83 FR 48581 - Environmental Protection Agency Acquisition Regulation (EPAAR); Scientific Integrity
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 187 (September 26, 2018)
Federal Register Volume 83, Issue 187 (September 26, 2018)
| Page Range | 48581-48584 | |
| FR Document | 2018-20857 |
[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
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Minnesota requesters) and for additional requirements in the creation of a addition to one complete version of the
public hearing locations are denied. contract clause for inclusion in comment that includes information
Automakers will need maximum lead solicitations and contracts when the claimed as CBI, a copy of the comment
time to respond to the final rule, and contractor may be required to perform, that does not contain the information
extending the comment period and communicate, or supervise scientific claimed as CBI must be submitted for
holding additional public hearings activities or use scientific information to inclusion in the public docket.
(which would also cause the comment perform advisory and assistance Information so marked will not be
period to be extended) are inconsistent services. This clause will complement disclosed except in accordance with
with provision of maximum lead time. the EPA scientific integrity policy to procedures set forth in 40 CFR part 2.
We recognize, however, that the original ensure all scientific work developed and 2. Tips for Preparing Your Comments.
schedule for the proposed rule public used by the Government is When submitting comments, remember
comment period did not reflect the accomplished with scientific integrity. to:
Clean Air Act requirement that the DATES: Comments must be received on • Identify the rulemaking by docket
record of proceedings allowing oral or before November 26, 2018. number and other identifying
presentation of data, views, and ADDRESSES: Submit your comments, information (subject heading, Federal
arguments on a proposed rule be kept identified by Docket ID No. EPA–HQ– Register date and page number).
open for thirty days after completion of OARM–2015–0657; FRL–9936–63– • Follow directions—The Agency
the proceeding to provide an OARM, at https://www.regulations.gov. may ask you to respond to specific
opportunity for submission of rebuttal Follow the online instructions for questions or organize comments by
and supplementary information. 42 submitting comments. Once submitted, referencing a Code of Federal
U.S.C. 7607(d)(5). Because the final comments cannot be edited or removed Regulations (CFR) Part or section
‘‘proceeding allowing oral presentation from Regulations.gov. The EPA may number.
of data, views, and arguments,’’ is publish any comment received to its
• Explain why you agree or disagree,
expected to be the September 26, 2018 public docket. Do not submit
suggest alternatives, and substitute
public hearing in Pittsburgh, electronically any information you
language for your requested changes.
Pennsylvania, the comment period for consider to be Confidential Business
the proposed rule is being extended by Information (CBI) or other information • Describe any assumptions and
3 days to Friday, October 26, 2018. To whose disclosure is restricted by statute. provide any technical information
provide additional flexibility to Multimedia submissions (audio, video, and/or data that you used.
commenters, NHTSA is also extending etc.) must be accompanied by a written • If you estimate potential costs or
the public comment period for the DEIS comment. The written comment is burdens, explain how you arrived at
by 32 days to Friday, October 26, 2018. considered the official comment and your estimate in sufficient detail to
The agencies believe that this amount of should include discussion of all points allow for it to be reproduced.
time should be adequate for commenters you wish to make. The EPA will • Provide specific examples to
to comment meaningfully on the generally not consider comments or illustrate your concerns, and suggest
proposal and on NHTSA’s DEIS. comment contents located outside of the alternatives.
Issued on September 21, 2018 in primary submission (i.e. on the web, • Explain your views as clearly as
Washington, DC, under authority delegated cloud, or other file sharing system). For possible, avoiding the use of profanity
in 49 CFR 1.95 and 501.5 additional submission methods, the full or personal threats.
Heidi R. King, EPA public comment policy, • Make sure to submit your
Deputy Administrator, National Highway information about CBI or multimedia comments by the comment period
Traffic Safety Administration. submissions, and general guidance on deadline identified.
Dated: September 21, 2018. making effective comments, please visit:
http://www2.epa.gov/dockets/ II. Background
William L. Wehrum,
commenting-epa-dockets. The Agency’s policy on scientific
Assistant Administrator for Air and
Radiation, Environmental Protection Agency. FOR FURTHER INFORMATION CONTACT: integrity was based on a Presidential
[FR Doc. 2018–20962 Filed 9–21–18; 4:15 pm]
Holly Hubbell, Policy, Training, and Memorandum for the Heads of
Oversight Division, Acquisition Policy Executive Departments and Agencies,
BILLING CODE 4910–59–P
and Training Service Center (3802R), Subject Line: Scientific Integrity, Dated:
Environmental Protection Agency, 1200 March 9, 2009. The memo directs the
Pennsylvania Ave. NW, Washington, DC Director of the Office of Science and
ENVIRONMENTAL PROTECTION 20460; telephone number: 202–564– Technology Policy (OSTP) to work with
AGENCY 1091; email address: hubbell.holly@ the Office of Management and Budget
48 CFR Parts 1503 and 1552 epa.gov. (OMB) and agencies to develop policies
SUPPLEMENTARY INFORMATION: to ensure all scientific work developed
[EPA–HQ–OARM–2015–0657; FRL–9936– and used by the Government is done so
63–OARM] I. General Information with scientific integrity. This proposed
1. Submitting Classified Business rule requires the Contractor to ensure
Environmental Protection Agency
Information. Do not submit CBI to EPA that all personnel within its
Acquisition Regulation (EPAAR);
website https://www.regulations.gov or organization, subcontractors and
Scientific Integrity
daltland on DSKBBV9HB2PROD with PROPOSALS
email. Clearly mark the part or all of the consultants, that perform, communicate,
AGENCY: Environmental Protection information that you claim to be CBI. or supervise scientific activities or use
Agency (EPA). For CBI information in a disk or CD– scientific information to perform
ACTION: Proposed rule. ROM that you mail to EPA, mark the advisory and assistance services under
outside of the disk or CD–ROM as CBI, the specified contract, have read and
SUMMARY: The Environmental Protection and then identify electronically within understand their compliance
Agency (EPA) is issuing a proposed rule the disk or CD–ROM the specific responsibilities regarding the EPA’s
to address scientific integrity information that is claimed as CBI. In Scientific Integrity Policy.
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communicate, or supervise scientific and pessimistic projections when Contracting Officer’s Representative on the
activities, or use scientific information to communicating scientific findings, if appropriate remedy for any actual or
perform advisory and assistance services applicable; potential loss of scientific integrity. The
under this contract, have read and (viii) Document the use of independent Contractor bears the primary responsibility
understand their compliance responsibilities validation of scientific methods; for prevention and detection of research
with EPA’s Scientific Integrity Policy. This (ix) Document any independent review of misconduct and for the inquiry,
requirement applies to any personnel that the Contractor’s scientific facilities and investigation, and adjudication of research
will supervise, conduct, utilize, or testing activities, as occurs with accreditation misconduct alleged to have occurred in
communicate scientific activities or scientific by a nationally or internationally recognized association with its own institution.
information. Examples of such scientific sanctioning body; and However, EPA retains the ultimate oversight
activities include, but are not limited to, (x) Make scientific information available authority for EPA-supported research. The
computer modelling, economic analysis, field online in open formats in a timely manner, Contractor shall take the actions required as
sampling, laboratory experimentation, including access to data and non-proprietary described in EPA Order 3120.5 Policy and
demonstrating new technology, statistical models. Procedures for Addressing Research
analysis, and writing a review article on a (2) To assure protection of staff supported Misconduct when research misconduct is
scientific issue. by this contract, consistent with the suspected or found.
(1) Consistent with the objective of objectives described in the Scientific (f) Remedies. The Contracting Officer will
promoting a culture of scientific integrity and Integrity Policy, the Contractor agrees to: make the final decision on any remedy to an
transparency, as discussed in EPA’s (i) Prohibit intimidation or coercion of actual or potential loss of scientific integrity.
Scientific Integrity Policy, the Contractor scientists to alter scientific data, findings, or Potential remedies include:
agrees to: professional opinions or non-scientific (1) Acceptance of the Contractor’s
(i) Produce scientific products of the influence of scientific advisory boards. In proposed mitigation plan to the scientific
highest quality, rigor, and objectivity, by addition, employees, subcontractors, and integrity issue;
adhering to applicable EPA information consultants, including scientists, managers, (2) Acceptance of an alternate mitigation
quality policy, quality assurance policy, and and other leadership, shall not knowingly plan negotiated by the parties;
peer review policy; misrepresent, exaggerate, or downplay areas (3) Termination for convenience, in whole
(ii) Prohibit the suppression, alteration, or of scientific uncertainty; and or in part, if no mitigation plan will
otherwise impede the timely release of (ii) Prohibit retaliation or other punitive adequately resolve the actual or potential loss
scientific findings or conclusions; actions toward employees who uncover or of scientific integrity; or
(iii) Adhere to the Peer Review Handbook, report allegations of scientific and research (4) Termination for default or cause, in
current edition, for the peer review of misconduct, or who express a differing whole or in part, if the Contractor was aware
scientific and technical work products scientific opinion. Employees who have of an actual or potential loss of scientific
generated through this contract; allegedly engaged in scientific or research integrity under this contract and did not
(iv) Act honestly and refrain from acts of misconduct shall be afforded the due process disclose it or misrepresented relevant
research misconduct, including publication protections provided by law, regulation, and information to the Contracting Officer.
or reporting, as described in EPA Order applicable collective bargaining agreements, Additionally, the Government may debar the
3120.5 Policy and Procedures for Addressing prior to any action. The Contractor shall Contractor from Government contracting, or
Research Misconduct. Research misconduct ensure that all employees, subcontractors, pursue other remedies as may be permitted
does not include honest error or differences and consultants shall be familiar with these by law or this contract.
of opinion; protections and avoid the appearance of (g) Subcontractors and Consultants. The
(v) Require that reviews of the content of retaliatory actions. Contractor agrees to insert in any subcontract
a scientific product be based only on (e) Loss of scientific integrity. If during or consultant agreement placed hereunder
scientific quality considerations, e.g., the performance of this contract the Contractor which shall conform substantially to the
methods used are clear and appropriate, the becomes aware of an actual or potential loss language of this clause, including this
presentation of results and conclusions is of scientific integrity, the Contractor shall paragraph (g), unless otherwise authorized by
impartial; immediately inform the Contracting Officer the Contracting Officer.
(vi) Ensure scientific findings are generated and Contracting Officer’s Representative with (h) Additional resources. For more
and disseminated in a timely and transparent a description of the issue and any corrective information about the Scientific Integrity
manner, including scientific research action the contractor will take to mitigate the Policy, an introductory video can be accessed
performed by subcontractors and consultants issue. The Contracting Officer and at: https://youtu.be/FQJCy8BXXq8. A training
who assist with developing or applying the Contracting Officer’s Representative will video is available at: https://youtu.be/
results of scientific activities; consult with the Agency’s Scientific Integrity Zc0T7fooot8.
(vii) Include an explication of underlying Official on all issues related to the loss of (End of clause)
assumptions, accurate contextualization of scientific integrity under this contract. The
uncertainties, and a description of the Agency’s Scientific Integrity Official will [FR Doc. 2018–20857 Filed 9–25–18; 8:45 am]
probabilities associated with both optimistic advise the Contracting Officer and BILLING CODE 6560–50–P
daltland on DSKBBV9HB2PROD with PROPOSALS
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Document Created: 2018-09-26 00:47:07
Document Modified: 2018-09-26 00:47:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Comments must be received on or before November 26, 2018. | |
| Contact | Holly Hubbell, Policy, Training, and Oversight Division, Acquisition Policy and Training Service Center (3802R), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, | |
| FR Citation | 83 FR 48581 | |
| CFR Citation | 48
CFR
1503 48 CFR 1552 | |
| CFR Associated | Environmental Protection and Government Procurement |
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