The Food and Drug Administration (FDA) announced a new crackdown Wednesday on the flow of American DNA to labs in China and other adversaries.
The FDA previously allowed for the outsourcing of research involving the genetic manipulation of American citizens’ living cells to China, the agency said in a press release. The cells would then be reimported into the U.S., sometimes without the knowledge of the clinical trial participants.
The U.S. began enforcing new export controls limiting sensitive genetic data flowing to adversarial countries last year. The rule, finalized in December 2024 and implemented in April, carved out a loophole for the pharmaceutical industry and other intuitions running clinical trials, allowing them to export biological material like living cells to China. FDA officials said the exemption applied even to companies with ties to the Chinese Communist Party.
“The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” FDA Commissioner Dr. Marty Makary said in a statement.
Before the change in policy, the emerging technology of cell therapy, which involves the transfer of live cells to treat a disease, may have risked exposing the genetic data of many Americans to hostile countries. There are approximately 8,000 active cell therapy and 1,000 gene therapy experiments listed on ClinicalTrials.gov, according to the American Society of Gene-Cell Therapy.
The U.S. government has begun cracking down on the potential diversion of American genetic data to the Chinese military in recent years. The issue has grown in salience following the outbreak of the COVID-19 pandemic in Wuhan, China — a city with a high-security lab with ties to the People’s Liberation Army.
Shenzhen-based BGI Group, previously known as Beijing Genomics Institute, is the world’s largest company genomic sequencing company. The U.S. Commerce Department in recent years has blacklisted five BGI affiliates from U.S. trade because they could aid in “surveillance by the government of China” and present a significant risk of diversion of genetic data to China’s military programs.
Some biosecurity experts have voiced concerns about People’s Liberation Army writings that speculate about the possibility of “specific ethnic genetic attacks,” while other experts emphasize this concept remains theoretical.
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