Establishments regulated by the Food Safety and Inspection Service (FSIS) frequently face the dilemma on whether to appeal agency decisions that could have a negative impact on their businesses. Even when there are valid grounds for an appeal, the decision to appeal is not always easy, particularly since inspector retaliation or enhanced regulatory scrutiny are real concerns.
Recently, FSIS issued a fact sheet on its Web site regarding appeals in order to help establishments understand the appeal process as well as their rights. The fact sheet is also intended, in part, to encourage establishments to exercise their right to appeal “without fear of retaliation.”
The fact sheet notes meat and poultry establishments have the right to appeal any agency decision pursuant to FSIS regulations. Although establishments most frequently appeal Noncompliance Records (NRs), enforcement actions (e.g., Notice of Suspension or Notice of Intended Enforcement Actions), sampling results, regulatory waiver suspensions or withdrawals and other actions can be appealed. Establishments also can choose to appeal an entire decision (e.g., NR or NOIE) or part of a decision.
There are many reasons why establishments may choose to appeal an inspection decision. Among other reasons, the fact sheet states that an inspection decision may be appealed based on incorrect facts or facts that were not considered, incorrect citations to regulations, or because the establishment was in compliance with regulatory requirements. Although incorrect facts such as wrong dates, times and names can be appealed, it should be noted that if there is no disagreement regarding whether there was an underlying noncompliance, the agency decision can simply be corrected and reissued.
One important reason to appeal that is given brief attention in the fact sheet is linkage of NRs. Often, when NRs are issued, they cite to other NRs that purportedly involve noncompliances of the same cause. Even if an establishment agrees with the issuance of the most recent NR, it is strongly encouraged to appeal an inspection decision to link other NRs if the other NRs resulted from a different cause. If the linkage is not appealed, all of the NRs could later be used to support an enforcement action based on the failure of the establishment to prevent repetitive noncompliances.
If an establishment decides to appeal an agency decision, the establishment should ensure the appeal is accompanied by supporting documentation. This would include the original agency decision (e.g., NR, NOIE, LIMS Direct Form) and subsequent appeal responses. It would also include a narrative explanation of why the establishment disagrees with the decision and documentation to support the establishment’s version of the facts (e.g., photographs, affidavits by employees, and HACCP, SSOP, prerequisite program records).
Although establishments are not required to submit appeals within a specific time frame, factual disagreements should be resolved as soon as possible, while the facts are fresh in everyone’s minds and can be documented. Submitting appeals in a timely manner also helps ensure a timely response by the agency. Importantly, when appealing all or part of NOIEs, the fact sheet cautions establishments to still respond to the agency with corrective actions within three business days. This is because the failure of the establishment to respond with corrective actions within three days could result in a suspension of inspection.
As noted above, deciding whether to appeal an agency decision is not easy. While the agency encourages establishments to appeal agency decisions without the fear of retaliation, the threat of retaliation is real. Moreover, appealing too many agency decisions, particularly when they are on shaky grounds, could undermine the establishment’s credibility and can cause the agency to question the company’s commitment to meeting regulatory requirements. On the other hand, not appealing agency decisions that are unjustified can lead to more dire consequences, such as enforcement actions or continued wrong application of regulatory requirements to the detriment of the establishment.
In order to make the decision easier, we would suggest establishments answer two simple questions. First, does the establishment have a sound basis to challenge the agency decision based on applicable law? Second, if the establishment does not appeal, could the agency decision be later used to support an enforcement action, or result in continued wrong application of regulatory requirements to the detriment of the plant? If the answer to both questions is yes, the decision to appeal should be relatively straightforward.