Pallone Urges Swift Use of New Biomedical Guidelines to Protect Horseshoe Crabs and Ecosystems

LONG BRANCH, NJ - Congressman Frank Pallone, Jr. (NJ-06) today expressed strong support for the U.S. Pharmacopeia's (USP) new guidelines for the use of synthetic alternatives to horseshoe crab blood in drug and medical device safety testing. Pallone emphasized the importance of these guidelines as a step toward reducing pharmaceutical industry reliance on Atlantic horseshoe crabs while ensuring a safe medical product supply chain. A key ingredient found in the blood of horseshoe crabs is used to detect dangerous contaminants known as endotoxins in everything from routine vaccines to medical devices like heart stents.

"I fully support U.S. Pharmacopeia's new guidelines for synthetic alternatives to horseshoe crab blood for biomedical testing. For years, I've been leading the charge in Congress to track horseshoe crabs, study coastal ecosystems, and modernize our biomedical testing guidelines. Horseshoe crabs predate the dinosaurs and are an iconic Atlantic species. They are a crucial part of the local ecosystem and a food source for birds like the critically endangered rufa red knot, which famously has one of the longest migrations of any species in the world, and stops in my home state of New Jersey to feed. Increasing global demand for vaccines, and therefore, horseshoe crab blood, is straining their populations and threatening biodiversity. Synthetic alternatives offer a viable solution to get these ancient creatures out of the biomedical supply chain and keep them in their natural habitats," said Congressman Pallone.

The USP is an independent, non-profit organization that collaborates with regulatory agencies, including the U.S. Food and Drug Administration, to establish public standards for the quality, purity, strength, and consistency of medicines, food ingredients, and dietary supplements. These standards are widely recognized and enforced by regulatory bodies in the United States and many other countries.

Congressman Pallone highlighted the urgent need to transition to testing methods that utilize synthetic reagents stating,"Endotoxin testing using horseshoe crab blood has been the gold standard of safety for years, but now scientists have innovated an alternative that no longer depends on animal blood. Horseshoe crabs' habitat is experiencing greater environmental stress every day due to climate change. The entire endotoxin supply chain cannot be reliant on such a limited, fragile source when we now have reliable alternatives. This is a matter of public health and national security. I applaud the USP for taking action to make it easier for pharmaceutical manufacturers to start using safe alternatives just as the European Union and Japan have done for years. It is imperative that our health care system prioritize the welfare of horseshoe crabs and transition to synthetic testing methods to protect public health and ecological balance."

"There are substantial scientific, supply chain, economic, environmental, and animal protection benefits to using recombinant Bacterial Endotoxin Tests (rBET) over blood-based methods," said Elizabeth Baker, Director of Research Policy at the Physicians Committee for Responsible Medicine. "Many companies developing critical new therapies have been awaiting this policy change to transition testing to rBET. Under USP Chapter 86, companies can confidently use nonanimal approaches for testing new products, capitalizing on the many advantages. Thanks to both Rep. Pallone for his leadership on this issue in Congress and to the USP for this much needed policy change."

"Approximately 1 million horseshoe crabs are collected each year for biomedical bleeding, and an estimated 15 percent die in the process. Many more suffer painful and disorienting aftershocks," said Larry Niles co-founder of the Horseshoe Crab Recovery Coalition."The USP recognition of synthetic lysate could drastically reduce these numbers. We thank Rep. Pallone for his support of chapter 86 and urge pharmaceutical companies to convert to synthetic equivalents."

Recently, officials from five major pharmaceutical companies met at Reeds Beach, NJ to witness the impact of horseshoe crab bleeding on the Delaware Bay ecosystem. Conservationists hope the meeting will persuade industry actors who have not yet moved to adopt synthetic alternatives to take action.

"Biomedical use of horseshoe crabs means less horseshoe crab eggs on beaches for shorebirds to feed on," said Annie Chester, Policy Director at American Bird Conservancy. "The USP Microbiology Expert Committee's action to approve Chapter 86 is an important step in the right direction toward wider adoption of synthetic endotoxin tests that do not use horseshoe crab blood."

"Approximately 1 million horseshoe crabs are collected each year for biomedical bleeding, and an estimated 15 percent die in the process. Many more suffer painful and disorienting aftershocks," said Larry Niles co-founder of the Horseshoe Crab Recovery Coalition. "The USP recognition of synthetic lysate could drastically reduce these numbers. We thank Rep. Pallone for his support of chapter 86 and urge pharmaceutical companies to convert to synthetic equivalents."

"There are substantial scientific, supply chain, economic, environmental, and animal protection benefits to using recombinant Bacterial Endotoxin Tests (rBET) over blood-based methods," said Elizabeth Baker, Director of Research Policy at the Physicians Committee for Responsible Medicine. "Many companies developing critical new therapies have been awaiting this policy change to transition testing to rBET. Under USP Chapter 86, companies can confidently use nonanimal approaches for testing new products, capitalizing on the many advantages. Thanks to both Rep. Pallone for his leadership on this issue in Congress and to the USP for this much needed policy change."

Pallone has been a staunch advocate for the protection of horseshoe crabs, which serve as a crucial part of the ecosystem and a food source for migratory birds like the red knot. Pallone's past efforts include collaborating with USP to promote safe testing methods, advocating for federal funding to support conservation projects, and working with environmental organizations to raise awareness about the decline in horseshoe crab populations.

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