Open Letter to the U.S. Department of Health & Human Services on Gain-of-Function Research
If You Are to Continue Gain‑of‑Function and ePPP Research, Establish a Verifiable BSL‑5 Standards. The Cost to Offset Risk Makes it a Proven Investment.
9/3/2025
To the Honorable Secretary of Health & Human Services, Robert F. Kennedy, Jr.:
The United States currently recognizes Biosafety Level 4 (BSL‑4) as the ceiling for laboratory containment. If HHS elects to continue funding or permitting any work that enhances transmissibility or virulence in potential pandemic pathogens (ePPP) or otherwise qualifies as gain‑of‑function (GoF), the public interest requires a new, auditable standard beyond today’s practices. We propose a BSL‑4‑plus (“BSL‑5”) policy framework—codified, independently verified, and enforceable—built on existing U.S. and international guidance but adding non‑optional controls and governance.
Our goal is not to support GoF research on potential pathogens; our position is that modality of research is fraught with unmeasureable risk beyond benefit. However, cognizant of the intelligence community’s strong influence on certain HHS agendas, we feel it is imperative for the US to shore up safety.
One-third of the US population lives within 100 miles of BSL-3 or BSL-4 laboratories. This is motivation enough to call for upgrades based on national security concerns. We urge you to take immediate action as needed given ongoing or planned GoF research studies funded by HHS or conducted by HHS scientists.
Purpose and Scope
Establish mandatory, uniform requirements for siting, engineering, operations, waste/effluent management, workforce, security, governance, transparency, and verification for any GoF/ePPP project. No GoF/ePPP may proceed unless conducted in a facility certified to this standard and operating under continuous third‑party oversight.
Core Requirements (Charter)
These are only the beginning; other experts may weigh in with additional options. All subject to mandatory process audits and intensive failure analysis by independent third party with licensure suspension/revocation power.
1) Siting & Campus Envelope. Remote, low‑risk geography; multi‑ring campus with secure standoff; hardened/bermed structures; independent ingress/egress; flood, fire, and seismic risk below defined thresholds.
2) Containment Engineering. One‑way clean‑to‑dirty flows; interlocked compartmentalization; single‑pass air with pressure cascades; terminal air decontamination with multi‑stage better-than-HEPA plus validated UV-C kill before stack release; validated pass‑throughs for materials; room‑level UV‑C pulses when vacant as adjunct only.
3) Robotics‑First Operations. Default to sealed robotic/telemanipulated handling for high‑risk steps; barcoded chain‑of‑custody; immutable time‑stamped audit trails; human presence is the exception and requires written justification.
4) Emergency Modes. Replace any “panic” kill switch with sequenced, interlocked emergency states: isolate; pressure‑hold; personnel egress and roll‑call; initiate validated room decon; forensic freeze of block-chained logs; mandatory notifications.
5) Effluent & Waste. No open burn pits. On‑site, permitted high‑temperature destruction meeting HMIWI emission limits with continuous emissions monitoring; segregated, batch‑treated liquid effluent with validated kill and pre‑release verification; design toward zero‑liquid‑discharge where feasible.
6) Energy & Resilience. Islandable microgrid; N+2 for critical HVAC/decon; fuel diversity; black‑start capability; environmental telemetry buffered for extended outages; recommission after any major change.
7) Workforce & Occupational Health. Tiered competencies mapped to CDC/APHL frameworks; hiring screens and continuous fitness‑for‑duty; baseline sera/immunization as indicated; daily symptom reporting; two‑person integrity rule in containment; on‑site occupational health clinic with isolation rooms and regional transfer agreements. On-campus housing with quarterly work seasons; 10-day quarantine and biologics screening prior to campus egress.
8) Digital & Physical Security. Military base level security with 24/7 stationed security expert detail. Select‑agent‑grade access controls; dual‑key movement of agents and critical materials; air‑gapped research networks; cryptographically signed egress of code/sequence data; quarterly red‑team and failure analysis exercises; insider‑risk program.
9) Governance & Allowable Work. Apply the 2024 USG DURC/ePPP policy. Default‑deny for ePPP unless a public‑interest test and risk‑mitigation plan pass external review. Prohibit concealed sponsorship, undisclosed conflicts, or off‑books subcontracting.
10) Transparency & Accountability. Live (redacted) public dashboard for stack releases (target: zero), waste batches, uptime of critical systems, incident counts; predefined notification triggers to public health, environmental, and emergency‑management authorities; annual public assurance report.
11) Verification & Certification. Initial commissioning to standard; periodic re‑commissioning; blinded drills; third‑party certification of containment, air, decon, and effluent systems; independent incident review with corrective‑action mandates; loss‑of‑certification for willful non‑compliance.
12) Funding Conditions & Moratorium. Federal funds or approvals for GoF/ePPP are contingent on active BSL‑5 certification. A national moratorium or ban applies to GoF/ePPP outside certified facilities.
Implementation Notes (Normative References)
CDC/NIH BMBL 6th ed. as the U.S. biosafety baseline (advisory today; BSL‑5 elevates key controls to mandatory).
WHO Laboratory Biosafety Manual 4th ed. as the global risk‑based framework (safety culture, national oversight).
ASHRAE Standard 241‑2023 to anchor infectious‑aerosol control, planning, commissioning, O&M.
Federal Select Agent Regulations (42 CFR 73; 7 CFR 331; 9 CFR 121) for inventory, access, and accountability.
USG Policy (May 6, 2024) for DURC & Pathogens with Enhanced Pandemic Potential for project‑level eligibility and review.
EPA HMIWI rules for on‑site high‑temperature destruction with emissions monitoring.
CDC/APHL Competency Guidelines (MMWR 2011; 2015) for workforce standards and training.
Request to HHS
Convene a public rulemaking to codify BSL‑5 as above and designate an independent accreditor.
Condition all GoF/ePPP funding, approvals, and revocable permits on active BSL‑5 certification and continuous third‑party oversight.
Publish a transition plan and temporary moratorium timeline; do not allow retrofits where compliance is infeasible.
The national interest requires verifiable risk reduction, not reassurances. If GoF/ePPP is to continue, it must do so under BSL‑5—audited, transparent, and enforceable.
References
BMBL, 6th ed. CDC/NIH. https://www.cdc.gov/labs/bmbl/index.html
BMBL 6th ed. full text (PDF). https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf
WHO Laboratory Biosafety Manual, 4th ed. https://www.who.int/publications/i/item/9789240011311
ASHRAE Standard 241—Control of Infectious Aerosols. https://www.ashrae.org/technical-resources/bookstore/ashrae-standard-241-control-of-infectious-aerosols
USG Policy for Oversight of DURC & PEPP (May 6, 2024) (PDF). https://aspr.hhs.gov/S3/Documents/USG-Policy-for-Oversight-of-DURC-and-PEPP-May2024-508.pdf
Federal Select Agent Regulations (42 CFR Part 73). https://www.ecfr.gov/current/title-42/chapter-I/subchapter-F/part-73
EPA—Hospital/Medical/Infectious Waste Incinerators (HMIWI). https://www.epa.gov/stationary-sources-air-pollution/hospital-medical-and-infectious-waste-incinerators-hmiwi-new
CDC/APHL—Competency Guidelines for Public Health Laboratory Professionals (MMWR 2015). https://www.cdc.gov/mmwr/pdf/other/su6401.pdf
Related:
I prefer a full ban on GoF research. If that’s not achievable, then I support the proposal of level 5 restrictions.
This insane research needs to stop. Scientists working for vaccine manufacturers have funders convinced that if they force a bioweapon to emerge, they can "get ahead of it" with a vaccine to be used as a countermeasure. This makes no sense. "Vaccines" cannot stop the infection from happening, nor can they stop the spread... a very expensive lesson that should've been learned from mass distribution of covid vaccines. What they're trying to do is inject people with something that makes serum antibodies that will be protective. This is impossible. The idea is to inject the protein parts of the bioweapon that attaches to human cells, or the mRNA message to make those parts. Can people not see this? The injection is the bioweapon. They are injecting the weaponized part, and it has to be the weaponized part or the antibodies created from doing these injections wouldn't block the bioweapon from attaching. That sounds good, and that's what people are sold on. The problem is, it takes a couple of weeks to get antibodies made, so in the meantime you've got bioweaponized antigens attaching to cellular receptors causing immune responses leading to adverse reactions that they can't seem to figure out.