Why US Banned Transfer Of Genetic Samples To China

Authored by Leo Timm via The Epoch Times (emphasis ours),

The Food and Drug Administration has halted a program that allowed the transfer of U.S. citizens’ biological samples to China and other “hostile countries.”

The FDA’s ban and review are a necessary move to bolster U.S. biosecurity against the potential threat of biological warfare and bioterror by the Chinese Communist Party (CCP), said experts who spoke with the Chinese-language edition of The Epoch Times.

In recent decades, China has developed a broad array of specialized medical research capabilities, including genetic engineering. Due to their low handling costs, Chinese facilities have become popular destinations for biological samples.

“This [genetic] data is the key to understanding how different population groups respond biologically,” said Sean Lin, a former U.S. Army microbiologist.

He warned that sensitive genetic information in the hands of capable, malicious actors such as the Chinese regime could be used to further research on biological weapons targeting people of specific races or ethnicities.

What was once regarded as implausible or belonging to the realm of science fiction, Lin said, is now “a real threat made possible by current biotechnology.”

Lin said the cell samples being sent to China, rather than being static DNA sequences, “contain dynamic data about gene regulation and expression under different stimuli.”

The FDA said on June 18 that its immediate review of the program will scrutinize a variety of new clinical trials that sent the participants’ living cells abroad “for genetic engineering and subsequent infusion back into U.S. patients—sometimes without their knowledge or consent.”

Biological samples from the clinical trials were exported to “countries of concern” due to loopholes in a data security rule drafted at the end of 2024 and implemented in April by the Justice Department, according to the FDA.

Last December, the Biden administration had “specifically requested and approved a sweeping exemption that allowed U.S. companies to send trial participants’ biological samples” overseas, the agency said.

The Trump administration’s move to halt exports of American genetic samples overseas will likely impact a number of U.S.–China biomedical collaborations in the short term, Lin said, but the action is necessary to protect U.S. national security and Americans’ data privacy.

Asymmetric Biowarfare Threat

Shen Ming-shih, a researcher at Taiwan’s government-run Institute for National Defense and Security Research, said that China’s collection of foreigners’ DNA samples likely plays into the CCP’s asymmetric approaches for challenging the United States and its allies.

Asymmetric warfare refers to the tactics and strategies adopted in conflicts where there is a vast gap in the military capabilities of both sides.

“Variations in how different ethnic groups respond to specific pathogens could become decisive strategic variables” in biological warfare scenarios, he said.

While China’s People’s Liberation Army (PLA) is regarded by some experts as being qualitatively inferior to the militaries of the United States and its allies, the CCP could employ asymmetric means—including biological attacks—to its advantage, even without direct conflict.

The 1999 book “Unrestricted Warfare,” by PLA colonels Qiao Liang and Wang Xiangsui, details how Beijing could wage an indirect war against the United States by undermining it in the economic, informational, technological, legal, and biological domains.

Shen noted the possible artificial origins of COVID-19, the outbreak of which various authorities, including the Trump administration, have linked to China’s Wuhan Institute of Virology.

In January, the CIA released a report concluding that the SARS-CoV-2 pathogen was “more likely” to have leaked from the Wuhan Institute’s P4-level laboratory, rather than from a source in the natural environment.

On June 3, Chinese researcher Jian Yunqing was arrested for allegedly attempting to smuggle into the country Fusarium graminearum, a fungus classified as a restricted pathogen by the U.S. government.

According to the criminal complaint, Jian was found to be a loyal member of the CCP. She worked at the University of Michigan and had received Chinese state funding to research Fusarium graminearum.

The U.S. Attorney’s Office in Michigan’s Eastern District described Fusarium graminearum as a “noxious fungus” that blights wheat, barley, corn, and rice, and “is responsible for billions of dollars in economic losses worldwide each year.”

Jian’s boyfriend, Liu Zunyong, was also arrested and denied entry to the United States. He was sent back to China, where he works at Zhejiang University in Hangzhou city, studying the same pathogen as his girlfriend.

Another Chinese researcher, Han Chengxuan, was arrested on June 8 at the airport in Detroit. She had arrived on an exchange visitor visa and was planning to spend a year in the United States researching roundworms at the University of Michigan.

According to the complaint, Han initially lied to customs officials about packages she had sent to individuals at a university laboratory, and later admitted that they contained biological materials related to roundworms.

Tightening Restrictions

Lin noted the national security risks and ethical concerns of working with the Chinese regime on biotechnology research.

“Under the CCP, biotechnological development is subject to a high degree of civil-military fusion,” he said, referring to how, in China, even companies and institutions without explicit ties to the Communist Party can be enlisted at will to serve the regime’s needs.

“Once American samples enter this research ecosystem, the U.S. loses all control over their final usage or research direction,” Lin said.

Lin added that China very likely engages in secret genetic research at the CCP’s behest, something he believes should raise alarm bells among U.S. national security agencies.

He pointed out that the FDA’s review may only serve as a starting point in countering the Chinese regime’s harvesting of American biological information. Lin recommended that the U.S. government impose a stricter, more comprehensive review system to ensure that participants in clinical trials do not have their cellular samples sent abroad without their consent or knowledge, and that no such samples are delivered to China or other countries of concern.

Last September, the U.S. House of Representatives passed a revised version of the BIOSECURE Act (H.R.8333), which explicitly prohibits the federal government from signing any new cooperation agreements with five key Chinese biotech companies—including BGI Genomics and WuXi AppTec—and their associated service providers.

The law’s core objective is to block the CCP’s access to sensitive U.S. biological data via corporate channels. A Senate version of the bill (S.3558) also passed its initial committee review.

Shen said that in policies concerning the CCP, it is necessary to adopt strict strategic precautions and prepare for worst-case scenarios.

“The CCP is a malicious communist regime,” he said. “Its policy decisions are primarily geared toward maintaining the stability of its rule and expanding its global influence, not promoting international cooperation or universal human welfare.”

Li Jing and Luo Ya contributed to this report.