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From: Food Quality & Safety magazine, October/November 2010

Money for the Food Safety Mission

Fed budget backs up safety talk

by Edward J. Johnson and Daniel R. Matlis

The Institute of Medicine (IOM) report Enhancing Food Safety: The Role of the Food and Drug Administration, released on June 8, criticized the U.S. Food and Drug Administration’s (FDA) approach to food safety. The report recommended that the FDA take a proactive approach by relying on prevention and surveillance rather than continuing its current reactive approach to address potential failures in ensuring the safety of the nation’s food supply. (For more on the report, see “The FDA’s Evolving Approach to Food Safety.")

The IOM report recommended a risk-based approach to food safety. The institute made several recommendations to the FDA to further the development of a proactive, risk-based food safety program. One suggestion was to develop a centralized repository for sharing food safety data with other federal, state, and local agencies.

A second recommendation involved streamlining the inspection program by developing inspection standards to be shared with state and local agencies, by delegating more of the actual inspections to those agencies, and by increasing food safety education and risk communication. Yet another recommendation was to establish a single, centralized food safety agency to unify the food safety efforts of all federal, state, and local agencies.

Insight Into the Budget

Although the FDA’s fiscal year (FY) 2011 proposed budget was not developed specifically with the IOM report in mind, examination of its plans and allocations against the report’s findings may provide some insight. President Obama’s FY 2011 budget includes $22.02 million for user fees to register food facilities, to conduct import review and product sampling, and to conduct additional food safety and good manufacturing practices inspections of domestic and foreign facilities. With these resources, the FDA will increase its capacity to establish an integrated national food safety system and further strengthen food safety inspection, response, and import review.

The FDA plans to execute its regulatory responsibilities through four announced subprograms. Under the first, “Prioritizing Prevention,” the agency will set new standards for food safety, including preventive controls, record keeping, requirements for identifying food facilities, and program standards for inspections and for collecting and analyzing samples. Included among those will be standards for evaluating food safety systems in foreign countries, part of the FDA’s development of a modern import safety program.

The agency will also develop standards for enforcement, response, and recovery for use in an integrated national system for food safety. Audits of regulatory and public health partners against those food safety program standards will be conducted. Funding for the “Prioritizing Prevention” program is $7,117,000 and 20 full-time equivalents (FTE). User fees will generate $75,633,800 and 144 FTES.

The Government Accountability Office defines FTE as the number of total hours worked divided by the maximum number of compensable hours in a work year as defined by law. For example, if the work year is defined as 2,080 hours, then one worker occupying a paid full-time job all year would consume one FTE. Two employees working for 1,040 hours each would consume one FTE between the two of them.

Strengthening Surveillance

The second subprogram, “Strengthening Surveillance and Enforcement,” will see the FDA enhance its surveillance capabilities using the integrated national food safety system. This will be done in conjunction with state liaisons and by developing and implementing a national work plan for inspecting and sampling at food manufacturing and distribution facilities. Enhanced surveillance capacity, including gathering data and evaluating food safety systems in foreign countries, will play a key part in the FDA’s strengthened import safety program.

The FDA will improve risk analysis and research for food and feed safety to allow the agency to better target and prioritize food safety efforts, sampling, and inspections. The agency will improve data collection for risk analysis and detection of food safety signals by helping consumers report problems with foods and expanding the National Antimicrobial Resistance Monitoring System in partnership with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture. The agency will expand laboratory capacity and capability, including a new mobile laboratory for remote, on-site testing, and will increase inspection capacity through the integrated national food safety system by hiring and training new food safety inspectors.

Funding will go to increased state sampling of animal feeds and feed ingredients. In addition, the FDA will establish a system designed to facilitate the exchange of data electronically between the agency itself and state agencies to improve the efficiency of inspections and inspection analysis. The FDA’s increased audits of foreign regulatory bodies and updates of its inventory of foreign facilities to support more foreign inspections are also seen as part of the surveillance and enforcement subprogram. The funding for this program is $53,693,000 and 111 FTEs; user fees will generate $119,470,200 and 13 FTEs.

Pursuing Pilot Studies

In the third subprogram, “Improving Response and Recovery,” the FDA will pursue pilot studies with industry using track and trace technology to develop food product tracing regulations. FDA laboratory capacity and capability will be expanded to enhance response and recovery and overall efficiency in food testing laboratories. Funding is $812,000 and one FTE; user fees will generate $938,000 and two FTEs.

Under the fourth subprogram, “IT and Program Support for Initiative Priorities,” FDA will invest $10 million in two enterprise-wide information technology (IT) projects to establish, support, and maintain the systems necessary to collect food registration and inspection user fees. This is part of a multi-year FDA effort to modernize its enterprise-wide IT infrastructure to allow sharing of regulatory data across FDA food programs and to support data centers, IT security, telecommunication networks, and related operations that support FDA food programs.

In addition to enterprise IT investments, the Transforming Food Safety Initiative includes resources to ensure that the participating food program offices receive the support necessary to achieve the proposed public health outcomes. Funding is $4,950,000 and eight FTEs; user fees will generate $18,460,000 and 20 FTEs.

Axendia’s analysis of the 2011 FDA budget shows that the agency plans to allocate significant resources to address IOM report findings.

Johnson is an analyst of counsel and Matlis is president of Axendia; for more information, contact Matlis at dmatlis@axendia.com.

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