Comment [6163-1215]: Comment (6133) states that the proposed rule's definitions are vague, arbitrary, and capricious, and fail to provide fair notice to the public of how EPA would implement any final rule.
The APA requires notices of proposed rulemakings to include "the terms or substance of the proposed rule or a description of the subjects and issues involved." 5 U.S.C. § 553(b)(3). Proposals must "provide sufficient factual detail and rationale for the rule to permit interested parties to comment meaningfully." Honeywell International, Inc. v. EPA, 372 F.3d 441, 445 (D.C. Cir. 2004).
The instant Proposal lacks any statutory authority for regulatory terms and text, concepts, and other inventions that make up its foundation. Moreover, many of these regulatory terms and text are vague, unexplained, internally inconsistent, and otherwise arbitrary and capricious.
Response: See response to Comment 2157-149.
Comment [6351-3238]: Commenter (6373) suggests that the Rule includes several definitions and requirements that are vague or appear to contradict standard scientific practice, which will make it difficult if not impossible for the scientific community to comply with its mandates. According to the commenter, this is impermissible under the APA, which requires that "general notice of proposed rulemaking shall be published in the Federal Register," including the "terms or substance of the proposed rule." As currently drafted, the Rule's ambiguity about what constitutes "independent validation" prevents clear direction to researchers. While this Rule governs EPA actions, the commenter notes that third party researchers must rely on its direction in order to design studies that the agency may use to inform regulations.
Additionally, the commenter states that the Executive Orders cited as providing the Rule's authority require that regulations must be "simple and easy to understand, with the goal of minimizing uncertainty and litigation," and must specify regulations' effect "in clear language." The commenter contends that the Rule is inconsistent with these mandates.
Response: See response to Comment 2157-149. The final rule does not cite to any Executive Orders as authority.
Comment [6895-3299]: Commenter (6916) states that the rulemaking process set forth in the APA, and in more detail in the CAA, provide a Congressionally-directed framework to assure that the Agency's rulemaking decisions are not arbitrary  -  that they are made transparently and based on an adequate record that is subject to public scrutiny. Similarly, the commenter notes that the ERDDAA requirement to submit CAA regulatory proposals to SAB review serves as a check to ensure that the scientific basis underlying the rule is robust.
The commenter contends that the EPA failed to submit the rule to its SAB, and additionally did not prepare a regulatory impacts analysis of the Proposal as required by Executive Order 12,866. Nor did the Administrator provide sufficient time for a meaningful OMB OIRA review, having signed the rule on April 24, 2018 after having submitted the Proposal to OIRA on April 19, 2018  -  despite the requirement to provide OIRA with at least 10 working days to decide whether to waive review.
According to the commenter, nor did the Agency comply with other Executive Orders requiring analyses of other potential aspects of rulemaking proposals, despite their relevance to this proposed action. For example, the Agency did not satisfy the requirements of Executive Order No. 13,045, "Protection of Children from Environmental Health Risks and Safety Risks," 62 Fed. Reg. 19,885 (Apr. 21, 1997), which requires federal agencies to "make it a high priority to identify and assess environmental health risks and safety risks that may disproportionately affect children," in proposing regulatory actions. Instead, despite the fact that among the "dose response data and studies" the Agency is questioning are those analyzing the disproportionate health effects of air pollution on children's health, and the fact that as Executive Order 13,045 itself notes, children "breathe more air in proportion to their body weight than adults," EPA simply states that the Proposal "does not concern an environmental health risk or safety risk." Similarly, EPA dismisses Executive Orders 12,898 "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations," and 13,175, "Consultation and Coordination with Indian Tribal Governments," single sentence stating for each that they do not apply. EPA's failure to subject the Proposal to these required analyses denies the public "transparency"  -  because information is withheld on which the affected public might base meaningful comments  -  as well as denying OMB the information it needs to complete its reviews.
EPA's Proposal claims to be "consistent with" Executive Order 13,777, which ordered a Regulatory Reform Task Force to identify regulations that "rely in whole or in part on data, information, or methods that are not publicly available or are insufficiently transparent to meet the standard for reproducibility," and 13,783, which required a focus on energy independence, but also the "achieve[ment of] environmental improvements for the American people."] But the Executive Order 13,777 Task Force report does not identify any regulations that rely on insufficiently transparent data, nor is this Proposal - which would deny access to scientific studies - consistent with the goal of advancing environmental improvements for the American public.
Response: See responses to Comments 2157-149 and 6112-4452.
Comment [9069-3312]: Commenter (6185) states that the Proposal is too vague as written to provide the public with a meaningful opportunity to comment. According to the commenter, the Proposed Rule, as written, lacks credible specificity and is overly vague in its terms and scope. Under the APA, a federal regulatory agency must publish notice of either the substance of a proposed rule or a "description of the subjects and issues" covered by a proposed rule (5 U.S.C. § 553(b)(3)). In Fertilizer Institute v. EPA, 935 F.2d 1303 (D.C.Cir. 1991), the court observed that it "has consistently interpreted that requirement to mean that an agency's notice must `provide sufficient detail and rationale for the rule to permit interested parties to comment meaningfully'" [citing Florida Power & Light Co. v. United States, 846 F.2d 765, 771 (D.C. Cir. 1988), cert. denied, 490 U.S. 1045 (1989)]. As such, the commenter notes that the EPA is required to articulate the specifics of its proposed rulemakings in a manner that provides a valid opportunity for public comment.
In this proposal, the commenter provides that the EPA solicits comment across a long list of topic areas, but fails to provide the Agency's own "sufficient detail and rationale" on the solicited comment areas, in contravention to APA § 553(b)(3). Commenters are left in the position of speculating on EPA's views and on those of other commenters that would presumably shape EPA's final rule. It is well settled law that this approach fails to provide adequate notice for informed public comment. In Fertilizer Institute v. EPA, the court held "Commenting parties cannot be expected to monitor all other comments submitted to an agency." In commenters' trying to anticipate potential rule revisions in response to comments from others, the court has also stated, "the EPA must itself provide notice of a regulatory proposal. Having failed to do so, the commenter argues that it cannot bootstrap notice from a comment" [Fertilizer Institute v. EPA, at 1312, quoting Small Refiner Lead Phase-Down Task Force v. EPA, 705 F.2d 506, 547 (D.C.Cir. 1983) (emphasis in original)].
Response: See response to Comment 2157-149.
Comment [9078-3457]: Commenter (6194) provides that the statutory requirements that Congress established for the process by which agencies develop regulations -- while often described as "procedural" in nature -- assure that agencies reach substantively valid and informed outcomes. These statutory and other rulemaking procedures were put in place for a reason; failing to follow them suggests a lack of informed analysis and, without an authorized basis for foregoing the process, an agency decision cannot be upheld. Thus, the commenter states that while lack of compliance with required procedures is itself a fatal flaw in the Proposal, it also undermines the basis of and credibility for the substance of the Proposal. Here, the contends that the proposal violates multiple procedural requirements, including but not necessarily limited to: compliance with the APA and Paperwork Reduction Act (PRA); consultation with the OMB, other federal agencies, and EPA's own SAB; and application of Executive Orders regarding the Protection of Children from Environmental Health Risks and Safety Risks, and Environmental Justice in Minority Populations and Low-Income Populations.
The commenter states that under the APA, notices of proposed rulemakings must reference the legal authority under which the rule is proposed. 5 U.S.C. § 553(b)(2). The Federal Register notice of the Proposal fails to meet this requirement. The Proposal cites provisions from several statutes, but does not explain how any of those provisions provide authority for the Proposal. Even if relevant authority could be found somewhere in the statutes, the APA does not countenance placing the burden on the public to search for it.
The commenter adds that notices of proposed rulemakings must also include "the terms or substance of the proposed rule or a description of the subjects and issues involved." 5 U.S.C. § 553(b)(3). The purpose of this requirement is to "provide sufficient factual detail and rationale for the rule to permit interested parties to comment meaningfully." Honeywell International, Inc. v. EPA, 372 F.3d 441, 445 (D.C. Cir. 2004). The Federal Register notice of the Proposal fails to meet this requirement. It is too vague to allow for fully meaningful and targeted comments. For example, the purported need and objective of the Proposal is couched in references to "transparency" and "validation" but these terms are not defined in the Proposal, nor do they have a single definition amongst professionals in the fields impacted by the Proposal. According to the commenter, the Proposal also improperly uses distinct concepts, such as "reproducibility" and "replicability," as though they are interchangeable.
The commenter states that the notice similarly presents key issues beyond definitions at only broad stroke levels, raising issues in such a general manner that it fails to provide the public with adequate notice of what EPA intends. For instance:
 The Proposal requires that certain data and models be made "publicly available in a manner sufficient for independent validation," and indicates that information will satisfy this standard when "it includes the information necessary for the public to understand, assess, and replicate findings." 83 Fed. Reg. at 18,773-74. But it is not clear what degree of availability or explanation would satisfy the Proposal. For example, the "public" referenced in the Proposal could be scientists trained in the relevant field or members of the general public.
 The Proposal provides that, "where necessary, data would be made available subject to access and use restrictions." Id. What this process would look like is not addressed in the Proposal or discussed at all in the preamble. This leaves significant open questions, such as who will pay for and implement these restrictions and who will decide which people are allowed to access the data and under what standards.
 The Proposal appears to require EPA to conduct independent peer review of all "pivotal regulatory science," but provides no detail as to what this means or how it will be implemented. Id. For example, it is unclear who within the agency would perform this peer review, when it would occur, and whether (and when) prior peer review in the journal publication process would serve as a substitute for EPA peer review.
 The Proposal includes an exemption mechanism but does not provide information about the process or conditions under which exemptions shall or can be sought and granted.
Given these and other ambiguities, the public cannot adequately assess what EPA thinks the Proposal means or how it will implement it. Nevertheless, for purposes of these comments, we assume EPA intends a broad interpretation that would preclude a swath of scientific studies and information from use and consideration in regulatory proceedings.
Moreover, the commenter states that many of the sources cited in the Proposal either do not support the text of the proposed regulation, do not support the proposition for which they are cited, or are so broad that the public does not have fair notice of, and therefore cannot evaluate, EPA's rationale for the Proposal. For example, EPA asserts that it considered policies or recommendations of third-party organizations that advocate for open science. The Proposal, however, does not cite specific policies or recommendations, instead merely listing the names of institutions. 83 Fed. Reg. at 18,770 & n.9. Even when a specific report is referenced, such as the National Academies' reports on Improving Access to and Confidentiality of Research Data, Expanding Access to Research Data, and Access to Research Data in the 21st Century, the Proposal fails to cite the specific sections EPA purportedly considered or relied upon or the specific policies embodied in these reports that are allegedly advanced by the Proposal. Id. at 18,770 n.10. Other references are similarly vague.
The overall lack of clarity is illustrated by EPA's own solicitation of feedback; it covers so wide a range of issues -- posing over two dozen questions -- that it makes clear EPA has not identified a proposed path forward on which the public can comment. The Proposal would be more appropriately posited as an Advanced Notice of Proposed Rulemaking; it does not meet the APA's standards for proposed rules.
Response: See response to Comment 2157-149.
Comment [6112-3191]: Commenter (6137) states that, to the extent EPA decides to apply this Proposed Rule in the context of enforcement, adjudicatory, and permit actions  -  which it should not  -  it must first issue a proposal setting out its basis for such a rule and provide opportunity for comment under the APA and CAA § 307(d). EPA cannot rely on the comment opportunity provided by its April 30, 2018 Proposal, as the Proposal provides no notice whatsoever of the substance of what EPA might or might not include in a rule applying to enforcement and other actions excluded from the regulatory text of the proposal. See 83 Fed. Reg. at 18,773 (proposed 40 C.F.R. § 30.3).
Response: As discussed in the final rule preamble at Section III.A, EPA will issue statute-specific regulations following this procedural rule. Any substantive regulations will be issued via notice and comment rulemaking.
Comment [6141-2555]: Commenter (6166) suggests that procedurally, the Proposal violates the APA and a number of other laws that set forth specific procedures EPA must follow during its rulemaking process.
Response: See response to Comment 2157-149.
Comment [6133-2161]: Commenter (6158) states that a lack of analysis is unfair to the public and may also itself constitute a violation of the APA and Executive Order requirements for promulgation of agency rules. The lack of analysis and rationale is further evidence that this proposed rule is unnecessary and burdensome and should be withdrawn.
Response: See response to Comment 2157-149.
Comment [9066-1949]: Commenter (6188) contends that, in addition to the substantive deficiencies, EPA has failed to satisfy the appropriate procedural requirements for the Proposed Rule's promulgation.
First, the NPRM does not meet the federal APA requirement to cite adequate authority providing a basis for EPA's promulgation of the rule. See 5 U.S.C. § 553(b)(2) (requiring that an agency make reference to the authority under which the rule is proposed in a NPRM). As discussed, none of the statutory authority identified by EPA authorizes it to support the proposed rule, and further, EPA has solicited comment on this basic question, asking the public to supply the basis for EPA's rulemaking authority. This is not permissible under the APA.
The NPRM, by soliciting comment on the very nature of the rule itself, also suggests that EPA could adopt a Final Rule that deviates significantly from the Proposed Rule, an outcome which would violate the APA's notice provisions were the rule not first subjected to another round of notice and comment. 5 U.S.C. § 553(b)(3); see National Black Media Coalition v. FCC, 791 F.2d 1016 (2d Cir. 1986) (final rule that deviated significantly from NPRM did not provide the public with adequate opportunity to engage in the rulemaking process as required by the APA). Given the Proposed Rule's potential to affect scores of significant regulatory decisions, its brevity and ambiguity are breathtaking. Indeed, the Proposed Rule is more akin to a brainstorming document than a precisely noticed regulatory action. Without a clear statement of the Proposed Rule's reach and implications, members of the public cannot engage as informed participants in the rulemaking process, the very purpose of the APA. As the Third Circuit recognized in Prometheus Radio Project v. FCC, 652 F.3d 431, 450 (3d Cir. 2011):
      ...there must be an exchange of views, information, and criticism between interested persons and the agency...Consequently, the notice required by the APA...must disclose in detail the thinking that has animated the form of a proposed rule and the data upon which that rule is based...[A]n agency proposing informal rulemaking has an obligation to make its views known to the public in a concrete and focused form so as to make criticism or formulation of alternatives possible." (quoting Home Box Office, Inc. v. FCC, 567 F.2d 9, 35-36 (D.C. Cir. 1977) (internal citations and footnotes omitted))
Here, according to the commenter, despite EPA's purported commitment to transparency, the Proposed Rule contains no "concrete and focused" explanation of its impacts upon which the public can rely to formulate opinions regarding the rule's potential adoption. For example, nowhere does the Proposed Rule assess possible impacts on environmental quality and public health from implementation of this rule, including the likelihood that EPA would be unable to consider important scientific research in its rulemakings and other activities; discuss how issues associated with patient privacy and CBI will be resolved; or identify any authority or data supporting the rule's promulgation.
Instead, the Proposed Rule creates a confused and muddled picture, soliciting comments on "additional or alternative sources of authority" for the rulemaking and "whether other alternative or additional regulatory or other policy vehicles on a programmatic or statutory level would be appropriate as alternative or additional steps." 83 Fed. Reg. 18769, 18771. Far from satisfying the APA's requirements, the Proposed Rule entirely fails to "describe the range of alternatives being considered with reasonable specificity." Horsehead Res. Dev. Co. v. Browner, 16 F.3d 1246, 1268 (D.C. Cir. 1994) (citing Small Refiner Lead Phase - Down Task Force v. EPA, 705 F.2d 506, 549 (D.C. Cir. 1983)). In other words, the Proposed Rule, on its face, provides the public with no opportunity to understand the authority for its implementation or precisely how its mandates would apply to future regulatory decision-making, and leaves the door open to adoption of a Final Rule that looks very different from EPA's proposal. Given the vagueness of the Proposed Rule and the broad request for comments, the commenter asserts that the EPA must engage in another round of notice and comment before finalizing the rule if it intends to follow any substantive suggestions offered by commenters.
Response: See response to Comment 2157-149.
Comment [8750-1820]: Commenter (9227) notes that EDF has two FOIAs directly related to the substance of this rulemaking pending at EPA, for which we have received no responsive documents thus far, despite the passage of the statutory deadlines for a response. The first request (No. EPA-HQ-2018-005636) was submitted on March 20, with a determination from EPA statutorily due by April 19 -- which has not been provided. EDF submitted a second request (No. EPA-HQ-2018-007397) on May 4. According to the commenter, given the lack of transparency and information around the basis for this rule, its impacts, and its true motivations, EDF and the public cannot provide informed comment on this rule without the public records that have been requested. The commenter suggests that, for EPA to close the public comment period on this Proposal before all relevant records are released to the public is arbitrary and prevents our ability to meaningfully comment.
Response: Both FOIA requests EPA-HQ-2018-005636 and EPA-HQ-2018-007397 have been addressed and closed. The EPA disagrees that there was insufficient opportunity for informed comment at the proposed rule stage because the rulemaking docket contains the materials relevant to the public's review.
Comment [8750-1806]: Commenter (9227) provides that Section 553 of the APA, 5 U.S.C. § 553(b)(3), requires that an agency proposing a rule "provide sufficient factual detail and rationale for the rule to permit interested parties to comment meaningfully." The CAA requires even more, that the Federal Register notice be accompanied by a statement of basis and purpose that includes a summary of the factual data on which the proposed rule is based, the methodology used in obtaining the data and in analyzing the data; and the major legal interpretations and policy considerations underlying the proposed rule. The commenter notes that all data, information, and documents on which the proposed rule relies must be included in the docket on the date of publication of the proposed rule.
These core requirements are "designed (1) to ensure that agency regulations are tested via exposure to diverse public comment, (2) to ensure fairness to affected parties, and (3) to give affected parties an opportunity to develop evidence in the record to support their objections to the rule and thereby enhance the quality of judicial review." In addition, "a chance to comment ... [enables] the agency [to] maintain[] a flexible and open-minded attitude towards its own rules," and "avoid[s] the inherently arbitrary nature of unpublished ad hoc determinations." The "notice required by the APA ... must disclose in detail the thinking that has animated the form of a proposed rule and the data upon which that rule is based .... [A]n agency proposing informal rulemaking has an obligation to make its views known to the public in a concrete and focused form so as to make criticism or formulation of alternatives possible." Home Box Office, Inc. v. FCC, 567 F.2d 9, 35-36 (D.C. Cir. 1977); see also Horsehead Res. Dev. Co., Inc. v. Browner, 16 F.3d 1246, 1268 (D.C. Cir. 1994) ("[A]n agency must describe the range of alternatives being considered with reasonable specificity. Otherwise, interested parties will not know what to comment on, and notice will not lead to better-informed agency decisionmaking.") (internal citations and quotation marks omitted).
According to the commenter, the failure to include critical documents relevant to the proposed rule in the docket, as required by the CAA, itself constitutes a notice violation because "absence of those documents, or of comparable materials. . . makes impossible any meaningful comment on the merits of EPA's assertions." By failing to provide a more developed docket, EPA is frustrating the terms and purposes of these statute's notice requirements. These procedures are in place to form a "specific" proposal that can serve as a "focus for comments," Small Refiner Lead Phase Down Task Force v. EPA, 705 F.2d 506, 548-49 (D.C. Cir. 1983); see Home Box Office, Inc. v. FCC, 567 F.2d 9, 36 (D.C. Cir. 1977) (agency must "make its views known . . . in a concrete and focused form so as to make criticism or formulation of alternatives possible"). Because EPA has not provided supporting evidence, has not included key items it points to as major considerations underlying the Proposal, and has generally presented a vague and unspecified proposed rule and docket, EDF [the commenter] and the public are hindered in our ability to provide specific comment focused on the underpinnings of the Proposal, because we do not know and can only guess as to what they are.
The commenters adds that even the text of EPA's proposed rule and the statement of basis and purpose fails to provide the requisite notice to allow meaningful comment. At the most fundamental level, the commenter contends that it contains vague and contradictory statements about the actual effect of the Proposal. The Proposal generally appears to make its requirements mandatory -- i.e., failure to make information publicly available will preclude the agency from relying on the study at all. See 83 Fed. Reg. at 18,769 n. 3 ("EPA is proposing to exercise its discretionary authority to establish a policy that would preclude it from using such data in future regulatory actions."); id. at 18,771 ("the regulatory text would impose requirements"); see also id. at 18,769 ("EPA will ensure that the data and models underlying the science is publicly available...") (emphasis added) and proposed section 30.5 ("When promulgating significant regulatory actions, the Agency shall ensure that does response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation"). In a few places, however, the Proposal makes it sound as if its aims are more aspirational. See id. at 18,770 ("Where available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments.") (emphasis added); id. at 18,772 ("The proposed rule directs EPA to make all reasonable efforts to" make data publicly available, but "does not compel the Agency to make that information available where it concludes after all such reasonable efforts that doing so in way [sic] that complies with the law and appropriate protections is not possible.") (emphasis added); see also id. at 18,768 ("EPA should ensure that the data underlying those are publicly available...") (emphasis added). The commenter states that the difference between a requirement precluding use of science and making all best efforts to make data publicly available is enormous.
To the extent EPA intends to propose a rule that would preclude use of science, as it appears the Proposal would do, the commenter contends that the proposed rule is further flawed because it contains no analysis of how that would affect regulations. How many studies does EPA typically rely on in promulgating regulations? What percentage of these would meet EPA's new requirements? For those that do not, how many could not meet these requirements for patient privacy, CBI, or other reasons? How would EPA set standards if it must rely on many fewer studies? Would EPA be precautionary in the face of less evidence? Would EPA delay promulgating regulations in order to comply with this new mandate? How does this mandate interact with statutory deadlines or statutory requirements that EPA look at a wide range of science? None of these very basic questions are addressed in the proposed rule and without answering them, it is impossible for the public to assess the import and likely consequences of the Proposal. Even more basically, the agency gives no notice as to the Proposal's impacts, its costs, its benefits, why it applies only to regulatory requirements but not to any regulatory actions (like licensing or permitting) that confer a benefit, substantive and procedural criteria for adjudicating waivers, or even the legal theory under which the Proposal issues -- the plaintive solicitation for comment as to "additional or alternative sources" of authority, 83 Fed. Reg. at 18771, does not suffice.
The commenter states that to the extent the Proposal is intended to solicit comment on how EPA may make reasonable efforts to make data publicly available it is also unlawfully vague. The proposed rule includes numerous footnotes referencing entire websites or even Departments of the Executive Branch. For example, the Proposal claims that "EPA believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly used across some parts of the Federal government." To support this proposition, EPA remarkably cites (without any further elaboration or explanation in the proposal itself) to "examples from the U.S. Department of Health and Human Services, National Institute of Standards and Technology, U.S. Department of Education, and the U.S. Census Bureau." See Small Lead Refiner Phase Down, 705 F. 2d at 548 (requirement that comments are to raise issues with "reasonable specificity" applies equally to the agency giving notice). For example, it is not possible to identify whether the sources referenced support EPA's claim that there are approaches available to address the serious privacy issues raised by the Proposal --  without providing the specific policies and recommendations, a public commenter has no way of knowing whether they are consistent or why EPA believes them to be consistent. It is impossible to respond in a meaningful way without significant guesswork.
Similarly, in footnote 10, where EPA lists a number of organizations whose "policies and recommendations" the Proposal allegedly took under consideration -- no explanation is provided. In addition, in the proposed rule EPA fails to adequately define key terms like "validation", "independence", "reproducibility," "replication," and "uncertainty," while also citing a "replication crisis" in science. The commenter states that it is important that these terms are defined clearly as these terms are not defined consistently across the scientific community nor governments -- which has implications for the scope and purview of the proposed rule.
The commenter asserts that this amount of information is wholly insufficient to allow a public commenter to provide meaningful comments about these issues. Courts have been reluctant to find that important information appearing solely in the footnote of a rulemaking document satisfied the notice requirement of the APA, holding that "an agency may not turn the provision of notice into a bureaucratic game of hide and seek." Referencing a key document without further discussion in the rulemaking document itself, and without incorporating it by reference or publishing it in the Federal Register, also does not satisfy the notice requirements of the APA. Subsequent publication of the document may not be enough to cure a defect of notice where an important issue is "belied by the obscurity of the footnote intended to give notice" and further agency procedure is required to provide the public with "the opportunity to comment on a significant part of the agency's decisionmaking process as required by section 553." Thus, the undifferentiated citations in the footnotes of the Proposal do not give adequate notice for public comment.
Response: See response to Comment 2157-149. The rulemaking docket contains the materials relevant to the public's review.
Comment [8750-1779]: Commenter (9227) asserts that the EPA has failed to provide a properly developed record in support of the proposed rule. EPA has not identified sufficient supporting evidence in the Proposal or in its docket and has failed to provide adequate notice of the supporting evidence for the public to respond to meaningfully, as the APA, the CAA and other substantive statutes require.
Under the APA, agencies must base their actions on examination of the facts, "the agency must examine the relevant data and articulate a satisfactory explanation for its action including a `rational connection between the facts found and the choice made.'" The factual determination underlying the agency decision must be based on substantial evidence and will be set aside "if the agency `relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.'"
Rulemaking under the CAA is subject to the same general requirements of statutory conformity and reasoned decision-making derived from the APA and basic principles of administrative law. CAA rules cannot be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," "in excess of statutory jurisdiction, authority, or limitations, or short of statutory right," or "without observance of procedure required by law."
As noted in Appendix A (of their comment letter) and in Section VIII.D (in their comment letter), the commenter states that the EPA's citations for support in the Proposal are vague and uninformative, and even where the particular citation can be identified and located, it is often not clear how EPA thinks the citation supports the Proposal. The commenter asserts that this does not meet the standards of the APA and CAA.
Additionally, the commenter contends that the EPA has failed to meet the docket requirements of the CAA. CAA section 307(d)(3) requires that publication of the proposed rule in the Federal Register include a summary of the factual data on which the proposed rule is based, the methodology used in obtaining the data and in analyzing the data, and the major legal interpretations and policy consideration underlying the proposed rule. It also requires the agency to place "[a]ll data, information, and documents. . . on which the proposed rule relies" in the rulemaking docket on the date of publication of the proposed rule. The undifferentiated citation of articles and policies, most of which contradict the Proposal or otherwise offer no support for it, fails abjectly to satisfy these requirements. Any document that becomes available after the proposed rule has been published and that is of central relevance to the rulemaking must also be placed in the docket as soon as possible after its availability. The agency must allow enough time for participants in the rulemaking to respond to those documents with comments.
As of the date of the publication of the Proposal, the commenter states that the docket at regulations.gov contained only the following 12 documents: (1) OIRA Review Start Document (Apr. 17, 2018); (2) OIRA Review Conclusion Document (Apr. 23, 2018); (3) White House Memorandum on Scientific Integrity (Mar. 9, 2009); (4) Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies; Republication, 67 Fed. Reg. 8,452 (Feb. 22, 2002); (5) Exec. Order 13,777, Enforcing the Regulatory Reform Agenda, 82 Fed. Reg. 12,285 (Feb. 24, 2017); (6) EPA, Plan to Increase Access to Results of EPA-Funded Scientific Research (Nov. 29, 2016); (7) OMB Memorandum M-05-03 on Issuance of OMB's "Final Information Quality Bulletin for Peer Review" (Dec. 16, 2018); (8) EPA, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency (Oct. 2002); (9) Exec. Order 13,563, Improving Regulation and Regulatory Review, 76 Fed. Reg. 3,821 (Jan. 18, 2011); (10) Exec. Order 16, 093, Promoting Energy Independence and Economic Growth, 82 Fed. Reg. 16,093 (Mar. 28, 2017); (11) OMB Memorandum M-13-13: Open Data Policy-Managing Information as an Asset (May 9, 2013); (12) Commission on Evidence-Based Policymaking, The Promise of Evidence-Based Policymaking (Sep. 2017).
According to the commenter, this clearly is not enough to meet the APA's or CAA's requirements. Aside from the drafts of the proposed rule submitted to OIRA, each of these documents was a pre-existing memorandum, policy document, or executive order that contains no specific analysis -- factual, legal, policy or otherwise -- that pertains to the impacts of or at all justifies this proposed rule. While EPA in the proposed rule cites to some of these documents as purportedly being consistent with these prior policies, see, e.g., 83 Fed. Reg. at 18,769-70, as is discussed in Section II and in Appendix A (of their comment letter), these policies do not in fact provide any basis for the Proposal. The record that EPA provides clearly fails to support its proposed action. Some of the factual data, legal interpretations, and policy considerations that EPA has not sufficiently provided evidence for include: the number of scientific studies that would be precluded from consideration under the Proposal; whether there are fields of research where the Proposal would result in insufficient scientific information available for EPA to meet its statutory duties; how EPA will address the substantial privacy concerns implicated by the Proposal; how application of this Proposal will impact substantive agency actions; what the costs of implementing this Proposal are if EPA intends to not just exclude studies from consideration where too costly to provide access, etc.
The commenter notes that the EPA, for instance, includes Executive Order 13,563 in the docket to support its statement that "[t]he best available science must serve as the foundation of EPA's regulatory actions."While Executive Order 13,563 makes that statement, it does not support EPA's Proposal, which as explained above, hinders EPA's use of the best available science. EPA provides no evidence or explanation in the docket or Proposal for why EPA believes this policy would further that goal. 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. Meanwhile, EPA blatantly violates the executive order's provisions requiring agencies to weigh costs and benefits; to write regulations that are easy to understand; and to provide the scientific and technical findings underlying the rule for the public to comment on.
Section 307(d)(3) of the CAA requires that "[a]ll data, information, and documents ... on which the proposed rule relies shall be included in the docket on the date of publication of the proposed rule." Many items that EPA cites to in the Proposal as providing a basis for the proposed rule do not appear in the docket. For example, EPA states: "The proposed rule takes into consideration the policies or recommendations of third party organizations who advocated for open science." In a footnote, EPA provides: "These include policies and recommendations from: The Administrative Conference of the United States' Science in the Administrative Process Project; National Academies' reports on Improving Access to and Confidentiality of Research Data, Expanding Access to Research Data, and Access to Research Data in the 21st Century; the Health Effects Institute; Center for Open Science; members of the Risk Assessment Specialty Section of the Society of Toxicology, the Dose Response Section of the Society for Risk Analysis, and the International Society for Regulatory Toxicology and Pharmacology; and the Bipartisan Policy Center's Science for Policy Project." Many of these policies and recommendations did not appear in the docket on the data of publication of the Proposal and still do not appear in the docket -- a clear violation of the CAA -- nor are the specific documents or reports even identified or properly cited so that they may be tracked down. This is evidently prejudicial to commenters -- it undermines commenters ability to submit meaningful feedback when the agency is hiding the ball in this manner.
These policies and recommendations are not easily identifiable on their own either, even after significant internet research. This is also true of footnote 16, where EPA lists a number of agencies to support its claim that the federal government is already implementing solutions to data disclosure. EPA cites, for example, the National Institute of Standards of Technology. NIST has numerous policy documents on protecting privacy concerns and keeping data secure as well as its own internal policies on releasing data. It is hard to see how any are relevant here, but without a particular cite the public is denied even a chance to respond to whatever EPA is trying to use as support -- or must respond to everything that might be being referenced, creating a burdensome task. Throughout these comments, as we attempt to respond to EPA's Proposal, we have been very practically limited by our inability, even after much research and consideration, to be fully certain we have identified the appropriate policies to respond to. This presents a situation that the CAA's docket requirement was exactly formulated to prevent.
On May 25, 2018, EPA added a memorandum to the docket for this rulemaking. This memorandum contains hyperlinks apparently intended to accompany various citations in the footnotes of the Proposal. This document does not cure the former procedural defect, as the CAA requires information the proposed rule relies on to be placed in the docket on the day the proposed rule is published. Further, these hyperlinks still link ambiguously to various documents and agency websites without providing any information about what specifically EPA intends to cite or how the cited information is being used or considered by EPA. Additionally, simply adding such a document to the docket does not provide adequate notice to the public. Someone who had access only to the proposed rule and was not carefully monitoring the docket would have no indication or notice of this new document. Either EPA is failing to comply with the CAA's requirements by failing to include in the docket factual data, legal interpretations, and policy considerations that support the Proposal, or these supporting items do not exist, deeming this rulemaking completely arbitrary -- in either case the Proposal fails to meet the standards of the APA and CAA. Under the CAA the rulemaking docket "must provide the entire basis for the final rule and the exclusive record for judicial review," this docket clearly cannot support a final rule.
Response: See response to Comment 2157-149. The rulemaking docket contains the materials relevant to the public's review. EPA notes that this is an internal procedural rule and is not subject to CAA § 307(d). As discussed in the final rule preamble at Section III.A., EPA will issue statute-specific transparency regulations or programmatic regulations after this procedural rule.
Comment [8750-1776]: Commenter (9227) provides that the APA, the CAA, and other federal statutes proscribe procedures that must be followed in agency rulemaking, and which EPA has failed to meet in its Proposal. This proposed rule does not fit into any of the exceptions the APA provides for the procedural requirements of rulemaking -- it is neither an interpretive rule, general statement of policy, or a rule of agency organization, procedure or practice.
The commenter states that the proposed rule does not purport to clarify or explain an already existing statute or rule, and thus is not an interpretive rule. The proposed rule is not a general statement of policy, because it establishes a standard of conduct, which has the force of law. It uses mandatory language indicating a requirement: "When promulgating significant regulatory actions, the Agency shall ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation." Unlike a general statement of policy, which "does not establish a `binding norm,'. . . [and] is not finally determinative of the issues or rights to which it is addressed," EPA here makes no qualifications that it has any leeway to not follow the Proposal's new requirements in all future regulatory actions. The provision allowing the EPA Administrator to grant exceptions in a limited number of cases does not turn this rule into a general statement of policy because it also binds the Administrator's discretion, allowing deviation from the policy only when they make specific findings. EPA has not indicated that "in subsequent proceedings it will thoroughly consider not only the policy's applicability to the facts of a given case but also the underlying validity of the policy itself," but seems poised to apply the policy in all instances -- granting exceptions only in limited circumstances where compliance is deemed impracticable. It nowhere indicates that EPA may reassess in each case whether following this rule is the best means to achieve scientific integrity as it undertakes regulatory action. The Proposal has other indications of a binding rule, including that EPA intends to codify it in the CFR, and EPA has itself characterized the Proposal as a binding rule.
The commenter adds that this rule is also not a rule of agency organization, procedure or practice, for purposes of the APA. Agency actions in this category are those "that do not themselves alter the rights or interests of parties, although it may alter the manner in which the parties present themselves or their viewpoints to the agency." An agency action that "trenches on substantial private rights and interests" does not fall under this exemption. By restricting the scientific studies on which EPA may base final significant regulatory actions, EPA severely limits parties from relying on excluded studies in advocating for particular safeguards. In the preamble, EPA makes clear that the rule is about "EPA's regulatory actions" and underlying conclusions. Because the rule substantively impacts agency conclusions and regulations, it impacts private rights and interests. The rule does not allow private individuals to submit for consideration (or renders such submittal a nullity) studies that they would have been permitted to prior to the proposed rule, thus impacting the substantive standards that EPA is able to justify setting -- which has implications for the regulated community as well as for public health. The Proposal "encodes a substantive value judgment or puts a stamp of approval or disapproval on a given type of behavior" by requiring regulatory actions to be supported only by certain scientific information deemed acceptable by the proposed rule.
In CropLife Am. v. E.P.A., the commenter provides that the Court held that a similar rule promulgated by EPA, barring third-party human studies from agency consideration during pesticide registrations was a binding regulation because it used "clear and unequivocal language" reflecting "an obvious change in established agency practice" that created a "binding norm." The Court stated: "EPA's stated rule is binding on petitioners, who are now barred from relying on third-party human studies (even in cases where such studies formerly were approved), and is binding on the agency because EPA has made it clear that it simply `will not consider' human studies." Similarly, the Proposal appears to bind EPA to not consider scientific information it could consider before, unless it falls under certain narrow, ambiguously defined exceptions, and binds the public and organizations such as EDF who can no longer submit studies to EPA that EPA would previously have been required to consider as part of the rulemaking process.
Response: See response to Comments 84-1403 and 4829-2022.
Comment [6894-3628]: Commenter (6915) argues that the EPA's skeletal outline falls far short of the APA's notice requirements and fails entirely to "examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made." Natural Res. Defense Council, Inc. v. U.S. Envtl. Prot. Agency, 859 F.2d 156, 209 (D.C. Cir. 1988). The commenter states that the EPA should withdraw the proposal on these grounds alone.
Response: See response to Comment 2157-149.
<IP_ADDRESS> APA (SNPRM Comments)
Comment [25-96]: Commenter (10972) writes that Section 553(c) gives interested persons a right to participate and a right to consideration of their submissions.
Interested persons have a right to participate in a rulemaking through submission of written data, views, or arguments. The EPA here fails to comply with the APA's participation requirements in three ways. First, the scheme suggested in section 30.5 of the proposed regulation, particularly the option 1, channels the work of interested persons from the submission desk into the dustbin on a bright-line basis which has nothing to with the substance of the data, views or arguments expressed therein. This serves to guillotine interested persons' right to participate, in contravention of the APA.
Second, the SNPRM itself is non-compliant with section 553(b)(3) of the APA as read with the participation requirement in section 553(c) in that it negates realistic participation by providing no clarity on the nature and scope of the problem sought to be regulated. The SNPRM fails to meaningfully discuss the fundamental expansion it works on the NPRM. It provides no justification for jumping from a rule applicable to dose-response models to a rule that applies to essentially any research the EPA may use; as noted above, there seems to be no real basis for this. An explanation of the problem that necessitates this expansion is necessary. This is not least because the EPA has dealt with such data for a long time and it must  -  if this proposed rule is in any way supportable  -  undoubtedly be able to point to incidents where regulatory error arose (especially beyond the dose-response context) due to apparent transparency failings. Realistic participation of the public is seriously compromised when the agency fails to provide clarity on the nature and scope of the problem to be regulated. How is the public supposed to participate in determining the size of the bridge to be built when the size of river underneath is concealed by a vast tarp? The inconsistencies of this SNPRM with substantive laws that the EPA itself points to  -  together with the vast scale of application introduced by this SNPRM  -  suggest that Executive Order 12866 ought to apply. Under Executive Order 12866, regulation should only occur when law or compelling public need requires it. Yet the expansion of the NPRM to the SNPRM was carried out with nary a word on what compelling public need required it; that is improper.
Third, the very fact that this is an SNPRM attaches it to the NPRM to which it is supplementary. The NPRM was about dose-response models and data  -  a feature of a very limited set of sciences; the SNPRM is about all models and data across all sciences  -  including the social sciences. To make that type of vast expansion as a "supplement" to the very narrow initial concept raises the probability  -  well-nigh certainty  -  of restricting participation. The SNPRM then points out that there will be no consideration of anything that relates to the NPRM. Further, the EPA has limited comments to 60 days in the middle of a national emergency. All this highlights the procedural invalidity of the SNPRM.
Section 553(c) gives a right to consideration of such relevant matter as is presented by interested persons. The determination of relevance is surely a matter of substance. The EPA cannot purport to turn it into a non-substantive procedural fiat as it seeks to under section 30.5 of the proposed rule. Section 30.5 of the proposed rule is therefore unlawful.
Given the rights to participate and to consideration of their submissions, an interested person would expect that exclusion of their submission would occur in terms of a clear-cut procedure with appropriate safeguards of their rights. Yet the proposed rule makes no such provision. Exclusion of an interested person's study from consideration is also a substantial repudiation of that person; it is a restrictive action or limitation that can be classified as a sanction as defined under section 551 of the APA, with all the legal consequences which that entails. The proposed regulation is also silent as to whether a reanalysis will be sent to an initial author for comment and response and how this will be administered.
Response: As explained in Section III.E of the final rule preamble, the final rule adopts a weighting approach to considering data availability and not the categorical exclusion presented as an option in the NPRM. EPA has explained that this procedural rule has limitations on its scope in terms of conflicts with other substantive requirements and that, in situations where this rule applies, EPA will give greater consideration to those studies where the underlying data and models are available for independent validation. That means that the agency will consider all relevant studies when taking covered actions.
EPA disagrees that this rulemaking does not comply with the APA. EPA explains the expanded scope and the basis for that expansion in Section I.B of the SNPRM preamble (85 FR 15396) and Sections II.B and III.B of the final rule preamble. EPA notes that this rule is purely procedural in nature and therefore is not subject to APA notice and comment. Nevertheless, EPA initiated two rounds of notice and comment of 60 days each and made changes to both the SNPRM and the final rule in response to those comments. While EPA was not required to take comment on this procedural rule, the 60-day comment period meets the recommendation of Executive Order 12866 pertaining to the recommended length of comment periods for significant rulemakings.
Comment [34-154]: Commenter (11192) writes that this SNPRM demonstrates a disingenuous request for public input from the EPA. The EPA is obligated through the APA to notify the public and invite public comment on proposed regulations. While fulfilling the procedural requirements of the APA through this SNPRM, the EPA downplays the public interest of this sweeping proposed regulation, repeatedly asserts that this proposed rule is an affair internal to the agency, and sets up a path for the agency to dismiss public input regarding the STRS rule.
In the first paragraph of the Executive Summary, the EPA appears to dissuade public comment by understating the interest of members of the general public in a proposed rule designed to significantly alter regulations protecting public health. First, the EPA frames the proposed rule as internal to the agency, stating "This SNPRM does not regulate any entity outside the Federal Government. Rather, the proposed requirements would modify the EPA's internal procedures regarding the transparency of science underlying regulatory decisions." The EPA then concedes that "any entity interested in EPA's regulations may be interested in this proposal," providing an example of "entities that conduct research or another scientific activity that is likely to be relevant to EPA's regulatory activity."
Response: Please see the response to comment 25-96.
Comment [34-156]: Commenter (11192) writes that in addition to asserting that the EPA can introduce these changes under its housekeeping authority, the EPA also lays the groundwork in this SNPRM to subvert public comment in the future. The EPA states that it is "considering how to proceed, apart from this supplemental proposal, to establish regulations interpreting provisions of, and/or exercising substantive rulemaking authority delegated to it by programmatic statutes." Creating regulations specifically about how the EPA interprets or carries out its statutes could result in a process whereby many, perhaps all, new environmental regulations pursuant to the EPA's statutes, including the CAA and CWA, would be considered internal procedures and thus give the EPA leeway to circumvent the APA's required notice-and-comment rulemaking. The EPA has been acting with an aggressive deregulatory agenda for the last three years. This action not only shuts the public out of federal environmental decisions but could lay the groundwork for discarding all of the EPA's regulatory accountability. We firmly oppose the establishment of regulations that could allow the EPA to circumvent notice-and-comment rulemaking.
Response: This action underwent two rounds of public notice and comment despite being a procedural rule and therefore not subject to those requirements. Furthermore, and as mentioned in Section III.D of the final rule preamble, any substantive actions implementing this procedural rule will be subject to public notice and comment.
Comment [48-502]: Commenter (12727) writes that the Supplemental Notice would violate the APA and EPA's authorizing statutes by depriving the public of an adequate opportunity to comment on future rulemakings.
The SNPRM would prevent the public from commenting meaningfully on future rulemakings by withholding information on the studies the agency is considering or will consider. In order to comment in an informed way, it is essential for the public to understand the agency's rationale for ignoring otherwise relevant information. If the agency fails to explain why it has excluded a study in issuing a proposal, or will not consider it when submitted by commenters, the public cannot object to its exclusion and has no indication whether the agency has rejected it because of the requirements of this rule or because the agency deemed the study irrelevant to its regulation. The latter, if true, would be crucial to an understanding of the agency's view of the scope and purpose of its regulation. Yet the Supplemental Notice suggests that EPA will only provide an explanation for disregarding or discounting a study under its alternative "weighting" option. It has not indicated that it will identify the studies it has entirely ruled out under the preferred "tiered access" approach. Without an understanding of how this rule is operating to suppress scientific information in future rulemakings, commenters cannot understand the basis of the agency's proposals and may develop and submit information that the agency will discard out of hand. They would also be unable to oppose EPA's disregard of otherwise relevant information, which it may be required to consider under the controlling statute. This `black box' precludes fully informed comment on future rulemakings and therefore violates the APA and EPA's authorizing statutes.
Response: As mentioned in Section III.D of the final rule preamble, any substantive actions implementing this procedural rule will be subject to public notice and comment. EPA will make available to the public all information necessary to ensure meaningful comment on those actions upon their proposal.
Comment [48-1481]: Commenter (12727) writes that EPA's failure to consider how its proposed rule could interfere with its ability to discharge its statutory duties and fulfill its mission of protecting public health and the environment renders its proposed action arbitrary and capricious under the APA.
Response: EPA disagrees that it failed to consider this issue, as evidenced by its specific request for comments on the appropriateness of relying on the substantive statutes that EPA administers as authority for the rule. See NRPM and SNPRM at Section I. C. of preamble (83 FR 18768) and Section I. B. of preamble (85 FR 15396), respectively.
Comment [54-2034]: Commenter (11361) writes that in addition to asserting that the EPA can introduce these changes under its housekeeping authority, the EPA also lays the groundwork in this SNPRM to subvert public comment in the future. The EPA states that it is "considering how to proceed, apart from this supplemental proposal, to establish regulations interpreting provisions of, and/or exercising substantive rulemaking authority delegated to it by programmatic statutes." Creating regulations specifically about how the EPA interprets or carries out its statutes could result in a process whereby many, perhaps all, new environmental regulations pursuant to the EPA's statutes, including the CAA and CWA, would be considered internal procedures and thus give the EPA leeway to circumvent the APA's required notice-and-comment rulemaking. The EPA has been acting with an aggressive deregulatory agenda for the last three years. This action not only shuts the public out of federal environmental decisions but could lay the groundwork for discarding all of the EPA's regulatory accountability. We firmly oppose the establishment of regulations that could allow the EPA to circumvent notice-and-comment rulemaking.
Response: Please see response to comment 48-502.
Comment [81-590]: Commenter (12715) writes that the supplemental proposal is arbitrary, and too vague to allow for meaningful public participation.
The APA requires that "general notice of proposed rulemaking shall be published in the Federal Register," including the "terms or substance of the proposed rule." 5 U.S.C. § 553(b). The straightforward purpose of this requirement is to give the affected public an opportunity to provide meaningfully informed comment on an agency's proposal. See Home Box Office, Inc., supra, 567 F.2d at 35-36. Further, an agency's regulations cannot be arbitrary, capricious, or contrary to the agency's statutory authority. 5 U.S.C. § 706. Courts will not hesitate to strike down final rules based on proposals lacking in specificity. See, e.g. Horsehead Res. Dev. Co. v. Browner, 16 F.3d 1246, 1268 (D.C. Cir. 1994) ("general notice that a new standard will be adopted affords the parties scant opportunity for comment"). Here, however, in the words of EPA's own SAB, "[g]iven the relatively skeletal nature of the Proposed Rule, it is not possible to define the implications of the rule with confidence." SAB Report, at 2. In particular, it is unclear which definitions are included in the proposed rule, EPA fails to define key features of the two "options" proposed for determining which data and models may be used, and the proposed rule's exemptions provision contains insufficient standards to guide the Administrator's discretion. The supplemental proposal thus runs afoul of the APA's substantive and procedural requirements due to its vagueness as well as its arbitrariness, thus depriving the public of a meaningful opportunity to comment. Accordingly, if EPA does not abandon the proposal altogether, it should reclassify the proposal as, at most, an Advance Notice of Proposed Rulemaking.
Response: EPA clarifies the relevant definitions in the final rule preamble at Section III.C elaborates on key features for determining which data and models may be used at Section III.E, and outlines the standards the Administrator will be required to apply in determining whether to grant an exemption at Section III.G.
Comment [81-593]: Commenter (12715) writes that the supplemental proposal's definitions section is contradictory and unclear.
The supplemental proposal's contradictory and confusing discussion and presentation of the definitions section of the proposed rule violates the APA's requirement that a proposal must allow for meaningfully informed comment. Specifically, the narrative section of the supplemental proposal states that EPA is "modifying, deleting and proposing new regulatory text" in the definitions section, including "deleting the first paragraph of the 2018 proposed rulemaking regulatory text" and the definition of research data. 85 Fed. Reg. at 15,398. But in the proposed rule section, EPA states that it is "[r]evis[ing] § 30.2 by adding the [listed] definitions . . . to read as follows." Id. at 15,404 (emphasis added). Unlike other sections of the supplemental proposal where EPA appears to have included the full revised provision, the proposed rule text for section 30.2 appears to include only the added definitions. It is thus unclear which, if any, portions of the original proposed rule text are being "modif[ied]" or "delet[ed]" as the narrative description indicates. EPA's unclear presentation of the changes it is making to this section of the supplemental proposal deprives the public of the opportunity to provide meaningful feedback on this portion of the rule.
The definitions are also problematic because the proposed rule repeatedly refers to "significant regulatory decisions," id. at 15,405-06, but the proposal fails to provide any definition of the terms "significant regulatory decisions" or "significant." Even more confusingly, "regulatory decisions" are defined in the original proposal as "final regulations determined to be `significant regulatory actions' by the Office of Management and Budget." 83 Fed. Reg. 18,768, 18,773 (Apr. 30, 2018). Moreover, numerous other definitions in the proposed rule are also fatally flawed as described in our Technical Comments below.
The confusion throughout the definitions section infects the entire proposal because understanding whether and how EPA has defined key terms is critical to understanding how the other substantive provisions of the rule would operate. The supplemental proposal, like the original proposal, is therefore unlawfully vague and arbitrary.
Response: EPA made several changes to the definitions section to address these concerns. Please see the final rule preamble at Section III.C and final regulatory text at §30.2.
Comment [82-711]: Commenter (12464) writes that multiple aspects of the supplemental notice are incomplete, ambiguous, or otherwise fail to provide adequate notice of the contents of the proposal.
Under the APA, a notice of proposed rulemaking must include "the terms or substance of the proposed rule or a description of the subjects and issues involved." 5 U.S.C. § 553(b)(3). The purpose of this requirement is to "provide sufficient factual detail and rationale for the rule to permit interested parties to comment meaningfully." The Supplemental Notice fails to meet this requirement. Several aspects of the Proposal remain too incomplete or vague to allow for meaningful and targeted comments.
While we identify multiple topics on which the Supplemental Notice has not provided sufficient detail throughout this comment letter, some of the most important issues are highlighted below.
Response: Both the SNPRM and final rule contain a description of the subjects and issues involved. See 85 FR 15396 and final rule Federal Register notice for this action, respectively.
Comment [97-901]: Commenter (11479) writes that while EPA does not cite the APA as a source of its authority, this proposal would be violating the law because the agency would be arbitrarily and capriciously selecting which information to use in decision-making. This is especially true given section 30.9 of the rule, which would allow the administrator to exclude certain studies from the rule's requirements on a case-by-case basis. Furthermore, under the APA, agencies are required to consider and respond to all information presented in the docket. If EPA chooses to ignore a portion of this evidence because it cannot access or publicize the underlying data, models, and codes, such action would be arbitrary and capricious.
Response: Per section 30.9 of the final rule, the Administrator may grant an exemption, but in so doing, the Administrator must apply specifically enumerated standards and provide a justification for the Administrator's decision. EPA has articulated the standards to be applied and imposed a process for documenting an exemption decision which demonstrates that this rule will not be applied in an arbitrary or capricious manner. Furthermore, the rule does not require EPA to "ignore" underlying data and models. Rather, in lieu of a categorical exclusion, EPA has finalized a weighting approach to considering such information. EPA has explained that this procedural rule has limitations on its scope in terms of conflicts with other substantive requirements and that, in situations where this rule applies, EPA will give greater consideration to those studies where the underlying data and models are available for independent validation. That means that the agency will consider all relevant studies when taking covered actions.
Comment [157-1480]: Commenter (12422) writes that under the provisions of the APA, the EPA administrator does not have the authority to refuse to consider any comment submitted to the agency. If she or he thinks it is not valid, inaccurate, or inapplicable, she or he must explain why. Under the APA, submissions, including scientific studies, cannot arbitrarily or capriciously be discarded because the underlying data are not provided. When I was OSHA Administrator, we wanted to protect the integrity of the science used in setting regulations, so we explored asking for conflict-of-interest disclosures, similar to those requested by every leading scientific journal. Our legal experts determined that we could request this disclosure, but we could not reject submissions that failed to include them. This is a comparable situation  -  rejecting submitted studies because the underlying data are not available is prohibited under the APA.
Response: EPA has finalized a weighted approach to considering underlying data and models, not a categorical exclusion. EPA has explained that this procedural rule has limitations on its scope in terms of conflicts with other substantive requirements and that, in situations where this rule applies, EPA will give greater consideration to those studies where the underlying data and models are available for independent validation. That means that the agency will consider all relevant studies when taking covered actions.
Comment [159-1415]: Commenter (12430) writes that Agency action violates the APA, 5 U.S.C. section 706, if it is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." Agency action is arbitrary and capricious when the agency "has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise[,]" or otherwise fails to "examine the relevant data and articulate a satisfactory explanation for its action `including a rational connection between the facts found and the choice made.'"
If finalized, the SNPRM would be arbitrary and capricious, and not in accordance with law. Congress has directed U.S. EPA to use the "best available science" or the "latest scientific knowledge" in a multitude of programs. Congress has never directed U.S. EPA to consider the public availability of underlying data and models as the sole or even predominant factor in evaluating the soundness of science. Nevertheless, U.S. EPA is proposing to codify public availability as a threshold requirement for agency consideration or publication of or reference to a scientific study. Codifying this requirement, when public availability is not a factor that Congress intended U.S. EPA to prioritize, would itself be arbitrary and capricious in violation of the APA. U.S. EPA has also manifestly failed to consider important aspects of the ostensible problem, offered explanations for its proposed decision that run counter to the evidence, and failed to articulate any rational explanation for the proposal, as discussed below under, "The SNPRM Fails to State a Reasoned Basis for the Proposed Regulation."
Finalizing the SNPRM would render subsequent U.S. EPA actions arbitrary and capricious as well. The SNPRM would prohibit or restrict U.S. EPA's consideration of relevant and high-quality data, studies, and models that do not meet U.S. EPA's arbitrary and outcome-seeking proposed requirements for public availability. In excluding relevant science from expert consideration, based on a factor that Congress did not intend for the agency to prioritize, U.S. EPA would inevitably fail to consider important aspects of the problems under consideration, issue decisions counter to the evidence before the agency, and commit other basic APA violations with every affected action. Indeed, the D.C. Circuit Court of Appeals rejected the proposed approach decades ago, agreeing that, "[i]f EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment." This instability would also create significant liabilities, and hence reliance risks, for States, regulated entities, and the public.
In addition to its substantive prohibition on arbitrary and capricious actions, the APA establishes general procedural requirements for agency rulemakings, including a requirement for agencies to consider the relevant information presented via public comment on proposed rulemakings. By precluding agency experts from considering relevant studies and models raised in public comments on proposed agency actions, the SNPRM would also cause future U.S. EPA actions to violate the APA's procedural requirements.
Response: Regarding notice and comment on subsequent agency actions, please see response to comment 48-502. The SNRPM is not being finalized as is. As discussed in great detail in the final rule preamble, the final rule makes a number of important changes to the SNPRM. Notably, EPA is finalizing a weighting approach to considering underlying data and models that are not publicly available, not a categorical exclusion. EPA has explained that this procedural rule has limitations on its scope in terms of conflicts with other substantive requirements and that, in situations where this rule applies, EPA will give greater consideration to those studies where the underlying data and models are available for independent validation. That means that the agency will consider all relevant studies when taking covered actions.
Comment [159-1417]: Commenter (12430) writes that under the APA, changes in agency policy positions are permissible only when the agency provides a reasoned justification for the change. Further, "[t]he requirement that an agency provide reasoned explanation for its action would ordinarily demand that it display awareness that it is changing position." U.S. EPA fails to acknowledge that the SNPRM and NPRM comprise a profound change in agency policy position, let alone provide a justification. Instead, the agency struggles to situate the proposals within existing federal policies and guidance on public data availability and peer review. This includes referencing a variety of U.S. EPA and OMB guidance documents dating back to 2002 that, as discussed above, bear little relationship to the current proposals. The SNPRM represents a wholesale departure from past and current U.S. EPA policy with powerful and far-reaching impacts for U.S. public health and the environment. U.S. EPA's failure to justify or even acknowledge its proposed policy change falls far short of the APA's requirements.
Response: EPA disagrees that it has failed to acknowledge a change in agency position or to provide a reasoned explanation for that change. Please see the preamble to the final rule at Section III.A.1 for further discussion of these issues.
Comment [159-1451]: Commenter (12430) writes that the NPRM and SNPRM conflict with many of the statutes that U.S. EPA administers, which include requirements to use, for example, the "best available science," the "best available public health information", the "latest scientific knowledge", or "generally accepted scientific principles or laboratory tests, or appropriately designed and conducted epidemiological or other population studies", among others. U.S. EPA tacitly acknowledges these conflicts in the SNPRM by adding proposed section 30.3, providing, "In the event the procedures outlined in this part conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." Yet neither this proposed provision nor the SNPRM preamble identify statutory or regulatory provisions with which U.S. EPA believes a conflict could emerge. Moreover, the proposed regulatory text does not provide any parameters for determining whether there is a conflict. Rather than improving the legality and workability of the SNPRM, this provision is impermissibly vague, in violation of the APA, and likely to mire the agency in additional litigation.
Response: Conflict analyses will be conducted and discussed as appropriate when EPA develops subsequent substantive rulemakings implementing this final procedural rule. See the final rule preamble discussion at Section I.A.3. If implementing this procedural rule will result in a conflict with an environmental statute that EPA administers, then this procedural rule will yield.
Comment [179-1609]: Commenter (12688) writes that this proposed policy change would lead the EPA away from its mandate -- in its mission and under various environmental statutes -- to use the best scientific evidence in assessing environmental risks, and its obligation under the APA to refrain from arbitrary decision making. The practical effect of this rule would be to limit EPA's ability to protect public health and meet both its statutory obligations and its overall mission.
Response: Please see response to comment 159-1451.
Comment [179-1790]: Commenter (12688) writes that this proposed policy change would lead the EPA away from its mandate -- in its mission and under various environmental statutes -- to use the best scientific evidence in assessing environmental risks, and its obligation under the APA to refrain from arbitrary decision making. The practical effect of this rule would be to limit EPA's ability to protect public health and meet both its statutory obligations and its overall mission.
Response: Please see response to comment 159-1451.
Comment [205-2125]: Commenter (13788) writes that this rule is not procedural. If finalized, it will have substantial effects on EPA decisions that impact regulated entities. For example, under the CAA's NAAQS program, EPA is required to issue air quality criteria for pollutants that "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air." If EPA were to ignore or diminish the value of the latest scientific studies because they involve human health data that cannot be made publicly available, that would significantly impact the health-protectiveness of the resulting ambient air quality standards, which would have a substantial effect on both regulatory beneficiaries and regulated industries.
In addition to the Chrysler Court's decision, the D.C. Circuit held in Pickus v. United States Bd. Of Parole, that rules of practice or procedure "should not be deemed to include any action which goes beyond formality and substantially affects the rights of those over whom the agency exercises authority," and that "adherence to congressional purpose counsels a construction of this exemption [for procedural rules] that excludes from its operation action which is likely to have considerable impact on ultimate agency decisions." By restricting EPA's consideration of science in regulatory decision-making based only on the public availability of underlying data, this rule would have a clear and substantial effect on ultimate agency decisions, including decisions that affect the rights of regulated entities, and therefore it is not a procedural rule.
Nor is this a proposed "internal rule of agency procedure" that "exclusively pertains to the internal practices of the EPA." According to details provided to staff of the House Committee on Science, Space, and Technology, EPA's proposed tiered access system would not be implemented internally at EPA, but rather the Agency expects that the bulk of the burden of implementing such a system would fall on the researchers who conduct (or conducted, as this relates to retroactive application of this new policy) the study. According to information shared with committee staff, EPA anticipates that researchers would be responsible for managing the logistics of making data and models publicly available in compliance with the rule, for judging the sensitivity of study data and models and what information can or cannot be made publicly available through tiered access, and what tier of access should be designated for different types of information. It is unclear how EPA would ensure compliance with this rule, or whether after this rule is finalized, it will in effect ban all studies based on confidential human health data. However, what is clear is that this rule would have significant impacts beyond the Agency's internal practices and procedures.
Response: As discussed in the final rule preamble at Section II.C, this is a procedural rule governing EPA's internal affairs. It does not regulate or affect the legal rights and obligations of parties outside of the agency, and therefore is not a substantive rule. An internal rule of agency procedure is not substantive merely because it may indirectly affect the voluntary behavior of parties outside of the agency. See American Hosp. Ass'n v. Bowen, 834 F.2d 1037, 1051 (D.C. Cir. 1987) ("[A]gency rules that impose `derivative,' `incidental,' or `mechanical' burdens upon regulated individuals are considered procedural, rather than substantive.").
This procedural rule does not impose requirements on external scientists. In fact, it exclusively regulates EPA employees. While it is entirely possible that this procedural rule may influence how scientists choose to conduct their studies or present their research to EPA, that potential incidental effect does not render the rule substantive.
Comment [205-2128]: Commenter (13788) writes that under the APA and CAA, agency actions that are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" are to be held unlawful and set aside. Agencies are required to "articulate a satisfactory explanation for [the] action including a `rational connection between the facts found and the choice made.'" Here, however, EPA is proposing to exclude or devalue scientific studies based on criteria that are unrelated to scientific value or merit, and that would eliminate the Agency's ability to rely on research that may be the best available science.
The Agency's newly claimed statutory authority under the housekeeping statute does not save this rule, and actually undermines any transparency justification for the rule. Many of the studies EPA relies on are done outside of the Agency, and therefore must be beyond the reach of the housekeeping statute. The Agency's conflation of transparency in EPA's processes with data availability in scientific research outside the Agency cannot be used to provide satisfactory justification for this rule.
EPA seems to believe that by wielding the terms "validation" and "reanalysis" it shows concern about the quality of studies relied on by the Agency. But EPA's real intention in the SNPRM, as in the Proposal, is to limit the Agency's access to public health science, not to ensure the quality of the studies the Agency relies on. That is made abundantly clear by the Agency's statement that if "multiple high-quality studies exist but only two studies have data and models that are available for independent validation and reanalysis, EPA would only include those two studies as pivotal regulatory science and/or pivotal science." By acknowledging that the highest quality studies will be ignored if confidential data and models are not made available for validation and reanalysis, EPA is admitting that this rule is not concerned with improving the quality of studies relied on by the Agency. The SNPRM is instead laser-focused on information availability, even if it comes at the expense of the quality of scientific work. The best studies may not rely on available underlying data -- precisely because they are human health studies that requires the maintenance of the privacy of the study participants  -- and in those situations this rule would clearly prioritize data availability over quality.
Unlike the 2018 Proposal, the SNPRM does not include any acknowledgement that EPA must use the "best available science" for regulatory actions -- but it must. This lack of concern for quality is evident throughout the SNPRM and is particularly alarming in an agency that relies heavily on science -- as it must, given its statutory mandates. Additionally, the suggestion that the rule could apply to studies retroactively if the Administrator does not grant an exemption further illustrates the intention to undermine longstanding reliance on the human health studies that have done the most to advance air quality and public health. The SNPRM states that the "proposal would apply to reviews of data, models, and studies at the time a rule is developed or influential scientific information is finalized, regardless of when the data and models were generated." EPA has provided no reasoning to explain how retroactive application to past studies -- including the Harvard Six Cities and American Cancer Society particulate matter health studies and subsequent work that links exposures to air pollution with declines and damages to human health -- is justified. It certainly has not provided any information to suggest that this rule would encourage the release of more data from those studies. This proposal's focus is clearly on arbitrarily excluding or diminishing the value of quality scientific research rather than any real commitment to transparency.
Response: EPA disagrees that the true intent of this rulemaking is to diminish the value of quality scientific research. As discussed in the final rule preamble at Section I.A, EPA is taking this action to help strengthen the transparency of the data and models underlying EPA's significant regulatory actions and ISI.
Regarding the scientific standards that EPA is required to apply, this purely procedural rule does not interpret or apply the provisions of any environmental statutes that EPA administers, and such efforts will occur in the subsequent rulemakings under the relevant statutes. If implementing this procedural rule will result in a conflict with an environmental statute that EPA administers, then this procedural rule will yield. See the final rule preamble at Section I.C.
Comment [205-2164]: Commenter (13788) writes that EPA has failed to provide a meaningful opportunity to review and comment on the proposed rule as required by the APA, because many of the provisions in the SNPRM are described only in vague terms, with very little detail provided about the proposed policies and how they would be implemented. This continued failure to address critical details ignores significant problems that will arise on implementation of a final rule. For example, EPA in the SNPRM proposes to apply its data release requirements across the board, without distinguishing between types of studies and the data they rely on, which may or may not include confidential information. Additionally, while the 2018 Proposal was limited to dose-response data and models, the SNPRM expands that to all data and models broadly and without justification. The SAB's report on the 2018 Proposal stated that:
the requirement to make data available for public inspection will be more easily implemented for some datasets than others (e.g., [certain] studies include individual sample data as part of standard reporting). The expectation that data and methods will be available for all endpoints may be unrealistic.
The SAB was clearly concerned that the rule's requirements could not even be put into practice, never mind whether they are lawful or rational or adequately justified. And, although the SNPRM allows the Administrator to grant an exception to the requirements, the SNPRM provides no reason to believe that provision will sufficiently address the concern identified by the SAB. Nor is there any safeguard included to ensure that the EPA Administrator, in exercising his discretion, will not bring extra-statutory political considerations into the decision-making process.
Response: Please see response to comment 25-96. The SNPRM and final rule address these and many other concerns articulated by public commenters. See 85 FR 15396 and final rule Federal Register notice for this action, respectively.
1.7 Other Authorities (NPRM Comments)
Comment [6835-2704]: Commenter (6857) writes that increased scientific transparency can improve the application of the Endangered Species Act (ESA), specifically in the determination of "critical habitat." Proper determination of critical habitat is a very important issue for state and local governments, as well as businesses located in areas impacted by ESA activity. A determination of critical habitat can literally remove hundreds of miles from the possibility of any type of development. Currently, regulatory agencies can even make this designation based on the "historical" presence of a species, years in the past. In the transportation arena, the critical habitat designation is especially relevant as states promulgate transportation plans years, if not decades, in advance. If a regulatory agency summarily declares an area "off limits" through an overly broad critical habitat designation, then it can unnecessarily jeopardize carefully designed plans for economic development. At a minimum, all economic and scientific analysis necessary for a critical habitat determination should be based on the best data available and incorporate an area's planned transportation improvements.
Response: EPA appreciates your comment but critical habitat determinations under the ESA would be made by other agencies and not EPA. See ESA section 4. 16 U.S.C. § 1533
Comment [6427-1069]: Commenter (6449) writes that the Final Information Quality Bulletin implements the IQA (Pub L. No. 106-554, § 515, Dec. 21, 2000) This rule should reference the IQA along with the bulletin.
Response: We cite OMB's bulletin because it interprets terminology in the IQA that Congress left undefined. The IQA directed OMB to issue guidelines for use by federal agencies in developing their own information quality guidelines, which EPA did in 2002.
Comment [4921-366]: Commenter (4932) recommends that EPA should clarify that nothing in the Transparency Proposal is intended to diminish the Agency's existing legal authority to enhance the transparency of EPA's regulatory science.
The Transparency Proposal omits discussion of EPA's ample existing legal authority to enhance the transparency of the Agency's regulatory science, at least as it relates to public health research sponsored by the federal government. As set forth in the Office of Management and Budget's guidance for financial assistance to non-Federal entities (2 C.F.R. § 200.315), federal agencies have unfettered legal authority to "[o]btain, reproduce, publish, or otherwise use the data produced under a Federal award," or to "[a]uthorize others to receive, reproduce, publish, or otherwise use such data for federal purposes." In addition, any public health research data (a) produced under a Federal award, and (b) used by the Federal Government in developing agency action that has the force and effect of law, must be released to the public if a request for the data is made pursuant to the FOIA.
Because the federal government has sponsored a substantial majority of the public health research conducted in the United States over the past 50 years, the federal government is well positioned, using existing legal authority, to facilitate release of public health research data if it is inclined to do so as a matter of policy. MIG recommends that EPA clarify in the final regulation that the Transparency Proposal's omission of these existing authorities was not intended, nor should it be interpreted in any fashion, to diminish the Agency's existing legal authority to enhance the transparency of EPA's regulatory science. Further, the scope of EPA's authority noted above should be identified in the Transparency Policy as an additional source of support.
Response: EPA agrees that there are existing regulations that govern the ownership and use of data generated with federal funding. Because the final rule is one of internal agency procedure, it does not impact or diminish those authorities. Rather, as EPA states in the preamble, "[t]his rule builds upon prior EPA actions in response to government-wide data access and sharing policies" such as the regulations cited by the commenter. The focus of § 30.5 is how the Agency will handle pivotal science based on the availability for independent validation of the underlying dose-response data. Where the data is available, the pivotal science will be given greater consideration. Where it is not available for reasons that may include confidentiality and privacy protections, the pivotal science will be given lesser consideration unless an Administrator's exemption is granted under § 30.7.
Comment [6169-2818]: Commenter (6179) states that EPA is authorized by Congress to promulgate internal housekeeping regulations like the transparency proposal.
The Transparency Proposal relies upon authority under various environmental statutes, including Clean Air Act sections 103 and 301(a). EPA solicits comment on whether additional or alternative sources of authority are an appropriate basis for the Transparency Proposal.
In addition to those statutes cited in the Transparency Proposal, we note EPA's authority under 5 U.S.C. § 301. More commonly known as the "Federal Housekeeping Statute," this provision authorizes the "head of an Executive department" to "prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property."
The Federal Housekeeping Statute authorizes the Transparency Proposal  -  a regulation for the government of EPA and the performance of its business  -  on a general basis, similar to how the environmental statutes cited by EPA do so specifically. As seen in the Federal Housekeeping Statute, Congress expected that regulations like the Transparency Proposal would be so commonplace within agencies that it provided a general federal government-wide authorization for their promulgation. We recommend EPA to consider the Federal Housekeeping Statute as additional support for the Transparency Proposal.
Response: EPA appreciates your comment in support of the rule. EPA is relying on its authority to promulgate housekeeping regulations as legal authority for this rule and not the Federal Housekeeping Statute. Also see the response to Comment 31-135.
Comment [6334-3154]: Commenter (6356) expresses that EPA's proposal is consistent with Congressional directives that EPA is to utilize the "best science." In the Notice of Proposed Rulemaking at 18,771/col.2, EPA requests additional authority for the proposed regulation. The federal "Information Quality Act," provides additional authority for the proposed regulation. Pub. L. 106 - 554 (2001), codified at 44 U.S.C. §§ 3504(d)(1), 3516. While numerous other federal agencies have adopted guidelines implementing the 2001 law, EPA is conspicuous because it has not adopted such guidelines.
Response: EPA disagrees that the Agency hasn't adopted information quality guidelines. EPA issued its guidelines in 2002. See https://www.epa.gov/quality/guidelines-ensuring-and-maximizing-quality-objectivity-utility-and-integrity-information. Also see the response to Comment 6427-1069.
Comment [6353-2324]: Commenter (6375) notes that EPA solicits comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation. (pg. 18,771). EPA's statement concerning its legal authority could be enhanced by reference to statutory provisions that require it to rely on "accurate," "useful," or "best" data. For example, section 108(a)(2) requires that the Administrator issue air quality criteria that "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health and welfare . . .." 42 U.S.C. § 7408(a)(2). Similarly, section 304 of the CWA requires water quality criteria that "accurately reflect [] the latest scientific knowledge . . .." 33 U.S.C. § 1314(a)(1). The SDWA requires the Administrator to assess risk using "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices." 42 U.S.C. § 300g1(b)(3)(A). Increasing the transparency of regulatory science and ensuring that it is reproducible helps in evaluating its accuracy and usefulness.
Furthermore, making data and methods underlying regulatory decisions publicly available is not new. Guidelines issued by both the OMB and EPA implementing the IQA, Treasury and General Government Appropriations Act for Fiscal Year 2001, § 515, P.L. No. 106-554, 114 Stat. 2763 (Dec. 21, 2001), emphasize the importance of reproducibility in assessing the quality and utility of data used in making regulatory decisions. It appears the OMB's IQA guidelines recognize that the reproducibility of underlying science helps to ensure the integrity of agency decisions and explain that "[m]aking the data and methods publicly available will assist in determining whether analytic results are reproducible." 67 Fed. Reg. 8452, 8460 (Feb. 22, 2002) (OMB IQA Guidelines).
EPA's IQA guideline states: "A higher degree of transparency about data and methods will facilitate the reproducibility of such information by qualitied third parties, to an acceptable degree of imprecision. . .. It is important that analytic results for influential information have a higher degree of transparency regarding (1) the source of the data used, (2) the various assumptions employed, (3) the analytic methods applied, and (4) the statistical procedures employed."
EPA should also consider replacing some of the citations it provides for its legal authority with others that might be more relevant. For example, the Agency may want to cite 42 U.S.C. § 6981, on research, instead of 42 U.S.C. § 6979, which concerns "Labor standards." In addition, section 115 of CERCLA, 42 U.S.C. § 9615, which authorizes regulations, might be a more appropriate citation than section 116 of that Act, 42 U.S.C. § 9616, which specifies schedules for assessment and evaluation of facilities subject to the Act's requirements.
Response: EPA is not relying on any of the environmental statutes cited in the 2018 and 2020 proposal as legal authority for the rule. EPA acknowledged that there were errors in a few of the citations in the 2018 proposal and corrected them in the 2020 supplemental proposal. EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In the final rule, EPA does not interpret or apply provisions of a particular statute or statutes that it administers. EPA will undertake such efforts in forthcoming substantive actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule.
EPA agrees with the commenter that the IQA provides support for the final rule. That is why the Agency has referenced both the OMB and EPA IQA guidelines, which interpret the IQA, in the rule's preamble.
Comment [6353-2331]: Commenter (6375) notes that EPA solicits comment on whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles at the programmatic or statutory level would be appropriate as alternative or additional steps the agency may take to further the policies articulated in Section II. (pg. 18771 of the NPRM FR notice).
The regulatory language that EPA proposes provides general requirements that apply to the Agency's use of science under the many statutes that it implements. The generality of the proposed regulations may be a function of the diverse purposes of those statutes Specifically, some of these statutes focus on the introduction of new substances into the marketplace (e.g., FIFRA and TSCA), while others primarily concern regulation of emissions or releases to (e.g., CAA and CWA), or removal from (e.g., CERCLA), the environment. The scientific analyses required for these different programs and the sources of the scientific information underlying those analyses differ. The Agency should consider supplementing the general language that it has proposed with statutory specific regulations. A statutory-specific rulemaking would provide greater certainty going forward.
Response: EPA agrees that this rule should be supplemented with statute-specific transparency regulations. EPA intends to undertake such rulemakings beginning in 2021.
Comment [6851-3717]: Commenter (6873) writes that the authority to make data public to the extent envisioned in this proposal, may not lie with the EPA.
This proposal concludes that the EPA has appropriate sources of statutory authority for this regulation; you have asked for comment on whether additional or alternative sources of authority are appropriate. The concern raised by some in our group is not necessarily whether the EPA's authority is appropriate or complete, but whether it is realistic and sufficient to affect the kind of changes you're looking for. It is understood that your proposal is to modify EPA practices, not science publishing practices, but the impact on science publishing -- or at least the collision it sets up with existing publishing practices -- will be significant. As you know, most US research funding comes from NIH, NSF, DoD, DOE and NASA. The researchers who receive funding from these agencies adhere to the publishing policies set forth by these agencies -- which include open and transparency policies -- which in turn work in parallel with the US public access program policies managed by OSTP, and with a wide variety of publishing, open and transparency policies put forth by universities, publishers, private funders, foreign governments, and other groups. It's unclear how the EPA will be able to influence this existing symphony of public and private regulation, at least for the research it doesn't fund. The EPA certainly has a right to try, but without broad agreement amongst other stakeholder groups, it's unlikely that any one stakeholder in this space will be able to promulgate or enforce regulations that will have such a broad impact.
Response: EPA disagrees that the final rule will impact science publishing practices. This rule governs internal agency procedures and does not obligate or impact any entity besides EPA. The rule governs how EPA will handle pivotal science based on the availability of the underlying dose-response data. This final rule does not regulate the rights and obligations of any party outside of the EPA let alone have legal force and effect on them. Any incidental impacts on voluntary behavior outside of the EPA do not render this a substantive rule.
Comment [6873-1710]: Commenter (6895) writes that EPA incorrectly cites various authorities in an attempt to use an unsupported claim of lack of transparency as a means to justify the proposed rule, when in fact those authorities make no such findings. For example, in American Trucking Associations v. EPA 283 F.3d 355, (DC Cir., 2002), the court found that EPA did not violate procedural rights in relying on scientific studies rather than raw data. EPA itself argued that [i]f EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment...[S]uch data are often the property of scientific investigators and are often not readily available because of ...proprietary interests...or because of [confidentiality] arrangements [with study participants].
Response: EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In this final procedural rule, EPA does not rely on, interpret or apply provisions of a particular statute or statutes that it administers. Nothing in the final rule will prohibit EPA from relying on studies where the underlying dose-response data are not publicly available. Nor does the rule require that independent validation occur before EPA can use any studies.
Comment [6339-1801]: Commenter (6361) writes that the proposed HONEST Act, the Secret Science Reform Act, and this proposed rule all directly contradict a 2002 ruling and a 2010 ruling from the D.C. Circuit Court of Appeals which states "[w]e agree with EPA that requiring agencies to obtain and publicize the data underlying all studies on which they rely 'would be impractical and unnecessary". American Trucking Associations, Inc. v. EPA, 283 F.3d 355, 372 (D.C. Cir. 2002) (citation omitted); see also Coalition of Battery Recyclers Assoc. v. EPA, 604 F.3d 613, 622-23 (D.C. Cir. 2010) (rejecting claim that EPA was arbitrary and capricious for not making public data from its studies).
Response: EPA did not finalize the categorical exclusion approach from the 2018 proposal. EPA will consider all relevant studies when developing significant regulatory decisions and influential scientific information and will use the availability of dose-response data in determining the weight to assign to the subset of studies identified as pivotal science. The Agency will provide the basis for giving studies lesser consideration in the record for the rulemaking or in the documentation for the influential scientific information. This would provide an opportunity for public comment on the rationale for how EPA handled pivotal science. Further, the final rule does not require EPA to obtain and publish data underlying the studies it uses to support significant regulatory actions and influential scientific information.
Comment [6161-1514]: Commenter (6131) writes that the proposed HONEST Act, the Secret Science Reform Act, and this proposed rule all directly contradict a 2002 ruling and a 2010 ruling from the D.C. Circuit Court of Appeals which stated "[w]e agree with EPA that requiring agencies to obtain and publicize the data underlying all studies on which they rely `would be impractical and unnecessary'". American Trucking Associations, Inc. v. EPA, 283 F.3d 355, 372 (D.C. Cir. 2002) (citation omitted); see also Coalition of Battery Recyclers Assoc. v. EPA, 604 F.3d 613, 622-23 (D.C. Cir. 2010) (rejecting claim that EPA was arbitrary and capricious for not making public data from its studies).
Response: See the response to Comment 6339-1801.
Comment [5154-419]: Commenter (5165) states that the U.S. Court of Appeals for the District Columbia Circuit has affirmed EPA's use of non-public data in support of NAAQS, and in so doing it characterized as "persuasive" EPA's approach to data availability, which the court quoted as follows:
      If EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment. [S]uch data are often the property of scientific investigators and are often not readily available because of ... proprietary interests ... or because of [confidentiality] arrangements [with study participants].
Now, EPA indicates that it intends to reverse this policy and adopt one that would expressly preclude it from using studies based on such "non-public data." It is inappropriate for EPA to undertake such a consequential policy change without explaining why it believes the concerns it expressed above are incorrect or no longer valid.
Response: See the response to Comment 6339-1801.
Comment [6163-1116]: Commenter (6133) writes that no case law supports the proposal.
The Proposal "directs EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773. However, the Proposal fails to identify a single court decision supporting an agency's decision to bar itself from considering relevant studies or information on the grounds that underlying data are not "publicly available in a manner sufficient for independent validation," where such a requirement is not statutorily imposed. Indeed, EPA in the entire Proposal only cites two cases related to this question, and EPA admits, as it must, that both cases "upheld EPA's use (sic) nonpublic data in support of its regulatory actions." Id. at 18,769 n.3 (citing Coal. of Battery Recyclers Ass'n v. EPA, 604 F.3d 613, 623 (D.C. Cir. 2010) & Am. Trucking Ass'ns v. EPA, 283 F.3d 355, 372 (D.C. Cir. 2002)).
Footnote 3 in the Proposal contains two noteworthy, albeit unintended, indictments of the approach proposed by EPA. First, footnote 3 states that "[h]istorically, EPA has not consistently observed the policies underlying this proposal." Tellingly, EPA does not and cannot identify even one example in which EPA has observed the policies underlying the Proposal. Our research, to the contrary, has identified no instance in which EPA has followed the policies underlying the Proposal, to bar EPA from considering relevant studies or science submitted by the public or gathered by EPA, on the grounds that the underlying data are not "publicly available in a manner sufficient for independent validation."
Second, footnote 3 implies that there are instances where EPA's use of non-public data in support of its regulatory actions was rejected by a court. See id. ("courts have at times upheld EPA's use (sic) non-public data in support of its regulatory actions.") (emphasis added). Again, the Proposal does not and cannot cite a single court decision that failed to uphold use of nonpublic, relevant science or studies relied on by EPA or any other federal or state agency in support of its regulatory actions. Id. Our research also failed to identify a single instance in which a court failed to uphold an agency's use of non-public, relevant science or studies by an agency, after that practice was challenged by commenters or petitioners in court.
Of course, in both the cases that the Proposal cites in footnote 3, the D.C. Circuit Court of Appeals refused to prohibit EPA from considering non-public data. In American Trucking, the court declined to "impose a general requirement that EPA obtain and publicize the data underlying published studies on which the Agency relies," holding that the "Clean Air Act imposes no such obligation." 283 F.3d at 372. The court agreed with EPA that "requiring agencies to obtain and publicize the data underlying all studies on which they rely would be impractical and unnecessary." Id. (quoting EPA in Particulate Matter NAAQS, 62 Fed. Reg. at 38,689).
The D.C. Circuit reaffirmed this holding in its 2010 decision, Coalition of Battery Recyclers, in which the court reiterated that requiring publication of all data underlying studies would be impractical and unnecessary, and was not required by the Clean Air Act. 604 F.3d at 623. EPA in the Proposal utterly fails to explain or demonstrate why its proposed, self-imposed restriction would be any less impractical or unnecessary than those it previously opposed on these grounds. This failure to explain, failure to offer any convincing counterproof, and failure to explain the agency's reversal of its positions in American Trucking and Coal. Of Battery Recyclers Ass'n provide independent grounds for finding EPA's Proposal arbitrary and capricious and an abuse of discretion. Similarly, the Proposal does not identify any case law supporting EPA's claimed ability to "exercise its discretionary authority to establish a policy that would preclude it from using such [non-public] data in future regulatory actions." 83 Fed. Reg. at 18,769 n.3. Our research failed to identify any case in which the courts allowed an agency to categorically bind itself from considering relevant, peer-reviewed science, or otherwise valid studies or evidence, because the underlying data was not made publicly available. Cf., e.g., Southwest Airlines Co. v. Tr. Sec. Admin., 554 F.3d 1065, 1074 (D.C. Cir. 2009) (holding TSA was not required to disclose to airline companies the underlying data file used in a GAO report that informed TSA's calculation of security fees given the nature of the decision -- which was industry-wide rather than an adjudicative decision -- and the deference given to agency denials of discovery); Pharm. Research and Mfrs. v. FTC, 790 F.3d 198, 210 - 11 (D.C. Cir. 2015) (holding the FTC was not required to disclose the 66 individual filings underlying its decision to target only the pharmaceutical industry in a new rule because the filings were confidential, were used as a general source of background in the rulemaking process, and were exempted from disclosure by statute); State Corp. Comm'n of Kan. v. FERC, 876 F.3d 332, 335 - 36 (D.C. Cir. 2017) (holding FERC was justified in relying on a study used by the agency to assess the benefits of a power facilities merger, even though the study was objected to by Kansas on the grounds that the study was performed by a third party and its results could not be verified by Kansas. The court rejected Kansas's objections to the study because Kansas had access to a redacted electronic version of the study, though not the underlying data; Kansas did not pinpoint a specific reason to question the study, and the study's assumptions and results had been reviewed for reasonability.)
Under some circumstances, the D.C. Circuit has upheld an agency's decision to exclude an individual piece of evidence from the decision-making process. In API v. EPA, the D.C. Circuit upheld the EPA's decision to discount a published meta-analysis that ran counter to the rule ultimately adopted. 684 F.3d 1342, 1350 (D.C. Cir. 2012). There, EPA considered the study but discounted its results after "[finding] its methodology wanting." The court found the EPA decision to discount the study was not arbitrary and capricious because EPA had not "entirely failed to consider an important aspect of the problem [or] offered an explanation for its decision that runs counter to the evidence before the agency." Id. (quoting North Carolina v. EPA, 531 F.3d 896, 906 (D.C. Cir. 2008)). Critically, EPA did consider the study (unlike the censorship approach in the instant Proposal). Moreover, following consideration, the agency offered specific reasons for not relying on the study, including its disagreements with the methodology. Id.
Likewise, the D.C. Circuit found in Intercollegiate Broadcasting System v. Copyright Royalty Board, that the Copyright Royalty Board had "properly excluded" from evidence a reference to a survey because the survey itself was not entered into evidence and could not be verified. 796 F.3d 111, 129 (D.C. Cir. 2015). In both cases, the court yielded to an agency's discretion to exclude a particular piece of information where the agency had made an individualized determination about the source. None of these cases support the Proposal's categorical ban on EPA considering relevant data, science, or studies (where data are not "publicly available in a manner sufficient for independent validation"), that have been submitted to the agency and that have not been the subject of any individualized determination that the studies or information are flawed or erroneous.
In its Proposal, EPA proposed to categorically ignore and exclude all peer-reviewed research with non-public underlying data, without individually considering each study or offering specific reasons for not relying on that study. The Proposal, by barring consideration of foundational scientific research premised upon non-public data, would result in EPA "fail[ing] to consider an important aspect of the problem." API, 684 F.3d at 1350. There is no evidence of a court supporting an agency's decision to exclude entire categories of evidence, or studies or information based on categorical prohibitions like the ones in the Proposal, without considering the source and offering specific reasons for not relying on the study. Instead, both EPA and the Courts have indicated already in API and Coalition of Battery Recyclers, that a rule like the one EPA is currently proposing is not required by the Clean Air Act and would be both impractical and unnecessary. This Proposal runs counter to the D.C. Circuit's decision in API and would render EPA's regulatory actions based on the Proposal arbitrary and capricious and an abuse of EPA's discretion. The Proposal's blanket rule would represent a significant and unlawful departure from D.C. Circuit rulings on agencies' limited discretion to choose the sources it will consider and ignore.
Response: See the response to Comment 6339-1801.
Comment [6157-901]: Commenter (6127) writes that this is a rejection of the scientific mandate and approach of the agency as mandated in the Environmental Protection Act, including multiple court precedents in favor of the EPA in the use of non-public data for regulatory purposes including Coalition of Battery Recyclers Assn. v. EPA, 604 F.3d 613, 623 (D.C. Cir. 2010) and American Trucking Assn's v. EPA, 283 F.3d 355, 372 (D.C. Cir. 2002).
Response: EPA has no knowledge of the Environmental Protection Act referenced in this comment. Nothing in this rule prohibits EPA from using non-public data for regulatory purposes. Also see the response to Comment 6339-1801.
Comment [1425-4482]: Commenter (1440) suggests that the authorities listed for promulgating this regulation do not make sense. (See "Authority" section for proposed 40 CFR part 30 at 83 FR 18773). For example, the proposed regulations cite to 42 U.S.C. 6912(a)(1) and 42 U.S.C. 6979 under the RCRA as the authority for EPA to promulgate them. There appears to be no basis to such a citation.
42 U.S.C. 6912(a)(1) does give the Administrator the authority to promulgate regulations "as are necessary to carry out his functions under this chapter." However, the "functions" this section refers to involve activities "to promote the protection of health and the environment and to conserve valuable material and energy resources." The proposal provides no justification for how the new regulation would accomplish this goal. Depending exactly on how the vaguely worded provisions are implemented, the proposed regulation could in fact be in direct opposition to the goals of the RCRA statute.
Even stranger is the citation to 42 U.S.C. 6979, which discusses labor standards that must be followed for construction grants made under RCRA and does not appear even tangentially related to the proposed regulation.
While in general the goal of increasing transparency of EPA regulatory science is a laudable one, it is not one that Congress has given EPA explicit authority to promulgate administrative rules to carry out. Since administrative rules have the effect and force of law, they must have a clear basis before EPA can promulgate them. The Agency would better accomplish this goal through developing internal policies rather than attempting a change to the regulation.
Response: EPA is not relying on any of the environmental statutes cited in the 2018 and 2020 proposal as legal authority for the rule. EPA acknowledged that there were errors in a few of the citations in the 2018 proposal and corrected them in the 2020 proposal. This rule does not change any existing EPA regulations. It only applies prospectively to significant regulatory actions and influential scientific information, based on dose-response data, that are developed after the effective date of the rule.
Comment [2393-4702]: Commenter (2408) writes that this effort to exclude important environmental and public health studies while privileging industry-sponsored research is clearly contrary to the public interest as well as to EPA's legislative mandates.
Response: The rule does not require the exclusion of any studies from consideration when the Agency develops significant regulatory actions and influential scientific information. All relevant studies, including industry research will be evaluated using study quality factors in § 30.5.
Comment [5173-455]: Commenter (5184) notes that the TSCA story provides further evidence that NEPA requires EPA to prepare a thorough EIS before it adopts the proposed regulation.
Response: NEPA does not apply to this rulemaking because the rule is not a "major Federal action significantly affecting the quality of the human environment." NEPA section 102(2)(c); 42 USC § 4332(2)(c). The rule is one of internal agency procedure that describes the consideration the agency will give to studies based on data availability and the factors EPA uses to evaluate studies that may be used for regulatory purposes and influential scientific information and, as such, will not affect the quality of the human environment.
Comment [6112-1612]: Commenter (6137) contends that administrative statutes prohibit the proposed prohibitions.
EPA's Proposed Rule likewise ignores requirements set forth in two administrative statutes that govern its rulemaking: the Regulatory Flexibility Act and the Data Quality Act. Under the Regulatory Flexibility Act, 5 U.S.C. § 601 et seq., federal agencies must consider the impacts their regulations will have on small entities and must consider less burdensome alternatives. In developing a new regulation, an agency must take one of two actions: certify that a proposed rule will not have a significant economic impact on a substantial number of small entities, or prepare an initial regulatory flexibility analysis. EPA must publish its initial regulatory flexibility analysis or a summary of it in the Federal Register along with the proposed rule. Here, EPA includes a certification with the Proposed Rule stating that it will not have a significant economic impact on a substantial number of small entities. However, it provides no support for this certification.
Pursuant to the DQA, also known as the IQA, Treasury and General Government Appropriation Act for Fiscal Year 2001, Pub. L. No. 106-554, § 515 Appendix C, 114 Stat. 2763A-153 (2000), the OMB issued government-wide guidelines that "provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by Federal agencies. . . ." The OMB guidelines directed each federal agency to issue its own information quality guidelines to "ensure and maximize the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by the agency." 67 Fed. Reg. 8451, 8459 (Feb. 22, 2002). Following OMB's instructions, EPA issued its own guidelines that apply to information it disseminates to the public. EPA, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity, or Information Disseminated by the Environmental Protection Agency (Oct. 2002), https://www.epa.gov/sites/production/files/2017-03/documents/epa-info-quality-guidelines.pdf. According to these guidelines, EPA uses a "weight-of-evidence" approach that "considers all relevant information and its quality, consistent with the level of effort and complexity of detail appropriate to a particular risk assessment." EPA Guidelines 6.4 (emphasis added). The Proposed Rule contravenes these requirements, as it will prevent EPA from considering all relevant information by precluding consideration of certain data.
Moreover, pursuant to EPA's guidelines, EPA must ensure that the information it disseminates "is accurate, reliable and unbiased." EPA Guidelines 6.4(A). To do so, it uses:
      the best available science and supporting studies conducted in accordance with sound and objective scientific practices, including, when available, peer reviewed science and supporting studies; and (ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies the use of the data).
Id. Given that the Proposed Rule eliminates from consideration any scientific study where the underlying data cannot be made publicly available, it undoubtedly precludes the use of the best available science in certain situations. Thus, the Proposed Rule is inconsistent with EPA's implementation of the DQA.
Response: EPA disagrees that the final rule is inconsistent with the Regulatory Flexibility Act (RFA) or the DQA (also known as the IQA). The final rule is a rule of internal agency procedure. It does not govern or apply to any entity other than EPA. Therefore, it will not result in impacts to small entities. The final rule does not include the categorical exclusion proposed in 2018. Under § 30.5, EPA will evaluate all relevant studies when developing significant regulatory actions and influential scientific information. Studies considered pivotal science will then be weighed based on the availability of the underlying dose-response data.
Comment [6112-1620]: Commenter (6137) contends that the proposed rule violates Public Law 95-622 and the common rule for research involving human subjects.
EPA's Proposed Rule also conflicts with Public Law 95-622 and the interagency regulations on testing of human subjects required by that law. In 1978, Congress created a President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (the "Commission") and directed the Commission to study the "protection of human subjects," defined to include the "health, safety, and privacy of individuals." 42 U.S.C. § 300v - 1(b)(2), (f)(2) (emphasis added). This included a study of and issuance of recommendations concerning, among other subjects, procedures and mechanisms "to safeguard the privacy of human subjects of behavioral and biomedical research, [and] to ensure the confidentiality of individually identifiable patient records." Id. § 300v - 1(a)(1)(E), (a)(4) (emphasis added).