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From: The eUpdate, 7.12.11

FDA Outlines Ambitious Global Effort

Agency’s “Pathway to Global Product Safety and Quality” draws mixed reviews

FDA Outlines Ambitious Global Effort

Given the scarcity of resources, the U.S. cannot work alone to ensure the safety of food imported from other countries, says the “Pathway to Global Product Safety and Quality,” a new report from the U.S. Food and Drug Administration (FDA) that outlines its plan to work globally to track the movement of food and drugs.

Nearly two-thirds of all fruits and vegetables and 80% of all seafood consumed in the U.S. come from overseas. The new report acknowledges the seriousness of threats to the safety of America’s food supply and the importance of working with global partners, rather than independently, to ensure food safety.

“Just as public health leaders have long recognized that disease knows no borders, FDA in crafting its vision for the next decade knows that product safety and quality no longer begin or end at the border,” says the report’s executive summary.

After describing the expanded technological and regulatory capabilities, new offices, new collaborations, and new authority that will take place under the FDA Food Safety and Modernization Act of 2010, the report notes that these changes will not be enough. “In order to cope with the magnitude of the fundamental shifts on the horizon, FDA is committed to substantially and fundamentally revising its approach to global product safety and quality.”

That will involve four key building blocks, the report says:

  1. Assembling global coalitions of regulators dedicated to building and strengthening a worldwide product safety net;
  2. With these coalitions, developing a global data information system and network to share real-time information;
  3. Expanding intelligence gathering, focusing on risk analysis and modern information technology; and
  4. Allocating agency resources based on risk, utilizing industry and public- and private-sector third parties here and abroad to augment government forces.

“How are they actually going to get more inspections done in the countries in question? Many of them don’t have the infrastructure that we expect our regulatory agencies to have.”

—Robert Buchanan, a senior adviser with the FDA Center for Food Safety and Applied Nutrition

The plans are laudable but far easier said than done, suggested Robert Buchanan, PhD, director of the University of Maryland’s Center for Food Safety and Security Systems. “How are they actually going to get more inspections done in the countries in question? Many of them don’t have the infrastructure that we expect our regulatory agencies to have. They’ll either have to agree to things that are a little less sophisticated than we’re used to or invest a lot of money in capacity building.”

Dr. Buchanan recently returned from India, one of the major exporters of food products to the U.S. “They’re in the process of finally putting together a food safety agency,” he said. “But they have no infrastructure. To think that we’re going to get them to devote their limited resources to our concerns unless we’re going to help them build that infrastructure—that’s not going to happen.”

While commending the FDA for its honesty in developing the report and its realism in acknowledging that the agency cannot do it all without help, Dr. Buchanan suggested that it’s lacking in detail. He also pointed out that the U.S. Department of Agriculture (USDA) is not mentioned in the report. “I would like to see this as not just an FDA activity,” he said. “The USDA has a very different approach to global food safety than the FDA. It may cause confusion if there’s not harmony among our own regulatory agencies, so I would love to see a joint DHHS[Department of Health and Human Services]/USDA proposal.”

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