Merck & Co Inc: Disclosure Regarding Horseshoe Crab-Derived Endotoxin Testing

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WHEREAS:  Pharmaceutical and medical device companies have historically relied on blood extracted from horseshoe crabs to detect bacterial contamination in injectable drugs, vaccines, and medical devices. Blood from millions of horseshoe crabs is harvested annually for this testing, with mortality rates of 15-30%.[1] Population declines, tightening harvest regulations, and ongoing environmental litigation are compounding supply-chain vulnerability and elevating regulatory and reputational exposure for companies dependent on this input.[2],[3]

Declining Crab Population

Pharmaceutical use of horseshoe crab blood has put substantial pressure on this keystone species whose eggs provide critical food for at least 11 species of migratory shorebirds and fish species.[4] A decline in horseshoe crabs threatens the entire Atlantic coastal ecosystem, including the red knot shorebird population which has plummeted 75% since the 1980s,[5] due to horseshoe crab egg depletion.[6] In response, state legislatures where horseshoe crab harvesting is based are enacting restrictions. New York banned both commercial and biomedical collection in 2025; similar measures are underway in Connecticut and New Jersey.[7]

Synthetic Alternatives Are Approved and Readily Available

Synthetic alternatives offer more reliable and cost-effective testing for contamination and avoid quality and supply issues tied to horseshoe crab blood, while delivering more consistent results.[8] With new U.S. Pharmacopeia standards taking effect in May 2025, these synthetic alternatives are fully recognized – removing the primary adoption barrier.[9]

Merck Co Inc. Continues to Use Horseshoe Crab Blood Testing

Merck participated in the landmark 2016-2017 BioPhorum Operations Group (BPOG) study which scientifically validated synthetic alternatives.[10] However, while several other pharmaceutical companies participating in BPOG have disclosed transition progress with specific timelines, Merck has not.[11]

Merck’s failure to develop a public transition strategy for endotoxin testing is at odds with its commitment to the 3Rs principles (Replace, Reduce, Refine) for animal welfare and its development of other non-animal research methods,[12] creating a significant policy gap between its public and welfare principles and its testing practices.

Disclosure Gaps Create Reputational Risk

Merck has not responded to the 2024 industry survey and Sustainability Scorecard for Endotoxin Testing.[13] Without transparency on testing methods, usage volumes, or transition planning, shareholders cannot assess whether Merck is positioned competitively on this issue as regulatory restrictions expand and supply chain risks increase. Merck's lack of disclosed strategy creates material uncertainty for investors evaluating supply chain resilience and its competitive positioning.

BE IT RESOLVED:  Shareholders request that Merck issue a report, at reasonable expense and omitting proprietary information, analyzing the supply chain risks of horseshoe crab materials and whether synthetic endotoxin testing alternatives would reduce material risk to the Company.

Resolution Details

Company: Merck & Co Inc

Lead Filers: As You Sow

Year: 2026

Filing Date: 
December 2025

Initiative(s): Oceans

Status: Filed

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BiodiversityAs You SowBiodiversity, biodiversity, biodiversity loss, horseshoe crabs, pharmaceutical, Pharmaceutical, Biomedicalbiomedical, keystone, Keystone, keystone species, Merck, Merck & Co.