Time is running out to comment on the 2010 Food Safety Modernization Act’s Produce Safety and Preventive Control rules and advocates for farmers markets and sustainable agriculture are urging the public to weigh in on what they say are regulations that could make it more difficult and more expensive for small farmers to do business.
“The rules are based on assumptions of farming that are not necessarily accurate,” Jen O’Brien of the Farmers Market Coalition said during a webcast held to explain grower issues and generate public comments before the Nov. 15 deadline.
O’Brien said some definitions in the rules are unclear and parts conflict with mandates of the FSMA, which covers standards of production and food safety issues.
A big issue is how the FDA determines what constitutes a farm and what makes up a facility, definitions that govern which regulations that must be followed. Farm advocates also are concerned whether the regulations are scaled to appropriate risk for small farmers and larger growers and facilities.
Under the proposed rule, enterprises that grow, harvest and pack or hold produce are covered by the produce rule, said Sarah Hackney of the National Sustainable Agriculture Coalition. Those that process and manufacture, pack or hold are covered by preventive control rules. Some are covered by both and some simple farm activities can lead to a facilities designation.
The produce rule sets up new regulations governing production of fresh fruits and vegetables on farms, how farms manage health and hygiene and agricultural water. The preventive control rule focuses on standards for facilities that make and process foods, governing hazards, prevention and good manufacturing practices.
But there are layers within these rules, allowing for modification of requirements if certain conditions are met, which makes them even more confusing and difficult for farmers to navigate. The worry is it could put a damper on diversification, which could hurt business for farmers and farmers markets.
“Many activities that many farmers would consider part of the daily operations on a farm may erroneously be considered processing by the FDA and cause the farm to fall under facilities portion of the rule,” Hackney said.
That could include something as simple as slicing apples that will go to school food programs.
Hackney said the FDA has broad new authority to take away exemptions and modify requirements if there is any reason to suspect food safety problems and there is no defined way for farmers to get an exemption back, even if safety issues are resolved.
“This does not give farmers and businesses fair due process,” she said. “This is a huge concern for growers.”
Beyond just asking for comments, some groups want the rules rewritten entirely to address concerns.
The National Sustainable Agriculture Coalition wants the FDA to rewrite the rules. State agriculture officials at the annual meeting of the National Association of State Departments of Agriculture in September reaffirmed support of FSMA but said they were hearing concerns from growers. The group said Congress should let the FDA postpone finalizing the rules until a second draft can be issued.
Even though the rules affect farmers, O’Brien and Hackney believe consumers are the audience that needs to comment on the proposals, adding that the FDA will weigh each comment carefully.