FDA proposes crucial food-safety rules under FSMA
The U.S. government on Friday proposed two major rules under a landmark food-safety law aimed to pre…The U.S. government on Friday proposed two major rules under a landmark food-safety law aimed to prevent foodborne illnesses that claim thousands of American lives each year.
"We really need to do more than react after the fact," Margaret Hamburg, Commissioner of Food and Drugs for the U.S. Food and Drug Administration (FDA), said Friday during a conference call with the media to discuss the proposals.
FDA has proposed the measures under the 2-year-old Food Safety Modernization Act (FSMA), which President Obama signed into law on Jan. 4, 2011. The rules affect food manufacturers and farmers, focusing on prevention of Salmonella, E. coli and other foodborne illnesses that the Centers for Disease Control and Prevention (CDC) estimates impact 1in 6 Americans every year.
“FDA’s proposed regulations on preventive controls and fresh produce form the cornerstone of FSMA," said attorney Joe Levitt, a partner with Hogan Lovells and the former Director of FDA’s Center for Food Safety and Applied Nutrition, in a statement. "They get to the very heart of the new law’s paradigm shift from reaction to prevention."
Michael Taylor, FDA's Deputy Commissioner for Foods and Veterinary Medicine, noted the produce safety rule requires standards to prevent the introduction of reasonably foreseeable hazards that result in people falling ill. The proposed rule establishes standards for growing, harvesting, packing and holding produce. It zeroes in on agricultural water, biological soil amendments of animal origin, health and hygiene, animals in the growing area and buildings, equipment and tools.
The other proposed rule is rooted in food principles the industry has developed over decades known as HACCP (hazard analysis & critical control points). It would cover facilities that manufacture, process, pack or hold human food. The facilities would be required to identify potential food-safety hazards and implement controls to reduce such risks.
"We are in a moment and time when science is going to provide a lot of new tools and answers of how to manage these contamination risks and there will be need to be" updates of the agency's approach, Hamburg said.
The proposed rules are available for public comment over the next 120 days, and it could take up to one year or longer before they are finalized and actually take effect.
"As with all FDA proposed rules, public comment is a key component of the process, and the food industry and other stakeholders will review these proposals thoroughly and submit comments to FDA on how to make the final rules as beneficial and cost-effective as possible," Levitt said.
Implementation of the rules will be phased over time, and FDA officials could not pinpoint the cost to the federal government. "I think we will all see the benefits substantially outweigh the cost of implementation," Taylor said.
During Friday's call with FDA officials, some journalists appeared to question whether the agency will have the necessary resources to implement the rules. Hamburg acknowledged "resources remain an ongoing concern."
It is clear FDA doesn't anticipate implementing and enforcing the rules without outside assistance. In a speech last year at the Global Food Safety Conference, Taylor noted FSMA includes about 50 directives from Congress for the agency to collaborate with other federal and state agencies and foreign governments in designing and implementing the new food-safety system.
FDA continues to work on other proposed rules under FSMA. Born out of a series of outbreaks, FSMA has been hailed as the most sweeping food-safety law in decades.
It is definitely a work in progress: Taylor has said it will take several years to fully implement.