Food Inspection User Fees Under Fire At FDA Budget Hearing

At the recent House of Representatives’ Subcommittee hearing to review the Fiscal Year 2013, budget request for the Food and Drug Administration proposed user fees for food inspections dominated the discussion as far as food safety was concerned, according to a report on the hearing from the Food Institute.

At the recent House of Representatives’ Subcommittee hearing to review the Fiscal Year 2013, budget request for the Food and Drug Administration proposed user fees for food inspections dominated the discussion as far as food safety was concerned, according to a report on the hearing from the Food Institute.

In a brief opening statement, Chairman Jack Kingston (R-GA) offered an overview of FDA’s mission and described the requested increase of $11.5 million in appropriated funds as “very moderate,” and extremely sensitive to the overall budget situation.

Dr. Margaret Hamburg, Commissioner of FDA, stated that the agency is seeking a total of $4.5 billion in FY 2013, including user fees, a 17% increase over FY 2012. Increases for current law user fees and amounts associated with seven proposed new user fee programs account for 98% of the budget increase.

Food Inspection Resources
Chairman Kingston asked if FDA has enough resources for food inspections. Dr. Hamburg said that FDA will need additional resources in the future due to increased demand for imported product. In the meantime, FDA wants to do more information sharing and work with industry in order to handle inspection needs.

FSMA: User Fees
Congressman Tom Latham (R-IA) repeated Dr. Hamburg’s point that 98% of the proposed FDA budget increase comes from user fees, including a new registration fee for food facilities. He claimed that the fee would result in no benefit to the food facilities but instead is a tax on existence. How does FDA justify the fee? Dr. Hamburg said that this user fee is needed since food safety is of the utmost importance. According to polls, consumers lack confidence in the food safety system. Between 50% and 60% of fresh produce comes from overseas. There is also a growing complexity in our own food supply. She said that FDA does need to be engaged with the food industry as part of the process of developing these fees.

Congressman Latham continued that legislation will be needed to implement these fees, and that Congress has not gone along with similar proposals in the past. He also pressed Dr. Hamburg regarding portions of her prepared statement in which she says that inspection requirements are currently being met.

Congressman Bishop asked if FDA has a backup plan if the user fees are not approved. Dr. Hamburg said that food comes in from more than 200 countries and more than 250,000 facilities. FDA will never have enough resources to inspect all of them in the traditional ways envisioned by the Food, Drug and Cosmetic Act as originally adopted in 1938. New ways of determining which facilities to inspect are necessary, and FDA wants to use risk-based criteria to determine which facilities should be inspected.

Congressman Sam Farr (D-CA) also said that FDA is not likely to get the $200 million in user fees that are being proposed and asked what FDA will do and what outcomes to expect. Dr. Hamburg said that she believes that if FDA does not get the money there will be more foodborne outbreaks. She knows there will be a problem with imports. Right now the food safety inspection system costs Americans only $3.50 per person, per year. Congressman Farr then asked her to provide to the Subcommittee a list of FDA’s priorities in the case of FDA not getting the user fee.

Congressman Latham pointed to a letter that the Subcommittee received from several agricultural groups in opposition to the proposed user fees. He asked why FDA did not simply request more money within their budget for their purpose, rather than going for user fees that have been rejected in the past.

Congresswoman DeLauro said that user fees going up are an abdication of Congressional responsibility, and that user fees are driving what work is being done by FDA. She claimed that industry has more control over the agenda. She went on to ask if consumers and safety groups have equal representation in these discussions. Dr. Hamburg said that they have engaged all stakeholders in the discussion.

Congresswoman DeLauro noted that Dr. Hamburg’s prepared testimony regarding the implementation of FSMA states “…the simple truth is that FDA cannot meaningfully deliver on these mandates without sufficient funding."

Congresswoman Cynthia Lummis (R-WY) asked if the user fee would be a flat or graduated fee. Dr. Hamburg said that it will more likely vary according to the size of the company, reflecting what is currently done with drugs.

FSMA: Imported Foods
Congressman Sanford Bishop (D-GA) asked about FDA’s authority to block the importation of food from foreign facilities when FDA has been denied inspection access. Dr. Hamburg responded that given the global food supply there is a need for a parity of standards. She noted that FDA has on a few occasions used the FSMA authority to refuse the importation of a product.

FSMA: Menu Labeling
Congresswoman Rose DeLauro (D-CT) asked about the status of menu labeling regulations and said that she opposes carving out any exemptions. She continued to focus on foods sold at movie theater concession stands, as she did during the subcommittee hearing with USDA’s Food and Nutrition Service. Dr. Hamburg said that a proposed rule was put out for public comment, thousands of comments were received in response, and that she expects a rule to be issued in the “not too distant future."

FSMA: State Inspections
Congressman Bishop said that he has been working with State of Georgia authorities regarding inspection of food grown within the state. He asks if the role of states in the inspection of food items should be increased given current budget concerns. Dr. Hamburg replied that food safety does have to be a partnership, and that FSMA calls for nationally integrated programs.

Moving Food Safety to USDA
Congresswoman Lummis suggested that perhaps the food safety portion of FDA’s portfolio should be moved to USDA. There was no response from Dr. Hamburg.