[Federal Register Volume 81, Number 80 (Tuesday, April 26, 2016)]
[Rules and Regulations]
[Pages 24498-24500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09601]



[[Page 24498]]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

48 CFR Parts 1535 and 1552

[EPA-HQ-OARM-2016-0046; FRL 9941-86-OARM]


Environmental Protection Agency Acquisition Regulation; 
Institutional Oversight of Life Sciences Dual Use Research of Concern

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is issuing a direct 
final rule to amend the EPA Acquisition Regulation (EPAAR) to include a 
new solicitation provision and contract clause to implement the United 
States Government Policy for Institutional Oversight of Life Sciences 
Dual Use Research of Concern (iDURC Policy). This direct final rule 
requires certain domestic institutions that receive contract funding 
from EPA to conduct or sponsor life sciences research and institutions 
outside of the United States that receive contract funding from EPA to 
conduct or sponsor research with the agents or toxins listed in the 
iDURC Policy, to review and communicate their research responsibly in 
accordance with the iDURC Policy.

DATES: This rule is effective on June 27, 2016 without further notice, 
unless EPA receives adverse comment by May 26, 2016. If EPA receives 
adverse comment, we will publish a timely withdrawal in the Federal 
Register informing the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OARM-2016-0046; FRL 9941-86-OARM at http://www.regulations.gov. Follow 
the online instructions for submitting comments. Once submitted, 
comments cannot be edited or removed from Regulations.gov. The EPA may 
publish any comment received to its public docket. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. Multimedia submissions (audio, video, etc.) must be 
accompanied by a written comment. The written comment is considered the 
official comment and should include discussion of all points you wish 
to make. The EPA will generally not consider comments or comment 
contents located outside of the primary submission (i.e. on the web, 
cloud, or other file sharing system). For additional submission 
methods, the full EPA public comment policy, information about CBI or 
multimedia submissions, and general guidance on making effective 
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Holly Hubbell, Policy, Training, and 
Oversight Division (3802R), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-
1091; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Direct Final Rule

    EPA is publishing this rule without a prior proposed rule because 
we view this as a noncontroversial action and anticipate no adverse 
comment as this final rule amends the EPAAR to add a new solicitation 
provision and contract clause for iDURC Policy compliance. The iDURC 
policy was already published in the Federal Register for comment on 
September 25, 2014. If EPA receives adverse comment, we will publish a 
timely withdrawal in the Federal Register informing the public that the 
rule will not take effect. Any parties interested in commenting must do 
so at this time.

II. Applicability

    The EPA is promulgating a solicitation provision and contract 
clause to implement the iDURC Policy. The solicitation provision and 
contract clause notify institutions of the need to comply, and to 
ensure that institutions subject to the iDURC Policy represent that 
they shall comply with the iDURC Policy prior to or upon contract 
award. Institutions within the United States that receive funding from 
EPA to conduct or sponsor life sciences research are subject to the 
iDURC Policy if they conduct or sponsor research involving any of the 
agents or toxins listed in the iDURC Policy, regardless of the funding 
source. Institutions outside of the United States are subject to the 
iDURC Policy if they receive funding from EPA to conduct or sponsor 
research with any agents or toxins listed in the iDURC Policy. 
Institutions that are subject to the iDURC Policy have a number of 
responsibilities--at a minimum, they are advised to train laboratory 
personnel involved in such projects and maintain records of that 
training, establish an institutional review process to assess the 
research for its potential to meet the definition of dual use research 
of concern, and if it meets the definition, ensure the research is 
conducted and communicated responsibly.

III. Submitting Comments

    A. Do not submit CBI to EPA through the Web site http://www.regulations.gov or by email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI, and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    B. Tips for Preparing Your Comments. When submitting comments, see 
the commenting tips at: http://www2.epa.gov/dockets/commenting-epa-dockets and remember to:
     Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date and 
page number).
     Follow directions--The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) Part or section number.
     Explain why you agree or disagree, suggest alternatives, 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     Provide specific examples to illustrate your concerns, and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
    C. Make sure to submit your comments by the comment period deadline 
identified.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the 
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and 
is therefore not subject to review under the EO 12866 and 13563 (76 FR 
3821, January 21, 2011).

[[Page 24499]]

B. Paperwork Reduction Act

    The information collection activities in this rule have been 
submitted for approval to the Office of Management and Budget (OMB) 
under the PRA. The Information Collection Request (ICR) document that 
the EPA prepared has been assigned EPA ICR number 2530.01. You can find 
a copy of the ICR in the docket for this rule, and it is briefly 
summarized here. The information collection requirements are not 
enforceable until OMB approves them.
    The iDURC Policy instructs institutions subject to the Policy train 
individuals within their institution that are conducting research 
involving any of the agents or toxins identified in the Policy. 
Additionally, institutions are to maintain records of that training. 
EPA is submitting an information collection request for these 
recordkeeping requirements. EPA may collect the training records to 
ensure EPA is in compliance with the Policy, and that institutions 
receiving EPA funding are appropriately complying as well. EPA does not 
expect any issues of confidentiality to be relevant to this information 
collection.
    Respondents/affected entities: Private Industry; Federal Government 
(in the form of government-owned/contractor-operated laboratories).
    Respondent's obligation to respond: Mandatory (48 CFR Chapter 15, 
Part 52 and Part 35).
    Estimated number of respondents: 12 to 24.
    Frequency of response: Only once, or as necessary.
    Total estimated burden: 36 to 64 hours per year.
    Total estimated cost: $1,440 to $4,320.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

C. Regulatory Flexibility Act (RFA), as Amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et. 
seq.

    This action is not subject to the RFA. The RFA applies only to 
rules subject to notice and comment rulemaking requirements under the 
Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. 
This rule pertains to contracts, which the APA expressly exempts from 
notice and comment rulemaking requirements under 5 U.S.C. 553(a)(2).

D. Unfunded Mandates Reform Act

    This action does not contain any unfunded mandates as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action imposes no enforceable duty on any State, 
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications, as specified in 
Executive Order 13175. No substantial compliance costs are expected. 
There will be no impact on the relationship between the federal 
government and Indian tribes, or on the distribution of power and 
responsibilities between the federal government and Indian tribes. 
Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that concern environmental health or safety risks 
that the EPA has reason to believe may disproportionately affect 
children, per the definition of ``covered regulatory action'' in 
section 2-202 of the Executive Order. This action is not subject to 
Executive Order 13045 because it does not concern an environmental 
health risk or safety risk.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28335 
(May 22, 2001), because it is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995 (NTTAA)

    This action does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    EPA has determined that this final rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations because it does not 
affect the level of protection provided to human health or the 
environment in the general public.

K. Congressional Review Act

    This action is subject to the CRA, and the EPA will submit a rule 
report to each House of the Congress and to the Comptroller General of 
the United States. This action is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects

48 CFR Part 1535

    Environmental protection, Dual use research, Institutional 
oversight, Life sciences, Research and development.

48 CFR Part 1552

    Environmental protection, Dual use research, Institutional 
oversight, Life sciences, Research and development.

    Dated: April 19, 2016.
John R. Bashista,
Director, Office of Acquisition Management.

    For the reasons stated in the preamble, 48 CFR parts 1535 and 1552 
are amended as set forth below:

PART 1535--RESEARCH AND DEVELOMENT CONTRACTING

0
1. The authority citation for part 1535 continues to read as follows:

    Authority:  Sec. 205(c), 63 Stat. 390, as amended, 40 U.S.C. 
486(c).


0
2. Amend section 1535.007 by adding paragraph (c) to read as follows:


1535.007  Solicitations.

* * * * *
    (c) Contracting officers shall insert 48 CFR 1552.235-81--``Notice 
of Institutional Oversight of Life Sciences Dual Use Research of 
Concern-Representation'' when notified in the Advance Procurement Plan 
(APP) or by an EPA funding/requesting office, in accordance with the 
Institutional Oversight of Life Sciences Dual Use Research of Concern 
(iDURC) EPA Order 1000.19--``Policy and Procedures for Managing Dual 
Use Research of Concern,'' in solicitations that will result in a 
contract under which EPA funding will be used by the recipient to 
conduct or sponsor ``life sciences research''.

0
3. Amend section 1535.007-70 by adding paragraph (h) to read as 
follows:


1535.007-70  Contract clauses.

* * * * *
    (h) Contracting officers shall insert 48 CFR 1552.235-82--
``Institutional

[[Page 24500]]

Oversight of Life Sciences Dual Use Research of Concern'' into all 
solicitations containing 48 CFR 1552.235-81 and in existing contracts 
that are bilaterally modified at the request of an EPA funding/
requesting office in accordance with EPA Order 1000.19.

PART 1552--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

0
4. The authority citation for part 1552 continues to read as follows:

    Authority:  5 U.S.C. 301 as amended, 40 U.S.C. 486(c); and 41 
U.S.C. 418b.


0
5. Add section 1552.235-81 to read as follows:


1552.235-81  Institutional oversight of life Sciences dual use research 
of concern--representation.

    As prescribed in 1535.007(c), insert the following solicitation 
provision:

Institutional Oversight of Life Sciences Dual Use Research of Concern--
Representation (JUNE 2016)

    (a) Definitions. As used in this provision--
    Institution means any government agency (Federal, State, tribal, 
or local), academic institution, corporation, company, partnership, 
society, association, firm, sole proprietorship, or other legal 
entity conducting research.
    Life Sciences research means a systematic investigation designed 
to develop or contribute to generalizable knowledge involving living 
organisms (e.g., microbes, human beings, animals, and plants) and 
their products, including all disciplines and methodologies of 
biology such as aerobiology, agricultural science, plant science, 
animal science, bioinformatics, genomics, proteomics, microbiology, 
synthetic biology, virology, molecular biology, environmental 
science, public health, modeling, engineering of living systems, and 
all applications of the biological sciences. The term is meant to 
encompass the diverse approaches to understanding life at the level 
of ecosystems, populations, organisms, organs, tissues, cells, and 
molecules. Life sciences research does not include routine product 
testing, quality control, mapping, collection of general-purpose 
statistics, routine monitoring and evaluation of an operational 
program, observational studies, and the training of scientific and 
technical personnel.
    (b) Representation. By submission of its offer or quotation, the 
Offeror represents that if it is:
    (1) An institution within the United States that conducts or 
sponsors life sciences research that involves one or more of the 
agents or toxins listed in section 6.2.1 of the ``United States 
Government Policy for Institutional Oversight of Life Sciences Dual 
Use Research of Concern'' (iDURC Policy), even if the research is 
not supported by United States Government funds; or
    (2) An institution outside of the United States that receives 
funds to conduct or sponsor research that involves one or more of 
the agents or toxins listed in section 6.2.1 of the iDURC Policy; 
then the Offeror will comply with the iDURC Policy.
    (c) Resources. Information about dual use research in the life 
sciences, as well as specific details on the iDURC Policy can be 
found on the U.S. Department of Health and Human Services Dual Use 
Research of Concern page: http://www.phe.gov/s3/dualuse/Pages/default.aspx.

    (End of Provision)

0
6. Add 1552.235-82 to read as follows:


1552.235-82  Institutional oversight of life sciences dual use research 
of concern.

    As prescribed in 1535.007-70(h), insert the following contract 
clause:

Institutional Oversight Of Life Sciences Dual Use Research Of Concern 
(JUNE 2016)

    (a) Definitions. As used in this clause--
    Institution means any government agency (Federal, State, tribal, 
or local), academic institution, corporation, company, partnership, 
society, association, firm, sole proprietorship, or other legal 
entity conducting research.
    Life Sciences research means a systematic investigation designed 
to develop or contribute to generalizable knowledge involving living 
organisms (e.g., microbes, human beings, animals, and plants) and 
their products, including all disciplines and methodologies of 
biology such as aerobiology, agricultural science, plant science, 
animal science, bioinformatics, genomics, proteomics, microbiology, 
synthetic biology, virology, molecular biology, environmental 
science, public health, modeling, engineering of living systems, and 
all applications of the biological sciences. The term is meant to 
encompass the diverse approaches to understanding life at the level 
of ecosystems, populations, organisms, organs, tissues, cells, and 
molecules. Life sciences research does not include routine product 
testing, quality control, mapping, collection of general-purpose 
statistics, routine monitoring and evaluation of an operational 
program, observational studies, and the training of scientific and 
technical personnel.
    (b) Compliance. The Contractor agrees that it shall comply with 
the ``United States Government Policy for Institutional Oversight of 
Life Sciences Dual Use Research of Concern'' (iDURC Policy) during 
the period of performance of this contract, including all option 
periods or other extensions, if the Contractor:
    (1) Is an institution within the United States that conducts or 
sponsors, or begins to conduct or sponsor life sciences research 
that involves one or more of the agents or toxins listed in Section 
6.2.1 of the iDURC Policy, even if the research is not supported by 
United States Government funds; or
    (2) Is an institution outside the United States that receives 
funds through this contract to conduct or sponsor research that 
involves one or more of the agents or toxins listed in Section 6.2.1 
of the iDURC Policy.
    (c) Resources. Information about dual use research in the life 
sciences as well as specific details on the iDURC Policy can be 
found on the U.S. Department of Health and Human Services Dual Use 
Research of Concern page: http://www.phe.gov/s3/dualuse/Pages/default.aspx.

    (End of clause)

[FR Doc. 2016-09601 Filed 4-25-16; 8:45 am]
 BILLING CODE 6560-50-P