PDF Version

[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

[[Page 12371]]

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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