Environmental Protection Agency Acquisition Regulation (EPAAR); Scientific Integrity, 66266-66270 [2020-20665]
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Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Rules and Regulations
Subpart AA—Missouri
§ 52.1320
[Amended]
2. In § 52.1320, the table in paragraph
(c) is amended by removing the entry
‘‘10–5.360’’ under the heading ‘‘Chapter
5-Air Quality Standards and Air
Pollution Control Regulations for the St.
Louis Metropolitan Area’’.
■
[FR Doc. 2020–21150 Filed 10–16–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
48 CFR Part 1503 and 1552
[EPA–HQ–OARM–2015–0657; FRL–10012–
65–OMS]
Environmental Protection Agency
Acquisition Regulation (EPAAR);
Scientific Integrity
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is issuing a final rule to
address scientific integrity requirements
in the creation of a contract clause for
inclusion in solicitations and contracts
when the Contractor may be required to
perform, communicate, or supervise
scientific activities or use scientific
information to perform advisory and
assistance services. This clause will
complement the EPA’s Scientific
Integrity Policy to ensure all scientific
work developed and used by the
Government is accomplished with
scientific integrity.
DATES: This final rule is effective on
October 19, 2020.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OARM–2015–0657; FRL–
10012–65–OMS. All documents in the
docket are listed on the https://
www.regulations.gov website. Although
listed in the index, some information is
not publicly available, e.g., confidential
business information or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available electronically
through https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Holly Hubbell, Policy, Training, and
Oversight Division, Acquisition Policy
and Training Branch (3802R),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
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SUMMARY:
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20460; telephone number: 202–564–
1091; email address: hubbell.holly@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The EPA’s Scientific Integrity Policy
is based on a Presidential Memorandum
for the Heads of Executive Departments
and Agencies, Subject Line: Scientific
Integrity, Dated: March 9, 2009. The
memorandum directs the Director of the
Office of Science and Technology Policy
(OSTP) to work with the Office of
Management and Budget (OMB) and
agencies to develop policies to ensure
all scientific work developed and used
by the Government is done so with
scientific integrity. OSTP issued further
guidance in the Scientific Integrity
memorandum dated December 17, 2010.
This final rule requires EPA
contractors to ensure that all personnel
within their organization,
subcontractors and consultants, that
perform, communicate, or supervise
scientific activities or use scientific
information to perform advisory and
assistance services under their specified
contracts with EPA, have read and
understand their compliance
responsibilities regarding the EPA’s
Scientific Integrity Policy.
The proposed rule was published in
the Federal Register (83 FR 48581–
48584) on September 26, 2018,
providing for a 60-day comment period.
Interested parties were afforded the
opportunity to participate in the making
of this rule.
II. Public Comments on the Proposed
Rule
The following is a summary of the
public comments received on the
proposed rule and the EPA’s response to
these comments.
1. Comment: Several commenters
expressed concerns about the costs of
making scientific information available
online and also that requiring scientific
information to be available online could
compromise confidentiality of the
scientific information.
Response: The proposed clause
requirement at EPAAR § 1552.203–
72(c)(1)(x) to make scientific
information available online has been
deleted.
2. Comment: One commenter
suggested that the EPA inform
contractors of their need to evaluate
computer models in adherence to the
EPA Models Guidance.
Response: This requirement is
described in general terms because
listing specific guidance may not be allinclusive or the guidance may change in
the future.
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3. Comment: One commenter noted
that preventing intimidation or coercion
of scientists to alter their scientific
findings is a crucial element of the
EPA’s Scientific Integrity Policy and
proposed adding the terms ‘‘attempted
or actual intimidation or coercion’’ to
the clause to clarify that both attempted
or actual intimidation or coercion
would be a loss of scientific integrity.
Response: The EPA agrees and has
added the terms ‘‘attempted or actual’’,
defining intimidation or coercion to
EPAAR 1552.203–72(c)(2)(i).
4. Comment: One commenter
expressed concern that the proposed
rule does not explicitly address whether
an individual employee of a contractor
has an obligation to report loss or
potential loss of scientific integrity to
the contracting officer, his or her
supervisor, or both, or to whom and
how to report.
Response: In this final rule, the EPA
does clarify in paragraph (d) of the
clause that an employee of the
contractor must report any loss or
potential loss of scientific integrity in
writing to the contractor who must
communicate it to the EPA.
5. Comment: Concern was expressed
that there is no explicit mechanism for
resolving a dispute if the contractor, or
an individual contractor employee, feels
that the contracting officer has reached
an incorrect conclusion or is applying
an inappropriate remedy with regard to
a loss of scientific integrity.
Response: The EPA agrees that a party
who has been accused of a loss of
scientific integrity should be able to
respond to the Agency’s decision
regarding the loss of scientific integrity
and the remedy. Section (e)(5) of the
clause has been edited to state that if the
party who has been accused of a loss of
scientific integrity feels that the Agency
has reached an incorrect conclusion or
the Agency has applied an
inappropriate remedy, that party may
provide a written response to the
Contracting Officer, Scientific Integrity
Official, and/or Office of Inspector
General (OIG).
6. Comment: One commenter noted
that it was not clear if the proposed rule
intended to cover a situation where a
contractor, or employee of a contractor,
became aware of a loss or suspected loss
of scientific integrity by an EPA
employee, but suggested the rule should
cover this situation. Further, the
commenter suggested such a loss or
suspected loss of scientific integrity by
an EPA employee be reported to
someone other than the contracting
officer or the contracting officer’s
representative.
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Response: EPA agrees and has revised
paragraph (d) of the clause to clarify that
the final rule addresses the situation
where a contractor, or employee of a
contractor, becomes aware of an actual
or suspected loss of scientific integrity
by an EPA employee. Language has been
added to state that, if the actual or
potential loss of scientific integrity is by
an EPA employee, the contractor may
inform the EPA’s Scientific Integrity
Official in addition to the contracting
officer or contracting officer’s
representative. An employee of the
contractor must report any actual or
potential loss of scientific integrity to
the contractor who must communicate it
to the EPA.
7. Comment: One commenter stated
that the two clauses need to be further
emphasized to prevent bias during
scientific inquiry.
Response: To clarify, there is only one
clause, EPAAR § 1552.203–72. EPAAR
§ 1503.1071 is the prescription for the
use of the clause. The EPA believes that
there is sufficient emphasis in the
clause requirements to prevent bias
during scientific inquiries. Additionally,
contractors are legally bound to adhere
to all terms of the clause, if it is
included in their contract(s).
8. Comment: One commenter noted
that the proposed rule requires EPA
contractors to adhere to the standards
set forth in the EPA’s Scientific Integrity
Policy, but the commenter was
concerned that contractors cannot
comply with standards if they don’t
know about them. The commenter
suggested additional language be added
to the clause noting all the guidance
upon which the EPA’s Scientific
Integrity Policy is built.
Response: The EPA believes such
additional language is not necessary.
Contractors are notified of the scientific
integrity requirements, which includes a
link to the EPA’s Scientific Integrity
Policy, when this clause is included in
the solicitation and contract.
9. Comment: One commenter
suggested that the rule should be
designated as ‘‘significant’’ under
Executive Order (E.O.) 12866, as other
agencies may not require contractor
compliance with the EPA’s Scientific
Integrity Policy, which could create
serious inconsistencies when the EPA is
working with the other agencies on
matters of interest to both agencies. The
commenter was also concerned that
contractor adherence to the EPA’s
Scientific Integrity Policy could also
raise legal or policy issues arising out of
legal mandates, the President’s
priorities, or E.O. 12866.
Response: The Office of Management
and Budget determines if a rule is a
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significant regulatory action. The EPA’s
Scientific Integrity Policy is based on
OSTP guidance and developed in
conjunction with OMB’s approval.
10. Comment: One commenter
expressed concern that the proposed
rule provides that it is the contracting
officer who decides when the Scientific
Integrity clause applies and when it
should be inserted in a contract. The
commenter was concerned that while
some examples of activities that may
trigger the rule’s application are listed
in the clause, the list of examples is not
exhaustive, and the applicability may be
misinterpreted by the contractor officer.
Response: The EPA agrees that the
technical experts regarding applicability
would be the EPA program office.
Therefore, this final rule adds language
so the contracting officer will consult
with the program office regarding
inclusion of the Scientific Integrity
clause in a contract.
11. Comment: One commenter
proposed adding language requiring
contractors to use the most refined
species location maps and best actual
sampling and test data available.
Response: The EPA believes this
language is redundant to what is already
stated in the clause § 1552.203–
72(c)(1)(i), which states the contractor
agrees to produce scientific products of
the highest quality, rigor and objectivity.
12. Comment: Several respondents
that provided comments expressed their
support of the scientific integrity
requirement for contractors.
Response: EPA appreciates the
support of the respondents.
III. Final Rule
The final rule amends FAR Part
1503—Improper Business Practices and
Personal Conflicts of Interests, Subpart
1503.10—Contractor Code of Business
Ethics and Conduct, by adding EPAAR
§ 1503.1070—Scientific integrity and
1503.1071—Contract clause. FAR Part
1552—Solicitation Provisions and
Contract Clauses is amended by adding
EPAAR clause § 1552.203–72—
Scientific Integrity.
1. EPAAR § 1503.1070 explains the
basis for the subsection.
2. EPAAR § 1503.1071 establishes the
prescription for use of EPAAR clause
§ 1552.203–72 in all solicitations and
contracts when the contractor may be
required to perform, communicate, or
supervise scientific activities, or use
scientific information to perform
advisory and assistance services.
3. EPAAR § 1552.203–72—Scientific
Integrity clause states the applicability,
term definitions as used in this clause,
compliance requirements, reporting
requirements, if an actual or suspected
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loss of scientific integrity is detected,
and potential remedies.
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 (E.O.) 12866 (58 FR
51735, October 4, 1993) and is therefore
not subject to review under the E.O.
B. Paperwork Reduction Act
This action does not impose an
information collection burden under the
provisions of the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq. Burden is
defined at 5 CFR 1320.3(b).
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.
The Regulatory Flexibility Act
generally requires an agency to prepare
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements under the
Administrative Procedure Act or any
other statute; unless the agency certifies
that the rule will not have a significant
economic impact on a substantial
number of small entities. Small entities
include small businesses, small
organizations, and small governmental
jurisdictions. For purposes of assessing
the impact of this final rule on small
entities, ‘‘small entity’’ is defined as: (1)
A small business that meets the
definition of a small business found in
the Small Business Act and codified at
13 CFR 121.201; (2) a small
governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; or (3) a
small organization that is any not-forprofit enterprise which is independently
owned and operated and is not
dominant in its field. After considering
the economic impacts of this rule on
small entities, I certify that this action
will not have a significant economic
impact on a substantial number of small
entities. In determining whether a rule
has a significant economic impact on a
substantial number of small entities, the
impact of concern is any significant
adverse economic impact on small
entities, because the primary purpose of
the regulatory flexibility analyses is to
identify and address regulatory
alternatives ‘‘which minimize any
significant economic impact of the
proposed rule on small entities’’ 5
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U.S.C. 503 and 604. Thus, an agency
may certify that a rule will not have a
significant economic impact on a
substantial number of small entities if
the rule relieves regulatory burden, or
otherwise has a positive economic effect
on all the small entities subject to the
rule. This action establishes a new
EPAAR clause that will not have a
significant economic impact on a
substantial number of small entities. We
continue to be interested in the
potential impacts of the rule on small
entities and welcome comments on
issues related to such impacts.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA, Pub. L.
104–4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, Local,
and Tribal governments and the private
sector. This rule contains no Federal
mandates (under the regulatory
provisions of the Title II of the UMRA)
for State, Local, and Tribal governments
or the private sector. The rule imposes
no enforceable duty on any State, Local
or Tribal governments or the private
sector. Thus, the rule is not subject to
the requirements of sections 202 and
205 of the UMRA.
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E. Executive Order 13132: Federalism
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999), requires EPA to develop an
accountable process to ensure
‘‘meaningful and timely input by State
and Local officials in the development
of regulatory policies that have
federalism implications.’’ ‘‘Policies that
have federalism implications’’ is
defined in the Executive Order to
include regulations that 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.’’ This rule 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
Executive Order 13175, entitled
‘‘Consultation and Coordination With
Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), requires EPA
to develop an accountable process to
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ensure ‘‘meaningful and timely input by
tribal officials in the development of
regulatory policies that have tribal
implications.’’ This rule does not have
tribal implications as specified in
Executive Order 13175.
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
Executive Order 13045, entitled
‘‘Protection of Children From
Environmental Health and Safety Risks’’
(62 FR 19885, April 23, 1997), applies
to any rule that: (1) Is determined to be
economically significant as defined
under E.O. 12886, and (2) concerns an
environmental health or safety risk that
may have a proportionate effect on
children. This rule is not subject to E.O.
13045 because it is not an economically
significant rule as defined by Executive
Order 12866, and because it does not
involve decisions on environmental
health or safety risks.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211, ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution or Use’’ (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)
Section 12(d) (15 U.S.C. 272 note) of
the National Technology Transfer and
Advancement Act of 1995, Public Law
104–113, directs EPA to use voluntary
consensus standards in its regulatory
activities unless to do so would be
inconsistent with applicable law or
otherwise impractical. Voluntary
consensus standards are technical
standards (e.g., materials specifications,
test methods, sampling procedures and
business practices) that are developed or
adopted by voluntary consensus
standards bodies. The NTTAA directs
EPA to provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards. This
action does not involve technical
standards. Therefore, EPA is not
considering the use of any voluntary
consensus standards.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order 12898 (59 FR 7629,
February 16, 1994) establishes federal
executive policy on environmental
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justice. Its main provision directs
federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States. EPA
has determined that this proposed 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 in 48 CFR Parts 1503
and 1552
Environmental protection,
Government procurement, Antitrust,
Conflict of interest, Reporting and
recordkeeping requirements.
Kimberly Patrick,
Director, Office of Acquisition Solutions.
For the reasons stated in the
preamble, EPA amends 49 CFR parts
1503 and 1552 as follows:
PART 1503—IMPROPER BUSINESS
PRACTICES AND PERSONAL
CONFLICTS OF INTERESTS
1. The authority citation for part 1503
is revised to read as follows:
■
Authority: 5 U.S.C. 301 and 41 U.S.C.
1707.
2. Add section 1503.1070 to read as
follows:
■
1503.1070
Scientific integrity.
The EPA’s Scientific Integrity Policy
is based on a Presidential Memorandum
for the Heads of Executive Departments
and Agencies, Subject Line: Scientific
Integrity, Dated: March 9, 2009. The
memorandum directs the Director of the
Office of Science and Technology Policy
(OSTP) to work with the Office of
Management and Budget (OMB) and
agencies to develop policies to ensure
all scientific work developed and used
by the Government is done with
scientific integrity. OSTP issued further
guidance in the Scientific Integrity
memorandum dated December 17, 2010.
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This section and clause complement the
EPA’s Scientific Integrity Policy.
■ 3. Add section 1503.1071 to read as
follows:
1503.1071
Contract clause.
Contracting Officers, with advisement
from the program office, must insert the
contract clause at 1552.203–72—
Scientific Integrity, in solicitations and
contracts when the Contractor may be
required to perform, communicate, or
supervise scientific activities, or use
scientific information to perform
advisory and assistance services.
Examples of such scientific activities
include, but are not limited to,
computer modeling, economic analysis,
field sampling, laboratory
experimentation, demonstrating new
technology, statistical analysis, and
writing a review article on a scientific
issue.
PART 1552—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
4. The authority citation for part 1552
is revised to read as follows:
■
Authority: 5 U.S.C. 301 and 41 U.S.C.
1707.
5. Add section 1552.203–72 to read as
follows:
■
1552.203–72
Scientific integrity.
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As prescribed in § 1503.1071, insert
the following clause:
Scientific Integrity (Month Year)
(a) Applicability. This contract will require
the Contractor to perform, communicate, or
supervise scientific activities or use scientific
information to perform advisory and
assistance services. When performing,
communicating, supervising, or utilizing
scientific activities or scientific information,
the Contractor must adhere to the EPA’s
Scientific Integrity Policy.
(b) Definitions. The following definitions
apply:
Advisory and assistance services (see 48
CFR 2.101).
Scientific activities means those activities
leading to the systematic knowledge of the
physical or material world, largely consisting
of observation and experimentation. It also
includes the supervision, utilization, and
communication of these activities.
Scientific information means factual
inputs, data, models, analyses, technical
information, or scientific assessments related
to such disciplines as the behavioral and
social sciences, public health and medical
sciences, life and earth sciences, engineering,
or physical sciences. This includes any
communication or representation of
knowledge, such as facts or data, in any
medium or form, including textual,
numerical, graphic, cartographic, narrative,
or audiovisual forms. This definition
includes information that an agency
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disseminates from a web page but does not
include the provision of hyperlinks on a web
page to information that others disseminate.
This definition excludes opinions, where the
agency’s presentation makes clear that an
individual’s opinion, rather than a statement
of fact or of the agency’s findings and
conclusions, is being offered.
Scientific Integrity means the adherence to
professional values and practices, that is, the
codes of ethics and behaviors in the
scientists’ fields of study, when conducting,
supervising, communicating, and utilizing
the results of science and scholarship. It
ensures objectivity, clarity, reproducibility,
and utility. It also provides insulation from
bias, fabrication, falsification, plagiarism,
improper outside interference, and
censorship.
(c) Compliance with policy. Prior to
beginning performance under this contract,
the Contractor must ensure that all personnel
within their organization, including
subcontractors and consultants, that perform,
communicate, or supervise scientific
activities, or use scientific information to
perform advisory and assistance services
under this contract, have read and
understand their compliance responsibilities
with the EPA’s Scientific Integrity Policy.
This requirement applies to any personnel
that will supervise, conduct, utilize, or
communicate scientific activities or scientific
information. Examples of such scientific
activities include, but are not limited to,
computer modeling, economic analysis, field
sampling, laboratory experimentation,
demonstrating new technology, statistical
analysis, and writing a review article on a
scientific issue.
(1) Consistent with the objective of
promoting a culture of scientific integrity and
transparency, as discussed in the EPA’s
Scientific Integrity Policy, the Contractor
agrees to:
(i) Produce scientific products of the
highest quality, rigor, and objectivity, by
adhering to applicable EPA information
quality policy, quality assurance policy, and
peer review policy;
(ii) Prohibit suppressing, altering, or
otherwise impeding the timely release of
scientific findings or conclusions;
(iii) Adhere to the Peer Review Handbook,
current edition, for the peer review of
scientific and technical work products
generated through this contract;
(iv) Act honestly and refrain from acts of
research misconduct, including publication
or reporting, as described in EPA Order
3120.5 Policy and Procedures for Addressing
Research Misconduct. Research misconduct
does not include honest error or differences
of opinion;
(v) Require that reviews of the content of
a scientific product be based only on
scientific quality considerations, e.g., the
methods used are clear and appropriate, the
presentation of results and conclusions is
impartial;
(vi) Ensure scientific findings are generated
and disseminated in a timely and transparent
manner, including scientific research
performed by subcontractors and consultants
who assist with developing or applying the
results of scientific activities;
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(vii) Include an explication of underlying
assumptions, accurate contextualization of
uncertainties, and a description of the
probabilities associated with both optimistic
and pessimistic projections when
communicating scientific findings, if
applicable;
(viii) Document the use of independent
validation of scientific methods; and
(ix) Document any independent review of
the Contractor’s scientific facilities and
testing activities, as occurs with accreditation
by a nationally or internationally recognized
sanctioning body.
(2) To assure protection of Contractor staff
supported by this contract, consistent with
the objectives described in the EPA’s
Scientific Integrity Policy, the Contractor
agrees to:
(i) Prohibit attempted or actual
intimidation or coercion of scientists to alter
scientific data, findings, or professional
opinions or non-scientific influence of
scientific advisory boards. In addition, the
Contractor agrees to inform its employees,
subcontractors, and consultants, including
scientists and managers, of their
responsibility not to knowingly misrepresent,
exaggerate, or downplay areas of scientific
uncertainty; and
(ii) Prohibit retaliation or other punitive
actions toward employees who uncover or
report allegations of scientific and research
misconduct, or who express a differing
scientific opinion. The Contractor must
afford employees who have allegedly
engaged in scientific or research misconduct
the due process protections provided by law,
regulation, and applicable collective
bargaining agreements, prior to any action.
The Contractor must ensure that all
employees, subcontractors, and consultants
are familiar with these protections and avoid
the appearance of retaliatory actions.
(d) Loss of Scientific Integrity. If during
performance of this contract the Contractor
becomes aware of an actual or suspected loss
of scientific integrity, the Contractor must
immediately inform the Contracting Officer
and the Contracting Officer’s Representative
with a description of the actual or suspected
issue in writing. If the actual or suspected
loss of scientific integrity is by an EPA
employee, the Contractor may inform the
Agency’s Scientific Integrity Official, in
addition to the Contracting Officer and
Contracting Officer’s Representative. The
Contractor must ensure that its employees are
aware of their responsibility to immediately
report any actual or suspected loss of
scientific integrity to the Contractor, who
must communicate it to the EPA in writing.
The Contracting Officer and the Contracting
Officer’s Representative must consult with
the Agency’s Scientific Integrity Official on
all issues related to an actual or suspected
loss of scientific integrity under this contract
and with the EPA Office of Inspector General
(OIG), in accordance with EPA Order 3120.5
Policy and Procedures for Addressing
Research Misconduct, on all issues related to
research misconduct. The Agency’s Scientific
Integrity Official and/or OIG must advise the
Contracting Officer and Contracting Officer’s
Representative on the appropriate remedy for
any actual or suspected loss of scientific
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integrity. The Contractor bears the primary
responsibility for prevention and detection of
research misconduct and for the inquiry,
investigation, and adjudication of research
misconduct alleged to have occurred under
the contract in association with its own
institution. However, the EPA retains the
ultimate oversight authority for the EPAsupported research. The Contractor must take
the actions required as described in EPA
Order 3120.5 Policy and Procedures for
Addressing Research Misconduct when
research misconduct is suspected or found
under its contract.
(e) Remedies. The Contracting Officer in
consultation with the Scientific Integrity
Official and OIG, if applicable, will make the
final determination on any remedy to an
actual or suspected loss of scientific integrity.
Potential remedies include:
(1) Acceptance of the Contractor’s
proposed mitigation plan to the scientific
integrity issue;
(2) Acceptance of an alternate mitigation
plan negotiated by the parties listed in the
first paragraph of this section;
(3) Termination for convenience, in whole
or in part, if no mitigation plan will
adequately resolve the actual or suspected
loss of scientific integrity; or
(4) Termination for default or cause, in
whole or in part, if the Contractor was aware
of an actual or suspected loss of scientific
integrity under this contract and did not
disclose it or misrepresented relevant
information to the EPA. Additionally, the
Government may debar or suspend the
Contractor from Government contracting or
pursue other remedies as may be permitted
by law or this contract.
(5) Opportunity to Respond—If the party
who has been accused of a loss of scientific
integrity feels that the Agency has reached an
incorrect conclusion or the Contracting
Officer has applied an inappropriate remedy,
the party may provide a written response to
the Contracting Officer, Scientific Integrity
Official, and/or OIG.
(f) Subcontractors and Consultants. The
Contractor agrees to insert language in any
subcontract or consultant agreement placed
hereunder which must conform substantially
to the language of this clause, including this
paragraph (f), unless otherwise authorized in
advance in writing by the Contracting
Officer.
(g) Additional Resources. For more
information about the EPA’s Scientific
Integrity Policy, an introductory video can be
accessed at: https://youtu.be/FQJCy8BXXq8.
A training video is available at: https://
youtu.be/Zc0T7fooot8.
jbell on DSKJLSW7X2PROD with RULES
(End of clause)
[FR Doc. 2020–20665 Filed 10–16–20; 8:45 am]
BILLING CODE 6560–50–P
VerDate Sep<11>2014
16:28 Oct 16, 2020
Jkt 253001
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 660
[Docket No. 180625576–8999–02]
RIN 0648–BK14
Magnuson-Stevens Act Provisions;
Fisheries Off West Coast States;
Pacific Coast Groundfish Fishery;
2019–2020 Biennial Specifications and
Management Measures; Inseason
Adjustments
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final rule; inseason adjustments
to biennial groundfish management
measures.
AGENCY:
This final rule announces
routine inseason adjustments to
management measures in commercial
groundfish fisheries. This action is
intended to allow commercial fishing
vessels to access more abundant
groundfish stocks while protecting
rebuilding and depleted stocks.
DATES: This final rule is effective
October 19, 2020.
FOR FURTHER INFORMATION CONTACT:
Gretchen Hanshew, phone: 206–526–
6147 or email: Gretchen.Hanshew@
noaa.gov.
SUMMARY:
Electronic Access
This rule is accessible via the internet
at the Office of the Federal Register
website at https://
www.federalregister.gov. Background
information and documents are
available at the Pacific Fishery
Management Council’s website at https://
www.pcouncil.org/.
SUPPLEMENTARY INFORMATION:
Background
The Pacific Coast Groundfish Fishery
Management Plan (PCGFMP) and its
implementing regulations at 50 CFR part
660, subparts C through G, regulate
fishing for over 90 species of groundfish
off the coasts of Washington, Oregon,
and California. The Pacific Fishery
Management Council (Council)
develops groundfish harvest
specifications and management
measures for two-year periods (i.e., a
biennium). NMFS published the final
rule to implement harvest specifications
and management measures for the
2019–2020 biennium for most species
managed under the PCGFMP on
December 12, 2018 (83 FR 63970).
PO 00000
Frm 00070
Fmt 4700
Sfmt 4700
Pacific Coast groundfish fisheries are
managed using harvest specifications or
limits (e.g., overfishing limits [OFL],
acceptable biological catch [ABC],
annual catch limits [ACL] and harvest
guidelines [HG]) based on the best
scientific information available at that
time (50 CFR 660.60(b)). The harvest
specifications and management
measures developed for the 2019–2020
biennium used data through the 2017
fishing year. In general, the management
measures (e.g., trip limits, area closures,
and bag limits) set at the start of the
biennial harvest specifications cycle
help catch in the various sectors of the
fishery reach, but not exceed, the limits
for each stock. The Council, in
coordination with Pacific Coast Treaty
Indian Tribes and the States of
Washington, Oregon, and California,
recommends adjustments to the
management measures during the
fishing year to achieve this goal. At its
September 11, and 14–18, 2020 webinar,
the Council recommended increasing
the limited entry fixed gear (LEFG) and
open access (OA) trip limits for
sablefish north of 36° North latitude (N
lat.) and increasing the incidental
landing limit for Pacific halibut in the
LEFG primary sablefish fishery. Each of
the adjustments discussed below are
based on updated fisheries information
that was unavailable when the Council
completed the initial analysis for the
current harvest specifications.
Since spring 2020, declines in Asian
markets and restrictions for domestic
restaurants, among other factors, have
led to a decline in markets and therefore
an overall decline in fishing effort. The
combination of these factors has
resulted in estimated year-end catches
that are lower than was anticipated
under normal market conditions. The
following changes were requested by
industry to increase access to available
harvestable quotas for sablefish and
incidentally caught Pacific halibut.
Increases to Limited Entry Fixed Gear
and Open Access Trip Limits for
Sablefish
Sablefish is an important commercial
species on the west coast with vessels
targeting sablefish using both trawl and
fixed gear (longlines and pots/traps).
Sablefish is managed with a coast-wide
ACL that is apportioned north and south
of 36° N lat. with 73.8 percent going to
the north and 26.2 percent going to the
south. In 2020, the portion of the ACL
for sablefish north of 36° N lat. is 5,723
mt with a commercial HG of 5,113 mt.
The commercial HG north of 36° N lat.
is further divided between the limited
entry and OA sectors with 90.6 percent,
or 4,632 mt, going to the limited entry
E:\FR\FM\19OCR1.SGM
19OCR1
]]>Agencies
[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Rules and Regulations]
[Pages 66266-66270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20665]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
48 CFR Part 1503 and 1552
[EPA-HQ-OARM-2015-0657; FRL-10012-65-OMS]
Environmental Protection Agency Acquisition Regulation (EPAAR);
Scientific Integrity
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is issuing a final
rule to address scientific integrity requirements in the creation of a
contract clause for inclusion in solicitations and contracts when the
Contractor may be required to perform, communicate, or supervise
scientific activities or use scientific information to perform advisory
and assistance services. This clause will complement the EPA's
Scientific Integrity Policy to ensure all scientific work developed and
used by the Government is accomplished with scientific integrity.
DATES: This final rule is effective on October 19, 2020.
ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OARM-2015-0657; FRL-10012-65-OMS. All documents in
the docket are listed on the https://www.regulations.gov website.
Although listed in the index, some information is not publicly
available, e.g., confidential business information or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Holly Hubbell, Policy, Training, and
Oversight Division, Acquisition Policy and Training Branch (3802R),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number: 202-564-1091; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The EPA's Scientific Integrity Policy is based on a Presidential
Memorandum for the Heads of Executive Departments and Agencies, Subject
Line: Scientific Integrity, Dated: March 9, 2009. The memorandum
directs the Director of the Office of Science and Technology Policy
(OSTP) to work with the Office of Management and Budget (OMB) and
agencies to develop policies to ensure all scientific work developed
and used by the Government is done so with scientific integrity. OSTP
issued further guidance in the Scientific Integrity memorandum dated
December 17, 2010.
This final rule requires EPA contractors to ensure that all
personnel within their organization, subcontractors and consultants,
that perform, communicate, or supervise scientific activities or use
scientific information to perform advisory and assistance services
under their specified contracts with EPA, have read and understand
their compliance responsibilities regarding the EPA's Scientific
Integrity Policy.
The proposed rule was published in the Federal Register (83 FR
48581-48584) on September 26, 2018, providing for a 60-day comment
period. Interested parties were afforded the opportunity to participate
in the making of this rule.
II. Public Comments on the Proposed Rule
The following is a summary of the public comments received on the
proposed rule and the EPA's response to these comments.
1. Comment: Several commenters expressed concerns about the costs
of making scientific information available online and also that
requiring scientific information to be available online could
compromise confidentiality of the scientific information.
Response: The proposed clause requirement at EPAAR Sec. 1552.203-
72(c)(1)(x) to make scientific information available online has been
deleted.
2. Comment: One commenter suggested that the EPA inform contractors
of their need to evaluate computer models in adherence to the EPA
Models Guidance.
Response: This requirement is described in general terms because
listing specific guidance may not be all-inclusive or the guidance may
change in the future.
3. Comment: One commenter noted that preventing intimidation or
coercion of scientists to alter their scientific findings is a crucial
element of the EPA's Scientific Integrity Policy and proposed adding
the terms ``attempted or actual intimidation or coercion'' to the
clause to clarify that both attempted or actual intimidation or
coercion would be a loss of scientific integrity.
Response: The EPA agrees and has added the terms ``attempted or
actual'', defining intimidation or coercion to EPAAR 1552.203-
72(c)(2)(i).
4. Comment: One commenter expressed concern that the proposed rule
does not explicitly address whether an individual employee of a
contractor has an obligation to report loss or potential loss of
scientific integrity to the contracting officer, his or her supervisor,
or both, or to whom and how to report.
Response: In this final rule, the EPA does clarify in paragraph (d)
of the clause that an employee of the contractor must report any loss
or potential loss of scientific integrity in writing to the contractor
who must communicate it to the EPA.
5. Comment: Concern was expressed that there is no explicit
mechanism for resolving a dispute if the contractor, or an individual
contractor employee, feels that the contracting officer has reached an
incorrect conclusion or is applying an inappropriate remedy with regard
to a loss of scientific integrity.
Response: The EPA agrees that a party who has been accused of a
loss of scientific integrity should be able to respond to the Agency's
decision regarding the loss of scientific integrity and the remedy.
Section (e)(5) of the clause has been edited to state that if the party
who has been accused of a loss of scientific integrity feels that the
Agency has reached an incorrect conclusion or the Agency has applied an
inappropriate remedy, that party may provide a written response to the
Contracting Officer, Scientific Integrity Official, and/or Office of
Inspector General (OIG).
6. Comment: One commenter noted that it was not clear if the
proposed rule intended to cover a situation where a contractor, or
employee of a contractor, became aware of a loss or suspected loss of
scientific integrity by an EPA employee, but suggested the rule should
cover this situation. Further, the commenter suggested such a loss or
suspected loss of scientific integrity by an EPA employee be reported
to someone other than the contracting officer or the contracting
officer's representative.
[[Page 66267]]
Response: EPA agrees and has revised paragraph (d) of the clause to
clarify that the final rule addresses the situation where a contractor,
or employee of a contractor, becomes aware of an actual or suspected
loss of scientific integrity by an EPA employee. Language has been
added to state that, if the actual or potential loss of scientific
integrity is by an EPA employee, the contractor may inform the EPA's
Scientific Integrity Official in addition to the contracting officer or
contracting officer's representative. An employee of the contractor
must report any actual or potential loss of scientific integrity to the
contractor who must communicate it to the EPA.
7. Comment: One commenter stated that the two clauses need to be
further emphasized to prevent bias during scientific inquiry.
Response: To clarify, there is only one clause, EPAAR Sec.
1552.203-72. EPAAR Sec. 1503.1071 is the prescription for the use of
the clause. The EPA believes that there is sufficient emphasis in the
clause requirements to prevent bias during scientific inquiries.
Additionally, contractors are legally bound to adhere to all terms of
the clause, if it is included in their contract(s).
8. Comment: One commenter noted that the proposed rule requires EPA
contractors to adhere to the standards set forth in the EPA's
Scientific Integrity Policy, but the commenter was concerned that
contractors cannot comply with standards if they don't know about them.
The commenter suggested additional language be added to the clause
noting all the guidance upon which the EPA's Scientific Integrity
Policy is built.
Response: The EPA believes such additional language is not
necessary. Contractors are notified of the scientific integrity
requirements, which includes a link to the EPA's Scientific Integrity
Policy, when this clause is included in the solicitation and contract.
9. Comment: One commenter suggested that the rule should be
designated as ``significant'' under Executive Order (E.O.) 12866, as
other agencies may not require contractor compliance with the EPA's
Scientific Integrity Policy, which could create serious inconsistencies
when the EPA is working with the other agencies on matters of interest
to both agencies. The commenter was also concerned that contractor
adherence to the EPA's Scientific Integrity Policy could also raise
legal or policy issues arising out of legal mandates, the President's
priorities, or E.O. 12866.
Response: The Office of Management and Budget determines if a rule
is a significant regulatory action. The EPA's Scientific Integrity
Policy is based on OSTP guidance and developed in conjunction with
OMB's approval.
10. Comment: One commenter expressed concern that the proposed rule
provides that it is the contracting officer who decides when the
Scientific Integrity clause applies and when it should be inserted in a
contract. The commenter was concerned that while some examples of
activities that may trigger the rule's application are listed in the
clause, the list of examples is not exhaustive, and the applicability
may be misinterpreted by the contractor officer.
Response: The EPA agrees that the technical experts regarding
applicability would be the EPA program office. Therefore, this final
rule adds language so the contracting officer will consult with the
program office regarding inclusion of the Scientific Integrity clause
in a contract.
11. Comment: One commenter proposed adding language requiring
contractors to use the most refined species location maps and best
actual sampling and test data available.
Response: The EPA believes this language is redundant to what is
already stated in the clause Sec. 1552.203-72(c)(1)(i), which states
the contractor agrees to produce scientific products of the highest
quality, rigor and objectivity.
12. Comment: Several respondents that provided comments expressed
their support of the scientific integrity requirement for contractors.
Response: EPA appreciates the support of the respondents.
III. Final Rule
The final rule amends FAR Part 1503--Improper Business Practices
and Personal Conflicts of Interests, Subpart 1503.10--Contractor Code
of Business Ethics and Conduct, by adding EPAAR Sec. 1503.1070--
Scientific integrity and 1503.1071--Contract clause. FAR Part 1552--
Solicitation Provisions and Contract Clauses is amended by adding EPAAR
clause Sec. 1552.203-72--Scientific Integrity.
1. EPAAR Sec. 1503.1070 explains the basis for the subsection.
2. EPAAR Sec. 1503.1071 establishes the prescription for use of
EPAAR clause Sec. 1552.203-72 in all solicitations and contracts when
the contractor may be required to perform, communicate, or supervise
scientific activities, or use scientific information to perform
advisory and assistance services.
3. EPAAR Sec. 1552.203-72--Scientific Integrity clause states the
applicability, term definitions as used in this clause, compliance
requirements, reporting requirements, if an actual or suspected loss of
scientific integrity is detected, and potential remedies.
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 (E.O.) 12866 (58 FR 51735, October 4, 1993)
and is therefore not subject to review under the E.O.
B. Paperwork Reduction Act
This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b).
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.
The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute; unless the agency certifies that the rule
will not have a significant economic impact on a substantial number of
small entities. Small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impact of this final rule on small entities, ``small
entity'' is defined as: (1) A small business that meets the definition
of a small business found in the Small Business Act and codified at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; or (3) a small organization that is any
not-for-profit enterprise which is independently owned and operated and
is not dominant in its field. After considering the economic impacts of
this rule on small entities, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, because the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities'' 5
[[Page 66268]]
U.S.C. 503 and 604. Thus, an agency may certify that a rule will not
have a significant economic impact on a substantial number of small
entities if the rule relieves regulatory burden, or otherwise has a
positive economic effect on all the small entities subject to the rule.
This action establishes a new EPAAR clause that will not have a
significant economic impact on a substantial number of small entities.
We continue to be interested in the potential impacts of the rule on
small entities and welcome comments on issues related to such impacts.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L.
104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, Local, and Tribal
governments and the private sector. This rule contains no Federal
mandates (under the regulatory provisions of the Title II of the UMRA)
for State, Local, and Tribal governments or the private sector. The
rule imposes no enforceable duty on any State, Local or Tribal
governments or the private sector. Thus, the rule is not subject to the
requirements of sections 202 and 205 of the UMRA.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and Local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that 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.'' This rule
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
Executive Order 13175, entitled ``Consultation and Coordination
With Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This rule does not have
tribal implications as specified in Executive Order 13175.
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
Executive Order 13045, entitled ``Protection of Children From
Environmental Health and Safety Risks'' (62 FR 19885, April 23, 1997),
applies to any rule that: (1) Is determined to be economically
significant as defined under E.O. 12886, and (2) concerns an
environmental health or safety risk that may have a proportionate
effect on children. This rule is not subject to E.O. 13045 because it
is not an economically significant rule as defined by Executive Order
12866, and because it does not involve decisions on environmental
health or safety risks.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This action is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution or Use'' (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)
Section 12(d) (15 U.S.C. 272 note) of the National Technology
Transfer and Advancement Act of 1995, Public Law 104-113, directs EPA
to use voluntary consensus standards in its regulatory activities
unless to do so would be inconsistent with applicable law or otherwise
impractical. Voluntary consensus standards are technical standards
(e.g., materials specifications, test methods, sampling procedures and
business practices) that are developed or adopted by voluntary
consensus standards bodies. The NTTAA directs EPA to provide Congress,
through OMB, explanations when the Agency decides not to use available
and applicable voluntary consensus standards. This action does not
involve technical standards. Therefore, EPA is not considering the use
of any voluntary consensus standards.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. EPA has determined that this proposed
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 in 48 CFR Parts 1503 and 1552
Environmental protection, Government procurement, Antitrust,
Conflict of interest, Reporting and recordkeeping requirements.
Kimberly Patrick,
Director, Office of Acquisition Solutions.
For the reasons stated in the preamble, EPA amends 49 CFR parts
1503 and 1552 as follows:
PART 1503--IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF
INTERESTS
0
1. The authority citation for part 1503 is revised to read as follows:
Authority: 5 U.S.C. 301 and 41 U.S.C. 1707.
0
2. Add section 1503.1070 to read as follows:
1503.1070 Scientific integrity.
The EPA's Scientific Integrity Policy is based on a Presidential
Memorandum for the Heads of Executive Departments and Agencies, Subject
Line: Scientific Integrity, Dated: March 9, 2009. The memorandum
directs the Director of the Office of Science and Technology Policy
(OSTP) to work with the Office of Management and Budget (OMB) and
agencies to develop policies to ensure all scientific work developed
and used by the Government is done with scientific integrity. OSTP
issued further guidance in the Scientific Integrity memorandum dated
December 17, 2010.
[[Page 66269]]
This section and clause complement the EPA's Scientific Integrity
Policy.
0
3. Add section 1503.1071 to read as follows:
1503.1071 Contract clause.
Contracting Officers, with advisement from the program office, must
insert the contract clause at 1552.203-72--Scientific Integrity, in
solicitations and contracts when the Contractor may be required to
perform, communicate, or supervise scientific activities, or use
scientific information to perform advisory and assistance services.
Examples of such scientific activities include, but are not limited to,
computer modeling, economic analysis, field sampling, laboratory
experimentation, demonstrating new technology, statistical analysis,
and writing a review article on a scientific issue.
PART 1552--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
0
4. The authority citation for part 1552 is revised to read as follows:
Authority: 5 U.S.C. 301 and 41 U.S.C. 1707.
0
5. Add section 1552.203-72 to read as follows:
1552.203-72 Scientific integrity.
As prescribed in Sec. 1503.1071, insert the following clause:
Scientific Integrity (Month Year)
(a) Applicability. This contract will require the Contractor to
perform, communicate, or supervise scientific activities or use
scientific information to perform advisory and assistance services.
When performing, communicating, supervising, or utilizing scientific
activities or scientific information, the Contractor must adhere to
the EPA's Scientific Integrity Policy.
(b) Definitions. The following definitions apply:
Advisory and assistance services (see 48 CFR 2.101).
Scientific activities means those activities leading to the
systematic knowledge of the physical or material world, largely
consisting of observation and experimentation. It also includes the
supervision, utilization, and communication of these activities.
Scientific information means factual inputs, data, models,
analyses, technical information, or scientific assessments related
to such disciplines as the behavioral and social sciences, public
health and medical sciences, life and earth sciences, engineering,
or physical sciences. This includes any communication or
representation of knowledge, such as facts or data, in any medium or
form, including textual, numerical, graphic, cartographic,
narrative, or audiovisual forms. This definition includes
information that an agency disseminates from a web page but does not
include the provision of hyperlinks on a web page to information
that others disseminate. This definition excludes opinions, where
the agency's presentation makes clear that an individual's opinion,
rather than a statement of fact or of the agency's findings and
conclusions, is being offered.
Scientific Integrity means the adherence to professional values
and practices, that is, the codes of ethics and behaviors in the
scientists' fields of study, when conducting, supervising,
communicating, and utilizing the results of science and scholarship.
It ensures objectivity, clarity, reproducibility, and utility. It
also provides insulation from bias, fabrication, falsification,
plagiarism, improper outside interference, and censorship.
(c) Compliance with policy. Prior to beginning performance under
this contract, the Contractor must ensure that all personnel within
their organization, including subcontractors and consultants, that
perform, communicate, or supervise scientific activities, or use
scientific information to perform advisory and assistance services
under this contract, have read and understand their compliance
responsibilities with the EPA's Scientific Integrity Policy. This
requirement applies to any personnel that will supervise, conduct,
utilize, or communicate scientific activities or scientific
information. Examples of such scientific activities include, but are
not limited to, computer modeling, economic analysis, field
sampling, laboratory experimentation, demonstrating new technology,
statistical analysis, and writing a review article on a scientific
issue.
(1) Consistent with the objective of promoting a culture of
scientific integrity and transparency, as discussed in the EPA's
Scientific Integrity Policy, the Contractor agrees to:
(i) Produce scientific products of the highest quality, rigor,
and objectivity, by adhering to applicable EPA information quality
policy, quality assurance policy, and peer review policy;
(ii) Prohibit suppressing, altering, or otherwise impeding the
timely release of scientific findings or conclusions;
(iii) Adhere to the Peer Review Handbook, current edition, for
the peer review of scientific and technical work products generated
through this contract;
(iv) Act honestly and refrain from acts of research misconduct,
including publication or reporting, as described in EPA Order 3120.5
Policy and Procedures for Addressing Research Misconduct. Research
misconduct does not include honest error or differences of opinion;
(v) Require that reviews of the content of a scientific product
be based only on scientific quality considerations, e.g., the
methods used are clear and appropriate, the presentation of results
and conclusions is impartial;
(vi) Ensure scientific findings are generated and disseminated
in a timely and transparent manner, including scientific research
performed by subcontractors and consultants who assist with
developing or applying the results of scientific activities;
(vii) Include an explication of underlying assumptions, accurate
contextualization of uncertainties, and a description of the
probabilities associated with both optimistic and pessimistic
projections when communicating scientific findings, if applicable;
(viii) Document the use of independent validation of scientific
methods; and
(ix) Document any independent review of the Contractor's
scientific facilities and testing activities, as occurs with
accreditation by a nationally or internationally recognized
sanctioning body.
(2) To assure protection of Contractor staff supported by this
contract, consistent with the objectives described in the EPA's
Scientific Integrity Policy, the Contractor agrees to:
(i) Prohibit attempted or actual intimidation or coercion of
scientists to alter scientific data, findings, or professional
opinions or non-scientific influence of scientific advisory boards.
In addition, the Contractor agrees to inform its employees,
subcontractors, and consultants, including scientists and managers,
of their responsibility not to knowingly misrepresent, exaggerate,
or downplay areas of scientific uncertainty; and
(ii) Prohibit retaliation or other punitive actions toward
employees who uncover or report allegations of scientific and
research misconduct, or who express a differing scientific opinion.
The Contractor must afford employees who have allegedly engaged in
scientific or research misconduct the due process protections
provided by law, regulation, and applicable collective bargaining
agreements, prior to any action. The Contractor must ensure that all
employees, subcontractors, and consultants are familiar with these
protections and avoid the appearance of retaliatory actions.
(d) Loss of Scientific Integrity. If during performance of this
contract the Contractor becomes aware of an actual or suspected loss
of scientific integrity, the Contractor must immediately inform the
Contracting Officer and the Contracting Officer's Representative
with a description of the actual or suspected issue in writing. If
the actual or suspected loss of scientific integrity is by an EPA
employee, the Contractor may inform the Agency's Scientific
Integrity Official, in addition to the Contracting Officer and
Contracting Officer's Representative. The Contractor must ensure
that its employees are aware of their responsibility to immediately
report any actual or suspected loss of scientific integrity to the
Contractor, who must communicate it to the EPA in writing. The
Contracting Officer and the Contracting Officer's Representative
must consult with the Agency's Scientific Integrity Official on all
issues related to an actual or suspected loss of scientific
integrity under this contract and with the EPA Office of Inspector
General (OIG), in accordance with EPA Order 3120.5 Policy and
Procedures for Addressing Research Misconduct, on all issues related
to research misconduct. The Agency's Scientific Integrity Official
and/or OIG must advise the Contracting Officer and Contracting
Officer's Representative on the appropriate remedy for any actual or
suspected loss of scientific
[[Page 66270]]
integrity. The Contractor bears the primary responsibility for
prevention and detection of research misconduct and for the inquiry,
investigation, and adjudication of research misconduct alleged to
have occurred under the contract in association with its own
institution. However, the EPA retains the ultimate oversight
authority for the EPA-supported research. The Contractor must take
the actions required as described in EPA Order 3120.5 Policy and
Procedures for Addressing Research Misconduct when research
misconduct is suspected or found under its contract.
(e) Remedies. The Contracting Officer in consultation with the
Scientific Integrity Official and OIG, if applicable, will make the
final determination on any remedy to an actual or suspected loss of
scientific integrity. Potential remedies include:
(1) Acceptance of the Contractor's proposed mitigation plan to
the scientific integrity issue;
(2) Acceptance of an alternate mitigation plan negotiated by the
parties listed in the first paragraph of this section;
(3) Termination for convenience, in whole or in part, if no
mitigation plan will adequately resolve the actual or suspected loss
of scientific integrity; or
(4) Termination for default or cause, in whole or in part, if
the Contractor was aware of an actual or suspected loss of
scientific integrity under this contract and did not disclose it or
misrepresented relevant information to the EPA. Additionally, the
Government may debar or suspend the Contractor from Government
contracting or pursue other remedies as may be permitted by law or
this contract.
(5) Opportunity to Respond--If the party who has been accused of
a loss of scientific integrity feels that the Agency has reached an
incorrect conclusion or the Contracting Officer has applied an
inappropriate remedy, the party may provide a written response to
the Contracting Officer, Scientific Integrity Official, and/or OIG.
(f) Subcontractors and Consultants. The Contractor agrees to
insert language in any subcontract or consultant agreement placed
hereunder which must conform substantially to the language of this
clause, including this paragraph (f), unless otherwise authorized in
advance in writing by the Contracting Officer.
(g) Additional Resources. For more information about the EPA's
Scientific Integrity Policy, an introductory video can be accessed
at: https://youtu.be/FQJCy8BXXq8. A training video is available at:
https://youtu.be/Zc0T7fooot8.
(End of clause)
[FR Doc. 2020-20665 Filed 10-16-20; 8:45 am]
BILLING CODE 6560-50-P
