January 7, 2013
(The New York Times News Service) -- The Food and Drug Administration on Friday proposed wide-ranging rules to prevent the spread of food-borne illnesses like the 2006 E. coli outbreak caused by contaminated California spinach that killed at least three people and sickened as many as 205.
The planned regulations -- additional rules are pending -- come two years after Congress passed the Food Safety Modernization Act, said to be the first major overhaul intended to prevent contamination in produce and processed foods since 1938. In addition to spinach, a spate of other illnesses tied to eggs and peanut butter was the impetus for the 2011 law.
"The FDA Food Safety Modernization Act is a common-sense law that shifts the food safety focus from reactive to preventative," Kathleen Sebelius, the secretary of Health and Human Services, said in a written statement. "With the support of industry, consumer groups and the bipartisan leadership in Congress, we are establishing a science-based, flexible system to better prevent food-borne illness and protect American families."
One in six Americans gets sick from eating contaminated food each year, according to the government, which estimates that of those sickened, 130,000 are hospitalized and 3,000 die. The FDA oversees the majority of the food that the nation eats.
Government health officials estimate the new regulations could cost farmers and food companies $1.1 billion a year, although it's unclear how or if those added costs will be passed on to consumers.
"These rules are amplification of what has been talked about since the mid '90s," said William Marler, a leading lawyer on food-borne illnesses who represented 105 plaintiffs in a lawsuit against Dole, Mission Organics and Natural Selection Food in the 2006 E. coli case, which was settled for tens of millions of dollars.
"They're going to have an enormous and positive impact on the leafy green and fruit and vegetable industry in which California is a world leader," he said. "It should in the long run not only be good for the consumer, but for the industry. When one of these big outbreaks happens, it costs hundreds of millions of dollars in lawsuits, lost business and bad publicity."
The federal agency's first rule calls for manufacturers to develop a formal plan to prevent food sold in the United States from causing a food-borne illness, including pinpointing and adopting measures that would snuff out contamination. The proposal would also require food makers to rectify any problems that arise.
The second rule proposes enforceable safety principles for the production and harvesting of produce on farms, including science- and risk-based standards.
Senior lawyer George Kimbrell of San Francisco's Center for Food Safety said that although he's delighted there has finally been some movement, the rule proposals took too long. Last August the nonprofit health and consumer-interest group filed suit against the FDA for missing its deadline to finalize the set of regulations.
"We're talking about human health and safety, life and death," he said. "If you have law and don't implement it, it's an empty vessel."
Kimbrell said he hopes the government moves quicker on the remaining regulations needed to fulfill the food safety act's requirements.
"Sometimes you have to light a fire under an agency with litigation to get them to move," he said. "It's a good start they have finally taken some tardy action, although there is much, much more to be done. We will continue to keep the pressure on them until they comply with Congress' orders."
In the meantime, the FDA is seeking public comment on its proposals, detailed in more than 1,000 pages on its website (http://www.fda.gov/). The agency plans to give farmers and food manufacturers anywhere from a year to more than 26 months -- depending on the operation and its size -- to come into compliance after the requirements are published in the Federal Register.
"We know one-size-fits-all rules won't work," Michael Taylor, the FDA's deputy commissioner for foods and veterinary medicine, said in a statement. "We've worked to develop proposed regulations that can be both effective and practical across today's diverse food system."
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