WASHINGTON — Industry association executives responded to a recent government report on traceability by acknowledging the report's disclosures about failures on the part of food facilities to follow federal traceability regulations, while insisting that the industry is addressing the issue, at least for produce, via the program known as the Produce Traceability Initiative.
The report, “Traceability in the Food Supply Chain,” was issued March 26 by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. According to the report, 59% of the food facilities in a study on traceability conducted in 2007 did not provide all of the Food and Drug Administration's required contact information for sources of food (one step back in the supply chain), recipients (one step forward) and transporters. The FDA requirements are derived from the Bioterrorism Act of 2002.
“Obviously, it's a concern when the government believes the industry is not complying with the Bioterrorism Act,” said Kathy Means, vice president of government relations and public affairs for the Produce Marketing Association, Newark, Del. “Everyone should be complying with the Bioterrorism Act. If they're not, they need to step up.”
PMA's website, www.pma.com, includes information on the Bioterrorism Act, but the association plans to increase its education efforts in regard to federal traceability requirements as well as the Produce Traceability Initiative, Means said.
The inspector general's study focused on 10 types of food, four products per type, for a total of 40 products (see a list at the end of the story). Due to the absence of records, the researchers were able to track just five of the 40 products through each stage of the food supply chain; three of the five were egg cartons coming directly from a farm. For 31 of the 40 products, they identified the facilities that likely handled the products, but for the remaining four products — a tomato, a bag of ice, a bottle of fruit juice and a bottle of water — they could not locate the facilities that probably handled them.
The [inspector general's] report demonstrates that enhancements are needed to improve everyone's ability to locate specific products in the supply chain,” noted Bill Greer, director of communications at the Food Marketing Institute, Arlington, Va.
For Tom Stenzel, president and chief executive officer of the United Fresh Produce Association here, the inspector general'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.” His comments were delivered in testimony on March 26 before the House Committee on Appropriations Subcommittee on Agriculture, as part of a hearing to address food traceability systems and to discuss the inspector general's report released that day.
At the same hearing, Dr. Craig Henry, senior vice president and chief science and regulatory affairs operating officer for the Grocery Manufacturers Association here, observed that the food industry “is prepared to work collaboratively with government to identify and address gaps in our current traceability system.”
Food retailers in the inspector general's study provided researchers with the study's initial data — the immediate sources of the 40 food products. In some cases, when the product had a single source, retailers provided the information from memory rather than from documents required by the FDA. Indeed, half of the retailers said they were not aware of the FDA's records requirement. Overall, 25% of all participants in the study were unaware of the requirement.
Companies participating in the study ran processing, packing and manufacturing facilities; distribution, wholesale and storage facilities; and retail stores. After excluding some facilities that were exempt from records requirements, the study found that 70 out of 118 facilities (59%) did not provide all of the documented information, such as complete address or phone number, required by the FDA. Of the 28 retail stores in the study, the report did not indicate how many were not fully compliant.
One of the factors limiting the ability of the researchers to trace products was the absence of lot information, though the FDA does not require distributors, wholesalers, storage facilities or retailers to keep that information.
The inspector general's report comes on the heels of the widespread peanut-product recalls stemming from unsanitary conditions reported by the FDA at plants operated by Peanut Corp. of America. Those recalls continued for more than two months as some small food makers belatedly discovered their link to PCA. In an unrelated case, last week new recalls were issued for pistachio nuts processed at Setton Pistachio in Central California.
Both Stenzel and Means stated that systemic deficiencies in produce traceability identified by the report would be addressed by the Produce Traceability Initiative, launched last year to build a common framework and standardized coding for produce carton labeling. Some observers believe the initiative could eventually serve as a traceability model for other perishables and non-perishables suppliers.
Spearheaded last year by PMA, the United Fresh Produce Association and the Canadian Produce Marketing Association, the initiative has defined two pieces of information that will be on all produce cases: the Global Trade Identification Number (GTIN), which identifies the originator of the case and the type of product inside, and a lot number naming the specific batch of produce, including its packing or harvest date.
“We believe that the Produce Traceability Initiative is the way to enhance traceability,” said Means. “It's not easy, but it may be among the easiest ways to do it.”
In his testimony, Stenzel urged the House committee to support the Produce Traceability Initiative as it considers legislative solutions. “We are likely to find that overly prescriptive mandates from the top down are not as likely to be effective as bottom-up efficiencies and systems designed for unique challenges,” he said. “That's what we believe we have achieved in the Produce Traceability Initiative.”
But he also asked the committee to consider supporting the cost of traceability requirements. “It is essential that cost burdens do not prevent companies from adopting either food safety or traceability protocols,” he said.
Last October, the produce groups and participating companies established an “Action Plan” for the Produce Traceability Initiative, with milestones beginning this year and concluding in 2012. The first two milestones — obtaining a company prefix and assigning GTIN numbers — were expected to be completed by produce brand owners in the first quarter of 2009. The PMA has not tracked the number of companies that have achieved those milestones, said Julia Stewart, PMA's public relations director.
However, PMA is seeking companies, including produce suppliers, retailers and wholesalers, to endorse the Action Plan, indicating their intention to execute the milestones within the designated timelines. As of March 31 that list contained 57 companies, including eight retailers (Food Lion, H.E. Butt Grocery Co., Safeway, Schnuck Markets, Supervalu, Kroger, Wal-Mart Stores and Wegmans Food Markets) and one wholesaler (Associated Wholesale Grocers). Companies are invited to add their names to the endorsement list at www.producetraceability.org, where the complete list is available.
“We were involved in the development of the Produce Traceability Action Plan and have endorsed it as a meaningful opportunity to enhance product supply chain safety,” said John Hanlin, vice president, food safety, for Supervalu, Minneapolis.
NEW LAWS EXPECTED
Food safety legislation submitted this year addresses traceability in different ways. The FDA Food Safety Modernization Act, unveiled last month, would establish a pilot project to test and evaluate new methods for tracing produce in the event of a foodborne illness. The FDA Globalization Act of 2009 attempts to fill in the loopholes in the Bioterrorism Act by mandating a standard electronic record of shipments and receipts, as well as a standard lot number for each shipment. The Obama administration has also pushed for food safety legislation.
Means expects food safety legislation to be enacted into law this year and hopes that it will incorporate the Produce Traceability Initiative. “It's voluntary unless regulators adopt it,” she said. “We have kept the FDA up to speed on [the initiative], and we would hope it would factor into any action they might take.”
The inspector general's report made several recommendations to the FDA. One of them suggested that the FDA seek statutory authority to request facilities' records at any time, as opposed to only when there is a serious health threat, to ensure that they are complying with the record-keeping requirement. “We support some increased access to records to determine if there is compliance,” Means said. The FDA said that it would consider the report's recommendations.
Stenzel said the industry has “repeatedly urged” the FDA to enforce the Bioterrorism Act as it currently stands. “However, we know of no instances where the FDA has taken any regulatory action to cite a produce company or its customers for failure to provide adequate records as required by the act,” he testified.
PRODUCTS IN STUDY
Carton of eggs
Milled unbleached flour
Tomatoes, fresh whole
Bag of fresh-cut leaf vegetable
SOURCE: Office of Inspector General