Reading Room Production — page 179
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pathogens already listed what is meant by "synthetic construct" in addition to previous
use of "synthetic" and does this mean that using only a piece of a "high-consequence
pathogen" (e.g. synthesizing the receptor-binding site and studying receptor affinity in
vitro, or synthesizing a viral or bacterial enzyme and studying inhibitors in vitro) would
potentially still be considered "high-consequence"?
o
Subparagraph B is auto-referential creating an exclusion for seasonal influenza unless
genetic sequences have been introduced from the list of pathogens that includes influenza A -
does this mean that any introduction of genetic material from one seasonal influenza virus into
another seasonal influenza virus would be considered "high-consequence"?
o
Some other included pathogens besides influenza may be commonly circulating in the
population, and classifying them as automatically "high-consequence" could potentially
delay or interfere with clinical diagnosis and care depending on how the other criteria for
centralized Board review are interpreted (e.g. all sarbecoviruses, all mpox viruses).
o
According to the next section at the bottom of the page, it looks like maybe only
experiments that meet DURC/GOF criteria with these agents would need centralized
board review, and if it were possible to obtain clarification that non-DURC/GOF
experiments are not subject to the Act provisions that might mitigate some of the
potential concerns, but there is the possibility that uncertainty about interpretation could
still have major impact on willingness to conduct or review research in some of the
relevant areas of importance for public health.
•
The text of the proposed legislation reads as if the Life Sciences Research Security Board could
review all life sciences research. Throughout the text of the proposed legislation, the terms used
seem to vary between "high-risk life sciences research," which is defined very specifically, and
broader terms like "life sciences research." The scope of review seems far beyond what a single
Board could reasonably be able to review especially given the broad definition of life sciences
research, even if limited to high-risk life sciences research and even with the Board trying to
develop expert committees. Creating such a broad scope of review for the Board risk delays of
important research, which does not rise to the level of high-risk life sciences research, that could
be adequately addressed at a more local or Agency review level and is already subject to laws,
regulations, guidances, and policies.
Expertise/Board Processes and Makeup
•
While biosafety expertise is now included, the makeup and processes of the board could
introduce a number of issues. For example, the limitations on prior federal service and
designation of participation in high-risk research as a "conflict of interest" could limit the
board from accessing relevant national security and life sciences expertise. The exclusion
of those involved in high-risk research, based on the definition in the draft legislation,
could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with
key expertise on how to conduct work safely. These limitations may also exclude
individuals who work in government with relevant knowledge of intelligence, threat
assessments, and biosecurity. Risk assessment is best when diverse voices are heard, the lack
and actually clear refusal to ensure persons with experience in high and maximum containment
principles are included would not provide a comprehensive and scientifically robust review of
this work. and threat assessments.
•
We also recommend relaxing the limitations on membership of the board and note that a number
of the timelines are untenable (e.g., Congressional notification requirements within 3 days of
identifying a potential conflict of interest; publishing procedures in the Federal Register within 90
days of the appointment of initial members; etc.). We note that several provisions relating to the
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Records on this page
| Record | Date | Type | Pages |
|---|---|---|---|
| reading_room:exh:00053 | — | attachment | 179 |