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2013 Power 50: Margaret Hamburg, No. 6 in Associations/Government/Public Sphere

Margaret Hamburg

When Congress passed the Food Safety Modernization Act in 2011, it granted the Food and Drug Administration unprecedented authority to regulate the country’s food supply.

Rolling out the FSMA guidelines has been a longer process than expected, but this January the FDA — led by Commissioner Margaret Hamburg — released two proposed rules. These rules addressed produce safety on the farm and preventive controls for all food-processing facilities.

“The rules build on voluntary industry guidelines for food safety that many producers and growers now follow so that we are hopefully well on our way to reducing the burden of compliance and speeding successful implementation because of this familiarity with accepted best practices,” said Hamburg at the time of the rules’ release.

Industry groups requested more time to review the new requirements than the FDA initially allotted, and FDA pushed the comment period from May to September.

The third major rule will regulate foreign suppliers.

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“The foreign supplier verification program will ensure that the foods entering the U.S. meet the same safety standards that domestic growers and suppliers are required to meet. It will represent a huge leap forward,” spokesperson Shelly Burgess told SN.

The rule was expected to come out this spring, but the Office of Budget Management is still reviewing it.

FDA was recently handed a court order that all FSMA proposed rules must be published by Nov. 30, and the final rules issued by June 30, 2015.

In addition to these time constraints, another challenge the FDA faces in the coming year is finding a way to finance the costs of effecting and enforcing all of these rules.


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“We’ve said from the beginning that we do require additional resources to fully implement the law,” said Hamburg.

In the FDA budget for 2014, Hamburg asked for the authority to collect fees on food facility registrations and inspections and food imports to help make up the shortfall.

Recently, a Senate appropriations subcommittee approved a bill that would give FDA $53 million in additional funding for FSMA implementation.

Outside of FSMA, FDA has started flexing its muscles when it comes to caffeine in energy drinks and foods.

Wrigley put its caffeinated gum on hold after FDA announced a general investigation of the additive. The agency is working with the Institute of Medicine to gather more information on caffeine and its health risks, particularly for children.

“We need to better understand caffeine consumption and use patterns and determine what is a safe level for total consumption of caffeine,” said Burgess.

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