Notice2023-18906
Request for Information; Potential Changes to the Policies for Oversight of Dual Use Research of Concern (DURC) and the Potential Pandemic Pathogen Care and Oversight (P3CO) Policy Framework
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Published
September 1, 2023
Issuing agencies
Science and Technology Policy Office
Abstract
Life sciences research is vital for improving health outcomes and protecting the Nation from infectious disease threats, but a small subset of this research could potentially pose risk of accidents or misuse that could harm human health. It is important to regularly evaluate and update biosafety and biosecurity oversight policies to keep pace with new technological developments and the evolving risk landscape. The Office of Science and Technology Policy (OSTP) invites comments on potential changes to the Policies for Federal and Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC) and Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO). These policies establish frameworks for review and oversight requirements for certain categories of life sciences research, namely research with certain pathogens and toxins, including at institutions that accept Federal funding for such research. These requirements are intended to complement activities under existing Federal regulations or guidelines such as the Federal Select Agent Program. OSTP requests comments on how potential changes to these research oversight policies could mitigate risks associated with DURC and research with enhanced potential pandemic pathogens (ePPP) while minimizing undue burden on institutions. The public input provided through this Request for Information (RFI) will inform policy evaluations and issuance of a revised policy (Revised Policy).
Full Text
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<title>Federal Register, Volume 88 Issue 169 (Friday, September 1, 2023)</title>
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[Federal Register Volume 88, Number 169 (Friday, September 1, 2023)]
[Notices]
[Pages 60513-60516]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18906]
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OFFICE OF SCIENCE AND TECHNOLOGY POLICY
Request for Information; Potential Changes to the Policies for
Oversight of Dual Use Research of Concern (DURC) and the Potential
Pandemic Pathogen Care and Oversight (P3CO) Policy Framework
AGENCY: Office of Science and Technology Policy (OSTP).
ACTION: Notice of request for information.
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SUMMARY: Life sciences research is vital for improving health outcomes
and protecting the Nation from infectious disease threats, but a small
subset of this research could potentially pose risk of accidents or
misuse that could harm human health. It is important to regularly
evaluate and update biosafety and biosecurity oversight policies to
keep pace with new technological developments and the evolving risk
landscape. The Office of Science and Technology Policy (OSTP) invites
comments on potential changes to the Policies for Federal and
Institutional Oversight of Life Sciences Dual Use Research of Concern
(DURC) and Recommended Policy Guidance for Departmental Development of
Review Mechanisms for Potential Pandemic Pathogen Care and Oversight
(P3CO). These policies establish frameworks for review and oversight
requirements for certain categories of life sciences research, namely
research with certain pathogens and toxins, including at institutions
that accept Federal funding for such research. These requirements are
intended to complement activities under existing Federal regulations or
guidelines such as the Federal Select Agent Program. OSTP requests
comments on how potential changes to these research oversight policies
could mitigate risks associated with DURC and research with enhanced
potential pandemic pathogens (ePPP) while minimizing undue burden on
institutions. The public input provided through this Request for
Information (RFI) will inform policy evaluations and issuance of a
revised policy (Revised Policy).
DATES: Responses are due by 11:59 p.m. Eastern Time on October 16,
2023. Submissions received after the deadline may not be taken into
consideration.
ADDRESSES: Comments must be submitted via the Federal eRulemaking
Portal at <a href="http://regulations.gov">regulations.gov</a>. However, if you require an accommodation or
cannot otherwise submit your comments via <a href="http://regulations.gov">regulations.gov</a>, please use
the email or phone number listed under FOR FURTHER INFORMATION CONTACT.
OSTP will not accept comments by fax or by email. To ensure that OSTP
does not receive duplicate copies, please submit your comments only
once. Additionally, please include the Docket ID (EOP-2023-0001) at the
top of your comments.
Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a> to submit
your comments electronically. Information on how to use
Regulations.gov, including instructions for accessing agency documents,
submitting comments, and viewing the docket, is available on the site
under ``FAQ'' (<a href="https://www.regulations.gov/faq">https://www.regulations.gov/faq</a>).
Privacy Note: OSTP's policy is to make all comments received from
members of the public available for public viewing in their entirety on
the Federal eRulemaking Portal at <a href="http://www.regulations.gov">www.regulations.gov</a>. Therefore,
commenters should be careful to include in their comments only
information that they wish to make publicly available. OSTP requests
that
[[Page 60514]]
no proprietary information, copyrighted information, or personally
identifiable information be submitted in response to this RFI.
Instructions: Response to this RFI is voluntary. Each individual or
organization is requested to submit only one response. Commenters can
respond to one or multiple questions. Submissions are suggested to not
exceed the equivalent of ten (10) pages in 12 point or larger font.
Submissions should clearly indicate which questions are being
addressed. Responses should include the name(s) of the person(s) or
organization(s) filing the response. Responses containing references,
studies, research, and other empirical data that are not widely
published should include copies of or electronic links to the
referenced materials. Responses containing profanity, vulgarity,
threats, or other inappropriate language or content will not be
considered.
Please note that the U.S. Government will not pay for response
preparation, or for the use of any information contained in the
response. A response to this RFI will not be viewed as a binding
commitment to develop or pursue the project or ideas discussed.
FOR FURTHER INFORMATION CONTACT: Direct questions to Asad Ramzanali,
<a href="/cdn-cgi/l/email-protection#2b594e584e4a59484306445d4e5958424c435f065b44474248526b44585f5b054e445b054c445d"><span class="__cf_email__" data-cfemail="d2a0b7a1b7b3a0b1baffbda4b7a0a1bbb5baa6ffa2bdbebbb1ab92bda1a6a2fcb7bda2fcb5bda4">[email protected]</span></a>, or 202-456-4444.
SUPPLEMENTARY INFORMATION: Life sciences research is essential to the
scientific advances that underpin improvements in the health and safety
of the public, agricultural crops, and other plants, animals, and the
environment. While life sciences research provides enormous benefits to
society, there can be risks associated with certain subsets of work,
typically related to biosafety and biosecurity, that can and should be
mitigated. The United States has existing, complementary statutes,
regulations, policies, and guidelines that address these potential
biosafety and biosecurity risks, particularly those associated with
research oversight and management.\1\ Together these existing
regulatory authorities and guidelines provide a foundation to ensure
that scientific research and innovation is safe and secure.
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\1\ Examples include: Select Agents and Toxins Regulations (42
CFR part 73, 9 CFR part 121, and 7 CFR part 331); National
Institutes of Health Guidelines on Research Involving Recombinant
and Synthetic Nucleic Acids; (<a href="https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf">https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf</a>); Biosafety in Microbiological &
Biomedical Laboratories (BMBL) 6th Edition (<a href="https://www.cdc.gov/labs/BMBL.html">https://www.cdc.gov/labs/BMBL.html</a>); Additional U.S. Laws, Regulations and Guidelines
(<a href="https://www.phe.gov/s3/law/Pages/default.aspx">https://www.phe.gov/s3/law/Pages/default.aspx</a>).
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Scientists, institutions, and the USG have gained valuable insight
over the past decade from implementing research oversight policies such
as the policies for oversight of DURC \2\ and the P3CO Policy
Framework.\3\ During this time, advances in science and technology have
occurred that present realized and potential future benefits. However,
these advances also present potential risks of misuse. The National
Science Advisory Board for Biosecurity (NSABB), a Federal advisory
committee that addresses issues related to biosecurity and dual use
research, provided recommendations in a March 2023 report \4\ to inform
United States Government (USG) policy evaluations and the development
of a more comprehensive and integrated framework for the oversight of
research with pathogens and toxins that may pose significant biosafety
or biosecurity risks. Since the release of this report, OSTP has been
working with Federal departments and agencies to review, harmonize, and
revise these policies in accordance with USG goals of promoting safe
and secure biological practices and strengthening responsible conduct
for biological research as outlined in the 2022 National Biodefense
Strategy and Implementation Plan.\5\
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\2\ United States Government Policy for Oversight of Life
Sciences Dual Use Research of Concern (<a href="https://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf">https://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf</a>); United States
Government Policy for Institutional Oversight of Life Sciences Dual
Use Research of Concern (<a href="https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf">https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf</a>).
\3\ Recommended Policy Guidance for Departmental Development of
Review Mechanisms for Potential Pandemic Pathogen Care and Oversight
(P3CO) (<a href="https://www.phe.gov/s3/dualuse/Documents/P3CO-FinalGuidanceStatement.pdf">https://www.phe.gov/s3/dualuse/Documents/P3CO-FinalGuidanceStatement.pdf</a>).
\4\ Proposed Biosecurity Oversight Framework for the Future of
Science (<a href="http://nih.gov">nih.gov</a>); <a href="https://osp.od.nih.gov/wp-content/uploads/2023/03/NSABB-Final-Report-Proposed-Biosecurity-Oversight-Framework-for-the-Future-of-Science.pdf">https://osp.od.nih.gov/wp-content/uploads/2023/03/NSABB-Final-Report-Proposed-Biosecurity-Oversight-Framework-for-the-Future-of-Science.pdf</a>.
\5\ National Biodefense Strategy and Implementation Plan:
<a href="https://www.whitehouse.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf</a>.
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The policy review and revision process has three broad goals:
1. Assess whether and how to merge the existing Federal DURC,
Institutional DURC, and P3CO policies into a harmonized policy that
addresses oversight for research with pathogens and toxins.
2. Consider revising the scope of the Federal DURC, Institutional
DURC, and P3CO policies to include a broader set of pathogens and
toxins, including--but not limited to--biological select agents and
toxins (BSAT) that impact humans or have the potential to impact
humans.
3. Examine ways to strengthen effective implementation of oversight
for life sciences research on pathogens and toxins throughout the
research lifecycle.
The USG acknowledges that effective oversight helps maintain public
trust in the life sciences research enterprise by demonstrating that
the scientific community recognizes the implications of research
conducted and is acting responsibly to protect public welfare and
preserve national security.
Scope: OSTP invites comment from any interested stakeholders. In
particular, OSTP is interested in input from research institutions,
including both domestic and international entities, currently subject
to the PC3O Policy or the DURC policies or that may be subject to the
revised scope of a potential policy update, researchers within those
institutions, scientific and professional organizations, and
organizations representing diverse interests across the U.S. research
ecosystem.
Information Requested: Respondents may provide information for one
or more of the topics included below. Respondents are asked to note the
corresponding number/s to which responses pertain.
1. The NSABB recommended that USG develop an integrated approach to
oversight of research that raises significant biosafety and biosecurity
concerns, including ePPP research and DURC (Recommendation 1). By
merging the existing Federal DURC, Institutional DURC, and P3CO
policies into a harmonized policy, a merged policy could potentially
adopt the institutional applicability outlined in the Institutional
DURC policy framework, making the following entities subject to a
Revised Policy:
<bullet> U.S. Government departments and agencies that fund,
sponsor, or conduct life sciences research.
<bullet> Institutions within the United States or its territories
that both:
[ssquf] Receive U.S. Government funds to conduct or sponsor life
sciences research; and,
[ssquf] Conduct or sponsor research that is within the revised
scope, regardless of the source of the funding for the specific
project.
<bullet> Institutions outside of the United States that receive
U.S. Government funds to conduct or sponsor research that falls under
the scope.
(a) What are the anticipated benefits and challenges of applying a
Revised Policy, inclusive of both DURC and
[[Page 60515]]
ePPP research, to the scope of entities outlined above?
(b) What are the anticipated benefits and challenges of
investigators and institutions having primary responsibility for
identification of both DURC and ePPP research?
(c) What types of resources or tools would be useful for
researchers and institutions to determine if their research falls into
a revised policy scope that is risk-based rather than list-based, and
adequately conduct risk assessments to identify DURC and ePPP research?
2. Currently, the scope of the DURC policies is research that uses
one or more of 15 listed agents or toxins and that produces, or is
anticipated to produce, any of seven listed experimental effects. The
NSABB recommended that the scope of research requiring review for
potential DURC should include research that directly involves any
human, animal, or plant pathogen, toxin, or agent that is reasonably
anticipated to result in one or more of the seven experimental effects
outlined in the DURC policy \6\ (Recommendation 10.1).
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\6\ United States Government Policy for Oversight of Life
Sciences Dual Use Research of Concern (<a href="https://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf">https://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf</a>); United States
Government Policy for Institutional Oversight of Life Sciences Dual
Use Research of Concern (<a href="https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf">https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf</a>).
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a. Considering the diversity of federally-funded research settings
and portfolios, how would adoption of NSABB's Recommendation 10.1
affect policy implementation and research programs at the institutional
level?
b. Rather than including any pathogen within the scope of DURC
review, one possible modification of Recommendation 10.1 would be to
include DURC experiments that utilize:
i. HHS and Overlap Biological Select Agent and Toxins (BSAT) List
\7\ and/or
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\7\ Select Agents and Toxins Regulations (42 CFR part 73, 9 CFR
part 121, and 7 CFR part 331).
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ii. Pathogen risk group (RG) classification of 3 or 4 \8\ and/or
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\8\ Risk groups as defined in ``NIH Guidelines for Research
Involving Recombinant or Synthetic Nucleic Acid Molecules'' (<a href="https://osp.od.nih.gov/wp-content/uploads/2019_NIH_Guidelines.htm">https://osp.od.nih.gov/wp-content/uploads/2019_NIH_Guidelines.htm</a>).
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iii. Any pathogen where the conduct of work (e.g., one of the DURC
experimental categories) would require biosafety level 3 or 4
containment.
Would a modification of Recommendation 10.1, in line with the
outlined scope of pathogens above, be useful for policy implementation?
What specific benefits, challenges, and/or gaps are anticipated by this
revised scope?
c. Are there other risk-based approaches that would expand the
scope beyond the current list of 15 agents and toxins provided in the
DURC policy that would facilitate the identification of research that
poses significant risks by investigators and institutions while not
resulting in undue burdens?
d. Given the possible revised scope of research requiring review
for potential DURC, what modifications, if any, to the current DURC
policy list of 7 experimental effects should be considered for a
Revised Policy that captures appropriate research without hampering
research progress?
e. What resources or tools would be valuable to assist with
implementation of a DURC policy with a scope that is revised to include
more than the current list of 15 agents and toxins?
3. A PPP is currently defined in the P3CO policy framework \9\ as:
``a pathogen that satisfies both of the following: 1. It is likely
highly transmissible and likely capable of wide and uncontrollable
spread in human populations; and 2. It is likely highly virulent and
likely to cause significant morbidity and/or mortality in humans.''
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\9\ Recommended Policy Guidance for Departmental Development of
Review Mechanisms for Potential Pandemic Pathogen Care and Oversight
(P3CO) (<a href="https://www.phe.gov/s3/dualuse/Documents/P3CO-FinalGuidanceStatement.pdf">https://www.phe.gov/s3/dualuse/Documents/P3CO-FinalGuidanceStatement.pdf</a>).
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The NSABB recommended that the definition of PPP be modified to:
(1) Likely moderately or highly transmissible and likely capable of
wide and uncontrollable spread in human populations; and/or (2) Likely
moderately or highly virulent and likely to cause significant morbidity
and/or mortality in humans; and, in addition (3) Likely to pose a
severe threat to public health, the capacity of public health systems
to function, or national security'' (Recommendation 2).
(a) How would the change in the definition of PPP affect the
overall scope of a Revised Policy and its subsequent implementation?
(b) One possible modification to the NSABB PPP definition is to
specify a respiratory route of transmission within clause (1). Would
that definition of PPP be an appropriate scope to mitigate risks and
enhance effective implementation?
(c) Do you have additional suggestions to modify the PPP definition
to mitigate the most significant risks not currently addressed and
enhance effective implementation, while limiting negative or unintended
consequences and burden on researchers, institutions, and the Federal
government?
(d) Are there characteristics related to human pathology, pathogen
characteristics, or other features that would be helpful to clarify the
intent of ``moderately virulent''? Are there characteristics related to
human pathology that would be helpful to clarify the intent of
``moderately transmissible''?
4. A Government Accountability Office (GAO) report from January
2023 \10\ recommended that the Department of Health and Human Services
funding agencies should develop and document a standard to define
``reasonably anticipated'' to ensure consistency in identifying
research that falls within scope of a Revised Policy. One possible
definition of ``reasonably anticipated'' is:
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\10\ Public Health Preparedness: HHS Could Improve Oversight of
Research Involving Enhanced Potential Pandemic Pathogens. (GAO-23-
105455).
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`` `Reasonably anticipated' describes an assessment of an outcome
that an individual with scientific expertise relevant to the research
in question would expect this outcome to occur with a non-trivial
likelihood. It does not require high confidence that the outcome will
definitely occur and excludes experiments in which an expert would
anticipate the outcome to be technically possible, but highly
unlikely.''
(a) Does this definition of ``reasonably anticipated'' provide
additional clarity to ensure greater consistency in identifying
research that falls within scope of the Revised Policy? What
modifications to this definition (if any) would be most helpful?
5. NSABB recommends the removal of blanket exclusions for research
activities associated with surveillance and vaccine development or
production for research with ePPPs (Recommendation 3).
(a) Should exemptions for certain activities be included in a
Revised Policy?
(b) What are the benefits and drawbacks of including exemptions for
domestic and international pandemic preparedness, biosafety,
biosecurity, and global health security?
(c) If exemptions are included, how could they be bounded to
maximize safety and security and minimize negative impact on domestic
and global public health including outbreak and pandemic preparedness
and response? For example, would vaccine research and development
activities be unjustifiably impeded if the current P3CO policy
framework exemption for ``Activities associated with developing and
producing vaccines, such as generation of high growth strains'' was
either removed completely or modified
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to ``Research on PPPs directly associated with testing and/or producing
vaccines, such as generation of high growth strains''?
6. NSABB recommends that continued assessment of the risks and
benefits associated with advances and applications of bioinformatics,
modeling, and other in silico experimental approaches and research
involving genes from or encoding pathogens, toxins, or other agents
must inform future evaluations of the scope of research oversight
policies to help ensure that associated risks are appropriately
identified and managed. (Recommendation 10.2). This type of research is
not currently included in the DURC and ePPP oversight policies.
(a) Is there a subset of such in silico research that should
require risk assessment and review in a Revised Policy, and if so, how
should this research be defined so that the Policy captures the
appropriate research without hampering activities with limited
biosecurity risks?
(b) One possible way to define this category of in silico research
within a Revised Policy would be to include experiments that are
reasonably anticipated to:
``(i) Develop in silico models that directly enable the predictive
design of an enhanced potential pandemic pathogen or novel pathogen or
toxin covered under a Revised Policy that could be constructed via
genomic editing or de novo synthesis; and/or
(ii) Develop a dataset(s) connecting nucleic acid or amino acid
sequences with experimentally-determined pathogenic functions in a
manner sufficient to enable the development of in silico models
described in (i).''
If a new category of research, similar to the examples provided
above, were to require risk assessment and review in a Revised Policy,
what would be the benefits and challenges with implementation?
Dated: August 28, 2023.
Stacy Murphy,
Deputy Chief Operations Officer/Security Officer.
[FR Doc. 2023-18906 Filed 8-31-23; 8:45 am]
BILLING CODE 3270-F1-P
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