WASHINGTON, Sept. 10, 2015 - The Food and Drug Administration has finalized the first major food safety regulations under a sweeping federal law that’s intended to prevent illnesses linked to both domestic and foreign-produced foods. 

The first two rules, which were tweaked to address a range of concerns from industry and small-scale businesses and farms, will require food processors and animal feed manufacturers to have preventive controls aimed at preventing products from becoming contaminated. 

The rules were mandated by the Food Safety Modernization Act, which was signed into law in January 2011. FDA said the final versions  “incorporate thousands of public comments, including valuable input from farmers, consumers, the food industry and academic experts, to create a flexible and targeted approach to ensuring food safety.”

Industry groups praised the agency for making changes in the proposed rules to address processors’ concerns.

 “We welcome the final FSMA rules for preventative controls for human and animal food and commend FDA for the deliberative and inclusive approach it took in developing these regulations,” said Pamela Bailey, president and CEO of the Grocery Manufacturers Association.

Richard Sellers, senior vice president of legislative and regulatory affairs with the American Feed Industry Association, said the feed rule represented the largest change to feed regulation since the 1950s, and he praised FDA for allowing a phased-in approach.

Several additional rules, including one setting safety standards for growing produce, must be finalized by Oct. 31 under a court agreement.

Compliance dates for the two preventive control rules will be staggered over several years, depending on the size and type of business. 

Major food companies have implemented hazard control plans but the regulations set new standards industry-wide and extend them to foreign suppliers.

The final, 930-page rule for human food requires companies to implement a food safety system that includes both analysis of hazards and risk-based preventive controls. The final rule provides some flexibility in the regulations by, among other things, exempting facilities from implementing certain controls when it would duplicate what a customer down the supply chain already does. 

The final rule also attempts to clarify and expand the definition of a farm, which are exempt from the regulations. Off-farm packing operations could fall under the exemption as well as facilities for hulling and dehydrating nuts. Companies that solely harvest crops from farm also would be exempt.

The National Sustainable Agriculture Coalition, which has been concerned with how the proposed food rule would affect small operations with on-farm and off-farm operations and stores or subscription sales, was pleased with the changes. “The revised definition includes positive changes to account for the diversity of farm management structures and physical compositions that we believe will provide more clarity to farmers attempting to discern whether this rule applies to them,” said Ferd Hoefner, the group’s policy director.

FDA estimates that the regulations on food companies will cost domestic businesses about $380 million a year and foreign suppliers about $820 million annually. To cover those costs, the regulations need to prevent at least 157,000 illnesses, which is 17 percent of the estimated illnesses attributed to foods covered by the rule. 

FDA regulates most foods other than meat and poultry, which are regulated by the Agriculture Department. 

The 666-page feed rule was altered to address concerns of brewers. They and other companies that already have food safety controls, won’t have to implement additional measures for byproducts that they provide for feed, such as wet spent grains, fruit or vegetable peels and liquid whey.

There’s still the question of how FDA will pay for implementing the new regulations. The Obama administration asked for a $109 million increase in fiscal 2016, which begins Oct. 1, but congressional appropriators appear unlikely at this point to give them even half of that. 

The first $50 million requested by FDA is supposed to go toward implementing the preventive control rules, which will require ramping up FDA and state inspection programs and doing extensive training.

The Senate’s Agriculture appropriations bill, which funds USDA and FDA, would provide an extra $45 million for FSMA implementation. The House version contains $41.5 million. It’s also unlikely that lawmakers will reach agreement on fiscal 2016 spending before December at the earliest.

“Obtaining adequate federal funding and conducting stakeholder education are the only pathways to a workable preventive approach to food safety,” said Barbara Glenn, executive director of the National Association of State Departments of Agriculture.

David Plunkett, food safety attorney for the advocacy group Center for Science in the Public Interest, said the release of the “transformative” food rule represents a “major step toward creating a truly modern food safety system.” But, he added, “Now Congress must fund FDA so that it could actually conduct inspections and help industry comply with the new requirement.” 

Kraig Naasz, president and CEO of the American Frozen Food Institute, praised FDA for cultivating “collaborative working relationships” with industry while writing the rules.  


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