WASHINGTON, Feb. 25, 2016 -The $19 million the Food and Drug Administration is sending to states to help fruit and vegetable growers understand the agency’s new produce safety rule is “a good start,” Stephen Ostroff, who’s been acting FDA commissioner since early last year, told a House Appropriations subcommittee today.

Ostroff had just spent two and a half hours responding to questions ranging from sodium in Americans’ diets to arsenic in rice, but a recurring theme was the resources required to implement the Food Safety Modernization Act.

The Congressional Budget Office estimated in January 2011 that FDA would need $583 million to implement FSMA. So far, including the fiscal 2017 request, the agency is about $147 million short. "You don’t have the money to deal with what FSMA asks you to do,” Rep. Rosa DeLauro, D-Conn., told Ostroff. Ostroff didn’t disagree, but put his best face forward.

In contrast to a hearing on Tuesday, when USDA’s Food Safety and Inspection Service chief Al Almanza heard some blistering criticism from DeLauro about the service’s inspection and monitoring resources, Ostroff’s appearance engendered little sound and fury. The only exception was when Rep. Sam Farr, D-Calif., said Ostroff was an expert in the language of bureaucracy because he could not promise when certain actions would be completed.

“I don’t know what assurances you’re giving us,” Farr complained. Afterwards, Ostroff said he understood Farr’s frustration, but that “things never go as fast as you would like.”

Rep. Chellie Pingree, D-Maine, was one of a few members of the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development and FDA to express concern about the produce safety rule published Nov. 27.

Pingree said she was worried that small- to medium-sized farmers would be confused by the new rule’s requirements.

But Ostroff said that “one of the central points of FSMA is to educate while we regulate… They actually do go hand in hand. It’s really, really critical that we be able to develop the necessary educational programs (at) the farm level and also for the small producer so they have a full understanding of what they’re supposed to do.”

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The National Association of State Departments of Agriculture has said there isn’t enough money for states to help implement the produce rule. FDA’s fiscal 2017 budget proposes $25.3 million in new spending to implement FSMA, $11 million of which would go to states for the produce safety rule — on top of the $19 million being disbursed this year.

Other issues discussed at the hearing:

  • Arsenic in rice: FDA is currently preparing a risk assessment as a precursor to a risk management plan. “We’ve been working with a number of stakeholders inside and outside of government,” including rice farmers in several states. Ostroff told Rep. Steven Palazzo, R-Miss. “It is a very high priority of mine that we finalize that risk assessment.”
  • Salmonella in cucumbers. DeLauro asked Ostroff about the status of the investigation into the outbreak last fall that sickened 888 people in 39 states, killing six. FDA identified the distributor, but Ostroff said he wished he knew how consumers were being stricken. (He said there was still “a very steady, low-level incidence of cases associated with the very same strain.”) FDA and the Centers for Disease Control and Prevention have examined the supply chain and even looked at crates that the cucumbers were shipped in, but don’t have the final answer yet.
  • Labeling for sesame. Rep. Nita Lowey, D-N.Y., said a half million Americans are allergic to sesame, but there’s no way to know whether it’s in many foods. Ostroff said FDA cannot add it to the list included in the Food Allergen Labeling and Consumer Protection Act. But he said that the agency is conducting an assessment on the issue. No, he did not know when it would be completed.
  • Sodium in food. “We know that one of the most significant contributors to cardiovascular disease is high levels of sodium,” Ostroff said. “We feel that rational, voluntary approaches, which many in the industry are already embarked upon, are a very reasonable way to reduce sodium content” in diets.
  • Antimicrobial resistance. Ostroff said the agency has proposed shifting $1 million of the $8 million allocated to implement the Veterinary Feed Directive rule from the human to the animal side in order to monitor how VFD is being implemented. “One of the very important aspects of this is to actually drill down and find out what’s happening on the farm,” he said.


The Senate yesterday confirmed Dr. Robert Califf as the new FDA commissioner. Ostroff, FDA’s chief scientist, had been serving as acting commissioner since Dr. Margaret Hamburg left the post early last year.