FSIS and the era of enforcement

Editor’s note: This is part three of a four-part series.

Ten years after issuing the Pathogen Reduction; Hazard Analysis and Critical Control Point (PR/HACCP) Systems: Final Rule, The USDA’s Food Safety and Inspection Service (FSIS) had not produced a single metric demonstrating progress in reducing pathogens or foodborne illness. Unwilling to acknowledge failure, FSIS rationalized the absence of progress, not as a failure of FSIS policy, but as the result of industry lobbyists. Industry lobbied against FSIS initiatives in the past. They must be doing it again. 

FSIS turned to the only metric it truly controlled as a measure of success: enforcement actions (i.e., regulatory control action, withholding action, suspension). The FSIS logic was simple. Enforcement actions are as accurate a measure of food safety as traffic citations are an accurate measure of highway safety (sarcasm intended). When enforcement actions taken is your only measure of success, you document as many enforcement actions as possible, and you do not allow your enforcement actions to be overturned. The FSIS bureaucracy is very effective at both.

Presumption of Innocence or Guilt

Presumption of innocence is a tenet of American jurisprudence. FSIS is tasked with conducting inspection to determine if regulatory compliance does/does not exist. The burden of proof rests with FSIS, not industry. The standard of proof is a preponderance of evidence. Evidence is the available body of facts indicating that the establishment failed to meet the applicable regulatory performance standard. 

In theory, inspection program personnel (IPP) implement an enforcement action when a preponderance of evidence supports a determination that noncompliance is more probable than not. In theory, if the establishment disagrees, the establishment can offer a refutation of the IPP evidence. In theory, the immediate FSIS supervisor weighs the IPP evidence and the establishment refutation against the applicable regulatory performance standard, and decides the appeal based on a preponderance of evidence.

FSIS policy turns this tenet of American jurisprudence upside down. The PR/HACCP final rule states that “establishments will be afforded greater autonomy in decision-making affecting their own operations,” meaning that the responsibility for achieving compliance rests with the establishment and that FSIS with allow the establishment to determine the methods by which it achieves compliance. FSIS interprets this to mean that the establishment must prove that its choice of method achieves compliance, placing the burden of proof on industry. FSIS considers industry guilty until industry proves itself innocent. 

The Rules of Practice [9 CFR 500.2(a)(3)] authorize IPP to take a regulatory control action when conditions “preclude FSIS from determining that product is not adulterated or misbranded,” meaning that, IPP may retain product while they gather additional information to determine if noncompliance exists. FSIS interprets this to mean that the inability of IPP to determine compliance supports a determination of noncompliance. For FSIS, the absence of evidence is evidence. It is FSIS policy that any determination of noncompliance is valid until proven false via the appeal process, and that by not appealing the noncompliance, the establishment validates the noncompliance. IPP can assert, in the absence of evidence, that noncompliance exists. The supervisor accepts the assertion as true because the establishment cannot prove the assertion false. In effect, FSIS has “weaponized stupid” and eliminated the need for supervisory oversight.

The result is a history of noncompliance based on an absence of evidence, which FSIS may use to justify a Food Safety Assessment (FSA). The predictable outcome of an FSA is the identification of “concerns” suggesting an inadequate HACCP system [9 CFR 417.6], and a recommendation for further enforcement action. Like a determination of noncompliance, it is FSIS policy that any FSA recommendation is valid; therefore, FSIS performs zero quality control on the FSA. So, on the recommendation of IPP, the FSIS District Manager issues a Notice of Intended Enforcement (NOIE), informing the establishment that FSIS intends to implement a suspension. The FSIS decision to implement a suspension is administrative, not regulatory. If FSIS chooses to implement a suspension, an establishment cannot prevent it.

The establishment has two courses of action available: dispute the FSA findings and “petition the Government for a redress of grievances” or accept the FSA findings and correct the underlying “concerns.” Either way, FSIS can take and maintain the suspension until the petition or corrective action is complete.

Petition or Corrective Action

The First Amendment to the U.S. Constitution guarantees an establishment the right to petition government for redress of grievances. An establishment has a legal right to appeal an enforcement action without fear of punishment or reprisal. The First Amendment does not require government to respond. It is an FSIS tenet that “if it is not written down, it did not happen.” FSIS can and will ignore any petition not presented in written form. 

The Fifth Amendment prohibits government from depriving a citizen of liberty or property without due process. Any FSIS enforcement action is a deprivation of liberty or property. Procedural due process requires government to provide an establishment with notice, an opportunity to be heard, and a decision made by a neutral decisionmaker. The federal court system, not FSIS, provides procedural due process. Standing between the establishment and procedural due process is the doctrine of exhaustion of administrative remedies, the requirement that the establishment first pursue the FSIS administrative remedy defined in FSIS Directive 13,000.3 before seeking judicial review.

Any appeal of alleged noncompliance must pass up the FSIS chain of command until granted. It is FSIS policy that by ending the appeal process, the establishment validates the noncompliance. Moving an appeal through the FSIS chain of command can take months. Most establishments give up long before that. Once the FSIS Administrator denies the appeal, the establishment can seek judicial review in federal District Court [5 USC 702]. Only then is the establishment provided notice, an opportunity to be heard, and a decision by a neutral decisionmaker. The federal district court charges substantial filing and administrative fees. Given the time obstacle created by the doctrine of exhaustion of administrative remedies and the monetary cost of judicial review, no appeal can survive if FSIS chooses to oppose it.

An establishment may request a formal proceeding before an Administrative Law Judge (ALJ) if FSIS implements a suspension not held in abeyance, refuses to grant inspection, or rescinds or refuses label approval. If an establishment requests a formal proceeding, FSIS requests that the USDA, Office of General Council (OGC) file an administrative complaint requesting that the Secretary withdraw the establishment’s grant of inspection. OGC then notifies the establishment of the administrative complaint. Failure to respond within 20 days constitutes a waiver of hearing. The establishment’s request for a formal proceeding is denied, and a Judge issues an order refusing or rescinding the grant of inspection. The establishment must choose between a consent decision and a hearing. A consent decision is a negotiation. If the establishment and FSIS cannot agree on a consent decision, a hearing is held. The consent decision/hearing process can take up to a year, maybe longer. If the ALJ rules in favor of FSIS, the establishment can appeal to the OGC Judicial Officer. If the Judicial Officer rules for FSIS, the establishment can seek judicial review in federal District Court. The FSIS requirement to provide procedural due process has been satisfied. In the meantime, the suspension remains in place.

If the establishment acknowledges the underlying noncompliance, due process does not apply. The establishment must demonstrate to the satisfaction of FSIS that it corrected the noncompliance. FSIS can require the establishment to implement corrective actions that exceed the applicable regulatory requirements. If the establishment objects, then the establishment can appeal per 9 CFR 500. In the meantime, the enforcement action remains in place.

Epilogue

The FSIS enforcement action procedures are administrative, not regulatory. Legal tenets such as presumption of innocence and standards of proof do not apply. 

If the establishment petitions for a redress of grievances, FSIS can make the administrative process onerous and economically disenfranchise the establishment, unless the establishment submits to its will. The FSIS administrative state effectively functions as judge, jury, and executioner. This administrative power is equally functional as a resource management tool. The more establishments driven out of the system, the fewer establishments consuming inspection resources: a definite benefit to a federal agency struggling with insufficient manpower to conduct its required mission.

FSIS offers a free choice in which only one choice is offered (i.e., do it my way) because the alternative (i.e., bankruptcy) is highly undesirable. The FSIS bureaucracy does not obstruct the pathway to due process; however, it does put in place a detour of such magnitude that few establishments have sufficient political clout or pockets deep enough to navigate the detour. Those who choose to travel the detour (i.e., Supreme Beef Processors) risk finding themselves a party to bankruptcy. Such is the administrative power of FSIS. 

(To sign up for a free subscription to Food Safety News,click here)