they “believe[d] to be dangerous.”[1] Although some of the pathogens could have come from Nigeria or Canada (“[d]uring the move to the U.S., infectious material may have been imported”), “there were no import or shipping records available at the time of the visit” to establish “conclusive evidence of violations of 42 C.F.R. § 71.54 for the importation of infections agents.”[2]
Despite the fact that the Reedley Biolab was an illegal enterprise, the CDC suggested that local authorities “request[] all records of importation for infectious agents” to see if the violation occurred.[3] Among the CDC’s action items would be to send the company advisement letters on import requirements and federal requirements for Select Agents, and add the company to an importation watchlist.[4]
Even though it had not tested any samples from the Reedley Lab, the CDC concluded that “[t]here was no evidence of select agents or toxins.”[5] According to local officials, the CDC knew that absent testing, local officials would have to destroy all samples pursuant to a forthcoming abatement order. The CDC likewise instructed state officials not to test any remaining samples of transgenic mice based on concerns over the accuracy of potential testing.[6]
In sworn statements, local and county officials expressed “grave[] concern[] about the storage of potentially infectious bacterial, viral, and parasitic agents present at the Property and the health and safety risk to the public by these infectious agents.”[7]
- ↑ Id.
- ↑ Id.
- ↑ Id.
- ↑ Id. Specifically, the CDC stated that it would “[i]ssue 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]ssue 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.” Among other items, it also called for “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. If submitted, the application will be reviewed carefully, considering previous observations, and the program will inspect the facility before issuing any permit.”
- ↑ Id. It also found “insufficient evidence at [that] time to conclude that there has been a violation of 42 CFR 71.54 or 42 CFR part 73.”
- ↑ As part of its investigation, the Select Committee reviewed an email on August 28, 2023 where a CDC official stated the opinion above.
- ↑ In Re: Property Locate at 850 “I” Street, Reedley, California 93654, No. 23CECG00912, (Cal. Super. Ct. Jun. 15, 2023)
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