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Kristian G. AndersenJune 4, 2026 at 3:06 PM EDT

This is extremely chilling - virologists being targeted for what appears to be minor (if any) "offenses". We all know _why_ this is happening, so I'm not going to belabor that point - but I want to provide some context on the technical details. 🧵 science.org

Let me make this clear up front - I'm not a lawyer (yes, I have a ChatGPT subscription too...), but I am highly familiar with the landscape of international transfer of samples. I'm also speaking in a personal capacity - as always, unless stated otherwise. We used to export/import inactivated samples, however, it's been years, because we now have a stronger focus on doing as much work as possible locally, with local scientists - we outlined that "Roots, not Parachutes" philosophy back in 2016: sciencedirect.com

1️⃣ Let's first focus on the press release, as both the headline and lede states that the scientists are being charged with a "... conspiracy to smuggle monkeypox into the United States". That is outright false. justice.gov

First, that is not what the actual complaint states. Second - and this is critically important - the scientists *did not* bring "monkeypox" into the United States. They brought inactivated [diagnostic] samples (possibly, extracted DNA) from patients who had mpox. Such samples are harmless. And very specifically - such samples do not contain the virus itself. It is nothing more than a soup of nucleotides, proteins, and whatever else may be in an inactivated sample taken from humans. The FBI even confirmed it, so despite what the headline and lede states, there's no ambiguity.

As for the "lying" part, I can't speak to that as I was not in the room, however, as I will outline, this part is likely due to misunderstandings and down to the fact that the investigators seem very unfamiliar with how research is done. We'll get to that shortly. There are many other issues with the press release, but I will not get into that - just know that the headline and lede are both misleading, which is unfortunate, since that is what people will read. As for the complaint, here is a copy (note, there is a second amended version, which is what I will quote from). Note, you'll notice that I have redacted names throughout - they can be found elsewhere, but I am not going to share them here. web.archive.org 2️⃣ The confusion about "diagnostics", which is the main complaint used to accuse the scientists of lying. It is mentioned throughout the complaint that the scientists stated that e.g., they "told CBP officers the case contained diagnostics and testing equipment"..

.. , but that, according to the FBI, they "were instead deactivated monkeypox virus". The issue here is that those are no mutually exclusive and I am almost certain that what the scientists were referring to were "diagnostic specimens" (or samples used for diagnostics, etc.). Because that is exactly what the samples the scientists were carrying appear to have been - diagnostic specimens that were inactivated and hence harmless. This is a well-defined and widely used term, yet this is never mentioned once in the complaint. E.g.,: cbp.gov

Diagnostic specimens, by definition, are also "biological materials", however, the complaint accuses the scientists of denying that. I highly doubt this is correct - I simply think this is a misunderstanding. For example, the scientists may have tried to explain that the samples were inactivated.

In that same sentence "that may need additional documentation". But as I will go into next, no additional "documentation" appeared to have been needed, as it appears the scientists already had the required documentation (but I obviously can't know). This all seems like a misunderstanding. The complaint makes a big deal out of the "biological materials" part, because it is what is used to accuse the scientists of lying. For example, a whole section on how these biological materials were "Mpox". Again, they were not. They were inactivated diagnostic samples.

Second, the complaint states that specific "approval and documentation" for these samples were required. "Approval" is very loosely used throughout the complaint. While "approvals" are needed for this type of work, that is an *internal* process with an institution's biosafety committee.

3️⃣ No official "approval" (permit) is needed for these types of samples because (1) they were diagnostic specimens and (2) they were inactivated. Here, from the CDC's own website: cdc.gov

That said, several things *are* needed, including: (1) Approval from an institutional biosafety committee to carry out the work, (2) documentation/certification outlining samples and inactivation, (3) CBP declaration. cdc.gov cbp.gov

This whole process is codified via 42 CFR 71.54 ecfr.gov

For the institutional approvals part, there is a whole section of the complaint stating that the scientists did not have approvals from the NIH to do this work. I highly doubt that is the case, but since I don't know exactly what the scientists did or did not have, I can't comment on this further.

As for the "documentation/certification", this is not a rigid federal process, but a process between the principal investigator in charge of the project and his/her institution. This is codified in 42 CFR 73.17(a)(8)(vii) for Select Agents (we'll get back to this). ecfr.gov

In other words, for the "certification", the scientists needed documents describing the samples and the inactivation method used. In this case, it appears the scientists had all of that, as required.

[FWIW, for our work we would typically have this printed out and signed - but, again, not a federally regulated process with strict rules and instructions. Also, we would obtain CDC permits for "infectious" materials, even if not required and even if not infectious.] cdc.gov

Finally, declaration of materials are required upon entry into the United States. It is unclear if this was done when the scientists first talked to CBP officers, but appears to have been done when they were taken aside. cbp.gov

The complaint further states that the samples should have been marked as “scientific research specimens” citing de minimis exception 49 CFR 173.4b(b)(5). I don't believe this is correct. ecfr.gov

First of all, these samples - which were inactivated diagnostic specimens (or, possibly, extracted DNA derived from such) - do no seem to fall under 49 CFR 173.4b(b). Secondly, these samples should fall under the 49 CFR 173.134(b)(2) exceptions. ecfr.gov

4️⃣ The complaint also states that a "USDA permit, VS Form 16-6A" was required. That would certainly be news to me and I also don't believe is correct.

In this case, because the samples did not contain agents that can infect "livestock or poultry pathogen", USDA permit is not required to my understanding, so this just seems wrong. All of this is on the USDA's website. aphis.usda.gov aphis.usda.gov

5️⃣ Continued references to Mpox virus Clade I being a "Select Agent". This is scattered throughout the complaint and press release that Mpox virus is scary and especially scary because it is a "Select Agent".

It's true - Mpox virus, Clade I is a select agent, however, inactivated samples that previously contained the virus are not. And as the FBI itself confirmed, there was no live virus in the samples and therefore no select agent was present.

It is almost as if the scientists accused knew how to properly inactivate samples containing Mpox virus. Which is no surprise, given that they published some of the main protocols on exactly how to do that. mdpi.com

Select Agents are regulated under 42 CFR 73.3, where you'll find Mpox virus. That includes "Nucleic acids that can produce infectious forms" (42 CFR 73.3(c)(1)), but that is not the case for Mpox virus, which is a DNA virus (this instead applies to +sense RNA viruses). ecfr.gov

Specifically, because the scientist's samples were inactivated diagnostic specimens, they were no longer "select agents". This is under 42 CFR 73.3(d)(2). We already discussed the certification processes required for this and the FBI confirmed the samples were inactivated.

So no, no "select agent" was brought to the United States and, no, no "conspiracy to smuggle monkeypox into the United States" was at play. Whatever "offenses" might have occurred - and I'm not even sure there were any - they appear minor, yet, here we are with the feds charging scientists.. Again. Long post and I might add things later. As I mentioned in the beginning, we all know why this is happening and it is tragic - tragic for those targeted, tragic for science as a whole, and tragic because so few scientists are willing and/or able to speak out. Let's change that, because we must.

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