WASHINGTON, Sept. 19, 2014 – The Food and Drug Administration is suggesting revisions to four rules that it proposed early last year for implementing the Food Safety Modernization Act (FSMA) after receiving thousands of comments from agricultural stakeholders, processors and consumers.
The updated proposed rules – involving produce safety, preventive controls for human and animal food and the foreign verification program – are being published in the Federal Register and interested parties have until Dec. 14 to submit comments before final rules are issued in 2015, FDA said today in a news release.
“Based on valuable input from farmers, consumers, the food-industry and academic experts, the FDA is proposing to update these four proposed rules to ensure a more flexible and targeted means to ensure food safety,” said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.
The FDA proposals include:
-Revising the water quality testing provisions in the original proposed produce safety rule to account for natural variations in water sources and to adjust the agency’s approach to manure and compost used in crop production pending further research.
-Redefining which farms would be subject to the produce-safety rule to exempt operations with $25,000 or less in produce sales, rather than setting the threshold based on sales of all foods produced on the farm. The FDA is also proposing to simplify which entities are covered by the produce safety rule and which would be covered by the preventive controls rules.
-Clarifying that human food processors who create by-products used as animal food -- including brewers and other producers of wet spent grains -- and who are already complying with FDA human food safety requirements would not need to comply with the full animal food rule.
--Revising the foreign-supplier verification proposed rule to give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.
“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,” FDA Commissioner Margaret Hamburg said in the release. “We look forward to public comments on these proposals.”
President Barack Obama signed FSMA into law in January 2011, the first major food safety legislation in decades. The law aims to strengthen food safety by shifting the focus to preventing food safety problems rather than responding to situations that threaten human and animal health. The Centers for Disease Control estimates that each year roughly one in six Americans, or about 48 million people, are sickened by foodborne illnesses. The illnesses result in about 128,000 hospitalizations and 3,000 deaths annually, CDC says.
The National Sustainable Agriculture Coalition (NSAC) commended the FDA for listening to stakeholder rules and recognizing that revisions were necessary.
“These rules must not only ensure a safe food supply, but also that family farms can thrive and that consumers can access foods that are safe, healthy, and sustainably produced, including fresh food from local sources,” NSAC Policy Specialist Sophia Kruszewski said in a news release.
NSAC said FDA’s original proposed regulations, issued in 2013, “included several highly problematic requirements that would have put many sustainable and organic farmers out of business, dampened the growth of local food systems and innovative supply chains, and halted the conservation of critical natural resources.”
Kruszewski said NSAC is reviewing the revised language in the latest FDA proposal.
Laura Batcha, executive director and CEO of the Organic Trade Association (OTA), said she was encouraged that FDA had listened to the feedback from members of her organization.
“OTA looks forward to continued collaboration with FDA to formulate regulations that create a system that meets the needs of both organic farmers and organic eaters,” Batch said in a statement.
Gwendolyn Wyard, OTA regulatory director for organic standards and food safety, said FDA has done “a fine job” reaching out to organic stakeholders in order to understand how the proposed food safety rules will interact with the organic standards.
The American Feed Industry Association also issued a news release applauding FDA’s action.
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