Although farmers might not be surprised to face an inspection from a state agency such as the Maryland Departments of Agriculture or Environment, they may be unprepared for an inspection from the federal Food and Drug Administration (FDA). Understanding the legal authority and permissible scope of an FDA inspection can alleviate confusion surrounding this type of inspection and help the process run a bit smoother.
The federal Food, Drug and Cosmetic Act (FDCA) (Section 704 of the Act- 21 U.S.C. 374) gives the FDA the legal authority to conduct inspections of farms growing produce. There are some exclusions for farms growing raw agricultural commodities which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public.
In the last decade, the FDA has increased its inspections of both farms and food processing facilities due to an increase in reported outbreaks of foodborne illness and passage of the federal Bioterrorism Act. The 2002 Bioterrorism Act provides that any facility engaged in manufacturing, processing, packing, or holding food for U.S. consumption is required to register with the FDA. The Bioterrorism Act gives the FDA authority to impose record-keeping requirements on registered facilities and to enter and inspect those facilities under its federal food-safety authority. Under the Food Safety Modernization Act (FSMA) and specifically, the recent finalization of the Produce Rule (detailed in this past post), implementing FSMA will create the need for additional inspections either by FDA or a state regulatory body enforcing the law.
According to the FDA, the purpose of a farm investigation “is to gather information, and observe and document practices that may have led to the pathogen specific contamination of produce, and that will support regulatory action if appropriate.” Further, the FDA indicates there are two primary reasons for conducting a farm investigation:
1. An outbreak and trace back investigation implicating the farm and related operations
2. A follow-up to a positive produce sample. Prior to implicating the farming operation, all other possible sources of contamination in the distribution chain should have been fully investigated.
Although many folks have questioned the authority of the FDA to conduct an inspection, such an inspection, like other government inspections authorized by law, will be found valid if it is conducted at a reasonable time, within reasonable limits, and in a reasonable manner. In other words, the inspection should be done during typical business hours, the scope of the inspection should not go beyond what is necessary and authorized by law, and it should not be unduly burdensome for the farmer. The legality of an FDA inspection will not depend on the consent of the property owner or operator to the search but on the validity of the FDA’s statutory authority to conduct it. An inspection warrant is not a prerequisite to lawful inspection done with valid authority. A property owner or operator has the right to ask the FDA inspector to present identification and a written notice explaining the reason or basis for the inspection. If the FDA inspector presents the requested documentation and conducts a valid inspection, a property owner’s refusal to permit an inspection exposes the property owner to criminal penalties (21 U.S.C. 331(f) and 333).
To learn more about the FDA’s inspection policies and procedures, see: http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074962.htm