samples.[1] 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.”[2] 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.[3]
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.[4] This importation without a CDC permit would put the violation under the CDC’s purview.[5] It would also reveal a potential gap in CDC’s efforts
- ↑ 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).
- ↑ Id.
- ↑ 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.”
- ↑ In Re: Property Locate at 850 “I” Street, Reedley, California 93654, No. 23CECG00912, (Cal. Super. Ct. Jun. 15, 2023) at Ex. D – CDC Letter.
- ↑ 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.
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