In the previous three articles, I described what I consider the underlying causes of the devolution of FSIS as an organization. Any fool can criticize. I am not a fool. Here is what I would do to address my criticisms if I were the FSIS Administrator. You may call me naïve; but, where there is a will, there is a way. The impossible just takes a little longer. 

Mission

I consider the 1993 decision by FSIS to declare itself a public health agency with a mission to “prevent foodborne illness and protect public health” as the most significant strategic error in the history of federal meat inspection. FSIS is neither a public health agency nor is its mission to “prevent foodborne illness and protect public health.” For thirty years, FSIS has traveled the wrong path, pursuing a goal it cannot achieve, while ignoring it actual mission.

The FSIS mission includes much more than just assuring that adulterated and/or misbranded meat, poultry, or egg products are not distributed in commerce. It includes implementing the provisions of all the statutes listed in 7 CFR 2.53, and more. Every aspect of FSIS must be reoriented to support the total FSIS mission. The first step in reorienting FSIS is completion of an “ends, ways, and means” analysis of the total FSIS mission. Think of it like a hazard analysis for the entire FSIS process. Ends explain “what” is to be accomplished. Ways explain “how” ends are to be accomplished. Means are resources used to apply ways to accomplish ends.

The analysis begins with an “ends, ways, and means” statement that captures in a single statement the sum of all FSIS ends, ways, and means. This global statement is repeatedly subdivided until every end pursued by every staff in every program area is identified; the way by which each end is accomplished is described; and the means necessary to apply the way to accomplish the end is identified.

Peter Drucker famously said, “If you can’t measure it, you can’t manage it.” FSIS counts many things, but measures nothing, particularly foodborne illness attributable to meat, poultry, and egg products. Only after you identify the required FSIS ends, ways, and means can you apply quantifiable values to them. Only after you quantify the FSIS ends, ways, and means can you determine if they are in balance. Experience tells me that the FSIS ends, ways, and means will be out of balance.

Institutional Culture

I consider the FSIS institutional culture counterproductive. FSIS is an inspection service, a service provider, not a prosecutor. The official establishment is the only recipient of inspection services and the only FSIS customer. FSIS cannot effectively service a customer that FSIS views as a “bad actor” requiring a self-appointed prosecutor. 

In 1996, FSIS told industry that “command and control” was dead. FSIS failed to deliver. The FSIS, OFO monopoly on decisions concerning inspection, noncompliance, enforcement, and industry appeals is evidence of that failure. To deliver on that commitment, I would break up the FSIS, OFO monopoly.

• OPPD would be the policy arm of FSIS, solely responsible for inspection, noncompliance, enforcement, and appeals policy. Policy applicable to FSIS employees would be documented in directives or notices and limited to instructions on who acts, what action is taken, when action is taken, and how action is taken. Policy applicable to the regulated industry will be documented in the Federal Register, subject to public comment, and limited to determinations of how regulatory performance standards apply under defined conditions.
• OFO would be the inspection arm of FSIS, solely responsible for performing inspection at official establishments and in-commerce facilities. OFO would implement inspection policy, not interpret inspection policy. OFO Inspection Program Personnel (IPP) would perform inspection tasks and document results. OFO IPP could recommend enforcement action. OFO IPP could not take enforcement action.
• OIEA would be the enforcement arm of FSIS, solely responsible for any enforcement action taken under 9 CFR 500 and proceedings pursuant to the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H. If OFO recommends enforcement action, OIEA must agree, and then OIEA takes over management and resolution of the enforcement action, to include appeals, with the official establishment.
• OEED would be the training arm and knowledge base of FSIS, solely responsible for ensuring the IPP have the knowledge needed to correctly interpret inspection results. OIEA would manage appeals, but OEED would decide, once and for all, if an appeal is granted or denied. If an appeal is denied, the establishment may appeal to the National Appeals Division (NAD), an independent office reporting directly to the Secretary. The sole mission of NAD is to conduct impartial administrative appeals hearings of adverse program decisions by the USDA agencies.
• OPHS would be the science and technology arm of FSIS, solely responsible for any science- or technology-based decisions. OPHS would make the science-based decisions on what inspection tasks OFO performs, when and where OFO performs the inspection tasks, and why.

Industry success in achieving regulatory compliance is a measure of FSIS mission success. FSIS must not tell industry how to comply, but that does not stop FSIS from making every effort to ensure that official establishment owners understand what compliance looks like within their official establishment. To that end, I would restructure askFSIS into a platform, staffed by OPPD, OFO, OIEA, OEED, and OPHS personnel, with the sole raison d’être of ensuring that official establishment owners and FSIS, OFO IPP understand what compliance looks like within their official establishment or duty assignment. To facilitate that effort, I would cause a complete revision of 9 CFR Chapter III. The existing body of regulations is a redundant, often conflicting, hodgepodge of changes made over the last one hundred and fifteen plus years.

Parsing out responsibility for inspection, noncompliance, enforcement, and appeals among multiple program areas may appear counterproductive. Not really. The existing OFO monopoly fosters “command and control” and undermines accountability. Breaking up the OFO monopoly undermines “command and control” and fosters accountability. When multiple program areas share responsibility, no one program area can exercise “command and control.” If multiple program areas must cooperate, the system is self-correcting and inspection results improve over time. If one program area fails to meet its obligation, the other program areas suffer, which should incentivize FSIS senior executives to self-police their program area.

Institutional Personality

I consider the FSIS practice of hiding behind its bureaucratic walls and the FSIS practice of “management by avoidance” counterproductive. To address that problem, I would take down bureaucratic walls. I would make every regulatory, administrative, and managerial document, record, or piece of information that can legitimately be obtained from FSIS under the Freedom of Information Act automatically available via the FSIS website; no written request required. Sunshine is good for the soul. 

Borrowing from Michael Crichton, “The Japanese have a saying: ‘Fix the problem, not the blame.’ Find out what’s [screwed] up and fix it. Nobody gets blamed. Their way is better.” My goal is not to assign blame. My goal is to find and fix a problem. No one is perfect. I make mistakes. I expect and accept that other people make mistakes too.

Epilogue

FSIS is a huge federal bureaucracy; a self-governing empire built on an untruth, pursuing a self-determined mission it cannot achieve. It is constitutionally off-track, operationally lost, and tactically dysfunctional. It is broken and in need of repair. FSIS is an inspection service, not a public health agency. The intended outcome of providing inspection service is that adulterated and/or misbranded meat, poultry, or egg products are not distributed in commerce; not that foodborne illness is prevented. Meat, poultry, and egg products that are not adulterated and/or not misbranded are safe and do not cause foodborne illness. 

Federal inspection is a public service. FSIS organizational culture and personality do not serve the public interest. FSIS practices “management by avoidance.” FSIS neither admits nor corrects mistakes. FSIS fails to adapt to its ever-changing operational environment. FSIS pursues a mission it cannot accomplish and fails to accomplish its most basic constitutional responsibility; “promote the general Welfare” by assuring the adulterated/misbranded product is not distributed in commerce. FSIS is in need for reform.

After observing FSIS from the inside for thirty years, and from the outside for eight years, I have no reason to believe that FSIS will reform itself. Government reform requires public tragedy. It is only a matter of time until another “Jack in the Box” tragedy occurs. When that happens, I hope the public responds with the same energy seen in response to recent social disturbances and demand reform of the federal agency responsible for providing meat, poultry, egg products inspection service.

If you would like to read Dr. Fisher’s entire series, please use the following links.

Part 1

Part 2

Part 3

Part 4

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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. 

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Editor’s note: This is Part 2 of a 4-part series.

Between 1906 and 1992, FSIS and its predecessors attracted minimal public attention as they quietly pursued their assigned mission: assure that adulterated and/or misbranded meat, poultry, or egg products are not distributed in commerce. Then in January 1993, improperly prepared raw ground beef patties at “Jack in the Box” restaurants resulted in the deaths of several small children. The primary problem was foodservice, not inspection. Had “Jack in the Box” properly handled and prepared the product, the offending bacteria, Escherichia coli O157:H7, would have been destroyed. 

That became irrelevant when Secretary of Agriculture Mike Espy threw FSIS under the bus by describing the existing federal meat inspection system as “no longer adequate; . . . no longer good enough.” The 1906 BAI decision to subordinate federal meat inspection to the BAI mission priority; animal disease control, rather than microbial causes of adulteration had recoiled unfavorably upon FSIS.

Overnight, FSIS became front page, prime-time news. To distance itself from its identification with a failed “inspection system,” FSIS management declared FSIS a public health agency with a mission to “prevent foodborne illness and protect public health.” The decision may have been politically expedient, but it was the most significant strategic error in the history of federal meat inspection. 

A Fundamental Truth

Federal meat inspection is part of the vast legal system which is the American government, and the U. S. Constitution delineates what government can and cannot do. The Constitution grants Congress the power to “regulate commerce . . . among the several States.” The Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act, (PPIA), and Egg Products Inspection Act (EPIA) regulate meat, poultry, and egg products commerce by tasking the Secretary of Agriculture (i.e., Secretary) with inspecting meat, poultry, and egg products for the purpose of assuring that adulterated and/or misbranded meat, poultry, or egg products are not distributed in commerce. The Secretary delegates this task to the FSIS Administrator.

FSIS is neither a public health agency nor has a mission to “prevent foodborne illness and protect public health.” If FSIS were a “public health agency,” then FSIS would be an agency in the Department of Health and Human Services, not the USDA. The Constitution reserves any power not granted to the federal government, and not prohibited to the States, “to the States.” The Constitution neither grants to the federal government, nor prohibits to the States, the power to regulate “foodborne illness and public health.” Foodborne illness and public health are human conditions that take place within the individual States, not “commerce … among the several States.” The Constitution reserves the power to regulate “foodborne illness and public health” to the States, not the federal government. This fact played out clearly in the Nation’s response to the COVID-19 pandemic, as State governments, not federal agencies, regulated the response.

By Act of Congress, the FSIS mission is to assure that adulterated and/or misbranded meat, poultry, or egg products are not distributed in commerce. Meat, poultry, and egg products that are not adulterated and/or not misbranded are safe and do not cause foodborne illness. The simple fact that the absence of foodborne illness is an indirect effect of the FSIS mission does not justify FSIS’ claim that it is a public health agency preventing foodborne illness and protecting public health.

It is a point of law and a fundamental truth that the Constitution does not grant Congress the power to enact legislation tasking the Secretary with regulating “foodborne illness and public health.” The Secretary cannot delegate to the FSIS Administrator powers the Congress cannot assign to the Secretary. FSIS is not a public health agency. The FSIS mission is not “prevent foodborne illness and protect public health.” FSIS fails to operate in accordance with the rule of law.

A Renaissance?

The “Jack in the Box” incident forced FSIS to change. The “old guard” that had ruled over an animal disease-oriented, veterinarian-dominated inspection service for nine decades was ushered from the stage. A new generation of FSIS employees came to the forefront. In 1996, change came in the form of the Pathogen Reduction; Hazard Analysis and Critical Control Point (PR/HACCP) Systems: Final Rule. Twenty-five years later, FSIS describes the PR/HACCP final rule as still making a difference. I would disagree. The PR/HACCP final rule was a step in the right direction, but it failed in two important ways.

First, it promised to reduce human illness through pathogen reduction, with Salmonella being the pathogen of choice. The FSIS logic was simple. Salmonella causes human illness. Reducing Salmonella in meat, poultry, and egg products would reduce meat, poultry and egg related human illness. The cornerstone of the FSIS pathogen reduction strategy was the 9 CFR 310.25(b) and 9 CFR 381.94(b) Salmonella Performance Standards. Failure to meet the regulatory Salmonella Performance Standard defined product as adulterated and allowed FSIS to suspend inspection. The regulatory Salmonella Performance Standards went live on January 26, 1998. In May 2000, a federal district court struck down the regulatory Salmonella Performance Standard as unconstitutional [Supreme Beef Processors, Inc. v. USDA]. The regulatory Salmonella Performance Standard over-reached FSIS statutory authority. FSIS no longer had a pathogen reduction strategy.

FSIS had predicated success on pathogen (i.e., Salmonella) reduction. The loss of its regulatory Salmonella Performance Standard denied FSIS its regulatory mechanism for success. Not one to let a good court ruling stand in the way of a bad decision, FSIS doubled down and implemented its unconstitutional regulatory Salmonella Performance Standard as an FSIS policy standard. FSIS would test product for Salmonella and interpret a positive test result as a “license to hunt” for yet to be identified regulatory noncompliance. 

FSIS also posted the policy-based Salmonella test results in a public forum. If FSIS could not, by regulation, force industry to reduce Salmonella on raw product, then FSIS would publicly shame industry into pursuing a course of action that FSIS lacked regulatory authority to impose by insinuating that product testing positive for Salmonella was unsafe. FSIS ignored the fact that most Salmonella are not pathogens. The strategy worked wonderfully. Industry, fearing economic loss, reduced Salmonella on raw meat and poultry. Once industry achieved the FSIS policy-based standard, FSIS lost its leverage. Not a problem. FSIS simply lowered the FSIS policy standard so that industry no longer met the standard. FSIS then resumed public shaming. FSIS will never allow industry to escape this vicious circle. To do so would be to lose power over industry. This practice may be immoral, but it is not illegal. It allows FSIS to pursue policy goals that exceed its statutory reach.

Second, the PR/HACCP final rule promised an end to institutionalized “command and control” and “greater reliance on performance standards” that afforded establishments “greater autonomy in decision-making affecting their own operations.” The promise could not overcome 87 years of bureaucratic inertia. The institutional culture and personality of federal meat inspection remain unchanged with one exception. FSIS replaced the active “command and control” of the Inspector-in-Charge with the passive aggressive “command and control” of the District Manager. 

Epilogue

That FSIS declares itself a public health agency with a mission to “prevent foodborne illness and protect public health” may play well with the public, but that does not make it true. It is a point of law and a fundamental truth that FSIS is neither a public health agency nor has a mission to “prevent foodborne illness and protect public health.” The FMIA, PPIA, and EPIA task FSIS with assuring that adulterated and/or misbranded meat, poultry, or egg products are not distributed in commerce. For FSIS to claim otherwise thwarts the will of Congress and the rule of law. 

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I had two simultaneous careers: the U.S. Army Reserve and the USDA’s Food Safety and Inspection Service (FSIS). I graduated from the U.S. Army War College (USAWC) with a masters degree in Strategic Studies. I earned a bachelors of science, Doctor of Veterinary Medicine, and masters in Veterinary Pathology with a minor in Meat Science. I participated in strategic planning on two general staffs. I was an Inspector-in-Charge in slaughter and processing establishments in the pre-HACCP era, a member of the team that implemented the Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems final rule (PR/HACCP rule), and a participant in the inspection policy initiatives that followed. I understand how bureaucracies work and the difference between what FSIS has the authority to require and what FSIS wants but lacks the authority to require.

In 2014, Food Safety News published my “Reflections on 30 Years as a USDA Veterinarian” where I shared my thoughts on FSIS culture and inspection initiatives. I did not intend to pursue regulatory-related work following retirement from FSIS. Then fate stepped in. A very small official establishment solicited my assistance, exposing me to the raw, unfettered administrative power of the FSIS bureaucracy in a way that working for FSIS never did. 

The FSIS bureaucracy abuses its administrative power in pursuit of what it wants but lacks the authority to require. I have assisted small and very small establishments push back against this administrative abuse. I have seen establishment owners stand their ground and succeed. I have seen them appease FSIS and suffer unnecessary economic hardship. I have seen them give up in frustration and close their doors. 

The USAWC teaches that strategic planning is how an organization adapts to its operational environment to achieve its mission. For what it’s worth, I’d like to share my thoughts on how federal meat inspection has failed to adapt to its operational environment, resulting in a federal agency that abuses its administrative power in pursuit of a mission it cannot achieve. 

The FSIS Mission
American government is a vast legal system. Everything flows from the U. S. Constitution, which defines the fundamental mission of government: “to form a more perfect Union, establish Justice, ensure domestic Tranquility, provide for the common defense, promote the general Welfare, and secure the Blessings of Liberty to ourselves and our Posterity.” Promoting the general welfare means seeking ways to solve social and economic problems.

It is the finding of Congress [21 USC §§ 451, 602, 1031] that adulterated and/or misbranded meat, poultry, and egg products in interstate commerce injure the general welfare by destroying markets, an economic problem. To address the economic problem, Congress passed the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA). The FMIA, PPIA, and EPIA task the Secretary of Agriculture (i.e., Secretary) with assuring that meat, poultry, and egg products distributed in commerce are not adulterated (i.e., wholesome) and not misbranded (i.e., properly marked, labeled, and packaged). The FMIA, PPIA, and EPIA assign specific functions to the Secretary, which the Secretary delegates, through the Under Secretary for Food Safety [7 CFR 2.18], to the FSIS Administrator [7 CFR 2.53]. 

The FMIA, PPIA, and EPIA task FSIS with assuring that adulterated and/or misbranded meat, poultry, or egg products are not distributed in commerce, but implementing the FMIA, PPIA, and EPIA is only part of the total FSIS mission. 7 CFR 2.53 is just a partial list of other legislation that drives the total FSIS mission. 

Institutional Culture Matters
The FSIS institutional culture is counterproductive. Domestic federal meat inspection came into its own following legislative reform [34 Stat 674] to address economic abuses by meat packers. Industry had behaved badly. The Secretary tasked the Bureau of Animal Industry (BAI) with implementing federal meat inspection. The BAI responded like a prosecutor (i.e., justice system) empowered to protect a victim (i.e., consumers) by punishing the criminal (i.e., industry). An institutional culture was established: the federal inspector is righteous; industry is immoral; coercion is required and justified to control industry. That same institutional culture exists today in FSIS.

The FMIA, PPIA, and EPIA do not authorize the Secretary to prosecute and punish industry. They do not empower the Secretary to determine how industry operates. The FMIA, PPIA, and EPIA task the Secretary with causing an inspection of products prepared for commerce and empower the Secretary to remove inspectors from any establishment that fails to destroy product marked ‘‘Inspected and condemned;’’ withhold use of marking or labeling that is false or misleading; and refuse to mark products ‘‘inspected and passed’’ if sanitary conditions are such that products are rendered adulterated. They empower the Secretary to use regulatory techniques (i.e., withholding inspection service or the mark of inspection) to achieve regulatory compliance. Withholding inspection service or the mark of inspection is intended to motivate compliance by depriving industry of access to a marketplace, not deprive industry of the ability to operate. That said, FSIS administrative abuse of regulatory techniques can feel like prosecution and punishment by the criminal justice system.

I cannot say why, in 1906, the BAI believed a heavy-handed approach necessary, but it is now 2022. The operational environment changed. Household consumers are informed and demand quality. Commercial consumers (e.g., McDonalds, Walmart) impose purchase standards exceeding federal standards. The economic calculus changed. Producers of lesser quality foods lose market share and go out of business. Economic realities, not federal oversight, motivate companies to produce not adulterated/not misbranded products. The “prosecutor-criminal” mentality of the past is not conducive to an efficient, effective federal inspection.

Institutional Personality Matters
Between 1906 and 1981, annual reports from USDA bureau/division chiefs repeatedly describe insufficient manpower as a primary challenge to the conduct of inspection. In 1907, the BAI reported needing “more than double” the existing number of employees to conduct federal inspection. The problem continues to exist. These annual reports do not describe operational shortfalls due to insufficient manpower, but they must have occurred. It is unlikely that the BAI could triple its workforce in one year, or that bureau/division chiefs would acknowledge, in public documents, mission shortfalls linked to the lack of inspection personnel.

Between 1906 and 1981, the federal inspection mission passed amongst 10 different parent agencies. Within each parent agency, federal inspection was subordinated to the parent agency’s existing mission and implemented by a bureau/division with no management control over inspection resources. The BAI subordinated federal meat inspection to its mission to promote livestock disease research, enforce animal import regulations, and regulate the interstate movement of animals. The effect is still evident in the emphasis on animal disease in 9 CFR 309 and 9 CFR 311.

In my opinion, herein lies the origin of the institutional personality and the practice of “management by avoidance” within federal inspection services. It is human nature to avoid blame if possible. Bureau/division chiefs of under-resourced federal programs that get passed around the USDA like an unwanted Christmas gift do not become confident, assertive, and transparent. They become insular, insecure, and non-transparent. They avoid making decisions. They hide behind their bureaucratic walls and administrative practices. They do whatever they must to avoid exposing their mission shortcomings. They don’t “make waves.”

In 1981, for the first time, federal meat and poultry inspection became the primary mission of a single agency: FSIS. FSIS inherited an insular, insecure, non-transparent bureaucracy that ignores internal problems and practices management by avoidance. The FSIS bureaucracy dislikes change or outsiders. Most FSIS Administrators come to the job from within FSIS. Texas A&M University professor H. Russell Cross and director of the Wyoming Department of Health Garry McKee came to the position of FSIS Administrator as outside reformers. Cross resigned after 24 months, McKee after 19 months. Historically, FSIS has promoted from within with predictable results. FSIS increasingly lacks the advanced skill sets and outside knowledge to regulate a highly dynamic and diverse industry. FSIS continues to struggle to attract and keep high-functioning employees.

The FSIS bureaucracy neither admits nor corrects mistakes. Just read the “Legg’s Regs” exposé in the Montana Standard and the FSIS response to a congressional request that the USDA Inspector General investigate alleged misconduct within FSIS. FSIS does not like to be questioned. Try getting a straight answer from asking FSIS a simple question. As an FSIS staff officer, I was instructed to not answer questions from industry. FSIS does not welcome criticism. Just read an FSIS response to a GAO audit.

Epilogue
Organizational culture and personality can positively or negatively impact an organization’s ability to accomplish its mission. FSIS culture and personality are incompatible with the FSIS strategic mission: promote the general welfare by preventing adulterated/misbranded product in commerce. Federal inspection is a public service, not a justice system. Yes, industry must be held to regulatory performance standards, but industry in toto is not a bad actor that requires a prosecutor. Such an approach hinders, not promotes, American agriculture. An organization that practices management by avoidance, that is closed to outside input, that hides internal failures, and ignores it critics, is incapable of addressing change in a highly dynamic and diverse operating environment. FSIS is such an organization. 

FSIS faces significant challenges from within and without. A counterproductive organizational culture and personality is a challenge from within. FSIS has done nothing to address its internal institutional shortfalls. FSIS views the direct recipient of its inspection services as a “bad actor.” FSIS manages problems by avoiding problems. FSIS managers don’t “make waves.” Consequently, FSIS fails to adapt to its ever changing operational environment.

About the author: Dr. Michael Fisher is the son of Iowa swine producers He earned BS, DVM, and MS degrees from Iowa State University. He began his FSIS career in the Office of Field Operations and retired from the Office of Policy and Program Development. Dr. Fisher is also Col. Fisher, U.S. Army (Retired). He is a graduate of the Army Command and General Staff Colleges and Army War College, where he earned a second MS degree. His military assignments focused on food service sanitation, subsistence inspection, and animal care from company level to general staff. He is currently an Adjunct Professor with Johns Hopkins University.

• I give FSIS a B for its training programs. Moving the training center to Texas A&M, increasing the scholastic standards for training courses, and standardizing field training significantly improved training. The current training program is even better. New-hire veterinarians no longer arrive at their first assignment unprepared and alone. The absence of sustaining support from OPPD in Omaha prevents a higher grade. The previous Office of Field Operations (OFO), Technical Service Center (TSC) operation engaged in critical thinking and problem-solving in partnership with field employees. The current OPPD operation does not.  Solving problems is not their job.

• I give FSIS a D for data collection. FSIS does not collect data with improvement in mind. The Public Health Information System and its predecessors, the Performance Based Inspection System and Inspection System Work Plan, are little more than scheduling tools. They document the quantity of work performed, but nothing about its quality or effect. FSIS abandoned its Public Health Human Resources System, another data-driven initiative, after managers failed to implement the system as designed and deliver the increased performance sought. Right now, FSIS struggles with the fact that its data-collection efforts cannot validate its strategic plan.

• I give FSIS an A for its residue program. When I joined FSIS, residue testing was a passive activity, in-plant testing nonexistent, SVMO-generated samples rare, and carcass condemnation rarer. Today, SVMOs proactively retain and test suspect carcasses. Carcass condemnation for a residue violation is common. No other FSIS program is as successful at finding and eliminating adulterated product. The credit belongs not to FSIS, but to Dr. S., an FSIS SVMO whose curiosity led him to prove that the existing residue program failed to identify residue violations in dairy cattle.

• I give FSIS a C for its humane slaughter program. When I joined FSIS, there was no District Veterinary Medical Specialist and humane slaughter was a non-issue. Today, humane slaughter is a front-page concern. Unfortunately, fear of unfavorable press, not the intent of Congress, drives the FSIS humane-handling agenda, which allows the animal-rights movement to co-opt FSIS. The best evidence of co-opting is the FSIS extra-legal attempt to create the perception of inhumane slaughter of poultry where it does not exist.

• I give FSIS a C for its pathogen-control programs. The 1993 E. coli O157:H7 outbreak was a kick in the pants for FSIS, and it responded commendably. FSIS declared the microorganism a “poisonous or deleterious substance.” It required safe-handling statements on raw meat products. It elevated standards for determinations that E. coli O157:H7 was not a food safety hazard reasonably likely to occur. It introduced product verification testing. The policies for Listeria monocytogenes in RTE products were a logical next step. FSIS deserves no commendation, however, for its Salmonella policies. In 1974, FSIS successfully argued in federal court that Salmonella does not adulterate raw poultry. In 2001, again in federal court, FSIS unsuccessfully argued that Salmonella does adulterate raw meat. No one wants Salmonella on raw meat and poultry products. However, attempting to regulate Salmonella as a food safety hazard is as fruitless as pounding square pegs in round holes. Even worse, expending resources to perpetuate the public perception of a regulatory Salmonella performance standard – which does not exist – is bad stewardship of appropriated funds.

• I give FSIS a C for its implementation of Hazard Analysis and Critical Control Point (HACCP). The sanitation and HACCP regulations in 9 CFR 416 and 417 are the most significant change to meat and poultry inspection since the Wholesome Meat and Poultry Products Acts. FSIS called HACCP a “paradigm shift” in the FSIS approach to inspection and declared “command and control’ dead. The battle cry from the OFO, TSC, which implemented HACCP, was “let the system work.” It was an exciting time, a potential renaissance. FSIS made progress and credit is due, but the paradigm did not shift. Command and control did not die. FSIS simply replaced the strong-arm dictatorship of the Inspector in Charge with the bureaucratic tyranny of the policy-maker. Offering waivers to establishments that promise to do your bidding is subornation, not experimentation. Threatening public disclosure of opinions called Memorandums of Interview is intimidation, not enforcement.

Ask FSIS why it exists and you hear about Upton Sinclair’s novel, “The Jungle,” and how USDA inspectors protected the consumer from the meat-packing industry. That same 1905 command-and-control culture is alive and well in 2014. To abandon command and control, to allow the system to work, suggests that a policeman is no longer necessary. Perpetuating the perception of a “bad guy” serves FSIS interests, not public interests. I do not know when or where the culture of management by avoidance originated, but it, too, is alive and well. Fecal Soup, Jack in the Box, AgriProcessors and Hallmark are all evidence of avoidance to act until after third parties made public what FSIS previously ignored. A reliance on product verification testing evidences avoidance to apply its own inspection processes, the HACCP principles FSIS requires of industry. Managerial avoidance also exists. I have witnessed FSIS managers exclude employees from productive work because it is easier to avoid a dissenting opinion than to consider it. Beginning in May 2013, I watched FSIS pay a co-worker to stay home and do nothing because it is easier to hide management failures than admit them and easier to avoid individuals than deal with them. Her sole responsibility is to call in each morning and ask if the director has any work for her to do. To date, no work has been assigned. FSIS serves a useful public purpose, and I do not regret 30-plus years invested in that purpose. I will miss the people, but not the process. A lot changed in 30 years, but some important things did not.