The Food and Drug Administration published yesterday its schedule for fees associated with facility reinspections, failure to comply with a recall order and import reinspections. FDA established an hourly fee of $224 for all domestic work and $335 if foreign travel is required. The fees will be in effect October 1, 2011, through September 30, 2012.
The fees will apply to facilities reinspected by FDA following a previous inspection that had a final classification of Official Action Indicated (OAI) and where FDA determined the non-compliance was materially related to food safety requirements. FDA will reinspect to determine whether corrective and effective actions have been implemented and compliance has been achieved to the agency's satisfaction.
Failure to Comply
A failure to comply will trigger reinspection fees if it is related to adulteration or the presence of undeclared allergens. FDA does not consider circumstances where the non-compliance is "of a technical nature and not food safety related (e.g., failure to comply with a food standard or incorrect font size on a food label)" to be a trigger for reinspection fees.
FDA may issue guidance to provide additional information about the circumstances that would trigger reinspection fees.
FDA also explained its intent to apply reinspection fees to foreign facilities. Because the Food Safety Modernization Act only established a definition of "reinspection" for domestic facilities, FDA announced that it will apply the term to foreign facilities as well.
According to this definition, FDA requires the initial inspection to be conducted by officers or employees designated by the agency. FDA believes this will ensure that a foreign facility is only subject to reinspection fees when FDA, or an entity designated to act on its behalf, has identified a non-compliance situation materially related to a food safety requirement.
Reinspection fees will apply for time spent on the following activities:
- Conducting physical surveillance and/or compliance reinspection at the facility;
- Making preparations and arrangements for the reinspection;
- Traveling to and from the facility;
- Preparing reports;
- Analyzing samples or examining labels, if required; and
- Performing other activities until the facility is in compliance.
FDA will assess fees related to recall orders if a company fails to 1) initiate a recall, 2) conduct the recall in the manner specified by FDA in the recall order or 3) provide FDA with requested information regarding the recall. The fee will be based on activities such as conducting recall audit checks, reviewing periodic status reports, conducting inspections and monitoring product disposition.
FDA will assess import reinspection fees in at least the following four specific situations:
- Reconditioning of imported food;
- Importers seeking admission of an article that has been detained;
- Entities requesting removal from an import alert for detention without physical examination; and
- Destruction of food that has been refused admission.
These fees will only be assessed after two sets of examinations. FDA must conduct an initial examination that identifies non-compliance related to a food safety requirement. Additionally, FDA must conduct at least one subsequent examination to determine whether compliance has been achieved.
Members with questions may contact Clay Detlefsen, vice president of regulatory affairs, at email@example.com.