I edited this email I recently got from a client to protect their identity.

Dear Bill,

What to say? Thank you so much for your tireless work on __________’s behalf. We are so grateful for your willingness to take on her case, and for the help you offered before she was even your client. We know it could have worked out very differently if it weren’t for your generosity, knowledge and finesse. We consider ourselves very lucky….

All the folks at Marler Clark have been amazing. It’s quite a team you have there. Please extend our thanks to everyone. I know we kept Marybeth, Josh and Chris busy for some time. We are grateful for their patience with us, and their careful and thorough work. We know others were drawn in, Bruce, Drew, Jenny, maybe everyone? Thank you to all!

I won’t forget my first phone call with you, Bill, and how you said that after all your years of working on these cases you still couldn’t imagine the hell we went through (and also that you were an ass for making me relive it). I knew that you were a different kind of lawyer. Thank you for your patience when I kept thinking of another horrible story to share. It was cathartic for me, but not your job to listen to it all….

I still can’t believe your responsiveness to email, calls and texts. I thought I might wear you out, but you hung in there. It made it all so much easier knowing that you would be there for us if anything came up. Thank you….

Speaking of that, I am more than willing to be available if there is ever anything, I can do to help you, or your clients…. Believe it or not, I’ve become pretty good at listening to and supporting folks coping with hardship.

Feel free to share my contact info with other parents if you think I could be helpful. I will also speak highly of you, of course. And, I’m happy to be another pair of eyes on any mediation letter:0) Pretty sure if it’s not my kid’s it won’t take me 10 iterations to get it right.

I am so happy __________ will be spending the summer at your firm. What an opportunity for her! Thank you for that too! I hope she is able to contribute to your work.

I will forever be grateful for all you’ve done for our family, and the immeasurable difference you’ve made on food safety. My interest in your good work will not fade.

I will always think the world of you.

With much love and gratitude,

Your friend,

__________

In March 2017, the Centers for Disease Control and Prevention (CDC) and several state health departments attributed a multi-state outbreak of Shiga toxin-producing Escherichia coli O157:H7 to I.M. Healthy brand SoyNut Butter manufactured by Dixie Dew, sold through the World Finer and KeHe distribution network and sold at retail at Target and other retailers.[1]

Outbreak investigators collected open containers of SoyNut Butter from the homes of sick people, and unopened containers from retail locations. Containers of SoyNut Butter from lots #243162 and 244161 tested positive for E. coli. Whole genome sequencing revealed that the same strain of E. coli was found in clinical isolates from sick people and containers of I.M. Healthy SoyNut Butter. Epidemiologic investigation determined that 32 people ill with this strain of E. coli had been infected by eating or attending a facility that served I.M. Healthy SoyNut Butter. This included residents of Arizona (4), California (5), Florida (2), Illinois (1), Massachusetts (1), Maryland (1), Missouri (1), New Jersey (1), Oregon (11), Virginia (2), Washington (2), and Wisconsin (1).[2]

During the outbreak, investigators identified 2 ill people who either developed HUS or had a culture independent diagnostic test (CIDT) showing infection with STEC bacteria. In interviews, both patients reported eating I.M Healthy SoyNut Butter in the week before the illness. However, the CDC did not include these people as case patients because no bacterial isolates were available for molecular subtyping, so there were unable to confirm if they were infected with one of the outbreak strains.

On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter. On March 24, 2017, Pro Sports Club recalled 20/20 Lifestyle Yogurt Peanut Crunch Bars because they contain a recalled ingredient. However, I.M. Healthy SoyNut Butter continued to be sold at least through early September 2017.

An outbreak strain of STEC O157 was isolated from 11 I.M Healthy SoyNut Butter samples. Multiple STEC isolates were identified from some samples. Nine samples were from opened, leftover products from case patient homes in California, Oregon, and Washington, and 2 samples were from unopened containers from retail stores in California; all had best-by dates of August 30, 2018 (10 products) or August 31, 2018 (1 product).

On March 3, 2017, the FDA issued a warning about the presence of E. coli O157:H7 in I.M. Healthy Creamy SoyNut Butter with a Best Buy Date of 08/30/2018.  Outbreak investigators identified Lot No. 243162 as one of the lots that was contaminated with E. coli O157:H7.

What the FDA found

The FDA inspected the facility between March 3 and 15, 2017.  On March 3, 2017, Dixie Dew refused to allow FDA investigators access to the facility’s environmental sampling and production records; the FDA subsequently issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. After receiving the Demand for Records, Dixie Dew provided FDA investigators with the necessary records. At the close of the inspection, the FDA provided Dixie Dew with a list of the investigators’ inspectional observations (Form FDA 483), noting objectionable conditions seen during the inspection. Dixie Dew responded to the report in writing with a list of actions it had taken to correct the conditions; however, FDA found the corrective actions were not adequate to fully address the risks that were identified and issued the Suspension Order to prevent further illnesses from occurring.

The FDA announced on March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky, because products manufactured in this facility may be contaminated. The FDA’s decision to suspend the registration of Dixie Dew Products was prompted by the E. coli O157:H7 outbreak and the findings of FDA’s March 2017 inspection of Dixie Dew, which identified insanitary conditions that could lead to contamination with E. coli O157:H7 in finished products. The FDA determined that no food could leave the Dixie Dew facility for sale or distribution while the food facility registration was suspended.

Specific problems noted in the suspension order and Form 483 included (blanks reflect redacted information):

  • investigators observed grossly insanitary conditions that cause your firm’s soy nut butter products to be adulterated;
  • food contact surfaces, floors, walls, and ceilings in the soy nut butter processing and packaging rooms were heavily coated with soy nut butter build-up from previous production runs;
  • firm does not routinely wash and sanitize smaller pipes, pipe fittings, gaskets, seals, “or the rubber _____ plug” when broken down following a production run;
  • firm does not conduct a kill step for SoyNut Butter product remaining in your firm’s mixing kettle leftover from a production run;
  • plant Manager stated, up to _____ may remain in the kettle overnight or weekend prior to resuming production. You and your Plant Manager stated the kettle is shut off when product remains in the kettle overnight and/or over the weekend;
  • plant manager and maintenance supervisor reported your _____ machine, used for fine mixing of the SoyNut Butter and ________, routinely shuts off during processing. Your Plant Manager stated this occurs one to two times per day and, this problem has persisted for approximately 15 years despite repeated maintenance intended to correct the problem;
  • firm monitors the SoyNut ______ with a ______ thermometer, but plant manager stated he has never verified the accuracy of this instrument;
  • you and your plant manager report, your temperature probe and chart recorder, initially engineered to verify and record _____ of product in the large mixing kettle, is not functioning properly and has not been used for well over a year.

FDA inspectors also noted problems with Dixie Dew’s food safety testing program, noting the company’s “failure to perform microbial testing where necessary to identify possible food contamination.” Inspectors found the testing materials on hand at Dixie Dew had expired in July 2016 and October 2015.

Problems in the Dixie Dew quality control lab were described in detail by FDA inspectors.

“An apparent fly infestation in your firm’s Quality Control and Product Development Laboratory was observed on 3/13/2017. Small apparent flies and fly larvae, too numerous to count, were inside an unplugged chest freezer,” according to the 483 report.

“A sealed blue plastic bag was inside the freezer and according to your plant manager, contained an egg product that became rotten when power was disconnected. The small apparent flies were observed along the laboratory counters and flying throughout the laboratory.”

Linda J. Harris, Ph.D., a well-known and respected expert from the University of California at Davis, critiqued the failure of Dixie Dew to have an adequate plan to control for the risk of bacterial contamination.  Specifically, after visiting the facility, Dr. Harris commented:

The Dixie Dew documents and especially the FDA 483 report based on inspections conducted March 3 to 15, 2017 as well as the onsite tour of the facility May 9, 2019 clearly show that Dixie Dew had not implemented either basic Good Manufacturing Practices or best practices for low moisture foods. Outbreaks of foodborne illness from nut butters in the U.S. in 2006/2007, 2008/2009, 2013, and 2014 are well known among food industry professionals and food safety community. These outbreaks are frequently used as instructional tools that provide multiple examples of what not to do when producing food. The outbreaks have been influential in changing the way that the microbial safety of low moisture foods are viewed and have led to well documented and freely shared industry best practices. In 2016, IM Healthy and those buying from them should have been aware of the risks of foodborne pathogens (both Salmonella and E. coli O157:H7) in their products. Any reasonable audit or inspection would have identified substantial systemic food safety issues in the production of Soynut butter at Dixie Dew.

The issues were there to be seen.

PAST OUTBREAKS LINKED TO NUT BUTTERS

It is not as if, in 2017, contaminated nut butters were not a foreseeable issue for manufacturers, suppliers and retailers.

In November 2006, public health officials detected a substantial increase in reports of Salmonella Tennessee isolates. In February 2007, a multistate, case-control study linked the consumption of either Peter Pan or Great Value Peanut Butter brands to infection[3]. As a result of that outbreak, 715 people were sickened and 129 required hospitalization. Subsequently the same strain of Salmonella Tennessee was isolated from unopened jars of peanut butter and from environmental samples collected from the processing plant. The product was recalled, and new illness reports declined. Unsanitary conditions at the Sylvester, Georgia, processing plant were known about since 2004. On April 5, 2007, ConAgra announced that inadvertent moisture from a leaking roof and sprinkler system could have promoted bacteria growth in the plant. Great Value brand was sold at Walmart stores.[4]

Beginning in November 2008, CDC PulseNet staff noted a small and highly dispersed, multistate cluster of Salmonella Typhimurium isolates. The outbreak consisted of two pulsed field gel electrophoresis (PFGE) defined clusters of illness. The first cluster displayed a unique primary enzyme (XbaI) restriction pattern and an uncommon secondary enzyme (BlnI) pattern. The second cluster had two closely related XbaI patterns that were very similar to the first cluster and a BlnI pattern that was indistinguishable from the first cluster. Illnesses continued to be revealed through April 2009, when the last CDC report on the outbreak was published. A total of 714 were sickened, with 171 hospitalized, and at least nine deaths. Peanut butter and peanut butter containing products produced by the Peanut Corporation of America plant in Blakely, Georgia, were implicated. King Nut brand peanut butter was sold to institutional settings. Peanut paste was sold to many food companies for use as an ingredient. Implicated peanut products were sold widely throughout the USA, 23 countries, and non-U.S. territories.[5]

On September 22, 2012, the CDC announced a multistate outbreak of Salmonella serotype Bredeney linked to Trader Joe’s Valencia Creamy Salted Peanut Butter. Collaborative efforts by local, state, and federal public health and regulatory officials traced the product to Sunland, Inc., a Portales, New Mexico company. Sunland issued a recall of multiple nut butters and products made with nut butters. When the outbreak was declared over, a total of 42 people infected with the outbreak strain of Salmonella serotype Bredeney had been reported by 20 states. Among persons for whom information was available, illness onset dates ranged from June 14, 2012 to September 21, 2012. Ill persons ranged in age from less than 1 year to 79 years, with a median age of 7 years. Sixty-one percent of ill persons were children less than 10 years old. Among 36 persons with available information, 10(28%) patients had been hospitalized. The FDA confirmed that environmental samples collected at the Sunland facility had a DNA fingerprint that was indistinguishable to the DNA fingerprint found in outbreak associated patients.[6]

On August 21, 2014, the CDC announced a multistate outbreak of Salmonella Braenderup involving 6 people residing in Connecticut (1), Iowa (1), New Mexico (1), Tennessee (1), and Texas (2). Almond and peanut butter manufactured by nSpired Natural Foods, Inc. was named as the likely source of this outbreak. The outbreak was declared over on October 16, 2014. Illness onset dates range from January 22, 2014 to May 16, 2014. Among 5 ill persons with available information, one person reported being hospitalized. During inspections at the nSpired Natural Food facility in Ashland, Oregon, between January 2014 and August 2014, the FDA isolated Salmonella Braenderup from environmental samples. A search of the PulseNet database linked ill patients to the environmental isolates taken from the nSpired production plant. On August 19, 2014 nSpired Natural Foods issued a voluntary recall of certain lots of almond and peanut butters because of potential contamination with Salmonella. The recalled brands include Arrowhead Mills, MaraNatha, and specific private label almond and peanut butters.[7]

On December 2, 2015, JEM Raw Chocolate LLC (JEM Raw) of Bend, Oregon announced a recall of its full line of all nut butter spreads due to possible contamination with Salmonella. Health authorities at the FDA, Oregon Health Authority, Oregon Department of Agriculture and the CDC had linked illnesses in 13 persons who consumed nut spreads. Dates of onset ranged from July 18, 2015 to November 22, 2015. Cases were reported from California, Colorado, Georgia, Hawaii, Idaho, Illinois, Maine, North Carolina, New Jersey and Oregon.[8]

___________________

[1]           https://www.cdc.gov/ecoli/2017/o157h7-03-17/index.html

[2]           32 cases from 12 states. Twenty-six (81%) cases occurred in children,18 years old; 8 children developed hemolytic uremic syndrome. Twenty-five (78%) case patients ate the same brand of soy nut butter or attended facilities that served it. We identified 3 illness subclusters, including a childcare center where person-to-person transmission may have occurred. Testing isolated an outbreak strain from 11 soy nut butter samples. Investigations identified violations of good manufacturing practices at the soy nut butter manufacturing facility with opportunities for product contamination, although the specific route of contamination was undetermined. See, A Multistate Outbreak of E Coli O157: H7 Infections Linked to Soy Nut Butter – PEDIATRICS Volume 144, number 4, October 2019:e20183978.

[3]           A 1996 Salmonella Mbandaka outbreak linked to peanut butter sickened at least 15 in Australia – Aust NZJ Public Health 1998; 22: 536-9.

[4]           https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5621a1.htm

[5]           https://www.cdc.gov/mmwr/preview/mmwrhtml/mm58e0129a1.htm

[6]           https://www.cdc.gov/salmonella/bredeney-09-12/

[7]           https://www.cdc.gov/salmonella/braenderup-08-14/

[8]           https://www.cdc.gov/salmonella/paratyphi-b-12-15/

See also – ATTACHMENT NO. 2 – J.-Pediatrics-Article-02178215xAD20BATTACHMENT NO. 5 – Suspension-of-Food-Facility-Registration-Order-to-Dixie-Dew-Products–Inc.ATTACHMENT NO. 6 – Dixie-Dew-Products-Inc.-Erlanger–KY.-483-Dated-03-15-17

There are few in the business of combating diarrhea that I respect more that Frank Yiannis and Rob Tauxe.

I am sure that it is not reciprocated, because I am one of those “damn ambulance chasers.”  But, guys, it is past time to stop hiding foodborne illness outbreaks – regardless of the thin legal justification.

Failing to be transparent gives a false sense of security to both the leafy green industry and the public. And, when the outbreak is outed, there is no doubt that many consider that you are being toadies to the industry – that is not good and it is not accurate.  You and the agencies you lead are far, far too valuable to squander your good names.

If the two of you want to debate the pros and cons of transparency, please name the time and place.

This week from the good people at Food Safety News:

January 24, 2020:  Federal officials today confirmed another E. coli outbreak that they had previously not revealed to the public. Specific details were not available from the CDC or the FDA, but at least four states have been reported with confirmed patients.

The most likely source of the E. coli O157:H7, reported by 9 of 11 sick people who ate at fast food locations, was lettuce on Subway sandwiches, according to a source close to the investigation. Neither the FDA nor the CDC would confirm that Subway products are involved.

“This is an ongoing investigation into an outbreak that was identified in December,” Food Safety News learned from Peter Cassell, a press officer for the Food and Drug Administration.

“Upon detection, the outbreak had already ended. In an abundance of caution and to try to inform future prevention, we are working to see if we can identify the source. Per CDC and FDA policy, since there were no specific, clear and actionable steps for consumers to take to protect themselves from contaminated food associated with this outbreak, there was and is no current public health advisory.

“Should our investigation conclusively identify a source and/or contributing factors that could inform future prevention, we are committed to publicly communicating these insights.”

The CDC also provided Food Safety News with confirmation of the previously undisclosed outbreak. An official comment from the agency did not include any specific details except that patients were confirmed in four states.

“In early December 2019, CDC, along with the U.S. Food and Drug Administration and four states, began investigating a multistate outbreak of E. Coli O157 infections,” according to a press officer from the Centers for Disease Control and Prevention.

“No new illnesses have been reported since CDC initially identified this cluster, and the outbreak is over. CDC is continuing to work with FDA to identify the source of the outbreak.”

The four states are Nevada, Maine, Vermont and New Hampshire, according to a source close to the investigation.

January 28, 2020: Officials in two states have confirmed they are working with federal officials on an investigation into E. coli illnesses linked to lettuce served by a national restaurant chain.

Spokespeople with the Nevada and Vermont state health departments say the agencies are working with the federal agencies on the investigation. Both the CDC and the FDA confirmed for Food Safety News on Friday that they have an open investigation into the outbreak, which had not previously been made public. A source close to the investigation says the implicated restaurant chain is Subway.

Health department officials in the other two outbreak states, Maine and New Hampshire, did not respond to requests for information about the outbreak and investigation. Vermont had five confirmed patients, Maine had four and New Hampshire and Nevada each had one.

A spokeswoman for the Vermont health department said the state’s five confirmed outbreak patients were all children. She could not provide any information regarding how many were hospitalized because of the department’s patient privacy policy. However, she said none of the children developed hemolytic uremic syndrome (HUS), which is a type of kidney failure that is often fatal.

The Vermont spokeswoman echoed what federal officials said Friday in regard to why the public had not been informed about the outbreak when it was discovered. She said there wasn’t any actionable information for the public and that public risk has now passed.

However, as with the FDA’s statement, the Vermont spokeswoman said officials became aware of outbreak illnesses in November but then said that by the time the outbreak was discovered in December the illnesses had stopped.

The FDA and CDC are being notably silent on the outbreak and ongoing investigation.

The outbreak marks the second time in the recent months when the FDA and CDC did not go public with information about an outbreak.

On Halloween, Food Safety News learned of an E. coli O157:H7 outbreak that the two federal agencies had not revealed to the public. It ended in September and involved romaine lettuce. [A total of 23 people infected with the outbreak strain of E. coli O157:H7 were reported from 12 states: Arizona (3), California (8), Florida (1), Georgia (1), Illinois (2), Maryland (1), North Carolina (1), Nevada (1), New York (1), Oregon (1), Pennsylvania (2) and South Carolina (1). Eleven people were hospitalized and no deaths were reported. Illnesses started on dates ranging from July 12, 2019 to Sept. 8, 2019. No illnesses were reported after CDC began investigating the outbreak on Sept. 17, 2019.]

Spokespeople from FDA and CDC said at the time that because they believed all of the implicated romaine had passed expiration dates by the time the outbreak was discovered, agency officials did not think the public needed to know.

I wrote this several years ago when I was complaining about the same lack of transparency in another case:

It is therefore with mixed emotions, and the knowledge that I likely make my relationship with public health – both federal and state – even more tenuous, that I question his quotes in today’s MSNBC dust-up over the disclosure or non-disclosure of “Mexican-style fast food restaurant chain, Restaurant Chain A” that is a source of a Salmonella outbreak that sickened 68 people in 10 states.  Here is what he had to say to MSNBC:

Dr. Robert Tauxe, a top CDC official, defended the agency’s practice of withholding company identities, which he said aims to protect not only public health, but also the bottom line of businesses that could be hurt by bad publicity. The CDC, the Food and Drug Administration and state health departments often identify companies responsible for outbreaks, but sometimes do not.

“The longstanding policy is we publicly identify a company only when people can use that information to take specific action to protect their health,” said Tauxe, the CDC’s deputy director of the Division of Foodborne, Waterborne and Environmental Diseases.

“On the other hand, if there’s not an important public health reason to use the name publicly, CDC doesn’t use the name publicly.”

Because companies supply vital information about outbreaks voluntarily, CDC seeks to preserve cordial relationships.

“We don’t want to compromise that cooperation we’ll need,” Tauxe said. …

Tauxe acknowledged there’s no written policy or checklist that governs that decision, only decades of precedent.

“It’s a case-by-case thing and all the way back, as far as people can remember, there’s discussions of ‘hotel X’ or ‘cruise ship Y,” he said.

I too was quoted in the article above and was repeatedly asked if I thought that the CDC was bending to company pressure to keep the restaurant name quiet.  I said emphatically no!  But that did not make it into the article.  So, not to put words in Dr. Tauxe’s mouth (and granted he may have had more to say), but as best as I can tell, these are his arguments for disclosure and non-disclosure and my thoughts in italics:

A.  Although there is no written policy, it is the way we have done things for years;

Why do I hear my mom saying, “just because so and so does that does not mean you should too.” Like all government policies (and neckwear) – change is good.

B.  Since the outbreak has concluded, there is not an immediate public health threat;

Frankly, that is true in most foodborne illness outbreaks.  In nearly every single outbreak investigated by the CDC the outbreak is figured out far after the peak of the illnesses happened.  However, disclosure gives the public information on which companies have a strong or weak food safety record.

C.  Disclosing the name of the company jeopardizes cooperation from the company in this and future outbreaks; and

If a company will only cooperate if they are placed in a witness protection program and with promises of non-disclosure, it does not say much for our government’s and the company’s commitment to safe food.

D.  Bad publicity may cause economic hardship on the restaurant.

True, but not poisoning your customers is a better business practice.

I would also add a couple more reasons that I have received via email (mostly anonymously):

1.  The source was an unknown supplier, so naming the restaurant might place unfair blame on the restaurant;

This one does make some sense.  However, is this the unnamed restaurants first problem with a faulty supplier, or is this a pattern?  And, even if it is the first time, perhaps some of the unnamed product is still in the market?

2.  Since the outbreak involves a perishable item, by the time the CDC announces the outbreak, the tainted product has long been consumed;

This one I have heard a “bunch” of times – especially in leafy green outbreaks.  However, why should the public be left in the dark about the type of product that sickens as well as the likely grower and shipper so they can make future decision who to buy from?

3.  Going public with the name of the restaurant compromises the epidemiologic investigation by suggesting the source of the outbreak before the investigation is complete;

I completely agree with this one.  This is a tough call, and one that must create the most angst for public health officials – they decide the balance between having enough data to go forward to protect the public health or wait for more data.  The point is do not go forward until the investigation is complete.

4.  Public health is concerned of making an investigation mistake like, it’s the tomatoes, err, I mean peppers; and

See my answer to 3 above.  This is why under the law; public health officials are immune for liability for the decisions that they make in good faith to protect the public.

5.  Public health – especially surveillance – is under budgetary pressures and there is simply not the resources to complete investigations; and

There is no question that this is true.  I have seen it in dropped investigations over the last few years.  Labs are not doing genetic fingerprinting to help reveal links between ill people.  And, many tracebacks are stopped by the lack of peoplepower to do the research necessary to find the “root cause” of an outbreak.

For me it is easy – the public has a right to know and to use the information as it sees fit, and people – especially government employees – have no right to decide what we should and should not know.

Perhaps when Congress gets back to governing, we can do a hearing or two on the above.  Its been a decade since Energy and Commerce grappled with food safety issues.  It is past time to do it again.

This is a stunning piece of both journalism and photo journalism by Nomatter Ndebele and Thom Pierce of the Maverick Citizen

Thank you for taking the time to tell these peoples’ stories.

The victims of the 2017 listeriosis tragedy and the surviving families of those who died are taking on Tiger Brands in an effort to win some form of justice and force some form of accountability. A Maverick Citizen team travelled to all four corners of South Africa to tell the stories of the claimants who are fighting back.   (see more on the status of the class action and Marler Clark’s role at https://listeriaclassaction.co.za/)

Alana Julie, 37

Alana Julie with her children (L-R) Jayden, Joshua, Lance, Tamsyn and Caitlan; in their bedroom at Alana’s mother’s house in Mitchells Plain, Cape Town. In 2017 Alana’s husband, Antonio, died from listeriosis at the age of 42. (Photo: Thom Pierce)

In 2017, Alana Julie lost her husband, Antonio. He died a gruesome death. He was in excruciating pain from the moment he fell ill. Within 72 hours, Antonio lost his eyesight. By the fourth day he was put on life support, and by the fifth, all his organs had shut down. Doctors told Alana she had two hours to decide whether or not to take him off life support. Since Antonio died, Alana has moved back to her mother’s house, where she shares a single bedroom with her five children. The family struggles to make ends meet, living solely off Alana’s salary, which doesn’t go very far. Her children remember their dad as an ever-present father who used to play the guitar and sing songs to them. A few weeks ago, their house was broken into and thieves stole Antonio’s guitar, devastating his eldest son Jayden.

Carla Verlaat, 23

Carla Verlaat at home in Manenburg, Cape Town. At 22 weeks pregnant, Carla lost her baby, Shem. He was diagnosed as having listeriosis. (Photo: Thom Pierce)

Carla Verlaat lost her first baby in 2017. She went into premature labour at 22 weeks. Her son Shem only lived for 24 hours before he died. The doctors told Carla her baby had a clot in his brain and he was later diagnosed with listeriosis. Carla cries as she speaks about the pain of her milk running out of her breasts intended for a baby who had died. She has a single picture of Shem on her phone. He is lying in an incubator, with many pipes attached to his fragile body, his face a dark grey. Since Shem passed away, Carla has battled with her grief. Despite having gone to therapy, she still struggles to manage her mood swings. Sometimes she stabs her bedroom door with a knife, in an attempt to find some kind of release. She blames herself for Shem’s death and is too afraid to have another baby.

Annelize le Roux, 42

Annelize and Martin Le Roux with their dog Max and their pet lion Caesar on their farm in Winburg, Free State. Annelize suffered a miscarriage at 23 weeks, their baby boy was later diagnosed with listeriosis. (Photo: Thom Pierce)

Annelize le Roux lost her “miracle baby”. The year before giving birth to her miracle, she terminated another pregnancy when told the unborn baby had Down’s syndrome. She was told that she would never have another child. Being subsequently pregnant with her son Andreas was an unexpected but happy surprise. The family was devastated when Andreas died.

Before Andreas died, Annelize’s whole family fell ill. “It was just like strong flu symptoms,” she said. Her husband Martin did not think much of his illness. Annelize, who is a microbiologist, was determined to find out what happened. So after Andreas died, they sent his blood for tests to England. The results confirmed that Andreas had contracted listeriosis while in his mother’s womb. When Annelize found out about the outbreak, she isolated and packaged foodstuffs from her fridge. When the health inspectors came to her home, she had prepared all the samples for them. This played a crucial role in assisting the health department in confirming the source of the contaminated foodstuffs.

Amelia Govender, 28, and Kyle Victor, 26

Kyle Victor and Amelia Govender at their home in Kingsburgh, KwaZulu-Natal. At one day old, their daughter Summer Reign died from listeriosis. For the last two years Amelia has suffered severe health complications brought on by listeriosis. (Photo: Thom Pierce)

Amelia and Kyle were incredibly excited for the arrival of their baby girl, Summer Reign. They both describe the birth of their little girl as the best day of their lives. Kyle, who had initially hoped for a boy, fell in love with his daughter at first sight. “I saw her and I just thought, ‘why did I ever want a boy?’” Amelia and Kyle had been thoroughly prepared for their baby. Amelia had bought little outfits for Summer Reign, she’d even got her a Louis Vuitton designer baby blanket. She became worried when her baby’s movements started to wane. That was the first sign of trouble. A few days later, Summer died. She and Kyle were devastated. Amelia has tears in her eyes as she talks about how she prayed that her baby would wake up during her funeral, but Summer was gone. Since then, Amelia has dealt with debilitating health issues. Every morning, she wakes up to a swollen face, and often her lower body breaks out in an itchy rash that leaves welts all over her. She still has not been able to figure out the cause of her symptoms.

Meryl Khotia, 38

Meryl and Shabeer Khotia at home in Shallcross, KwaZulu-Natal. At seven months, Meryl had to have an emergency Caesarean section and gave birth to a boy, Saiheer, who died less than 24 hours later. He was diagnosed with listeriosis. (Photo: Thom Pierce)

Meryl and her husband were looking forward to having their first child together in 2017. Shabeer immediately started a separate savings account to cater for the baby’s future needs. Seven months into her pregnancy, Meryl started to feel ill. She struggled with fever on and off, until the doctors told her they would have to perform an emergency Caesarean section. Baby Saiheer was born on 28 November 2017 and, as far as Meryl was aware, the baby was healthy. When her husband arrived at the hospital to see her and the baby, he found little Saiheer dead. Saiheer had lived less than a day before he died due to a listeriosis infection contracted while in his mother’s womb.

After Meryl was discharged from the hospital, she started to notice that she was getting severe allergic reactions, especially when it was hot. Her skin would start to itch badly and welts would develop where she scratched. She also described her face swelling up, so much so that she is afraid of leaving the house. “I don’t want people to see me like that,” she said.

Johan Keisser, 65

Johan Keisser at home in Forest Hill, Gauteng. In late 2017, Johan was rushed to hospital where he spent a total of 25 days, 12 of which were in the hospital intensive care unit. He was diagnosed with listeriosis and considers himself lucky to be alive. (Photo: Thom Pierce)

Johan Keisser considers himself “one of the lucky ones”. The 65-year-old pensioner fell ill and was taken to hospital by his wife. He has no recollection of being in the hospital for 25 days, 12 of which he spent in the hospital’s intensive care unit. “I took polony with cheese, lettuce and tomatoes to work every single day, and it almost cost me my life,” he said. While Johan has made a full recovery, he notes that he has a weakness in his legs, making it difficult for him to get up when sitting. He has high praise for the doctors who attended to him. “I am so grateful that they pulled me through because, according to me, I was a dead person for 20 days,” he says.

Aletta Masie, 44

Aletta Masie at home in Xihoko, Limpopo. Annette spent two weeks in hospital being treated for listeriosis after her one-day old baby died from the infection. (Photo: Thom Pierce)

Aletta Masie held her baby girl only once before she died. The infant contracted listeriosis in her womb and died soon after birth. As the baby was premature and weighed less than a kilogram, the foetus was disposed of as medical waste. She was unable to have a funeral for her child. She was discharged the same day and told to come back at a later stage to have her womb cleaned.

Aletta spent at least two weeks in hospital being treated for listeriosis with antibiotic intravenous drips. When she finally returned home to Limpopo, accompanied by her husband Thomas, her two elder children were devastated to find that she did not come home with a baby. “Losing my baby was so painful, especially because I didn’t really know what killed my baby,” said Anetta. Since the death of her baby girl, Anetta does not eat any Enterprise products. She is terrified that she will get ill again.

Christina Ledwaba, 31

Christina Ledwaba at home in Mankweng, Limpopo. Since losing her baby, Mohau, to listeriosis, Christina has managed to give birth to a healthy baby girl.(Photo: Thom Pierce)

Christina Ledwaba’s baby was stillborn.

She knew something was amiss when she noticed that the unborn baby’s movements in her womb had dwindled. She consulted the gynaecologist in Mankweng, Limpopo, who told her not to worry, that perhaps baby was “sleeping”. Not long afterwards Christina fell ill, suffering headaches and a fever. She was again taken to hospital to check on her baby.

“I knew something was wrong the minute I saw that sonar,” she said. Doctors confirmed that the baby had no heartbeat. She then gave birth to Mohau. When the baby was delivered, the nurses merely left the umbilical cord attached. For hours she lay on the bed with her dead baby under her legs.

Since then Christina has had another baby, but when she was eight months pregnant, she experienced diarrhoea and started to panic, worried that something was wrong again, but she was able to give birth to a healthy little girl. Despite good evidence that her stillborn baby’s death was linked to listeriosis, Christina still consumes Enterprise products, but she makes sure that the food is heated first.

Stephen Thokwane, 43

Stephen Thokwane at his home in Steelpoort, Limpopo where he lives with his wife and four children. Once fit and healthy, Stephen contracted listeriosis and is now a shadow of his former self. (Photo: Thom Pierce)

Stephen Thokwane is a shadow of his former self. The once fit and healthy man fell ill in December 2017. What started off as a headache and flu-like symptoms turned into a nightmare for his family.

Dumbfounded by his sudden illness, which he self-diagnosed as a stroke, the family first sought spiritual help. The family said that the prophet told the family that they needed to pray for Stephen. Stephen deteriorated and he was admitted to hospital, where he lost his eyesight, suffering severe delirium and temporary paralysis.

The man, who used to jog 15 kilometres at a time, found himself having to learn how to walk again. And while he is back on his feet, his health is still not what it was. He is fatigued, and he has lost strength. Due to this, he is no longer able to continue his work as a boilermaker, something he did part-time besides his formal employment, in order to support his family.

Thokwane is now working towards paying off a loan he took out to build a house for his wife and four kids. “After he got so sick, he was worried that he may die without leaving us with a roof over our heads, so he took out a loan to build this house,” his wife Maggi said.

Monthla Ngobeni, 37

Monthla Ngobeni with her daughter, Thetho, at home in Polokwane, Limpopo. Montlha is the first named claimant in the listeriosis class action. Thetho was born with severe health complications due to contracting listeriosis in the womb. (Photo: Thom Pierce)

Monthla Ngobeni is the first named claimant in the court papers. Her daughter Thetho, who is almost two, has undergone four operations since she was born. After contracting listeriosis in her mother’s womb, Thetho developed a condition called Hydrocephalus, a build-up of fluid in the brain. A shunt that drains the fluid has been inserted into Thetho’s head in order to manage her condition and, ultimately, save her life. She will always have a shunt and it will have to be replaced periodically as she grows.

The shunt has been blocked twice so far, forcing the little girl to undergo surgery to remove and replace it. Doctors have told Monthla that Thetho’s development milestones will be significantly delayed. At two, Thetho cannot speak yet. There is no certainty of what the future holds for her.

Monthla has fallen into debt trying to manage both her and Thetho’s medical bills. She currently owes a hospital R26,000 for a hip replacement that she needed due to her own listeriosis infection.

Ephraim Chinula, 64

Ephraim Chinula, Riley’s grandfather, at home in Eldorado Park, Soweto. After his grandson fell ill along with nine other children from their creche, Ephraim rallied the community and the result has been the listeriosis class action. (Photo: Thom Pierce)

Ephraim Chinula is Riley Chinula’s grandfather. Riley Chinula contracted Listeriosis alongside nine other children after eating contaminated meat at their creche in Soweto. The stools from the sick children were investigated and led to the first confirmation of the listeriosis outbreak.

Riley, who was three years old at the time, was the youngest of the kids at the creche. They all had high fevers, stomach cramps, vomiting and diarrhoea. The entire group was taken to Chris Hani Baragwanath hospital, where doctors were ready to receive them.

“I got the impression that the doctors knew what they were dealing with, as they had been briefed by the local clinic, so they already suspected listeriosis.”

Laboratory tests were run on the kids and it was confirmed that the children had indeed contracted listeriosis. When the news broke, the community came together and committed themselves to seeking justice for what they viewed as negligence on the part of Tiger Brands.

Tebogo Ntjana, 31

Teddy and Tebogo Ntjana at home in Midrand, Johannesburg. They lost their second daughter to listeriosis, Tebogo and Teddy are still searching for closure. (Photo: Thom Pierce)

Tebogo became very ill in October 2017 and was taken to hospital where she later suffered a miscarriage, four months into her pregnancy. The doctors took blood samples and told her that she had contracted listeriosis. Not knowing anything about the illness, Tebogo and her husband, Teddy, searched online for it and were alarmed to discover the severity of the condition. “We googled listeria … yoh, we got scared.”

Thinking that it was a singular case, they presumed that they had done something to cause the illness.

One month later, the couple heard the then minister of health, Dr Aaron Motsoaledi, announcing the listeriosis outbreak on the radio. The news came as a relief to the couple who would often buy polony and viennas from a Tiger Brands factory shop in Germiston. They have been blaming themselves for the miscarriage since it happened. “You blame yourself as if you killed your baby,” Tebogo said.

If I had heard about the problem even one week earlier … life today would be very different.’

By CHRISTINE HAUGHNEY and POLITICO

People had been getting sick from eating I.M. Healthy Original Creamy SoyNut Butter for more than two months when Peter Ebb, a 59-year-old Boston lawyer and health enthusiast, went for a run and then ate his usual gluten-free English muffin smeared with soy nut butter.

Later that morning — March 6, 2017 — Ebb saw a message from Amazon, which had sold him the nut butter, that the manufacturer had recalled it for contamination by E. coli bacteria. Ebb threw away a protein drink he had made with the soy nut butter, but didn’t worry too much. The Food and Drug Administration warning that was linked to the email was worded very cautiously: Though serious illnesses might result, even potentially leading to death, “most healthy adults can recover completely within a week.”

Six days later, Ebb was hospitalized and developed a deadly type of kidney failure. Within days, doctors told his wife to send for their children in case they needed to bid him a last goodbye. He survived, but remains unable to work full time and has trouble climbing the stairs. Now , he’s joining with 18 other victims to file claims against the companies responsible and call attention to the inadequacy of the nation’s recall system.

“If I had heard about the problem even one week earlier and stopped then, I might have been able to avoid the disease completely, and life today would be very different,” Ebb said.

A POLITICO investigation found that the I.M. Healthy SoyNut Butter case — which officials at the FDA and the Centers for Disease Control and Prevention have hailed as an improvement over past failures — was nonetheless emblematic of persistent weaknesses in the nation’s food-safety system, some of which haven’t been corrected for two years after being flagged by the agency’s inspector general.

Two months elapsed between the first person sickened by eating I.M. Healthy SoyNut Butter on Jan . 4 and the recall orders that began on March 3 and expanded three more times until March 10. The FDA, working through a national network of labs that identifies outbreaks, pinpointed the contamination on Feb . 22. The nine-day lag time in persuading the manufacturer to begin recalling the tainted products was a significant improvement over previous lag times — which were as high as 165 days in one infamous case, according to the inspector general. But victims maintain that the FDA should have ordered a recall on its own authority, given that a few days or even hours can make a difference in a deadly outbreak.

“They have the authority to mandate a recall and, in theory, that would go more quickly than a voluntary recall,” said Sandra Eskin, who directs food safety at the Pew Charitable Trusts. The FDA has used its authority to order recalls only three times since 2011. Instead, it usually waits to give companies time to decide whether to pull a product from shelves voluntarily.

There were complications, as well, in alerting customers to the fact of the recall. The FDA did not identify which retailers sold the contaminated batches of products. (The agency has traditionally considered this information to be trade secrets, and left it to manufacturer s to alert retailers.) Thus, customers who saw only the FDA’s recall notice had no way of knowing whether the products they bought were among those that were contaminated.

“They just did not effectively execute the recall,” said Eskin. “You really have to monitor where the product is sold and reach out to the sellers online.”

Indeed, the contaminated products remained available for months afterward . Linda Harris, a food-safety microbiologist for the University of California at Davis who researched the case for the victims, said she was able to buy a three-pack of I.M. Healthy Original Creamy SoyNut Butter on Amazon in September, five months after the recall. In addition, some stores either missed or ignored the recall and kept the product on the shelves, Harris discovered.

Part of the problem, critics contend, was a lack of urgency: The cautious language of the FDA’s warning didn’t mention potential illnesses until the third paragraph, and the only instruction offered was to return the product to the place it was bought to receive “a full refund.”

“Amazon didn’t provide the information about the seriousness of the recall and the reason,” contended Sarah Sorscher, deputy director of regulatory affairs for the Center for Science in the Public Interest. “You should not have to click through to a government website while you’re eating breakfast to find out that you have a deadly product in your kitchen.”

The weaknesses in the soy nut butter case were all the more notable because they came 8½ months after the FDA’s inspector general declared that it lacked adequate procedures for handling food outbreaks.

“We found that the FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply ,” Inspector General Daniel Levinson wrote on June 8, 2016. “This issue is a significant matter and requires the FDA’s immediate attention.”

Now, more than two years after the IG’s warning, the agency is still updating its procedures. In congressional hearings and blog posts earlier this year, FDA officials have pledged to take specific steps to improve the recall system, including a proposed rule to alert the public to dangers before recalls are announced. Among the other changes promised include revealing which retailers sold the tainted products “in certain cases,” developing a database to help the agency identify contaminated products and requiring companies to issue public warnings more quickly .

Meanwhile, the Trump administration, seeking to improve safety standards, proposed in mid-June consolidating all food-safety functions in a new agency within the U.S. Department of Agriculture as part of a broader reorganization that would require congressional approval. But few observers expect any congressional action in the near term.

In a statement to POLITICO, FDA Commissioner Scott Gottlieb, who took over the agency in May 2017, just after the soy nut butter recall, stressed his commitment to improving the current system.

“When the FDA learns about potentially unsafe foods in the marketplace, we must act quickly to keep people from getting sick or being harmed,” Gottlieb wrote. “The FDA is taking several policy steps this year as part of a broader action plan to further improve our oversight of food safety, and ensure that all food recalls are initiated, overseen, and completed quickly and effectively to best protect consumers. These and other efforts will increase transparency, empower consumers and ultimately lead to fewer potential recall situations with less people getting sick from contaminated food.”

Ten-year-old Mason Stoll began showing digestive symptoms suggestive of a food-borne illness on Jan . 7, 2017. Within four days, the boy was admitted to Johns Hopkins University Hospital, where his father, Bob, works as a project manager in the Applied Physics Laboratory.

Pretty soon, Mason was clinging to life with complications so severe that he coded four times. As he fought for his life, his parents began speaking with Maryland State Department of Health officials, trying to locate the cause of the contamination and passing on information about everything Mason had eaten, including the soy nut butter.

Like many of the families whose relatives were poisoned by contaminated I.M. Healthy Original Creamy SoyNut Butter, the Stolls were familiar with the threats posed by digestive illnesses: Many of the victims were eating soy nut butter because they had food-borne allergies or diseases like Crohn’s that left them unable to eat nuts or dairy products. For his part, Mason was allergic to peanuts, dairy and eggs. The Stolls were comfortable navigating the public-health bureaucracy. Like other families who spoke to POLITICO, they moved quickly on their own initiative to brief local officials and eventually the CDC, sharing receipts and providing detailed information about the foods they consumed.

More than three weeks after Mason began feeling sick, on Jan . 30, an 8-year-old boy named Trevor Simmons entered a hospital in Santa Clara, California , suffering from E. coli poisoning.

Trevor’s mother, Erin Parisi Simmons, said she spoke within two days to the Santa Clara Health Department and discussed possible sources of the illness. When his condition worsened, Trevor was moved to the intensive-care unit of the Stanford Medical Center. Erin Parisi Simmons recalled with chagrin that she unsuspectingly brought I.M. Healthy Original Creamy SoyNut Butter to the hospital on two different occasions to try to entice Trevor to eat, because it was his favorite food. Fortunately, he was too sick even to take a bite.

Around the same time, a Seattle woman named Nicole Cash purchased soy nut butter for her 11-year-old son, Oliver, and 8-year-old daughter, Hannah: Because of Oliver’s peanut allergy, the soy nut butter was a family staple. By Feb . 21, Hannah was experiencing diarrhea so severe that Nicole had to put her in diapers; when Hannah said she had blood in her stool and began vomiting uncontrollably, Nicole rushed her to the hospital.

Within a few days , Hannah was experiencing kidney failure and had to go on dialysis, and Nicole was talking to the CDC about what products m ight have made the girl so sick.

On March 2, Nicole had her answer, via an unlikely source: A closed group of people on Facebook who were posting reports about the E. coli outbreak said it was caused by soy nut butter, a day before I.M. Healthy began its first recalls.

At the same time, Maryland state officials told Mason Stoll’s family that his E. coli poisoning was caused by I.M. Healthy Original Creamy SoyNut Butter, which contained fecal matter. And California officials delivered the same news to Erin Parisi Simmons.

On March 3, the SoyNut Butter Company began its series of voluntary recalls. Even then, the recall s applied only to products with best-by dates of Aug . 30 and 31, 2018. More batches of soy nut butter were recalled the following day, March 4, and the recall was expanded again on March 7 and 10.

The FDA launched an inspection of the facility in which the soy nut butter was made by a food services company called Dixie Dew. Inspectors were at the Dixie Dew facility from March 3 through March 15, finding that it had rodent droppings, a sink that had not had hot water running in two years and an infestation of flies.

FDA records show that it wasn’t until March 28 that the agency finally suspended operations at the Dixie Dew facility.

Even though the FDA announced that the recall was completed by May 4, batches of the tainted products remained on sale through the fall. Over Labor Day weekend, Harris, the University of California at Davis food-safety microbiologist helping lawyer Bill Marler , who represents 19 victims, bought a three-pack on Amazon for $40. Once she received it, she notified Amazon and the state of California.

“It was a complicated recall, in part because it was a small company,” said Harris. “It still was a product that should not have been on the market.”

The vendor selling the nut butter contacted Harris to tell her that the specific jars she purchased were not affected. Harris had to explain that they were, indeed, part of the lot that was recalled. Amazon pulled the nut butter from its site by the Tuesday after Labor Day.

“They did not scroll to the bottom of the website and click to the link that said expanded recall,” Harris said. “When there are these complex recalls that happen in stages, you can’t have the notice of the expanded recall at the bottom of the page.”

Then, in October, Harris found another online retailer selling the nut butter and contacted FDA. The agency ensured that it was removed quickly. But it took until Oct . 13 for the FDA to issue a statement that read “FDA Reminds Public that All I.M. Healthy Soy Nut Butter Products are Recalled.” The notice added that “retailers cannot legally offer for sale” the product.

The FDA said it responded promptly once it learned that the recalled products were being offered for sale.

“The agency worked quickly to locate any remaining products to ensure they were no longer available to consumers and we put out a public notice to remind consumers of the dangers of these recalled products,” an FDA spokesman wrote in an email.

While the recall may be over, most of the victims are still dealing with long-term health effects and the trauma the experience left on their families.

After Peter Ebb left the hospital on March 30, his family had to reconfigure their house because he has trouble taking the stairs. He remains anemic and his kidneys have not returned to normal. “It’s definitely been a life – changing event, one of the worst,” said his wife, Fran Green.

Nicole Cash’s daughter Hannah has largely recovered, but she still has annual checkups to make sure there are no lingering complications. The Cashes, who are Australian, have reconsidered why they are living so far away from family.

Erin Parisi Simmons said her son is still being seen regularly by Stanford University’s nephrology department and is struggling with post-traumatic stress disorder. Her family is trying to stitch itself back together: She said she lost her tech job because her company was taken over while she was caring for her son. Her husband is trying to restore his stature within his company since some colleagues did not understand why he was off for so long. And their older son is still struggling with feelings of abandonment because his parents spent so much time caring for Trevor.

Bob Stoll reports that Mason’s 14 months of illness have depleted the family’s savings. Mason returned to school full time in April. On June 26, he had cervical spine surgery. And they’re preparing for a kidney transplant in their son’s future.

“It has had an emotional impact,” said Bob. “We’re just trying to piece together what normal looks like again.”

In the months after the outbreak, Marler, the victims’ attorney, filed four lawsuits in federal court in Chicago, after which both the SoyNut Butter Company and Dixie Dew declared bankruptcy. Now , the 19 victims represented by Marler are applying to bankruptcy court to divide up $12 million in insurance and assets. After that, Marler said, he plans to file suit against the retailers and shippers who provided the products.

Terrence Guolee, the lawyer representing the SoyNut Butter Company, said that his client only handled marketing and that Dixie Dew handled the manufacturing.

“My client’s company shut down within a couple of weeks of being notified by the CDC as to what happened because they couldn’t survive any further,” Guolee explained.

Dixie Dew did not respond to requests for comment through its lawyer.

An Amazon spokesperson said in an email that “Customer safety is our highest priority. Third-party sellers are required to comply with all relevant laws and regulations when listing items for sale on Amazon. When sellers don’t comply with our terms, we work quickly to take action on behalf of customers.”

The spokesperson noted that after FDA sent out its March recall, Amazon immediately stopped selling the soy nut butter. Then, six months later, when a third-party seller evaded Amazon’s systems and offered the item again for sale, Amazon took the item down, took action against the seller and notified customers.

While Marler is targeting the companies involved, he also has choice words for the FDA, particularly over its failure to publicize the retailers who sold the tainted products.

“This is, in my view, a classic failure of the FDA’s recall system,” he said. “When you don’t have full transparency, there’s confusion not only from consumers — retailers fall into the same trap. They either ignored the warnings or they simply didn’t understand the recall notice.”

In most cases, the FDA does not publicize the stores, restaurants or online retailers that sold contaminated food, a policy that has raised the ire of some members of Congress. “The primary goal of the FDA is to keep food safe,” declared Rep. Rosa DeLauro (D-Conn.). “FDA’s mission is not to protect the trade secrets of corporations.”

The FDA policy is especially perplexing since the U.S. Department of Agriculture, which is responsible for the safety of meat and poultry, changed its own policy against disclosing retailers nearly a decade ago.

Former USDA Under Secretary for Food Safety Richard Raymond recalls taking on the Grocery Manufacturers Association and other big food lobbies to get the policy changed. “Most of the people at USDA said ‘You won’t get this done. You’re wasting your time,’ ” said Raymond. “The FDA does not have to replow new ground. It was plowed by me.”

Gottlieb, the FDA commissioner, suggested in a statement that his agency is moving toward providing more information about retailers.

“Following on our commitment earlier this year to improve our oversight of food safety and how we implement our recall authorities, the FDA will soon issue guidance on additional information the FDA will now make available during certain recall notifications,” Gottlieb wrote. “Note that the agency recently released detailed distribution information by state for the outbreak linked to pre-cut melon so consumers could better know how to avoid the hazardous recalled food.”

As to lessons learned from the soy nut butter case, he wrote: “Anytime there’s a serious outbreak and consumers are hurt the answer is that we could always have done better. We won’t be able to prevent every outbreak and prevent every consumer from being at risk of a food-borne illness but our aim is a system that continues to reduce these risks and we strive toward that goal. I believe we’re heading in the right direction and over time we will see the benefits of our efforts.”

The Trump administration’s proposal to combine all the government’s food-safety functions into a new agency under USDA will continue to be debated. The notion of creating a new food-safety agency won the early support of key advocates and the House Agriculture Committee Chairman Mike Conaway (R-Texas), though even he suggested that it was just the start of a longer review process.

Changes cannot come quickly enough for the victims of the I.M. Healthy contamination, who remain convinced that tighter government oversight and earlier warnings might have spared themselves or their children.

“When it was happening, we felt helpless,” said Bob Stoll. “Now I don’t feel helpless. I feel angry.”

Leafy green vegetables have become the leading cause of E. coli poisoning. And the federal government still lacks the means, and maybe the will, to take it on.

By Christine Haughney of the Boston Globe

Nathan Parker slept with his son Lucas Parker on a mattress in the living room because of his medically fragile condition. Lucas Parker suffered severe permanent injuries after eating romaine lettuce contaminated with E. coli bacteria during a visit to California in 2018. SUZANNE KREITER/GLOBE STAFF

RICHMOND, BRITISH COLUMBIA — It was the vacation of a lifetime for three generations of the Parker family. For much of 2018, Nathan Parker and his wife, Karla Terry, plotted their road trip from this Vancouver suburb down the Oregon coast to their final destination: Disneyland.

No one was more thrilled than Lucas Parker, the endlessly energetic 2-year-old who knew Mickey Mouse’s hot dog dance by heart. When the big week finally came in early October, Lucas and his two siblings delighted in exploring Disneyland’s Tomorrowland and descending into the darkness of the Pirates of the Caribbean ride.

Then Lucas began to throw up.

By the time his mother changed his diaper that early morning, it was bloody. “He was shaking. He was pale,” said Nathan Parker. “He looked just horrible.”

The Parkers immediately started the 22-hour drive home to seek medical help, but family members were so worried that they stopped at an emergency room in Olympia, Wash.

“My kid is limp in my arms,” he recalled. A doctor told him, “I suspect it’s E. coli.’’

The Parkers had no way of knowing, but Lucas was one of the first victims of a disease outbreak that would shake public confidence in a seemingly benign, even virtuous, vegetable: lettuce. Five bites of a salad the boy shared with his father nearly a week earlier were enough to infect him with the toxic bacteria.

Over the next month, 61 more people in 16 states would be diagnosed with E. coli poisoning — all traced to romaine lettuce. Many more might have been sickened if not for drastic action by Scott Gottlieb, then director of the Food and Drug Administration, who tweeted to a startled nation that they should stop eating romaine lettuce just two days before Thanksgiving 2018.

It was a crisis that faded from the news almost as soon as it was safe to restock store shelves. Still, it should have been the wake-up call that mobilized the government to defeat this threat to food safety.

But the call was muted, and the response so far underwhelming.

More than a year after the Thanksgiving outbreak, the E. coli threat is as real as it ever was, and the government still lacks the means, and maybe the will, to take it on, a six-month Globe review finds. There have been four E. coli outbreaks traced to lettuce since September alone, sickening people in more than two dozen states. Since 2017, there are nearly 500 documented victims and six deaths from leafy green vegetables contaminated by E. coli. Because the disease is difficult to document, the actual numbers are likely many times higher.

In fact, leafy green vegetables now cause more E. coli outbreaks than any other food, including beef, but the government’s efforts to secure the safety of greens remains a pale shadow of its policing of red meat. The Globe review found that the FDA still sometimes seems more concerned with preventing panic than fully informing the public about health hazards in the food supply.

Despite the growing number of outbreaks, the agency remains protective of the growers, taking little enforcement action and sometimes shielding growers suspected of causing outbreaks from bad publicity. Consider:

■ The FDA has called little attention to the surge in E. coli outbreaks from leafy green vegetables. It has been slow to investigate or publicize risks and did not disclose one outbreak to the public until the Globe contacted agency officials about reports of E. coli poisonings. FDA officials insist they planned to disclose the early fall 2019 outbreak all along.

■ The FDA has not punished any farm or distributor in connection with the seven outbreaks traced to lettuce since 2017 even though federal law prohibits the sale of contaminated foods. The agency concluded that three of the outbreaks were linked to a single California lettuce grower but declined to release the name.

■ The FDA staff monitoring lettuce production is just a small fraction of that detailed to the federal oversight of beef: There are 614 FDA field investigators responsible for leafy greens compared to 7,068 workers overseeing beef for the Department of Agriculture. Congress recently gave the FDA $8 million to better handle outbreaks, but the agency doesn’t want to talk about the state of its staffing. When the Globe tried to examine just how understaffed the agency is, officials redacted hundreds of pages of records discussing their internal problems.

■ The agency relies almost entirely on voluntary cooperation from the lettuce industry, an approach that has brought about some safety improvements. But FDA has asked relatively little of the industry and recently delayed implementing rules aimed at preventing E. coli contamination of irrigation water until 2022.

“There is no oversight,” said food safety lawyer Shawn Stevens, who previously represented beef powerhouse Cargill in cases brought by contamination victims and who sees the major differences between the regulation of meat and leafy greens. “There is no one watching (lettuce) being harvested or distributed or transported to the processing facility or being washed or being packaged.”

FDA officials defend their performance, noting that pinpointing the source of E. coli contamination is complex, especially for lettuce. Many of the outbreaks appear unrelated to each other, they said, and investigators have not always been able to conclusively identify the source.

“We did not conclude in any of these outbreaks, which are not all related, how the romaine lettuce (or leafy greens) . . . became contaminated,” said spokeswoman Lyndsay Meyer. “We often are not able to explain the full route of contamination.”

Nathan Parker built an aquatic center for his son Lucas in their home. Nathan said the best days of Lucas’s childhood are behind him. “I still have dreams of him running around here,” said Nathan, but he knows that’s extremely unlikely. SUZANNE KREITER/GLOBE STAFF

The importance of closing that investigative gap is as clear as the potential consequences of E. coli poisoning are devastating. Fifteen months after the Parkers’ trip of a lifetime, Lucas still deals with the long-term consequences: He is legally blind. He cannot speak or move. He requires a feeding tube because he cannot swallow, and his medical records show he suffers a litany of other serious conditions.

Nathan Parker now cares for his son full time. As Lucas rested on his chest in the family’s cramped apartment, the father of four wondered what he could have done differently. He thought he was eating sensibly and encouraging his family to do the same. He never saw any warnings to avoid eating lettuce.

“I had no reason to believe that I couldn’t eat salad,” said Nathan Parker. “It’s America’s best kept secret.”

Green Gold 

ACROSS 101,500 DUSTY and sun-soaked acres of Yuma, Ariz., and California’s Central Coast, farmers grow the greens that fill the salad bowls of much of the nation. Over the faint buzz of insects, row after meticulously planted row of romaine lettuce sprout and bloom like verdant bouquets. Once picked, they are sent to processors, where the leaves are soaked in sudsy baths, packaged, boxed, and shipped to restaurants and supermarkets.

The arrival of these delicate greens on menus and supermarket shelves is welcomed by consumers in these health-conscious times. US lettuce production has grown nearly 50 percent since 2000, reaching 4 billion pounds in 2018, according to federal figures.

Romaine lettuce has become a star among leafy greens, its crunchy leaves most often used in Caesar salad or as the bed for countless foods, from a scoop of chicken salad to a charcuterie platter.

But just as consumers have learned to love lettuce, so has a dangerous type of bacteria. A particular strain of E. coli called “Shiga Toxin producing E. coli” or sometimes STEC O157:H7 for short, is a common contaminant, especially of romaine lettuce. Scientists have found that the thirsty plants, which grow close to the ground, offer easy access for E. coli to latch onto them through soil or by water. Once E. coli has landed on romaine’s leaves, it settles into the plant’s pores and rides along through the long journey from field to salad bowl.

Modern farming has made E. coli and lettuce a perfect match. Lettuce thrives in water-starved areas where finding any water and keeping that water clean are ongoing challenges. When water levels are low, contamination becomes even more of a problem, because irrigation is essential and E. coli often settles into sediments at the bottom of the canals that bring water to crops.

Romaine lettuce grew near Yuma, Ariz., one of the nation’s leading producers of leafy green vegetables. At least one recent E. coli outbreak has been traced to farms in the region. CAITLIN O’HARA/FILE 2016

Under the best of circumstances, E. coli is a maddening bacteria for investigators to trace; the Shiga toxin complicates the process further because it takes its time doing its dirty work. Lucas Parker, as is typical for those infected, did not get sick until a week after he ate contaminated lettuce. By that time, any traces of the contaminated lettuce have often been disposed of, making the path of contamination that much harder to trace.

Also, only a few of those infected become seriously ill, dampening the sense of regulatory urgency. The severity of symptoms varies widely. Some victims have mild diarrhea while a few become gravely ill. Case in point: Lucas Parker’s father, grandmother, aunt, and younger brother all had brief symptoms of vomiting or diarrhea after eating the same salad. But they recovered quickly and are fine.

Perhaps not surprisingly, the vast majority of victims are never even identified. The Centers for Disease Control estimates that 265,000 Americans are sickened by E. coli from all causes each year, though only a few thousand cases are confirmed.

Facing this formidable and many-layered challenge, the FDA deploys a modest, overworked team that struggles to handle the workload, especially during a contamination crisis.

A review of 413 pages of internal FDA e-mails during the October-November 2018 outbreak shows that the FDA team worked day and night and through the Thanksgiving holiday weekend to obtain basic information about the outbreak from the leafy greens industry, which still uses paper documentation for much of its produce tracking.

The agency was also, in that moment, still dealing with a previous E. coli outbreak caused by lettuce, tying up staff. On Nov. 27, 2018, FDA executive Jim Gorny, who had returned to FDA to help prevent illnesses caused by contaminated produce, wrote to colleagues, in a heavily redacted e-mail, “I have no resources to deploy.”

FDA spokeswoman Meyer, who responded on behalf of Gorny, said that because Gorny’s job is an advisory position, “he simply meant that he personally could not send anyone to assist” because he had no direct staff. However, Gorny declined to explain his comments.

“The FDA has a number of agents and staff, but nothing in terms of the number of field inspectors needed,” said Darin Detwiler, a Northeastern University dean with an expertise in food policy. His research has found staff shortages are a chronic problem.

Two days before Thanksgiving in 2018, Scott Gottlieb, then commissioner of the Food and Drug Administration, urged consumers to dispose of all romaine lettuce amid an outbreak of E. coli. It was a stark reminder of the perils of toxic bacteria in the US supply of produce. DREW ANGERER/FILE 2017/GETTY IMAGES

The FDA is further hamstrung by what Gottlieb called the agency’s culture of caution, a fear that putting out a false alarm about an E. coli outbreak could damage public trust in the FDA — and needlessly alarm consumers. They want to be absolutely sure they have found the correct source before going public. But this cautiousness has a price.

In the E. coli outbreak that sickened Lucas in October 2018, the FDA waited three weeks after it first heard about the problem to announce anything. The outbreak finally came to national attention two days before Thanksgiving, when Gottlieb, fearful that millions of Americans were about to eat E. coli-contaminated salads with their holiday meals, tweeted that Americans should just throw away all their romaine lettuce. The health warning triggered a massive disposal of lettuce. Gottlieb felt he had no choice.

“This information was getting into the press,” said Gottlieb. “I thought it was important for the agency to have a voice in speaking to these issues.”

A beefy comparison

IN JANUARY 1993, Jack in the Box restaurants triggered one of the worst E. coli outbreaks in US history when workers mostly in the Seattle area did not follow newly created standards to cook its burgers. Detwiler, who was then living in Seattle, found himself caught in the crisis.

Detwiler’s toddler son, Riley, had never even eaten a hamburger. But he picked up E. coli in day care from another child whose parents both worked at Jack in the Box. Riley was one of four who died in the outbreak.

The tragedy upended Detwiler’s life, wrecking his marriage and turning him into an influential advocate for food safety. It also brought unprecedented pressure on the agency charged with keeping meat safe, the Department of Agriculture. New inspectors were hired, and a sophisticated tracking system called PulseNet was launched, bringing together data from 82 labs in all 50 states and accelerating identification of emerging outbreaks and their source.

It was a much-needed regulatory revolution — but it had little impact on the oversight of leafy green vegetables.

These changes “had nothing to do with produce,” said Detwiler. “I actually think that in terms of food safety, you’re better off eating ground beef than you are eating leafy greens today.”

Indeed, since the late 1990s, leafy green vegetables have overtaken beef as a source of E. coli poisonings. Data compiled by the Centers for Disease Control show that, from 2009 to 2018, almost twice as many people suffered E. coli poisoning from leafy green vegetables compared to beef.

Detwiler notes that most produce inspectors are concentrated overseas and at borders, forcing the FDA to delegate most monitoring to state agencies. Most farms are inspected every three years. By comparison, beef has a much more clear-cut system. Federal officials are assigned to individual plants to oversee daily inspections of the process.

After beef leaves the packing plant, the industry employs sophisticated tracking systems that enable investigators to more easily isolate the source of an outbreak without disrupting the nation’s entire beef supply anytime an outbreak occurs. By comparison, both FDA officials and lawyers involved with leafy green outbreaks note that farmers, distributors, restaurants, and retailers still keep paper files and have no computerized way to trace the source.

The Agriculture Department also discloses far more information about retailers that are selling contaminated beef so that customers have better information about whether their local supermarket has been affected. The FDA releases only limited information about retailers selling potentially contaminated produce, arguing that the disclosure could reveal “trade secrets” or information desired by competing stores. The FDA has not identified individual stores selling contaminated lettuce in any of the outbreaks.

But the lettuce industry never had a galvanizing event like the Jack in the Box outbreak to give urgency to the need for reforms. Detwiler predicts it’s only a matter of time. “Pathogens like E. coli, they do not discriminate,” he said.

Missed opportunities

EMERGENCY ROOM STAFF at New Jersey hospitals were the first to notice what would turn out to be the biggest E. coli outbreak linked to lettuce in a decade. In late March 2018, multiple patients with gastro-intestinal symptoms said they had eaten at a Panera restaurant, and doctors began asking other ER patients whether they, too, had visited the chain. Some had, including one woman who tested positive for E. coli.

The outbreak would officially sicken 240 people and kill five across 36 states, a toll that rivaled the Jack in the Box outbreak. But the FDA was slow to catch on that an outbreak was unfolding, first hearing about the growing number of illnesses on April 5, 2018, when a county health official in New Jersey confirmed to a reporter they were investigating two E. coli cases traced to a Panera. By then, the Centers for Disease Control had seen a rise in E. coli cases on PulseNet, but CDC officials said nothing to the FDA until April 4 because “the source of the illnesses was unclear at the time,” a CDC spokesman said.

Despite the specific warnings from New Jersey health officials, the FDA waited another six days before it said anything publicly. An FDA official explained to the Globe that they waited to make an announcement in part because “we did not have a specific location where the romaine was coming from.”

The delays didn’t stop there. The agency got a break in April when eight inmates at an Alaska prison got E. coli poisoning that was traced to some lettuce from Harrison Farms in Yuma, Ariz. That immediately narrowed the search for the cause of at least some poisonings, holding out the promise that, this time, FDA might move quickly.

But the FDA did not send field inspectors to the 140-mile stretch of Arizona farms until June 4, two months after their first call from the New Jersey Department of Health. Meyer, the FDA spokeswoman, said the agency initially did not have enough information to go on.

Karla Terry had her hands full with children, Seth, 4 months, Alex, 2, and Lucas, 3. Lucas became so gravely ill from eating contaminated romaine lettuce that doctors had prepared Terry and her husband, Nathan Parker, for his death. They had Lucas baptized and waited at his bedside. “He never really woke up from the coma,’’ Parker said. SUZANNE KREITER/GLOBE STAFF

But she said the FDA treated the episode as “a major outbreak with all hands on deck,” including nearly two dozen workers in the field and more staff at headquarters.

Eventually, FDA officials found three samples of E. coli O157:H7 in water within a mile of the Wellton irrigation canal that provides water for the lettuce fields in Yuma. The same strain of E. coli was found one mile upstream, next to a large lot where thousands of Holsteins cattle were fed.

Stephen Ostroff, then a top FDA commissioner overseeing the case, said agency investigators had to negotiate with the feedlot owners for access to the land and ended up with only six samples from the manure and water, an amount Ostroff called “inadequate to fully assess” whether E. coli was present.

A vice president of the company, Five Rivers Cattle Feeding, insisted that FDA investigators were welcome to take as many samples as they wanted and that the company cooperated fully.

Officials from Five Rivers as well as the National Cattlemen’s Beef Association went to FDA headquarters in September 2018 to press their case that the feedlot didn’t cause the E. coli outbreak. Ostroff, who attended the meeting, said industry officials thought there was considerable uncertainty about the cause.

In the end, Gottlieb concluded, mildly, that the cattle feed operation was “one potential source” that could have caused the outbreaks.

No one was ever penalized in the spring 2018 outbreak. No lettuce was ever officially recalled.

Some important changes, however, did follow that outbreak. The Leafy Greens Food Safety Task Force, composed of more than 100 industry representatives, called for longer distances between romaine lettuce fields and large-scale cattle feeding operations.

Protecting the source

AT LEAST SOME of the cases in the Thanksgiving outbreak — the one that sickened Lucas — were eventually traced back to one California farm. It is a vast fifth-generation family business located roughly 75 miles north of Santa Barbara that local press reports have said employs hundreds of workers to tend to thousands of acres.

Adam Brothers had sent its harvested lettuce seven miles away to a distributor, United Foods, in Nipomo, Calif. Then United Foods shipped an order of romaine 11 miles away to Gino’s Pizza, which is where the Parkers placed their delivery order for salad and pizza.

The FDA found that the chemical tablets Adam Brothers used to sanitize its irrigation water had not dissolved, leaving the water dirty. Though investigators could not determine where the E. coli had come from, the farm’s failure to fully treat the water allowed the bacteria to survive, contributing to an outbreak that sickened at least 62 people in the US and another 29 in Canada, including Lucas.

Nonetheless, FDA took no action against Adam Brothers, and even allowed the farmers to announce their own recall of potentially tainted red and green leaf lettuce and cauliflower. The farm’s Dec. 13, 2018, announcement of an outbreak did not mention that Adam Brothers had been the source of the deadly contamination. It did, however, mention other Adam Brothers vegetables subject to the recall, noting that “no illnesses have been reported” from eating those.

FDA spokesman Peter Cassell defended Adam Brothers’ recall statement in an e-mail, saying he did not find it misleading. Cassell’s FDA colleague, Meyer, reiterated that “Adam Brothers was cooperative and agreed to a voluntary recall” of other vegetables it grew. That meant “no additional action was needed.”

Adam Brothers officials declined to speak to the Globe, but one of the brothers, Peter Adam, seemed to take the whole episode in stride, telling a local television outlet that the recall was nothing special.

“This isn’t the first time we’ve been under the microscope,” Adam said in the February 2019 interview. “This is part of life in vegetable world in California today and maybe just in business in general in the United States.”

The produce industry took some additional steps.

In September, 100 public health and industry professionals released a report, facilitated by food producers, with specific suggestions on how to avoid outbreaks, encouraging growers to follow higher standards for issues such as the water they irrigate with. As of Jan. 1, the task force instructed all leafy green suppliers to place scannable labels on their products. Industry officials say the vast majority have complied.

Jennifer McEntire, vice president of food safety and technology for United Fresh, one of the organizations that worked on the report, stressed industry’s commitment to helping federal authorities solve the E. coli problem.

Contaminants, the report said, must be traced to their source and eliminated quickly, through the combined efforts of business and government. Otherwise, “we are preordained to repeat those results and ultimately may find ourselves in the middle of yet another outbreak.”

Nathan Parker delivered one of six morning medications through the feeding tube for his son Lucas. Parker quit his job to care for his son full time. SUZANNE KREITER/GLOBE STAFF

What does the public need to know?

ANOTHER OUTBREAK CAME very soon, posing a test of the FDA’s new commitment to protect consumers of leafy greens.

What followed was a repeat of the old patterns, with the FDA trailing a state agency — and the Globe — in taking full notice of the new threat,

The New York State Health Department confirmed to the Globe that it had identified one case tied to a multistate outbreak. Within hours of that announcement, a CDC spokesman confirmed to the Globe that the outbreak had grown to sicken 23 people across 12 states between July and September.

Still, the CDC issued no public warning, a spokesman said, because the “romaine lettuce eaten by sick people was past its shelf life and no longer available for sale.” The FDA took a similarly low-key posture, saying it made no sense to notify the public about an outbreak that was over.

“We don’t have anything specific to tell consumers,” an FDA official told the Globe. “We can’t point to a company and say their lettuce is bad.”

But the night before FDA officials believed the Globe was about to report on the outbreak, and the agency’s passive response, they changed course. FDA contacted the Safe Food Coalition, a group of consumer advocates and foodborne illness victims, to say it would soon announce that a recent outbreak had come and gone.

Frank Yiannas, a former Walmart executive and the current FDA deputy commissioner for Food Policy and Response, then personally called members of the foodborne illness community to say he had planned to announce the outbreak all along. Meyer reiterated that claim in a statement. “FDA was always planning to report, as we did, that an outbreak occurred,” the spokeswoman said. “It was simply not an urgent advisory.”

Since then, the FDA has faced three E. coli outbreaks affecting lettuce that state health departments in Maryland and Wisconsin helped them solve. Combined they sickened 193 people in 29 states. All three outbreaks were traced back to a single grower in Salinas — California’s largest growing region with nearly 60 percent of the state’s total lettuce acreage.

The FDA, citing lingering uncertainty, declined to identify the “common grower” when asked by the Globe.

“It’s still too early to determine whether this grower was in fact the source of this outbreak,” said FDA spokeswoman Meyer.

Karla Terry and Nathan Parker traveled with their children last month to have photos taken with Santa. Lucas (right) became uncomfortable and cried as they made their way through the Home Depot parking lot. They missed last year’s holiday photo because Lucas was in the hospital battling the effects of the contaminated lettuce he ate. SUZANNE KREITER/GLOBE STAFF

Lucas

SINCE LUCAS PARKER was discharged from the hospital in March 2019, he has rarely moved from his family’s couch. On a recent morning, Lucas had his right arm wrapped around his gold-colored Care Bear. His eyes flitted toward the sounds of the History Channel in the background, while Ginger, his grandma’s Chihuahua, and Bella, the Parkers’ cat, protectively encircled him. The only sounds Lucas seems to make are mournful, guttural cries when he needs help.

Lucas’s relatives search for hopeful signs: Lucas’s aunt asked him if he had a busy day and it looks as if he was nodding. Nathan Parker said Lucas lights up at the sounds of wrestling on television. His mother pressed a chocolate doughnut to his lips, and he cooed.

Before his debilitating sickness, Lucas loved to watch Star Wars movies with his father, Nathan, who still props up a phone for Lucas to watch. SUZANNE KREITER/GLOBE STAFF

The Parkers’ lawyer, Bill Marler, said he is getting as many as three calls a week about people who have contracted E. coli from eating romaine lettuce. Ninety percent of his E. coli cases now involve lettuce instead of ground beef. The damage has been so devastating that they have fetched settlements for more than $15 million.

But that number, while large, is far from adequate, given the number of victims and the cost of the medical care Lucas and others will require. Lucas, despite his dire condition, could live a long life. Will the expense and complexity of his care one day outrun his family’s capacity?

Nathan Parker wonders: What will happen to his broader family, when he can no longer care for his son?

“Everybody is gonna be affected by this in their own way,” he said. “This is like casting a stone in a pond and watching ripples. You know, those ripples just get bigger and bigger and bigger.”

Well, this just landed in my inbox:

FDA and CDC are investigating a cluster of 11 cases of E. coli O157:H7 from 4 states: Maine(4), New Hampshire(1), Nevada(1), and Vermont(5).  Illness onset dates range from November 19, 2019 to December 4, 2019.  Patients range in age from 3 years to 41 years (median 12 years), and 55% are female.  Five (45%) of patients were hospitalized, and no deaths were reported.  Bacteria from all the ill people were closely related genetically by whole genome sequencing (WGS).  In interviews, 9 (82%) of 11 people reported eating at locations of the same national sandwich restaurant chain in Maine, New Hampshire, and Vermont.  Eight (89%) of the 9 people who ate at the restaurant chain reported eating lettuce.  Lettuce was the only ingredient reported by over half the ill people.  CDC has not identified any other foods eaten by ill people that were linked to illness.  The epidemiological investigation suggests that the illnesses could be associated with iceberg lettuce.  

Perhaps people in food safety are concerned that this outbreak might be swept under the rug and that the farm where the lettuce was grown and the “national sandwich restaurant chain in Maine, New Hampshire, and Vermont,” will not be named?

Petition seeks to classify all salmonella strains as meat adulterants
By Julie Larson Bricher on 1/23/2020
https://www.meatingplace.com/Industry/News/Details/89900

Seattle-based law firm Marler Clark LLP filed a petition Jan. 19 with USDA’s Food Safety and Inspection Service (FSIS) urging the agency to declare 31 salmonella outbreak serotypes as adulterants in meat and poultry products.

The 60-page petition details current scientific and medical research to show that “the health hazards posed by outbreak serotypes of Salmonella enterica subsp. are undeniable.” It cites CDC estimates that salmonella causes 1.35 million illnesses, 26,500 hospitalizations, and 420 deaths annually in the U.S.

The petition asks FSIS to issue an interpretive rule declaring salmonella outbreak serotypes adulterants within the meanings of the Federal Meat Inspection Act and the Poultry Products Inspection Act.

Attorney Bill Marler, who petitioned FSIS in the early 1990s to declare E. coli as an adulterant following the Jack in the Box outbreak, said that as with E. coli, there is ample evidence over the past 25 years that salmonella makes people sick. (Note:  Actually, FSIS declared E. coli O157:H7 an adulterant in hamburger in 1994.  I petitioned to add O26, O45, 0103, O111, O121, and O145 in 2009).

“Intellectually, there’s little justification to say that E. coli O157:H7 and the Shiga-toxin producing E. coli [serotypes] are adulterants but salmonella is not,” Marler told Meatingplace in an interview. “The question is, what are we going to do about it?”

“There are a lot of things that the industry and government can do to combat this [pathogen]. And I’m a firm believer in, if we can put people on the moon and we can build the Panama Canal, we can figure out how to get chicken shit out of chicken,” he added.

The bottom line, Marler told Meatingplace, is that “even though it seems like we’re asking for a lot, it’s really based in science and on the fact that these strains have caused human illnesses and deaths over the last 25 years.”

Marler says that the law requires that FSIS either accept or deny a petition before the petitioner can take the case to federal court. For example, Marler Clark’s 1994 petition to expand the definition of adulterant to include Shiga toxin-producing E. coli other than O157:H7 languished in decision purgatory at the agency for more than two years, until the attorney pressed for an answer within a six-month period.

“I finally just said, ‘Hey, look, if you don’t deny it or approve it within six months, I’m just going to take it that you’ve denied it, and I’m going to sue you,” Marler recounts. “During that period they made the decision to expand the definition of adulterant for E. coli without actually approving my petition.”

Still, Marler is hopeful that FSIS will act more quickly this time around.

“I don’t think [FSIS] will just come out and deny it. It’s more problematic for them to get into federal court than to try to find a compromise or deal. We will just have to see what FSIS’s approach is going to be. We’re obviously prepared, but prepared either way,” Marler said. “Prepared to work with them, prepared to sue them. It’s completely up to the agency.”

The legal firm filed the petition on behalf of Rick Schiller, Steven Romes, the Porter Family, Food & Water Watch, Consumer Federation of American and Consumer Reports. The two individuals and one family named as petitioners were sickened by and experience ongoing health issues as a result of contracting salmonellosis from consuming meat products.

“When I tell people that chicken manufacturers can knowingly and legally sell something that can kill you, they don’t believe me,” Marler said in an interview. People are equally surprised, he said, to learn that the federal government “stamps meat ‘USDA certified,’ all along knowing that it could be contaminated with cow or chicken” feces.

“Chicken s— shouldn’t be on chicken flesh, it should be in chickens’ guts. Period. End of story,” Marler said. “Same with cows and same with pigs. It shouldn’t be on our food.”

From the Washington Post – Kimberly Kindy – 2020

Lawyer Bill Marler, 62, outside his office in downtown Seattle. (Stuart Isett/for The Washington Post)

Bill Marler, the Seattle lawyer who represented hundreds of victims in the Jack in the Box food poisoning case in the 1990s, was outraged by the avoidable tragedy that sickened 700 and claimed the lives of four children.

He courted the media to get the E. coli bacteria on the agenda of policymakers — and played a key role in getting the U.S. Department of Agriculture to outlaw the most virulent strains of the pathogen in meat.

Now, Marler, 62, is at it again. This time he is taking aim at salmonella, which over the past decade has become the most dangerous bacteria in meat.

On Sunday, Marler filed a petition with the USDA — just as he did regarding E. coli a decade ago — asking it to agree with his legal, scientific and moral arguments to ban dozens of salmonella strains from meat.

The USDA’s data shows that about 1 in every 10 chicken breasts, drumsticks or wings that consumers purchase is probably contaminated with salmonella, which largely comes from fecal matter getting on meat during slaughter.

“When I tell people that chicken manufacturers can knowingly and legally sell something that can kill you, they don’t believe me,” Marler said in an interview. People are equally surprised, he said, to learn that the federal government “stamps meat ‘USDA certified,’ all along knowing that it could be contaminated with cow or chicken” feces.

If the USDA approves the petition, the department would have far-reaching power to recall or seize meat for a variety of salmonella strains. It could also pull its inspectors from wayward meat plants, effectively shutting them down, a move that could cost big operations millions of dollars a day.

A microscopic image of clustered Gram-negative, Salmonella typhimurium bacteria, isolated from a pure culture. (Janice Haney Carr/CDC)

The meat industry opposes banning salmonella, saying the technology needed to prevent and eliminate the contamination has not yet been developed. It also argues that meat prices would rise for consumers.

“With E. coli, it was a wake-up call for an industry that wasn’t paying attention to that pathogen. The industry is not asleep at the wheel with salmonella,” said Mark Dopp, a vice president of the North American Meat Institute, a trade association. “We are doing everything we can think of. Declaring something to be an adulterant isn’t going to make us swim faster or harder. We are swimming as fast and hard as we can.’’

If the USDA moved forward with a ban, meat companies would be legally obligated to make sure the salmonella strains are not on their products before shipping them to restaurants or grocery stores. Marler’s petition calls for new regulations, which would spell out what meat companies must do to comply. That would include new testing for the pathogens.

Meat industry officials, federal regulators and food safety advocates all agree: Marler’s latest petition is audacious.

Rather than attempting to ban a handful of the very worst salmonella strains — a common approach with such petitions — Marler is seeking to label as “adulterants” 31 different salmonella types. The petition includes each type of salmonella responsible for recalls and outbreaks that have made people sick over the past two decades.

“It’s a big leap,” said Sarah Sorscher, deputy director of regulatory affairs at the Center for Science in the Public Interest, which is advocating for a ban of a narrower set of salmonella types. “One of my colleagues described his petition as a punch in the face. You know, maybe [the USDA] needs a punch in the face.”

The timing of the petition is also daring. The Trump administration has a track record for siding with industry, consistently resisting new policies or regulations proposed by public health advocates.

An attorney for the meat industry said Marler should not be underestimated. When Marler embraces a food safety solution, he can be unrelenting, as he was with E. coli.

“He fought that fight and surprisingly won,” said Al Maxwell, an Atlanta-based lawyer who represents food industry clients and has gone up against Marler in hundreds of food poisoning cases. “The meat industry said the sky was going to fall if the government declared the pathogens as adulterants, but that didn’t happen. Meat got safer.”

A copy of the first complaint filed against Jack in the Box for the 1993 E. coli outbreak hangs in Marler’s office. (Stuart Isett)

Salmonella outbreaks

E. coli illnesses and outbreaks linked to meat — especially beef — have plummeted since the USDA banned the most dangerous strain in 1994 and six other deadly strains in 2011.

Salmonella illnesses and outbreaks, however, have remained stubbornly high.

The U.S. Centers for Disease Control and Prevention estimates that salmonella bacteria causes about 1.35 million infections, 26,500 hospitalizations and 420 deaths in the United States every year.

About one-third of those cases involve meat, the CDC says.

“The whole time I was there we had two recalls for salmonella. Now, there can be four or five a month,” said Richard Raymond, who was undersecretary for the USDA’s Food Safety and Inspection Service from 2005 to 2008. “The contamination rate with chickens is a particular embarrassment.”

CDC data shows that when salmonella outbreaks are linked to meat, chicken causes the most illnesses, followed by pork and then beef.

The USDA has rejected two salmonella petitions, both filed by Sorscher’s group, saying there wasn’t yet sufficient scientific data to support the ban of specific strains. The latest rejection came in 2018.

Raymond says the department is hesitant to ban salmonella because it fears the industry will launch a fierce and costly legal battle, as it has with other efforts by the USDA to limit the amount of salmonella allowed on meat.

Marler hopes his 62-page petition — which presents legal arguments against past positions by the USDA and the meat industry opposing such a ban — will mark a turning point.

The petition process is also a mandatory first step before a lawsuit can be filed against the federal government. Marler said he plans to take this next legal step if the USDA rejects his request.

The USDA said it has not yet reviewed Marler’s petition and could not comment on how it might respond.

The department said in a statement that it has made “significant advances” using other enforcement tools and cited the success of a four-year-old rule that limits the amount of salmonella allowed on chicken parts. The rate of contamination on chicken parts has dropped from 24 percent to 9 percent.

Even with this improvement, CDC data shows the rates of salmonella-related illnesses have remained steady.

“Chicken s— shouldn’t be on chicken flesh, it should be in chickens’ guts. Period. End of story,” Marler said. “Same with cows and same with pigs. It shouldn’t be on our food.”

Marler contends that chicken, pork and beef start out as sterile and that salmonella does not naturally occur on meat. Humans and processing equipment, he said, spread the contamination during slaughter.

The North American Meat Institute and the National Chicken Council argue there is nothing unnatural about bacteria from an animal’s gastrointestinal tract ending up on meat. And although contamination typically happens as Marler describes, it’s not the only way.

Katie Rose McCullough, a food scientist with the meat institute, said unlike E. coli, salmonella can be part of the animal’s flesh — in the lymph nodes — which filter and collect potentially harmful pathogens to keep animals healthy. “You can’t remove all of it; that’s impossible,” she said.

The National Chicken Council says that one of the best ways to prevent illness is to cook meat at temperatures high enough to kill the bacteria. “Raw chicken, just like any other raw agricultural commodity, is not a sterile product, and no regulation will ever make it sterile,” the council said in a statement.

But Marler argues that making restaurant chefs and consumers fully responsible for killing the bacteria is foolhardy. In his petition, Marler repeatedly cited research that shows how rare it is for people to follow USDA safety instructions. “You can’t put this burden on the consumer — it doesn’t work,” he said.

‘Put me out of business’

Marler at his Seattle office. Pathogens in food helped him build a lucrative law career. (Stuart Isett/for The Washington Post)

Marler’s role as a food safety crusader might seem odd.

The existence of pathogens in food helped him build a lucrative law career and move his family from a 500-square-foot cabin to a spacious home on bucolic Bainbridge Island, with views of Puget Sound.

In the 1990s and early 2000s, more than 90 percent of Marler’s legal cases involved victims sickened by E. coli in meat. After the ban took effect and reforms followed, he said these cases dwindled and now account for fewer than 5 percent of his firm’s caseload.

Victims of salmonella poisoning in meat now account for 20 percent of his practice, he said.

Marler says he wants to drastically reduce the salmonella cases at the Marler Clark law firm.

“Bill’s very common refrain to industry is, ‘Put me out of business,’ ” said Denis Stearns, who started the firm with Marler, after first being his adversary as legal counsel for Jack in the Box. “He means it. If he had to choose between being a lawyer or a food safety advocate, I’m confident he would chose the food safety advocacy.”

Maxwell, the food industry attorney, is convinced Marler is trying to prevent food poisoning. But he also says Marler has “a selfish reason” for wanting the ban on many types of salmonella.

Making the bacteria illegal in meat could help Marler quickly win settlements for his clients, Maxwell said, since food companies could no longer argue that his clients got sick because they undercooked their meat. It would be illegal for the pathogens to be there in the first place.

Marler can be disarmingly casual. He wears shorts and sweats to his fifth-floor office in downtown Seattle. He sits in a cubicle like the rest of his staff. But his devotion to cases, and an uncanny ability to simultaneously track dozens of them, can sometimes create a tense atmosphere in the firm.

When he asks for a document or other information from a staff member who doesn’t have it, his green eyes burrow into the person.

“We call it Marlerizing,” said Peggy Paulson, who recently retired after working as his administrative assistant and bookkeeper for more than 20 years. “Just bug . . . whoever has it until they comply with what you want. Just Marlerize them.”

In his advocacy work, Marler uses his blog to hammer away at the policy and legislative changes he would like to see. He posts editorials throughout the day — many of them landing at 3 a.m. Pacific time — when people on the East Coast are just beginning their day, but when nearly everyone on the West Coast is still asleep.

He said he spends about $250,000 annually to help finance an online publication, Food Safety News, considered a must-read for food policy leaders that attracts 2.5 million page views each month.

When Marler gives speeches at meat industry and food safety conferences, he speaks of his clients by name. His voice sometimes trembles.

Their stories are woven into his 2009 E. coli petition to the USDA; they are also part of his salmonella petition he filed Tuesday.

There is Rick Schiller, a 57-year-old Californian, whose fiancé rushed him to the hospital, his leg swollen to three times its normal size, after eating chicken contaminated with salmonella. He now suffers from arthritis and diverticulitis of his colon.

And 10-year-old Mikayla Porter of Florida, who spent weeks in a hospital intensive-care unit because of salmonella poisoning from pork.

Putting a human face on food poisoning has worked for Marler in Washington.

After contaminated spinach and peanut butter killed at least a dozen people in the mid-to-late 2000s, Congress considered overhauling the Food and Drug Administration’s food safety laws. Instead of focusing on stopping the flow of poisoned food, the FDA would do more to prevent contamination. (The FDA regulates some aspects of food safety, as does the USDA. Critics, including Marler, say the two federal agencies have policies inconsistent with each other.)

Marler fought for the bill for years, spending his own money to fly clients in to tell their stories in congressional hearings and in meetings with lawmakers and FDA officials.

When the proposed Food Safety Modernization Act stalled in the Senate just before a holiday break in 2010, Marler passed out custom T-shirts to senators that had a small picture of him on the front with a red X over his face. On the back it said: “Put a trial lawyer out of business. Pass meaningful food safety legislation by Thanksgiving.”

It was viewed as a showboat move by some, but when the bill passed, members of Congress and their staffs recognized Marler. A staff member for Rep. Rosa L. DeLauro (D-Conn.), one of the most vocal proponents in the House, gave him a signed copy of the legislation, a nod to the outsize role the lawmaker and Hill staffers believed he played.

Petitioners, Rick Schiller, Steven Romes, The Porter Family, Food & Water Watch, Consumer Federation of America and Consumer Reports.

Each year, Salmonella enterica subsp. enterica causes 1.35 million illnesses, 26,500 hospitalizations, and 420 deaths in the United States.[1] However, for every diagnosed and reported case of Salmonella, scientists estimate that 38 similar cases go unreported.[2] If these scientific predictions are accurate, Salmonella causes approximately 51.3 million illnesses each year and sickens one in six Americans.

There exist Salmonella serotypes that have demonstrable histories of foodborne illness outbreaks and have thus been proven injurious to human health. These “Outbreak Serotypes”[3] have been associated with numerous recalls, demonstrating not only failures within consumer and retail kitchens but also within federally inspected establishments. Thus, Marler Clark LLP, PS, on behalf of Rick Schiller, Steven Romes, the Porter Family, Food & Water Watch, Consumer Federation of America, and Consumer Reports are requesting that the United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) declare these Salmonella Outbreak Serotypes adulterants in meat and poultry products.

Rick Schiller was one of hundreds of persons sickened in the March 2013 Salmonella outbreak linked to Foster Farms poultry. Late one night in September of 2013, Rick was awakened by a sharp pain. When he pulled back the covers, he was startled by the sight of his own body—his right leg was dark purple and swollen to about three times its normal size. When a doctor examined Rick’s leg, she warned him that it was so swollen there was a chance that it might burst. Rick’s doctors eventually discovered that he had contracted Salmonella Heidelberg, which triggered a cascade of conditions, including an inflamed colon and an acute form of arthritis.

In September 2018, Steven Romes consumed medium-to-well done hamburgers as part of a Labor Day family cookout. Two days later, Steven fell ill with painful diarrhea, fever, and stomach cramps. Tests in the emergency room revealed that Steven was suffering from acute kidney injury and his illness was determined to be one of many illnesses in a nationwide outbreak of Salmonella Newport linked to various ground and non-intact beef products manufactured by JBS USA, the world’s largest meatpacker. Steven was later diagnosed with Irritable Bowel Syndrome (IBS). Today, he can only tolerate bland foods and he still occasionally suffers from stomach cramps and diarrhea.

Rose Porter and her 10-year-old daughter Mikayla Porter were two of nearly 200 people reported ill in the summer of 2015 from tainted pork in Washington state. On June 28, 2015, Rose hosted a party at her home. For the event, Rose had purchased a whole hog from a local butcher and spit-roasted it for the recommended 13 hours. By Independence Day of that year (July 4, 2015), a doctor warned Rose and Roger Porter that their daughter Mikayla could die within hours. For nearly a week, Rose and Mikayla had suffered from intensifying bouts of fever, diarrhea, and stomach pains because Salmonella I 4,[5],12:i-. In the end, Rose and Mikayla survived, but the threat of the infection that nearly killed them continues.

Modern scientific and medical research has revealed the health hazards posed by Outbreak Serotypes of Salmonella. Turkeys, chickens, pigs, and cows carry Salmonella and eventually shed the pathogen in their feces, thus delivering it to the environment. As a result, Salmonella is frequently transmitted to humans through the consumption of contaminated animal-based foods, namely poultry, beef, and pork. Although virulence markers are not serotype specific, research has shown that certain Salmonella serotypes are more likely to cause systemic disease. Additionally, a variety of processing methods have been proven to contaminate parts previously uncontaminated with bacteria and exacerbate the spread of pathogens in meat and poultry.

Accordingly, we (the Petitioners) urge the administration of FSIS to issue an interpretive rule declaring Salmonella Outbreak Serotypes adulterants within the meanings of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). By banning recurring serotypes in meat and poultry products, FSIS will take a significant leap forward in ensuring the safety of American consumers. As the burden of Salmonella infection within the U.S. steadily increases, immediate action on this issue is critical.

Thanks to Denis, Josh, Carl, Ilana and the dozens of others, unnamed at their request, who provided invaluable comments on the Petition.  You can download it here:

FSIS SALMONELLA PETITION 1.19.20 FINAL

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[1]Salmonella Homepage.” Centers for Disease Control and Prevention, 2019.

[2] Mead, P. S., et al. (2000). Food-Related Illness and Death in the United States. J Environ Health. 62(7):9-18.

[3] For the purposes of this petition, the term “Outbreak Serotypes” refers to thirty-one Salmonella serotypes: S. Agona, Anatum, Berta, Blockely, Braenderup, Derby, Dublin, Enteritidis, Hadar, Heidelberg, I 4,[5],12:i:-, Infantis, Javiana, Litchfield, Mbandaka, Mississippi, Montevideo, Muenchen, Newport, Oranienburg, Panama, Poona, Reading, Saintpaul, Sandiego, Schwarzengrund, Senftenberg, Stanley, Thompson, Typhi, and Typhimurium.