Attendees at the FDA Food Safety Modernization Act (FSMA) Public Meeting in April encouraged FDA officials to understand the resources and needs of both small and large farms when implementing prevention-oriented food safety standards.
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According to one farmer at a session on preventive controls, the economic impact of compliance with FSMA rules will be significant. Another farmer agreed, adding that smaller farms need a “hands-on” approach where technical assistance is provided to “help people recognize potential hazards within their environment and processes. …Show-me, don’t-tell-me” methods would be most effective and could help farmers better understand and comply with the regulations, he said.
Several attendees recommended a mentoring system and said that the FDA should “incentivize mentoring” so that larger businesses could share their knowledge with smaller entities. Record keeping and documentation required by FSMA will be a new demand for some farming enterprises, and the FDA needs to provide assistance, with explanations, guidelines, and “real-world” examples that are written in straightforward language rather than “legalese.”
In a session on produce, attendees said they need paperwork in advance of an inspection so that they know what is going to happen when the inspector visits. Inspectors should have a farming background and there should be consistency among the inspectors. They said they are confused about how often farming enterprises will be inspected, if advance notice will be given, and if inspections related to FSMA regulations will overlap with state and other regulators. “It’s important that we don’t suddenly have two to three regulatory agencies going out to the same farm and then farms having to take the time from their business for multiple days for the same thing,” one farmer said.
In a session on how the FDA should collaborate with private international partners, an attendee said that clarification will be needed about the differing roles of the FDA and other entities, such as the Global Food Safety Initiative, which collaborates with international organizations and governments to provide guidance on food safety management systems to assure safety along the supply chain.
On the second day of the public meeting, David E. Gombas, PhD, from United Fresh Produce Association, noted that the FDA seems to support change in its regulatory approach “from reacting to noncompliances to promoting and rewarding compliance.” A significant challenge will be implementing that culture change “throughout the ranks,” he said. “The real test will come during the enforcement period when FDA starts knocking on that door, but I am cautiously optimistic that by continuing to work together we can achieve that mutual goal,” he said.
Comments about any of these issues can be submitted to the FDA at www.regulations.gov.