Hamburg Addresses Questions Regarding FDA's Funding Request

By Melissa Lind, contributing writer

The FDA budget proposal for fiscal year 2016 asks for $109.5 million for implementation of the Food Safety Modernization Act (FSMA). The total budget request amounts to $4.9 billion and represents a near 10 percent increase over the previous year.

Margaret Hamburg, the FDA’s outgoing Food and Drug Administration Commissioner, appeared at a recent Senate budget hearing and indicated that efforts for implementation of the FSMA requirements will be threatened if the agency does not receive the funding requested. Hamburg faced a number of questions from the Senate Appropriations Agriculture subcommittee regarding the agency’s request. Included were concerns about the implementation of FSMA and the overall budget increase in today’s budgetary environment.

Senator Steve Daines (R-MT) relayed concerns from the farming community that the President’s proposal for consolidation of the Department of Agriculture Food Safety Inspection Service (FSIS) and FDA into a combination agency in the Department of Health and Human Services may have negative impact on implementation of FSMA requirements, asking “Why are you removing the USDA from the food inspection process?” Hamburg addressed this concern by stating that a single agency has not been decided and that USDA, FDA, and other departments would be involved in coordination of the efforts and that consolidation has been discussed for some time. She also indicated that though coordination and consolidation were planned and in process, implementation of FSMA was taking priority.

Senator Jeff Merkley (D-OR) expressed opposition to continued requirements for testing of irrigation water, particularly involving onion growers. Merkley indicated that though it was known that E.coli does not survive in onion crops that lie fallow and there have been no known contamination events, farmers who will be exempted after positive results are still required to test, which presents a cost burden with no health benefits.

Another Montana Senator, Democrat Jon Tester, indicated that though he supported funding, he was concerned that even with training, new regulations may be misinterpreted by investigators and inquired about industry redress regarding such overreach. Tester was also interested in procedures for outreach to community participants. Hamburg’s response says that rules and contact personnel were well-known and communicated to the industry regarding objection to reports following inspection. She also assured Tester that outreach programs were in place and a portion of the additional funding would go to continued efforts.

In near final statements, Hamburg acknowledged that while the budget increase was bigger than previous requests, it wasn’t more than what was needed. The Congressional Budget Office had estimated in 2010 that full implementation of FSMA would require funding of $590 million. If the requested increase is approved, funding will only have reached about half of what was estimated.