Investigation into the Reedley Biolab/Chapter 3

by Select Committee on the Chinese Communist Party

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III. Public Health Risks, Safeguards, and the Federal Response

A. The Public Health Risks Posed by the Lab Are Unknown and, at This Point, Unknowable

With the exception of Ebola, the labeled pathogens (which CDC accepted at face value) are inconsistent with the operation of a bioweapons program. Most fall into Risk Groups 2 and 3, which may pose a high risk to individuals (i.e., infecting specific people with HIV, tuberculosis, or malaria through targeted attacks or contamination of a specific area) but are unlikely to cause a mass casualty event. While Risk Group 2 or 3 pathogens are unlikely to infect a city, they could still pose a substantial risk to the community. A blood supply infected with HIV, for example, or immunocompromised communities like nursing homes suddenly falling ill with tuberculosis, could spark a localized panic.

In addition, individuals can use even simple pathogens to great effect to harm a large population. For instance, in the 1984 Rajneeshee bioterror attack—the largest bioterror attack in U.S. history—attackers sickened more than 700 Oregonians by spreading salmonella they had purchased at a U.S. lab on a few local salad bars.^[1] The pathogens found at the Reedley Biolab, such as the many different types of E. coli strains or a potentially antibiotic-resistant strain of Tuberculosis, could be used to an even deadlier effect.

Figure 39 – Congressional record discussing the Rajneeshee bioterror attack.

The Reedley Biolab also presented an ongoing transmissibility risk to the wider community. The Reedley Biolab’s precautions, if any, fell well below the standard of care for facilities containing these types of diseases. This in turn means that any worker there—including the workers forced to care for the transgenic mice that, per the other employees’ own statements, were infected with diseases like COVID-19—could become a vector for a pathogenic outbreak within the community. In addition to respiratory-based pathogens, there are ongoing risks that a worker could suffer infection from blood-based pathogens through cuts or other openings in the skin. First responders could also be at risk, should they arrive on scene due to a fire or other emergency, and, if they are infected, lead to a broader outbreak. Lab-based infections occur even in professional laboratories with well-trained staff, and the risks to the community were much higher here.

B. The United States Lacks Effective Safeguards and Tripwires for Pathogenic Research

A disturbing realization is that no one knows whether there are other unknown biolabs in the United States because there is no monitoring system in place. Zhu, UMI, and other confederates at the Reedley Biolab were able to buy pathogens from accredited and respected U.S. laboratories. Zhu is a wanted fugitive in Canada and serial fraudster. UMI and its successor organizations like Prestige Biotech are little more than a corporate filing and a website. There does not appear to be any voluntary vetting of the purchase of pathogens or the equipment and materials needed to increase the lethality of pathogens. That is dangerous and requires reform.

The federal government and state authorities have implemented identification and reporting requirements related to acquiring other potentially dangerous substances. Federal law, for instance, requires that anyone purchasing items containing pseudoephedrine—a key ingredient in methamphetamine—has to provide a valid photo ID while the selling organization needs to keep a record of the purchase.^[2] There are similar restrictions on the purchase of bulk fertilizer and certain types of chemicals.^[3] However, there is no current requirement for acquiring pathogens (aside from Select Agents) or materials that allow for pathogenic research. Just as we require Americans to show a valid photo ID subject to government review in these instances, it is altogether reasonable to have similar policies in place for dangerous pathogens and equipment that can allow for malicious research relating to the same.

Similarly, the United States currently “does not conduct oversight of privately funded research, including enhancement of potential pandemic pathogens, if those pathogens are not select agents.”^[4] That means that pathogenic and other related research that could have benign or malicious intent—known as Dual Use Research of Concern (DURC)—are not currently under any oversight policies if they do not receive federal funding or conduct research with any harmful pathogen outside the 15 expressly listed in the policy.^[5] In addition, the CDC Division of Select Agents and Toxins program has no oversight on laboratories engaging in pathogenic research if their research does not involve Select Agents and toxins.^[6] This is a substantial gap that, along with the presence of illegal biolabs, local communities are currently trying to address on their own.^[7] There needs to be a comprehensive federal regulatory regime that safeguards Americans while still promoting responsible research.

C. The CDC’s Response was Unacceptable

The CDC’s response was inadequate and raises serious questions about its standard practices. It is unacceptable that the CDC, according to accounts of local officials, refused to take a phone call from city and county officials concerned about a biolab found in their region.^[8] Even if the CDC normally works through state agencies, it could have given the necessary contact information to local officials. It should not require a Member of Congress – in this case, Congressman Jim Costa – to personally call the CDC or any other federal agency for them to provide meaningful support.

The CDC’s refusal to test any samples is likewise baffling.^[9] The CDC observed in its own reporting that “[t]housands of vials had unclear labeling, coded labeling, or no identifications,” that biohazard signs were around many of these unlabeled vials, and that the labeled vials included Risk Group 2 and 3 pathogens.^[10] Despite the probability that the unlabeled or coded vials contained additional unknown and dangerous pathogens, CDC officials refused to take any further investigative steps.^[11] The fact that they seemingly took the word of biolab operators and noted fraudsters and concluded that the named labels are wholly correct is also strange. It is entirely within the realm of probability that the vials of Toxoplasmi gondii, for instance, were filled with an entirely different and potentially far more dangerous pathogen. Because of this, the Select Committee—and, more importantly, the American people—can never resolve what pathogens Zhu and the Reedley Biolab possessed.

The CDC’s continuing refusal to test pathogens despite reasonable requests and the offer to pay from local officials facing a concerned populace simply does not make sense.^[12] Despite the CDC official’s statement to City Manager Zieba, there does not appear to be any law prohibiting the CDC from testing unlabeled samples.^[13] If the CDC knew that a specific sample was a Select Agent, it would not need to test it. Even if the CDC were limited to testing Select Agents, it falls well within its authority to test suspected Select Agents. Furthermore, if the CDC had a limited capability, other federal government organizations (like the Department of Homeland Security or the Department of Defense) may have had the means to assist. Yet the CDC did not even mention this as a possibility, let alone offer to connect them so that these organizations could conduct their own analysis of whether they should help this community.

Key aspects of the CDC report’s recommendations are likewise hard to understand. It speaks of “[i]ssu[ing] an Import Permit advisement letter to Prestige Biotech to ensure they know the Import Permit Regulations for importing infectious substances into the U.S.” and “[i]ssu[ing] a Federal Select Agent Program advisement letter to Prestige Biotech informing them of the requirements for possession, use, and transfer of select agents and toxins if the entity decides to possess them.”^[14] In these and other passages, the CDC acts as if the operators of biolab engaged in fraud are respected and trusted members of the research community. These particular recommendations were not actionable or helpful.^[15]

The CDC’s insisted that there was “no evidence” that Select Agents were within Reedley Biolab or that Zhu and UMI imported infectious agents and “insufficient evidence at this time” of legal violations. It seems to have made this claim without conducting any investigation beyond reading the labels that were in English on a limited number of the pathogenic samples.

The CDC also clearly did not review any of the many documents or containers found within the Reedley Biolab, as the Select Committee did find evidence showing importation of “infections agents, substances, or vectors” in violation of 42 CFR § 71.54.^[16] This importation without a CDC permit would put the violation under the CDC’s purview.^[17] It would also reveal a potential gap in CDC’s efforts to identity pathogen importation: when an importer does not tell the CDC, the CDC simply does not seem to have any idea.

Finally, we are concerned by the freezer labeled “Ebola” reported by local officials. It is concerning that, when this was brought to the CDC’s attention, a CDC employee did not take meaningful action in response.

Congress should examine the state of biosafety in our country, and act to identify and remedy gaps in relevant statute or practice.

1. Scott Keyes, A Strange but True Tale of Voter Fraud and Bioterrorism, The Atlantic (June 10, 2014).
2. Combat Methamphetamine Epidemic Act of 2005, Pub. L. No. 109-177, tit. VII (2006).
3. See, e.g., 18 U.S.C. § 842 (unlawful acts relating to explosive materials).
4. GAO-23-105455: Public Health Preparedness, GAO (Jan. 2023).
5. Id.
6. Id.
7. See generally Brianna Willis, Fresno lab transparency ordinance passes first vote by city council, ABC News (Aug. 24, 2023).
8. Select Committee conversation with local officials.
9. See Footnote 40, infra.
10. In Re: Property Locate at 850 “I” Street, Reedley, California 93654, No. 23CECG00912, (Cal. Super. Ct. Jun. 15, 2023) at Ex. D – CDC Letter.
11. See Footnotes 40 and 32, infra (referencing email correspondence and local official accounts).
12. Id.
13. See, e.g., John Lancaster and Susan Schmidt, When anthrax-laced letters terrorized Washington and New York, The Washington Post (Oct. 24, 2018, 1:02 PM) (describing how CDC officials tested unlabeled suspected anthrax spores).
14. Id.
15. Id. Other CDC recommendations included that “if the material is relocated, the California State Department of Health and the City of Reedley should ensure professionals or subject matter experts move the inventory to ensure there is no potential exposure to individuals or the environment.” The CDC also did recommend “add[ing] Prestige Biotech and associated entity names to the CDC Import Permit Program watch list in case the entity attempts to apply for a CDC Import Permit.”
16. In Re: Property Locate at 850 “I” Street, Reedley, California 93654, No. 23CECG00912, (Cal. Super. Ct. Jun. 15, 2023) at Ex. D – CDC Letter.
17. 42 CFR § 71.54(a) defines “infectious biological agent” and “infectious substances” as follows—
    
    Infectious biological agent. A microorganism (including, but not limited to, bacteria (including rickettsiae), viruses, fungi, or protozoa) or prion, whether naturally occurring, bioengineered, or artificial, or a component of such microorganism or prion that is capable of causing communicable disease in a human.
    Infectious substance. Any material that is known or reasonably expected to contain an infectious biological agent.