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Food safety attorney Bill Marler is seeking public comments on a draft petition asking the FDA to require testing for botulinum toxin-producing bacteria in powdered infant formula and its dairy ingredients. The proposal follows two outbreaks in which 52 infants were hospitalized; FDA has not yet received the petition, and the requested rules are not in force.
Food safety attorney Bill Marler is seeking comments on a draft petition asking the U.S. Food and Drug Administration to require testing of powdered infant formula and dairy ingredients for bacteria that can cause infant botulism. The proposal follows two formula-associated outbreaks in which 52 infants were hospitalized; Marler says he plans to file the petition with 23 parents whose infants became ill.
The draft asks FDA to add Clostridium botulinum and other botulinum neurotoxin-producing clostridia to the organisms covered by the finished-product testing requirements in 21 C.F.R. § 106.55(e). It proposes a result of none detected in at least 30 samples of 200 grams each per production aggregate, or an equivalent testing plan. It also seeks testing of each lot of specified dairy ingredients before use, including whole milk powder, nonfat dry milk, milk protein concentrate and whey.
Other proposed measures include one-business-day notice to FDA of a confirmed positive result, finalizing a test method within 180 days, and records identifying the drying facility and dairy farms supplying milk. The draft calls for environmental monitoring as a secondary control and asks FDA to grant measures it can adopt promptly if it does not accept the full proposal. These are requests in a draft petition, not current FDA requirements.
Marler says the petition would be filed on behalf of 23 parents: 21 whose infants were affected in the ByHeart outbreak and two in the Nara Organics outbreak. He represents the families in litigation, according to the draft. He is seeking input from scientists, laboratories, public health officials, formula and dairy companies, pediatricians and parents, including comments on test design, practicality, cost, laboratory capacity and information that could weigh against the proposal.
Testing Could Reach Ingredients
The proposal focuses on finding contamination before dairy ingredients are used, as well as testing finished formula. That approach matters because the draft says FDA found the organism in a lot of organic whole milk powder that whole-genome sequencing matched to an ill infant. It also reports that ByHeart tested 472 samples from its plant environment and found no positives. Those figures are presented in the petition’s supporting account; they do not establish that environmental monitoring is never useful or that every ingredient lot is contaminated.
If FDA adopted the proposed requirements, manufacturers would face a standardized testing and reporting obligation rather than relying solely on voluntary company practices. Marler says ByHeart conducted about 5,000 tests during its investigation and now tests dairy ingredients, bulk powder and finished product before release, but no rule currently requires that approach across the industry. The petition could also affect reporting: the source says Senate-passed S. 272 would require one-business-day notice for organisms on FDA’s testing list. The draft argues that adding botulism would bring it within that provision if the legislation becomes law.
For families and caregivers, the issue is whether safeguards can detect a hazard before formula reaches infants. The petition does not seek a product or brand ban. It asks for testing, traceability and notification rules; whether those measures are technically workable and what they would cost are among the questions Marler is putting to commenters.
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Two Outbreaks Behind the Proposal
Federal rules currently require infant formula manufacturers to test finished product for Cronobacter and Salmonella. The draft says FDA added Cronobacter to the list in 2014 after concluding voluntary industry testing might be insufficient for a food that can be an infant’s sole source of nutrition. It also cites a March 8, 2023, letter from the FDA commissioner to powdered formula manufacturers identifying C. botulinum as a hazard to consider when designing controls. The organism is not currently on the finished-product list described in the draft.
According to the source report and petition, ByHeart formula was associated with 48 infant illnesses across 17 states, with onsets from December 2023 through November 2025. A separate Nara Organics outbreak involved four infants in California, Pennsylvania and Washington in April and May 2026. The account says every affected infant was hospitalized. On Aug. 27, 2026, FDA reported that whole-genome sequencing linked the outbreaks and that evidence pointed to a common source. The draft says both products were made with milk supplied by Organic West Milk and spray-dried by Dairy Farmers of America.
The petition also describes FDA sampling 48 powdered milk samples from four suppliers in February 2026, with two testing positive for a Clostridium carrying a botulinum toxin gene. It says FDA’s investigation found a matching milk-powder lot. These details are part of the case Marler presents for a rule change; FDA’s final findings and the proposed petition’s claims should not be conflated.
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Testing Plan Still Under Review
The proposal has not yet been filed, and FDA has not acted on it. The source says an interim testing method was presented at a July 2026 FDA roundtable but remained pending validation. It is unclear whether that method can support the proposed sampling plan at commercial scale, how quickly laboratories could process samples, or what the requirements would cost manufacturers and suppliers.
Other open questions include which dairy ingredients should be covered, whether ingredients treated through a validated spore-reduction process should be exempt, and whether farm-level traceability is practical. The draft itself asks commenters to identify evidence unfavorable to its recommendations. The source also says the milk supplier provided FDA an incomplete customer list during the 2025 investigation and that a television report traced milk to 22 dairies whose identities were not made public; the available account does not identify those dairies or provide further detail on FDA’s findings.
dairy ingredient testing for bacteria
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Comments Due October 30
Marler is asking interested parties to email comments to bmarler@marlerclark.com by Friday, Oct. 30, 2026. He says edits and redlines are welcome and that he can provide a Word version for those who want to mark up the draft. The proposed petition includes 31 footnotes and four appendices, according to the announcement.
After the comment period, Marler says he plans to file the petition with FDA alongside the 23 parents. The agency would then need to consider the request; the source provides no timetable for FDA review or decision. Until the agency acts, the proposed testing thresholds, notification deadline and traceability rules remain recommendations rather than binding requirements.
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Key Questions
Has the FDA received the petition?
Not according to the announcement. Marler is seeking comments on a draft before filing it with FDA.
What would the petition require?
It asks FDA to require testing of finished powdered formula and relevant dairy ingredients for botulinum toxin-producing bacteria, along with positive-result reporting, supplier traceability and a finalized test method.
How many infants were hospitalized in the outbreaks cited?
The source account says 52 infants were hospitalized: 48 associated with ByHeart formula and four associated with Nara Organics formula.
When and where can people comment?
Comments are requested by Friday, Oct. 30, 2026, by email to bmarler@marlerclark.com. Marler says a Word version is available on request.
Would the proposal ban any formula brand?
No. Marler says the petition does not seek a product or brand ban. It asks for testing and related safety and traceability requirements.
Source: rss
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