A pair of U.S. senators from opposite sides of the aisle are pushing Congress to reckon with a rapidly evolving biosecurity challenge: the dual-use risks posed by advances in engineering biology. The legislation, introduced April 21, 2026, responds to growing concerns that the regulatory and strategic frameworks governing biotechnology have not kept pace with the science.
Senators Tim Kaine (D-VA) and Ted Budd (R-NC) introduced the Engineering Biology Readiness Act, bipartisan legislation designed to strengthen U.S. defenses against biological threats stemming from the misuse or accidental release of engineered biological materials. Both senators serve on the Senate Armed Services Committee; Kaine also sits on the Senate Health, Education, Labor, and Pensions (HELP) Committee.
A New Era of Engineering Biology
Engineering biology has driven significant advances in medicine, diagnostics, and industrial biotechnology in recent years. The field encompasses technologies ranging from synthetic biology and gene editing to directed evolution and metabolic engineering.
But the same capabilities that accelerate vaccine development or disease diagnostics can, if misused or improperly secured, enable the creation or release of harmful biological agents. As the technology becomes more accessible and its applications more powerful, biosecurity experts have raised alarms about gaps in governance, oversight, and threat assessment.
“Bioengineering has tremendous potential to accelerate innovation in health care, science, industry, and more,” Kaine said in a statement. “But there are also significant risks if these innovations are used the wrong way.”
Two Core Provisions: Strategy Renewal and Risk Assessment
The Engineering Biology Readiness Act addresses two distinct but related needs.
First, it would renew the congressional reporting requirement for the National Biodefense Strategy (NBS) for five years, extending the mandate through the enactment of a future National Defense Authorization Act for Fiscal Year 2027. The NBS coordinates federal efforts to protect Americans from biological risks across the health, defense, and intelligence communities. The most recent strategy was issued in 2022. In the years since, novel biotechnologies have outpaced that framework, and key biosecurity functions have been reorganized across agencies including the Department of Homeland Security, the Office of the Director of National Intelligence, and the White House National Security Council.
Second, the bill would direct an interagency coalition — drawing from departments and agencies involved in the existing biodefense threat assessment process — to produce a comprehensive analysis of engineering biology risks. That report would include:
- An intelligence assessment of current and anticipated threats to national security and public safety
- A review of existing authorities, regulations, and programs governing engineering biology in the United States, including biosafety, biosecurity, and biodefense
- An evaluation of gaps, redundancies, and ambiguities in current governance
- Recommendations for modernizing those frameworks, including proposed legislative actions and funding estimates
The legislation also requires that recommendations be developed in consultation with representatives from industry, academia, and civil society — including life sciences researchers who have not received federal grants or contracts in the preceding five years, a provision aimed at ensuring independent perspectives.
“With advancements in engineering biology, the U.S. must be ready to confront potential national security and public safety threats,” said Budd. “The COVID-19 pandemic showed how devastating biological threats can be.”
The bill has been referred to the relevant Senate committee. Full text of the legislation is available here.
Sources and further reading:
Kaine & Budd Introduce Bill to Boost Safety and Security Against Biological Threats – Senate.gov