Representatives from various food interests recently cited the preventative approach that is the hallmark of the 4-year-old Food Safety Modernization Act (FSMA) and discussed key considerations in helping to make the law a success.
During a two-day meeting last week that was hosted by FDA, executives from such varied organizations as the Grocery Manufacturers Association, The Pew Charitable Trusts and Specialty Food Association gathered in Washington, D.C. to discuss FSMA’s future. Various perspectives during the meeting, which FDA included in a YouTube clip, are summarized below.
“Now I’m convinced that the FDA leadership here wants the regulatory approach to change from reacting to noncompliances to promoting and rewarding compliance," said David Gombas, senior vice president of Food Safety & Technology with the United Fresh Produce Association. “But the herculean task that FDA still faces will be to implement that culture change throughout the ranks. The real test will come during the enforcement period when FDA starts knocking on that door."
“How do you assess whether or not someone has actually woven safety into the culture … the way they do their work each day?" asked Leon Bruner, senior vice president for Scientific and Regulatory Affairs and chief science officer of the Grocery Manufacturers Association (GMA).
Bruner also noted the food-safety industry is moving to a system focused on prevention, and he indicated the industry’s work to date with FDA on the crafting of FSMA regulations has been a successful venture. “We had phase one where we’ve had an unprecedented opportunity to work with the FDA on the development of the regulations," Bruner said. “And I think that working together we’ve made huge improvements in what we started out with and we are going to continue on this journey."
Stephanie Barnes, regulatory counsel with the Food Marketing Institute, said FDA shouldn’t ignore food-safety programs outside the United States.
“Global food-safety programs have improved food-safety practices around the world," Barnes said, “and regulations issued pursuant to FSMA should recognize such programs rather than supplant them."
Another speaker pointed out states have a role in overseeing a safe food supply. Citing recent recalls of ice cream, Sandra Eskin of The Pew Charitable Trusts noted state inspectors tested the food and discovered contamination.
“The only way that FDA is going to make this work is if they leverage all of the possible ways to assure food-safety: their own inspectors, state inspectors, auditors," said Eskin, food-safety director of The Pew Charitable Trusts. “Whatever method, whatever personnel are used to assure food safety there must be accountability and there must be transparency."
Richard Sellers, senior vice president of Legislative and Regulatory Affairs with the American Feed Industry Association, cited the importance of ensuring industry and FDA are on the same page as it relates to FSMA.
“Both sides, the regulators and the regulated industry, should have a clear understanding of each other’s responsibilities and expectations and there should be no surprises on either side," he said.
Marsha Echols, legal advisor to the Specialty Food Association, called on FDA to give small companies “clear instructions, clear guidelines, clear priorities so that they can work within your parameters and still conduct their business."
Otherwise, she warned, FDA regulations will unduly burden such businesses.
Eskin referenced an observation from another speaker that “whenever you regulate an industry, people go out of business."
“My hope is the only people that go out of business—whatever size they are—are the people who don’t want to produce safe food," Eskin said.
Speakers also discussed the importance of enforcing FSMA.
“Taking a graduated approach to enforcement, particularly in the beginning, will be essential to set the tone for inspectors and foster critical relationships, so we can all achieve the ultimate objective, which is to enhance a safe global food supply," Barnes of the Food Marketing Institute said.
“FSMA will only be successful," GMA’s Bruner said, “if it is enforced effectively, uniformly and fairly by the agency."
“Key to this is going to be effective training," he added, citing the need for “competent" inspectors.
“We can’t have inspectors who are just box checkers. They need to understand food-safety principles so that they can apply this understanding in the diverse situations that they are going to face, in audit situations," Bruner said. “The training is also important in promoting consistent decision-making."
Finally, Eskin addressed an important question related to FSMA.
“How is a person going to know when FSMA is in effect? How will they know?" she asked. “And I said what I would always say and I still say: fewer recalls, fewer outbreaks."