Mar 27, 2009 (CIDRAP News) – Federal inspectors who conducted a survey to identify gaps in the nation's food traceability system told a House subcommittee yesterday that they managed to trace only 5 of 40 products through the full production and distribution chain and that some food facilities didn't know they needed to keep source contact information.
The traceability report, conducted by the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) was requested by the House Appropriations subcommittee that oversees the Food and Drug Administration (FDA). Daniel Levinson, the HHS inspector general, presented the 38-page report, which appears on the HHS Web site.
Rep Rosa DeLauro, D-Conn., subcommittee chairwoman, said in her opening statement that last year's Salmonella outbreak linked to hot peppers raised questions about the effectiveness of the nation's food traceability system. "What if an effective traceability system had been in place?" she asked. "Would the FDA have been able to find peppers as the original source sooner in its investigation? Minimize the impact on the tomato industry? Prevent needless additional illnesses?"
Levinson told legislators that some specific factors limited investigators' ability to trace the food products through the entire supply chain. Facilities often did not keep lot-specific information, some products weren't labeled with lot numbers, and some firms mixed raw food products from many farms. He added that the FDA doesn't always require firms to maintain lot-specific information or label foods with lot information.
The OIG report said investigators were able to identify facilities that likely handled 31 of the 40 products and that they couldn't identify likely handlers for four of the products.
Levinson said that starting in 2005 the FDA required manufacturers, processors, packers, transporters, and distributors who receive, hold, or import food to keep records of all sources, recipients, and transporters. However, he said that when inspectors reviewed records and interviewed managers at food facilities linked to the 40 products they tracked, they found that more than half (59%) of the handlers failed to meet the FDA requirements. In many cases, the managers had to look through reams of paper records to find information, and some that had electronic data systems had multiple systems that weren't linked.
Twenty-five percent (26 of 104) managers who responded to investigator questions said they didn't know about the FDA's records requirements, the OIG report said.
Levinson said the findings show that more needs to be done to protect public health and to ensure that the FDA has the tools and resources it needs to respond to food emergencies.
DeLauro said in her opening statement that the OIG findings confirm what Congress already believes: "That we can do better—that we have the responsibility, in the event of a foodborne illness outbreak, to effectively find the source of contamination as quickly as possible to prevent further illness and even death."
The OIG recommended six ways the FDA could improve food traceability:
- Seek statutory authority, if warranted, to strengthen records requirements regarding lot-specific information, and extending the requirement to facilities not now subject to them
- Consider requiring food facilities to strengthen traceability through various methods, such as using certain technology to improve recordkeeping
- Work with the food industry to develop traceability guidance
- Address the issue of mixing raw foods from multiple sources
- Obtain authority to verify compliance with FDA record requirements during food facility inspections
- Work to educate the food industry about the records requirements
The FDA has sought additional traceability in its Food Protection Plan, but legislators should ask if the agency could have done a better job with the authority it already had, DeLauro said. "At the same time, traceability has considerable support in Congress and will likely be included in food safety legislation that moves forward this year."
Two food industry officials also testified at the hearing: Craig Henry, senior vice president for science and regulatory affairs at the Grocery Manufacturers Association (GMA) and Thomas Stenzel, president and chief executive officer of the United Fresh Produce Association (UFPA).
Henry said the GMA recommends several strategies for improving the nation's food safety, such as increasing FDA funding, requiring food companies to have food safety plans, and establishing federal safety standards for certain fruits and vegetables. He said that government and industry should work together to address traceability gaps.
"In particular, GMA strongly supports House and Senate proposals to develop and test promising new traceability systems through pilot programs in the produce sector," Henry said.
Stenzel urged lawmakers to keep in mind that not all food products are difficult to trace, especially prepackaged produce such as bagged salads, bags of apples, or mixed vegetables that have UPC codes that link back to sources. "We are unaware of any instance in which public health investigators, having a package in hand, have been unable to quickly and efficiently reach the company that packaged the product and obtain information about the product's component ingredients," he testified.
He said that the produce industry has shown its commitment to the requirement in the Bioterrorism Act of 2002 that companies keep records permitting them to trace products one step forward and one step back, but Stenzel said he didn't know of any instances in which the FDA has taken regulatory action against companies that failed to maintain the information.
However, he acknowledged that produce companies vary in their ability to trace the flow of products. Stenzel lauded the OIG's investigative approach. "The IG's research provides precisely the type of analysis we need—conducted before an outbreak investigation—that can help us focus on the areas where individual operators can improve in their own traceability systems," he said, urging the FDA to conduct more traceability exercises with the food industry.
Produce industry associations, including UFPA, have developed and are working on adopting a standardized coding system for produce cartons sold in the United States, he told legislators. Also, he said the industry is increasing its use of GS1 databars, an electronically readable code that can even fit on a fruit or vegetable sticker.
He told Congress members that prescriptive federal mandates won't be as effective as industry-driven efficiencies and systems.
Stenzel said he believes federal officials wrongly blamed their slowness in finding contaminated produce during last summers Salmonella outbreak on traceability problems. "We all know now they were simply searching for the wrong product," he said. "Traceback worked; it just didn't confirm the original false hypothesis."
Once Minnesota officials identified the outbreak strain in jalapeno peppers, they were able to quickly trace the peppers back to a farm in Mexico, he said. "We are capable of tracking most produce one-step-up and one-step-back today. And we are committed to streamlining and expediting that process just as fast as we can."
Mar 26 House committee hearing testimony from Daniel Levinson
Mar 26 HHS OIG report