[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Notices]
[Pages 12369-12372]
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OFFICE OF SCIENCE AND TECHNOLOGY POLICY
United States Government Policy for Institutional Oversight of
Life Sciences Dual Use Research of Concern
AGENCY: Office of Science and Technology Policy (OSTP).
ACTION: Notice; request for comment.
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SUMMARY: The United States Government (USG) invites comments on the
proposed United States Government Policy for Institutional Oversight of
Life Sciences Dual Use Research of Concern. The proposed Policy
establishes institutional review and oversight requirements for certain
categories of life sciences research at institutions that accept
Federal funding for such research. These requirements are intended to
address risks of dual use research not addressed under existing Federal
regulations or guidelines. Requirement for compliance with this Policy,
once finalized, will be incorporated by Federal funding agencies in
accordance with their relevant statutory authorities, into the terms
and conditions of awards with funded institutions that conduct research
falling into the categories identified in the Policy. The public input
provided through this Notice will inform future deliberations and
issuance of a final Policy.
DATES: Release date: February 22, 2013. Response date: April 23, 2013.
ADDRESSES: Comments may be submitted electronically to:
[email protected]. Comments may also be mailed to: Dr. Franca R.
Jones, Assistant Director--Chemical and Biological Countermeasures,
Office of
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Science and Technology Policy, Eisenhower Executive Office Building,
1650 Pennsylvania Avenue, Washington, DC 20504. See SUPPLEMENTARY
INFORMATION for specific information about submitting comments.
The proposed Policy is available on the U.S. Department of Health
and Human Services Science Safety Security (S3) Web site: http://www.phe.gov/s3/dualuse/Pages/default.aspx.
FOR FURTHER INFORMATION CONTACT: Dr. Franca R. Jones, Assistant
Director--Chemical and Biological Countermeasures, Office of Science
and Technology Policy, Eisenhower Executive Office Building, 1650
Pennsylvania Avenue, Washington, DC 20504, [email protected].
SUPPLEMENTARY INFORMATION:
Background
The United States Government (USG) invites comments on the proposed
United States Government Policy for Institutional Oversight of Life
Sciences Dual Use Research of Concern. The proposed Policy establishes
institutional review and oversight requirements for certain categories
of life sciences research at institutions that accept Federal funding
for such research. These requirements are intended to address risks of
dual use research not addressed under existing Federal regulations or
guidelines. Requirement for compliance with this Policy, once
finalized, will be incorporated by Federal funding agencies in
accordance with their relevant statutory authorities, into the terms
and conditions of awards with funded institutions (see Applicability,
Section 6.1) that conduct research falling into the categories
identified in the Policy (see Scope, Section 6.2). The public input
provided through this Notice will inform future deliberations and
issuance of a final Policy.
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, the environment,
materiel,\1\ and national security. Life sciences research has and will
continue to yield benefits, but no life sciences research comes without
risk. Indeed, certain types of research that are conducted for
legitimate purposes may also be utilized for harmful purposes. Such
research is called ``dual use research.'' Dual use research of concern
(DURC) is a smaller subset of dual use research defined as life
sciences research that, based on current understanding, can be
reasonably anticipated to provide knowledge, information, products, or
technologies that could be directly misapplied to pose a significant
threat with broad potential consequences to public health and safety,
agricultural crops and other plants, animals, the environment,
materiel, or national security.
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\1\ Materiel includes food, water, equipment, supplies, or
material of any kind.
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In general, there are risks associated with life sciences research,
such as accidental exposure of personnel or the environment to a
pathogen or toxin. Many existing and synergistic statutes, regulations,
and guidelines are in place to address risks associated with biosafety,
physical security, and personnel reliability.\2\ Some risks relate
directly to the characteristics of DURC--the risk that knowledge,
information, products, or technologies resulting from the research
could be used in a manner that results in harm or threatens society.
DURC should be evaluated for possible risks, as well as benefits, in
all these domains to ensure that risks are appropriately managed and
benefits realized. This proposed Policy addresses dual use research
risks holistically, that is, the risk that knowledge, information,
products, or technologies generated from life sciences research could
be used in a manner that results in harm.
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\2\ e.g. Select Agents and Toxins Program (42 CFR part 73, 9 CFR
part 121, and 7 CFR part 331); National Institutes of Health
Guidelines on Research Involving Recombinant DNA Molecules (http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.pdf); Biosafety in
Microbiological and Biomedical Laboratories 5th Edition (http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf).
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Given these dual use risks, the USG issued, on March 29, 2012, its
Policy for Oversight of Life Sciences Dual Use Research of Concern
(March 29 Policy). The March 29 Policy formalized a process of regular
federal review of USG-funded or -conducted research with certain high-
consequence pathogens and toxins to identify DURC and implement
mitigation measures, where applicable. The goal of the March 29 Policy
is to preserve the benefits of life sciences research while minimizing
the risk that the knowledge, information, products, or technologies
generated by such research could be used in a manner that results in
harm.
Funders of life sciences research and the institutions and
scientists who receive those funds have a shared responsibility for
oversight of DURC and for promoting the responsible conduct and
communication of such research. The proposed Policy herein, United
States Government Policy for Institutional Oversight of Life Sciences
Dual Use Research of Concern, addresses the institutional oversight of
DURC, and will operate in tandem with the March 29 Policy that requires
Federal agencies to implement similar measures for oversight of DURC.
Oversight includes policies, practices, and procedures that are put in
place to ensure DURC is identified and risk mitigation measures are
implemented, where appropriate. Institutional oversight of DURC is a
critical component of a comprehensive oversight system because
institutions are most familiar with the life sciences research
conducted in their facilities and are in the best position to promote
and strengthen the responsible conduct and communication of DURC. This
proposed Policy delineates the procedures for the oversight of DURC and
responsibilities of Principal Investigators, research institutions, and
the USG. This proposed Policy, in addition to the March 29 Policy,
emphasizes a culture of responsibility by reminding all involved
parties of the shared duty to uphold the integrity of science and
prevent its misuse.\3\ The components outlined in the March 29 Policy
and in this Policy, once finalized, will be updated, as needed,
following domestic dialogue, international engagement, and input from
interested communities including scientists, national security
officials, and global health specialists.
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\3\ The March 29 Policy and this proposed Policy are
complemented by other extant laws and treaties (e.g. 18 U.S.C. 175
and the Biological and Toxin Weapons Convention) that prohibit the
development, production, acquisition, or stockpiling of biological
agents or toxins of types and in quantities that have no
justification for prophylactic, protective or other peaceful
purposes and that prohibit the use of biological agents and toxins
as weapons.
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Because institutional oversight of DURC will be a new undertaking
for many institutions, the USG is currently limiting the requirements
in this proposed Policy, as well as the March 29 Policy, to research
that meets the scope in Section 6.2, which focuses on a well-defined
subset of life sciences research that involves 15 agents and toxins and
seven categories of experiments. The USG will solicit feedback on the
experience of institutions in implementing the Policy; will evaluate
the impact of DURC oversight on the life sciences research enterprise;
will assess the benefits and risks of expanding the scope of the Policy
to encompass additional agents and toxins and/or categories of
experiments; and will update the Policy, as warranted. Research
institutions are
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encouraged to be mindful that research outside of the categories
articulated in this proposed Policy may also constitute DURC.
Institutions have the discretion to consider other categories of
research for DURC potential and may expand their oversight to other
types of life sciences research as they deem appropriate.
Finally, and importantly, research that meets the definition of
DURC often increases our understanding of the biology of pathogens and
makes critical contributions to the development of new treatments and
diagnostics, improvements in public health surveillance, and the
enhancement of emergency preparedness and response efforts. Thus,
designating research as DURC should not be seen as a negative
categorization, but simply an indication that the research may warrant
additional oversight in order to reduce the risks that the knowledge,
information, products, or technologies generated could be used in a
manner that results in harm. As a general matter, designation of
research as DURC does not mean that the research should not be
conducted or communicated.
Nothing in this proposed Policy supersedes the Department of Health
and Human Services and the United States Department of Agriculture
Select Agents and Toxins Program's (SAP) statutory authority or SAP
regulations as published in 42 CFR part 73, 9 CFR part 121, and 7 CFR
part 331.
Specific Questions
Public comments are sought on the entirety of the proposed United
States Government Policy for Institutional Oversight of Life Sciences
Dual Use Research of Concern. In addition, we are seeking input on the
following specific questions:
1. For institutions conducting research that involves one or more
of the 15 listed agents, please describe the feasibility and
anticipated burden (administrative, resources, etc.), if any, to
implement the requirements of this proposed Policy. What effect, if
any, do you anticipate the proposed Policy would have on your ability
to support or engage in research on any of the listed pathogens or
toxins?
2. Are there alternatives to the administrative requirements of
this proposed Policy that could be more easily implemented by
Federally-funded research institutions and that would meet the intent
of this proposed Policy or the March 29 Policy? If so, please specify.
3. How could DURC oversight be usefully integrated with other
existing institutional oversight processes in order to reduce
duplication and any resulting excess administrative burdens on
institutions?
4. For institutions who have registered an Institutional Biosafety
Committee (IBC) with the NIH Office of Biotechnology Activities in
accordance with the NIH Guidelines for Research Involving Recombinant
DNA Molecules, is it feasible for the IBC to conduct the DURC
institutional review process? What are the benefits or limitations of
using IBCs in this role?
5. Should research that has undergone institutional DURC review but
has been determined not to be DURC be monitored for emerging DURC
issues? If so, how often should such review take place?
6. Is it feasible for a single individual, the Institutional
Contact for Dual Use Research (ICDUR), to be the point of contact for
all dual use research-related questions to and from the funding agency?
If not, who else could help fill this role?
7. The proposed Policy calls for principal investigators (PIs) to
refer any research involving one or more of the 15 listed agents to an
institutional dual use research review entity (Section 7.1.A). The
institutional review entity will then determine whether the research
can be reasonably anticipated to produce any of the seven effects, and
if so, if that research meets the definition of DURC. Is it preferable
to instead require PIs to determine both whether their research
involves one or more of the listed agents and also whether their
research can be reasonably anticipated to produce any of the listed
effects? In this scenario, the institutional dual use research review
entity would then only determine whether the research meets the
definition of DURC. (Note: In either scenario, the institutional dual
use research review entity would also then assess the risks and
benefits of the research and develop a risk management plan.)
8. Is additional guidance or explanation needed for interpreting
the seven effects/categories of experiments listed in Section 6.2.2?
9. The USG is developing a document that contains the following
analytic tools and guidance to assist in implementation of the Policy,
once finalized:
a. Understanding and identification of DURC
b. Assessment of risks and benefits associated with DURC
c. Developing a risk mitigation plan for DURC
d. Responsibly communicating DURC
e. Training and education on DURC
Are there any additional tools or guidance documents that would be
useful in implementing and complying with this Policy, once finalized?
10. We are interested in views on the optimum relationship between
the March 29 Policy and this proposed Policy. Are there any conflicts
or challenges posed by implementing both policies? Should research
institutions review projects for DURC issues prior to proposals being
submitted to a funding agency for review? (If not, funding agencies
implementing the March 29 Policy will not have the benefit of input
from institutional dual use review when reviewing research proposals
for DURC.) If so, should the PI and/or institution designate on the
grant application that such a review has taken place and indicate its
findings?
11. This proposed Policy is intended to apply to projects that
directly use non-attenuated forms of the 15 agents or toxins listed in
Section 6.2.1 and/or use botulinum toxin at any quantity. Should the
scope also include (please provide information to support your answer):
a. The use of any of the listed 15 agents or toxins in attenuated
forms;
b. The use of the genes from any of the listed 15 agents or toxins
(all genes? Only certain types of genetic information? If the latter,
how could this be specified?);
c. In silico experiments (e.g. modeling experiments, bioinformatics
approaches) involving the biology of the listed 15 agents or toxins;
d. Research related to the public, animal, and agricultural health
impact of any of the 15 listed agents or toxins (e.g. modeling the
effects of a toxin, developing new methods to deliver a vaccine,
developing surveillance mechanisms for a listed agent)?
12. Is the scope of the proposed Policy appropriate? If not, why
not? Should the scope be expanded to all select agents, microbes, or
all life sciences? If so, why? What factors should be considered in
determining the final scope of oversight? What criteria might be used
to determine what research should/should not be subject to oversight?
If the Policy, once finalized, were expanded to cover other types of
life sciences research (i.e. beyond the 15 listed agents), what effect,
if any, would it have on your ability to conduct that research?
13. The USG recognizes that there may be some institutions that
choose to expand their oversight beyond the 15 agents listed in Section
6.2.1 and/or beyond the seven categories listed in Section 6.2.2 or
currently have a DURC oversight process in place that is beyond the
scope of this proposed Policy. For
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those institutions, what additional agents or toxins, other categories
of experiments, and/or other domains within the life sciences were
considered for potential oversight? What impact has the expanded
oversight had on the conduct and administration of the institution's
life sciences research?
14. The USG recognizes that there will be situations where a PI is
conducting potential DURC at multiple institutions. Should each
institution have oversight of these projects and if DURC is being
conducted at their institution, develop and implement risk mitigation
plans? Or should the PI's primary institution have this responsibility?
(Refer to ``Note'' following Section 7.2.K)
15. The proposed Policy requires institutions that would be subject
to the proposed Policy by virtue of Federal funding, to apply the
proposed Policy to non-Federally funded research. Under the proposal,
institutions would submit information about DURC reviews and risk
mitigation plans on non-Federally funded projects to the National
Institutes of Health (which may in turn refer the results and plans to
the appropriate Federal agency based upon the nature of the research).
Applying the DURC policy to Federally and non-Federally funded research
promotes more meaningful oversight of DURC at the institutional level
and fosters uniform approaches to the responsible conduct and
communication of all research that may raise DURC concerns at an
institution. Is this approach feasible? If not, what is the best
mechanism for structuring oversight for non-Federally funded research?
16. The proposed Policy requires institutions to maintain records
of DURC reviews, risk mitigation plans, and personnel training for
three years. However, grant cycles are often longer than three years
and DURC communications may arise even after funding has ended. This
could result in situations where important records (e.g., the risk
mitigation plan) are not available at the institution for certain DURC
projects. Should the record-keeping requirements for this proposed
Policy be longer to allow access to records over (and beyond) the
lifetime of a DURC project? What is an appropriate amount of time that
institutions should be required to retain such records?
Availability of the Proposed Policy
The proposed Policy is available on the U.S. Department of Health
and Human Services Science Safety Security (S3) Web site: http://www.phe.gov/s3/dualuse/Pages/default.aspx.
Comment Submission
Comments may be submitted electronically to: [email protected].
Comments may also be mailed to: Dr. Franca R. Jones, Assistant
Director--Chemical and Biological Countermeasures, Office of Science
and Technology Policy, Eisenhower Executive Office Building, 1650
Pennsylvania Avenue Washington, DC 20504. In your response, please
provide the following information:
Date
Name/Email/Phone Number
Affiliation/Organization
City, State
General Comments
Comments to Specific Questions (1-16) Listed in Supplementary
Information as Follows:
Comment to Question 1
Comment to Question 2
Comment to Question 3
Comment to Question 4
Comment to Question 5
Comment to Question 6
Comment to Question 7
Comment to Question 8
Comment to Question 9
Comment to Question 10
Comment to Question 11
Comment to Question 12
Comment to Question 13
Comment to Question 14
Comment to Question 15
Comment to Question 16
You will receive an electronic confirmation acknowledging receipt
of your response, but will not receive individualized feedback on any
suggestions. No basis for claims against the U.S. Government shall
arise as a result of a response to this request for comment or from the
Government's use of such information.
Ted Wackler,
Deputy Chief of Staff.
[FR Doc. 2013-04127 Filed 2-21-13; 8:45 am]
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