83 FR 48581 - Environmental Protection Agency Acquisition Regulation (EPAAR); Scientific Integrity

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 187 (September 26, 2018)

The Environmental Protection Agency (EPA) is issuing a proposed 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 scientific integrity policy to ensure all scientific work developed and used by the Government is accomplished with scientific integrity.

[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Proposed Rules]
[Pages 48581-48584]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20857]


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ENVIRONMENTAL PROTECTION AGENCY

48 CFR Parts 1503 and 1552

[EPA-HQ-OARM-2015-0657; FRL-9936-63-OARM]


Environmental Protection Agency Acquisition Regulation (EPAAR); 
Scientific Integrity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is issuing a 
proposed 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 scientific integrity policy to ensure all scientific work 
developed and used by the Government is accomplished with scientific 
integrity.

DATES: Comments must be received on or before November 26, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OARM-2015-0657; FRL-9936-63-OARM, at https://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, Acquisition Policy and Training Service Center 
(3802R), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460; telephone number: 202-564-1091; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

    1. Submitting Classified Business Information. Do not submit CBI to 
EPA website https://www.regulations.gov or 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.
    2. Tips for Preparing Your Comments. When submitting comments, 
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.
     Make sure to submit your comments by the comment period 
deadline identified.

II. Background

    The Agency's policy on scientific integrity was based on a 
Presidential Memorandum for the Heads of Executive Departments and 
Agencies, Subject Line: Scientific Integrity, Dated: March 9, 2009. The 
memo 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. This proposed rule requires the Contractor to ensure that 
all personnel within its organization, subcontractors and consultants, 
that perform, communicate, or supervise scientific activities or use 
scientific information to perform advisory and assistance services 
under the specified contract, have read and understand their compliance 
responsibilities regarding the EPA's Scientific Integrity Policy.

[[Page 48582]]

III. Proposed Rule

    The proposed 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 EPA Acquisition Regulation 
(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 1552.203-72--Scientific Integrity.
    1. EPAAR Sec.  1503.1070 explains the basis for the section.
    2. EPAAR Sec.  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 Sec.  1552.203-72--Scientific Integrity clause states the 
applicability, term definitions as used in this clause, compliance 
requirements, reporting requirements, if a 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 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 of 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, Public 
Law 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 environment 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

[[Page 48583]]

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

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a major rule may take effect, the agency 
promulgating the rule must submit a rule report, which includes a copy 
of the rule, to each House of the Congress and to the Comptroller 
General of the United States. Section 804(2) defines a ``major rule'' 
as any rule that the Administrator of the Office of Information and 
Regulatory Affairs of the Office of Management and Budget finds has 
resulted in or is likely to result in (1) an annual effect on the 
economy of $100,000,000 or more; (2) a major increase in costs or 
prices for consumers, individual industries, Federal, State, or local 
government agencies, or geographic regions; or (3) significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based enterprises to 
compete with foreign-based enterprises in domestic and export markets. 
EPA is not required to submit a rule report regarding this action under 
section 801 as this is not a major rule by definition.

List of Subjects in 48 CFR Parts 1503 and 1552

    Environmental protection, Government procurement.

    Dated: August 21, 2018.
Kimberly Patrick,
Director, Office of Acquisition Management.

    For the reasons stated in the preamble, 48 CFR parts 1503 and 1552 
are proposed to be amended as set forth below:

PART 1503--IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF 
INTERESTS

0
1. The authority citation for part 1503 continues to read as follows:

    Authority: 5 U.S.C. 301 and 41 U.S.C. 418b.

0
2. Add Sec.  1503.1070 to read as follows:


Sec.  1503.1070  Scientific integrity.

    The EPA's policy on scientific integrity was based on a 
Presidential Memorandum for the Heads of Executive Departments and 
Agencies, Subject Line: Scientific Integrity, Dated: March 9, 2009. The 
memo 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. 
This section and clause complement the EPA Scientific Integrity Policy.
0
3. Add Sec.  1503.1071 to read as follows:


Sec.  1503.1071   Contract clause.

    Contracting Officers shall 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 modelling, 
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 continues to read as follows:

    Authority: 5 U.S.C. 301 and 41 U.S.C. 418b.

0
5. Add Sec.  1552.203-72 to read as follows:


Sec.  1552.203-72  Scientific integrity.

    As prescribed in 1503.1071, insert the following clause:

Scientific Integrity (Date)

    (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 shall adhere to 
EPA's Scientific Integrity Policy.
    (b) Definitions. ``Advisory and assistance services'' (see FAR 
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 shall ensure that all personnel within 
their organization, including subcontractors and consultants, that 
perform,

[[Page 48584]]

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 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 
modelling, 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 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 the suppression, alteration, or otherwise impede 
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;
    (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; and
    (x) Make scientific information available online in open formats 
in a timely manner, including access to data and non-proprietary 
models.
    (2) To assure protection of staff supported by this contract, 
consistent with the objectives described in the Scientific Integrity 
Policy, the Contractor agrees to:
    (i) Prohibit intimidation or coercion of scientists to alter 
scientific data, findings, or professional opinions or non-
scientific influence of scientific advisory boards. In addition, 
employees, subcontractors, and consultants, including scientists, 
managers, and other leadership, shall not 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. 
Employees who have allegedly engaged in scientific or research 
misconduct shall be afforded the due process protections provided by 
law, regulation, and applicable collective bargaining agreements, 
prior to any action. The Contractor shall ensure that all employees, 
subcontractors, and consultants shall be familiar with these 
protections and avoid the appearance of retaliatory actions.
    (e) Loss of scientific integrity. If during performance of this 
contract the Contractor becomes aware of an actual or potential loss 
of scientific integrity, the Contractor shall immediately inform the 
Contracting Officer and Contracting Officer's Representative with a 
description of the issue and any corrective action the contractor 
will take to mitigate the issue. The Contracting Officer and 
Contracting Officer's Representative will consult with the Agency's 
Scientific Integrity Official on all issues related to the loss of 
scientific integrity under this contract. The Agency's Scientific 
Integrity Official will advise the Contracting Officer and 
Contracting Officer's Representative on the appropriate remedy for 
any actual or potential loss of scientific 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 in 
association with its own institution. However, EPA retains the 
ultimate oversight authority for EPA-supported research. The 
Contractor shall 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.
    (f) Remedies. The Contracting Officer will make the final 
decision on any remedy to an actual or potential 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;
    (3) Termination for convenience, in whole or in part, if no 
mitigation plan will adequately resolve the actual or potential 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 potential loss of 
scientific integrity under this contract and did not disclose it or 
misrepresented relevant information to the Contracting Officer. 
Additionally, the Government may debar the Contractor from 
Government contracting, or pursue other remedies as may be permitted 
by law or this contract.
    (g) Subcontractors and Consultants. The Contractor agrees to 
insert in any subcontract or consultant agreement placed hereunder 
which shall conform substantially to the language of this clause, 
including this paragraph (g), unless otherwise authorized by the 
Contracting Officer.
    (h) Additional resources. For more information about the 
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. 2018-20857 Filed 9-25-18; 8:45 am]
BILLING CODE 6560-50-P