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FDA still taking comments on FSMA through May 26


By RACHEL LANE
D.C. Correspondent

WASHINGTON, D.C. — Concerns, comments and information about new food safety regulations were the topics of a meeting conducted by the U.S. Food and Drug Administration (FDA) in late April.
The Food Safety Modernization Act, or FSMA, is expected to rollout over the next several years. The new regulations have updated standards for everything from farm inspections to food distribution.
In addition to providing answers to some questions involved in the rollout, the FDA also had stakeholders speak about concerns from their own sectors of the agriculture industry. Over two days of meetings, recurring themes included training of inspectors and the speed of the rollout.
“Training is important in consistent decision-making,” said Leon Bruner, executive vice president for scientific and regulatory affairs and chief science officer with Grocery Manufacturers Assoc.
He suggested the FDA make the training process for all inspectors available for review, to allow farmers to better understand what goals need to be met. “We urge the FDA to make their training public as soon as possible … In the spirit of ensuring high levels of competence,” he said.
He wanted to know details of the training offered and who will attend. He also urged the FDA to remember flexibility will be important, especially as technology changes and improves innovations.
“All of the fresh produce industry will be affected in one way or another. Many areas were not involved previously in the FDA, and we’re not sure what to expect. There is some general fear of when that’ll happen,” said David Gombas, senior vice president of food safety and technology, with the United Fresh Produce Assoc.
“When the FDA knocks at the door, it generally doesn’t bode well.”
It is important for the FDA to provide necessary information to farmers – not just through passing the knowledge off to others, but in making sure the farmers themselves can get the information directly from the FDA through websites, webinars and phone calls.
The FDA has been asking for recommendations since the process began. This transparency allowed the agricultural community to participate, Gombas said.
“That showed interest in the industry, trust that we were being heard and it was being acted on,” he said. “Not that we agree with everything; we still have some concerns, but they did good.”
Sophia Kruszewski, policy specialist for the National Sustainable Agriculture Coalition, said the FDA needs to finalize its plans as soon as possible. The rollout will give smaller farms some more time to make changes, but the farmers often need to plan for such changes years in advance.
“Diverse small farms are making decisions now,” she pointed out.
Flexibility is a key component needed for small-scale farmers. Kruszewski urged the FDA to allow flexibility to be built into the regulations. She also mentioned her concerns that third party auditors would not be properly trained and might be overused.
In addition to inspectors on the farms, she suggested the FDA provide alternative compliance indicators, such as having farmers provide paperwork to show compliance. “There have been a lot of great comments and views over the past two days,” Kruszewski said.
The first of the FSMA compliance dates is set for September 2015. Public comments about the proposed regulations are due by May 26 and can be provided electronically at www.regulations.gov or in writing to: Dockets Management, Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, HFA-305, Rockville, MD 20852.
More information about the conference and the new regulations can be found on the website, www.fda.gov/FSMA
5/7/2015