Overburdened FDA Expands
Oversight to High-Risk Produce
News21 research shows that more than 70 percent of safety plan violations for seafood and juice processors remain unresolved after more than a year.
The U.S. Food and Drug Administration is expanding oversight of high-risk fruits and vegetables, even though experts say the agency is struggling to enforce existing regulations.
Prevention-based safety plans already used for seafood- and juice-processing facilities will now be required for facilities that process produce under the new Food Safety Modernization Act.
But a News21 analysis of FDA records from September 2009 to December 2010 shows that more than two-thirds of safety plan violations for seafood and juice processors remain unresolved after more than a year.
These violations range from missing paperwork to “a live spider crawling on one of the tuna salad sandwiches” to “a live cockroach” in a preparation area to employees touching unsanitary objects before handling food, according to the FDA records.
Tony Corbo, senior lobbyist for the advocacy group Food & Water Watch, and other critics of the FDA called the number of uncorrected violations too high.
“There needs to be immediate follow-up to make sure those deficiencies are corrected,” Corbo said. “Otherwise you run the risk of somebody putting out contaminated food.”
FDA spokesman Doug Karas said the fact that a warning letter has not been “administratively closed out” did not mean that the agency had failed to follow up on enforcing the regulations. In fact, he said “the vast majority of firms do take corrective actions based on the warning letter.”
In order to close out a case, however, Karas said the FDA will do so only after an on-site inspection that verifies the violations have been addressed.
For more than a decade, seafood- and juice-processing facilities have been required to follow written plans that identify how contamination can occur and how to prevent it. Under the new 2011 Food Safety Modernization Act, these plans also will cover produce processors.
But Corbo and other consumer advocates said that the FDA’s enforcement record for existing food plans has them concerned about whether it can effectively improve the safety of foods and vegetables.
Contaminated produce is linked to more than 1 million illnesses, 7,000 hospitalizations and 130 deaths annually, according to estimates from “Ranking the Risks,” a University of Florida Emerging Pathogens Institute report.
Past Enforcement
Prevention-based food safety plans — called Hazard Analysis and Critical Control Points or HACCP, plans — were put in place to minimize foodborne illnesses associated with seafood and juice processing.
In these company-written, government-approved food safety plans, processing firms identify potential risks — improper temperature control and poor employee hygiene, for example — that could lead to contamination.
Companies then implement and monitor ways to minimize or eliminate risks.
For example, a company will have a list of proper temperatures for each fruit and vegetable and will check to make sure produce stays properly chilled.
Many industry experts and consumer advocates say the plans can be vital to ensuring safe food if they are enforced.
If an FDA inspection finds that such plans are missing, are inadequate or are not being followed, the agency sends a warning letter citing the problems. Companies have 15 days to respond with how they will correct safety issues.
In the 15 months reviewed by News21, the FDA inspected 2,502 of 6500 seafood-processing companies and 420 of 800 juice companies. The agency issued warning letters to 114 seafood companies and six juice companies for food safety plan violations.
Altogether, 36 seafood companies and one juice company made corrections that were approved by the FDA, according to the News21 analysis. The majority of facilities with unresolved violations continued to produce seafood and juice products.
“The people who are running their business in a sloppy manner know that they can continue to do it,” said Carol Tucker-Foreman, distinguished fellow in food policy at the Consumer Federation of America, a consumer food safety advocacy organization.
She added: “The FDA is under the illusion that sending somebody a warning letter makes a difference. If they just send them out there and don’t follow up, then no action is taken to protect public health.”
Karas said in response to News21 questions that the FDA believes the warning letters do make a difference because most companies voluntarily correct the deficiencies outlined in the warnings. And if companies fail to comply, the FDA can initiate tougher actions like injunctions and seizures.
Former FDA official acknowledge that the agency’s leverage in compelling industry to correct deficiencies has been hampered by a lack of funding. But David Acheson, a former FDA associate commissioner of foods, asserted that federal regulations — even absent the funds to enforce the rules — is an improvement over no regulations at all.
Produce Plans
While prevention-based food safety plans for produce-processing facilities are not expected to be in place until the end of 2011, they will likely mirror current plans for seafood and juice companies, Karas said.
Corbo of Food & Water Watch said that what happens with seafood and juice companies “is going to be an indicator of how well or not so well the FDA is going to be able to enforce the preventative control requirements [for produce] under the new Food Safety Modernization Act.”
Until the new law, there was no federal government regulation for produce — only voluntary standards that meant companies couldn’t be punished for poor safety practices.
Consumer advocates contend that additional oversight can improve produce safety but worry about the FDA’s budget constraints and lack of resources.
“They have a lot to learn and a lot to change if they are going to become an agency that is really out there in a different way,” said Patty Lovera, the assistant director of Food & Water Watch. “Part of this law is to change the culture of the agency and make it more aggressive in going out and preventing problems instead of just responding to them.”
Fruits and vegetables have a problematic history, including a 2006 E. coli outbreak caused by bagged spinach that killed five people and sickened 238, according to the U.S. Centers for Disease Control and Prevention.
Some severely ill victims of the E. coli outbreak lobbied Congress for stronger produce regulations in the new law. Among them was Jacob Goswick of Prescott, Ariz., now a healthy 12-year-old, who battled kidney failure as a second grader.
“I was definitely surprised how something so good could turn out so bad from a little bug you can’t even see,” said Goswick, who as a 7-year-old chose salads over ice cream and ate spinach so he could be like Popeye.
Possible Improvements
The new law gives the FDA more authority that could lead to better enforcement of produce-safety plans, food safety advocates said.
For instance, companies that get warning letters will be required to pay for follow-up inspections, a change expected to encourage companies to make food safety a bigger priority.
While additional funds will come from companies paying for follow-up inspections, resources will continue to be a problem.
“The fact that they will have a revenue stream … to conduct follow-up inspections is going to make the job easier for them,” Corbo said.
The FDA also will be able to shut down companies with severely flawed food safety plans if firms fail to correct problems.
Corbo calls this the agency’s ability to “put a club over a company’s head if they aren’t complying.”
Shutting down companies will be less expensive and time-consuming than seeking an injunction, the current practice for halting production at problem companies.
Sandra Eskin, project director for the Pew Charitable Trust’s food safety campaign, said the FDA can take additional steps to effectively enforce produce-safety plans, particularly better education so produce companies understand the new law.
The FDA agrees that effective compliance will come with proper training for and outreach to produce companies, said Karas.
It may be several years before the effectiveness of the new law is clear, both FDA and food safety advocates say. And the stakes are high.
“If FDA fails to carry this out correctly, if Congress fails to fund it, then foodborne illness will probably not decline,” Tucker-Foreman said.