U.S. Department of Health and Human Services (HHS) Secretary Mike Leavitt recently announced a comprehensive initiative by the Food and Drug Administration (FDA) designed to proactively address the safety of the nation’s food supply.

Back in May, FDA was charged with developing the comprehensive plan to protect U.S. food supplies from both unintentional and deliberate contamination.

The Food Protection Plan proposes the use of science and a risk-based approach to ensure the safety of domestic and imported foods eaten by American consumers. “America’s food supply is among the safest in the world, and we enjoy unprecedented choice and convenience in filling the cupboard. Yet we face new challenges to meet both the changing demands of a global economy and consumers’ expectations,” Secretary Leavitt said. “This Food Protection Plan will implement a strategy of prevention, intervention, and response to build safety into every step of the food supply chain.”

According to FDA’s plan, the agency regulates some $417 billion worth of domestic food and $49 billion in imported food (2003 data) annually. The challenges of the current food industry—changing food production technology, human demographics (susceptible populations) and consumption (“convenience” food), business practices, new microbial threats, and communication issues—are all major hurdles that the plan is expected to address.

HHS Deputy Secretary Tevi Troy and FDA Commissioner Andrew von Eschenbach, M.D., presented the Food Protection Plan at a press conference in Washington, DC. “The Food Protection Plan calls for effective action before an outbreak occurs,” said Commissioner von Eschenbach.

Figure 1. HHS Deputy Secretary Tevi Troy, FDA Commissioner Andrew C. von Eschenbach, M.D., and FDA Assistant Commissioner for Food Protection David Acheson, M.D., announce FDA’s integrated strategy for protecting the food supply. Photo courtesy of FDA.Click here to enlarge image

The plan is premised on preventing harm before it can occur, intervening at key points in the food production system, and responding immediately when problems are identified. Within these three overarching areas of protection, the plan contains a number of action steps as well as a set of legislative proposals.

Figure 2. An investigator from FDA’s San Francisco District (left) is shown working with an investigator from the California Department of Health Services collecting soil samples as part of an investigation into an outbreak of E. coli O157:H7 in spinach. The contamination, which occurred during the fall of 2006 and sickened people in the United States and Canada, originated on farms in California. Photo by Black Star/Steve Yeater for FDA.Click here to enlarge image

The FDA says it will work with industry, state, local, and foreign governments to identify vulnerabilities and will look to industry to mitigate those vulnerabilities, using effective methods such as preventive controls.

The plan’s intervention element emphasizes focusing inspections and sampling based on risk at the manufacturer and processor level, for both domestic and imported products, that will help verify the preventive controls. This approach is complemented by targeted, risk-based inspections at the points where foreign food products enter the United States, including ports. According to the report, “Risk-based targeted inspections at the border will serve as a second layer of protection, rather than the principal one.”

The plan also calls for enhancing FDA’s information systems related to both domestic and imported foods to better respond to food safety threats and communicate during an emergency. The Food Protection Plan’s three core elements—prevention, intervention, and response—incorporate four principles for comprehensive food protection along the entire production chain:

• Focus on risks over a product’s life cycle from production to consumption.
• Target resources to achieve greatest risk reduction.
• Use interventions that address both food safety (unintentional contamination) and food defense (deliberate contamination).
• Use science and employ modern technology, including enhanced information technology systems.

Aspects of the plan that require additional legislative action include (but are not limited to) endowing FDA with the authority to require “practical defense measures” at vulnerable points in the supply chain to prevent deliberate contamination (e.g., requiring locks on tanker trucks that transport food); authorizing FDA to accredit qualified third parties to perform voluntary food inspections in order to provide more in-depth and potentially quicker review of imported goods; and implementing a new user fee requiring manufacturers and labs to pay the costs of re-inspections and follow-up services when the facilities fail to meet cGMPs or other FDA requirements.

The Food Protection Plan complements the Import Safety Action Plan recently delivered by Secretary Leavitt to President George W. Bush that recommends how the U.S. can improve the safety of all imported products. This year, $2 trillion worth of goods will be imported into the U.S., with predictions that amount will triple by 2015. Taken together, the two plans will improve efforts by the public and private sector to enhance the safety of a wide array of products used by American consumers.

For more information, visit http://www.fda.gov/oc/initiatives/advance/food/plan.html.