Statements on New U.S. Gov't Policy

Biosafety Now's Statements Opposing the New U.S. Government Policy on Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential

In May 2024, the United States government introduced a new Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential. You can read the policy details here.

Several members of the Biosafety Now leadership team have expressed their opposition to this new policy. Below are their statements explaining why they do not support it.

In July, Board Members Jay Bhattacharya and Bryce Nickels elaborated on their concerns in an Op-Ed published in the New York Post. You can read their article here.

“The new policy, if implemented, will increase the likelihood of research-related pandemics. First, the new policy is a White House policy “statement,” not formal federal regulation. Such statements are mere recommendations without legal enforcement.  Second, the policy is written in opaque language, inviting the scientists entrusted with adopting the safety rules to find loopholes. Instead of correcting and tightening the loopholes scientists exploited in the past, the policy institutionalizes these gaps, paving the way for future public health disasters. Third, and perhaps most worrisome, the new framework entrusts scientists who conduct dangerous experiments with regulating themselves. Trust us, they say — but their track record in the COVID era does not inspire confidence.”

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In August, Advisory Board members Richard H. Ebright and Harish Seshadri submitted their feedback via email to the White House Office of Science and Technology Policy (ASPRBIO@hhs.gov).

From: Richard H. Ebright

To: The White House Office of Science and Technology Policy (ASPRBIO@hhs.gov).

Date: August 22, 2024

Dear Colleagues:

As a molecular biologist, a pathogens and medical-countermeasures researcher, a project leader on two National Institutes of Health research grants, and a member of a university institutional biosafety committee and institutional review entity, I wish to submit the following comments on proposed changes to policies on dual-use research of concern and pathogens with enhanced pandemic potential:

I am writing to express my concerns about the new US-government policy on dual-use research of concern (DURC) and pathogens of enhanced pandemic potential (PEPP), proposed to enter into effect in May 2025 (https://www.whitehouse.gov/ostp/news-updates/2024/05/06/united-states-government-policy-for-oversight-of-dual-use-research-of-concern-and-pathogens-with-enhanced-pandemic-potential/).

The proposed new policy is a step backward from the policies in effect in 2014-2017 and in 2018-present.

The proposed new policy is extraordinarily complex and has extraordinarily narrow and internally inconsistent definitions. Ethically challenged researchers and research administrators will be able to circumvent the proposed new policy at will and with impunity.

In particular, the definition of "potential pandemic pathogen" provided in the proposed new policy and implementation guidance is narrower than the definition in the current policy, is narrower than the definition in all previous policy deliberations over the preceding decade, is scientifically unsound, and will have the effect of exempting almost all research on potential pandemic pathogens from mandatory federal-level risk-benefit assessment.

The following examples are illustrative:

Example 1:  The implementation guidance for the new policy asserts, nonsensically, that SARS-CoV-2--a pathogen that currently is causing a pandemic, that has infected billions of humans in 2019-2024, killing 20 million and costing $25 trillion--does not meet the definition of a "potential pandemic pathogen."

Example 2: The implementation guidance for the new policy asserts, nonsensically, that H5N1 avian influenza virus--a pathogen that currently is infecting multiple species of mammals, including humans, in multiple US states and that is being closely monitored for its potential to trigger a pandemic--does not meet the definition of a "potential pandemic pathogen." 

Example 3: The implementation guidance for the new policy asserts, nonsensically, that Mpox virus--a pathogen that infected 90,000 humans worldwide in 2022-2024, that currently is infecting humans in multiple nations, that this month caused the World Health Organization to declare a Public Health Emergency of International Concern, and that is being closely monitored for its potential to trigger a pandemic--does not meet the definition of a "potential pandemic pathogen."  

Example 4: The implementation guidance for the new policy asserts, nonsensically, that Ebola virus--a pathogen that infected 29,000 humans worldwide in 2014-2016--does not meet the definition of a "potential pandemic pathogen." 

Example 5: The implementation guidance for the new policy makes it clear that bat SARS-related coronaviruses--the pathogens that were the subjects of the research that likely caused the current pandemic, killing 20 million and costing $25 trillion--do not meet the definition of "potential pandemic pathogen."

Example 6: The policy and implementation guidance for the new policy make it clear that research on bat SARS-related coronaviruses--the pathogens that were the subjects of research that likely caused the current pandemic, killing 20 million and costing $25 trillion--are not subject to mandatory intra-institutional DURC or PEPP review, much less mandatory federal-level DURC or PEPP review.

I urge OSTP and HHS to reconsider.

If you have any questions, please do not hesitate to contact me.

Sincerely,

Richard H. Ebright

Board of Governors Professor of Chemistry and Chemical Biology, Rutgers University

Laboratory Director, Waksman Institute of Microbiology

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From: Harish Seshadri

To: The White House Office of Science and Technology Policy (ASPRBIO@hhs.gov).

Date: August 25, 2024

Dear Colleagues,

I am a mathematician at the Indian Institute of Science, Bangalore,
and a member of BiosafetyNow.org, a non-profit organization devoted to
biosafety.

Let me briefly explain why I, an Indian citizen, am deeply concerned
about this new USG policy:

(1)  US policies are used as benchmarks globally, especially in
developing countries.

(2)  Prominent experts and members of the WHO biosecurity committee
Tom Inglesby and Filippa Lentzos have expressed their intent to
promote this policy in other countries.

My objections to the policy concern the process for funding approval
and the oversight mechanism.

From what I understand, the former will consist of

(i)  An "independent" assessment of the scientific merits of a
proposal by a committee set up by the funding agency and

(ii) A multidisciplinary  "review entity"  set up by the department
that will take (i) into account.

A simpler (and necessary) solution would be to have an independent
regulatory body, like the Nuclear Regulatory Commission. The needless
complexity in the current proposal will likely result in a lack of
transparency and accountability.

Moreover, there is little chance of this working as intended in
countries with bloated bureaucracies. In contrast, independent bodies,
such as the Election Commission, have fared very well in India.

As for oversight, the policy is a disappointment - it is a mere
reiteration of the status quo.

The existing IBC system is shockingly unprofessional considering the
risks of the research under consideration. An obvious objection is the
inevitable nonuniform application of guidelines. This problem is far
worse in developing countries. Again, an independent federal oversight
authority is the obvious solution.

I hope you take these points into account and substantially revise
your policy.,

Thank You,

Sincerely,

Harish Seshadri

Department of Mathematics
Indian Institute of Science
Bangalore 560012
India