President's FY 2011 FDA Budget Proposes Add'l Food Safety Funding

Highlights of the FY 2011 budget request for the Food and Drug Administration include:

30% Increase Requested for "Transforming Food Safety Initiative"

The FY 2011 FDA budget request includes an additional $318.3 million for FDA's "Transforming Food Safety Initiative." This represents an approximately 30% increase from what was appropriated to this initiative in FY 2010.

According to the FDA's budget request, the FDA plans to fund a large part of the increased funding through user fees on: (i) food registration and inspection; (ii) reinspection; and (iii) export certification. The Food Safety Enhancement Act of 2009 (H.R. 2749), as passed by the House on July 30, 2009, would establish user fees to fund these types of activities¹.

The FDA states that the FY 2011 resources proposed for the Transforming Food Safety initiative would achieve the Administration's goal of establishing food safety as a national priority. FDA's initiative implements the three core principles announced on July 7, 2009 by the Food Safety Working Group: prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery. FDA states that the FY 2011 resources for Transforming Food Safety will begin to establish an integrated national food safety system that protects U.S. consumers.

FDA Budget Proposes Funding for Standards, Surveillance, Inspections, Etc.

The FY 2011 budget proposes funding for the following activities related to its Transforming Food Safety Initiative:

New food safety standards. FDA would develop guidelines and binding regulations to serve as a foundation for a prevention-oriented food safety system. New standards would include preventive controls, recordkeeping, requirements for identifying food facilities, and program standards for inspections and for collecting and analyzing samples. FDA would develop standards for enforcement, response, and recovery for use by FDA and its regulatory partners in an integrated national system for food safety.

Food safety system focused on prevention. FDA would conduct audits of regulatory and public health partners. FDA audits would include reviews of inspection, investigation, sample collection and analysis, enforcement, response, recovery and outreach activities. The audits would measure performance against FDA food safety program standards. Through the integrated system, FDA would substantially increase food inspections and enhance feed surveillance.

Foreign food safety evaluation, 3rd party certification. FDA will develop standards for evaluating food safety systems in foreign countries, continue third-party certification efforts, and develop a registry of all importers. FDA will also expand and strengthen efforts to leverage information and build capacity with U.S. trading partners. When fully implemented, this program will hold imported and domestic foods to a common high standard of safety.

Enhanced surveillance capabilities and capacity. FDA will also develop and implement a national work plan for inspecting food manufacturing and distribution facilities and for collecting and analyzing compliance, surveillance, and environmental samples. FDA will also gather data and evaluate food safety systems in foreign countries. FDA will also collect 3,000 additional import samples.

Improved risk analysis and research. FDA will expand its capacity to identify products at highest risk for contamination. This will allow FDA to better target and prioritize food safety efforts and sampling and inspection priorities. In addition, FDA will improve data collection for risk analysis and detecting food safety signals. FDA will enhance the reportable food registry to help consumers report problems with foods. FDA will also expand the National Antimicrobial Resistance Monitoring System (NARMS) surveillance and monitoring to test additional high-priority commodities such as seafood and animal feeds. In partnership with CDC and USDA, FDA will adapt the NARMS platform to monitor emerging pathogens in food animals and retail foods of animal origin in the U.S.

Expanded laboratory capacity and capability. FDA will expand laboratory capacity and establish a new mobile laboratory for remote, on-site testing. FDA will increase its capacity to analyze and assess patterns in test results and develop and deploy rapid tests to identify food and environmental contamination.

Increased foreign inspection capacity. As part of an import safety program, FDA will conduct audits of foreign regulatory bodies and begin developing an updated inventory of foreign facilities to support the increase in foreign inspections. FDA will hire 94 new food safety inspectors. When fully trained, new inspectors will conduct an additional 150 foreign food inspections.

Track and trace technology pilot studies. Track and trace studies will guide FDA as it develops food product tracing regulation that provides for rapid tracing without overly burdening industry.

Many of activities are provided for in House-passed food safety bill. Many of the activities listed above are provided for in House-passed Food Safety Enhancement Act of 2009 (H.R. 2749)¹.

¹The House has passed H.R. 2749. Press reports indicate that the Senate may take up food safety legislation in summer 2010.

(See ITT's Online Archives or 09/01/09, 07/08/09, 07/02/09, 06/30/09, 06/26/09, and 06/25/09 news, 09090120, 09070820, 09070210, 09063015, 09062625 and 09062515, for BP summaries of various aspects of the House Energy and Commerce Committee version of H.R. 2749.

See ITT's Online Archives or 12/02/09 news, 09120215, for BP summary of the Senate Health, Education, Labor, and Pensions Committee's version of a food safety bill, S. 510.

See ITT's Online Archives or 07/09/09 news, 09070915, for BP summary of the July 7, 2009 recommended by the Food Safety Working Group.)

FDA FY 2011 budget justification available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM199447.pdf.