Mark S. Hostetler

The Food and Drug Administration (FDA) has released its anticipated Food Protection Plan, subtitled “An integrated strategy for protecting the nation’s food supply.” Through integration with the “Import Safety Action Plan,” the combined plans address safety for both domestic and imported food products.

As the title suggests, the emphasis of the plan is on measures that can be increased, rebuilt or added to maximize an overall food safety approach. The three components of the plan are: 1. prevention—“build safety in from the start”; 2. intervention—“risk-based inspections and testing”; and 3. response—“rapid reaction, effective communication.”



1. In the area of prevention, FDA intends:

To meet with consumer groups, states, and corporate and food industry representatives to focus on voluntary initiatives.

To develop new Salmonella regulations by spring of 2008.

To heighten FDA’s overseas presence, thereby “improving food safety at the source” and to offer technical support.

To begin to develop a risk-based food import trend analysis and database.



To pursue this prevention agenda, FDA seeks the legislative authority:

To compel the food industry to develop measures to specifically prevent intentional adulteration.

To regulate additional control measures for high-risk foods.

To require an every two years’ registration of food facilities.



To assist in the identification of food vulnerability, risk assessment and effective mitigation techniques, FDA intends:

To work with all stakeholders to develop additional understandings of vulnerabilities and risks within the food safety system.

To use modeling and other technical advances to assess and prioritize risk.

To work more closely with the Centers for Disease Control.

To develop a basic research plan for contamination detection.

To develop new methodologies for detection of food contaminants.

To develop new and better communication systems for disseminating information that the programs develop.

No changes in legislative authority are anticipated to pursue these prevention objectives.



2. To advance the objective of increased and better inspections, sampling and surveillance, FDA intends:

To focus on risk assessment in inspection protocols.

To seek development of better on-site foodborne pathogen detection devices.

To increase training of inspectors in risk assessment and evaluation.

To work with foreign governments to reduce the risks from imported foods.



Legislative changes sought by FDA to effect its goal of better inspections include:

Legislation to allow accreditation and use of third-party inspectors.

Authority to require re-inspection fees and costs to producers who initially fail to meet current Good Manufacturing Practices procedures.

Authority to establish foreign soil inspection and certification for imported food products.

Authority to deny admission of imported foods where an on-site inspection has been delayed or refused.



3. To implement the third element of the plan:

FDA seeks the legislative authority to order a mandatory food product recall, when efforts to implement a voluntary recall have failed. FDA anticipates the authority would be limited to those circumstances where the FDA believes the product to be adulterated, and where serious adverse health consequences are a threat and would be sought only after a voluntary recall was rejected.

FDA seeks authority to expand its access to additional records and controls in the event of an emergency. For example, FDA would have the authority to seek records of other foods produced on the same equipment or at the same time as an adulterated food product. The demanded access would be limited to safety and security records and not to formula, financial or other confidential business records.

FDA concludes by stating, “FDA will aggressively pursue the Food Protection Plan, so that U.S. consumers can be assured that their food remains among the safest in the world.”





Mark S. Hostetler is an attorney at Blackwell Sanders LLP.  He can be reached at mhostetler@blackwellsanders.com.