WASHINGTON, D.C. — Nearly 4 1/2 years and thousands of public and food industry comments after President Barack Obama signed into law the Food Safety Management Act (FSMA), the FDA has issued the long-awaited and much debated “FSMA Prevented Controls Rules for Human and Animal Food” in a nationwide effort to combat foodborne illnesses.

The rules, outlined in a 666-page FDA directive, take effect Sept. 1, 2016, and are the biggest changes in food safety since 1938. They focus on implementing modern food manufacturing processes for both human and animal foods and are designed to provide a greater collaboration between food producers and the FDA.

All this is aimed at preventing illnesses to consumers and animals, rather than waiting for an outbreak to occur. The preventive control rules mandate both human and animal food facilities to develop and implement written food safety plans detailing a crisis plan if an incident occurs.

“We’ve been meeting with the states, food companies, farmers and consumers to create smart, practical and meaningful rules,” said Michael Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine. “We have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first.” 

To implement the new rules, FDA estimates total costs at between $139 million-$170.7 million per year over 10 years, significantly lower than some of the higher estimates of $700 million per year. The federal budget for 2016 has yet to be approved by Congress, but includes a $301 million increase for the FDA’s $4.9 billion proposal. Food safety enforcement is budgeted at $1.5 billion for 2016.

Earlier this summer, the House and Senate appropriations committees allocated $41.5 million and $45 million increases, respectively, for the FDA’s food safety activities. As part of the House committee proposal, a special provision of the law targets animal foods and requires the FDA to provide lawmakers with semiannual reports on its tainted pet food investigations.

Foodborne human illnesses and contamination outbreaks have had a significant public health and economic impact, the FDA reported, accounting for $75 billion in lost productivity, illness-related mortality and medical costs as a result of some 48 million food related illnesses.

Nearly $220 million is targeted for animal food safety. Last year, the FDA reported 1,000 dogs died and 5,800 became sick, along with 25 cats, from tainted pet foods, most imported from China. The FDA has documented 13 distinct recalls of pet foods and treats, 10 due to salmonella or listeria contamination.

The 575-member American Feed Industry Assoc. (AFIA) had praise for the FDA’s new animal food safety rules. “This has been no easy endeavor for the agency and they should be commended,” AFIA’s Senior Vice President Richard Sellers said.

“AFIA is also pleased (the) FDA recognized animal food is different from human food in revising the Current Good Manufacturing Practices (CGMPs) to be more applicable to animal food facilities and addressing the hazards in our industry.”

Richard Williams, vice president of policy research and director of the regulatory studies program and senior research fellow at the Mercatus Center, authored a critical study of the new rules, saying some of the most burdensome regulations fail to demonstrate the benefits of the new rules and outweigh the costs.

“For some rules,” Williams wrote, “there is very little evidence that (the rules) actually address a significant food safety program. For others, the FDA has been unable to provide evidence that the rules will be effective at reducing foodborne risk.”

In addressing animal food safety, Williams added, “The only significant hazards relating to animal food that the FDA can point to are associated with people touching or consuming contaminated pet food.

The FDA’s animal food regulation extends to all animal food, including food for farm animals.

“A more tailored rule would apply only to 300-400 pet food facilities instead of to all of the 4,000-7,000 animal food facilities, reducing costs tremendously while reserving all the expected benefits,” said Williams, a college professor at George Mason University in Virginia.

Consumers spent more than $58 billion last year on their pets, according to the American Pet Products Assoc., including $22 billion on food alone.

The FDA’s Taylor said the new rules have a single purpose: “The rules require registered food facilities to maintain a food safety plan, perform a hazard analysis and institute preventive controls for dealing with food hazards.”

The rule regarding preventive controls for human foods modernizes existing CGMPs for manufacturing, processing, packing or holding human food, which were last updated in 1986. The rule for animal food establishes for the first time CGMPs for the manufacturing, processing, packing and holding for food for animals.

Taylor said, “The flexibility built into the final rules is meant to ensure food safety across the great diversity of the food system.”

Compliance dates vary for different sizes of businesses; one year for large businesses, two years for small businesses – Aug. 31, 2017 – and very small businesses, three years, Aug. 31, 2018. Very small businesses, with less than $2.5 million in revenue, have up to four years to comply with the regulations.

Feed mills associated with farms are not covered by the new rules, the FDA said.

To help industry implement the new rules, the FDA will hold a daylong public meeting in Chicago on Oct. 20, at the Downtown Marriott Magnificent Mile hotel.

The FDA stated more public meetings will be held later and dates and registration will be posted on the FDA’s website at www.fda.gov/Food/GuidanceRegulation/FSMA

The National Grain and Feed Assoc. and the Pet Food Institute (PFI) will hold a special meeting Sept. 30-Oct. l, “Feed and Pet Food Joint Conference,” to address the expanded federal food safety requirements under the new FSMA rules.

The event will be at the Hyatt Regency Hotel in Columbus, Ohio.

Additional information is available at www.ngfa.org and www.petfoodinstitute.org