On Wednesday, September 16, and Thursday, September 17, we will be walking the Senate and House office buildings with two things for every member and staff of the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. The first is the t-shirt, rolled inside a small plastic baby bottle, that reads “For Babies’ Sake, Test for Botulism in Infant Formula.” The second is the stack of letters I have sent those two committees since June. Nobody has answered them.

Last week I wrote that the shirts were coming. Both chambers came back to Washington on Monday. The plan has not changed: all 23 HELP offices and all 54 Energy and Commerce offices get two shirts each, carried in by hand, and so do the committees themselves — the HELP Committee at 428 Dirksen and the Energy and Commerce majority and minority staff in Rayburn. That is 77 member offices, each getting a person at the counter rather than a package on a mail cart.

The letters are going in by hand this time

I have written each committee twice. Energy and Commerce received a letter on June 23 supporting H.R. 7867, with the statements and photographs of fourteen families attached, and a follow-up on August 28. HELP received a letter on June 29 and a follow-up on August 28. Four letters, two to each committee. Not one reply.

Mail to a congressional committee goes through screening, then a mailroom, then a cart, and it can sit a long time before it reaches the staffer who works the issue. This week the two letters each committee has not answered go in with the shirts, handed to a person rather than dropped in a bin. A letter in an envelope is easy to file. A letter that arrives with a baby bottle is harder to lose.

What the government confirmed after the first letters

The June letters made an argument. The August letters reported a laboratory result. On August 27 the CDC closed the Nara Organics investigation and found that epidemiologic, traceback and laboratory data showed Nara Organics Whole Milk Organic Infant Formula was contaminated with Clostridium botulinum and made infants sick. Whole genome sequencing linked a patient sample from the Nara outbreak to a patient sample, product samples and an ingredient sample collected during the 2025 ByHeart investigation. CDC reported that both brands were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America, and that the matching sequences point to a common source of contamination.

One qualification belongs in every account of this, and I put it in both letters. Neither agency has determined a root cause, and FDA says it does not yet have enough evidence to say whether the milk was contaminated before drying or during it. That question divides responsibility among the companies. It does not change whether the formula was contaminated, or whether it paralyzed babies.

Forty-eight infants in seventeen states in the ByHeart outbreak. Four in the Nara Organics outbreak, in California, Pennsylvania and Washington. Fifty-two babies hospitalized, many on ventilators, each treated with BabyBIG antitoxin that the State of California prices at $69,300 a dose.

What has not changed

Federal regulation, 21 C.F.R. § 106.55, still requires powdered infant formula makers to test finished product for two organisms, Salmonella and CronobacterC. botulinum is not on the list. FDA named the organism by genus and species in a March 8, 2023 Call-to-Action letter to the powdered infant formula industry. The rule never followed, and as I wrote yesterday, it still does not require the test.

H.R. 7867, the Infant Formula Safety Modernization Act of 2026, would put C. botulinum on the required testing list, require environmental monitoring inside the plants, hold foreign manufacturers to American standards and require notice to Congress of confirmed positives. Representatives Rosa DeLauro and Jeff Van Drew introduced it on March 9. The Energy and Commerce Health Subcommittee held a hearing on it on April 29. No markup has been scheduled. The Senate passed S. 272 by unanimous consent the same day, which shows this is not a hard vote, but S. 272 reaches only the organisms already on the list.

What we are asking both committees to do

The shirts carry the same requests the August letters did. To Energy and Commerce: mark up H.R. 7867 and report it favorably. To HELP: pass a bill that reaches botulism, whether a companion to H.R. 7867 or one of the Committee’s own. To both: hold an oversight hearing with FDA, Dairy Farmers of America, Organic West Milk, Nara Organics and ByHeart at the table; put the parents at the witness table, because they have already written to you and are willing to say it in person; and send FDA a written question with a deadline asking what its root cause investigation has found, whether it intends to require testing for C. botulinum by regulation, and when.

Quick answers

What is being delivered to Congress on September 16 and 17, 2026? T-shirts packed in baby bottles reading “For Babies’ Sake, Test for Botulism in Infant Formula,” along with hand-delivered copies of four letters Bill Marler sent the Senate HELP Committee and the House Energy and Commerce Committee in June and August 2026, which have gone unanswered. Every member office on both committees receives them, and so do the committee staff offices.

Why is powdered infant formula not tested for botulism? The federal rule at 21 C.F.R. § 106.55 requires finished-product testing only for Salmonella and CronobacterClostridium botulinum is not on the list, even after two outbreaks that hospitalized 52 infants and that whole genome sequencing has linked to a common source.

What would H.R. 7867 change? It would add C. botulinum to the required testing list, require environmental monitoring in formula plants, apply the same standards to foreign manufacturers and require notice to Congress of confirmed positive tests. It has had a subcommittee hearing and is waiting on a markup in the House Energy and Commerce Committee.

Four letters, no reply

My direct line is printed on every one of those letters. By Thursday afternoon every office that can put this bill on a calendar will have it twice, once on paper and once rolled up in a baby bottle. We will see which one gets a call back.

The four letters

https://www.marlerblog.com/files/2026/08/HR_7867_Support_Letter_6_23_26_WDM_FINAL.pdf

Letter to the House Committee on Energy and Commerce, June 23, 2026, with Appendix A — statements and photographs of fourteen families.

https://www.marlerblog.com/files/2026/08/Marler_Senate_HELP_Letter_Letterhead.pdf

Letter to the Senate Committee on Health, Education, Labor, and Pensions, June 29, 2026.

https://www.marlerblog.com/files/2026/08/HR7867_Follow_Up_Letter_8-28-26.pdf

Follow-up letter to the House Committee on Energy and Commerce, August 28, 2026.

https://www.marlerblog.com/files/2026/08/Senate_HELP_Follow-Up_Letter_8_28_26_WDM.pdf

Follow-up letter to the Senate Committee on Health, Education, Labor, and Pensions, August 28, 2026.

On September 14, Representative Debbie Dingell and nine House colleagues wrote to Agriculture Secretary Brooke Rollins asking why USDA shelved two of its three Cyclospora research projects during the largest foodborne illness outbreak the country has recorded. It is the fourteenth congressional letter on the 2026 outbreak, the first addressed to USDA, and the first since Senator Warren wrote on August 13. Six letters have now come from the House and eight from the Senate, every one of them from Democrats. I last wrote about the letters when the season closed. As of this morning I still cannot find a published answer to any of them.

Three days before the letter went out, CDC declared the outbreak over. Its final update ties 12,883 illnesses in twenty-one states, at least 570 hospitalizations and two deaths in Michigan to iceberg lettuce from Taylor Farms de Mexico. The national season count is larger. CDC’s case data show 19,595 laboratory-confirmed domestic cases from May 1 through September 8, with 1,043 hospitalizations in forty-nine states and the District of Columbia, against 1,180 cases for the same months of 2025. FDA says its investigation continueswhile it moves into what it calls post-response, prevention-oriented work. Ending an outbreak is an epidemiological call. It does not answer anybody’s questions.

What the fourteenth letter asks

The letter rests on reporting by Politico, carried by Reuters, that two of three Agricultural Research Service Cyclospora projects at the Beltsville Agricultural Research Center in Maryland have been shelved and that the third is moving to Iowa. The members write that the scientists on that third project are not expected to relocate, that researchers can do little beyond preserving samples from past outbreaks, and that they are turning away requests for help from other federal agencies investigating this one. Senator Warren raised the Beltsville closure in August. This is the first letter built around it.

USDA told Reuters that Congress did not fund the two projects for fiscal 2026 and that the research service is working with research leaders on an orderly transition. The letter answers that the same November 2025 law barred USDA from spending money on its reorganization without congressional approval. Its first question asks whether the Department will seek that approval or proceed without it. The other five ask how many research service employees have left and what work their departures affected, how many relocating staff are expected to quit rather than move, how the vacancies will be filled, and how the Cyclospora samples and equipment will get from Maryland to Iowa intact. The members want answers within two weeks of receipt, which makes roughly September 28 the only live deadline on this outbreak.

Why it matters

For two months I have written that the letters asked about surveillance cuts, political influence and the recall, and that none asked how to keep the next outbreak from happening. This one comes closest. The members describe the research as what helps officials understand an outbreak and build a strategy to prevent the next one. There is no whole genome sequencing for this parasite. CDC links cases by genotyping, and used it in this outbreak to show the parasites making people sick were genetically related. The science that makes that possible does not maintain itself.

In July, Secretary Rollins told a Hill audience that cyclosporiasis is an FDA issue, not a USDA one. On outbreak response that is mostly right, since FDA regulates produce. On research it is not, and the fourteenth letter went to the department that holds the bench.

Here is the whole list, updated. The column on the right is still the one to read.

DateWho wrote, and to whomWhat was asked forDeadline and status
Jul 14Sen. Amy Klobuchar (MN) to CDC and FDARestore FoodNet, FERN, inspection staffing and public health grantsNone set. No answer found
Jul 15Rep. Greg Stanton (AZ) to Sec. KennedySix questions: who ordered the surveillance change, what funding was cut, how many staff lostAug 3. Passed, no answer found
Jul 16Sen. Jon Ossoff (GA) to Sec. KennedyThree questions on restoring Cyclospora tracking and the state of the investigation72 hours, Jul 19. Passed, no answer found
Jul 17Reps. Dingell, McDonald Rivet, Scholten and Tlaib (MI) to CDC and FDATen questions from inside the outbreak, including whether the agencies agree with Michigan on the sourceJul 24. Passed, no answer found
Jul 20Rep. Josh Gottheimer (NJ) to CDCRestore FoodNet to mandatory active surveillance, plus two billsNone set. No answer found
Jul 20Sens. Blumenthal (CT) and Booker (NJ) to CDCA briefing on how the outbreak was tracked and whether staffing cuts caused delayUndated. No answer found
Jul 24Sen. Ossoff, second letter, to Sec. KennedyThe same three questions, plus the fact that the first letter went unansweredNone set. No answer found
Jul 27Rep. Robert Garcia (CA), Oversight Ranking Member, to Bruce TaylorFive categories of documents and five written questions, including facility records back to 2013Aug 10. Passed, no production found
Jul 28Sen. Kirsten Gillibrand (NY) to CDC and FDASix questions on the collapse of the federal laboratory networkJul 31. Passed, no answer found
Jul 30Sen. Blumenthal, PSI Ranking Member, to FDAAll records, including every communication with the White House and with the companyAug 13. Passed, no answer found
Jul 30Sen. Blumenthal, PSI Ranking Member, to Bruce TaylorAll records, including every communication with the White House and with FDAAug 13. Passed, no production found
Jul 30Reps. Veasey, Dingell and Sewell with about fifty colleagues, to CDC and FDATransparency and immediate action to identify the sourceNone set. No answer found
Aug 13Sen. Elizabeth Warren (MA) to Sec. KennedyNine questions on the retracted test, the White House call, what the outbreak has cost, and which states still reportAug 27. Passed, no answer found
Sep 14Rep. Dingell (MI) and nine House colleagues to Sec. Rollins, USDASix questions on the shelved Cyclospora research, staff losses at the research service, and whether USDA will seek congressional approval for its reorganizationTwo weeks from receipt. Pending

I believe that is every letter and I am not certain it is. I built the list from posted letters, press releases and, for the Blumenthal and Booker letter, a television report, and I have had to add letters after publishing before. No answer found means exactly that and nothing more; an agency can answer a member privately, and neither side has to publish it. If you have an answer to any of these, send it and I will correct this post.

The fix sits in the same law as the traceability delay

USDA’s answer puts the two shelved projects in an appropriations decision. The November 2025 law that ended the shutdown also carries Section 780, which bars FDA from spending money to administer or enforce the food traceability rule before July 20, 2028. One law holds both the research cut USDA now points to and the delay that made this outbreak harder to trace. Congress wrote both provisions, and Congress can undo both in the next funding bill. Neither fix needs a letter.

Still no hearing

Eight dated deadlines have passed without a published answer, the last on August 27. No committee has noticed a hearing. The Senate Permanent Subcommittee on Investigations, which held a hearing on Cyclospora in imported raspberries in July 1998, can issue a subpoena; Senator Blumenthal wrote as its ranking member and copied Chairman Ron Johnson, and a ranking member cannot subpoena alone. The House Oversight majority can adopt Representative Garcia’s document request as the committee’s own. The Agriculture Committees in both chambers oversee USDA, and the appropriators fund all three agencies. Every one of those tools belongs to the majority.

CDC says the outbreak is over. The questions are not. Fourteen letters have put them in writing, thirteen of them have gone unanswered in public, and the newest is due in about two weeks. If a letter will not put anyone in a chair, a subpoena to a hearing will.

On Sunday and Monday I posted about this outbreak. One post showed that FDA already answered the argument Taylor Farms is making, in a 2020 warning letter to another salad company. The other walked through every public version of the theory that the parasite came out of Michigan and Ohio water, and the papers offered to support it.

Monday, the International Fresh Produce Association posted the final version of its consumer FAQ — stamped September 14 at 10:00 a.m., with a note that the page will not be updated again and that readers should go to the federal sites. It is now the association’s permanent record of the 2026 season. Some of it deserves credit. One part of it should still be withdrawn. And on the central question my first post was about, the association and one of its largest members are now on opposite sides, with the association plainly in the right.

On the question Taylor Farms is fighting, IFPA answers it straight

Asked whether a specific food was identified, the page says yes. Asked whether the recalled product tested positive, it says there were no confirmed positive product results at any point in the investigation, that the recall and the findings rested on epidemiologic evidence and traceback rather than a positive laboratory test, that produce testing for this parasite has real and documented limitations including low sensitivity at low contamination levels, that implicated product is usually gone before testing is possible — and that the absence of a positive sample did not mean the epidemiological and traceback findings were wrong.

Compare that with the sentence still posted on the Taylor Farms hub: epidemiology can point to a potential source but cannot confirm that a specific product caused illness, and that confirmation requires a positive lab test. One of those two statements matches what FDA told Fresh Express in October 2020 — that it is not uncommon to see many negatives even when contamination has occurred. It is not the one on the company’s website.

The narrowing on water is real, and it belongs in print

In the version stamped September 4, the one I quoted on Sunday, the sewage-overflow material sat under a heading asking what else could be a source of infection. In the final version it has moved into a section describing what IFPA raised during the investigation, written in the past tense, and it is fenced: the page says those concerns were raised in connection with the smaller, still-unconfirmed clusters, not as an alternative explanation for the confirmed Taylor Farms de Mexico finding, which FDA tied to imported product from central Mexico.

That is a narrowing and I said in my last post that it belonged in print. It still does. The association has conceded the recall cluster and scoped water to the cases nobody can explain — roughly six thousand seven hundred laboratory-confirmed illnesses this season, on the agencies’ own figures, sitting outside the outbreak count with no source publicly identified. Those cases are real. Adding water questions to a hypothesis-generating questionnaire costs almost nothing and might answer something.

One claim survived the edit and should not have

The page still says there was documented, significant rainfall and combined sewer overflow activity in parts of the affected region in mid-June, and that the timing is worth continued attention. The page’s own biology answers it. IFPA states that oocysts need seven to fifteen days in a warm, moist environment before they can infect anyone, and that symptoms begin on average about a week after exposure. CDC puts the first outbreak-linked illness onset at June 14. Work backward through a week of incubation and one to two weeks of sporulation and the contamination event lands in late May. A mid-June overflow is downstream of the illnesses it is offered to explain.

Scoping that claim to the unexplained clusters does not repair it. The timing argument fails on IFPA’s own numbers no matter which cases it is pointed at. On a page that will never be updated again, it should come out.

The word doing the quiet work is subcluster

Throughout the final version, the 12,883 illnesses are a subcluster of a broader outbreak. Neither agency uses that word. CDC’s final update calls it a multistate outbreak and states in its own voice that epidemiologic and traceback data showed the Taylor Farms de Mexico iceberg lettuce was contaminated and made people sick. FDA’s advisory says the same and keeps its investigation open. Nothing is inaccurate about the word subcluster — there were other clusters — but it shrinks the largest confirmed produce outbreak in the history of this parasite into a portion of something unexplained, and vocabulary does argument work that footnotes cannot.

Two sentences on that page cut against me, and I will say so

The page says findings in a Cyclospora investigation are strongest when supported by multiple complementary lines of evidence rather than resting on any single source in isolation. And it says patient interviews and purchase records are an important piece of the puzzle, “but not a substitute for the physical and laboratory evidence” that is harder to come by with this parasite. A defense lawyer will put that second sentence next to everything else I have quoted and argue the association agrees with Taylor Farms.

The answer is on the same page. There were multiple lines here: epidemiologic interviews across twenty-one states, a traceback that converged on a single supplier, and CDC genotyping showing the parasites from sick people are genetically related. IFPA read all of that and still answered yes when asked whether a food had been identified. Wanting more evidence is not the same as saying the evidence you have proves nothing. Taylor Farms is making the second argument. Its association is not.

One error worth fixing even on a closed page

The page tells consumers that all water used for crop irrigation must meet cleanliness standards set by FDA. Three answers later it explains, correctly, that since the 2024 update to the Produce Safety Rule pre-harvest agricultural water is no longer tested against numerical criteria at all — farms perform a documented annual assessment instead, and only post-harvest water carries a testable microbial standard. Both statements cannot be true. The first is the one a worried consumer will remember, and it is the wrong one.

There is also a mismatch on the July 18 sample. IFPA describes it as routine random sampling unrelated to the recalled product. FDA’s own July 19 update describes it as a sample of lettuce supplied by Taylor Farms de Mexico. Both can be true if the lot was never part of the recall, but the supplier’s name is in FDA’s sentence and not in IFPA’s.

What the page gets right, and what I will back

Three things on that page are more useful than anything the implicated company has published all summer.

First, the undercount, stated by the industry itself: this parasite does not appear on the standard parasite panel, a physician has to ask for it specifically, and doctors are advised to test three separate stool samples on different days before calling a negative real. Every count this season is a floor.

Second, the admission that there is no FDA guidance and no validated, Cyclospora-specific protocol telling growers how to prevent contamination. IFPA calls it a real gap rather than an oversight, and points growers to university extension material for lack of anything federal. That is a striking thing for the largest produce association in the country to have to write, and it is an argument for a rule rather than against one.

Third, the FSMA 204 answer. IFPA says it cannot quantify what the delay cost this investigation but that the underlying gap is real, that traceback here ran on interviews, purchase records and manual work, and that it continues to advocate for full implementation. Good. I will take that sentence to Congress the next time somebody proposes to push the compliance date again.

The association has also proposed an FDA-led public-private task force to do a root cause analysis now that the investigation has closed. I support that, on three conditions: the findings get published, the sampling data behind them gets released, and somebody in the room does not work for the industry being examined. FDA has said it plans a root cause analysis of its own. Those are compatible.

The ask: nine things IFPA could put its name on before next May

On Saturday I listed ten things the FDA should do before the next season. This is the industry half of that list. None of it requires anyone to concede a lawsuit, and most of it does not require a statute. Several items IFPA has already half-endorsed, which is the point — finish the sentence.

1. Oppose any further delay of FSMA 204 and say so to Congress. The compliance date is July 20, 2028, moved there from January 2026, and last November’s appropriations law directed FDA not to enforce before that date. IFPA says it cannot quantify what the delay cost this investigation but that the gap is real. Then defend the date publicly and ask Congress to lift the spending prohibition that keeps FDA from building the receiving system Section 204 ordered in 2011.

2. Co-fund a detection method a grower can actually run. FDA has a validated laboratory method for finished produce. There is nothing comparable for irrigation water, sediment or soil at commercial scale and speed, and IFPA’s own page concedes there is no validated prevention protocol for this parasite at all. Put industry money behind method development, insist the limit of detection be published, and stop asking members to manage a hazard they cannot measure.

3. Back restoration of the defunded federal Cyclospora research. Two federal research projects went unfunded in the FY2026 agriculture bill and a third is being moved away from the scientists running it. An association that wants better tools should be saying which questions its members cannot answer without that work.

4. Support making Cyclospora mandatory in FoodNet again. Reporting for this parasite became optional on July 1, 2025, after twenty-eight years. We went into the worst season on record without the yardstick for normal. Restoring it costs the industry nothing and gives every member a defensible baseline.

5. Fund state laboratory capacity for genotyping. CDC’s genotyping was the first tool this summer that did not depend on somebody remembering a June salad, and it is the tool most likely to separate one company’s product from everyone else’s in the next outbreak. Industry has more to gain from that separation than anybody.

6. Adopt a members’ disclosure standard for testing claims. Any member that publicly cites its own testing numbers publishes the composition behind them: matrix, method, sample weight, dates, lots and results. FDA’s 2013 assessment of Taylor Farms de Mexico did exactly that — it printed the table, and the table showed that of 793 samples, 42 were finished product. An association can write that standard into its own code of practice tomorrow.

7. Write a worker sanitation standard built for a human-only parasite. That same 2013 assessment found field handwashing stations whose valve handles created a cross-contamination route and recommended that employees with diarrhea be encouraged to submit stool samples. Thirteen years later there is no standard requiring hands-free handwashing at field sanitary units, documented pump-out siting and service records, or access to testing and paid sick leave for symptomatic harvest workers. Humans are the only host. Everything else is downstream of that.

8. Make a documented growing-region assessment a condition of supply for imported leafy greens. For regions with a documented history of this parasite, ask members to require — under their existing foreign supplier verification obligations — a written assessment of the region’s sanitation infrastructure and water sources, and publish the audit standard so buyers and growers are working from the same document.

9. Fund wastewater surveillance for this parasite, including in growing regions. This one is IFPA’s idea and I am adopting it. The association asked CDC to consider routine wastewater surveillance to understand where the parasite is present. It is a sound proposal for an organism that exists only in human waste, and it would be more useful still in the valleys that grow American winter produce than in Lake Erie.

Add the condition I put on the task force: FDA publishes the root cause findings and the sampling results either way, and someone in the room does not work for the industry being examined. A published negative tells every farm in that valley the contamination was not where investigators looked. FDA’s letter to industry asks members to apply rules already on the books and promises to fold lessons into an action plan first published in 2021. Nine specific commitments from the largest produce association in the country would be worth more than that letter.

The association is carrying weight it should put down

IFPA’s page and Taylor Farms’ page now sit on opposite sides of the same question. One says the finding rested on epidemiology and traceback and that the absence of a positive sample did not make it wrong. The other says only a positive sample could have confirmed anything. FDA said the first thing in an enforcement letter six years ago. CDC said it in its final update this month. The association got it right.

What remains is the water paragraph, kept alive on a page that will never be edited again, on timing its own biology contradicts. Take it down and take up the nine. Nineteen thousand five hundred and ninety-five Americans were laboratory-confirmed with this parasite between May and September, and roughly six thousand seven hundred of them still have nothing written next to their names. The season starts again in May. There is time.

CDC closed the iceberg lettuce outbreak on September 11 with a final count of 12,883 illnesses in twenty-one states, at least 570 hospitalizations and two deaths in Michigan, with onsets running from June 14 to August 17. At the peak, before the recall, CDC says more than a thousand infections were occurring in a single day; by August the average was under two a day. Nationally, FDA reports that CDC had counted 19,595 laboratory-confirmed cyclosporiasis cases as of September 8. FDA’s investigation of Taylor Farms de Mexico is still open, and the samples FDA and Mexican officials collected at the growers and the processing plant are pending analysis.

CDC’s final update states the conclusion in its own voice: epidemiologic and traceback data showed that iceberg lettuce from Taylor Farms de Mexico was contaminated with Cyclospora and made people sick. There has never been a positive product test.

The company’s Cyclospora information hub, last modified September 1, answers that. Epidemiologic evidence, it says, is a legitimate tool that can point investigators toward a potential source. Then: it cannot confirm that a specific product caused illness, and that confirmation requires a positive lab test of the product. FDA has no confirmed positive result for any Taylor Farms product as of August 27. The company’s own testing, approximately two thousand samples taken in central Mexico since May, has returned zero positives. The investigation continues, and we will follow the science.

I have been reading company statements in outbreaks for more than thirty years. That paragraph was not drafted by a microbiologist. It reads like a causation defense, or like a communications team looking for a sentence that is technically defensible and lands like exoneration. Here is how you can tell, and here is why it does not survive contact with FDA’s own files.

FDA answered this exact argument in 2020, in writing, to another company

In the 2020 Cyclospora outbreak, FDA and CDC linked bagged salad mixes made at Fresh Express’s Streamwood, Illinois plant to at least 701 illnesses in fourteen states. FDA never found the parasite in a package of salad. It found it in canal water near a farm in south Florida. It then issued a warning letter dated October 20, 2020, and that letter is the best answer anyone has written to the paragraph now sitting on the Taylor Farms website.

Three things in it matter. First, the finding: based on epidemiological and traceback evidence, CDC and FDA determined that the bagged salad mixes made at that facility were the source of the outbreak. Second, the legal consequence: FDA declared the product adulterated under section 402(a)(1) of the Food, Drug, and Cosmetic Act, citing the presence of the parasite in the salad mixes as evidenced by the outbreak itself. Not by a laboratory result. By the outbreak.

Third, and this is the sentence Taylor Farms needs to reckon with. Fresh Express had handed FDA its own negative testing results. FDA wrote back that the company had provided results showing no detection of the parasite in any of its samples and then explained why that did not matter: human pathogens like Cyclosporaare not present in high numbers or homogeneously distributed, and it is not uncommon to see many negatives even when contamination has occurred.

That is FDA, in an enforcement document, telling a salad company that its own negative test results do not mean what the company wants them to mean. Taylor Farms is offering the public the same argument, with a bigger number attached.

The sentence states a legal standard, not a scientific one

Read the verb. The claim is not that the lettuce tested clean. The claim is that nothing can confirm that a specific product caused illness without a positive laboratory test. Causation and confirmation are courtroom words. Outbreak investigators do not use them that way; they identify a vehicle from the evidence that exists — interviews, case-control studies, product tracing, environmental assessment, and laboratory work when there is something left to test.

It also sets a standard higher than any court applies. In civil litigation the question is what more likely than not caused the harm. A rule requiring laboratory confirmation of the food would exceed the burden of proof in every American courtroom.

It appears in no guideline anywhere

The Council to Improve Foodborne Outbreak Response publishes the guidelines state and local health departments use. It is the joint work of the epidemiologists, laboratory directors, environmental health specialists and regulators who do this for a living, with CDC, FDA and FSIS at the table. Chapter 6, Box 6.4, sets out when contaminated food should come off the market, and lists the bases in the alternative, separated by the word OR. The first is specific exposure information linking illness to consumption of that food, even if the pathogen has not been isolated from the food. A definitive laboratory result on a representative sample is listed second, as another way to get there. Section 6.1.1 of the same chapter says waiting for laboratory results may not be necessary before control measures are implemented.

It borrows FDA’s phrase and leaves FDA’s sentence behind

No confirmed positive sample results for product testing is FDA’s wording, from its July 19 false-positive correction. Five days later, on the same advisory page, FDA wrote that the false-positive sample does not change the basis for its ongoing outbreak investigation or the overwhelming epidemiological data supporting the recall, and that traceback and outbreak data continued to converge on shredded iceberg lettuce from Taylor Farms growers in central Mexico. Both sentences are on one FDA page. The hub uses one of them.

It is frozen on a date that has been overtaken

As of August 27, was accurate when written. It is not the current state of the record. FDA updated the advisory on September 11 to 12,883 illnesses in twenty-one states with 570 hospitalizations, and CDC closed the outbreak the same day. The company’s page has not moved since September 1. The number of people has changed; the sentence has not.

It explains the limits of epidemiology and says nothing about the limits of its own testing

Two thousand samples is offered as evidence, and it is the only quantitative claim on the page that no member of the public can check. Samples of what, taken where, when, by whom, by what method, at what sample weight, from which lots? The paragraph that carefully explains what epidemiology cannot do says nothing at all about what its own testing program can do. And then the tagline: we will follow the science arrives one sentence after the page departs from it.

The company did not apply this standard itself, twice

The hub’s own timeline says FDA and CDC brought the traceback and epidemiologic data on July 15, that the company raised scientific questions about the government’s assumptions and methodology on July 15 and 16, and that on July 16 it decided to recall. On July 17 it announced a recall broader than FDA’s traceback — all iceberg sourced and processed through its central Mexico facility — and the page says it did this voluntarily, before FDA asked. There was no positive test on any of those days, and there never has been one. Under the standard the FAQ now proposes, nothing had been confirmed, there was nothing to recall, and the shredded iceberg would have stayed on the line.

The same thing happened in 2013, at the same plant. The company suspended shipments to the United States on August 9, 2013, with no positive product test in existence, and chairman Bruce Taylor told reporters at the time that all our tests have been negative and there was no evidence of Cyclospora in the product. FDA’s environmental assessment, conducted August 12 to 19 at Doctor Mora and five ranches, reports that in the combined sampling of CDC, FDA and Taylor Farms de Mexico, approximately 835 product, water and environmental samples were analyzed, including over 269 human fecal samples collected from on-ranch sanitary facilities. All tested negative except one FDA sample, number 744382, which was inconclusive because the turbidity of the recycled wash water inhibited analysis by the BAM method. The epidemiologic and traceback work still tied the salad mix from that plant to restaurant illnesses in Iowa and Nebraska; CDC’s surveillance summary counts 162 laboratory-confirmed cases among people who ate at two related restaurant chains.

A company that recalls without a positive test, twice, and then tells the public that only a positive test can confirm anything, is not describing how it thinks. It is describing what it would like a jury to believe.

Run the rule backward and almost nothing gets solved

In 1996, 1,465 cases of cyclosporiasis across twenty states, the District of Columbia and two Canadian provinces were associated with Guatemalan raspberries. As the National Advisory Committee on Microbiological Criteria for Foods recounts it, no positive results for the parasite were obtained from any of the environmental samples. In 2013, Texas investigators ran a case-control study on a restaurant cluster and found a matched odds ratio of 19.8 for cilantro, with traceback converging on three suppliers in Puebla. No positive product sample. In 2020, the Fresh Express outbreak above, where FDA found the parasite in a canal and never in a bag. Under the rule this page proposes, none of those vehicles was ever identified and nobody was ever asked to change anything.

A negative result is the expected result, even when the parasite is there

When Canadian federal scientists verified FDA’s BAM 19b method, leafy greens spiked with two hundred oocysts came back positive 93 percent of the time. Leafy greens spiked with ten oocysts came back positive 30 percent of the time. Seven out of ten known-contaminated samples read clean.

Here is the company’s best counterargument, and the produce industry does make it: FDA’s validated method can detect as few as five oocysts in a 25-gram sample. Read the fine print on what that means. Under FDA’s validation guidelines, the limit of detection is the seeding level that produces fractional results — roughly half of known-contaminated samples test positive and half do not. A method’s published floor is the point where it is a coin flip, not the point where it is reliable. Published modeling of FDA’s own validation data puts a number on it: a single 25-gram produce sample reliably detects contamination only above roughly 0.92 oocysts per gram. FDA’s 2013 assessment of this very plant estimates the infectious dose at ten to a hundred sporulated oocysts.

Do that arithmetic. A hundred-gram serving of lettuce carrying fifty oocysts is enough to put somebody in the hospital and sits well below the level at which one sample reliably reports anything. FDA called detection of this parasite complex when it walked back its own July 18 result. That complexity does not run in one direction.

The company’s own trade association says the opposite

The International Fresh Produce Association’s consumer Cyclospora FAQ, last updated September 14, asks whether a specific food was identified and answers yes. Asked whether the recalled product tested positive, it says there were no confirmed positive product results, that the recall and the findings rested on epidemiologic evidence and traceback rather than a positive laboratory test, that produce testing for this parasite has real documented limitations including low sensitivity at low contamination levels, and that the absence of a positive sample did not mean the epidemiological and traceback findings were wrong. That is the produce industry’s own association, writing for consumers, contradicting one of its largest members.

I have heard this argument in a courtroom. It lost.

In October 1998, eleven children were infected with E. coli O157:H7 after a taco lunch at Finley Elementary School in Benton County, Washington. I tried that case. The investigating team, headed by the state epidemiologist for communicable diseases, concluded in writing that because no other common school activity was identified, it was reasonable to conclude a meal served at the school was the likely source, and that the ground beef in the tacos was likely the vehicle. The team called it the most probable source, meaning greater than fifty percent certainty. The jury was asked whether the taco filling contained E. coli and whether it caused the children’s injuries and answered yes to both. The Court of Appeals affirmed on November 21, 2002.

That is what epidemiologic proof looks like when it is tested by cross-examination rather than posted on a website.

Two thousand samples of what?

We know exactly why this question matters, because the 2013 environmental assessment published the breakdown of the last time this company counted its own samples. Of the 793 samples Taylor Farms de Mexico collected across its plant and thirty ranches that year, 273 were sanitary samples, 238 were agricultural inputs, 164 were pre-harvest plant tissue, 47 were environmental, 29 were in-process — and 42 were finished product. A sample count is not a finding. The composition is the finding.

So, publish the composition. None of this is proprietary.

Samples of what. Finished product, incoming raw lettuce, standing crop, irrigation water, wash water, environmental swabs, sanitary facilities. Give the count for each, as the 2013 report did.

By what method. BAM 19b for produce and 19c for water, or an in-house assay? Was it verified for shredded iceberg specifically, and what limit of detection did that verification show?

At what sample size. Twenty-five grams each, or grabs composited into a single test? How many grams were tested against a lot of what weight?

When. The recalled product was distributed June 29 through July 16. How many of the two thousand samples came from lots produced in that window? If the answer is none, say so plainly.

Where. How many ranches, which ones, and how many samples came from the Doctor Mora plant as against the fields that supplied it.

Against what volume. The recall covered 236,192 cases of iceberg lettuce and salad mixes. Two thousand samples against a season of production is a sampling rate, and the company can state it.

Who ran them. The company’s laboratory or an accredited independent one? Will the reports, chain-of-custody records and raw Cq values go to FDA and to the public?

Were there presumptives. Any initial positives retested and reclassified, and any samples where inhibition was detected? FDA disclosed its own reversal within a day. An inhibited sample is not a negative one — FDA sample 744382 is the precedent, at this plant.

And the water. In 2013 this company committed to a sampling program covering products and water as a condition of resuming shipments. Thirteen years on, there is still no public result.

Publish the data or stop citing the number

I have been through every version of this company’s statement since July 17, and through four weeks of the public record since. The two thousand has been carried forward the whole time without ever acquiring a noun.

FDA already wrote the answer, to a different company, six years ago: it is not uncommon to see many negatives even when contamination has occurred. Twelve thousand eight hundred and eighty-three people are in CDC’s final count for this one outbreak. Five hundred and seventy went to a hospital. Two died. They are owed something better than a sentence built to survive a deposition.

Through the summer, one explanation competed with the lettuce for the largest Cyclospora outbreak in American history: that the parasite came out of American water — municipal sewage overflows around Detroit and Toledo, private wells, and Lake Erie. Below is every public instance of that argument I can document, what each one claimed, what each one cited, and the answer to each. Every source is linked. Check all of it.

A word on who IFPA is, because the name is newer than the organization. 

The International Fresh Produce Association began operations on January 1, 2022, formed by the merger of the two largest produce trade groups in the country, the United Fresh Produce Association and the Produce Marketing Association. It is the largest association serving the fresh produce and floral supply chain, with offices in Washington and Newark, Delaware, and it speaks for growers, shippers, processors, retailers and foodservice operators. Max Teplitski is its chief science officer.

One disclosure first. My firm represents people sickened in this outbreak and we have filed cases naming Taylor Farms entities. Everything below is public either way.

July 15 — the statement that started it

The original IFPA statement, attributable to Chief Science Officer Max Teplitski, is still posted beneath the July 19 revision. Its central claim is that a statement released by the Michigan Department of Health and Human Services defies reputable science in saying recreational waters are not a recognized risk factor. Three footnoted citations carry that charge, with a fourth to a federal advisory report. Around it runs the argument that everything pointing at produce rests on patient recollection, that no contaminated product sample has been found, and that naming a product without one destroys consumer trust and puts thousands of jobs in jeopardy.

July 16 — the interview version, with the Flint line

Teplitski expanded it in The Packer. He said it was puzzling that state public health officials still rebuilding trust with consumers after Flint would rush to dismiss water as the source. He said the first documented U.S. Cyclospora outbreak, in 1990, was traced to contaminated water, and that a 2023 USDA and FDA advisory report lists recreational water among the water types where the parasite has been detected, including chlorinated water. He added that if Michigan officials are outright refusing to test water, they will never have a positive sample.

July 19 — the claim comes out of the statement

The updated statement, timestamped 8:15 p.m. ET on July 19 at the same address, contains no reference to recreational water, to Michigan, or to the three citations. The association preserved the original beneath it, which is more than most trade groups do and should be said plainly. The argument did not stop. It moved.

August 3 and 4 — the claim is filed with CDC

IFPA submitted formal comments on CDC’s proposed extension of the Cyclosporiasis National Hypothesis Generating Questionnaire and announced them on August 4. The filing recommended structured questions on drinking water sources, recreational water activities, wastewater exposures and septic systems, asked CDC to revisit unresolved historical investigations, and urged evaluation of wastewater surveillance. Teplitski framed it as a need to “expand our thinking about this parasite and seriously consider other routes of exposure.” The nine attached questions asked about main drinking water source, water drunk away from home, awareness of flooding or sewer overflow or a boil-water advisory, septic systems and last service date, occupational contact with sewage treatment, stormwater, portable toilets and biosolids, camping on private water, and recreational water contact — with a checklist running pool, hot tub, splash pad, lake, river, pond, irrigation canal or ditch. The Packer and the rest of the trade press carried it.

August 5 onward — the geographic version, on the consumer page

The claim is stated most plainly on IFPA’s consumer FAQ, which was last updated September 4, 2026 and is still live. Under what else could be a source of infection, it says the association continues to raise concerns about recent municipal sewage overflows in the greater Detroit and Toledo region and the likelihood of those events affecting drinking water, especially wells, and recreational water in Lake Erie and surrounding bodies of water, and that Cyclospora is fundamentally a waterborne parasite. A later answer cites documented rainfall and combined sewer overflow activity in parts of the affected region in mid-June. An August 6 member alert carried the same recommendations to the membership.

August 19 — a scientist quoted, and then a correction

Trevor Suslow, a food safety consultant and emeritus professor at the University of California Cooperative Extension, was quoted in Ag Alert on how hard this parasite is to trace. As first published, the article attributed to him the view that it was possible and even likely that the outbreak stemmed from the parasite surviving wastewater treatment rather than from fresh produce. That attribution no longer stands. The article now carries an editor’s note recording it, along with a clarification Suslow provided after publication: several possible sources could explain the totality of cases, different sources of produce remain among them, and exposure from treated wastewater and possibly drinking water should be investigated before it is either included as plausible or ruled out. His own summary is that “neither fresh produce nor treated wastewater can likely explain all” the illnesses this summer. The article also discloses that he has consulted on food safety for Taylor Farms, among other produce companies, and visited the implicated Mexican farms and processing facility the month before. I relied on the earlier uncorrected version of that article in an August post, and I am correcting it here.

The lead citation says the opposite of what it was cited for

Start with the first footnote, because it carries the charge that Michigan defied reputable science. It is Beshearse and colleagues, Emerging Infectious Diseases, 2021 — a CDC-led structured expert judgment study of transmission pathways for thirty-three pathogens. Its finding for this parasite: Cyclospora cayetanensis was the only protozoan estimated to have majority transmission through the foodborne pathway. The numbers are 83 percent foodborne, with a 95 percent uncertainty interval of 59 to 99, against 6 percent waterborne. Of that 6 percent, the recreational subpathway takes 39 percent — roughly two percent of all domestically acquired cyclosporiasis, carrying an uncertainty interval that runs from 0 to 99, which is another way of saying the experts could not put a floor under it. The same paper’s comparison table puts earlier U.S. work at 99 percent foodborne and the Canadian expert elicitation at 83.1 percent. A document offered to prove that recreational water is a recognized risk factor is in fact the strongest American statement on record that this parasite is a food problem.

Finding the parasite in water is not finding a case of illness

The second and third footnotes are detection studies. Galván and colleagues, Applied and Environmental Microbiology, 2013, is a study of human-pathogenic microsporidia in Madrid; Cyclospora turned up in 9 percent of 223 samples from four drinking water plants, seven wastewater plants and six river locations across 2008 and 2009. No Spanish outbreak followed. Bilung and colleagues, 2017, is modified Ziehl-Neelsen microscopy on two rivers and two recreational sites in Malaysian Borneo, finding the parasite in two of twenty-four source-water samples. It measured no human illness and was not conducted in this country. Both papers establish that oocysts can be present in water. Neither establishes that anyone got sick from swimming.

The fourth citation is the 2023 NACMCF report on Cyclospora in produce, and it is the one IFPA should have read hardest. Teplitski chaired the NACMCF subcommittee that wrote it. The association’s own 2023 press release announcing the report says two things that cut against everything above. First, that Cyclospora is only carried by humans, and that individuals with a recent history of travel to areas where it is highly prevalent are likely the main source of contamination along the entire production, processing and food service continuum. Second, that current testing procedures do not adequately differentiate the species that sickens humans from others, referencing reports of 90 percent false-positive rates in the methodologies underlying some common tests. That is IFPA’s own summary of the federal report, and it is a warning about exactly the kind of detection study being offered as proof that the parasite is in the lake.

The 1990 outbreak was a building’s water tank, and it may not have been waterborne at all

The first reported U.S. outbreak, published by Huang and colleagues in the Annals of Internal Medicine in 1995, involved housestaff physicians and administrative staff at a Chicago hospital. CDC’s own reviewdescribes it as eleven confirmed infections among twenty-one people with diarrhea, associated with drinking tap water in a residents’ dormitory possibly contaminated by stagnant water from a rooftop storage reservoir after a pump failure. It is a plumbing story in one building. A 2019 review notes that examination of the water samples never revealed a single oocyst and that the incubation timing did not fit, so it is not clear the outbreak was waterborne at all. Offering it as support for a lake is offering a doubtful exception in the wrong category. The same CDC review records the only swimming-associated report in the American literature: one eight-year-old in Chicago who passed oocysts a week after swimming in Lake Michigan. One child, one case, thirty years ago, never an outbreak.

The parasite’s own life cycle puts mid-June overflows after the illnesses

This is the answer that uses their biology against their geography, and Michigan’s own provider bulletin states the premise: oocysts require days to weeks in the environment to become infectious, which is why direct person-to-person spread is unlikely. IFPA’s own consumer page puts the figure at seven to fifteen days in a warm, moist environment. Add roughly a week from ingestion to symptoms. CDC’s investigation page puts the first outbreak-linked onset at June 14. Work backward through a week of incubation and one to two weeks of sporulation and the contamination event lands in late May. Combined sewer overflows in mid-June are downstream of the illnesses they are offered to explain.

Humans are the only host, so the theory needs the outbreak to explain the outbreak

Nothing reaches a Detroit or Toledo sewer that a person did not shed first. This parasite infects no animal, multiplies in no lake, replicates in no soil — and that is not my characterization. IFPA’s own consumer page says humans are the only known host, and its 2023 release says the parasite can enter a farm environment only if human waste is not properly managed. For an overflow to carry it in quantity, a large population in southeast Michigan and northwest Ohio had to be infected already in late May. CDC’s national case data put the comparable 2025 figure at 1,180 domestic cases for the entire country and the entire season. That is not a reservoir. Whatever primed those sewers, if anything did, is the thing that needs explaining, and the arrow points toward the food rather than away from it.

Detroit does not drink Lake Erie water

The Great Lakes Water Authority, which supplies roughly four million people across southeast Michigan, draws from Lake Huron and from the Detroit River — a river that flows into Lake Erie. There is no Lake Erie intake. The drinking water half of the hypothesis points at a lake that is downstream of the people doing the drinking.

Water is local and this outbreak was not

CDC’s final outbreak update, posted September 11, puts the outbreak at 12,883 illnesses in 21 states, with onsets from June 14 through August 17 and at least 570 hospitalizations. The season behind it is larger: 19,595 laboratory-confirmed domestically acquired cases from May 1 through September 8, with 1,043 hospitalizations, across 49 states and the District of Columbia. Michigan’s own counts were never a Lake Erie pattern — West Michigan alone was reporting hundreds of cases by mid-July, including more than a hundred in Muskegon County, which is on Lake Michigan. Minnesota and Wisconsin share the same Great Lakes and never saw anything close. For contaminated American water to have done this, dozens of unconnected utilities and lakes would have had to fail in the same direction inside the same eight weeks, for the first time in the recorded history of the disease, and not one of them would ever have been found.

And the twenty-one states are not twenty-one places where people happened to fall ill. CDC defined this outbreak as people who reported exposure to processed iceberg lettuce from Taylor Farms de Mexico, so every one of those 12,883 illnesses is tied to one processor’s product. The last four states CDC added, named on its own page, were Georgia, Tennessee, Texas and Virginia. No body of water in Michigan or Ohio delivers a shared product exposure to Texas. A distribution list does.

The epidemic curve answered the question in July

The strongest single fact against the water theory is in CDC’s final update and it is one sentence long. At the peak, before the recall, more than a thousand infections were occurring in a single day. During August, after the lettuce came off the market, the average was fewer than two infections a day. Sewers and lakes do not respond to a produce recall. One contaminated commodity does.

No U.S. outbreak has ever been traced to swimming, and a Michigan water scientist said so

MDHHS’s July 13 statement is the sentence that drew the charge, and it is accurate: recreational water exposure is not a recognized risk factor for cyclosporiasis, and there is no evidence linking recreational water activities to this outbreak. Its consumer FAQ, revised July 24, gives the reasons rather than the conclusion — no documented U.S. outbreaks linked to pools or lakes, dilution across a lake volume against an infectious dose, the contrast with Cryptosporidium, the delay before an oocyst can infect anyone, and the fact that almost all U.S. outbreaks have been traced to fresh produce. The independent voice matters more than the department’s. Joan Rose, the Michigan State water microbiologist whose lab was developing wastewater testing for this parasite in August, said waterborne Cyclospora cases are rare, making it unlikely that people would be infected while swimming. That is the Flint-adjacent water expertise the argument reached for, answering it.

The genetics point at one source

CDC reported on August 20, on the same investigation page, that genotyping performed on samples from sick people showed the parasites that caused these illnesses are genetically related, which it called additional evidence that people in this outbreak got sick from the same source. Read it precisely: it ties patients to one another, not to any lettuce, and no product isolate exists to compare against. It is still the wrong result for the water theory. A summer of separate exposures across dozens of watersheds predicts genetic heterogeneity. None appeared.

The asymmetry in the ask

Nine proposed questions, and not one of them would improve produce traceback. No brand fields, no lot or date codes, no package type, no purchase location — nothing that moves an investigator faster from a sick person to a shipment. Anyone can read the questionnaire and see what is in it and what is not. If the goal is finding a source quickly and accurately, you want both halves. Asking only for the half that points away from your own sector is the tell, and it can be said without accusing anyone of bad faith.

What I grant, because the weak version of this loses

IFPA narrowed its claim, and the narrowing belongs in print. Its consumer page says that for the confirmed subcluster, FDA’s traceback points to imported product from central Mexico, a different pathway from the domestic water exposure it raises for the remaining clusters. It has scoped water to the cases nobody can explain and conceded the recall cluster. Those unexplained cases are real and there are a lot of them: on the two agencies’ own most recent figures, roughly six thousand seven hundred laboratory-confirmed illnesses this season sit outside the outbreak count with no source publicly identified. Adding water questions to a hypothesis-generating questionnaire costs almost nothing and might answer something. No product sample ever tested positive. Washington State and other departments published findings that cut against the simple version of the case. None of that is a reason to believe the parasite that sickened more than nineteen thousand Americans came out of Lake Erie.

IFPA knows it was not the water, and it should not be trying to carry it for some of its members.

The Justice Department announced today that Abbott Laboratories has agreed to pay $384,999,040 to resolve False Claims Act allegations that, between January 1, 2018 and December 31, 2022, it manufactured powdered infant formula and nutritional therapy products at its Sturgis, Michigan and Casa Grande, Arizona plants in violation of federal and state statutory, regulatory and contractual requirements — and that government programs bought the product anyway.

Abbott will pay $348,700,868 to the United States and $36,298,172 to states for claims settled by their Medicaid and WIC programs. Three former Abbott employees who brought the underlying qui tam case — Scott Millard, Kristine Cooper and Loren Cooper — will share $69 million. Abbott admits nothing, and says the Department has closed its criminal investigation.

It landed the same day both chambers of Congress walked back into the building. That timing is worth holding onto, and I will come back to it.

What the government said was happening inside the plant

The allegations come from the United States’ Complaint in Intervention, filed November 13, 2025 in the Western District of Michigan. As the Department describes it, roof leaks were a common occurrence at Sturgis, with water running and dripping over equipment. Rather than fix the roof, Abbott used what the complaint calls roof leak umbrellas to divert the water in product processing areas — while corporate leadership understood that a wet environment raised the risk of microbial contamination. Abbott kept running spray dryers after documenting cracks and pits in them, and lengthened the number of batches passing through those dryers between cleaning cycles, which increased production and made the dryer conditions worse.

Then the two allegations that matter most. The government alleges Abbott intentionally did not test for bacterial growth, so that it would not obtain positive results. And in certain instances where testing did show contamination, the government alleges Abbott failed to disclose those results to FDA during the agency’s 2019 and 2022 inspections of the Sturgis plant.

Read those again. Not a failure to find. A decision not to look, and then a decision not to tell the inspector what was found on the occasions when the company did look.

Why the money goes to the Treasury and not to the families

The False Claims Act is a fraud statute. The injured party it protects is the United States as a purchaser. More than half of all infant formula bought in this country is paid for with USDA funds through WIC, and state Medicaid programs pay for formula too. The theory of the case is that Abbott sold noncompliant product into those programs and billed the taxpayer for it.

That is a real injury and $385 million is a real number. But be clear about what this settlement is not. Four infants were hospitalized with Cronobacter sakazakii between September 20, 2021 and February 17, 2022 after consuming powdered formula made at Sturgis, and, as Commissioner Califf told the Senate HELP Committeein May 2022, Cronobacter may have contributed to death in two of those cases. Not one dollar of this settlement goes to those families. Their remedy was, and is, a lawsuit of their own.

The three relators will receive $69 million. I do not begrudge them a dime of it — the qui tam bounty is the reason anyone outside Abbott knows about the umbrellas over the production line, and it worked exactly as Congress designed it to. It is simply worth noticing which injuries American law is built to price, and which it leaves to private litigation and to luck.

The criminal investigation is closed

Under the Federal Food, Drug, and Cosmetic Act, a responsible corporate officer can be charged with a misdemeanor for shipping adulterated food without any proof that he intended to. That is the Park doctrine, and it has been good law since 1975. Here the government’s own complaint alleges considerably more than negligence — it alleges a company that chose not to generate test results and then withheld from FDA the results it did have. Whatever the evidence turned out to be, the Department looked at it and closed the file.

So the price of the conduct described in the complaint is a check, written by shareholders, with no admission and no individual held to account. For scale: Abbott reported net sales of $44.3 billion and net earnings of $6.5 billion in 2025. This settlement is about three days of sales, or about three weeks of profit.

About “no unopened product ever tested positive”

Abbott’s statement today says the settlement does not represent any finding of fault or liability, that no unopened, distributed Abbott infant formula has ever tested positive for Cronobacter sakazakii, that FDA’s testing in early March 2022 of unopened product from the homes of the infants under investigation was negative, and that CDC found no definitive link between the Sturgis facility and the clinical cases.

Every one of those statements can be true and none of them answers the complaint, because the same filing alleges that Abbott declined to test for bacterial growth precisely so that it would not have positives to report. A company accused of building a testing program to miss cannot then offer the absence of a positive as proof of a clean plant.

There is also the nature of the organism. Contamination in a dry powder is sparse and patchy; it does not distribute itself evenly through a lot so that a few retained cans will show it. Cronobacter infection was not reportable in most states at the time and CDC was receiving two to four case reports a year nationally, so four in five months was the signal, not the noise. The government’s case never rested on a positive can. It rested on the conditions the product was made in — which is how food safety law is supposed to work, because by the time you have a positive can you already have a sick baby.

Four years later, the rule has not moved

Abbott shut Sturgis down on February 17, 2022, a national formula shortage followed, and in May 2022 the company entered a consent decree of permanent injunction requiring outside expert oversight before it could reopen. Now there is a fraud settlement. All of it is after the fact, and none of it changed what a formula maker is required to test for.

21 C.F.R. § 106.55 still requires finished-product testing for exactly two organisms: Salmonella and Cronobacter. Clostridium botulinum is not on it. It was not on it in November 2025, when 48 infants across 17 states were hospitalized in the ByHeart outbreak. It was not on it this spring, when four more were hospitalized after consuming Nara Organics formula. It is not on it this morning. On August 27, 2026, CDC closed the Nara investigation and reported that whole genome sequencing tied the two outbreaks to a common source — milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. Fifty-two babies, many on ventilators, one organism, and it is the organism nobody is required to look for. FDA named it by genus and species in a Call-to-Action letter to the entire powdered formula industry on March 8, 2023.

Here is the arithmetic, since today is a day for numbers. California prices BabyBIG, the only treatment for infant botulism, at $69,300 a dose. Fifty-two doses at that price is about $3.6 million — roughly one percent of what Abbott agreed to pay today, and about five percent of what three relators will take home. Screening the ingredient costs a fraction of that again. This is the rare safety requirement that is cheaper than not having it.

Which brings me back to the timing

H.R. 7867, the Infant Formula Safety Modernization Act of 2026, puts C. botulinum on the required testing list, mandates environmental monitoring inside the plant, and holds foreign manufacturers to American standards. The House Health Subcommittee held its hearing on April 29, 2026. No markup has been scheduled since. The Senate passed the narrower S. 272 the same day, 22 to 0 in committee and by unanimous consent on the floor, which tells you this is not a hard vote once somebody puts it on a calendar. S. 272 reaches the organisms already on the list. It does not reach the one that paralyzed these children.

I have written the two committees with jurisdiction four times — Energy and Commerce on June 23 and August 28, HELP on June 29 and August 28, with fourteen families’ statements and photographs attached to the first one. I have had no reply to any of them. This week, in the week both chambers returned, two t-shirts are being hand-delivered to each of the 77 offices on those two committees. A shirt in a plastic baby bottle will not produce a markup. It will sit on a desk and say the argument in one line.

Today the Justice Department found $385 million worth of accountability for how infant formula was made between 2018 and 2022. Every dollar of it is backward-looking, and not one dollar of it requires anyone to run a single additional test tomorrow. Congress can do that part. It has had the bill since March.

The Environmental Working Group is holding a rally in Washington, D.C., on Tuesday, September 15, at 2 p.m., at the Ulysses S. Grant Memorial. It is called Toxics Off the Table!, and the target is the FDA Review and Evaluation for Safe, Healthy and Affordable Foods Act of 2026, better known as the FRESH Act. EWG has the details on its news page, and you can add the rally to your calendar here.

I am with EWG on this one. I wrote about the bill in Food Safety News on September 3, after Harvard Law School’s Food Law and Policy Clinic read the preemption clause line by line. What follows is the rally information, and then a few things a plaintiff’s lawyer notices that a food chemical fight tends to skip past.

The rally

What: Toxics Off the Table! — a rally to protect state food safety laws.

When: Tuesday, September 15, 2026, at 2 p.m.

Where: Ulysses S. Grant Memorial, Washington, D.C.

EWG president Ken Cook is speaking, along with chef and author Andrew Zimmern, Reps. Frank Pallone, Jim McGovern, Chellie Pingree and Grace Meng, Sen. Ed Markey, New York Assemblymember Anna Kelles, Maryland Delegate Sheila Ruth, California Assemblymember Jesse Gabriel, chef Johanna Hellrigl, and advocates from Consumer Reports, the Center for Science in the Public Interest, the Environmental Defense Fund, Greenpeace, Safer States, the Plastic Pollution Coalition, the Chef Ann Foundation, Eat Real, FoodFight USA, the Alliance of Nurses for Healthy Environments and NYU.

A good many of those organizations are on the list of fifty-nine food safety and food policy groups I mapped this summer, and several of them have signed the same petitions and comments I have. The acute side of food safety and the chemical side have spent too long in different rooms. Tuesday they will be standing in the same one.

What the bill actually says

Rep. Kat Cammack of Florida released the discussion draft on April 22, 2026, and presented it at an Energy and Commerce Health Subcommittee hearing a week later. It still has no bill number and has not been marked up. It runs thirteen titles.

Title II would make GRAS notification mandatory, which sounds like the reform everyone has been asking for. Read the procedure. A notification takes effect ninety days after FDA receives it unless the agency asks for more; if FDA says nothing, the substance is in. Substances reviewed by an established scientific panel are exempt from the notification requirement altogether, their submissions are automatically accepted, and they take effect the day they are filed. The Flavor Extract Manufacturers Association Expert Panel is accredited by operation of the statute on the date of enactment. The bill does require such panels to keep written conflict-of-interest policies. It does not require FDA to look at a single substance already on the market, and the mandatory notification section does not take effect for four years.

Title XIII is the part that brought the rally. It would supersede any and all state requirements or prohibitions relating to the use, labeling, sale or marketing of food, of anything that may be expected to become a component of food, and of any added or naturally occurring substance in food, wherever the state rule is not identical to the federal one. It preserves state enforcement under adulteration statutes identical to section 402, and it exempts state requirements adopted by ballot initiative before September 1, 1997. Everything else in that space goes, whether or not a federal rule exists to replace it. CSPI called the bill a shiny apple full of worms. EWG called it rotten to the core. The Harvard report is the careful version of the same conclusion.

Two provisions that have gotten almost no attention

The first is in Title VIII, which otherwise tightens infant formula reporting in a way I like. Current law tells a manufacturer to notify FDA promptly when it has reason to believe a formula may be adulterated or misbranded. The draft replaces promptly with twenty-four hours. Good. It then adds a new paragraph for confirmed positive finished-product tests, and inside that paragraph is an exception: where the product has not left an establishment under the manufacturer’s control, the twenty-four-hour clock does not start until the company finishes its own root cause investigation. Nothing in the draft limits how long that investigation may take. I represent two families in an infant formula botulism case right now. The interval between a company knowing and the government knowing is the interval in which babies keep drinking.

The second is three lines further down. When a formula plant has two repeat positives within six months sharing a root cause, the manufacturer turns over its isolates — but the draft says those isolates shall be de-identified from the manufacturer, aggregated in a data trust created by a memorandum of understanding with industry, and not posted in a publicly available database that tracks whole genome sequencing. That is a statutory carve-out from the public sequence data that solves outbreaks. When a child’s isolate matches a plant’s isolate, that match is how the source gets named, how the recall happens, and how a family finds out what made their baby sick. I have not seen anyone at the hearing or in the press discuss that sentence. It deserves discussion.

And the point I made two weeks ago still stands. The Federal Food, Drug, and Cosmetic Act creates no private right of action. A person injured by contaminated food recovers under state law or not at all, and every one of those theories is a state requirement. Any and all state requirements is broader language than what the Supreme Court read to wipe out common law claims in Riegel v. Medtronic. Whether a court would go there is not certain. That a defense lawyer will argue it is.

The parts I would testify for

I am not against this bill wholesale, and neither is anybody serious. Title IX would require powdered formula manufacturers to run written environmental monitoring programs for Cronobacter and Salmonella. Title X would extend FDA’s mandatory recall authority to infant and toddler food. Titles VI and VII would set enforceable limits on lead, cadmium and arsenic in baby food on a stated schedule and require quarterly finished-product testing at accredited laboratories with records FDA can demand. Title XI would let FDA hand shipping and distribution records to state and local health agencies during an outbreak, which is a thing investigators have wanted for years. Those are real improvements, and I would show up and say so under oath.

Strike Title XIII, narrow the ninety-day default, fix the root cause clock, and take the sequencing carve-out out, and this becomes a bill worth arguing on the merits. Leave them in and Congress will have taken nearly every tool the states have, replaced almost none of them, and closed the courthouse door on the way out.

Why it takes a rally

States did not wander into food chemical regulation out of boredom. California banned ephedra before FDA did. California and New York City banned trans fats years ahead of the federal ban. More than thirty states introduced additive legislation in 2025 alone. FDA’s own mandatory GRAS proposal, published last month, still does not require premarket approval and would not bind anyone until about 2029. The laboratories of democracy went to work because the lab upstairs had the lights off.

If you can be in Washington on Tuesday afternoon, be at the Grant Memorial at two. If you cannot, call your member of Congress and ask them where they stand on the preemption title. This one is not complicated. A federal floor is worth building. A federal ceiling is not.

I am headed to Norway. On September 23 and 24 I am giving two talks at the Aquatiq Food Forum at the Clarion Hotel Oslo, to a room of food industry leaders, Mattilsynet, Nestlé, McDonald’s Nordic, Mowi, Coop, NorgesGruppen and Norsk Kylling.

Day one is called “Why It Is a Bad Idea to Poison Your Customers.” Day two is “The Criminalization of Food Safety Failures.” They are one argument in two parts, and the second half is the part that has changed most in the last two years. The program is here: Aquatiq Food Forum 2026.

The first title gets a laugh when I say it out loud. It should not. In thirty-three years of representing people hurt by contaminated food, I have never met a company that set out to poison anybody. That is the whole point. The harm comes from a supplier nobody audited, a swab nobody took, a positive nobody acted on, a shipment somebody released because the alternative was expensive that week.

Day one: the business case

I will start where I always start, with two people. Stephanie Smith was twenty years old and teaching dance at three studios when she ate a hamburger in September 2007. She was in the hospital until June of the following year. E. coli O157:H7, hemolytic uremic syndrome, a stroke, brain injury, dialysis, transplants ahead of her, and no children. The jury numbers in her case were $1.9 million in past medical bills, $29.4 million in future care and $1.2 million in lost earnings. Notice the shape of that. The past medical bills are the smallest number. The expensive part of a catastrophic injury is the fifty years that follow it.

Linda Rivera was a mother of six who worked with disabled children. She ate raw cookie dough in May 2009 and was hospitalized until May 2011. Large intestine removed, stroke, liver failure, congestive heart failure. She missed three of her children’s graduations. She survived the outbreak and died later of its consequences.

Norway already knows this story

I do not need to import all of my examples. In the winter of 2006, Norwegian pediatricians reported a cluster of HUS cases to Folkehelseinstituttet. Seventeen people were identified with E. coli O103:H25 between February 20 and April 6. Ten children developed HUS. One of them died. The source was a traditional cured mutton sausage, morrpølse, from a single plant — 3.5 tonnes of it, sold nationwide. It took 931 food and environmental samples to find, and the strain was followed from the finished sausage back to a mutton supplier, a slaughterhouse and four farms (Schimmer et al., BMC Infectious Diseases 2008;8:41).

That is Norway’s Jack in the Box. It is worth adding the uncomfortable part, which the investigators published themselves: the first case-control study pointed at minced beef from a different producer, and the public was warned about the wrong product in February. The sausage was not identified until March 20. Their own stated lesson was to keep chasing alternative sources after you have already warned the public.

What actually destroys companies

Thirty-three years produces some pattern recognition. It is not the pathogen. Every processor will have a positive; that is not the story. It is the delay between knowing and telling, which juries and regulators count in hours. It is the denial, because attacking the health department is the most expensive sentence a company can say. It is the pattern, because one outbreak is bad luck and a file of prior noncompliances is a case. And it is the paper, because the email written to reassure a colleague becomes exhibit 14.

Most boards model one line of the cost — the verdict. Underneath it sit the recall, the plant suspension and requalification, the lost listings, and the covenants and valuation. Those four are, in practice, uninsurable, which is exactly backwards from how companies budget for this.

And then the good news

I end day one with the best thing that happened in food safety in my lifetime. Jack in the Box in 1993 produced more than 600 confirmed infections and killed four children. In 1994 USDA declared E. coli O157:H7 an adulterant in raw ground beef. HACCP followed, then testing with consequences. The 2002 ConAgra recall was the last of the great hamburger cases I litigated. Today my firm handles essentially none of them.

Government action took a large part of my practice away, and I am grateful. The industry fought that rule, called it a travesty, and sued the USDA over it. Those same companies are still in business thirty years later selling a safer product. Nothing about beef made it uniquely fixable. What has been missing for leafy greens, ready-to-eat meats and powdered infant formula is not technology. It is a clear standard and a price for missing it.

Day two: when it stops being about money

The second talk is colder. Civil cases mean a company pays and insurance absorbs part of it. Criminal cases mean a named person is charged, and insurance does not cover a prison sentence. The trigger is almost never the pathogen. It is the concealment.

Stewart Parnell of Peanut Corporation of America is serving twenty-eight years. Nine people died and 714 were infected across 46 states, but he was not convicted of killing anyone. He was convicted of what he told customers about laboratory results — the certificates, the positive retested until it came back negative, and fifteen years of ordinary internal email read aloud to a jury. Look at who else was indicted: the owner, his brother, a plant operator, a plant manager, and the quality assurance manager. That last one is the person sitting in the room in Oslo.

Intent is not required. Under the Park doctrine a person can be convicted under the Food, Drug, and Cosmetic Act without proof of knowing or willful conduct, on the basis that they held a position that would have let them prevent the violation. The Jensen brothers pleaded to a five-count information after their cantaloupes killed thirty-three people — I represented all thirty-three families — and nobody alleged they lied about anything. The DeCosters went to jail for three months each on a record with no proof of knowledge, and it was upheld on appeal.

The front line has moved to Europe

The most active food safety prosecutions in the world right now are not American. A British restaurant owner is serving six years for gross negligence manslaughter after substituting a cheaper nut mix and killing a customer who had written “no nuts” on the order. In France, Nestlé France and its subsidiary were placed under formal investigation in July 2024 over the Buitoni pizzas that gave 48 children HUS and killed two. Lactalis and its Craon subsidiary were placed under formal investigation in 2023 — and one of the allegations is failure to execute withdrawal and recall measures. Not contaminating the food. Failing to recall it properly.

That charge has no American equivalent, and it flows from architecture Norway already shares. Article 19 of Regulation 178/2002 puts primary responsibility on the food business operator and requires immediate withdrawal and notification. Norway took that regulation into the EEA Agreement in 2007, and Mattilsynet enforces it under the Food Act. A duty framed as immediate is a duty a prosecutor can measure in hours. Measure your own interval, because somebody else will.

Meanwhile America is stepping back

This is the part that will surprise a European audience. Executive Order 14294, signed in May 2025, states that criminal enforcement of strict liability regulatory offenses is generally disfavored and directs prosecution as a last resort. It does not repeal the Park doctrine. It changes who is willing to use it. The Justice Department moved to disband the Consumer Protection Branch that historically handled these cases. The Abbott infant formula investigation was closed in 2026.

And Boar’s Head, where ten people died and two members of Congress asked the Attorney General to consider charges, has produced no public answer at all. I filed a FOIA request in June asking what happened. Seventy-eight pages came back on July 2. Nothing in them says whether anyone is still working the case. What I did notice is that the law enforcement exemption USDA claimed in 2024 is no longer being cited. I cannot prove what that means, and I will say so from the platform.

The through line

Nobody sets out to poison anyone. Every person I have watched be charged believed they were managing a business problem. The evidence came from their own files, written by good people under commercial pressure. Which makes day two the same argument as day one: it is cheaper to be safe.

If you are in Oslo on the 23rd and 24th, come find me.

The work

I have four citizen petitions rough drafted on my desk. Each one asks a federal agency to change a rule:

  • FDA — require a consumer warning statement on the labels of packaged raw and lightly cooked sprouts.
  • FDA — require testing for Clostridium botulinum in powdered infant formula and in the dairy ingredients it is made from, after fifty-two infants were hospitalized in two outbreaks.
  • FDA — require access and microbial sampling at animal feeding operations implicated in multistate outbreaks, under section 361 of the Public Health Service Act.
  • FSIS — determine that Salmonella at or above 1 CFU/g is an adulterant in raw comminuted chicken and turkey and in raw chicken parts.

Actually, I have seven I have been working on.

A petition is only as strong as its weakest citation. No agency has to grant one, and the first thing a government lawyer or a trade association looks for is a fact that does not hold up. One wrong case count, one misread study, one Federal Register cite that does not say what the sentence claims it says, and the whole document becomes easy to set aside.

Your job is to find those errors before anyone else does. Specifically:

  • Check every factual assertion in the petition against the source it rests on.
  • Verify statutory, regulatory, Federal Register and case citations — that they exist, that they are current, and that they stand for what the text says.
  • Read the scientific literature cited and tell me whether it actually supports the sentence citing it.
  • Find any additional scientific literature that supports our petitions or not.
  • Confirm outbreak case counts, dates, recall records and agency findings against CDC, FDA and FSIS sources.
  • Flag anything overstated, unsupported or out of date — including my own writing. Especially my own writing.
  • Line edit for clarity and consistency.

Who I am looking for

A law student — 1L through 3L — an LL.M. candidate, or a recent graduate. An LL.M. in food and drug law, public health law or regulatory practice fits this work particularly well, as does a lawyer trained abroad who is now studying here. What I need in any case is:

  • A science background. Microbiology, food science, epidemiology, public health, biology, chemistry or similar. You should be able to read a peer-reviewed microbiology paper and tell me whether it says what I claim it says.
  • A real interest in public health, or in food and drug regulation.
  • Cite-checking stamina. Law review or journal experience helps.
  • Comfort with the Federal Register, the eCFR, regulations.gov, PACER and PubMed.
  • A willingness to tell me I am wrong.

One reason to think this works

On October 5, 2009, this firm petitioned the U.S. Department of Agriculture’s Food Safety and Inspection Service to declare non-O157 Shiga toxin-producing E. coli adulterants in beef. The industry said it would be ruinous. The agency said it lacked a laboratory method. We kept building the record. On September 20, 2011, FSIS published its determination that six serogroups — O26, O45, O103, O111, O121 and O145 — are adulterants in raw non-intact beef products. Routine verification testing of raw beef manufacturing trimmings began June 4, 2012. Those six are now what everyone in the industry calls the Big Six, and they are the law because a petition built a record the agency could not answer.

That took nearly three years and an enormous amount of checking. The petitions on my desk now are built the same way, and they will be read by people looking for a reason to say no.

Every one of them is meant to prevent an outbreak that would otherwise walk into this office as a case file. I have represented people injured by contaminated food since the 1993 Jack in the Box outbreak — children on dialysis, families who buried someone over a hamburger or a bag of lettuce. The goal is a country that does not need a lawyer like me. This work is a step toward putting me out of business, and I would like the help.

Terms

Paid hourly. Rate and weekly hours to be discussed and scheduled around your classes. Remote, with occasional calls. Project-based to start, with more work likely — the petitions do not stop coming. If your school awards externship or independent-study credit, I am glad to work with them.

To apply

Send a resume and a short note to bmarler@marlerclark.com with “Petition Research” in the subject line. Skip the cover-letter language. Instead, tell me about one time you caught an error in something you were reading — what it was, and how you found it. If you have a writing sample with citations in it, send that too.

Also, why I have your attention, please see the below:

WANTED AN ASSOCIATE ATTORNEY — 5+ YEARS

Want to Put Us Out of Business? Come Help Us Try.

Marler Clark has been suing the companies that poison people since 1993 — since a nine-year-old girl named Brianne Kiner nearly died from a hamburger. Sixteen years later it was Stephanie Smith, a children’s dance instructor paralyzed by a hamburger, whose case put the grinding of American beef on the front page of The New York Times and won Michael Moss a Pulitzer Prize. Thirty-plus years later we are still the only law firm in the country that does nothing but foodborne illness — tens of thousands of clients and over $850 million recovered — and there is more work than there are lawyers to do it. The names on the other side are ones you already know: Jack in the Box, Cargill, Dole, Nestlé, Walmart, Wendy’s, McDonald’s, Nebraska Beef, Yum Brands, and this year Taylor Farms, Taco Bell and Boar’s Head.

As I write this, on August 19, 2026: a Cyclospora outbreak the fifty state health departments now count at 31,521 people and rising. The federal government called it 1,947 in nine states until it changed what qualifies as a case in August; its own number is now 9,481 in seventeen states, 398 hospitalized, two dead. Michigan by itself reports 13,909 cases — more than the federal government counts for the entire seventeen-state outbreak. We have five cases filed against Taco Bell, four different franchise operators and Taylor Farms, and more than two hundred other people in twenty-six states have retained us to find out how they were poisoned. Salmonella Javiana in jalapeños grown in Sinaloa — 431 sick in 32 states, Chipotle and QDOBA — which Minnesota epidemiologists and a company traceback found before it ever reached FDA’s outbreak table; a month later the grower still has not been named and the recall of what it sold has spread to more than 160 grocery products. Infant botulism litigation against ByHeart and Nara Organics. Listeria out of Boar’s Head. E. coli O157:H7 from beef kofta and from romaine. Salmonella from nineteen million recalled eggs and from a Lexington pie shop. E. coli O145 in frozen blueberries. Vibrio from raw seafood in Queens. Read a month of marlerblog.com. Clients in need find us; that has never been the hard part.

Finding the defendant is. Nobody hands you one in a foodborne case. You will read FDA inspection reports and environmental assessments, USDA establishment records, whole genome sequencing and PulseNet clusters, epidemic curves built by state health departments, and — this summer — the sanitation and rainfall records of a Mexican municipality where the lettuce was grown and the traceback on a lot of peppers out of Sinaloa. That work gets done before the complaint is filed, not in discovery. You will also have the Outbreak Database, which this office built and still maintains — decades of outbreaks, searchable, and no other firm in the country has it. Spanish is a real plus.

And half of this job is not litigation at all. E. coli O157:H7 became an adulterant in American beef in 1994; six more strains followed because we petitioned USDA to make them so. We helped pass FSMA in 2011, petitioned — so far without success — to have outbreak strains of Salmonella declared adulterants in 2019, and pushed hepatitis A vaccination for food workers in 2020. This year alone: an infant formula bill in the House, a food safety bill in the Senate, the Stop Foodborne Illness petition pending at FDA asking it to tell the public where recalled food went, comment letters on the traceability rule Congress delayed to 2028, and a standing demand that CDC count Cyclospora again. I publish Food Safety News, I have written over 6,000 posts on Marler Blog since 2004, I speak all over the world, and I teach food safety at the Harvard T.H. Chan School of Public Health. You will do this too — including writing here under your own name, where reporters will read it. Within a few years it will be you the conference invites, the health department calls and the reporter quotes; our lawyers speak to industry groups, public health audiences and university classes, and that platform is handed over, not loaned. Work out of this office has been cited in more than a thousand media reports. We also correct in public: when a poultry veterinarian wrote in last month to tell me a post of mine was wrong, we ran the correction louder than the original. Being right matters less here than getting it right. Cases fix one company; the rest fixes the industry.

If you want to know what that adds up to, read the testimonials page on billmarler.com and pay attention to who is on it: a former FDA food safety czar, a former USDA food safety official, the retired head of the Produce Marketing Association. Michael Pollan wrote that the federal watchdog on food safety is asleep at the switch and we are what is left. One of the lawyers who defended the other side in the Jack in the Box cases became my law partner. You will spend your career arguing with the food industry, and some of the people you argue with will end up thanking you for it.

We are looking for an associate with at least five years of litigation experience — personal injury, product liability, med-mal, or complex tort — who is ready to run cases, not just paper. We are a handful of lawyers, not a floor of them: you will carry your own docket from the start.

Here is what you will not do here. There is no billable hour requirement and no origination credit to chase — the clients find us, and the firm carries the cost of every case out of its own pocket until it resolves. There is no committee, no partner standing between you and the person who decides, and no waiting your turn: when you need an answer you walk down the hall and get one. And there is no volume. We turn down cases every week that we could not do right, because a file nobody has time for is worse than no file at all.

Our office is on Bainbridge Island, and the honest truth is that we want you here — living on the island, not commuting to it. We are a few minutes’ walk up from the ferry terminal, thirty-five minutes across the water from downtown Seattle, in a town where you can walk to work, walk to lunch, and walk home. Most people who make the move do not move back. But the right lawyer matters more to us than the right zip code: if you are elsewhere in Puget Sound, or willing to relocate, and can be here most days, we should talk, and we will help the right person get here. 

What you’ll actually do: file in federal and state courts across the country, write the settlement demand letters that resolve most of our cases before anyone sees a courtroom — the medical chronology, the liability analysis, the damages model, all of it yours — take and defend depositions of plant managers and epidemiologists, work up hemolytic uremic syndrome, Listeria meningitis and Salmonella reactive arthritis cases with the best experts in the field, sit with families in hospital rooms, and try cases. The docket is national; you will be on airplanes. It has been international as well — outbreaks in Europe, Asia and Africa. You will be trusted early and often.

Many of our clients are children, and on those cases the last thing you do is the hardest. A settlement for a child has to be approved by a judge, cleared of Medicaid, Medicare, ERISA and sometimes federal military liens, and structured — now and then into a special needs trust — so the money is still there decades later, when the kidney an outbreak took finally has to be replaced. If you have never done a minor’s compromise, you will.

What you need: licensed and in good standing somewhere, admissible pro hac vice everywhere else — Washington admission is not required; real deposition experience; the writing chops to draft a complaint that reporters quote; and the stomach for what an outbreak does to a child. A science background is a bonus, not a requirement — we’ll teach you the microbiology.

What we offer: Competitive salary depending on experience, plus bonus; medical, dental and vision; 401(k) with match; paid vacation and holidays; bar dues and CLE; and cases that end up in The New York Times, in front of Congress, and in Poisoned, the Netflix documentary about this work — watch it before you apply. Also: a commute that involves a ferry or no ferry at all, and a firm that goes home for a safer dinner because of you.

One last thing, and it is the whole thing. Nobody here treats this as a practice area. Everyone here can name the child whose case they will never forget. That is why they stay. A client wrote to us that I came to the hospital while their son was there, and that somebody from this office was in touch every step after; that somebody is going to be you as often as it is me. I am not looking for a lawyer who wants a job. I am looking for one who cannot look away from it and wants to spend the next thirty years making a difference.

The job is open now. Resume, writing sample and a short note to bmarler@marlerclark.com — in the note, pick any case or outbreak off marlerblog.com and tell me what you would do with it first. The rest of it is public too: marlerclark.com and billmarler.com. No recruiters. Equal opportunity employer.

WANTED A PARALEGAL — 10+ YEARS

We Need Someone Who Reads 4,000 Pages of Medical Records and Finds the One That Matters.

Marler Clark represents people sickened by E. coliSalmonellaListeriaCyclosporaVibrio and botulism — from a single family to a thousand-plaintiff outbreak, tens of thousands of clients and over $850 million recovered since 1993. The companies on the other side are ones you already know — Jack in the Box, Cargill, Dole, Nestlé, Walmart, Wendy’s, McDonald’s, Yum Brands, and this year Taylor Farms and Boar’s Head. The cases are won or lost in the details, and the details live with our paralegals.

Right now, the details include a Cyclospora outbreak the fifty state health departments count at 31,521 people while the federal government counts 9,481, Salmonella Javiana in Sinaloa jalapeños that has sickened 431 in 32 states and set off a recall that now runs to more than 160 grocery products, infant botulism cases against ByHeart and Nara Organics, Listeria from Boar’s Head, Salmonella from nineteen million recalled eggs, and E. coli from beef kofta, romaine and frozen blueberries. Spend ten minutes on marlerblog.com and you will see the month we just had. Every one of those numbers is a person with a chart, a bill, a lien and a phone number.

The other half of this office is advocacy, and it runs on the same skills. Public records requests to state and county health departments. FOIA to FDA and USDA for inspection reports and environmental assessments and sometimes records in Spanish from a growing region in Mexico — Spanish is a real plus. Fifty health department dashboards read and reconciled every morning. Exhibits and family declarations assembled for a rulemaking petition, a congressional hearing, or a bill. FDA and USDA dockets tracked, and comment letters filed on deadline. The last time we petitioned USDA, six strains of E. coli became adulterants in American beef. That file had to be built by somebody. The same goes for the Outbreak Database and Food Safety News — this office built both and still feeds them. People here get their names on that work, and anyone who wants to speak or write about it is pushed forward, not held back.

We are hiring a paralegal with at least ten years of experience in plaintiffs’ personal injury or complex litigation. Ten years, because we need someone who already knows what a lien is, what a hospital billing department will and will not send you, and how to keep sixty clients straight without losing one. Ten years also because nobody here is going to look over your shoulder — you will run your own files.

Here is what you will not do here. No billable hours and no timesheets — nobody in this office bills by the tenth of an hour. No committee, and no layer between you and the person who decides; when you need an answer you walk down the hall and get one. And no volume: we turn down cases every week that we could not do right, because a file nobody has time for is worse than no file at all.

Our office is on Bainbridge Island, and we would like you to live here rather than commute here. We are a few minutes’ walk up from the ferry terminal — thirty-five minutes from downtown Seattle by boat, a town you can cross on foot, and a trip to work that is a walk or a short drive instead of an hour on I-5. People who make the move tend to stay. But the right person matters more to us than the right zip code: if you are elsewhere in Puget Sound and can be here most days, we should talk, and we will help you get here.

What you’ll actually do: run intakes with families who are frightened and exhausted, chase and chronologize medical records, build the damages and lien files that become the settlement demand, assemble the minor’s compromise petitions that put a child’s settlement in front of a judge, manage e-discovery and document productions, calendar and cite-check, coordinate with experts and state health departments, keep cases moving in courts in a dozen states, and travel with us when one of them goes to trial. The work has gone international too — outbreaks in Europe, Asia and Africa.

What you need: a decade in the trenches, mastery of medical records and chronologies, real lien experience — Medicaid, Medicare, ERISA plans and, more often than you would think, the federal government — e-discovery platform experience, absurd organizational instincts, and genuine kindness on the phone: the person calling you may have just buried someone.

What we offer: Competitive salary depending on experience, plus bonus; medical, dental and vision; 401(k) with match; paid vacation and holidays; and the rare paralegal job where the work actually changes how food is made in this country.

And one last thing. This is not a file-management job. One of our clients wrote that I came to the hospital while their son was there, and that somebody from this office was in touch every step after. Being that somebody is the job. The people who last here take it personally — they still remember a client’s child by name a year after the case settles, and they are angry that any of it happened at all. If that is you, you will fit here.

The job is open now. Resume and a short note to bmarler@marlerclark.com — in the note, tell me about the hardest lien you ever cleared or the record you had to fight hardest to get. marlerclark.com and billmarler.com if you want to know more before you write. No recruiters. Equal opportunity employer.

On September 11, 2026, CDC declared the multistate outbreak of Cyclospora infections linked to iceberg lettuce from Taylor Farms de Mexico over. The final federal count is 12,883 laboratory-confirmed illnesses across twenty-one states, 570 hospitalizations, two deaths in Michigan, and a last illness onset of August 17. Virginia was added as the twenty-first state on the day the outbreak closed. Nothing in the American record comes close.

Cyclosporiasis is an intestinal illness caused by Cyclospora cayetanensis, a microscopic parasite spread through human feces in contaminated food or water. It cannot come from animal manure, washing does not reliably remove it, and chlorine does not kill it.

The outbreak is only part of the season. As of September 8, CDC had recorded 19,595 laboratory-confirmed domestic cases since May 1, against 1,180 in the same stretch of 2025. Subtract the 12,883 tied to the lettuce and roughly 6,700 confirmed illnesses have no food named beside them at all. I intend to keep asking about those people into the winter.

What the FDA did on the way out

FDA opened a new page called Post-Outbreak Response Activities. It reports that senior FDA and Mexican officials met during the week of September 8 to encourage a prevention-focused framework, that FDA will fold what it learns into its Cyclospora Prevention, Response and Research Action Plan in the coming months, and that it is sending a letter to industry calling for collaboration across the supply chain.

Read the letter. It reminds the regulated industry that it must apply science-based agricultural water management, worker health and hygiene controls, and sanitation under the Produce Safety Rule at 21 CFR Part 112; preventive controls, including a supplier program, under 21 CFR Part 117 where they apply; and rigorous foreign supplier verification under 21 CFR Part 1, Subpart L. Every one of those is already the law. After the largest outbreak of this parasite ever recorded here, the federal output is a letter asking industry to comply with rules that have been on the books for years.

And here is the fact that should worry growers and shippers more than anything else on that page. FDA’s onsite inspections and sample collection at the lettuce growers and the processing facility in Mexico have ended. The samples are pending analysis. No root cause has been named. We have been here before: in the 2020 bagged salad outbreak, CDC declared the outbreak over and FDA’s traceback was complete, and the cause or source was never determined. Industry cannot fix what it is never told.

CDC was clear about why it closed the file: infections had declined and the lettuce was gone from stores and restaurants. That is a finding about future risk, not about cause, and the same update says FDA is still investigating how the contamination happened. The agency that counts the sick is finished; the one that is supposed to find out why is not, and only one of the two has a published finish line.

The ten states that got the lettuce and reported nobody sick

Put the two federal lists side by side. FDA confirmed distribution in thirty-one states, and all twenty-one outbreak states sit inside it. In an outbreak with no positive product sample, that coherence is real corroboration, and I will say so plainly.

The inverse is the more interesting number. Ten states got confirmed distribution and reported no outbreak illnesses at all: Alabama, Connecticut, Florida, Louisiana, Maryland, Mississippi, New Jersey, New York, South Carolina and Wisconsin. Look at New York and Florida. Both have run hundreds of cyclosporiasis cases this season with no source named. Either the lettuce arrived and sickened nobody, which is possible, or nobody did the interviews and typing that would have found out. The federal record cannot tell you which, and that is the whole problem.

Ten things the FDA should do before next May

1. Publish what the investigation found, including the negatives. FDA has its own root cause analysis program and a promise to update its action plan in the coming months. Name the month, and report the sample results either way. A published negative is real information: it tells every farm in that valley the contamination was not where investigators looked.

2. Describe the supply shed. Traceback converged on one processor, then inspections moved upstream to multiple growers. Tell us how many farms fed that plant and how many water sources served them, even if private farm names stay out.

3. Give industry a detection method it can actually run. FDA has a validated laboratory method for finding Cyclospora in fresh produce. There is no comparable routine tool a grower can use on irrigation water, sediment or soil at commercial scale and commercial speed. Fund it, validate it, publish it, and stop asking companies to manage a hazard they cannot measure.

4. Restore the parasite research and say plainly what the agency needs. Congress did not appropriate funding for two federal Cyclospora research projects in the FY2026 agriculture bill, and the third is being relocated away from the scientists who run it, as reported at the end of August. FDA should put in writing which research questions it cannot answer without that work.

5. Make genotyping routine and push it to the states. CDC used Cyclospora genotyping this summer to show that illnesses were genetically related. It is the first tool on this beat that does not depend on somebody remembering a June salad. Publish the protocol, fund state laboratory capacity, and make it standard again.

6. Put Cyclospora back into FoodNet, and make it mandatory again. FoodNet has been the audited count of foodborne illness since 1995, run by CDC with FDA, USDA and ten states. Cyclospora went on the list in 1997. On July 1, 2025, after twenty-eight years, reporting for it became optional, along with five other pathogens; only Salmonella and STEC stayed mandatory. I wrote about it in July, before this outbreak had a name. FoodNet is ten sites, not a national tally, so it would not have counted these cases. It is the yardstick for normal, and we entered the worst Cyclospora year on record without it.

7. Rebuild the Microbiological Data Program, and put a parasite on the panel. From April 2001 until December 2012, USDA tested roughly fifteen thousand produce samples a year at distribution centers, more than any other federal or state program. It was killed to save about five million dollars. I have been asking for it back since 2024. Here is the honest part: MDP looked for bacteria, not parasites, so restoring it as it was would not have found this. Rebuild it with Cyclospora on the panel, which is only possible once item three exists.

8. Attack the six-week reporting lag with a funded plan and a number. Every federal page carries the same caveat: it takes about six weeks to know whether a sick person belongs to an outbreak. That lag is why the recall came after most people had already eaten the lettuce. Say how fast the agencies intend to get, by when, and what it costs.

9. Lift the spending prohibition on traceability and water, and build the system Congress ordered in 2011. Section 780 of the November 2025 appropriations law bars FDA from spending a dollar to administer or enforce the Food Traceability Rule before July 20, 2028, and restricts enforcement money for the Produce Safety Rule and its pre-harvest agricultural water requirements. FDA’s letter asks industry to follow water practices Congress has defunded the agency from enforcing. Section 204 of FSMA also told the department to build a system inside FDA capable of receiving traceability information, and a Congressional Research Service report, citing a Government Accountability Office finding from this January, says no such system exists. Fifteen years.

10. Publish the framework with Mexico, including commitments and dates. A meeting during the week of September 8 is not a framework. The food safety partnership with Mexico has existed for years. Say what each side committed to, who verifies it, and when the first deliverable is due.

Why this is industry’s fight too

Fast, accurate traceback draws a line. It says this facility, this lot, this week, and what everything else is not. Without the line, fear prices the whole category, and this summer iceberg sales fell for growers with no connection to Guanajuato. Every one of the ten items narrows the circle. The alternative is the 2020 outcome, where the investigation quietly ends and the next grower learns nothing from the last grower’s disaster.

The count you will not find on any federal page

Add up what the state health departments published themselves and the total runs past thirty-two thousand. Michigan alone reported 14,277 cases as of August 20, more than CDC’s entire twenty-one-state outbreak figure. The two series do not measure the same thing, and the difference is worth understanding rather than shouting about. CDC counts only laboratory-confirmed illnesses it has attributed to this outbreak inside its May 1 season, and it files a sick traveler under the state visited rather than the state of residence. States count what they see: many include probable cases, some count on the calendar year, and all of them post before CDC finishes confirming. Neither number is wrong. They answer different questions, and the gap between them is about the size of the outbreak itself.

Now put the confirmed count in context. Scallan and colleagues, writing in CDC’s own journal in 2011, estimated an underdiagnosis multiplier of 83.1 for cyclosporiasis: for every laboratory-confirmed case, roughly eighty-three infections. Apply that to 19,595 and the estimate is on the order of 1.6 million Americans infected this summer. Apply it only to the 12,883 tied to the lettuce and it is still above a million. Treat those as orders of magnitude rather than counts. The multiplier was built before multiplex stool panels were common, so it probably runs high today, and testing this summer was unusually aggressive. Cut it in half twice and the answer is still that the people sickened by this lettuce number in the hundreds of thousands, and that almost none of them will ever appear in any government table.

The outbreak is closed. The investigation is not. All of those people are owed an answer about how a parasite that travels in human waste got onto lettuce bound for American tables. A letter asking industry to reread the regulations is not it.