Reactions mixed to FDA’s ‘Pathway’ report(Margaret Hamburg issued her "Pathways" report June 20.)

Reactions from produce industry insiders to a Food and Drug Administration report on import safety ranges from cautious, wait-and-see optimism to been-there, tried-to-do-that skepticism.

One common comment, regardless of the perspective on FDA’s commissioner Margaret Hamburg’s “Pathway to Global Product Safety and Quality,” has been that people are happy to see the FDA publicly acknowledge concern about the lack of oversight of imports.

“This recognition of a global marketplace is critical. … We’re all operating in the same global marketplace, and it would be great to be using the (same) concepts and rules,” said Kathy Means, vice president of government relations and public affairs for the Newark, Del.-based Produce Marketing Association.

The report and its recommendations are “recognition that we are raising the bar,” said Ray Gilmer, vice president of communications for the Washington, D.C.-based United Fresh Produce Association.

He said June 21 that he is impressed with how “formidable” the import plan is, though he doubts any immediate changes will come about.

“We are a long way away from actual protocols or rules for day-to-day importer operations,” Gilmer said. “The credibility of our industry is tested every day and we need to do what we can to make sure every step in the food chain is secure.”

Credibility is at the heart of the discussion in more than one way, according to Carl Neilson, who worked for FDA for 28 years, including as director of the agency’s Division of Import Operations and Policy for his final six years before retiring in 2005. He now runs a consulting business in Maryland.

“This report is the end of pretending that everything is OK,” Nielson said June 21, adding that many of the details in the report have been discussed within the agency for years, but not in public settings.

“It’s nothing new. We had a strategic document in 2001 with much of the same information and recommendations. FDA’s problem is not how to say nice things; it’s the execution, the follow-through that’s not there. … Imports is still the bastard child at the agency.”

The four key points in Hamburg's report:Reactions mixed to FDA’s ‘Pathway’ report

  • The FDA, in partnership with foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening a product safety net around the world.
  • With these coalitions, FDA intends to develop a global data information system to share information and resources across markets.
  • The FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and technology.
  • The FDA will effectively allocate agency resources based on risk, leveraging combined efforts of government, industry, and public- and private-sector third parties.

 Nielsen said the FDA should focus on technology to improve communication. Barriers include obsolete IT systems, a lack of organization; and a lack of follow-through management.

“When I was heading up the imports area I asked for a roster of (FDA staff) across the country dedicated 100% to imports,” he said. “No one could give it to me because they don’t have one.”

The retired import director acknowledged that part of FDA’s problems are related to a lack of funding, but he said a change in mindset is crucial to ensure safety of imported foods.

“FDA is all messed up. They are not monitoring and giving incentives to maintain the supply and cold chains,” he said, suggesting that expedited entry at ports and border crossings would be a great incentive for people sending produce to the U.S.

“And their ‘end point’ inspections are not statistically meaningful (for fresh produce imports).”

So how safe is the imported produce in U.S. grocery stores?

“My conclusion is we don’t know,” Nielsen said. “Country of origin labeling is OK, but until you can relate information about growing and handling practices it doesn’t mean that much.

“I’m a cautious buyer. I diligently wash and spin everything, even the triple-washed ‘ready-to-eat’ things.”