ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 124, Subpart H 
[EPA-HQ-XXX-XXX-XXXX; FRL-XXXX-XX]
RIN XXXX-XXXX
Strengthening Transparency and Validity in Regulatory Science 
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
SUMMARY: This notice proposes a regulation intended to strengthen the transparency and validity of EPA regulatory science. The proposed regulation provides that EPA shall ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation. When EPA develops regulations, including regulations for which the public is likely to bear the cost to comply, using public resources, EPA should require that the underlying scientific information is available to the public. In this notice, EPA solicits comment on this proposal and how it can best be promulgated and implemented in light of existing law and prior policies calling for increasing public access to data and influential scientific information used to inform federal regulation.   
DATES: Comments must be received on or before [Insert date 30 days after publication date].
ADDRESSES: Submit your comments, identified by Docket ID No. EPA - HQ - XXXX - XXXX, at http:// www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. 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. 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: EPA, Office of the Science Advisor, 1200 Pennsylvania Avenue NW, Washington, DC 20460. 
SUPPLEMENTARY INFORMATION: 
Submitting CBI. Do not submit information that you consider to be CBI electronically through http://www.regulations.gov or email. Send or deliver information identified as CBI to only the following address: OAQPS Document Control Officer (Room C404-02), Environmental Protection Agency, Research Triangle Park, North Carolina 27711; Attn: Docket ID No. EPA - HQ - OAR - 2017 - 0545. 

      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. If you submit a CD-ROM or disk that does not contain CBI, mark the outside of the disk or CD-ROM clearly that it does not contain CBI. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2. 
	
Organization of This Document. The following outline is provided to aid in locating information in this preamble.

 General Information
 Does this Action Apply to Me?
 What action is the Agency taking?
 What is the Agency's Authority for taking this action?
 Background
 Request for Comment
 Statutory and Executive Orders
         
 General Information
       A.  Does this action apply to me?
 This proposed regulation does not directly regulate any entity outside the federal government. However, any entity interested in EPA's regulations may be interested in this proposal. This proposal may be of particular interest to entities that conduct research and other scientific activity that is likely to be relevant to EPA's regulatory activity.
      B.  What action is the agency taking?
This notice solicits information and comment from the public on a proposed regulation intended to issue to strengthen the transparency and validity of EPA regulatory science. The proposed regulation provides that EPA shall ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for validation. In this notice, EPA solicits comment on this proposal and how it can best be implemented in light of existing law and prior statements of policy that have called for increasing public access to data and influential scientific information used to inform federal regulation. EPA has not previously implemented these policies and guidance in a robust and consistent manner. This proposal will help ensure that EPA is pursuing its mission of protecting public health and the environment in a manner that the public can trust and understand. 
      
       C.  What is the agency's authority for taking this action?
The Agency proposes to take this action under its authority to promulgate regulations necessary to carry out the Agency's functions under the statutes it administers, including that provided under Clean Air Act § 301(a); Clean Water Act § 501; Safe Drinking Water Act § 1450(a)(1); Resource Conservation and Recovery Act § 2002(a)(1); Comprehensive Environmental Response, Compensation, and Liability Act § 115, as delegated to the Administrator via Executive Order 12580; Emergency Planning and Community Right-To-Know Act § 328; Federal Insecticide, Fungicide, and Rodenticide Act § 25(a)(1); Toxic Substances Control Act, as amended, § 26(h). This action is consistent with requirements in the Administrative Procedure Act to ensure public participation in the rulemaking process.  As noted in Section III below, EPA solicits comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation. 

 Background 
Sound science must serve as the foundation of EPA's regulatory actions. Enhancing transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA's regulatory actions, and better informs the public about the science used in the regulatory process. EPA must apply the best available science to its regulatory decision-making in a way that complies with federal transparency and data integrity laws, and that ensures independence, objectivity, transparency, clarity, and reproducibility. Although these standards are important in all scientific endeavors, they are of paramount importance when the government relies on science to inform its regulatory decisions that will bind members of the public. When EPA develops regulations using public resources, including regulations for which the public is likely to bear the cost to comply, EPA should require that the underlying scientific information is available to the public. This proposed rule will ensure that there is transparency in the preparation, identification, and use of science in policymaking. 
This action follows basic principles of proper administration, including the requirements in the Administrative Procedure Act and programmatic statutes that EPA administers to disclose to the public the bases for agency rules and to rationally execute and adequately explain agency actions.  This proposed rule is also consistent with Executive Orders 13777 and 13783, and builds upon prior EPA actions, data access and sharing policies of other federal agencies, as well as policies or recommendations of third party organizations and major scientific journals. 
Today, EPA is proposing to establish a clear policy for transparency and validity of the scientific information used for regulation. With this notice, EPA is soliciting public comment on a proposed regulation designed to ensure all future EPA final agency actions are based on transparent, reproducible science. This proposed regulation is intended to provide a mechanism to increase access to EPA regulatory science while protecting sensitive information. This action will ensure that the best available science that provides the justification for regulation includes information that is truly available for validation. 
Regulatory determinations based on science should describe and document any assumptions and methods used, and should address variability, uncertainty, the degree of independent verification and peer review. EPA expects that regulatory decisions will be based on the weight of the publicly available scientific evidence and consider all information in a transparent and integrative framework. Particularly for EPA programs that evaluate information to determine whether a causal relationship exists between a pollutant/chemical and a specific effect, EPA should utilize a weight of evidence approach that considers and integrates all lines of evidence in a consistent manner and make determinations on the totality of the evidence. Where available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments. While the scientific community has identified some fundamental issues with peer review in recent years, EPA's regulatory science should be consistent with its 2015 Peer Review Handbook and the Office of Management and Budget's Final Information Quality Bulletin for Peer Review. 

EPA has not consistently followed previous EPA policy that encouraged the use of non-proprietary data and models.  EPA's regulatory science will be based on transparent data and model alternatives.
Transparency and validity in regulatory science addresses many potential issues for key studies, including identifying confounders and inconsistent findings in the data. Despite growing empirical evidence of non-linearity in the concentration-response function for specific pollutants and health effects, EPA has often based its assessments on a default model that assumes a linear, no-threshold dose response. To address these complex relationships, EPA should give greater weight to high quality studies that explore: a broad class of parametric concentration-response models with a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the exposure range; and geographic consistency that addresses spatial heterogeneity in many key studies. 

Across EPA programs, much of the science that informs regulatory actions is developed outside the Agency. In the era of "big data" as well as the "replication crisis" across scientific disciplines (in which a significant proportion of published research may be false or not reproducible), it is the charge of regulators to ensure that key findings are valid and credible. Using scientific information that can be independently validated will lead to better outcomes, and strengthen public confidence in the health and environmental protections underpinning EPA's regulatory actions. 
This proposed regulation is intended to apply prospectively to final agency actions. The Agency's offices should, however, be guided by this policy to the maximum extent practicable during ongoing regulatory action, even where such research has already been generated, solicited, or obtained. 
This action focuses on ensuring that the information used in regulation is publicly available in a manner sufficient for independent validation. These requirements are consistent with recent activities in the scientific community and reflect definitions of research reproducibility across scientific disciplines. Considering the breadth of scientific information used in various EPA programs, the requirements for availability may differ. These mechanisms may range from, consistent with requirements for many scientific journals, deposition in public data repositories to, for certain types of information, controlled-access in federal research data centers for secondary research use by the public.
Implementation of this proposed rule will be consistent with the definition of "research data" in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, exemptions in P.L. 89-487, and other applicable federal laws. EPA believes that concerns about access to confidential or private information are without merit. Nothing in the proposed rule compels the disclosure of any information. Other federal agencies have developed tools and methods to de-identify private information for a variety of disciplines. The National Academies have noted that simple data masking, coding, and de-identification techniques have been developed over the last half century and that "Nothing in the past suggests that increasing access to research data without damage to privacy and confidentiality rights is beyond scientific reach." 

 Request for Comment
EPA solicits comment on all aspects of the proposed regulation and the bases articulated for it above. Specifically, EPA believes that it has identified appropriate sources of statutory authority for this proposed regulation in Section I(c) above, and solicits public comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation. EPA further believes that a generally applicable regulatory provision of the type proposed here is the appropriate vehicle to establish and implement the policies articulated in Section II above, in the interests of consistency, predictability, and transparency across the functions that EPA performs. 
EPA solicits comment on whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles at the programmatic or statutory level would be appropriate as alternative or additional steps the agency may take to further the policies articulated in Section II above. 
EPA solicits comment on the effects of this proposed rule on individual EPA programs, including whether certain activities are appropriate to be excepted (§ 124.222) or if other requirements would affect implementation (§ 124.223). 
Although the proposed regulatory text (at proposed § 124.218) would impose requirements specifically on final agency action, EPA solicits comment on whether and to what extent these requirements, or other provisions and policies, should apply to other stages of the rulemaking process, including proposed rules, as well as to other types of agency actions and promulgations, such as guidance. EPA also solicits comments on whether and how EPA should apply these principles to EPA-funded science that does not provide the basis for regulation. EPA also solicits suggestions for a platform that would enable the Agency to implement this proposed regulation.
Furthermore, EPA seeks comment related to whether and how EPA, when utilizing a weight of evidence approach for regulatory determinations, whether and how EPA should give greater weight to scientific information that is more transparent and/or independently validated. EPA seeks comment on how to address a circumstance in which EPA has a statutory requirement to make a determination for which scientific information publicly available in a manner sufficient for independent validation does not exist. EPA also solicits comment on how EPA can build upon other federal agencies' policies regarding data access and data sharing in order to ensure consistency and confidentiality. 
 Statutory and Executive Orders Reviews 
A.	Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket. 
B.	Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs 
This action is not expected to be an Executive Order 13771 regulatory action because it relates to "agency organization, management or personnel."
C. Paperwork Reduction Act (PRA)
This action does not contain any information collection activities and therefore does not impose an information collection burden under the PRA. 
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. 
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531 - 1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
F. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
G.	Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
This action does not have tribal implications as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action. 
H.	Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks 
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of "covered regulatory action" in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
This action is not a "significant energy action" because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. 
J. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards. 
K.	Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard.
L. Congressional Review Act (CRA)
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 40 CFR Part 124: Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous waste, Indians-lands, Reporting and recordkeeping requirements, Water pollution control, Water supply.

Dated: __________________________________.



________________________________________



For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 124 [as follows:

PART 124 - PROCEDURES FOR DECISIONMAKING 

      Authority: The authority citation for Part 124 is amended to read as follows:
Resource Conservation and Recovery Act, 42 U.S.C. 6901 et seq.; Safe Drinking Water Act, 42 U.S.C. 300f et seq.; Clean Water Act, 33 U.S.C. 1251et seq.; Clean Air Act, 42 U.S.C. 7401et seq.; Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601 et seq.; Emergency Planning and Community Right-To-Know Act, 42 U.S.C. 11001 et seq.; Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq.; Toxic Substances Control Act, 15 U.S.C. 2601 et seq.

xx. Add subpart H, consisting of sections 124.215 through 124.223, to part 124 to read as follows:
Subpart H  -  Strengthening Transparency and Validity in Regulatory Science

Sec.

§ 124.215	What is the purpose of this subpart?
§ 124.216.	What definitions apply to this subpart?
§ 124.217.	How do the provisions of this subpart apply?
§ 124.218.	What requirements apply to EPA's use of studies in taking final action?
§ 124.219.	What requirements apply to EPA's regulatory determinations and decisions that 			are based on science?
§ 124.220.	How do requirements address use of certain EPA models and default assumptions?
§ 124.221.	What role does independent peer review play in EPA decision making?
§ 124.222.	How is EPA to account for cost under this subpart?
§ 124.223.	May EPA grant exceptions to this subpart?
§ 124.224.	What other requirements apply under this subpart?

Subpart H  -  Strengthening Transparency and Validity in Regulatory Science

§ 124.215.	What is the purpose of this subpart?
	
      This subpart directs EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation.

§ 124.216.	What definitions apply to this subpart?

	As used in this subpart, all terms not defined herein shall have the meaning given them in the Act or in subpart A; and the following terms shall have the specific meanings given them.

	Regulatory science means scientific information, including assessments, models, criteria documents, and regulatory impact analyses, that provide the basis for EPA final agency action.

	Research data means "research data" as that term is defined in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

§ 124.217.	How do the provisions of this subpart apply?

	The provisions of this section apply regardless of the source of funding or identity of the party conducting the regulatory science. The provisions of this section do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses.

§ 124.218.	What requirements apply to EPA's use of studies in taking final action?

	EPA shall clearly identify all studies (or other regulatory science) relied upon when it takes final agency action. The Agency shall ensure that the scientific and technical information supporting these studies will be publicly available in a manner sufficient for independent validation. Information "publicly available in a manner sufficient for independent validation" consists of information necessary for the public to understand, assess, and replicate findings. This includes, for example: data and associated protocols necessary to understand, assess, and extend conclusions; computer codes and models involved in the creation and analysis of such information; recorded factual materials; and detailed descriptions of how to access and use such information. The provisions of this section apply to regulatory science regardless of who funded or conducted the underlying research.

§ 124.219.	What requirements apply to EPA's regulatory determinations and decisions that are based on science?

	Regulatory determinations based on science should describe and document any assumptions and methods used, and should address variability, uncertainty, the degree of independent verification and peer review. EPA expects that regulatory decisions be based on the weight of the publicly available scientific evidence and consider all information in a transparent and integrative framework. Particularly for EPA programs that evaluate information to determine whether a causal relationship exists between a pollutant/chemical and a specific effect, EPA should utilize a weight of evidence approach that considers and integrates all lines of evidence in a consistent manner and make determinations on the totality of the evidence. Where available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments.

§ 124.220. 	How do requirements address use of certain EPA models and default assumptions?

      Transparency in regulatory science addresses issues associated with EPA's reliance on certain default models and assumptions, including the use of a default model that assumes a linear, no-threshold dose response despite growing empirical evidence of non-linearity in the concentration-response function for specific pollutants or chemicals and health effects. EPA shall give greater weight to high quality studies that explore: a broad class of parametric concentration-response models with a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the exposure range; and geographic consistency that addresses spatial heterogeneity in many key studies. 

§ 124.221.	What role does independent peer review play in EPA decision making?

	EPA shall conduct independent peer review on influential scientific information that Agency intends to disseminate to the public or use as the basis for regulation.

§ 124.222.	How is EPA to account for cost under this subpart?

	EPA shall implement the provisions of this subpart in a manner that minimizes costs.

§ 124.223.	May EPA grant exceptions to this subpart?

	Yes. The Administrator may grant exemptions to the provisions of this section on a case-by-case basis.

§ 124.224.	What other requirements apply under this subpart?

	EPA shall implement the provisions of this section consistent with the definition of "research data" in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, exemptions in P.L. 89-487, and other applicable federal laws. Where appropriate, data sharing agreements and state-of-the-art data-masking techniques may be employed to facilitate access to information. The provisions of this section do not create any right or benefit, substantive or procedural, enforceable at law or equity by a party against the United States, EPA, its officers or employees, or any other person.


