Federal health regulators have issued new safety rules that require food producers to create plans and take preventative actions designed to reduce the risk of food poisoning outbreaks in the United States.
In what some are calling the most sweeping changes to U.S. food safety in more than a century, the FDA announced the finalization of new regulations known as the Preventative Controls for Human Food rule (PDF) this week.
The new rules, which have been in development for several years, are required as part of the FDA Food Safety Modernization Act (FSMA) and will be published in the Federal Register on September 17.
The federal regulations will go into effect in one year for some businesses, calling for covered food facilities, considered separate from farms, to develop plans that analyze and mitigate potential hazards to the safety of the food they produce or distribute. These plans and preventative controls must be monitored, verified and corrected when problems occur.
They must also strengthen their supply chain by identifying potential threats that could come through the raw materials, making sure they are only receiving materials from approved suppliers, or verifying the safety of raw materials shipped through temporary unapproved suppliers.
“We’ve been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules,” Michael R. Taylor, deputy commissioner for foods and veterinary medicines at the FDA, said in a press release issued September 10. “And we have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first.”
In addition, the new rules clarify the definition of farms, which are not subject to the preventative controls rule. Food manufacturers with less than $1 million in sales would also be exempt from many of the requirements, but have to file to be confirmed as a small business by January 2016.
Recent Food Poisoning Outbreaks Raise Concerns
The regulations come on the heels of a string of large food poisoning outbreaks in recent years, most of which could have easily been prevented.
A recent Listeria contamination outbreak involving Blue Bell ice cream this spring was traced back to an Oklahoma facility that had signs of problems as far back as 2010. During the company’s own testing of nonfood contact areas of the facility Listeria was found in 2013. However, the ice cream was not recalled and no alarms were sounded until consumers began to fall ill earlier this year and, in some cases, die.
Inspections later revealed 26 violations involving lax sanitary practices. These findings lead investigators to believe if stricter plans were in place, this outbreak may have been prevented.
Another major food outbreak in 2011 infected nearly 150 people and causing 33 deaths when cantaloupes grown by a Colorado company became tainted with Listeria. An estimated 48 million people in the U.S. become sick due to food poisoning every year, and about 3,000 die.
The proposed regulations require further funding to be fully implemented. The agency is pushing for funding to ensure the rules can be operational. President Barack Obama has asked Congress for $109 million to help the FDA implement the food safety law.