FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses 

The following is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response,and Stic Harris, D.V.M. director of the FDA’s Coordinated Outbreak Response and Evaluation Network

The U.S. Food and Drug Administration has a longstanding commitment to strengthening food safety and better protecting consumers, as part of its public health agenda. Today, we are taking an important step to build on this commitment with the release of the Foodborne Outbreak Response Improvement Plan. This plan is designed to help the FDA and our partners enhance the speed, effectiveness, coordination and communication of foodborne outbreak investigations. We are confident that the actions outlined in this plan will in turn translate into activities focused on enhancing the prevention of outbreaks.

As part of our work implementing the FDA Food Safety Modernization Act (FSMA)and our New Era of Smarter Food Safety initiative, we have collaborated with experts in both the public and private sectors for input on additional ways to strengthen the agency’s outbreak response. Input from the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) and the Centers for Disease Control and Prevention (CDC), state health officials, industry and consumer foodborne outbreak experts, along with the input of FDA leadership and staff, was key to the development of our new improvement plan.

The agency also contracted with the University of Minnesota’s School of Public Health to assess the FDA’s capacity to support, join, or lead multistate outbreak investigations and to provide recommendations in an independent report, which we are also making public today. This report played an important role in the development of our new plan.

The Foodborne Outbreak Response Improvement Planfocuses on four specific priority areas in which improvements will have the most impact on outbreaks associated with human food.

  • Tech-enabled product traceback –Engaging smarter ways to digitize and routinely receive information needed to streamline the traceback process, which are the steps we use to pinpoint the source of contaminated foods during investigations. These tactics include obtaining more complete voluntarily provided consumer purchase data to better specify critical traceback information, facilitating and expediting how the FDA receives data, and employing more advanced analytical methods and computational approaches. We will work to harmonize our efforts with our federal, state, local and territorial counterparts, as well with industry and others involved in traceback investigations.
  • Root-cause investigations (RCIs) –Systematizing, expediting and sharing FDA RCIs. The plan focuses on adapting and strengthening protocols and procedures for conducting timely RCIs of foodborne illness outbreaks, standardizing criteria for producing FDA RCI reports, and expediting the release of investigation findings to industry and the public.
  • Strengthen analysis and dissemination of outbreak data –Working with the CDC, the USDA’s FSIS and other partners to identify reoccurring, emerging and persistent strains of pathogens. Specifically, we will facilitate improvements to sharing of data with the CDC as well as other regulatory partners to further increase transparency of outbreak investigations, increase public confidence in results, and facilitate improved collaboration on investigation activities.
  • Operational improvements –Building on performance measures across the FDA’s foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities. The FDA is committed to using performance and outcome measures to assess progress of this improvement plan by updating stakeholders, posting updates on FDA.gov and through a public webinar in early 2022 to discuss how regulatory partners, industry and others can work together to achieve these goals.

We know that the 21st century has brought new challenges in identifying, investigating and controlling outbreaks of foodborne disease, but it has also brought new tools to meet those challenges. We also recognize that today’s U.S.food system is large and decentralized, with a broad array of widely distributed products, which we must adapt to in order to help ensure the safety of these products.That is why we are taking steps through this improvement plan to evolve our outbreak investigations to meet modern-day needs using the most modern-day tools available. Our investigations must be faster, more streamlined and more effective to identify, pinpoint and remove contaminated food from the market and identify root-cause factors in the food system to prevent similar outbreaks in the future.

Our improvement plan sets out a clear pathway to achieving these important goals. We will continue to do everything we can to protect consumers from unsafe food. Adding the Outbreak Response Improvement Plan to our arsenal, which includes FSMA and the New Era of Smarter Food Safety, will ultimately prevent illnesses and save lives; and that is what this work is all about for us.

Additional Resources: 

Since early February 2020, I have continued to do talk on “why it is a bad idea to poison your customers,” but all have been by Zoom or some other video platform.  Today I had the honor to hang with one of my food safety heroes – Craig Wilson – from Costco.  I have known Craig from nearly 30 years.  His commitment to food safety is second to none.

“HACCP: A systematic approach to the identification, evaluation, and control of food safety hazards.”  – So says the FDA.

Although today’s announcement (FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce) is a bit to fully digest in one sitting, I am intrigued by FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for pathogens generally.  The FDA’s requirement of an annual water risk assessments by farms to “determine whether corrective or mitigation measures are reasonably necessary to reduce the potential for contamination,” arguably creates “HACCP for produce.”  That produce HACCP requires that produce growers take stock in what pathogen risks surround them on nearby lands, like cattle operations and/or wild animal populations that may impact water quality, and take measures to protect the produce consumer from possible infection from a deadly pathogen.

With respect to risky adjacent land operations, it is unclear at this point what a grower can do to mitigate those risks short of relocation or treatment and testing of water, however, this rule seems to remove certain water testing requirements.  One method of confirming if HACCP is working can be science-based  testing to help understand if mitigation measures are in fact working.

So, in my view the jury is still out on 1) will eliminating water testing and increasing assessments make for a safer product? and, 2) should there not be a recognition that produce is essentially a “ready-to-eat” product grown outside with the risks inherent by what is directly around it or what may blow or flow to it, and therefore a broader environmental approach will be required to assure produce safety?

I look forward to the comments and remaining engaged in the process.

Here is the FDA’s press release with links:

Today, the U.S. Food and Drug Administration issued a proposed rule that aims to enhance the safety of produce. It proposes to require farms to conduct comprehensive assessments that would help them identify and mitigate hazards in water used to grow produce. This is the latest step in the agency’s implementation of the FDA Food Safety Modernization Act (FSMA), and it proposes to replace some of the existing requirements for agricultural water in the Produce Safety Rule (PSR).

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms. As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

The proposed rule, if finalized, would change certain pre-harvest agricultural water requirements for produce and farms subject to the PSR, other than sprouts operations. Key provisions in the proposed rule include:

  • A requirement for farms to manage their agricultural water quality based on the results of a comprehensive systems assessment (“agricultural water assessment”) that is adaptable to the wide variety of water sources and uses and future scientific advancements.
  • An annual assessment by farms of their pre-harvest agricultural water to identify any conditions likely to introduce hazards into, or onto, covered produce or food contact surfaces. Based on these assessments, farms would then determine whether corrective or mitigation measures are reasonably necessary to reduce the potential for contamination. The assessment would include an evaluation of the farm’s water system, agricultural water use practices, crop characteristics, environmental conditions and other relevant factors, such as the results of any testing conducted to inform the assessment.
  • A requirement that farms implement expedited mitigation measures for hazards related to certain activities associated with adjacent and nearby lands, to protect the quality of the water used on produce. This is being included following several recent outbreak investigations on produce that revealed potential routes of contamination including activities and conditions, such as animal grazing and the presence of livestock and wildlife on land adjacent to, or near, produce farms or their water sources.
  •  The removal of certain testing requirements for pre-harvest agricultural water and replacing them with the agricultural water assessments identified above. The proposed revisions are intended to address stakeholder concerns about complexity and practical implementation challenges while protecting public health.

The FDA intends to continue working closely with stakeholders and our state and tribal partners to provide necessary training, technical assistance, education and outreach. The agency will hold two virtual public meetings to discuss the proposal and hear feedback, and more details will be announced in a forthcoming Federal Register notice. In addition, the agency is also developing an online tool to assist growers in understanding agricultural water assessments.

Recognizing that the current agricultural water compliance dates for covered produce other than sprouts under the PSR are set to begin in January 2022, the agency intends to exercise enforcement discretion for those agricultural water requirements while pursuing another proposed rule to extend the compliance dates for all of the agricultural water requirements in the PSR for such covered produce. More information on the proposed compliance date extension will be announced in a forthcoming Federal Register notice.

Today’s proposal is one of the critical remaining pieces of working towards FSMA implementation. The FDA has taken many important steps to achieve the food safety goals envisioned by Congress when FSMA was established in 2011, such as implementing seven foundational rules. The FDA also has developed multiple action plans to address specific food safety issues and has further built on the foundation under FSMA through the New Era of Smarter Food Safety initiative.

Related Information

Volume 28, Number 1—January 2022
Dispatch
Salmonella Serotypes Associated with Illnesses after Thanksgiving Holiday, United States, 1998–2018

Here is the CDC’s conclusion:

Salmonella Reading was the serotype most strongly associated with illness during the Thanksgiving holiday. Given the dramatic increase in turkey consumption around Thanksgiving, one might expect that serotypes we identified are primarily associated with turkey consumption, and indeed, Reading caused a multistate outbreak with a raw turkey source during 2017–2019, and a new clone of this serotype has emerged since 2014 in commercial turkey production. Other serotypes significantly associated with Thanksgiving in our study (i.e., Hadar, Schwarzengrund, and Heidelberg) have also been associated with turkey.

Other significantly associated serotypes are not among those most commonly identified in turkey (e.g., Heidelberg and 4,[5],12:i- are more commonly identified in chicken; Derby, Brandenburg, and 4,[5],12:i- in swine and pork; and 4,[5],12:i- in cattle). However, all these serotypes have been found in turkeys and in retail samples of turkey or have been associated with outbreaks attributed to turkey. Some of the serotypes significantly increased after Thanksgiving, such as, Baildon and Ohio, were rare, causing <200 illnesses annually, and were not reported among food animals, retail products, or outbreaks during 2015‒2020. Although our study may have identified serotypes associated with other foods eaten during the Thanksgiving holiday, particular attention probably should be paid to evidence of these serotypes emerging in turkey production.

So, again, why is Salmonella NOT an adulterant?

Goodness, it has been a crazy few years.  When the pandemic hit, Marler Clark went all in to help food banks, food service workers and first responders.  As the pandemic has continued (please 40% of our friends and neighbors, please get vaccinated), we have looked to other places to help.  Here is were we are focused this season and we would ask others to consider the same.

I can’t make it, but my daughter in D.C. will.  Please consider supporting – https://www.farmworkerjustice.org/2021-awards-dc/

No child should sleep outside.  Please consider supporting – https://secure.e2rm.com/p2p/event/368075

Some, I am sure are a bit tired of my ranting about the FSIS doing its job and deeming Salmonella that causes human illness an adulterant in meat.

Fact, after E. coli O157:H7 was deemed an adulterant in ground beef in 1994, it took about a decade for E. coli illness cases to drop.  During that time, we saw the same drop in clients seeking our help.  Go figure, the FSIS and the beef industry heeded my call.  It is time to do the same with Salmonella.

Here is a link to a PowerPoint from a presentation I gave a few days ago – https://www.slideshare.net/marlerclark/2021-british-columbia-food-safety-speech

It was in an Op-ed in the Denver Post on August 4, 2002, entitled, “Four steps to safer food.”  Here it is in full:

This summer, scores of Americans, most of them small children or senior citizens, have already or will become deathly ill after eating ground beef boldly labeled “USDA approved.”

The now infamous ConAgra case started with a few sick kids in Colorado and quickly spread coast-to-coast, eventually triggering the recall of 18 million pounds of ground beef tainted with E. coli.

Now we know that this recall came weeks late, after most of that meat had been consumed by innocent consumers from Washington State to New Jersey. Because they trusted government’s food inspections, several kids suffered kidney failure and spent days or weeks hooked up to kidney dialysis machines. For some, the long-term prognosis is grim, with the risk of further kidney failure, dialysis, transplants or worse. I know this because I am a trial lawyer who has built a practice on food pathogens. Many of those kids’ parents have hired me to help them get compensation for hundreds of thousands in medical costs. Which may prompt some readers to consider me a blood-sucking ambulance chaser who exploits other people’s personal tragedies.

If that’s the case, here’s my plea:

Put me out of business. Please.

For this trial lawyer, E. coli has been a successful practice – and a heart-breaking one. I’m tired of visiting with horribly sick kids who did not have to be sick in the first place. I’m outraged with a food industry that allows E. coli and other poisons to reach consumers, and a federal regulatory system that does nothing about it.

Stop making kids sick – and I’ll happily move on. Here’s how:

Actually inspect and sample food. At present, the U.S. Department of Agriculture employs thousands of inspectors across the nation to inspect hundreds of plants that produce millions of pounds of beef at processing plants and retail outlets. The General Accounting Office has warned that the USDA’s food samplings are so scattered and infrequent that there is little chance of detecting microscopic E. coli or any other pathogen.

So hire more inspectors and give them real authority to sample meat and stop its distribution as soon as a pathogen is detected. Implement a sampling system that provides a reasonable chance of preventing another outbreak.

Doing so might add a nickel a pound – maybe less – to the price of hamburger. But it will also cut into my business. And isn’t that the idea?

Consider mandatory recall authority. This authority was required in Sen. Tom Harkin’s Safer Meat, Poultry and Foods Act of 2002. Under the present system of voluntary recalls, no company has actually refused to recall contaminated product. But in its recent report, the GAO did document several instances where companies delayed complying with recall requests. Delays mean tainted product has more time to reach consumers.

Require the meat industry to document where specific lots of food are sold. That way, it can be recalled quickly if a pathogen is detected. In most E. coli outbreaks, there is no recall because retailers don’t know where the meat came from and processors rarely step forward. ConAgra deserves credit for owning up to its responsibility to track down as much of the tainted meat as possible and for covering the medical costs of its victims.

But ConAgra is the exception. Timely online records would allow meat to be efficiently tracked down and recalled as soon as inspectors get a positive test result. Those plastic club cards issued by grocery chains could enable stores to contact specific individuals who have bought suspect ground beef. Merge the two federal agencies responsible for food safety. Right now USDA’s Food Safety Inspection Service and the inspection arm of the Food and Drug Administration share this mission. The system is bifurcated, which leads to turf wars and split responsibilities. We need one independent agency that deals with food-borne pathogens.

None of this will stop E. coli entirely. This invisible poison has been around a long time and is bound to pop up again. But these steps will enable us to detect it far more quickly, to alert stores and families, and to keep our most vulnerable citizens – kids and seniors – out of harm’s way. And, with a little luck, it will force one more damn trial lawyer to find another line of work.

Here is me testifying before Congress in 2008.

Essentially, USDA/FSIS is treating Salmonella as an adulterant in this situation.

I mean, it is not a bad idea to protect school kids, but why the differences?

While you all were sleeping off your “turkey coma,” I was thinking about why Salmonella is not an adulterant by reading, Michael Ollinger, John Bovay, Casiano Benicio, and Joanne Guthrie. Economic Incentives to Supply Safe Chicken to the National School Lunch Program, ERR-202, U.S. Department of Agriculture, Economic Research Service, November 2015.

Here are the highlights:

The U.S. Department of Agriculture’s (USDA) National School Lunch Program (NSLP) provides subsidized and free meals to over 31 million qualified students across the United States each school day (USDA, FNS, 2013). Chicken is a major component of the meals served to students. Some of that chicken is purchased through typical commercial channels, but schools can also obtain it via the Poultry Products Purchase Program, which is administered by USDA’s Agricultural Marketing Service (AMS). The NSLP used about $9 million worth of raw and $240 million worth of processed chicken products in the 2009-10 school year (USDA, FNS, 2012). Most of the processed chicken used in the NSLP was purchased by AMS as raw product and then further processed by State agencies prior to distribution to schools. Like all chicken sold in interstate commerce, the chicken purchased by AMS for the NSLP must meet Federal food safety standards, including tolerances for Salmonella spp. established by the USDA’s Food Safety and Inspection Service (FSIS).

Proper cooking and handling of raw chicken can reduce the risk of foodborne illness by killing Salmonella and other pathogens. Nevertheless, Salmonella remains the second-most common
cause of foodborne illness in the United States, causing an estimated 1 million illnesses, 19,000 hospitalizations, and 380 deaths each year (Scallan et al., 2011). Schools generally use processed (precooked) products such as chicken nuggets, fajita strips, etc., in school meals (Hecht et al., 2008). Processing kills harmful pathogens if it involves cooking the meat to more than 165° Fahrenheit (Burr et al., 2005). Some school systems, however, contend that processing removes some control over the nutritional content of school meals, and purchase the raw commodity (Stanley and Conner, 2013).

Both raw and processed chicken products have been recalled in recent years for food safety reasons. Between 2009 and 2012, there were six recalls of processed chicken due to Salmonella contamination, amounting to nearly 8 million pounds. Processed chicken products have also been recalled due to contamination with Listeria monocytogenes, allergens, and other reasons. Additionally, Foster Farms recently recalled over 1 million pounds of raw chicken products due to excessive Salmonella. However, to our knowledge, there have been no product recalls of raw or processed chicken products purchased by AMS for the NSLP.

Previous research (Ollinger et al., 2014) showed that, from 2006 to 2012, ground beef sold to the NSLP performed better on Salmonella spp. tests than ground beef sold to the commercial market. AMS imposes a zero-tolerance standard for Salmonella spp. in ground beef, a higher standard than that required by FSIS for ground beef sold in general commerce. This may have incentivized suppliers of ground beef to the NSLP to be more diligent when fulfilling an AMS contract, but it also likely raised costs, since suppliers may have taken extra precautions to meet FSIS standards.

AMS does not impose stricter Salmonella tolerances for raw chicken sold to AMS for the NSLP relative to the FSIS standard. AMS selects the lowest cost bidder among all AMS-registered suppliers, as long as that bidder meets FSIS standards. The combined effect gives establishments an incentive to invest in food safety up to the point that the establishment just meets the FSIS standard. However, food recalls and other announcements about the safety of food products can affect demand and profit, leading to declines in the stock prices of implicated suppliers (Thomsen and McKenzie, 2001), and in some cases, bankruptcy (Andrews, 2012; Tavernise, 2013). A food safety recall from a school could be particularly costly because the NSLP is a highly visible program and subject to particular scrutiny, potentially resulting in a greater reputation loss than that which would occur in the commercial market for a similar event. Moreover, it may be easier to trace the AMS-purchased chicken served in schools to their suppliers than chicken sold in commercial markets, making a product recall more likely.

Traceability is the ability to identify the supply chain of a product. It enhances food safety because, if a food is linked to a foodborne illness outbreak or other public health threat, then the source can be identified and the producer can be managed by regulators and may be targeted by liability lawsuits. Traceability also helps pinpoint the location of products so they can be removed from the marketplace.

There are fewer AMS suppliers than suppliers in the broader commercial market since not all chicken plants are eligible to bid on AMS contracts. This smaller number of AMS suppliers facili- tates traceability because there are fewer possible sources, and public health officials can inspect shipping records to determine the suppliers most likely responsible for shipping food associated with outbreaks of foodborne illness. Traceability becomes more complicated if the school system buys identical products in the commercial market, since there are more suppliers.

This report investigates the food safety performance of suppliers of raw chicken purchased by
AMS for the NSLP. In particular, we examine whether concerns about reputation for food safety encourage AMS suppliers to outperform commercial-only suppliers on tests for Salmonella spp.
The results could have implications for the AMS purchase specifications and the FSIS food safety program and may help policymakers and private managers better understand the conditions under which stricter standards may be warranted, and those under which private incentives are sufficient to maintain food safety.

Some more recent papers with some interesting tidbits:

Ollinger, Michael, John Bovay. 2018. Pass or Fail: Economic Incentives to Reduce Salmonella Contamination in Ground Beef Sold to the National School Lunch Program. American Journal of Agricultural Economics.100:414–433, doi.org/10.1093/ajae/aax088

“… the incentives generated by the zero-tolerance standard for Salmonella are highly effective: ground beef supplied to the NSLP is 21–22 percentage points more likely to meet a zero-tolerance standard for Salmonella than ground beef tested as part of typical meat-plant inspections.”

Ollinger, Michael, Matthew Houser. 2020. Ground beef recalls and subsequent food safety performance. Food Policy.  97:101971, doi.org/10.1016/j.foodpol.2020.101971.

“The results show that plants have high Salmonella levels before and during the year of the recall and have much lower levels afterward.”

Ollinger, M. and Bovay, J. (2020), Producer Response to Public Disclosure of Food-Safety Information. Amer. J. Agr. Econ., 102: 186-201. doi.org/10.1093/ajae/aaz031

“We find that (1) announcements in 2003 and 2004 were associated with improved performance by the poorest-performing chicken-slaughter plants; (2) the introduction of an easily-understood measure of food-safety quality and the threat of disclosure of the identities of poorly performing plants in 2006 were associated with improved performance by all chicken-slaughter plants; and (3) implementation of a public disclosure program in 2008 was associated with improvements among better-performing chicken-slaughter plants.”

So, why zero-tolerance for Salmonella in ground beef at schools but not at the kids’ homes?

Baby Spinach

According to the CDC, as of November 15, 2021, a total of 10 people infected with the outbreak strain of E. coli O157:H7 have been reported from seven states. Illnesses started on dates ranging from October 15, 2021, to October 27, 2021. Sick people range in age from 2 to 71 years, with a median age of 26, and 70% are female. Of eight people with information available, two have been hospitalized. No deaths have been reported.

According to the NCBI database:

13 Isolates (11 clinical, 2 “Joisie’s Organic Baby Spinach”)

Group:  PDG000000004.2980

Cluster:  PDS000094499.76

Distance between selected isolates: minimum = 0 SNPs, maximum = 2 SNPs, average = 0 SNPs

Target creation date range: 2021-11-04 to 2021-11-19

Onions

According to the CDC, as of November 12, 2021, 892 people infected with the outbreak strain of Salmonella Oranienburg have been reported from 38 states and Puerto Rico. Illnesses started on dates ranging from May 31, 2021, to October 25, 2021. Sick people range in age from less than 1 year to 101 years, with a median age of 37, and 58% are female. Of 571 people with information available, 183 (32%) have been hospitalized.

According to the NCBI database:

961 isolates (960 clinical, 1 “mixed Produce”)

Group:  PDG000000002.2334

Cluster:  PDS000094913.45

Distance between selected isolates: minimum = 0 SNPs, maximum = 8 SNPs, average = 1 SNPs

Target creation date range: 2021-08-20 to 2021-11-19

Seafood

As of October 7, 2021, 102 people infected with the outbreak strain of Salmonella Thompson have been reported from 14 states. Most sick people are either Colorado residents or reported traveling to Colorado in the week before they got sick. Only two people did not report travel to Colorado in the week before they got sick. Illnesses started on dates ranging from May 11, 2021, to September 7, 2021. Sick people range in age from less than 1 to 85 years, with a median age of 39, and 53% are female. Of 89 people with information available, 19 have been hospitalized, and no deaths have been reported.

According the NCBI database:

168 Isolates (155 clinical, 13 “seafood manufacturer”)

Group  PDG000000002.2320

Cluster  PDS000032705.704

Distance between selected isolates: minimum = 0 SNPs, maximum = 4 SNPs, average = 1 SNPs

Target creation date range: 2020-07-07 to 2021-11-08

Remember this as you prepare Thanksgiving for your family and as you read this post – it is Food Safety and Inspection Service (FSIS) Mission Statement: Protecting the public’s health by ensuring the safety of meat, poultry, and processed egg products.

USDA/FSIS has the authority to deem Salmonella and other pathogens adulterants – they just need to use it.

In a few days millions of Americans will bring a food product (a turkey) into their homes that is likely teeming with Salmonella that the manufacturer – by law and with the USDA stamp of approval – knowingly can sell knowing that it may well be tainted with a pathogen that sickens over 1,000,000 yearly.  This is because USDA/FSIS does not consider Salmonella an adulterant.

Personally, as I said to the Los Angeles Times some time ago, “I think that anything that can poison or kill a person should be listed as an adulterant [in food].”

Ignoring Salmonella in meat makes little, if any, sense.

Even after the Court’s twisted opinion in Supreme Beef v. USDA, where it found Salmonella “not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat ‘inspected and passed’, ” our government’s failure to confront the reality of Salmonella, especially antibiotic-resistant Salmonella, is inexcusable.

The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it – at least with respect to E. coli – but the analysis is spot on for Salmonella as well:

The E. coli strain that killed Brianna and made the others sick is a “deleterious substance which may render [meat] injurious to health.” There is no dispute about this. Thus, under the first part of 21 U.S.C. § 601(m)(1), meat that either “bears or contains” E. coli O157:H7 (the “deleterious substance”) is “adulterated.” That E. coli O157:H7 contamination can be rendered non-“injurious to health” by cooking thoroughly, as discussed below, does not negate this; Congress used the phrase “may render,” not “in every circumstance renders.” Moreover, if the E. coli bacteria is not considered to be “an added substance,” because it comes from some of the animals themselves and is not either applied or supplied during the slaughtering process (although we do not decide this), it cannot be said that the E. coli strain “does not ordinarily render [the meat on or in which it appears] injurious to health.” Accordingly, meat contaminated by E. coli O157:H7 is also “adulterated” under the second part of § 601(m)(1).

Now, why would Salmonella be different? According to the CDC, it is estimated that 1.4 million cases of salmonellosis occur each year in the United States. Of those cases, 95 percent are related to foodborne causes. Approximately 220 of each 1,000 cases result in hospitalization, and 8 of every 1,000 cases result in death. About 500 to 1,000 deaths – 31 percent of all food-related deaths – are caused by Salmonella infections each year.

So, where do we stand with the existing USDA/FSIS law on adulteration?

Here is the law:

21 U.S.C. § 601(m)(4) – SUBCHAPTER I – INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING – CHAPTER 12 – MEAT INSPECTION – TITLE 21—FOOD AND DRUGS

(m) The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; …

Here is the law specifically related to poultry:

Title 21 – FOOD AND DRUGS CHAPTER 10 – POULTRY AND POULTRY PRODUCTS INSPECTION

(g) The term “adulterated” shall apply to any poultry product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

Hmmm. It is hard to read the above and not think that the words equate to all E. coli as well as Salmonella — frankly, all pathogens in food.

I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens, like Salmonella) in them, should be considered adulterated too?  But, hey, that is just me.

Another odd governmental fact is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not.

FDA’s enabling legislation – Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is:

(a) Poisonous, insanitary, or deleterious ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

(2) If it bears or contains any added poisonous or added deleterious substance … that is unsafe within the meaning of section 406;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health …

It would be interesting, and perhaps entertaining, to have House and Senate hearings focusing on what should and should not be considered adulterants in our food. I can see panels of scientists from various fields, FDA, USDA and FSIS officials, beef, poultry, fish and produce industry representatives, and consumers discussing this.

I would pay to watch it.

And so now onto some history to ruin your appetite.

In 1971 the American Public Health Association (APHA) sued the USDA on the grounds that its mark of inspection (“USDA inspected for wholesomeness”) was misleading because, even though the USDA had put its stamp of approval on meat—literally—it did not, for example, test the meat for bacteria. Moreover, APHA argued that raw meat was commonly contaminated with Salmonella, which posed a risk to the public health. According to APHA, the USDA should instead require that meat carry both a warning label and cooking instructions. The USDA opposed the APHA, helped ably (and predictably) by the meat industry. As quoted by Marion Nestle in her great book, Safe Food, the USDA’s position was that, given how many foods are contaminated with Salmonella, “it would be unjustified to single out the meat industry and ask that the [USDA] require it to identify its raw products as being hazardous to health.” Nestle at 66. (Note to Reader: No, I am really not making this up.)

In 1974, the DC Circuit Court of Appeals upheld the position of the USDA and the meat industry, doing so in a way that was as nonsensical as it was sexist. The court stated that: “The presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601 (m)]….As it said in its letter of August 18, 1971 ‘the American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness.” In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.’” APHA v. Butz, 511 F.2d 331, 334 (1974).

This remained the position of the USDA and the meat industry until 1994 when, in an act of both common-sense and bravado, Michael Taylor, then FSIS Administrator, announced that E. coli O157:H7 would be deemed an adulterant in raw ground beef. The Agency did not, however, change its tune with regard to any other pathogens, especially Salmonella. Indeed, in 1999, when FSIS announced it inane distinction between E. coli O157:H7 in “intact” meat versus “non-intact” meat, the Agency continued to focus on how a given meat was “customarily cooked” as a chief determinant of whether it must be treated as an adulterant. Thus, for example, because it decided that “intact steaks and roasts are customarily cooked in a manner that ensures that these products are not contaminated with E. coli O157:H7,” there was no need to treat this deadly pathogen as an adulterant on intact cuts of meat. Of course, this FSIS policy is also one that appears to have been silently jettisoned by the Agency of late.

The Agency’s position on Salmonella and meat came back to haunt it in a big way when FSIS tried to shut down Supreme Beef Processors, Inc. for repeatedly failing Salmonella performance standards that, according to the Agency, was proof that the ground beef being made there was being processed under “insanitary conditions.” Supreme Beef sued the USDA and not only won an injunction, but it succeeded in having the Salmonella regulations struck down as being “beyond the authority granted the Secretary [of the USDA] by the Federal Meat Inspection Act.” Supreme Beef v. USDA, 275 F.3d 432, 434 (5th Cir. 2001). Explaining its holding, the Court wrote:

The difficulty in this case arises, in part, because Salmonella, present in a substantial proportion of meat and poultry products, is not an adulterant per se, 21 meaning its presence does not require the USDA to refuse to stamp such meat “inspected and passed.” 22 This is because normal cooking practices for meat and poultry destroy the Salmonella organism, 23 and therefore the presence of Salmonella in meat products does not render them “injurious to health” 24 for purposes of § 601(m)(1). Salmonella-infected beef is thus routinely labeled “inspected and passed” by USDA inspectors and is legal to sell to the consumer.

Supreme Beef, 275 F.2d at 438-39. And, of course, not surprisingly, the court in this case was quick to cite the decision in APHA v. Butz, and to note that even now the “USDA agrees that Salmonella is not an adulterant per se.” Id. at 439 n. 21.

In my view the Supreme Beef decision is poorly reasoned and ill-informed. (For example, could not someone at the Court figure out that it is impossible for meat to be “infected” with Salmonella, and the proper term here is “contaminated”?) But the real lesson of Supreme Beef is that the USDA was, and continues to be, an Agency that is unable to decide whose side it is on. Sometimes it puts on its public safety hat, and sometimes—actually, most often—it puts on its pro-meat industry hat. And, unfortunately, these roles are too often contradictory. That is why USDA policy when it comes to meat safety is also too often contradictory.

Perhaps it is just time for the FSIS to take the the position that all pathogens that can kill you in meat are adulterants.  You have the authority – you just need to use it.

Let the meat industry sue you.  I know a good lawyer to defend you.

Happy Thanksgiving.

Last week the Camden County New Jersey Health Department reported that it had been notified by a health care provider that a food handler employed at a Starbucks at 1490 Blackwood Clementon Road in Gloucester Township tested positive for hepatitis A and worked through the infectious period. On Wednesday, Nov. 17, the Department of Health was notified that a patient tested positive for hepatitis A and an investigation was instantly commissioned. Based on the investigation and out of an abundance of caution, the Department of Health recommends any member of the public that patronized the Starbucks facility on Nov. 4, 5, 6, 11, 12 and 13 to get the hepatitis A vaccine.

Based on this exposure, the Department of Health will set up a hepatitis A vaccine clinic to administer shots for patrons starting last Saturday at the Camden County Sustainable Facility at 508 Lakeland Road. Tomorrow’s clinic will operate from 3 p.m. to 7 p.m. and on Saturday morning from 9 a.m. to 11:30 a.m. Vaccine appointments will be made on a first come first serve basis.

It was reported today that as many as 4,000 customers may have been exposed.

How soon we forget.

In July 2019, a hepatitis A (HAV) outbreak was discovered in New Jersey linked to Mendham Golf and Tennis Club at 2 Golf Lane in Mendham Township, New Jersey. On July 2, the Morris County Office of Health Management and the New Jersey Department of Health were informed of a positive HAV case who was a food handler at the Mendham Golf and Tennis Club, and an investigation was launched. That day, the club was inspected and documents from Club management were collected. On July 3, it was decided that club members should be notified of potential transmission and asked to seek medical attention if any symptoms were noted.

Cases were notified of their possible exposure on July 5. A total of 26 cases, secondary to the index case, were identified. Symptom onset dates ranged from July 11 to August 7, 2019. Eleven cases were hospitalized – one with a liver transplant, and one case died. Cases were located from three counties and two neighboring states. Cases ranged from 23 to 85 years old (median 54). The majority were male (73%). Eight cases reported dining at the facility multiple times. Only two cases were reported to have received the recommended post-exposure prophylaxis (PEP). No subtype testing was done to analyze the genetic relationship between case infections, so outbreak analyses were primarily based on epidemiological evidence.

The New Jersey Department of Health ultimately ascribed this outbreak to an infected, seasonal food handler at Mendham Golf & Tennis Club. This case’s symptoms started on June 24, 2019, and he was excluded from work on June 30. It was calculated that exposures to this case may have occurred between June 9 and June 30, which would mean that the last date by which affected individuals could receive post-exposure prophylaxis (PEP) would be on July 14, 2019. Unvaccinated cases who dined between June 9 and June 30 were asked to receive PEP by July 14. Patrons who visited the club when the infectious food handler worked were asked to inform any dining companions of the possible exposure to HAV to receive PEP as well. On August 30, 2019, the outbreak was considered over by the New Jersey Department of Health.