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FSIS and fixing the problem

Food Safety News 2022-12-02
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Tag: FSIS

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

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, wher 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 wher 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.

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