Families who’ve lost loved ones to food-borne illnesses have watched with alarm in recent months as producers have recalled mangoes, cantaloupe, ricotta cheese, dog food and peanut butter after people were sickened by the tainted goods.
A landmark food safety law passed nearly two years ago was supposed to help curtail such outbreaks. But the Obama administration has yet to issue the final rules that will give the Food and Drug Administration more authority over food producers.
The rules are supposed hold producers accountable for the quality of their products and produce and will allow federal regulators to better track and contain outbreaks. Some food safety advocates believe such rules could have helped prevent the most recent salmonella outbreak in peanut butter, which has sickened 35 people since June, mostly children younger than 10. A peanut butter recall was expanded last week and fallout continues; on Wednesday an ice cream company in California, Clemmy’s, recalled its peanut butter chocolate chip ice cream because of salmonella fears.
"We have to get ahead of it,” said Paul Schwarz of Independence, Mo., whose 92-year-old father died earlier this year after eating cantaloupe tainted with listeria, a particularly nasty bacteria for older people to fight off. "It’s not a matter of party. To me, it’s a matter of life or death."
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Three years ago, after a deadly salmonella outbreak in peanut butter, President Barack Obama pledged a top-to-bottom review of the FDA. His own daughters eat peanut butter, he told Americans during a television interview, and no one should doubt the safety of such a pantry staple.
Late in 2010, Congress followed up with the Food Safety Modernization Act, giving the FDA not only more regulatory authority over food producers, but the power to hold foreign food producers to the same standards as those in this country.
But two years later, rules that require food producers to evaluate the hazards in their operations and that give the FDA access to such records have yet to be released. The Food Safety Modernization Act rules remain under review by the Office of Management and Budget at the White House, though officials there won’t say why. Once released, the rules will need to go through a public review and comment process before taking effect.
As the rules have stalled at OMB, outbreaks have worsened. Last month, a peanut butter producer launched a recall after some people were sickened by peanut butter sold at Trader Joe’s grocery stores and made by Sunland Inc. On Friday, Sunland announced a voluntary expansion of its ongoing recall, which now includes 240 products made at the company’s New Mexico plant dating as far back as March 2010 and sold at a variety of retailers.
The food safety system has "once again let us down," said Rep. Rosa DeLauro, D-Conn., one of the leading food safety advocates in the House of Representatives. "We must improve oversight of food production facilities and we must implement the Food Safety Modernization Act without delay.”
Three Democratic senators wrote a letter to the Office of Management and Budget in July, noting three months ago that the rules had been sitting at the agency for seven months. OMB has 90 days to review such rules, said the senators, including Tom Harkin of Iowa, one of the bill’s authors. Their letter notes that a salmonella outbreak in dry dog food sickened 49 people who handled the food over the summer; one of the pending rules targets preventative controls for animal feed facilities.
"While we will never know definitively, it is possible this salmonella outbreak could have been prevented if the rule had been implemented," Harkin wrote, in a letter also signed by Sens. Kirsten Gillibrand of New York and Al Franken of Minnesota.
Moira Mack, a spokeswoman for the Office of Management and Budget, would not say when the rules will be released, or why they are so tardy. The Obama administration is "committed to food safety," Mack said, citing the administration’s food safety initiatives, both separate from the 2010 law, that address salmonella in eggs and that expand testing for E. coli in beef.
"We are working as expeditiously as possible to implement the food safety legislation we fought so hard for," Mack said. "When it comes to rules with this degree of importance and complexity, it is critical that we get it right."
Food safety advocates are antsy. "We’ve got to get these things moving," said Sandra Eskin, the project director of the Pew Health Group’s Food Safety Campaign.
Producers, including the Grocery Manufacturers Association, which represents food producers who sell goods to grocery stores, want the rules released, too, said Leon Bruner, chief science officer for group.
The new law will require processors to look at their entire operation to identify points where contamination is likely, and it will put in place measures to limit contamination. It would make FDA oversight more comparable to poultry and meat monitoring by the U.S. Department of Agriculture, experts say.
Most reputable food processors already comply with such rules, said Linda Harris, associate director of the Western Institute for Food Safety and Security at the University of California, Davis. "For most people who are applying food safety principles to food safety processing, it’s not going to be a huge change,” she said.
Once the rules are released, there are some in Congress and in the industry who fear the looming post-election budget fights could mean the FDA won’t have the money to actually implement the law. Pew Health Group’s Food Safety Campaign, citing congressional testimony from the FDA, said it will cost $200 million this fiscal year to apply the law.
FDA spokeswoman Carla Daniels said in a written statement that putting in place “such a broadly expansive mandate with limited resources is certainly a challenge.”
"While FDA lacks the resources to do everything at once, we have worked hard to prioritize our efforts and to deliver on both immediate and longer-term FSMA mandates,” she said.
Bill Marler, a prominent food safety lawyer from Seattle who has filed lawsuits on behalf of victims in outbreaks, including one against Sunland and Trader Joe’s in the most recent peanut butter outbreak, said he, too, has some concerns about funding.
"You’re going to have these really cool rules, but no way to enforce them," he said.
Marler, a major Democratic political donor who said he and his family gave and helped raise hundreds of thousands of dollars for the Obama campaign in 2008, has been so disappointed with the administration’s slow pace that he hasn’t donated to the campaign this year.
"I certainly don’t want Mitt Romney to be our president, but on the other hand, I always look at food safety as the incredibly low-hanging fruit in terms of doing something positive," he said.
Some families, though, are unsure that more government regulation is the answer. They include Jeff Allgood of Chubbuck, Idaho, whose 2-year-old son Kyle died in 2006 after drinking a homemade smoothie containing spinach tainted by E. coli. Allgood said he has come to believe that food producers need to regulate themselves.
"I look at the debt that our government’s incurring right now, and for them to hire a bunch of inspectors and more food police, doesn’t seem to make a lot of sense right now," Allgood said.
Yet he and his wife, Robyn, helped push for the law’s passage, and relate their son’s story frequently. They tell people they have five children, "including Kyle." He would have been 9 in December, a big brother to two younger siblings born after his death.
"In a lot of ways, we’re still raising our son Kyle," Allgood said. "We think about what he would be doing. We still talk about him daily."