Trade Compliance

GHY discusses changes to international trade regulations and explores cutting-edge compliance strategies.

FDA’s Operational Strategy for Implementing the Food Safety Modernization Act (FSMA)

Posted May 07, 2014

On May 2, 2014, the Food and Drug Administration (FDA) published a Food Safety Modernization Act (FSMA) Operational Strategy document outlining the agency’s guidelines and standards for the FSMA implementation. Under the FSMA, the FDA is appointed to establish and oversee requirements for the adoption of modern food safety prevention practices by individuals who grow, process, transport, and store food.

Having focused on creating regulations related to the food safety law, passed by Congress in 2010, the FDA says the next phase will concentrate on ensuring compliance with the rules.

“The agency has to design methods to promote widespread voluntary industry compliance with the new rules, as well as establish preventive/public health-focused inspection and sampling programs to oversee compliance,” according to an FDA news release.

The agency is developing enforcement strategies to be used when producers, processors, distributors and importers fail to comply voluntarily.

The FDA must change the way it works because of the global scale and complexity of the food system.

“Hundreds of thousands of growers and processors worldwide are producing food for the U.S. market, using increasingly diverse and complicated processes, managing complex and extended supply chains, and making millions of decisions every day that affect food safety,” according to the document. “The burgeoning scale and complexity of the food system make it impossible for FDA on its own, employing our historic approaches, to provide the elevated assurances of food safety envisioned by FSMA and needed to maintain a high level of consumer confidence in the safety of the food supply.”

In a blog post about the document, called “We’re Reinventing Ourselves to Keep Your Food Safe,” FDA officials Michael Taylor and Howard Sklamberg express their hope the new approach will be a “springboard for discussion.”

“And we know discussion is needed, because the strategy that will make FSMA a success requires significant change in how we at FDA do our work and how we work with our partners,” say the deputy commissioners.