The first major reform of food safety laws in seven decades, the Food Safety Modernization Act, was enacted in January 2011 with the intent of making food safer and reducing foodborne illness. However, the Food and Drug Administration’s plans to put FSMA rules in place are too broad to do the job well, according to farmers.
Among Farm Bureau’s top concerns with the proposed regulations is FDA’s apparent unwillingness to focus on commodities that are associated with foodborne illness.
“We urge FDA to reconsider standards that take into account the relative risks and comparative benefits associated with individual commodities. FDA should initially propose regulations for only those commodities with a history of microbial contamination,” Farm Bureau wrote in lengthy comments recently submitted to the FDA.
Only once those regulations are successfully put in place and enforced, should FDA even consider expanding regulations to cover other commodities.
“We know that there have been problems with E. coli in leafy greens or with salmonella in tomatoes, for example, and the industry has voluntarily taken the initiative to curb some of those problems,” said Kelli Ludlum, American Farm Bureau Federation food safety specialist. “That’s where it really makes sense for FDA to focus their efforts. Unfortunately, they’ve chosen to go significantly broader than that and regulate a whole scope of commodities that have never had foodborne illnesses, and, because of the way they’re grown and consumed, are very unlikely to have those issues.”
Including low- and no-contamination risk commodities is a waste of both growers’ and the governments’ time and money.
“Instead of shrinking the size of the haystack in which they’re looking for that public health threat needle, by choosing to regulate all produce, they’re only making that haystack bigger, which neither farmers nor government inspectors and regulators have the resources for,” Ludlum said.
Firm in its opposition to regulating all produce, Farm Bureau said that if FDA retains lists of “covered” and “exempt” produce, “the factors and/or standards that cause a specific commodity to be listed must be clearly explained and justified by science-based risk status.”
In addition, FDA must establish a process for regular review of the lists and clarify whether and how a commodity can move from one list to another.
Also in the comments, Farm Bureau raised red flags about other aspects of FSMA, including a regulatory process that could prevent a scientifically sound and effective set of rules.
While appreciative of FDA’s approval of Farm Bureau’s comment extension request, the organization said it still has concerns about the regulatory process. Specifically, because considerable changes to the draft rules are expected to be made as a result of public comments, Farm Bureau believes a second draft of the proposed rule should be put out for public comment.
“Given the complexity of the proposed rules, the current process of responding to comments on this draft rule with a final rule as a next step does not allow FDA to craft a sound and operable food safety framework. An interim step, such as a second draft rule or interim final rule, is needed to work through the regulatory process with adequate stakeholder input. ”
Congressional lawmakers are also calling for another round of comments. In a recent letter to FDA Commissioner Margaret Hamburg, 75 Democratic and Republican members of Congress called for a second draft of regulations for public comment before issuing final Food Safety Modernization rules. The 30 senators and 45 House members said they were concerned about the impact of proposed rules on farmers and businesses that an additional comment period could help alleviate.
“Despite your agency’s efforts to engage with stakeholders during the rulemaking process, we remain concerned about the ambiguity surrounding many aspects of these proposed rules,” the letter said.
Additionally, because many of the FSMA rules overlap, farmers and others who will be affected by them should have the opportunity to evaluate them as a complete package, Farm Bureau noted in its comments.
“We encourage FDA to release a second draft of the combined produce safety, preventive controls for human food and animal feed, foreign supplier verification program and third-party audit certification rules to allow for sufficient review as to how all the rules are intended to work together,” Farm Bureau wrote.
