Produce industry tells FDA there's no need for federal traceability rules
Produce industry tells FDA there's no need for federal traceability rules
WASHINGTON -- There is every incentive for the produce industry to follow the industry's new traceability guidelines, but there is no need for the federal government to mandate a new traceability system, produce trade groups said at an Oct. 16 meeting.
The U.S. Food & Drug Administration held its first of two public workshops to discuss what needs to be done to enhance a tracking system during outbreaks. The second workshop in Oakland, CA, is planned for Nov. 13.
At the Oct. 16 meeting in College Park, MD, FDA officials focused on gaps in the traceability system that have tripped up investigators during outbreak probes and resulted in costly, drawn-out attempts to find the food item responsible for making people sick.
But the produce industry said that it already has traceability systems in place, complies with the bioterrorism law's recordkeeping mandates, and maintains that the problem during the summer's Salmonella saintpaul outbreak centered on miscommunication snafus between FDA investigators and the industry.
In the future, David Acheson, the FDA's associate commissioner for foods, said that he wants to see a food-tracking system that would expedite outbreak investigations by relying on traceability systems that can work when multiple products are implicated.
Right now, the FDA needs industry to embrace a system that uses unique identifiers, more consistent nomenclature and an electronic means of capturing records throughout the custody chain, Dr. Acheson said.
The FDA's job is to look at an identified food source and plot distribution patterns to show how the produce item may have caused the outbreak, said Ellen Morrison, director of the FDA's Office of Crisis Management.
This summer, the FDA found hard-to-track commingled produce, a lack of lot numbers and a lack of consistent product description in those records, she said, adding that tomatoes were described as round, red, slicers or cookers, so information needs to be standardized.
"Nobody wants to spend two, three months trying to figure this out," said Ms. Morrison, referring to this summer's search for implicated fresh produce during the Salmonella saintpaul outbreak.
But produce industry representatives described a different traceability system and one that the industry will spend millions of dollars to improve.
"FDA should take advantage of our expertise and experience in this area by thoroughly examining the Produce Traceability Initiative's plan before blazing any new trails," said Kathy Means, vice president of government relations and public affairs for the Produce Marketing Association, based in Newark, DE. "Anything less would be shortsighted, limiting the produce industry's ability to safeguard its products and business interests."
If the FDA found problems during this summer's Salmonella saintpaul outbreak, the agency should have enforced the 2002 Bioterrorism Act to bring companies into compliance, said Ms. Means.
"We know of no instances where FDA cited industry [for violations of] the Bioterrorism Act," said Robert Guenther, vice president for public policy for the Washington-based United Fresh Produce Association.
"There needs to be better communication between FDA and industry," said Mr. Guenther, who recounted stories of investigators asking for all records from companies, rather than a more focused approach on certain products.
Ms. Means said that there are stories of companies offering electronic records only to be told by investigators to print out the records.
Florida may be the first testing ground of state-mandated traceability systems. The state has already written new traceability standards in its July 2008 tomato-safety standards, said Joanne Brown, deputy commissioner of the Florida Department of Agriculture & Consumer Services.
If the tomato rules work, "we hope [they are] applied nationally and adopted to other commodities," she said.
The FDA asked produce industry representatives whether there is enough incentive for produce businesses to develop traceability systems.
"We must avoid shutting down an entire industry," said Ms. Means. "They have every incentive to do this."
The U.S. Food & Drug Administration held its first of two public workshops to discuss what needs to be done to enhance a tracking system during outbreaks. The second workshop in Oakland, CA, is planned for Nov. 13.
At the Oct. 16 meeting in College Park, MD, FDA officials focused on gaps in the traceability system that have tripped up investigators during outbreak probes and resulted in costly, drawn-out attempts to find the food item responsible for making people sick.
But the produce industry said that it already has traceability systems in place, complies with the bioterrorism law's recordkeeping mandates, and maintains that the problem during the summer's Salmonella saintpaul outbreak centered on miscommunication snafus between FDA investigators and the industry.
In the future, David Acheson, the FDA's associate commissioner for foods, said that he wants to see a food-tracking system that would expedite outbreak investigations by relying on traceability systems that can work when multiple products are implicated.
Right now, the FDA needs industry to embrace a system that uses unique identifiers, more consistent nomenclature and an electronic means of capturing records throughout the custody chain, Dr. Acheson said.
The FDA's job is to look at an identified food source and plot distribution patterns to show how the produce item may have caused the outbreak, said Ellen Morrison, director of the FDA's Office of Crisis Management.
This summer, the FDA found hard-to-track commingled produce, a lack of lot numbers and a lack of consistent product description in those records, she said, adding that tomatoes were described as round, red, slicers or cookers, so information needs to be standardized.
"Nobody wants to spend two, three months trying to figure this out," said Ms. Morrison, referring to this summer's search for implicated fresh produce during the Salmonella saintpaul outbreak.
But produce industry representatives described a different traceability system and one that the industry will spend millions of dollars to improve.
"FDA should take advantage of our expertise and experience in this area by thoroughly examining the Produce Traceability Initiative's plan before blazing any new trails," said Kathy Means, vice president of government relations and public affairs for the Produce Marketing Association, based in Newark, DE. "Anything less would be shortsighted, limiting the produce industry's ability to safeguard its products and business interests."
If the FDA found problems during this summer's Salmonella saintpaul outbreak, the agency should have enforced the 2002 Bioterrorism Act to bring companies into compliance, said Ms. Means.
"We know of no instances where FDA cited industry [for violations of] the Bioterrorism Act," said Robert Guenther, vice president for public policy for the Washington-based United Fresh Produce Association.
"There needs to be better communication between FDA and industry," said Mr. Guenther, who recounted stories of investigators asking for all records from companies, rather than a more focused approach on certain products.
Ms. Means said that there are stories of companies offering electronic records only to be told by investigators to print out the records.
Florida may be the first testing ground of state-mandated traceability systems. The state has already written new traceability standards in its July 2008 tomato-safety standards, said Joanne Brown, deputy commissioner of the Florida Department of Agriculture & Consumer Services.
If the tomato rules work, "we hope [they are] applied nationally and adopted to other commodities," she said.
The FDA asked produce industry representatives whether there is enough incentive for produce businesses to develop traceability systems.
"We must avoid shutting down an entire industry," said Ms. Means. "They have every incentive to do this."
