By Michael Fisher

The FSN article “25 years later FSIS final rule on pathogen reduction still making a difference,” tells a story through rose-colored glasses. Like Paul Wolseley of the FSIS Office of Field Operations, I too saw the implementation of the Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule (PR/HACCP) first-hand. I saw a different 25 years.

The PR/HACCP final rule was FSIS’ response to the January 1993 foodborne outbreak linked to E. coli O157:H7 contaminated beef patties at 73 Jack in the Box restaurants, that injured 602, permanently injured 178, and killed four. Most victims were under 10 years old. The response was neither timely nor original.

Not timely because this was not FSIS’ first encounter with E. coli O157:H7 contaminated beef patties. A 1982 foodborne E. coli O157:H7 outbreak linked to contaminated beef patties at McDonald’s restaurants injured at least 47 people. FSIS was aware of the incident. No children died. The story did not make national news. The problem was conveniently ignored.

Not original because, in 1985, the Committee on the Scientific Basis of the Nation’s Meat and Poultry Inspection Program (the Committee) advised FSIS to implement the HACCP. FSIS ignored the advice and pursued inspection systems that required fewer inspectors. In 1987, FSIS proposed a “discretionary inspection” system in which the frequency and the manner of government inspection were based on considerations relevant to effective regulation of product. FSIS withdrew the proposal after receiving over 1,800 negative comments. In 1988: FSIS proposed a new post-mortem inspection system for cattle: Streamlined Inspection System/Partial Quality Control-Cattle (SIS/PQC- Cattle). The National Academies of Sciences Engineering and Medicine recommended fundamental changes necessary to “protect the public from health risks” before FSIS proceed with plans to implement SIS/PQC- Cattle. FSIS never published a final rule.

“Jack in the Box” was the FSIS equivalent of Sept. 11, 2001. “If it bleeds it leads,” as news people say, and there was blood in the water. Public criticism of FSIS was everywhere. The emotional distress — shock, disbelief, fear — within FSIS was palpable. The FSIS corporate psyche has yet to fully recover. Testifying before Congress, then Secretary of Agriculture Mike Espy threw FSIS under the bus, when he described the FSIS inspection system as “no longer adequate; . . . no longer good enough.” The secretary promised reform and FSIS had to deliver something. Public shame, not public health, drove FSIS to HACCP.

After 10 years of pursuing other options, FSIS published the PR/HACCP proposed rule. Behind the proposed rule was the comforting reality. If it failed, as “discretionary inspection” and SIS/PQC- Cattle had failed, it was not FSIS’ idea. FSIS had taken the committee’s expert advice. The PR/HACCP final rule followed 18 months later. What FSIS delivered is strategically flawed and operationally inadequate. 

Strategically flawed because PR/HACCP is built on a false premise. To distance itself from its public image as a “scratch and sniff” inspection service, FSIS declared itself a public health agency that prevents human illness by eliminating pathogens from meat and poultry. The Federal Meat Inspection and Poultry Products Inspection Acts are not public health legislation. FSIS is an inspection service. FSIS is not a public health agency. Congress charges the secretary with preventing the sale, transport, offer for sale or transport, or receipt for transport, in commerce, of adulterated and misbranded meat and poultry. Congress does not charge the secretary with preventing human illness. For 25 years, FSIS has pursued an inspection policy built on a false premise.

Operationally inadequate because achieving this “food safety” mission requires pathogen reduction. The regulatory authority for pathogen reduction was the Pathogen Reduction Performance Standard [9 CFR 310.12(b) and 9 CFR 381.94(b)] promulgated in the PR/HACCP final rule. In 2001, a Federal District Court struck down the Pathogen Reduction Performance Standard, holding that the regulations fell outside of the statutory rulemaking authority granted to the secretary. The court effectively eliminated FSIS’ regulatory authority for pathogen reduction. For 20 years, FSIS has pursued a pathogen reduction with no pathogen reduction authority. The result is an enforcement policy that coerces industry to accept and implement policies that FSIS wants, but lacks the regulatory authority to require.

The article “25 years later FSIS final rule on pathogen reduction still making a difference” is long on possibilities but short on results. 

Yes, the PR/HACCP rule was a significant regulatory change for both FSIS and industry, but having lost its pathogen reduction authority, the rule has no teeth.

Yes, the PR/HACCP rule was designed to reduce the occurrence and numbers of pathogenic microorganisms and reduce the incidence of foodborne illness associated with the consumption of meat and poultry products, but there is no evidence of actual reductions in pathogenic microorganisms and the incidence of foodborne illness.

Yes, the business of regulating meat, poultry, and egg products “is an ever-evolving process,” but FSIS has not evolved. True, FSIS has integrated technology to make implementation of inspection more efficient, but the inspection procedures currently in place are basically unchanged since 1906. In the meantime, FSIS ignores petitions for rulemaking to address recognized problems with the system.

I see a difference after 25 years, but not a positive difference. I see a federal agency chasing a public health mission it cannot achieve because it lacks the necessary statutory or regulatory authority. I see an inspection force that no longer has a working knowledge of how the industry they regulate truly works and how the regulations they enforce actually apply. I see the pre-HACCP command and control of the inspector with a U.S. Retain Tag replaced by the post-HACCP command and control of the district office with a Notice of Intended Enforcement. I see a federal agency with no vision, so afraid to make a mistake, that it avoids making any decisions at all.

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