Hey FDA, How about some actual “Radical Transparency” or simply Transparency

I mailed this letter to Secretary Kennedy and Commissioner Makary.

Full letter: https://www.marlerblog.com/recordsdata/2025/06/Draft-FOIA-Exemption-4-Letter-6.17.25-FINAL.pdf

Re:      2024 Multistate E. coli O157:H7 Outbreak Linked to Romaine Lettuce

Pricey Secretary Kennedy and Commissioner Makary:

On behalf of my injured shoppers and within the public’s pursuits in radical transparency, I’m writing on your assist.  We ask the FDA to reveal the names of the grower, processor, dealer, distributors, and factors of service recognized in its investigation of this E. coli O157:H7 outbreak.

My agency represents ten people who have been significantly sickened within the 2024 multistate E. coli O157:H7 outbreak linked to romaine lettuce. Every of them—Austin Carnaghi, Tina Graham, Alaina Mujkanovic, Sawyer Swearingen, Kimberly Everding, Colton George, Lilly Hasenour, Cynthia Hefling, Alec Schielke, and Brenda Lippert—suffered extreme sickness after consuming contaminated romaine lettuce served at faculties, eating places, catered occasions, or bought at retail. 

These sicknesses weren’t minor. They have been extreme, extended, and in lots of circumstances, life-threatening, requiring prolonged hospitalizations, intensive medical interventions, and ongoing restoration. A number of people developed hemolytic uremic syndrome (HUS), a critical and doubtlessly deadly complication that may end up in kidney failure, neurological damage, and dying.

Austin Carnaghi, a 15-year-old boy from St. Louis, Missouri, turned in poor health after consuming a salad served at a college occasion on November 6, 2024. The meal had been ready and catered by Andre’s Banquets & Catering. Shortly after consuming the salad, Austin skilled extreme belly cramping, persistent vomiting, and steady diarrhea, which progressed to bloody diarrhea. He sought medical consideration at an pressing care facility, the place a stool pattern examined optimistic for E. coli O157:H7. 

Lilly Hasenour, a 15-year-old lady from Greenwood, Indiana, additionally turned significantly in poor health after consuming romaine lettuce served at her college in late October 2024. Her situation quickly deteriorated, and she or he was hospitalized for 26 days—from November 11, 2024, to December 7, 2024—and recognized with HUS. Throughout her hospitalization, Lilly endured 17 days of hemodialysis and acquired 9 blood transfusions. She additionally developed pancreatitis and neurological issues on account of her sickness. 

Tina Graham, like Austin Carnaghi, turned in poor health after consuming meals, together with salad, catered by Andre’s Banquets on November 7, 2024. 4 days later, on November 11, she started experiencing excruciating belly ache, vomiting, and frequent episodes of bloody diarrhea. Her signs have been so intense that she was unable to sleep and required a bedside commode each 10 to fifteen minutes throughout her hospitalization. A stool pattern collected on the hospital subsequently examined optimistic for E. coli O157:H7.  

Alaina Mujkanovic, a 16-year-old lady, turned in poor health after consuming meals served by Andre’s Banquets at her highschool on November 8, 2024. Inside two days later, she developed intense belly cramping, dizziness, malaise and extreme diarrhea that progressed to bloody diarrhea. She sought emergency medical care, the place testing confirmed an an infection with E. coli O157:H7.

Sawyer Swearingen, additionally 16 years previous, fell in poor health after consuming meals catered by Andre’s Banquets on November 7, 2024. His signs mirrored these of others: persistent vomiting, diarrhea, and belly ache. He was hospitalized for 5 days as a consequence of dehydration and decreased fluid consumption exacerbated by the vomiting and diarrhea and was later confirmed to have E. coli O157:H7.

Kimberly Everding attended a funeral reception at Andre’s South Banquets & Catering in St. Louis on November 8, 2024, the place she ate salad. Three days later, on November 11, she developed extreme signs in line with E. colian infection. Her situation deteriorated quickly, requiring hospitalization for 9 days.

Colton George, simply 9 years previous on the time, turned significantly in poor health after consuming romaine lettuce bought by his mother and father at Kroger’s. His signs escalated shortly, and he was hospitalized for 18 days—from November 17, 2024, to December 5, 2024. He was recognized with HUS and confirmed to be a complete genome sequence (WGS) match to the outbreak pressure. Throughout his hospitalization, Colton underwent 9 days of steady renal substitute remedy (hemodialysis) adopted by 5 extra days of intermittent hemodialysis. He additionally acquired 5 blood transfusions. He spent his 10^th birthday within the hospital.

Cynthia Hefling additionally consumed romaine lettuce in November 2024 and developed nausea, vomiting, diarrhea, bloody diarrhea, abdomen cramps, muscle aches, fatigue, headache, and a urinary tract an infection. She was hospitalized for 25 days. As her situation worsened, she was transferred to an Intensive Care Unit (ICU) on November 29 for hemodialysis, the place she remained till December 7. She underwent 9 days of hemodialysis, acquired one blood transfusion, and was recognized with life-threatening HUS. She additionally developed acute encephalopathy within the ICU, requiring remedy.

Alec Schielke, like Alaina Mujkanovic and Sawyer Swearingen, is 16 years of age. He turned in poor health after consuming romaine lettuce bought at Kroger’s in November 2024. He was hospitalized for 21 days with signs that have been later confirmed to be attributable to an E. coli an infection. Alec endured a chronic gastrointestinal sickness, requiring in depth medical care.

Brenda Lippert, a 70-year-old lady from Franklin, Indiana, turned in poor health after consuming a aspect salad along with her lunch at Jockamo’s Pizza. The next day, she developed diarrhea, vomiting, and total weak point. As her situation worsened, she required hospitalization for 5 days. 

Given the severity of this outbreak, we respectfully urge the FDA to reveal the identities of all entities concerned—together with the lettuce grower and processor recognized because the supply of contamination via its inside investigation. This info doesn’t represent “business or monetary” knowledge “obtained from an individual” underneath FOIA Exemption 4 and subsequently doesn’t qualify as confidential. 

The general public curiosity in “radical transparency” is overwhelming and much outweighs any claimed curiosity in nondisclosure. This outbreak sickened the ten people described above, together with 79 others throughout 15 states. Seven developed hemolytic uremic syndrome (HUS), and one tragically died. Furthermore, this outbreak has been linked to 6 prior historic clusters, strongly suggesting the presence of a persistent, resident pressure of E. coli at or close to the supply.

Continued withholding of this info impedes accountability, undermines shopper safety, and obstructs important public well being efforts geared toward stopping future outbreaks. The general public has a proper to know which entities have been chargeable for these sicknesses in order that acceptable safeguards might be carried out, monitored, and enforced.

An(different) Outbreak of E. coli O157:H7 Linked to Romaine Lettuce

As detailed within the FDA’s CORE Report, on November 25, 2024, PulseNet coded an outbreak of E. coli O157:H7 2411MOEXH-2. On the time of closing, this investigation included 89 circumstances throughout 15 states: AR (2), CO (1), IL (7), IN (8), KS (1), KY (1), MO (50), MT (1), ND (2), NE (3), OH (8), PA (1), SD (1), TN (1), WI (2), all associated inside 0-4 alleles by cgMLST. 

Isolation dates ranged from November 7, 2024, to December 1, 2024. Reported onset dates (n=83) ranged from November 4, 2024, to November 30, 2024. Ages ranged from 4 to 90 years with a median age of 24. Sixty of 88 circumstances (68%) feminine. Consequence info was out there for 74 circumstances, of which 36 (49%) have been hospitalized. There have been 7 reported circumstances of HUS, and 1 dying attributed to this outbreak.

A case on this investigation was outlined as an infection with E. coli O157:H7 with an isolate associated to the outbreak pressure inside 0-4 alleles by cgMLST and isolation date starting from November 7 to December 1, 2024. This outbreak was associated to 6 historic investigations: 2302MLEXH-1, 2210MLEXH-3, 2210MLEXH-2, 2209MLEXH-1, 2112MLEXH-1, and 2106CAEXH-1. The one car recognized was for 2112MLEXH-1, which was closed with a confirmed car of natural energy greens. The NCBI tree (pictured under) for this pressure included quite a few nonclinical beef isolates.

NCBI tree

This outbreak was coded following notification from FDA colleagues in Missouri after they recognized and investigated a number of sicknesses linked to occasions catered by the identical Missouri-based caterer. These occasions occurred between November 6 and November 8. All occasions included the identical menu objects with a couple of modifications. Missouri colleagues carried out a retrospective cohort research at two of the occasions and located that salads have been the one statistically vital menu merchandise throughout each occasions. Salads contained an iceberg/romaine lettuce mix, carrots, purple cabbage, onions, canned pimento, canned artichokes, parmesan cheese, and a home made salad dressing.

In complete, 7 subclusters have been recognized throughout the multistate outbreak. These included 3 Missouri catered occasions, an Ohio secondary college, an Indiana restaurant, an Illinois restaurant, and an Illinois occasion catered by a different Missouri-based caterer. Salads have been the frequent hyperlink throughout all 7 subclusters, and circumstances in all subclusters ate an iceberg/romaine lettuce mix. CDC deployed a targeted questionnaire on November 26, 2024; 27 questionnaires have been returned. Epi info was out there for 65 circumstances, of which 60 (95%) reported consuming any sort of leafy inexperienced previous to sickness. Of 57 circumstances who might bear in mind the precise sort of leafy inexperienced consumed, 50 (88%) consumed romaine lettuce. That is statistically considerably larger than the background charge of 49% from the FoodNet Inhabitants survey. A traceback investigation was initiated in response to an E. coli O157 outbreak with leafy greens because the suspected car. 

The investigation consisted of three traceback legs representing twenty-eight circumstances and 5 factors of service (POS). The three traceback legs recognized 4 distribution facilities, one dealer, two processors, one grower, and one ranch. The traceback investigation decided {that a} sole processer sourced romaine lettuce from a single grower that may have been out there in any respect factors of service in the course of the timeframe of curiosity. Moreover, romaine lettuce equipped to 4 of the 5 POS have been traced again to a standard ranch and lot. By evaluation of information, 4 a number of romaine lettuce have been implicated, leading to affirmation of romaine lettuce because the car. Epidemiologic and traceback knowledge supported the conclusion that romaine lettuce was the supply of sicknesses on this outbreak. 

On February 11, 2025, the FDA printed its findings in a Coordinated Outbreak Response & Analysis (CORE) report titled “E. coli O157:H7/Romaine Lettuce/Nov 2024 Govt Incident Abstract CARA #1280.”^[1] The report features a redacted traceback diagram (pictured under) that identifies 5 POS, 4 distributors, one dealer, one processor, and one grower that the FDA linked to the outbreak via its inside investigation. However FDA officers by no means issued public communications following the investigation, nor did it disclose the identities of the entities that grew, processed, brokered, distributed, or served the contaminated lettuce. Company officers claimed that this info is protected underneath Exemption 4 of the Freedom of Info Act (“FOIA”), which shields confidential business info from public launch. In reality, such info will not be protected underneath Exemption 4, because it doesn’t meet the authorized customary for confidential therapy and immediately considerations public well being and security.

FDA’s redacted traceback diagram

The Identities Withheld by the FDA Are Not Protected Underneath FOIA Exemption 4

            The FDA’s choice to withhold the names of the grower, processor, dealer, distributors and factors of service linked to the 2024 E. coli O157:H7 outbreak involving romaine lettuce is legally unsound and opposite to the core rules of transparency embedded within the Freedom of Info Act (FOIA). Underneath Exemption 4 of FOIA, an company should display that the withheld info is: (1) “business or monetary” in nature; (2) “obtained from an individual”; and (3) “privileged or confidential”. 5 U.S.C. § 552 (b)(4). None of those situations are happy right here. 

• The Withheld Info Is Not “Industrial or Monetary” in and of Itself

To qualify for withholding underneath FOIA Exemption 4, the knowledge have to be business or monetary “in and of itself”—which means it should serve a business operate or be of a business nature. Residents for Resp. & Ethics in Wash. v. United States DOJ, 58 F.4th 1255, 1263 (D.C. Cir. 2023). The D.C. Circuit has made clear that Exemption 4 protects solely info that personal entities usually preserve confidential as a result of it reveals “fundamental business operations, equivalent to gross sales statistics, earnings and losses, and inventories, or relate[s] to the income-producing facets of a enterprise.” Id. (quoting Pub. Citizen Rsch. Grp. v. FDA, 704 F.second 1280, 1290, 227 U.S. App. D.C. 151 (D.C. Cir. 1983)). 

The names of the grower, processor, distributors, brokers, and retail or meals service shops linked to this outbreak don’t qualify as “business or monetary” info underneath any cheap studying of the statute. They don’t reveal confidential enterprise methods, proprietary processes, monetary knowledge, or every other competitively delicate materials. Quite, they’re factual identifiers of entities concerned within the provide chain of a contaminated meals product that induced a lethal public well being outbreak. 

The D.C. Circuit immediately addressed this challenge in Residents for Resp. & Ethics in Wash. v. United States DOJ, rejecting the argument {that a} contractor’s names could possibly be withheld merely as a result of disclosure would possibly lead to reputational damages or financial penalties. The Court docket defined:

The Bureau doesn’t clarify in any element how a contractors’ title is business “in and of itself”—that’s, how the title “serves a ‘business operate’ or is of a ‘business nature.’” As a substitute, the Bureau rests its declare of exemption completely on the potential business penalties of disclosure, asserting that the contractors might face public hostility and ensuing financial hurt if their names have been disclosed. […] However the business penalties of disclosure should not on their very own ample to deliver confidential info inside the safety of Exemption 4 as “business.”

58 F.4th 1255, 1267-1268 (inside citations omitted).

            The Court docket warned that permitting authorities companies to withhold info based mostly solely on the prospect of public scrutiny would invert FOIA’s objective: 

Underneath the Bureau’s method, each time public scrutiny might need reputational repercussions with potential knock-on business results, the federal government and a contractor might protect info from public view just by agreeing to maintain it secret. That’s not what Congress had in thoughts when it protected “residents’ proper to learn about ‘what their authorities is as much as.’” 

Id. at 1267-1268.

The identical logic applies right here. Merely figuring out the entities concerned within the distribution of contaminated meals doesn’t rework their names into “business” info. Exemption 4 doesn’t—and can’t—stretch that far, notably provided that FOIA exemptions “have to be narrowly construed.” Id. at. 1261.

• The Withheld Info Was Not “Obtained from a Individual”

Exemption 4 applies solely to info “obtained from an individual.” 5 U.S.C. § 552 (b)(4).  FOIA broadly defines “individual” to incorporate “a person, partnership, company, affiliation, or public or non-public group apart from an company.” 5 U.S.C. § 551(2). Courts have constantly held that info is “obtained from an individual” provided that it originates exterior the federal authorities. Ctr. for Organic Variety v. United States Forest Serv., 2025 U.S. Dist. LEXIS 59288 at *19 (D.D.C. 2025); see additionally Elec. Priv. Data. Ctr. v. DHS, 117 F. Supp. 3d 46, 63 (D.D.C. 2015) (“Info is taken into account ‘obtained from an individual’ … as long as the knowledge didn’t originate inside the federal authorities.”) 

Though this customary can embody company paperwork that immediately summarize or restate third-party knowledge, it doesn’t lengthen to info that has been independently generated or substantively reformulated by the federal government. “[W]hen an company analyzes, moderately than simply summarizes, third-party info, such info is not going to be thought of ‘obtained from an individual.’” 2025 U.S. Dist. LEXIS 59288 at *19 (quoting Philadelphia Newspapers, Inc. v. HHS, 69 F. Supp. second 63, 66-67 (D.D.C. 1999).

That distinction is dispositive right here. The identities of the grower, processor, distributors, dealer, and retail or meals service shops weren’t equipped to the FDA by any exterior celebration. Quite, the FDA independently uncovered these entities via its personal traceback investigation, carried out in coordination with different federal companies. The company didn’t merely compile or summarize date submitted by third celebration—it generated new info via its investigative efforts. Accordingly, the redacted identities mirror the FDA’s personal evaluation and don’t qualify as info “obtained from an individual” underneath Exemption 4. 

• The Withheld Info Is Not “Privileged or Confidential”

To qualify as “confidential” underneath Exemption 4, info should meet no less than one of many two situations described by the Supreme Court docket in Meals Mktg. Inst. v. Argus Chief Media, 588 U.S. 427, 434, 139 S. Ct. 2356, 204 L. Ed. second 742 (2019). First, the knowledge have to be “usually saved non-public, or no less than intently held, by the individual imparting it.” Id. Second, the federal government should present “some assurance that it’ll stay secret.” Id. Neither situation is happy right here. 

First, the identities of growers, processors, brokers, distributors, and retail or meals service shops concerned on this outbreak should not the kind of info that’s usually saved non-public. These entities function in public-facing, extremely regulated sectors—agriculture, meals distribution, and retail gross sales—the place their roles within the provide chain are extensively identified or readily discoverable via public sources. Farms, processors, and distributors routinely disclose their prospects, companions, and provide chains for advertising, compliance, and logistics functions. Not like commerce secrets and techniques, pricing fashions, or proprietary formulation, the fundamental truth of who grew or bought a meals product will not be “identified solely to a restricted few” or “meant to be held in confidence or saved secret.” Id. at 434. Certainly, many of those entities promote their participation in nationwide provide chains and their relationships with retailers or meals service firms. Furthermore, as detailed above, the FDA didn’t obtain this info from any exterior celebration; it uncovered and synthesized it via its personal unbiased investigation. This additional undercuts any declare that the knowledge was “imparted” by a “individual” in confidence, as required underneath Meals Mktg. Inst. v. Argus.

Second, there isn’t a indication that the FDA gave any assurance—formal or casual—that the identities of those entities can be saved confidential. Quite the opposite, disclosure is customary apply in lots of foodborne sickness outbreaks, the place figuring out implicated events is essential for public well being response and shopper safety. The FDA’s personal insurance policies emphasize transparency, notably in issues involving acute danger to human well being. With none assurance of confidentiality and no constant, established apply of secrecy by the entities themselves, the withheld info merely doesn’t meet the definition of “confidential” underneath Exemption 4.

• The Public Curiosity Calls for Disclosure

FOIA exists “to pierce the veil of administrative secrecy and to open company motion to the sunshine of public scrutiny.” Residents, 58 F.4th at 1261 (inside citations omitted). Disclosure—not secrecy—is the dominant goal of the Act. Id.Accordingly, the exemptions to FOIA have to be “narrowly construed,” and the burden of justifying any withholding rests with the company. Id. at 1261-1262.

            Exemption 4 doesn’t—and can’t—protect info from public scrutiny just because its launch might trigger discomfort to non-public entities or authorities companies. The statute protects confidential business info, not reputational pursuits or the federal government’s need to keep away from controversy. Id. at 1268. 

            Right here, the general public curiosity in disclosure is overwhelming. The FDA has withheld the identities of entities linked to a lethal E. coli O157:H7 outbreak that sickened no less than 89 individuals throughout 15 states, induced seven circumstances of hemolytic uremic syndrome (HUS), and led to 1 dying. Traceback evaluation revealed that the outbreak pressure matched six prior E. coliclusters—sturdy proof of a persistent, resident pressure at or close to the supply. Disclosure is crucial to public accountability and future prevention. 

            Though the outbreak investigation is closed, the well being dangers stay. With out transparency about the place the contamination occurred and who was accountable, the general public, regulators, and trade can not take knowledgeable steps to stop recurrence. That is exactly the sort of secrecy FOIA was enacted to stop: the place withholding info compromises public well being and conceals systemic failures from the scrutiny essential to appropriate them. 

            Accordingly, we respectfully request that the FDA disclose the names of the grower, processor, dealer, distributors, and factors of service recognized in its investigation. The regulation doesn’t assist secrecy right here—and neither does public curiosity.

Very really yours, 

William D. Marler

^[1] https://www.marlerblog.com/recordsdata/2025/04/2411MOEXH-2-Romaine-E.-coli-FDA-Data.pdf