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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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. 


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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Pondering the news from this week’s food safety beat, I found myself perplexed, paranoid and peeved. A terrifying trio of unrelated stories was begging for a beach beating. I was passionate enough to think I would not need to court the muse. Three hours later, nothing worth reading had crossed my keyboard. beach-beatThe “Pathogens’ Field of Dreams” concept was the first to be pitched in the general direction of the trashcan icon. When I got to “Triple Crown of Pathogens” and “Trifecta of Infections,” I started to panic. Enter my new favorite muse, Rod Serling. From 1970 to 1973, Serling — widely known for his work with “Twilight Zone” — provided the narration and no small part of the content for a weekly television series, “Night Gallery.” His weekly intro about a trio of unrelated pieces of art is the perfect start to this week’s triple threat from the world of food safety:

“Good evening and welcome to a private showing of three paintings, displayed here for the first time. Each is a collector’s item in its own way — not because of any special artistic quality, but because each captures on a canvas, suspended in time and space, a frozen moment of a nightmare.”

Here are three terrible tales from the food safety gallery this week. The perplexing problem of pathogens and state boundaries Once again, Organic Pastures Dairy Co., of Fresno, CA, was in the news, this week recalling unpasteurized, raw dairy products for the second time since May 9 because state inspectors found Salmonella contamination. The May 23 recall was the result of follow-up testing the state was conducting in response to finding Salmonella in the organic dairy’s milk earlier in the month. State officials say the 500-cow dairy, operated by founder and CEO Mark McAfee, will be subject to increased inspections and testing for an unspecified period. logo-Organic-Pastures-Dairy-CoMcAfee says if his dairy was in Pennsylvania, his milk would have been OK’d for sale. He contends the testing method used by California is too sensitive. He prefers a Dupont BAX brand test kit, which he says is adequate under Pennsylvania law. “This is an issue regarding conflicts in testing methodology. The state (California) uses BAM ‘Moore Swab’ and our private state-approved third-party lab uses PCR-BAX,” McAfee said. “Our BAX PCR tests are negative and the state returns mostly negative and some positive tests. This level of bacteria is at the far bottom reaches of the detection limits. “If (Organic Pastures Dairy Co.) was under Pennsylvania state law, we would not be under recall. In Penn State, PCR BAX is one of the approved methods for detection of salmonella.” Here’s the perplexing part. Leaving aside the arguments about the safety of consuming unpasteurized raw dairy products and leaving aside the scientific attributes of various testing methods, there is a major problem with this picture. Does anyone really believe pathogens are aware of state boundaries? States’ rights are crucial to our democratic republic, but seriously, shouldn’t there be one set of rules for things like foodborne pathogen testing? Consumers should be able to buy food in any state knowing that the same standards — and methods of checking and enforcing those standards — are uniform. Just because you’re paranoid, it doesn’t mean the sky isn’t falling CDC-graphic-antibiotic-resistanceHundreds of news stories — from legitimate news outlets, not just fear mongers and mommy bloggers — have been published since the U.S. Department of Health and Human Services (HHS) reported this week that health officials had confirmed the first case of a person infected with a super-resistant form of E. coli. Everyone in public health had been anticipating the finding since November 2015 when Chinese officials announced they had confirmed human as well as swine cases of colistin-resistant mcr-1 E. coli in their country. In fact, HHS and U.S. Department of Agriculture have been looking for the specific pathogen since the news in China broke. Efforts are detailed in the HHS report “Proactive Efforts by U.S. Federal Agencies Enable Early Detection of New Antibiotic Resistance.” USDA found the so-called superbug in the intestine of a domestic pig, proving that it is already present in both the human and animal food populations in the U.S. It has also been confirmed in Europe, Canada and other parts of Asia. Antibiotic-resistant bacteria have been an increasingly significant problem for decades, but this one is different, according to the head of the U.S. Centers for Disease Control and Prevention (CDC). “It basically shows us that the end of the road isn’t very far away for antibiotics — that we may be in a situation where we have patients in our intensive care units, or patients getting urinary-tract infections for which we do not have antibiotics,” CDC Director Tom Frieden told the Washington Post. Investigators are trying to determine how the Pennsylvania woman was exposed to the bug, which is proving difficult, especially since she had not traveled in recent months. The possibility of foodborne transmission routes have not been ruled out. FDA apparently missed the memo about the internet While the federal government jumped on the colistin-resistant mcr-1 E. coli situation quickly, it has not been so nimble when it comes to thinking outside the brick-and-mortar box regarding food recalls involving online retailers. I was shocked and disappointed this week when I checked in with the people at the U.S. Food and Drug Administration to learn that the agency does not have any procedures or notification requirements in place regarding online retailers and food recalls. When I queried the agency, I fully expected to be directed to a link where I could find a rundown of who is supposed to do what to make sure that online retailers pull recalled food from their distribution centers. I also expected that some kind of consumer notification guidance — if not a full-blown rule — would have been developed in the more than 20 years since consumers started buying food online.

Garden of Life provided the label sample on the left to the FDA for posting with its recall notice. As the outbreak linked via DNA to its "Organic Raw Meal" powders spread across the country, the company redesigned its labels and changed the word order in the product name to "Raw Organic Meal" as shown on the right.
Garden of Life provided the label sample on the left to FDA for posting with its recall notice. As the outbreak linked via DNA to its “Organic Raw Meal” powders spread across the country, the company redesigned its labels and changed the word order in the product name to “Raw Organic Meal” as shown on the right.
Ha. Why didn’t I know the round of Q&A would end with the consumer side of me peeved? The whole question came up when public health officials in Wisconsin confirmed a new case of Salmonella Vichrow infection in an outbreak that CDC had declared ended on April 21. The new Wisconsin case and another 33 spread across 23 states were linked via DNA tests to Garden of Life brand Raw Meal supplement shake powders. “The product, an organic shake and meal replacement, was recalled earlier this year by the company, but consumers have acquired recalled product from internet retailers such as eBay and Amazon,” according to the Wisconsin Department of Agriculture, Trade and Consumer Protection. “Consumers should not consume this product if it is from the lot codes listed in the previous recall announcements found on the FDA recall website. Contaminated product may still be for sale from eBay, Amazon and other internet retailers.” Wisconsin officials are to be commended for their diligence. FDA, not so much. Not only has the agency not updated its web posting on the outbreak since April 22, it apparently didn’t even have the topic of recall procedures for online retailers on its radar screen until this week. “In light of this recent case, we are considering other ways to reach retailers and consumers to make sure they are aware of the recall,” was FDA’s response. “In determining whether a recall is sufficient, FDA does not have different standards for products sold online versus through traditional ‘brick and mortar’ retailers, though we recognize that the steps needed to ensure that product has been accounted for may differ. We are still working with Garden of Life to determine the effectiveness of their recall.” Apparently the agency didn’t get the memo about that information superhighway thingy. I hear tell the whole thing’s electronic. (To sign up for a free subscription to Food Safety News, click here.)