HHS Issues Import Safety Report; FDA Simultaneously Announces Food Safety Protection PlanNovember 12, 2007
Earlier this year, President Bush signed Executive Order 13439 establishing the Interagency Working Group on Import Safety (“Working Group”). The Working Group, chaired by Department of Health and Human Services Secretary Mike Leavitt, was charged with conducting a comprehensive review of current import safety practices and determining where improvements can be made. In September 2007, the Working Group issued its initial findings in a Strategic Framework document, and committed to issuing a detailed action plan by mid-November 2007.
On November 6, 2007, the Working Group issued its Action Plan for Import Safety (“Import Action Plan”). HHS simultaneously announced an FDA Food Protection Plan (“Food Plan”). Although the Food Plan is presented as part of the broader Import Action Plan, FDA’s Food Plan covers food safety of both domestic and imported food.
Based on a 3-pronged strategy of prevention, intervention, and response, the Import Action Plan is a roadmap to keep hazardous products from entering the U.S. (Additional information about the Import Action Plan is available here.) The “roadmap to import safety” discussed in the Import Action Plan identifies 14 broad recommendations and 50 specific action steps to enhance product safety at every step of the import lifecycle. For each action step, the Import Action Plan specifies which agencies are affected, and whether the action steps are short-term (i.e., completed within the next 12 months) or long-term. The Import Action Plan is not limited to food products but covers all consumer goods including toys, drugs, and medical devices. Recommendations from the Import Action Plan that are also incorporated in the FDA’s Food Protection Plan include certification of imported products, mandatory product recalls, and expedited consumer notification of product recalls.
FDA’s Food Plan is based on the same strategy as the broader Import Action Plan; that is, a strategy of prevention, intervention, and response. FDA recognizes that a new approach to food safety is needed. According to the Food Plan, the safety of the U.S. food supply remains second to none, but increasing variety in food products, changing consumption patterns, changing food production technologies, changing consumer demographics, and new foodborne pathogens challenge a food safety system based solely on inspection. The change in volume, variety, and complexity of FDA-regulated products, and the stagnant or diminishing resources have resulted in a need for FDA to move away from the random inspection “snapshot approach” currently used by the Agency. The Food Plan proposes a proactive approach that focuses on risks throughout the food product lifecycle, reallocates resources to high risk food products, and implements modern technologies and detection methods. The Food Plan also “address[es] both unintentional and deliberate contamination” of all foods except meat, poultry, and processed egg products, which are within the U.D. Department of Agriculture’s jurisdiction.
The Food Plan identifies some issues that can be addressed within the current statutory framework by strengthening FDA actions. Many of these actions involve: (1) increased communication and cooperation with federal, state, local, and international partners, consumers groups and industry representatives; and (2) a shift of focus or reallocation of Agency resources. The Food Plan includes only two regulatory actions. Specifically, the Food Plan recommends that FDA finalize the Agency’s September 2004 proposed rule on prevention of Salmonella in shell eggs, and finalize the February 2003 proposal concerning prior notice of imported foods. The Food Plan also identifies numerous legislative changes necessary to provide FDA with the authority to “transform the safety of the nation’s food supply.”
Each of the three major components of FDA’s Food Plan (i.e., prevention, intervention, and response) is discussed below.
Prevention – From “Farm to Fork”
Prevention is the core element of the Food Plan. Recognizing that random inspections are ineffective, FDA proposes to identify risks and target resources to achieve the greatest risk reduction. In its risk analysis, FDA will focus on risks over a product’s lifecycle, from “farm to fork.” Such an approach requires cooperation with producers, manufactures, distributors, retailers, and importers, among other interested parties. FDA identifies the need for additional authority to: (1) “allow FDA to require preventative controls against intentional adulteration;” (2) “strengthen FDA’s ability to require manufacturers to implement . . . Hazard Analysis and Critical Control Point (HACCP) [plans] for high-risk foods;” and (3) “require that food facilities . . . renew their FDA registration every two years.”
Intervention – Verifying Preventative Measures
The intervention element in the Food Plan focuses on verification of implementation of preventative measures. Rather than random inspection, FDA proposes a risk-based inspection and surveillance program for imported as well as domestic food products. To allow such an approach, FDA needs additional legislative authority. To ease FDA’s burden of inspecting the ever-growing number of food facilities, FDA requests authority to “accredit independent third parties.” FDA would be not be bound by such voluntary inspections, but the Agency could use information collected during such voluntary inspections to address food safety issues.
Currently, foreign establishments importing food into the U.S. are required to provide prior notice of each shipment into the U.S. FDA requests additional authority to require electronic import certificates when such shipments concern high-risk products. Foreign regulatory authorities or third-party inspectors would inspect the product and certify its safety. Products certified as meeting U.S. safety standards could receive expedited entry. FDA also requests authority to stop import of food from foreign facilities that “unduly delayed, limited or denied” the Agency’s access to inspect the facility.
Finally, struggling with ever-shrinking resources, FDA also proposes that Congress grant the Agency the authority to charge a reinspection fee for facilities that require follow-up inspections because they failed the initial inspection, and to charge a user fee for issuance of export certificates. (Congress is currently considering legislation to create import user fees – see 8/15/2007 FDA Law Blog post.)
Response – Speed and Effectiveness are Key
Because no system is failure proof, a food safety plan would be incomplete without provisions addressing responses to contamination. As such, the Food Plan identifies “a need to respond faster and communicate more effectively with consumers and parties.” Not surprisingly, FDA asks Congress for legislative authority to issue mandatory recalls. In addition, citing the recent melamine pet food contamination, FDA requests Congress to increase the Agency’s authority to access company records. Such increased authority would include access to records concerning food products “related to” an adulterated food in addition to those records concerning the adulterated food product.
Overall, FDA’s Food Plan does not contain many new suggestions. Although the proposed changes will undoubtedly require additional resources, the Food Plan does not include an estimate of the costs associated with the proposed measures. Later this week, FDA will hold a blogger teleconference on the Food Plan. We plan to participate in that teleconference and will update you on issues discussed during the call.