The FSMA is the first major reform to food safety regulations since the 1930s. It includes seven major rules that are designed to focus on prevention of foodborne illnesses. FDA says the changes to four of the rules will make them "more flexible, practical and targeted."
The four rules affected are: Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food, and Foreign Supplier Verification Programs.
According to FDA, the changes are based on the input received during outreach to stakeholders and from input submitted by farmers and others directly affected by the rules. Thousands of comments were submitted electronically during the comment period, FDA says.
"Ensuring a safe and high-quality food supply is one of the FDA's highest priorities, and we have worked very hard to gather and respond to comments from farmers and other stakeholders regarding the major proposed FSMA regulations," said FDA Commissioner Dr. Margaret Hamburg. "The FDA believes these updated proposed rules will lead to a modern, science-based food safety system that will better protect American consumers from potentially hazardous food."
First, FDA is proposing to revise the water quality testing provisions in the proposed produce safety rule to account for natural variations in water sources and to adjust its approach to manure and compost used in crop production, pending further research on this issue.
The FDA also is proposing, based on feedback received to date, a new definition of which farms would be subject to the produce safety rule. The proposed rule would not apply to farms with $25,000 or less in produce sales, rather than setting the threshold based on sales of all foods produced on the farm.
The updated proposed rules also suggest simplifying which entities are covered by the produce safety rule and which would be covered by the preventive controls rules.
The revisions also address the issue of the use of spent grains, which are by-products of alcoholic beverage brewing and distilling that are commonly used as animal food.
Concerns were raised this spring that the proposed rules would require brewers and distillers to comply with the full human food and animal food rules if they made their wet spent grains available for animal feed.
According to FDA, the updated proposed rule would clarify that human food processors that create by-products used as animal food and are already complying with FDA human food safety requirements — such as producers of wet spent grains — would not need to comply with the full animal food rule if they are already complying with the human-food rule.
Finally, revisions to the foreign-supplier verification proposed rule give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.
The FDA will accept comments on the revised provisions for 75 days after publication in the Federal Register, while continuing to review comments already received on the original proposed rules.
No additional comments will be accepted on the original proposals, FDA says. FDA will consider both sets of comments—on the original proposed rules and on the revisions—before issuing final rules in 2015.