FDA Releases its Food Protection Plan for Domestic and Imported Products

The FDA states that the Plan operates through a set of integrated strategies that address the product life cycle (from production to consumption), a risk-based allocation of resources, the integration of food safety and food defense, and is built on a foundation of science and modern information systems.

FDA Plan is Integrated with Action Plan for Imported Product Safety

The FDA Plan is integrated with the Bush Administration's recently issued action plan for imported product safety. (See ITT's Online Archives or 11/08/07 or 11/09/07 news, 07110815 and 07110910, for Parts I and II of a BP summary of theAction Plan for Import Safety.)

First Element: Prevent Foodborne Contamination

The first element of the FDA's plan is the prevention of foodborne contamination by promoting increased corporate responsibility so that food problems do not occur in the first place. Highlights of the prevention elements of the FDA's Plan include the following (partial list):

Guidelines/inspection/overseas presence. The Plan calls for the FDA to strengthen its actions by, among other things, developing written food protection guidelines for industry to develop food protection plans for produce and other food products; focusing foreign inspections on high-risk firms and products; and improving FDA's presence overseas.

Supply chain measures. The FDA requests additional legislative authority to allow it to issue regulations requiring companies to implement practical food defense measures at specific supply chain points where intentional contamination has the greatest potential to cause serious harm (e.g. requiring locks on tanker trucks transporting food). The specific points would be determined using vulnerability assessments, and the authority would only apply to food in bulk or batch form, prior to being packaged, which has clearly demonstrated vulnerabilities (e.g., short shelf life), and where it would affect multiple servings and there is a high likelihood of serious adverse health consequences or death from intentional adulteration.

High risk food. The FDA requests explicit authority to issue regulations requiring that specific types of foods (those that have been associated with repeated instances of serious health problems or death to humans or animals from unintentional contamination) be prepared, packed, and held under a system of preventive food safety controls.

Bi-annual registration of food facilities. The FDA requests statutory changes that would require facilities to register every two years and authorize the FDA to establish food categories within the registration system. These categories would allow FDA to tailor registration categories based on up-to-date food safety information. Facilities whose registration remains unchanged would be able to file a simplified renewal registration or affirmation to that effect.

Second Element: Intervene at Critical Points in the Food Supply Chain

The second element of the FDA's Plan focuses on risk-based inspections, sampling, and surveillance at high risk points in the food supply chain. These interventions must verify that the preventative measures are in fact being implemented, and done so correctly. Highlights of the intervention elements of the FDA's Plan include the following (partial list):

Accredited third parties for voluntary inspections. The FDA seeks the legislative authority to allow it to accredit highly qualified third parties (or recognize entities that accredit) to evaluate compliance with FDA requirements in voluntary food inspections. (The FDA would use this information but would not be bound by it in determining compliance.)

Re-inspection fee for failure to meet CGMPs. As part of the 2008 budget process, the Bush Administration proposed a new user fee requiring manufacturers and laboratories to pay the full costs of reinspections and associated follow-up work when FDA reinspects facilities due to failure to meet Current Good Manufacturing Practices (CGMPs) or other FDA requirements.

Electronic import certificates for high-risk products. The FDA seeks authorization to require electronic import certificates for shipments of designated high-risk products. The FDA states it should have the option of moving the inspection of high-risk products of concern "upstream" by entering into agreements with the exporting country's regulatory authority for that authority (or an FDA-recognized third-party inspector) to certify each shipment or class of shipments for compliance with FDA's standards prior to shipment.

Export certification fee. As part of the 2008 budget process, the Bush Administration proposed a new export certification fee for the issuance of export certificates for foods and feeds to those situations where exportation is restricted without this type of certificate (such fees are currently collected by the FDA for export certificates for drugs and devices).

Prevent entry of imported food if inspection access denied/delayed. The FDA seeks the authority to prevent entry of food from foreign firms that delay, limit, or deny FDA inspection access, similar to its authority regarding domestic firms. The authority would include several procedural safeguards, including an informal hearing if food is refused admission into the U.S.

Third Element: Respond Rapidly to Minimize Harm

The third element of the FDA's Plan involves rapidly responding to minimize harm. The following is an example of the Plan's elements related to rapid response:

Mandatory recall authority. The FDA seeks the authority to empower it to issue a mandatory recall of food products when voluntary recalls are not effective. This authority would be limited to foods that the Health and Human Services (HHS) Secretary has reason to believe are adulterated and present a threat of serious adverse health consequences or death. It would be imposed only if a firm refuses or unduly delays conducting a voluntary recall. An order to recall food could only be issued by the HHS Secretary, Deputy Secretary, or Commissioner of Food and Drugs, and would be accompanied by appropriate due process rights.

FDA contact - Kari Barrett (301) 827-9831

FDA Food Protection Plan (dated November 2007) available at http://www.fda.gov/oc/initiatives/advance/food/plan.html

FDA press release (dated 11/06/07) available at http://www.hhs.gov/news/press/2007pres/11/pr20071106a.html