Come on RFK, Reside as much as your Hype – Radical Transparancy

I mailed this letter to Secretary Kennedy and Commissioner Makary – two weeks in the past – nonetheless no response.

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

Pricey Secretary Kennedy and Commissioner Makary:

Re:      2024 Multi-state E. coli O157:H7 Outbreak Linked to Romaine Lettuce

On behalf of my injured shoppers and within the public’s pursuits in radical transparency, I’m writing to 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 had been severely 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 and Alec Schielke —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 had 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 can lead to kidney failure, neurological harm, and demise.

Austin Carnaghi, a 15-year-old boy from St. Louis, Missouri, grew to become in poor health after consuming a salad served at a faculty 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 stomach 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 grew to become severely in poor health after consuming romaine lettuce served at her college in late October 2024. Her situation quickly deteriorated, and he or she was hospitalized for 26 days—from November 11, 2024, to December 7, 2024—and identified with HUS. Throughout her hospitalization, Lilly endured 17 days of hemodialysis and acquired 9 blood transfusions. She additionally developed pancreatitis and neurological problems because of her sickness. 

Tina Graham, like Austin Carnaghi, grew to become 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 stomach ache, vomiting, and frequent episodes of bloody diarrhea. Her signs had 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, grew to become 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 stomach 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 stomach 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 keeping with E. colian infection. Her situation deteriorated quickly, requiring hospitalization for 9 days.

Colton George, simply 9 years previous on the time, grew to become severely in poor health after consuming romaine lettuce bought by his dad and mom at Kroger’s. His signs escalated rapidly, and he was hospitalized for 18 days—from November 17, 2024, to December 5, 2024. He was identified with HUS and confirmed to be an entire 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 identified 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 grew to become in poor health after consuming romaine lettuce bought at Kroger’s in November 2024. He was hospitalized for 21 days with signs that had 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, grew to become in poor health after consuming a aspect salad together with her lunch at Jockamo’s Pizza. The next day, she developed diarrhea, vomiting, and total weak spot. 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 by means of its inner investigation. This info doesn’t represent “industrial or monetary” knowledge “obtained from an individual” below FOIA Exemption 4 and due to this fact 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 client safety, and obstructs very important public well being efforts aimed toward stopping future outbreaks. The general public has a proper to know which entities had been chargeable for these sicknesses in order that applicable safeguards might be applied, 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. End result info was accessible for 74 circumstances, of which 36 (49%) had been hospitalized. There have been 7 reported circumstances of HUS, and 1 demise 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 beneath) 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 had 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 whole, 7 subclusters had 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 had been the frequent hyperlink throughout all 7 subclusters, and circumstances in all subclusters ate an iceberg/romaine lettuce mix. CDC deployed a centered questionnaire on November 26, 2024; 27 questionnaires had been returned. Epi info was accessible for 65 circumstances, of which 60 (95%) reported consuming any sort of leafy inexperienced previous to sickness. Of 57 circumstances who might keep in mind the precise sort of leafy inexperienced consumed, 50 (88%) consumed romaine lettuce. That is statistically considerably increased than the background fee 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 accessible in any respect factors of service in the course of the timeframe of curiosity. Moreover, romaine lettuce provided to 4 of the 5 POS had been traced again to a standard ranch and lot. By means of evaluation of data, 4 a number of romaine lettuce had 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 revealed 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 beneath) that identifies 5 POS, 4 distributors, one dealer, one processor, and one grower that the FDA linked to the outbreak by means of its inner 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 below Exemption 4 of the Freedom of Data Act (“FOIA”), which shields confidential industrial info from public launch. In reality, such info is just not protected below Exemption 4, because it doesn’t meet the authorized customary for confidential therapy and straight issues public well being and security.

FDA’s redacted traceback diagram

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

            The FDA’s resolution 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 Data Act (FOIA). Beneath Exemption 4 of FOIA, an company should reveal that the withheld info is: (1) “industrial 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 Data Is Not “Industrial or Monetary” in and of Itself

To qualify for withholding below FOIA Exemption 4, the knowledge should be industrial or monetary “in and of itself”—which means it should serve a industrial perform or be of a industrial 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 non-public entities usually preserve confidential as a result of it reveals “fundamental industrial operations, equivalent to gross sales statistics, earnings and losses, and inventories, or relate[s] to the income-producing elements 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 “industrial or monetary” info below any cheap studying of the statute. They don’t reveal confidential enterprise methods, proprietary processes, monetary knowledge, or every other competitively delicate materials. Reasonably, they’re factual identifiers of entities concerned within the provide chain of a contaminated meals product that precipitated a lethal public well being outbreak. 

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

The Bureau doesn’t clarify in any element how a contractors’ identify is industrial “in and of itself”—that’s, how the identify “serves a ‘industrial perform’ or is of a ‘industrial nature.’” As a substitute, the Bureau rests its declare of exemption solely on the potential industrial penalties of disclosure, asserting that the contractors might face public hostility and ensuing financial hurt if their names had been disclosed. […] However the industrial penalties of disclosure are usually not on their very own ample to carry confidential info throughout the safety of Exemption 4 as “industrial.” 58 F.4th 1255, 1267-1268 (inner citations omitted).

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

Beneath the Bureau’s strategy, at any time when public scrutiny may need reputational repercussions with potential knock-on industrial 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 be told 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 remodel their names into “industrial” info. Exemption 4 doesn’t—and can’t—stretch that far, significantly provided that FOIA exemptions “should be narrowly construed.” Id. at. 1261.

The Withheld Data Was Not “Obtained from a Particular person”

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 personal group aside from an company.” 5 U.S.C. § 551(2). Courts have constantly held that info is “obtained from an individual” provided that it originates outdoors the federal authorities. Ctr. for Organic Range v. United States Forest Serv., 2025 U.S. Dist. LEXIS 59288 at *19 (D.D.C. 2025); see additionally Elec. Priv. Information. Ctr. v. DHS, 117 F. Supp. 3d 46, 63 (D.D.C. 2015) (“Data is taken into account ‘obtained from an individual’ … as long as the knowledge didn’t originate throughout the federal authorities.”) 

Though this customary can embody company paperwork that straight 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, relatively 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 provided to the FDA by any exterior celebration. Reasonably, the FDA independently uncovered these entities by means of 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 by means of its investigative efforts. Accordingly, the redacted identities mirror the FDA’s personal evaluation and don’t qualify as info “obtained from an individual” below Exemption 4. 

The Withheld Data Is Not “Privileged or Confidential”

To qualify as “confidential” below Exemption 4, info should meet at the least one of many two situations described by the Supreme Courtroom 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 should be “typically stored personal, or at the least carefully 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 are usually not the kind of info that’s typically stored personal. 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 recognized or readily discoverable by means of public sources. Farms, processors, and distributors routinely disclose their clients, companions, and provide chains for advertising and marketing, compliance, and logistics functions. Not like commerce secrets and techniques, pricing fashions, or proprietary formulation, the essential truth of who grew or bought a meals product is just not “recognized solely to a restricted few” or “meant to be held in confidence or stored 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 by means of its personal unbiased investigation. This additional undercuts any declare that the knowledge was “imparted” by a “individual” in confidence, as required below 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 could be stored confidential. Quite the opposite, disclosure is customary observe in lots of foodborne sickness outbreaks, the place figuring out implicated events is essential for public well being response and client safety. The FDA’s personal insurance policies emphasize transparency, significantly in issues involving acute threat to human well being. With none assurance of confidentiality and no constant, established observe of secrecy by the entities themselves, the withheld info merely doesn’t meet the definition of “confidential” below 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 (inner citations omitted). Disclosure—not secrecy—is the dominant goal of the Act. Id.Accordingly, the exemptions to FOIA should 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 personal entities or authorities companies. The statute protects confidential industrial 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 at the least 89 individuals throughout 15 states, precipitated seven circumstances of hemolytic uremic syndrome (HUS), and led to at least one demise. 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. 

            Although 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 business can’t take knowledgeable steps to stop recurrence. That is exactly the type 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 legislation doesn’t assist secrecy right here—and neither does public curiosity.

Very actually yours, 

William D. Marler

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