After much prodding, groups last week succeeded in convincing the Food and Drug Administration to recall two proposed rules under the Food Safety Modernization Act on concerns that they were flawed on multiple grounds.
FDA said it would recall the proposed rules and re-work them by mid-2014 to address concerns raised in a comment period that was extended three times.
Specifically, groups were concerned that the rules infringed on conservation and environmental standards, and included "unintended consequences" resulting from stricter management standards for a variety of crops not typically involved in foodborne illness.
Other groups were concerned with the costs of the programs and said the proposal wasn't clear on what agency would be responsible for implementing the rules, and at what level – state or federal – they would be managed.
In response to the FDA's decision to roll the rule back and start again, groups again reiterated their priorities in the new arrangement.
Earl Garber, president of the National Association of Conservation Districts, said the group "looks forward to continuing to work with FDA throughout the extended rule-making process to ensure the final rules accomplish our shared goals of improving food safety."
However, Garber added, the new rules should ensure commitment to conservation – a concern that several groups brought up in the comment period that concluded in November.
NACD said special consideration should be given to agricultural water and biological soil amendments like manure. Previously, FDA limited the use of manure to fertilize food crops. NACD also supports the decision for FDA to perform an Environmental Impact Statement on this rule before implementation, the group said.
Produce group United Fresh also lauded the decision, noting that new requirements should be "more science and risk based."
"It is critical that FDA gets these FSMA rules right, and we believe this is a step in the right direction," said David Gombas, United Fresh senior vice president of food safety and technology.
The group, like many others, has long been supportive of the FSMA and re-vamp of food safety regulations, however it posed several concerns with the flexibility of the basic produce rule, and facilities regulated under the preventive controls rule.
Legislators, too, supported revising the rule. Rep. Chellie Pingree, D-Maine, supported revising the rules on concerns that they were too restrictive, and a "one-size-fits-all" policy.
"We will have to wait and see what the rules look like next summer, but it's clear the FDA has heard what we've been saying and took it seriously," Pingree noted in a statement. "The farmers and consumers around the country who made their voices heard on this issue deserve a lot of credit for (FDA's) announcement."
A big concern for Pingree was the cost of the program. Her office noted that the FDA had estimated that a medium-sized farm with annual gross sales of $250,000 to $500,000 would spend $13,000 a year in compliance costs. For farms with sales over $500,000, that cost jumps to over $30,000 a year.
"The one-size-fits-all approach the FDA was pursuing was overkill for thousands of small farmers and would have put many of them out of business," Pingree argued." The size of the regulation just didn't match the size of the risk."
Pingree signed on with more than 75 Congress members to a letter to the FDA on Nov. 25 opposing the rule.
Another of the signatories, Sen. Roy Blunt, R-Mo., said the second draft of the rule will allow farmers to provide more input on the new rules and "alleviate the impact of these burdensome regulations on farm families in Missouri and nationwide."
FDA has not listed a final timeline for the release of the reworked rule, however, Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor estimated an "early summer" availability.