NGFA Unveils New Guide: ‘Rights and Obligations During FDA Inspections’

Over the last few years, the Food and Drug Administration (FDA) has increased its inspections of grain elevators, grain processors and animal feed manufacturers. To assist NGFA members, the association prepared a new guide, “Rights and Obligations During FDA Inspections.”

The increase in inspections is due to the Food Safety Modernization Act, which mandates that FDA inspect facilities subject to its regulations implemented under the law. As a result, NGFA designed the guide to review:

• The role of FDA in overseeing the safety of the U.S. food supply,
• FDA’s authority to inspect grain and feed facilities,
• Types of FDA inspections, and
• The FDA inspection process.

“Once the FDA investigator arrives, it is too late to establish policies and procedures for the inspection process,” said David Fairfield, NGFA vice president of feed services, who unveiled the guide during a workshop at NGFA’s recent Country Elevator Conference and Trade Show.

During his presentation, Fairfield outlined the types of FDA inspections:

• For Cause: Pertaining to public health concerns or animal illness and/or death.
• Surveillance: Conducted to evaluate compliance with applicable regulations.
• Compliance: Performed because FDA has information that suggests problems may or do exist at a facility.
• Criminal: Conducted when information suggests that serious willful and/or egregious violations of applicable requirements are occurring within a facility.

Further, Fairfield discussed preparing for a FDA inspection and stressed the importance of having a plan in place, knowing your facility’s rights and obligations, and designating employee(s) to accompany an investigator. In addition, he recommended establishing procedures and policies that prescribe:

• Specific responsibilities to employees directly involved with handling the inspection.
• How to handle requests by FDA to interview employees. (FDA does not have express authority to interview employees.)
• Whether to allow pictures to be taken. (FDA’s authority to use cameras during an inspection is not well established.)
• How to respond to FDA requests for copies of records, especially when confidential business information is requested.
• Whether to sign FDA affidavits and declarations.
• How to respond back to FDA after the inspection, if needed, in a prompt and appropriate manner.

For more information on preparing your facility, see Fairfield’s presentation and the guide. You may also contact him at dfairfield@ngfa.org with additional questions.