is having listening sessions on the produce rule to work with stakeholders to make sure that they can make all aspects of the rule work.

The FDA has issued a proposed rule for certification of third-party auditors. Taylor said that the FDA wants to strengthen the credibility of third-party audits. “These audits would be required for targeted uses initially; we think there is a broader rule potentially for accredited third party audits.” He explained that the FDA sees a potential for accredited third-party audits having a role beyond what has been spelled out initially in FSMA. This stance supports the goals of the Global Food Safety Initiative.

Taylor said that the changes to how the FDA looks at imported food mandated by FSMA are sweeping. “We are at the beginning of forming a brand new import oversight system, we look forward to working with stakeholders on developing it fully,” he said. When asked about the impact that increased food safety requirements might have on agriculture in the developing world, Taylor expressed optimism. “Increasing world trade for food can synergistically increase food safety.” He explained that FSMA’s rules regarding imported food along with help from the FDA and third-party audit schemes can prod agricultural operations in the developing world meet U.S. standards, which could open up markets around the world to their products.

When asked about resources that the FDA will need to fully implement FSMA, Taylor said, “FDA says they would need $400-450 million more than their 2012 base expenditures [per year] within in five years to be able to do everything that FSMA is requiring them to do. Without the funding, FSMA will not fulfill its promise.” He added that FSMA could be more disruptive than helpful if the needed additional funding is not provided.