FDA releases much-anticipated food safety rules
January 07, 2013 | 07:08 PM
The Food and Drug Administration on Friday released two long-awaited rules to enforce the Food Safety Modernization Act, but groups with an interest in the rule did not react directly to them on Friday, saying that they would have to analyze them.
The FSMA law is the first significant overhaul to the nation’s food safety laws since the 1930s. The announcement came on the two-year anniversary of the bill being signed by President Barack Obama in early 2011.
Michael Taylor
“It’s a big deal that these two are coming out because it’s the central framework for prevention,” Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, said in an interview with Food Safety News. “We’re eager to get to the next phase of the process.”
The rules are important because they cover fruits and vegetables and the rest of the 80 percent of the nation’s food supply that is regulated by
Chris Waldrop
After foodborne-illness outbreaks involving vegetables, the United Fresh Produce Association and other industry organizations joined with consumer groups to encourage Congress to write a bill that would address food safety issues and improve consumer confidence. But before it was finished, some industry groups had second thoughts about the new regulations.
“Congress granted FDA essential new food safety authorities aimed at preventing foodborne illness and protecting consumers,” said Chris Waldrop, director of the Food Policy Institute at Consumer Federation of America. “Preventive controls and produce safety are cornerstones of FDA’s new preventive system. We are eager to review the proposals and provide comments to the agency.”
Ray Gilmer
Ray Gilmer, vice president of issues management and communications for the United Fresh Produce Association, said in a news release, “We will be analyzing the proposed rules to ensure that they draw upon the principles we have supported throughout the development of the FSMA.”
Gilmer said the proposed rules must be:
“We are committed to ensuring that those critical provisions, and others, will be integrated into the final rules going forward,” Gilmer said.
One of the issues that bothered large agricultural concerns was a decision in Congress to include somewhat different production standards, reporting requirements, and prevention planning requirements for small and medium-sized family businesses.
Ariane Lotti
But Friday the National Sustainable Agriculture Coalition, which lobbied hard for those rules, said it would examine them to see if they work for smaller businesses without costly new investments.
“A ‘one-size-fits-all’ approach would put small and mid-sized farm operations out of business, consolidate agricultural markets, and eliminate opportunities for food and farm entrepreneurs in emerging sectors of agriculture – including organic and local and regional food systems, said Ariane Lotti, NSAC assistant policy director. “NSAC will be closely reading the rules to determine whether FDA followed congressional intent.”
In the regulations announced Friday, there are no criminal penalties for those who fail to comply with the proposed regulations once these are finalized.
Bill Marler
But Bill Marler, a preeminent food safety expert and advocate and partner in the Marler Clark law firm of Seattle, noted that FDA only has a modest amount of money for enforcement and that there are no criminal penalties for those who fail to comply with the proposed regulations once these are finalized.
“It’s all well and good to set the rules and expect companies to comply without enforcement,” Marler, who has won some of the biggest lawsuits in history following deadly foodborne disease outbreaks, told Obama Foodorama.
“Recent history shows the need for both rules and enforcement,” Marler said. “Having consumers protected through lawsuits as the enforcement mechanism is a blunt instrument for changing behavior. I think there also needs to be more inspections and more criminal prosecutions.”
Consumer advocates said that three other key draft rules remain under review at OMB.
Two of them, on foreign supplier verification and preventive controls for the feed industry, have been there for more than a year, and the other is on third-party audit certification, which was only recently submitted to the administration.
Still, the rules offer modest direct enforcement from FDA, which has a limited budget which could grow smaller in the coming months, as well as a limited number of inspectors. FDA monitors about 166,000 food production facilities that account for about 80 percent of the food that is consumed in the U.S.
The FSMA law is the first significant overhaul to the nation’s food safety laws since the 1930s. The announcement came on the two-year anniversary of the bill being signed by President Barack Obama in early 2011.
Michael Taylor
“It’s a big deal that these two are coming out because it’s the central framework for prevention,” Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, said in an interview with Food Safety News. “We’re eager to get to the next phase of the process.”
The rules are important because they cover fruits and vegetables and the rest of the 80 percent of the nation’s food supply that is regulated by
Chris Waldrop
After foodborne-illness outbreaks involving vegetables, the United Fresh Produce Association and other industry organizations joined with consumer groups to encourage Congress to write a bill that would address food safety issues and improve consumer confidence. But before it was finished, some industry groups had second thoughts about the new regulations.
“Congress granted FDA essential new food safety authorities aimed at preventing foodborne illness and protecting consumers,” said Chris Waldrop, director of the Food Policy Institute at Consumer Federation of America. “Preventive controls and produce safety are cornerstones of FDA’s new preventive system. We are eager to review the proposals and provide comments to the agency.”
Ray Gilmer
Ray Gilmer, vice president of issues management and communications for the United Fresh Produce Association, said in a news release, “We will be analyzing the proposed rules to ensure that they draw upon the principles we have supported throughout the development of the FSMA.”
Gilmer said the proposed rules must be:
- commodity-specific, based on best available science;
- risk-based;
- consistent no matter where produce is grown or packaged, in the U.S. or imported, large or small operations; and
- flexible to allow for advances in science and production technology.
“We are committed to ensuring that those critical provisions, and others, will be integrated into the final rules going forward,” Gilmer said.
One of the issues that bothered large agricultural concerns was a decision in Congress to include somewhat different production standards, reporting requirements, and prevention planning requirements for small and medium-sized family businesses.
Ariane Lotti
But Friday the National Sustainable Agriculture Coalition, which lobbied hard for those rules, said it would examine them to see if they work for smaller businesses without costly new investments.
“A ‘one-size-fits-all’ approach would put small and mid-sized farm operations out of business, consolidate agricultural markets, and eliminate opportunities for food and farm entrepreneurs in emerging sectors of agriculture – including organic and local and regional food systems, said Ariane Lotti, NSAC assistant policy director. “NSAC will be closely reading the rules to determine whether FDA followed congressional intent.”
In the regulations announced Friday, there are no criminal penalties for those who fail to comply with the proposed regulations once these are finalized.
Bill Marler
But Bill Marler, a preeminent food safety expert and advocate and partner in the Marler Clark law firm of Seattle, noted that FDA only has a modest amount of money for enforcement and that there are no criminal penalties for those who fail to comply with the proposed regulations once these are finalized.
“It’s all well and good to set the rules and expect companies to comply without enforcement,” Marler, who has won some of the biggest lawsuits in history following deadly foodborne disease outbreaks, told Obama Foodorama.
“Recent history shows the need for both rules and enforcement,” Marler said. “Having consumers protected through lawsuits as the enforcement mechanism is a blunt instrument for changing behavior. I think there also needs to be more inspections and more criminal prosecutions.”
Consumer advocates said that three other key draft rules remain under review at OMB.
Two of them, on foreign supplier verification and preventive controls for the feed industry, have been there for more than a year, and the other is on third-party audit certification, which was only recently submitted to the administration.
Still, the rules offer modest direct enforcement from FDA, which has a limited budget which could grow smaller in the coming months, as well as a limited number of inspectors. FDA monitors about 166,000 food production facilities that account for about 80 percent of the food that is consumed in the U.S.
Proposed Rule: Preventive Controls for Human Food
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
- Analysis of Economic Impacts
- Draft Qualitative Risk Assessment Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm
- External Peer Review
