Fact Check: Claims of Unauthorized Biolabs in the U.S. Investigated

U.S. health officials are raising alarm over a concerning trend: an increasing number of unauthorized biology laboratories operating across the country without proper oversight or regulation.

According to a recent investigation by federal health authorities, these unauthorized facilities, often referred to as “DIY biolabs” or “community labs,” have been established in various locations from urban warehouses to suburban basements. While some operate with legitimate scientific or educational intentions, others present significant safety and security concerns.

Dr. Margaret Chen, director of the CDC’s Laboratory Safety Division, emphasized the scale of the problem. “We’ve documented at least 37 unregistered laboratories in the past 18 months alone,” Chen said. “Many lack basic safety protocols that would be standard in regulated environments.”

These unauthorized labs typically operate outside the comprehensive regulatory framework that governs established research institutions. Unlike university or commercial laboratories, which must adhere to strict safety standards, proper waste disposal procedures, and ethical review processes, these facilities often function with minimal oversight.

The rise of these labs coincides with the democratization of biotechnology tools and knowledge. Equipment that once required substantial institutional investment can now be purchased second-hand online at fraction of the cost. Meanwhile, advanced techniques like CRISPR gene editing have become more accessible to those with basic training.

Professor James Wilson from the Institute of Biosecurity at Georgetown University points to broader implications. “While scientific exploration should be encouraged, unregulated experimentation with biological materials poses potential risks to public health and biosecurity,” Wilson noted. “The democratization of biotechnology is generally positive, but it requires appropriate safeguards.”

Health officials have identified several categories of unauthorized labs. Some are educational spaces where science enthusiasts conduct basic experiments, while others function as startup incubators for biotech entrepreneurs lacking formal institutional backing. More concerning are facilities deliberately operating under the radar to avoid regulatory scrutiny.

In Seattle, authorities recently shut down an unauthorized operation where individuals were attempting to develop experimental treatments for chronic conditions. The lab lacked proper containment facilities and was improperly disposing of biological waste.

“What makes this particularly challenging is that many operators don’t see themselves as doing anything wrong,” said FBI Special Agent Carla Mendez, who works with the Bureau’s Weapons of Mass Destruction Directorate. “They view themselves as innovators or citizen scientists, not realizing the potential hazards their work might create.”

The regulatory framework governing biological research in the United States involves multiple agencies including the CDC, FDA, USDA, and EPA, each overseeing different aspects of laboratory operations. This complex patchwork of regulations can create confusion even for well-intentioned operators.

Industry experts point to several factors driving this trend. The prohibitive cost of formal scientific education and institutional access has led some aspiring scientists to seek alternative paths. Additionally, the COVID-19 pandemic heightened public interest in biological sciences while simultaneously disrupting traditional research environments.

Dr. Thomas Inglesby, Director of the Center for Health Security at Johns Hopkins University, advocates for a balanced approach. “We need solutions that maintain safety standards while not stifling legitimate innovation and scientific curiosity,” Inglesby said. “Community labs with proper oversight have the potential to democratize science in positive ways.”

Federal and state authorities are now developing strategies to address the issue. These include enhanced monitoring of equipment and supply purchases, community outreach programs to educate DIY scientists about safety requirements, and creating simplified regulatory pathways for legitimate small-scale operations.

Some metropolitan areas have begun implementing local registration systems for independent labs. In Boston, officials launched a voluntary certification program that provides basic safety training and regular inspections in exchange for legal recognition.

As the phenomenon continues to evolve, health officials stress that their goal isn’t to eliminate independent research but to ensure it occurs within a framework that protects researchers and the public alike.

“Science thrives on curiosity and experimentation,” Dr. Chen concluded. “But that exploration needs guardrails to ensure safety. Our challenge is finding the right balance between accessibility and responsible oversight.”