The EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers. If implementing this procedural rule would result in conflicts with existing environmental statutes, and their implementing regulations, this rule will yield to the EPA statutes and regulations.
Comment: Commenter (12727) asserts that there are many circumstances under which EPA develops [Influential Scientific Information (ISI)] with broad applicability to multiple programs or varying governmental actions that have yet to be identified. The commenter provides that such products include IRIS chemical reviews by EPA's Office of Research and Development (ORD) (e.g., the 2019 "IRIS Toxicological Review of Ethyl Tertiary Butyl Ether (ETBE)" and "IRIS Toxicological Review of Tert-Butyl Alcohol (TBA)"), and reports by EPA's Office of Chemical Safety and Pollution Prevention (e.g., "Continuing Development of Alternative High- Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways"). Additionally, the commenter states that EPA's application of the proposed public disclosure regulations to such products is especially pernicious because it would likely be impossible -- or at least, immensely burdensome -- to determine at the time that the ISI is utilized in Agency decision- making whether, in developing the ISI, EPA omitted from consideration (or gave lesser weight to) valid scientific studies that EPA is obligated to consider fully under the relevant statutory or regulatory provisions.
For example, the commenter (12727) provides that the purpose of ORD's IRIS chemical reviews is to support EPA's mission of protecting public health and the environment by identifying and characterizing the health hazards of chemicals found in the environment. Among other things, the commenter states the EPA uses this information to help set national standards under TSCA, the CAA, the SDWA, and the Emergency Planning and Community Right-to-Know Act, and to clean up hazardous sites under Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)., but none of these statutes allow EPA to ignore valid, pivotal scientific studies based solely on the fact that underlying data or models are not publicly available. According to the commenter, if the ORD is forced to exclude consideration of such studies when developing its IRIS chemical reviews, EPA's reliance on these reviews when taking actions under these statutes would be unlawful and arbitrary unless EPA combs through the report and available science to confirm that all valid studies have been considered. Additionally, the commenter notes that the need to undertake such a comprehensive review of ISI before relying upon it would fundamentally undermine the purpose of preparing ISI for general use by EPA's various programs, offices, and regions.
Conversely, commenters (11499, 12454) promote the application of the rule to EPA's IRIS program. Specific comments include:
Commenter (11499) states that the lack of full transparency in the IRIS program's development of toxicity values, as well as the inability to independently reproduce some of those values, continues to present obstacles to ensuring sound scientific decisions. The commenter asserts that applying the principles of the transparency rule to IRIS assessments and allowing the public early access to the data and methods used by the Agency is essential to safeguarding transparency in significant regulatory actions that rely upon IRIS toxicity values. According to the commenter, the EPA should make clear that the final transparency rule applies to data and models underlying pivotal science in IRIS assessments.
Commenter (12454) urges EPA to apply the transparency rule to EPA's IRIS program and clearly states as such when it promulgates the final rule. The commenter provides that EPA acknowledges that IRIS assessments "[a]re the preferred source of toxicity information used by EPA" and are used in "set[ting] national standards and clean[ing] up hazardous sites" even though the IRIS program was not established by statute. Due to this use, the commenter presumes that IRIS assessments and the toxicity values derived in those assessments would be considered "influential scientific information" within the meaning of the proposed 40 C.F.R. Section 30.2, since EPA "reasonably can determine [that IRIS assessments and toxicity values] will have ... a clear and substantial impact on important public policies or private sector decisions." The commenter states that the lack of full transparency in the IRIS program's development of toxicity values, as well as the inability to independently reproduce some of those values, continue to present obstacles to ensuring sound scientific decisions and warrant application of the transparency rule.
Response: The EPA is finalizing the applicability of the rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. The EPA is not applying this rulemaking to permit proceedings, site-specific actions, or enforcement actions because these actions are typically focused on individual regulated entities.
The EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers. If implementing this procedural rule would result in conflicts with existing environmental statutes, and their implementing regulations, this rule will yield to the EPA statutes and regulations.
Comment: Commenter (11894) notes that despite the ambiguity of the definition of "agency action," it seems clear that EPA would regard pesticide registration as one of the "agency actions" to which its new rules would not apply. The commenter questions the legality of this.
According to the commenter (11894), first, under FIFRA, an applicant has the burden of showing that a pesticide meets the standard for registration. The commenter asserts that the stakes in that decision are great, since approval of a pesticide is approval for the release into the environment of a chemical specifically designed to kill living things. The commenter provides that EPA never explains how it can justify letting an applicant support licensing of such a chemical by submitting data that the Agency could not rely on for its own regulatory decisions often aimed at much smaller potential hazards. Second, the commenter states that given the scope of the information that must often be reviewed to grant or sustain a registration, it may well be that applicants will rely - directly or indirectly - on studies or models that EPA has already found do not meet the new disclosure requirements, or that would clearly fail to meet them.
The commenter (11894) notes that they are provided no indication of how EPA would react: Would a study that EPA has barred from use in other contexts still qualify to support a pesticide registration? Would any special waiver proceedings be required? Would that affect its acceptability in other contexts?
The commenter (11894) contends that these are important questions of general significance to all EPA regulatory decisions that rest in part on studies with broad social impact, some of which may be impacts on regulation, but most of which are not. The commenter maintains that such studies are relevant to EPA decisions far beyond pesticides.
Response: The EPA is finalizing the applicability of the rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. The EPA is not applying this rulemaking to permit proceedings, site-specific actions, or enforcement actions because these actions are typically focused on individual regulated entities.
The EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers. If implementing this procedural rule would result in conflicts with existing environmental statutes, and their implementing regulations, this rule will yield to the EPA statutes and regulations.
Comment: Commenter (11491) states that the TSCA §5 requires EPA to review the likelihood that a new chemical will present an unreasonable risk to human health or the environment before it can be marketed. At present, much of the information that EPA reviews rests on CBI or otherwise would not meet the requirements of the proposal. To fill some of these gaps, EPA relies on models that likewise would often not meet those requirements.
Commenter (11894) states that TSCA requires the EPA to review the safety of all chemicals deemed "High Priority" now on the market and to do so by set deadlines. The commenter states that this is a formidable task, as the current number is approximately 45,000. To accomplish this, the commenter provides that the EPA has established a three-stage process designed to review and evaluate all the scientific information relevant to a chemical, and then gradually narrow the number to those that might warrant regulatory action. The commenter notes that comprehensive surveys that EPA is undertaking would inevitably rely in part on studies and models that will not meet EPA's proposed new requirements. Accordingly, the commenter states that whether, and to what extent, EPA's proposals would apply to this program is of obvious critical relevance to its successful operation. According to the commenter, that question cannot be answered from the proposal, which does not discuss that impact in any way. In all those cases where the review does not result in formal regulatory action, the new rules would presumably apply unless EPA adopted a very broad definition of "agency action." The commenter states that such a broad definition would have to be broad enough to cover studies performed for completely non-regulatory purposes - perhaps as part an independent university research program or studies done in other countries - that became part of EPA's review. Under that approach, the commenter suggests that such a study would be covered by the new rules in some circumstances, but not in others. The commenter asks: Does EPA intend this? Is it even workable?
According to the commenter (11894), if the new rules would apply, EPA has a legal obligation to evaluate the new burdens it would place on the program, the resources that would be available to bear them, and the impact on EPA's ability to meet the statutory deadlines. To do this, the commenter states that the EPA would have to define exactly how the new requirements would work in practice. The commenter asks: At what point in this multi-stage process of evaluation would the restrictions on the studies and models that can be considered be applied? What would be the specific reason for that application point? How could that application point be defended given the clear desire of Congress for a comprehensive survey of all data relevant to a chemical?
Response: The EPA is finalizing the applicability of the rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. The EPA is not applying this rulemaking to permit proceedings, site-specific actions, or enforcement actions because these actions are typically focused on individual regulated entities.
The EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers. If implementing this procedural rule would result in conflicts with existing environmental statutes, and their implementing regulations, this rule will yield to the EPA statutes and regulations.
<IP_ADDRESS> Other Government Data Sharing Policies
Comment: Commenter (11479) notes that the 2018 proposed rule claimed that it "builds upon prior EPA actions in response to government-wide data access and sharing policies," citing EPA's 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research, the EPA's Scientific Integrity Policy, the Open Data Implementation Plan, the EPA Open Government Plan 4.0, and the Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency. The commenter provides that in EPA's proposed rule and supplemental notice, no details on how this policy will expand upon those established internal policies, nor justifies why this policy is going through the formal rulemaking process when all these efforts to improve transparency and access to data are already underway. According to the commenter, these existing policies largely govern science and policy procedures within EPA; in contrast, this proposed rule attempts to dictate how science is produced outside the Agency, clearly stepping beyond the provisions of current EPA policies and practices.
Response: This rule exclusively pertains to the internal practices of the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the federal government.
The purpose of this action is to increase transparency by codifying internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. These requirements build upon open data initiatives in the federal government and scientific community and advance the EPA's mission and commitment to the public by prioritizing transparency of the underlying dose-response data in pivotal science for the most impactful of EPA's assessments and regulatory actions. Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. Such independent reanalyses will subsequently enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or influential scientific information. This could occur through standard cyclical reviews (e.g., revisions to NAAQS, risk and technology reviews, national primary drinking water regulations), ad hoc revisions, or revisions through the information quality guidelines or other petition processes. Implementation of this rule will more effectively share pivotal science for external consideration and increase the opportunity for independent validation of pivotal science by subject matter experts. As data are better understood through independent reanalysis, the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information.
Comment: Commenter (12720) states that the Agency also fails to provide notice to other agencies within the federal government of new obligations placed on them as a result of the Supplemental Proposal's tiered access regime. The commenter provides that EPA evidently envisions that the CDC will play a major role in implementation the Supplemental Proposal -- a role which goes essentially unmentioned in the rulemaking according to its memo to the House Committee on Space, Science, and Technology. According to the commenter, the memo notes that EPA staff were "inconsistent concerning how the data and models would be managed," and discussed a pilot project the Agency is conducting with the CDC. Further, the commenter provides that the memo notes that EPA "raised the possibility that the data could be stored on multiple outside "secure enclaves," managed by CDC or another third party, who would also be responsible for reviewing research proposals" and that "this is the first time the Agency has described an implementation scenario that would potentially place such a large responsibility on an outside agency."
Response: This internal procedural rule does not place obligations on any federal government agency besides EPA. The EPA is finalizing the approach that gives greater consideration to pivotal science whose underlying dose-response data are publicly available or available through restricted access. Restricted or tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism (e.g., Data Use Agreements) that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information.
Comment: Commenter (12546) provides that the supplemental proposal differs from the 2016 EPA Plan in its ability to be applied to previously generated data while the 2016 EPA Plan only applies to information generated after its implementation. Of the two applications, the commenter contends that the 2016 EPA Plan's limitation to prospective studies is appropriate.
Response: The EPA Plan to Increase Access to Results of EPA-funded Scientific Research, requires that the Agency make the peer-reviewed journal articles and underlying data resulting from EPA-funded research available to the public.
The final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedure and does not direct or require any outside entity or the EPA to establish data sharing mechanisms. Further, the final rule does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science.
The final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on existing significant regulatory actions or influential scientific information. For future, significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data.
<IP_ADDRESS> Inability for Public to Adequately Comment
Comment: Commenter (12720) contends that the "clarifications" provided to House staff by EPA all but guarantee the arbitrary effect of the Proposal. According to the commenter, researchers, scientists, and fellow executive agencies are certainly entitled to receive notice that EPA intends the burden of compliance with the Proposal to fall on them and to incorporate their concerns about that approach into their comments on the rule. The commenter states that EPA's failure to disclose these elements of the Proposal has foreclosed that possibility. The commenter provides that the fact that details were provided to congressional staff during closed-door briefings, and memorialized in a non-binding House staff memorandum, is certainly insufficient to allow for statutorily-required public comment, and Agency consideration of those public comments.
The commenter (12720) asserts that neither the research community (nor the CDC) can be expected to meaningfully comment on this proposal and its imposition on their research practices without such detail. The commenter states that the fact that this emerging element of the Proposal imposes requirements on third parties -- researchers, scientists, as well as the CDC -- makes clear that the Proposal is not merely a "a proposed internal rule of agency procedure," to which the so-called Housekeeping Statute on which EPA relies might apply.
Commenter (12727) provides that by failing comprehensively to describe the scope of its proposal, EPA has denied the public the information it needs to comment in an informed way.
Response: EPA disagrees that the public was deprived of the opportunity to provide meaningful comments. The comment period for the proposal and supplemental totaled 168 days and the EPA received over 993,000 public comments.
The rule exclusively pertains to the internal practices of the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the federal government. Any incidental impacts on voluntary behavior outside of the EPA do not render this a substantive rule.
<IP_ADDRESS> Implementation Guidance
Comment: Commenter (11358) encourages EPA to follow the advice outlined in the SAB's April 24, 2020 comments to EPA suggesting the Agency develop a guidance document before implementing the final rule. The commenter agrees with the board's suggestion to include further context for the definitions included within both the proposal and supplemental notice and that it "may be beneficial for EPA to develop a guidance document with case studies based on past risk assessments to clarify some scenarios and how the requirement to make data and models publicly available in a manner sufficient for independent validation would be managed (p. 13)." The commenter also supports the SAB's recommendation that EPA
      consider seeking input from experts in library science, data curation management, and data retention to identify best practices and tools to ensure efficiency and utility of data that are made available (p. 14).
Response: This final rule is effective at publication in the Federal Register. The implementation guidelines are forthcoming.
Comment: Commenter (11381) states that Proposed 40 CFR 30.1 in the NPRM "directs EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation." According to the commenter, the SNPRM is not as clear because it includes only those circumstances "where the Agency is making data or models publicly available".
The commenter (11381) maintains that elsewhere in proposed new Part 30 there is no text that would ensure that this rule, regardless of its final text, is ever implemented. The commenter provides that rules without means of enforcement generally are hortatory or aspirational, not regulatory. The commenter notes that it is possible, of course, that the public could persuade a court to vacate and remand a substantive regulation on the ground that EPA had failed to comply with new Part 30. The commenter states that on the other hand, courts have only once interpreted the Information Quality Guidelines (IQG) as binding even though there typically is an ample administrative record on which a determination of noncompliance with the IQGs could be based.
Comment: Commenter (11894) maintains that as with EPA's initial proposal, EPA did not provide any analysis explaining how a bar on influential studies would work in the context of specific EPA programs. The commenter states that EPA does not discuss how its proposal might actually work in practice. The commenter contends that EPA has not examined the extent of any additional resource needs or the impact on statutory deadlines, nor has EPA examined even the most obvious of the conceptual problems that would arise. The commenter provides that for example, if an exempt Agency action relied on a scientific study that, in any other context, would be classified - or perhaps had already been classified - as "influential scientific information," how would that data be handled? Similarly, the commenter notes that EPA often relies on states to take regulatory actions that would be exempt from coverage if EPA undertook them itself and asks how would the rule treat any guidance that EPA might issue to advise states on how to take these actions?
Response: This final rule is effective at publication in the Federal Register. The implementation guidelines are forthcoming.
Under the final rule no studies are categorically excluded from consideration and the EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for final significant regulatory actions and influential scientific information. The EPA will also consider the degree to which pivotal science is available and give greater consideration to those studies with greater data and model availability, as described in this rule.
This final rule does not interpret or apply the provisions of any environmental statutes. If implementing this procedural rule would result in conflicts with existing environmental statutes, the procedural rule will yield to the existing statutes.
Comment: Commenter (12720) quotes the SAB's 2020 Letter to Administrator Wheeler concerning the proposal and supplemental proposal in its call that "the EPA clarify the definitions of "data and models" and "pivotal regulatory science." The commenter suggests that it would be useful to develop a guidance document that includes examples of the types of data and models of interest and requirements for reporting this information. The commenter adds that it would also be useful to clarify specific requirements for reporting information from animal toxicity and/or environmental epidemiology studies. In this statement, the commenter asserts that the definition of data fails to clarify what is covered by the supplemental proposal, leading to difficulties ascertaining the rule's effects.
Response: In the final rule the EPA is removing the term "pivotal regulatory science" and combining the definitions of "pivotal science" and "pivotal regulatory science" under the single term "pivotal science". Pivotal science means the specific dose-response studies or analyses that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information.
In the final rule, "Data means the set of recorded factual material commonly accepted in the scientific community as necessary to validate research findings in which obvious errors, such as keystroke or coding errors, have been removed and that is capable of being analyzed by either the original researcher or an independent party." The definition of model has been removed from the final rule.
This final rule is effective at publication in the Federal Register. The implementation guidelines and statute-specific transparency regulations or programmatic regulations are forthcoming.
Comment: Commenter (10042) urges EPA to codify its approach for how, when and under what circumstances it will use human health data and information in and for rulemaking and setting standards. The commenter adds that EPA should also adopt and develop standard operating procedures (SOPs) for managing human health data and information which will likely have a strong anonymization component that can or will be used to make human health risk assessments.
Response: The EPA is finalizing the approach that gives greater consideration to pivotal science whose underlying dose-response data are publicly available or available through restricted access. Restricted or tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism (e.g., Data Use Agreements) that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information.
The final rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to those studies for which such data are available.
Comment: Commenter (12699) states that the EPA should develop objective criteria to determine when a study should be excluded. The commenter states that these criteria are in effect a means to determine when there are not genuine privacy, confidentiality, and CBI concerns; these criteria should include:
 The authors simply do not want to provide the underlying information.
 The authors have already disclosed the underlying information to third parties. This should be prima facie evidence that the information can be made available to the public.
 The EPA has disclosed the underlying information to a third party. This too should be prima facie evidence the information should be made available to the public. If the disclosure was only made because the third party is an agent (e.g. contractor) of the EPA, then the EPA should make comparable arrangements for other third parties to review the underlying information.
 The study authors or the EPA have not exhausted all available commonly used practices to de-identify information (if such de-identification is required).
Response: The final rule is limited to dose-response data and, as no studies are categorically excluded from consideration, the EPA will continue to rely on the full body of the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Consistent with the requirements of this rule, the EPA will identify a subset of those studies based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints that would inform a dose-response assessment, and will give greater consideration to pivotal science for which the underlying dose-response data are available.
Section 30.5 of the final rule states, "The EPA will use the following factors to assess the quality of studies identified in the systematic review: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. . . . The Agency will identify the pivotal science that was given lesser consideration and provide a short description of why lesser consideration was given."
Comment: Commenter (12715) states that, if the EPA adopts this proposal, it should at least make its process for excluding studies transparent; any final rule should require that in any future rulemaking or standard setting, the EPA will clearly identify each study that it rejected based on the present rule and fully explain that the basis for the rejection.
Response: The final rule is limited to dose-response data and, as no studies are categorically excluded from consideration, the EPA will continue to rely on the full body of the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Consistent with the requirements of this rule, the EPA will identify a subset of those studies based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints that would inform a dose-response assessment, and will give greater consideration to pivotal science for which the underlying dose-response data are available.
Comment: Commenter (11473) states that the EPA proposed rule does not account for conflicts of interest (and in particular financial conflicts of interest) by those requesting access to data, opening the possibility for research data that are to be used for regulatory purposes to be accessed by anyone, regardless of their affiliation. The commenter states that, thus, it will not prevent agents of vested interests from obtaining the publicly available data demanded by this proposed rule, and then running their own studies with the intention of discrediting science. The commenter states that there is already empirically based evidence that results of studies conducted by the pharmaceutical and tobacco industry favor those industries; indicating that the commenter anticipates self-serving biased analyses of EPA provided data by vested interest funded analysts under this proposed EPA approach (White and Bero, 2010; Bero, 2017; Lundh et al., 2017). The commenter states that it has been previously documented in an extensive review of a similar proposal (upon which this EPA proposal is based) made by a vested interest (a tobacco company): when such data have been accessed using a similar provision in the state of Georgia, the data were abused in an attempt to discredit the research they did not like, but the original research was later replicated by other researchers (Thurston, 1998) (attached). The commenter states that this new attempt to implement the tobacco company-inspired data release proposal will undoubtedly have similar inappropriate and untoward damage to scientific research if this so-called "Transparency" rule is implemented.
Commenter (12546) states that, considering that EPA as of yet has failed to detail a strategy on monitoring and accounting for financial conflicts of interest, a potential influx of industry-funded studies with such conflicts of interest may bias the final results of EPA's analysis, leading to less stringent regulations and policies -- with the ultimate result of reducing protections for the health of families.
Response: The EPA does not agree that its approach will lead to systematic bias towards certain types of stakeholder goals. The final rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to those studies for which such data are available.
 Chapter 15: Statutory and Executive Order Reviews
The EPA provides documentation of their consideration of several Executive Orders in the development of the proposal in Section IV of the notice of proposed rulemaking (NPRM) preamble and Section VII the supplemental notice of proposed rulemaking (SNPRM). Comments provided on EPA's consideration and/or compliance with Executive Orders are organized as follows:
Section 15.1: NPRM Executive Orders
       Executive Order 12291, Federal Regulation
       Executive Orders 12866, Regulatory Planning and Review, and 13563, Improving Regulation and Regulatory Review
       Executive Order 12898 - Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
       Executive Order 13045  -  Protection of Children
       Executive Order 13132, Federalism
       Executive Order 13175 Consultation and Coordination with Indian Tribal Government
       Executive Order 13556, Controlled Unclassified Information
       Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs
       Executive Order 13777, Enforcing the Regulatory Reform Agenda
       Executive Order 13783, Promoting Energy Independence and Economic Growth
Section 15.2: SNPRM Statutory and Executive Order Requirements
       Executive Orders
       Paperwork Reduction Act
       Additional Related Comments
The specific comments provided in this Chapter reflect the comment letters that provide arguments supported by detailed rationale, examples, and references/documentation. The Docket ID numbers for these commenters are cited throughout this Chapter. In addition, some general comment letters may also include comments related to comments included and responded to in this Chapter. These comments are summarized in Appendix B. Note that points and issues raised in these general comment letters may also be raised by the more detailed comments summarized in this Chapter. The responses provided in this Chapter adequately address these more general comments.
15.1 NPRM Executive Orders
15.1.1 Executive Order 12291: Federal Regulation
Comment: Commenters (6924, 8281-PH20) assert that EPA does not present any analysis of cost-benefit in support of the rule which is required under Executive Order 12291. Commenter (6924) states that Executive Order 12291 requires Agencies to complete a benefit-cost analysis for any major rule which has an annual impact of $100 million or more.
Response: Executive Order 12291 was revoked in 1993 by President Bill Clinton (D), who issued a modified regulatory review program under Executive Order 12866.
15.1.2 Executive Orders 12866: Regulatory Planning and Review, and 13563: Improving Regulation and Regulatory Review
 <IP_ADDRESS> Executive Order 12866: Regulatory Planning and Review
<IP_ADDRESS>.1 Costs and Benefits
Comment: Commenters (2171, 5181, 6133, 6137, 6168, 6188, 6916, 6919, 9227, 11408) assert that EPA has failed to meet Executive Order 12886 requirements to analyze and provide an assessment of the proposed rule's costs and benefits. Commenters (6916, 9227) state that Executive Order 12866 requires agencies to assess the costs and benefits of proposed regulations and propose or adopt a regulation only upon a reasoned determination that the benefits justify the costs.
Response: This is a rule of internal procedure promulgated under the EPA's housekeeping authority and imposes no enforceable duty on any state, local, or tribal governments or the private sector. Additionally, this rule does not require the EPA or other parties to disclose or host data. Hence, this rule does not impose costs on the EPA or any other party to make such data available. As described in Section III.J of the final rule preamble, the EPA recognizes there will be some incremental review and administrative costs to the Agency but anticipates these will be small.
<IP_ADDRESS>.2 Need for New Regulation
Comment: Commenter (9227) states that EPA's failure to identify a problem or inadequacy that new regulations are needed to address is contrary to Executive Order 12866. The commenter states that, before proceeding with this proposal, EPA should clearly identify the problem it is trying to solve, provide evidence that there is a problem and allow for public comment on whether a problem exists that could be addressed through EPA regulation. The commenter states that Executive Order 12866 provides that "[f]ederal agencies should promulgate only such regulations as are required by law, are necessary to interpret the law, or are made necessary by compelling public need, such as material failures of private markets to protect or improve the health and safety of the public, the environment, or the well-being of the American people." The commenter states that Executive Order 12866 directs each agency to "identify the problem that it intends to address (including, where applicable, the failures of private markets or public institutions that warrant new agency action) as well as assess the significance of that problem."
Response: This is an internal housekeeping rule that does not impose an enforceable duty on any state, local, or tribal governments or the private sector. The purpose of the rule is detailed in the preamble of the final rule. In brief, the transparency provisions in this final rule are intended to build upon existing efforts and provide incremental progress toward the Agency's overarching goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. The scientific community has also embraced greater data transparency, as evidenced by data sharing and availability requirements for many high-impact journals and the emergence of several international organizations and initiatives focused on increased transparency and data sharing in science. The EPA supports these efforts and believes that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety. The incremental progress made by this rule provides an important step towards prioritizing transparency in particularly impactful rules and assessments and will inform future statute-specific rulemakings.
<IP_ADDRESS>.3 Regulatory Impact Analysis
Comment: Commenters (0568, 2171, 6446, 6916, 6919) express concern that EPA failed to prepare a Regulatory Impact Analysis (RIA), which is necessary to determine the impacts of the proposal. Commenters (2171, 6919) state that this action is correctly identified as a "significant regulatory action" under Executive Orders 12866 and 13563 which then requires an RlA.
Response: This is a rule of internal procedure promulgated under the EPA's housekeeping authority and imposes no enforceable duty on any state, local, or tribal governments or the private sector. Additionally, this rule does not require the EPA or other parties to disclose or host data. Hence, this rule does not impose costs on the EPA or any other party to make such data available. As described in preamble discussion of costs and benefits, the EPA recognizes there will be some incremental review and administrative costs to the Agency but anticipates these will be small.
<IP_ADDRESS> Executive Order 13563: Improving Regulation and Regulatory Review
Comment: Commenters (6133, 6188, 9227) state the EPA did not provide cost-benefits analysis for the proposal, which violates Executive Order 13563. Commenter (9227) states that Executive Order 13563 reaffirms the principles and requirements of Executive Order 12866, explaining that agencies "must take into account benefits and costs, both quantitative and qualitative."
Response: This is a rule of internal procedure promulgated under the EPA's housekeeping authority and imposes no enforceable duty on any state, local, or tribal governments or the private sector. Additionally, this rule does not require the EPA or other parties to disclose or host data. Hence, this rule does not impose costs on the EPA or any other party to make such data available. As described in preamble discussion of costs and benefits, the EPA recognizes there will be some incremental review and administrative costs to the Agency but anticipates these will be small.
Public input was also an important part of shaping the final rulemaking. The EPA accepted public comment on the proposed rule from April 30, 2018 to August 16, 2018, and held a public hearing on July 17, 2018. In response to public comments, the EPA released a supplemental notice of proposed rulemaking and took public comment from March 18, 2020 to May 18, 2020. In addition, the EPA's SAB provided advice and comments on mechanisms for secure access to personally identifying information (PII) and confidential business information (CBI) under the proposed rule on September 30, 2020, and the proposed and supplemental rulemakings on April 24, 2020. All of these comments were considered in developing the final rule.
Comment: Commenters (6125, 6133, 6137, 9227) assert that, while EPA states in the preamble that "[t]he best available science must serve as the foundation of EPA's regulatory actions," under Executive Order 13563, the proposed rule actually hinders EPA's use of the best available science.
Commenter (6125) states that, while Executive Order 13563 states that EPA shall base its regulations on the best available science, EPA's proposal would make this impossible by making wide areas of such science unavailable to regulatory decision makers.
Commenter (6133) asserts that, while the proposal cites and quotes from Executive Order 13563, the Executive Order not only does not support the proposal, it directly undermines the proposal. The commenter states that there is no suggestion in the cited Executive Order that "best available science" means or meant that science underlying an agency's actions must be publicly available in a manner sufficient for independent validation, nor that "pivotal regulatory science" has any meaning akin to the proposed uses in proposed 40 CFR 30.3. The commenter states that, to the contrary, no previous administration has conditioned any notion of "best available science" on the public availability of underlying data, or on the concepts behind the invented term, "pivotal regulatory science." The commenter states that EPA previously routinely used and considered science and studies for which the underlying data was not publicly available as examples of the "best available science." The commenter states that EPA did so for proposed and final regulations, along with other final agency actions, reports, studies and the like. EPA's use and consideration of such science was validated by EPA's science advisory bodies, the National Academy of Sciences (NAS), the SAB, and other scientific organizations. The commenter states that the proposal does not provide sufficient explanation for its departure from this past practice.
Commenter (6137) states that the proposal has the purpose and effect of precluding the use of some of the best available science, that is, all science based on non-public data, simply because the underlying data is not publicly available. The commenter states that best available science means "all existing scientific evidence relevant to the decision," and agencies simply "cannot ignore existing data." The commenter states that, however, the proposed rule requires EPA to ignore existing data if it is not available for public release. The commenter concludes that the proposed rule is inconsistent with Executive Order 13563, as well as those statutes or principles that require EPA to consider the best available science.
Commenter (6137) asserts that an Executive Order cannot override a statute, limit the delegated authority and the legal responsibilities provided to the EPA Administrator by federal law, add factors that are impermissible under the statute, or delay statutorily required agency action. The commenter states that weakening or delaying public health protections based on an executive order would be unconstitutional, violating separation of powers and the requirement to follow duly enacted laws passed by Congress and signed by the President. The commenter states that it would likewise be unlawful, contrary to the public health obligations and rulemaking requirements of EPA's governing statutes. The commenter states that EPA cannot consider or apply any other executive order in any way in this rulemaking without providing the requisite public notice and opportunity for comment that the Clean Air Act (CAA) and Administrative Procedure Act (APA) or proposal for why EPA believes this policy would further the goal of best available science. The commenter states that the Executive Order only states that agencies should make available to the public the scientific or technological findings or conclusions on which rules rely, as opposed to underlying raw data that EPA has targeted with this proposal.
Response: As further detailed in the preamble of the final rule, the transparency provisions in this final rule are intended to build upon existing efforts and provide incremental progress toward the Agency's overarching goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. The scientific community has also embraced greater data transparency, as evidenced by data sharing and availability requirements for many high-impact journals and the emergence of several international organizations and initiatives focused on increased transparency and data sharing in science. The EPA supports these efforts and believes that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety. The incremental progress made by this rule provides an important step towards prioritizing transparency in particularly impactful rules and assessments and will inform future statute-specific rulemakings.
This rulemaking is not intended to modify the Agency's interpretations of "best available science." The EPA will continue to consider all peer-reviewed science, consistent with existing study quality assessment factors and corresponding statutory mandates. The EPA will then identify and consider pivotal science in accordance with the provisions of this rule, unless the implementation of the rule conflicts with statutory requirements and associated implementing regulations. As this rule makes clear, if implementing this procedural rule would result in conflicts with existing environmental statutes, the procedural rule will yield to the existing statutes.
The final rule requires EPA to follow best practices to evaluate potential links between exposure to a pollutant, contaminant, or substance and the effect and the nature of the dose-response relationship. EPA will continue to use the following, well-established factors when assessing study quality: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. As further detailed in the preamble to the final rule, only when characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect, will the EPA identify pivotal science and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation. Title 40 CFR 30.5 also provides additional considerations for instances when underlying dose-response data are not available for independent validation. Because the final rule does not categorically exclude any studies from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
15.1.3 Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
Comment: Commenters (2171, 2337, 5178, 6122, 6133, 6137, 6144, 6166, 6188, 6194, 6373, 6874, 6915, 6916, 6920, 6924, 6939, 8272, 8281-PH20) assert that the proposed rule is subject to Executive Order 12898 and needs an environmental justice analysis. Commenter (6920) urges the EPA to consider the environmental justice implications of the rule and examine ways to further protect vulnerable people and disadvantaged communities, in accordance with Executive Order 12898.
Commenters (2171, 2337, 6133, 6137, 6144, 6188, 6194, 6373, 6915) do not agree with the proposal's statement that it does not need to address Executive Order 12898 because "it does not establish an environmental health or safety standard."
Commenters (2337, 6133, 6137, 6373, 6915) assert that Executive Order 12898 by its terms applies to Agency policies and Agency conduct of programs as well as to Agency adoption of regulatory standards. Commenter (2337) states that EPA's determination that the proposed rule is not subject to Executive Order 12898 because "it does not establish an environmental health or safety standard" too narrowly construes the scope of the Executive Order and the potentially broad impact of its proposed rule.
Commenters (2171, 6133) state the implementation of this rule would indirectly impact the rules and guidelines that are set to protect children, people of color, the elderly, low-income, and other underserved populations. Commenter (6133) asserts that, as the proposed rule concerns the scientific evidence EPA will consider in its regulatory decision making, including epidemiological and clinic research on the health impacts of pollutants, it has the potential to directly implicate the concerns addressed by Executive Order 12898.
Commenter (6137) asserts that EPA's claim that this proposed rule does not require an environmental justice assessment is clearly at odds with what the Agency itself recognizes it must do to comply both with Executive Order 12898, as well as its own policies. The commenter states that EPA has regularly and purposefully focused on the need for environmental justice assessments of its rulemakings. The commenter states that EPA consistently performs this sort of assessment when acting under the CAA, Clean Water Act (CWA), and other statutes. The commenter states that this information unquestionably has been relevant to public health rulemakings in the past. The commenter states that EPA's refusal to consider the environmental justice consequences of the proposed rule  -  consequences that are certainly "relevant" under State Farm  -  and its departure from its long-standing pattern and practice of considering such data without a reasoned explanation for changing course are therefore arbitrary and capricious.
Response: This action is not subject to Executive Order 12898 because it does not establish an environmental health or safety standard. This rule exclusively pertains to the internal practices of the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the federal government. In addition, the EPA does not agree that its approach will lead to systematic bias towards certain types of stakeholder goals of any party. As described in the preamble, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
Comment: Commenter (6122) states that the proposal directly violates Executive Order 12898, which directs every federal agency to "...collect, maintain, and analyze information assessing and comparing environmental and human health risks borne by populations identified by race, national origin, or income. To the extent practical and appropriate, Federal agencies shall use this information to determine whether their programs, policies, and activities have disproportionately high and adverse human health or environmental effects on minority populations and low-income populations." The commenter states that, in 2011, the EPA also signed and Memorandum of Understanding to implement the environmental justice goals of Executive Order 12898. The commenter states that EPA must ensure that high quality data analyze environmental justice impacts in order to protect vulnerable populations. The commenter states that requiring public availability of raw data is not a rational metric for deciding whether a study is of high enough quality to be used for setting thresholds or enacting regulatory protections.
Commenter (6373) asserts that that Executive Order 12898 specifically addresses federal human health and environmental research and analysis, requiring federal agencies to ensure that epidemiological and clinical research activities represent "segments at high risk from environmental hazards, such as minority populations, low-income populations and workers who may be exposed to substantial environmental hazards." The commenter states that Executive Order 12898 explicitly contemplates that agencies will use epidemiological data collected from at-risk communities, which necessarily relies on private information of members from those communities, to promulgate regulations to protect those at risk.
Commenter (6194) states that EPA has not addressed how the proposal would affect the agency's fulfillment of the human health and environmental data collection and analysis obligations imposed by Executive Order 12898 (§ 3-302).
Commenter (6133) expresses concern that the proposal makes no mention of the EPA Guidance on Considering Environmental Justice During the Development of Regulatory Actions. The commenter states that the proposal directly conflicts with many of the Guidance document's provisions. The commenter states that to achieve Executive Order 12898's goals, the Guidance directs rule-writers and decision-makers to respond to three core Environmental Justice questions throughout the process:
 How did the public participation process provide transparency and meaningful participation for minority populations, low-income populations, tribes, and indigenous peoples?
 How did the rule-writers identify and address existing and/or new disproportionate environmental and public health impacts on minority populations, low-income populations, and/or indigenous peoples?
 How did actions taken under #1 and #2 impact the outcome or final decision?
Commenter (6137) asserts that the proposal violates the environmental justice requirements of Executive Order 12898 because it ignores EPA's own environmental justice plan  -  promulgated pursuant to Executive Order 12898  -  the ultimate vision of which is for EPA to "integrate[] environmental justice into everything" it does. The commenter states that to accomplish this vision, EPA sets forth eight different priority areas, the first of which is rulemaking. The commenter states that EPA aims to "institutionalize environmental justice in rulemaking," including performance of "rigorous assessments of environmental justice analyses in rules," in order to "deepen environmental justice practice within EPA programs to improve the health and environment of overburdened communities." The commenter states that, recognizing that "[r]ulemaking is an important function used by the EPA to protect human health and the environment for all communities," EPA devotes the second chapter of the plan to "Rulemaking," and through this chapter, aims to "ensure environmental justice is appropriately analyzed, considered, and addressed in EPA rules with potential environmental justice concerns, to the extent practicable and supported by relevant information and law." The commenter states that consistent with its environmental justice plan and with Executive Order 12898, EPA issued its own Guidance on Considering Environmental Justice During the Development of Regulatory Actions, recognizing how "vital" it is "that Agency rule-writers identify and address potentially disproportionate environmental and public health impacts experienced by minority populations, low-income populations, and/or indigenous peoples,"
Response: This action is not subject to Executive Order 12898 because it does not establish an environmental health or safety standard. This rule exclusively pertains to the internal practices of the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the federal government.
Public input was also an important part of shaping the final rulemaking. The EPA accepted public comment on the proposed rule from April 30, 2018 to August 16, 2018, and held a public hearing on July 17, 2018. In response to public comments, the EPA released a supplemental notice of proposed rulemaking and took public comment from March 18, 2020 to May 18, 2020. In addition, the EPA's SAB provided advice and comments on mechanisms for secure access to PII and CBI under the proposed rule on September 30, 2020, and the proposed and supplemental rulemakings on April 24, 2020. All of these comments were considered in developing the final rule.
Comment: Commenter (5178) states that reproductive justice is the human right to maintain personal bodily autonomy, have children, not have children, and parent children in safe and sustainable communities. The commenter states that we cannot fully achieve reproductive justice when environmental exposures make it harder for parents to give birth to healthy children and raise them in safe homes. The commenter states that, in order for women and families to thrive, they must be able to choose to parent without fear of pollution and contamination interfering with their health and well-being. The commenter states that a reproductive justice perspective also recognizes the inequitable environmental burdens placed on communities composed of people of color and those with fewer economic advantages, and that these burdens will continue accumulating over generations if not corrected. The commenter states that EPA has oversight over numerous exposures that pose particular dangers during pregnancy and infancy, including neurotoxicants and endocrine disruptors.
Response: This action is not subject to Executive Order 12898 because it does not establish an environmental health or safety standard. This rule exclusively pertains to the internal practices of the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the federal government.
Public input was also an important part of shaping the final rulemaking. The EPA accepted public comment on the proposed rule from April 30, 2018 to August 16, 2018 and held a public hearing on July 17, 2018. In response to public comments, the EPA released a supplemental notice of proposed rulemaking and took public comment from March 18, 2020 to May 18, 2020. In addition, the EPA's SAB provided advice and comments on mechanisms for secure access to PII and CBI under the proposed rule on September 30, 2020, and the proposed and supplemental rulemakings on April 24, 2020. All of these comments were considered in developing the final rule.
Comment: Commenter (5178) states that, in the absence of substantial new resources, efforts to replicate studies and prepare data for public release would reduce the resources available for new research and delay the regulatory process. The commenter states that the consequences of this proposal would fall most severely on groups not adequately protected by current rules, which include racial and ethnic minorities, those with low socioeconomic status, the elderly, and pregnant individuals and their eventual children. The commenter states that the theoretical  -  but as yet undemonstrated  -  benefits of EPA's proposal must be weighed against the extensive and unequally distributed costs of such an approach.
Commenter (6373) asserts that, if EPA disregards findings from certain studies because of the proposed rule, and as a result adopts less protective national ambient air quality standards (NAAQS) for any of the criteria pollutants, then EPA will have violated Executive Order 12898.
 EPA's failure to use data collected from at-risk communities in the promulgation of NAAQS itself would be a violation of Executive Order 12898.
 Certain populations (often low-income, minority groups) are frequently subject to higher exposure to regulated chemicals, and should regulations be weakened because they are not grounded in the best science available, the exposures those communities face may increase and disproportionately burden these communities, which would result in additional adverse health consequences.
 Even when exposed to the same levels of a pollutant, communities with a higher level of disease prevalence (e.g., asthma) may suffer a higher burden if that disease is exacerbated by pollution. Therefore, EPA would fail its mandate to address the disproportionately high human health impact of air pollution.
Commenters (6133, 6137, 6188, 6373) express concern that the proposal does not address public participation of minority and low-income populations, as required under Executive Order 12898.
Commenter (6373) states that Executive Order 12898 requires that "[f]ederal agencies shall provide minority populations and low-income populations the opportunity to comment on the development and design of research strategies undertaken pursuant to this order." The commenter states that, despite the clear applicability of Executive Order 12898 to this action, there is no evidence in the record that EPA solicited input from the environmental justice community when promulgating the rule.
Commenter (6133) asserts that, because minority and low-income populations have historically been underrepresented in agency decision making, Executive Order 12898 aims to improve public participation of these populations in the decision-making process. The commenter states that, with the single English language hearing EPA held in Washington DC, EPA has not provided for meaningful participation of minority populations, low-income populations, tribes, and indigenous peoples.
Commenter (6137) asserts that, when promulgating rules "that substantially affect human health or the environment"  -  which this proposed rule does  -  EPA must "provide minority populations and low-income populations the opportunity to comment on the development and design of research strategies undertaken pursuant to this order." Commenter (6188) states that minority populations and low-income populations are guaranteed an opportunity to comment on the development and design of research strategies undertaken per the Order's direction.
Response: This is a rule of internal procedure promulgated under the EPA's housekeeping authorities, and imposes no enforceable duty on any state, local or tribal governments or the private sector. In addition, the EPA does not agree that its approach will lead to systematic bias towards certain types of stakeholder goals of minority and low-income populations. As described in the preamble, the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions and finalizing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
Public input was also an important part of shaping the final rulemaking. The EPA accepted public comment on the proposed rule from April 30, 2018 to August 16, 2018, and held a public hearing on July 17, 2018. In response to public comments, the EPA released a supplemental notice of proposed rulemaking and took public comment from March 18, 2020 to May 18, 2020. In addition, the EPA's SAB provided advice and comments on mechanisms for secure access to PII and CBI under the proposed rule on September 30, 2020, and the proposed and supplemental rulemakings on April 24, 2020. All of these comments were considered in developing the final rule.
15.1.4 Executive Order 13045: Protection of Children
Comment: Commenters (2171, 5178, 6130, 6133, 6188, 6373, 6915, 6916, 6920, 8281-PH20) assert that the proposed rule is subject to Executive Order 13045 and requires analysis of environmental health risks and safety risks that may disproportionately affect children. Commenters (6133, 6188, 6194) assert that Executive Order 13045 requires that federal agencies "shall make it a high priority to identify and assess environmental health risks and safety risks that may disproportionately affect children...." Commenters (6133, 6373, 6915) assert that Executive Order 13045 requires that every agency shall ensure that its policies, programs, activities, and standards address disproportionate risks to children that result from environmental health risks or safety risks.
Commenters (6133, 6188, 6194) assert that, in the case of a "significant regulatory action" such as the proposed rule, the promulgating agency must provide an evaluation of health or safety effects of the planned regulation on children.
Commenters (6133, 6188, 6194) assert that Executive Order 13045 requires an explanation of why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency (Executive Order 13054, § 5-501). Commenter (6188) states that EPA has not provided any such analysis of the proposed rule.
Commenter (6373) states that the proposed rule is in direct contravention of Executive Order 13045 -- complying with the rule will prevent EPA from effectively "ensure[ing] that its policies, programs, activities, and standards address disproportionate risks to children that result from environmental health risks or safety risks." The commenter states that when EPA regulates a substance pursuant to any one of its governing statutes or sets a standard for remedial work on property that presents a risk of exposure to children, Executive Order 13045 requires EPA to identify and assess health risks to children and ensure that its standards and actions protect children. The commenter states that, to do this effectively, EPA must consider scientific studies that include private information about children, however, should the proposal be finalized, EPA would have the discretion to discount scientific studies of exposure risks to children that rely on personal data or confidential information, contrary to Executive Order 13045's mandate. The commenter states that EPA cannot regulate in a matter compliant with both Executive Order 13045 and the proposed rule.
Response: 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.
Comment: Commenters (2171, 6130, 6133, 6194, 6373, 6920) do not agree with the proposal's statement that it does not need to address Executive Order 13045 because "this action does not concern an environmental health risk or safety risk" (83 FR 18773).
Commenters (6130, 6133, 6920) assert that the claim that this action "is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk" to children is not supported by scientific evidence. Commenters (6130, 6920) state that there is a substantial body of research showing children are more sensitive than adults to environmental pollution. Commenter (6373) states that EPA's determination that the proposed rule is not subject to Executive Order 13045 because it is not a regulatory action that "concern[s] environmental health or safety risks that the EPA has reason to believe may disproportionately affect children" is arbitrary and is a tragic relinquishment of EPA's obligation to protect our children.
Commenter (6133) states that, while EPA asserts that the proposal is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk, EPA does not explain how it reached this conclusion. The commenter states that EPA also does not characterize children's risk to the extent data are available. The commenter states that the proposal applies to "Pivotal regulatory science" and the proposal defines regulatory science as "scientific information, including assessments, models, criteria documents, and regulatory impact analyses, that provide the basis for EPA final significant regulatory decisions." The commenter states that the proposal explains that "`Pivotal regulatory science' is the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated; in other words, they are critical to the calculation of a final regulatory standard or level, or to the quantified costs, benefits, risks and other impacts on which a final regulation is based." The commenter states that, by its terms, the proposal will impact (and therefore concern) all environmental health and safety risks, including many that EPA knows disproportionately affect children.
Commenter (6194) states that the proposal would affect risk assessment analyses across a variety of environmental statutes. The commenter notes that studies that in the past informed regulations that address public health risks with disproportionate effects on young children, such as asthma from exposure to particulate matter and neurological damage from exposure to lead, could be precluded from consideration today by the proposal. The commenter states that the proposal is "intended to apply prospectively to final regulations that are determined to be `significant regulatory actions' pursuant to Executive Order 12866." The commenter states that, therefore, the proposal itself should be construed as an action subject to the review requirements of Executive Order 13045. The commenter states that this would not present a double-bite at the apple in terms of review under Executive Order 13045; rather it presents the only meaningful opportunity to consider the impact of the proposal on the protection of children. The commenter states that, once the proposal is adopted, it would preclude the use of certain science, so any analysis of feasible alternatives under Executive Order 13045 would already be limited in a way that precludes consideration of the impacts of the proposal.
Response: The EPA maintains that this action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers.
Comment: Commenter (6133) states that EPA created a Guide to help Agency staff involved in developing actions determine whether Executive Order 13045 applies to an Agency action and, if so, how to implement the Executive Order. The commenter states that the Guide includes "a set of questions EPA staff involved in action development can ask risk assessors to ensure that the various types of information relevant to the assessment of risks to children are considered and may be useful in addressing the issue of disproportionate risks." The commenter states that the Guide explains: "[i]f a rulemaking is not covered by Executive Order 13045, but it discusses environmental health or safety, it is advisable to characterize children's risk to the extent the data are available."
Response: 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. In addition, the EPA's approach will not lead to systematic bias towards certain types of stakeholder goals of any party. As described in the preamble, the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions and finalizing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
15.1.5 Executive Order 13132: Federalism
Comment: Commenter (6915) does not agree with the statement in the proposal that this rule would not affect any states, and therefore has no federalism implications. The commenter states that the adoption of this proposed rule would very likely affect the protectiveness of the standards that EPA sets, which would significantly impact federal and state efforts to protect the quality of our air, water, and land, and the health and welfare of the American people. The commenter notes that some states' environmental laws and regulations explicitly adopt EPA standards in all or some instances, or at the very least require an express justification for any deviation. The commenter states that, therefore, it is clear a fundamental change in how EPA develops standards would most certainly affect state standards, and therefore would affect the health of our residents and our natural resources.
Commenter (6915) states that the proposal fails to explain whether or how the proposed rule would apply to EPA's review and approval of state standards, and, accordingly, deprives commenters of a full and fair opportunity to assess and comment on the proposal's federalism implications.
Response: This action does not have federalism implications as it imposes no enforceable duty on any state, or local governments. 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.
15.1.6 Executive Order 13175: Consultation and Coordination with Indian Tribal Government
Comment: Commenters (0565, 6123, 6130, 6920) disagree with the statement in the proposal that this action does not have tribal implications as specified in Executive Order 13175 and does not require consultation with tribes. Commenters (0565, 6130, 6920) assert that this conclusion is not adequately supported and urge additional analysis of the probable impacts of the proposed rule on Tribal Nations.
Commenter (0565) points out that EPA's own Policy on Consultation and Coordination with Indian Tribes (May 4, 2011), adopted to implement its responsibilities under Executive Order 13175, begins with the following sentence: "EPA's policy is to consult on a government-to-government basis with federally recognized tribal governments when EPA actions and decisions may affect tribal interests." The commenter states that this is based on the 1984 EPA Policy for the Administration of Environmental Programs on Indian Reservations, reaffirmed by Administrator Pruitt last year, by which EPA, in keeping with its federal trust responsibility, commits in Principle 5 to "assure that tribal concerns and interests are considered whenever EPA's actions and/or decisions may affect reservation environments."
Commenter (0565) asserts that there is no question that the nature and scope of scientific studies and underlying data that form the basis of EPA's regulations have a bearing on the level of human health and environmental protections afforded by those regulations. The commenter states that tribal communities suffer the same affects as other communities from pollution of the nation's air, land and water; but are also disparately impacted in a variety of ways, reflected by the significantly higher instances of environmentally-based diseases that tribal communities experience compared with non-Indian populations. The commenter states that this disparity results from factors such as socio-economic conditions, lack of adequate infrastructure, and our fundamental relationship with the natural environment and reliance on a variety of plants, wildlife and habitats for subsistence and cultural practices. The commenter states that, in these circumstances, it is critically important to Tribal Governments to ensure in particular that data regarding the disparate impacts to Tribal community health from various pollution sources regulated by EPA, as well as Traditional Ecological Knowledge that can inform regulatory approaches, can continue to be taken into account in crafting and maintaining appropriate human health and environmental protections. The commenter states that, for these reasons, the proposed rule certainly has the potential to impact Tribal interests and must therefore be the subject of a meaningful consultation process.
Commenter (6125) states that, because few federally recognized Indian tribes operate their own regulatory programs, federal requirements and standards apply to most Indian lands. The commenter asks the following questions
 Has EPA considered whether it would be consistent with the federal trust responsibility to tribes to relax requirements or standards, and thus reduce protection for tribal lands solely because of a new regulation based on ignoring reliable and relevant science?
 Has EPA considered whether such a reduction in protection on tribal lands is consistent with principles of environmental justice?
 As this rule is implemented in regard to states and tribes, who may comment or have consultation roles in developing major regulations?
 Would states or tribes have any recourse if levels of protection are reduced under this new regulation that ignores evidence or could they keep the old standards?
Response: This action imposes no enforceable duty on any state, local or tribal governments or the private Sector. Therefore, this action does not have tribal implications as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.
15.1.7 Executive Order 13556: Controlled Unclassified Information
Comment: Commenter (4591) asserts that, in some instances, this proposed rule will directly conflict with Executive Order 13556 and the accompanying National Archives and Records Administration implementing directive, which place limitations on the release of specific non-classified information involving privacy, security, proprietary business interests, and law enforcement investigations. The commenter questions whether controlled unclassified information (CUI) categories limiting the release of information relating to health, genetic information, proprietary business information, pesticide producers and railroad safety analysis records might prevent valid scientific studies based upon these CUI categories from being released and as a result, prevent the best possible scientific evidence from being used to develop regulations aimed at protecting public health and safety.
Response: This rule does not require the EPA or other parties to disclose or host data. In addition, the EPA is finalizing the approach that gives greater consideration to pivotal science whose underlying dose-response data are publicly available or available through restricted access. Restricted or tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism (e.g., Data Use Agreements) that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. As discussed more fully in the preamble of the final rule, the rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making.
15.1.8 Executive Order 13771: Reducing Regulation and Controlling Regulatory Costs
Comment: Commenter (6915) does not agree with the proposal's assertion that it does not amount to an Executive Order 13771 regulatory action. The commenter states that, rather than acknowledging costs, the only place where the proposed rule even mentions costs is in section 30.8, which states that "EPA shall implement the provisions of this subpart in a manner that minimizes costs" -- a misleading and fatally vague projection of the impacts of the proposed rule.
Response: This final rule does not regulate any entity outside the EPA. Rather, the requirements modify the EPA's internal procedures regarding the transparency of pivotal science underlying final significant regulatory actions and influential scientific information. In addition, because this rule would not change the process by which the EPA already evaluates studies for scientific merit, the incremental costs of the rule would be for EPA to determine data availability for the limited subset identified as pivotal science. This is a small increment in effort relative to the Agency's extensive existing scientific review process. As described in preamble discussion of costs and benefits, the EPA finds that the incremental costs of this rule related to the additional review of data availability are anticipated to be small.
15.1.9 Executive Order 13777: Enforcing the Regulatory Reform Agenda
Comment: Commenter (6362) supports EPA's demonstrated commitment in this proposal to build upon the principles underlying Executive Order 13777. Commenter (6927) agrees with the statement in the proposed rule that the proposal is consistent with Executive Order 13777.
Response: The EPA appreciates this comment.
Comment: Commenter (6103) notes the proposal relies on Executive Order 13777, which provides that regulation reform efforts shall attempt to identify regulations that rely on non-publicly available data or are not transparent enough to meet the standards of reproducibility. The commenter states that this Executive Order does not justify the rule; it merely identifies the studies this proposal will target once enacted. The commenter states that the intent of this proposal is not to make data more publicly available but to exclude studies from the rule-making process to pave the way for deregulation. The commenter states that it would be a breach of confidentiality and personal security to release the private health data of research participants and entirely unethical to repeat studies that have shown harm to humans.
Commenter (1791) asserts that, as the EPA cites Executive Order 13777 in support of this proposed rule, so too does that order guarantee the preservation of air-quality measures surrounding soot and other chemicals less than 2.5 microns in diameter. The commenter states that the text from the order "or insufficiently transparent to meet the standard of reproducibility" applies because those epidemiological studies have met the standard of reproducibility; they have been repeatedly validated.
Commenters (6125, 6133, 6137, 9227) do not agree with the statement in the proposed rule that the proposal is "consistent with Executive Order 13777.
Commenter (6125) states that Executive Order 13777 calls on agency regulatory reform efforts to attempt to identify "those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility." The commenter states that this language calls for individual examination of rules for future unspecified action. The commenter contends that it in no way supports EPA's proposal to impose a blanket bar on all studies relying on undisclosed data.
Commenter (6133) states that Executive Order 13777 requires Regulatory Reform Task Forces to evaluate existing regulations and "make recommendations to the agency head regarding their repeal, replacement, or modification, consistent with applicable law." The commenter states that the Executive Order requires the task force to identify regulations that, among other things, "impose costs that exceed benefits," and "create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies." The commenter states that, in contrast, the proposal does not identify any regulations that it believes should be repealed, replaced, or modified, consistent with applicable law. The commenter states that, instead, the proposal creates a new burdensome regulation. The commenter states that, notwithstanding EPA's unsupported assertion that it "believes the benefits of this proposed rule justify the costs," the proposed rule will impose costs that exceed benefits. The commenter states that, rather than being consistent with the Executive Order, the proposed rule contradicts it.
Commenter (6137) asserts that Executive Order 13777 seeks to reduce regulation, and in no way authorizes EPA to promulgate new rules. The commenter states that this Executive Order establishes a task force to "evaluate existing regulations . . . and make recommendations to the agency head regarding their repeal, replacement, or modification." The commenter states that EPA's assertion that the proposed rule is consistent with an Executive Order focused on deregulation is tantamount to an admission that the rule's purpose and effect is to limit the development of rules that are critical to the protection of public health and the environment.
Commenter (6137) asserts that the proposed rule is contrary to the stated purpose and policy of Executive Order 13777, which is to "lower regulatory burdens on the American people by implementing and enforcing regulatory reform." The commenter states that the proposed rule will do just the opposite as it will preclude EPA from considering certain data regarding health and environmental impacts of pollutants, contaminants, and other substances in its rulemaking process. The commenter states that the overall impact of such limitations on rulemaking aimed at protecting public health and the environment will be increased burdens on the American people.
Commenter (9227) states that Executive Order 13777 is targeted at eliminating regulations including those that are "unnecessary" and "ineffective," which the proposal clearly would be.
Response: The EPA authority for this rule is not derived from Executive Order 13777. As stated in the preamble, the EPA is authorized to promulgate this procedural rule under its authority to promulgate housekeeping regulations governing its internal affairs under 5 U.S.C. App., and Pub. L. 98 - 80, 84 Stat. 2086. Additionally, this action is consistent with Executive Order 13777, and the focus on transparency in the OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies.
In addition, as described in the preamble, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. Consistent with existing Agency practice, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information. Further, the final rule only applies to dose-response data; studies informing other aspects of the EPA's evaluations are unaffected by this rule.
15.1.10 Executive Order 13783: Promoting Energy Independence and Economic Growth
Comment: Commenter (6141) states that Executive Order 13783 supports the adoption of clear, even-handed, and effective rules for ensuring scientific transparency. Commenter (6362) supports EPA's demonstrated commitment in this proposal to build upon the principles underlying Executive Order 13783. Commenter (6927) agrees with the statement in the proposed rule that the proposal is consistent with Executive Order 13783.
Conversely, commenters (4591, 6103, 6114, 6116, 6131, 6361) assert that Executive Order 13783 does not justify the proposed rule.
Commenter (6103) states that Executive Order 13783 states that environmental regulations should be developed through "transparent processes that employ the best available peer-reviews science and economics." The commenter states that, to achieve this, the EPA should continue to rely on the peer-review process, as it ensures transparent processes for the best available science.
Commenters (6114, 6116, 6131, 6361) state that Executive Order 13783 calls for transparency in process but does not address the issue of transparency in publication of studies. The commenters state that Executive Order 13783 simply calls for the use of the best available peer reviewed information.
Response: EPA appreciates the comments that this rule is consistent with Executive Order 13783. However, EPA authority for this rule is not derived from Executive Order 13783, as stated in the preamble, the EPA is authorized to promulgate this procedural rule under its authority to promulgate housekeeping regulations governing its internal affairs under 5 U.S.C. App., and Pub. L. 98 - 80, 84 Stat. 2086. The transparency provisions in this final rule are intended to build upon existing federal government efforts and provide incremental progress toward the Agency's goal of greater transparency.
Comment: Commenters (4591, 6125, 6133, 6137, 9227) do not agree with the statement in the proposed rule that the proposal is consistent with Executive Order 13783.
Commenters (6133, 6137) state that, in an effort to show the proposed rule's consistency with this Executive Order, EPA quotes the following part of the Order: "It is also the policy of the United States that necessary and appropriate environmental regulations comply with the law, are of greater benefit than cost, when permissible, achieve environmental improvements for the American people, and are developed through transparent processes that employ the best available peer-reviewed science and economics." Commenter (6133) asserts that Executive Order 13783 contradicts the proposal because the proposal would prevent EPA from promulgating regulations that comply with the law, would cost more than any benefit it could achieve, and would preclude the use of the best available peer-reviewed science.
Commenter (6137) states that the proposed rule contravenes this policy in a number of ways: it fails to comply with a number of statutes and executive orders; the costs of the rule far outweigh the benefits; it will cause substantial and far-reaching harm to public health and the environment; and it has been developed through a process that lacks transparency. The commenter states that, if implemented, the proposed rule will lead to future rulemakings that likewise will be inconsistent with this Executive Order, as it will preclude EPA from considering the best available peer reviewed science and economics, which in turn will impact the cost-benefit analysis, and may violate notice-and-comment and judicial review procedures.
Commenter (9227) states that Executive Order 13783 says nothing more than that environmental regulations should be developed through transparent processes that employ the best available peer-reviewed science. The commenter states that Executive Order 13783 calls for agencies to consider the costs and benefits "that are based on the best available science and economics" to ensure sound regulatory decision making. The commenter provides that the proposal provides no analysis of the costs and benefits of implementing this new policy, despite there likely being high costs to making research data public with little evidence of significant benefits achieved from this policy alone. The commenter states that, by arbitrarily excluding scientific information that EPA may use in its regulatory analyses, the proposal conflicts with the executive order's command to employ the best available science and economics.
Commenter (4591) states that EPA is bound through Executive Order 13783 to develop regulations through "transparent processes that employ the best available peer-reviewed science." The commenter states that the proposed rule presumes that peer-reviewed, otherwise credible scientific studies do not merit consideration in the agency's decision making, unless data supporting the study are made publicly available within the agency's specifications. The commenter states that this presumption is not in keeping with the spirit of data transparency as understood by the scientific community. The commenter states that science does not depend on the public availability of underlying data to indicate quality and reliability of evidence, and public availability of research data is not a proxy for the reproducibility of science. The commenter states that the trend toward data transparency championed by foundations and science agencies around the world is predicated on the view that peer-reviewed, published studies already have presumptive scientific merit.
Response: This is a rule of internal procedure promulgated under the EPA's housekeeping authorities, and imposes no enforceable duty on any state, local or tribal governments or the private sector. Additionally, this rule does not require the EPA or other parties to disclose or host data. Hence, this rule does not impose costs on the EPA or any other party to make such data available. As described in preamble discussion of costs and benefits, the EPA recognizes there will some incremental review and administrative costs to the Agency but anticipates these will be small.
The EPA disagrees that this action is inconsistent with Executive Order 13783. This rulemaking is not intended to modify the Agency's interpretations of "best available science." The EPA will continue to consider all peer-reviewed science, consistent with existing study quality assessment factors and corresponding statutory mandates. The EPA will then identify and consider pivotal science in accordance with the provisions of this rule, unless the implementation of the rule conflicts with statutory requirements and associated implementing regulations. As this rule makes clear, if implementing this procedural rule would result in conflicts with existing environmental statutes, the procedural rule will yield to the existing statutes.
The final rule requires EPA to follow best practices to evaluate potential links between exposure to a pollutant, contaminant, or substance and the effect and the nature of the dose-response relationship. EPA will continue to use the following, well-established factors when assessing study quality: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Comment: Commenter (6137) states that Executive Order 13783 provides that greenhouse gas impact estimates should be consistent with guidance in OMB Circular A-4 (Sept. 17, 2003), which specifically requires that this analysis be based on "the best reasonably obtainable scientific, technical, and economic information available." The commenter states that, though the Circular states that, where available, peer-reviewed, transparent, and reproducible studies should be used, it neither requires nor authorizes the preclusion of consideration of scientific studies based on data that cannot be made publicly available. The commenter states that, instead, it recognizes that there will be circumstances "[w]here other compelling interests (such as privacy, intellectual property, trade secrets, etc.) prevent the public release of data or key elements of the analysis," and provides in those cases that, rather than precluding the data, the use of "especially rigorous robustness checks to analytic results" should be applied and documented. The commenter states that, for this reason, the proposed rule is inconsistent with Executive Order 13783.
Response: This rule will not preclude information from consideration. Consistent with existing Agency practice, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information. The final rule requires EPA to follow best practices to evaluate potential links between exposure to a pollutant, contaminant, or substance and the effect and the nature of the dose-response relationship. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. As further detailed in the preamble to the final rule, only when characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect, will the EPA identify pivotal science and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation. Title 40 CFR 30.5 also provides additional considerations for instances when underlying dose-response data are not available for independent validation. Because the final rule does not categorically exclude any studies from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations. In addition, as this rule makes clear, if implementing this procedural rule would result in conflicts with existing environmental statutes, the procedural rule will yield to the existing statutes.
15.2 SNPRM Statutory and Executive Order Requirements
 15.2.1 Executive Orders
 <IP_ADDRESS> Executive Order 12291: Federal Regulation
Comment: Commenter (11183, 12719, 12546) provides that Executive Order 12291 requires executive agencies to perform a cost-benefit analysis for all major rules. The commenters note that this proposed rule -- which will limit EPA's use of a vast compendium of existing and forthcoming research -- does not include an analysis to illicit how this rule's costs compared to its benefits. Thus, according to the commenter, the EPA has failed to comply with this requirement.
Response: Executive Order 12291 was revoked in 1993 by President Bill Clinton (D), who issued a modified regulatory review program under Executive Order 12866.
<IP_ADDRESS> Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
Comment: Commenters (3788, 11479, 11903, 12464, 12715, 12727, 12751) state that the supplemental proposal violates the principles of Executive Order 12866, Regulatory Planning and Review, 58 Fed. Reg. 51,735 (Oct. 4, 1993). Commenters provide that EPA has failed to estimate the costs the Agency would incur to implement the proposal, despite the availability of information upon which to base such estimates.
Commenter (12727) provides that EPA has failed to estimate the costs the Agency would incur to implement the proposal, despite the availability of information upon which to base such estimates. The commenter notes that Executive Order 12866 specifically includes costs "to the government" among the costs the Agency "shall consider." The commenter maintains that it again references costs "to the government" when describing the required assessments for significant regulatory actions. The commenter states that moreover, the costs of administering a regulation are plainly relevant to the reasonableness of an Agency's interpretation of the statutes supposedly authorizing the regulation.
Commenter (11479) asserts that EPA suggests that the rule apply to "significant regulatory actions" under Executive Order 12866, which governs regulatory planning and review, is overly broad, and would allow for even more politicization of science in EPA rulemaking. Executive Order 12866 defines "significant regulatory action" as having an annual economic effect of $100 million or more; interfering with actions taken by other agencies; altering the budgetary impact of entitlements, grants or user fees; or raising "novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order." According to the commenter, this elastic clause would grant the Agency or OMB's Office of Information and Regulatory Affairs (OIRA) the discretion to categorize any rule as significant, depending on an administration's priorities.
Response: This is a rule of internal procedure promulgated under the EPA's housekeeping authority, and imposes no enforceable duty on any state, local or tribal governments or the private sector. Additionally, this rule does not require the EPA or other parties to disclose or host data. Hence, this rule does not impose costs on the EPA or any other party to make such data available. As described in the preamble discussion of benefits and costs, the EPA recognizes there will be some incremental review and administrative costs to the Agency but anticipates these will be small. The analysis by CBO noted by the commenter is not applicable to this rule because the analyses were not for this rule and the requirements analyzed are not the same as those in this rule.
<IP_ADDRESS> Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
Comment: Several commenters (10974, 11183, 11184, 11403, 11918, 12412, 12458, 12474, 12546, 12715, 12719, 13549, 14397) state that the EPA inadequately addressed environmental justice in minority populations and low-income population impacts of the rule as required under Executive Order 12898. Commenters state that the supplemental proposal does not address the potential environmental justice implications of the research restrictions it would impose and therefore fails to meet the requirements of Executive Order 12898.These comments include the following:
Commenter (11183) provides that Executive Order 12898 directs agencies, including EPA, to identify and address "disproportionately high and adverse human health or environmental effects of their actions on minority and low-income populations, to the greatest extent practicable and permitted by law." The commenter notes that that proposed rule does not identify or address the potential impacts it may have on environmental justice communities with restriction to regulatory science that excludes private data. Thus, EPA has failed to comply with this requirement.
Commenter (12715) states that while EPA states that the supplemental proposal is not subject to Executive Order 12898 because it does not establish an environmental health or safety standard, 85 Fed. Reg. at 15,404, Executive Order 12898 is not so limited in its application. Rather, the commenter notes that it broadly applies to all Agency "programs, policies, and activities," Exec. Order 12898 at 1, and, in any event, the commenter adds that the supplemental proposal would affect countless environmental health and safety standards. In addition, the commenter states that to the extent EPA looks to existing environmental statutes as its authority for the proposed rule, those statutes generally require EPA to consider protection of human health and the environment in taking any regulatory action, which includes potential environmental justice concerns. See, e.g., Resource Conservation and Recovery Act (RCRA), 42 U.S.C. § 6981(a).
Commenter (12719) expresses that the EPA states that Executive Order 12898 does not apply to the proposed rule because "it does not establish an environmental health or safety standard." The commenter states that this statement is not accurate. As this proposal addresses how EPA will consider data that informs environmental health or safety standards, the commenter contends it is therefore relevant to environmental justice communities. The commenter asserts that disproportionately impacted communities are affected by every decision that EPA makes-- including how EPA considers or analyzes its data. EPA should consider the Transparency in Science proposal as subject to Executive Order 12898.
Commenters (11184, 12412, 12474, 13549, 14397) state that they are disheartened by the supplemental proposal's lack of consideration and analysis relating to the proposal's impact on Environmental Justice communities: the supplemental proposal merely states, without further explanation, that "this action does not have tribal implications as specified in Executive Order 13175," and "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." 85 Fed. Reg. at 15,404.
Commenter (10974) notes that Executive Order 12898 was promulgated to guide "each Federal agency" to "make achieving environmental justice part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minority populations and low-income populations in the U.S. ..." (59 FR 7629)
As with children, the commenter (10974) states that decades of epidemiological health research has found that Indigenous people, people of color, and those with low income are disproportionately exposed to, and impacted by, pollution. The commenter notes that this puts those individuals and communities at a higher risk of side effects from drastic changes in health research or policy making. According to the commenter, the claim that Executive Order 12898 does not apply because the supplemental proposal "does not establish an environmental health or safety standard", misses the spirit of environmental justice considerations.
Commenter (12458) expresses that, while excluding important public health data from rulemaking has the potential to harm all people, it would disproportionately harm environmental justice communities. The commenter states that the EPA has an explicit legal obligation to avoid these kinds of harms under Title VI of the Civil Rights Act and the Environmental Justice Executive Order 12898. Title VI of the Civil Rights Act requires EPA to ensure that the programs and activities it funds do not use criteria, methods, or practices that discriminate on the basis of race, color, or national origin. By restricting the consideration of some public health research, the commenter states that the proposed rule would have an adverse disproportionate impact on people of color in downstream programs and activities.
The commenter (12458) states that the Agency's own Environmental Justice and Community Revitalization Priorities memorandum pledges to "improve EPA science to better understand the needs of underserved and overburdened communities...with an emphasis on public participation to identify solutions." Yet the commenter notes that the EPA now seeks to expand a proposed rule that environmental justice groups overwhelmingly opposed in 2018. Moreover, the commenter provides that the EPA Environmental Justice 2020 Action Agenda specifically prioritizes ensuring that environmental justice is appropriately analyzed, considered and addressed in EPA rules." The commenter concludes that environmental justice cannot be appropriately analyzed, considered, or addressed in rulemaking if large swaths of public health data are excluded from the rulemaking process.
Commenter (12715), the EPA must -- but has altogether failed to -- contend with the fact that the supplemental proposal would have significant and impermissible environmental justice implications. Specifically, the commenter notes that by limiting the scientific studies and data that EPA may consider in both crafting environmental regulations and finalizing "influential scientific information," the SNPRM and the original proposal are Agency actions that could have disproportionately high and adverse human health or environmental effects on environmental justice communities. Scientific evidence plays a crucial role in addressing the various sources of environmental pollution and reducing the public health burden attributable to environmental factors. The commenter adds that the role of such evidence is particularly important to environmental justice communities, which are disproportionately affected by environmental risk. The commenters provides as an example a recent study by EPA scientists that found that facilities emitting dangerous particulate air pollution -- like soot -- disproportionately impact low-income communities and communities of color. The commenter contends that if EPA can now ignore or give less weight to epidemiological or other studies where the underlying data is not publicly available, this could lead to even more disparities in the burdens that air pollution and other toxics impose on environmental justice communities.
Commenter (11403) states that the proposed rule's arbitrary inclusion criteria will create unnecessary and harmful biases against epidemiological studies that are the only source of data designed to protect overburdened and vulnerable populations. The commenter notes that this directly violates Executive Order 12898, which directs every federal Agency to ". . . collect, maintain, and analyze information assessing and comparing environmental and human health risks borne by populations identified by race, national origin, or income. To the extent practicable and appropriate, Federal agencies shall use this information to determine whether their programs, policies, and activities have disproportionately high and adverse human or environmental effects on minority populations and low-income populations." The commenter provides that in 2011, EPA also signed a Memorandum of Understanding to implement the environmental justice goals of Executive Order 12898.
Response: This action is not subject to Executive Order 12898 because it does not establish an environmental health or safety standard. The final rule will not lead to systematic bias towards certain types of stakeholder goals of any party. The final rule requires EPA to follow best practices to evaluate potential links between exposure to a pollutant, contaminant, or substance and the effect and the nature of the dose-response relationship. EPA will also use the following, well-established factors when assessing study quality: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. The EPA will continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. As further detailed in the preamble to the final rule, only when characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect, will the EPA identify pivotal science and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation. Title 40 CFR 30.5 also provides additional considerations for instances when underlying dose-response data are not available for independent validation.
<IP_ADDRESS> Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks
Comment: Several commenters (10974, 11183, 12430, 12540, 12546, 12719) cite Executive Order 13045 in part or whole as stating that EPA has reason to believe that environmental or safety risks we encounter in "the air we breathe, the food we eat, water we drink or use for recreation, the soil we live on, and products we use or are exposed to" may disproportionately impact children, and therefore EPA must evaluate the effects of planned regulation on children and explain why this regulation is preferable to others. The commenters express concern that the proposed rule does not consider the disproportionate impacts on children that may occur with the restriction to regulatory science based on publicly available data. Thus, according to the commenters, the EPA has failed to comply with this requirement.
Commenter (12719) states that since the proposed rule concerns all environmental and health data that would contribute to rulemaking, the EPA should provide an analysis on how the proposal would affect data used to make decisions on children's environmental risks. The commenter provides that as children are known to be uniquely vulnerable to environmental exposures (lead exposures are just one example), it is difficult to understand how EPA can state that Executive Order 13045 would not apply to this proposed rule.
Commenter (12430) expresses that the proposed regulation could disproportionately affect children by preventing U.S. EPA from considering children's health studies, thereby increasing risks and negative health outcomes for American children. The commenter adds that the U.S. EPA recognizes the supplemental proposal as significant (and submitted it to OIRA, as discuss below), but failed to conduct the evaluation of health impacts to children required by Executive Order 13045.
Commenter (10974) states that section 2-202 part (b) of the Executive Order is what EPA bases their statement that the supplemental proposal does not apply, since the proposal was deemed "economically significant" under Executive Order 12866 and was submitted to OIRA for review. The commenter notes that it has also been made plain that EPA does not consider this rulemaking to be substantive. Interestingly, the commenter states that the EPA failed to make the claim that it was not a "substantive action" under Executive Order 13045, as they attempted with the review of the housekeeping authority. In either case, the commenter does not believe that (b) applies: this is a substantive rule and, thus, a substantive action.
The commenter (10974) states that, if promulgated, this rule would have broad-reaching implications on entire fields of research. The commenter adds that the power vested in the administrator to make determinations about which studies could be used  -  without any defined criteria guiding such decisions  -  is alarmingly inappropriate. If entire fields of environmental health (and all) research are impacted by this rulemaking, the commenter contends that it follows that those more at-risk from environmental pollution  -  those who have the greatest need for stringent, health-protective pollution standards  -  will fare worse than healthy populations. According to the commenter, the EPA's statement that this would not disproportionately affect children is naïve and inept.
The commenter (10974) notes that, as stated in Executive Order 13045 itself, "...scientific knowledge demonstrates that children may suffer disproportionately from environmental health risks and safety risks." Since the signing of Executive Order 13045 over 20 years ago, the commenter states that epidemiological and other environmental health research has consistently demonstrated that children can be, and are, disproportionately exposed to, and impacted by, a variety of environmental pollutants. The commenter adds that research is among the multitudinous amount of literature currently available for consideration while EPA is conducting policy making actions.
By broadening the applicability of this rule to all data and models collected  -  not just epidemiological data and models  -  the commenter (10974) contends that the EPA is further endangering the lives of healthy and at-risk children. The commenters believe that Executive Order 13045 applies to this rulemaking, and that EPA has not done enough to address anticipated health and safety impacts on children as the Executive Order recommends.
Commenter (12546) failed to consult with critical stakeholders on the impacts of the Science Transparency Rule on children's health. The commenter notes that environmental health regulatory and science actions impacted by this rule and supplemental proposal may disproportionately affect children's health. For example, NAAQS for pollutants such as PM2.5 (fine particulate), ozone and lead all have highly relevant and important studies showing that children can be more sensitive and susceptible to these pollutants. Therefore, the commenter strongly asserts that EPA is required to conduct an analysis under Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks.
Response: 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.
In addition, the final rule will not lead to systematic bias towards certain types of stakeholder goals of any party. The final rule requires EPA to follow best practices to evaluate potential links between exposure to a pollutant, contaminant, or substance and the effect and the nature of the dose-response relationship. EPA will continue to use the following, well-established factors when assessing study quality: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. The EPA will continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. As further detailed in the preamble to the final rule, only when characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect, will the EPA identify pivotal science and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation. Title 40 CFR 30.5 also provides additional considerations for instances when underlying dose-response data are not available for independent validation. In addition, as this rule makes clear, if implementing this procedural rule would result in conflicts with existing environmental statutes, the procedural rule will yield to the existing statutes.
<IP_ADDRESS> Executive Order 13132: Federalism
Comment: Commenters (12430, 12435, 12715) contend that the supplemental proposal violates the principles set forth in Executive Order No. 13132, Federalism, 64 Fed. Reg. 43,255 (Aug. 4, 1999).
Commenter (12715) provides that Executive Order 13132 provides that agencies must have an accountable process to ensure meaningful and timely input by state and local officials in the development of regulatory policies that have federalism implications. Federalism implications are defined as including regulations and actions that have substantial direct effects on states or local governments (individually or collectively). Id. at 1. The commenter contends that, contrary to EPA's unsupported, cursory assertion, 85 Fed. Reg. at 15,404, the supplemental proposal indisputably has substantial federalism implications because, as explained herein, states and local communities are directly and significantly impacted by health and risk-based standards established by EPA.
The commenter (12715) notes that standards adopted by EPA under the supplemental proposal's directive to exclude or demote relevant and valid scientific studies will have substantial direct effects on states and cities. The commenter provides that states may be statutorily required to adopt EPA standards or to obtain EPA approval of state-set standards and may lack the resources or institutional capacity to deviate from EPA standards. The commenter adds that states, counties and cities are also significantly impacted through incorporation of EPA standards into the regulations or programs of other federal agencies that rely on EPA standards and/or modeling. The commenter provides that this includes, inter alia, fuel economy standards set by the National Highway Transportation and Safety Administration, which have an impact on vehicle emissions of harmful air pollutants. Despite the substantial impact EPA's supplemental proposal would have on states and local governments, the commenter states that the EPA did not seek any input from states and local governments in developing the supplemental proposal, in violation of Executive Order 13132. The commenter asserts that the EPA must engage in the required consultation with state and local officials, as required by the Executive Order, before proceeding further.
Similarly, commenter (12430) states that the supplemental proposal would disrupt the cooperative relationship between the federal government and California to implement federal environmental laws, including potentially undercutting state-level air quality standards under the CAA.
The commenter (12430) provides that the CAA represents a hallmark example of cooperative federalism, as U.S. EPA and state air agencies partner to protect public health from harmful effects of air pollution. The commenter notes that an essential aspect of this relationship includes basing federal and state-level implementation decisions on the best available science. According to the commenter, this includes U.S. EPA setting of NAAQS at a level requisite to protect the public health, while states meet the standards through development and implementation of State Implementation Plans (SIP). The commenter provides that the NAAQS must be based on air quality criteria developed using the "latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare," and updated at least every five years following a thorough review by an independent scientific review committee. The commenter adds that the CAA sets out specific actions for this committee to advise U.S. EPA on areas where additional knowledge is required for reviewing NAAQS and the research efforts necessary to obtain that information, among related topics.