The Proposal's focus on public release of the underlying data used in studies  -  particularly "dose response data" and studies, evinces a clear lack of understanding of the way science is conducted and verified. While replicating the results of a study with the same data set certainly verifies it, as the National Research Council said in 2002, "[f]or large epidemiological studies, repeating a study is seldom either possible or desirable." More effective, instead, is some combination of new studies testing the same question in different places, and/or an independent analysis with the same data. Formal peer review, whether or not prior to publication, also validates the outcome of scientific studies, as reflected in the OMB Guidelines presumption of objectivity and usefulness for scientific studies that have undergone formal peer review, described above.
An example of this is the series of studies, re-analyses, verifications, and extensions of work begun in 1974 on the prospective "respiratory health effects of respirable particles and sulfur oxides on a sample of adults and children in six U.S. cities." This work, first undertaken by researchers at the Harvard School of Public Health, became known as the Harvard Six Cities Study. The Six Cities Study, published in 1993, tracked 20,000 people in six U.S. cities for two years and found a definitive link between PM pollution and serious health effects, including death. The American Cancer Society Study, published in 1995, linked air pollution to cardiovascular disease, respiratory disease, and lung cancer. Since their publication the studies have been reanalyzed and extended and consistently validated. EPA has found that these additional studies provide "consistent and stronger evidence of an association with mortality at lower air quality distributions than had previously been observed."
Some of the early peer reviewed Harvard Six Cities work was relied on by EPA in setting the PM NAAQS in 1987. Industry challenged the 1987 24-hour PM standards in part by questioning that work. The court held that EPA must "take into account all the relevant studies revealed in the record," and noted the precautionary nature of the CAA.
The Harvard researchers and others continued to explore the effects of ambient PM exposures on human health and mortality, in the six cities, and various other places around the country and the world. As those results came out, industry-sponsored researchers again challenged them, in professional meetings and journals, arguing that because they could not reproduce or use the (confidentially provided) human health data set, the results could not be relied on. They claimed to come up with different results using other data.
The HEI was brought in to manage an evaluation of the studies. HEI, funded by industry and EPA, is an independent arbiter, which chose a new team of scientists to reconstruct the Six Cities data set and verify the original results. Subsequently, over 100 other studies were peer-reviewed and published by 2004, building on, expanding, corroborating, and verifying the relationship between PM exposures and adverse respiratory health effects and even early death. These included follow up using "the sample of adults in the Harvard Six Cities Study," that found an approximately two-year reduction in life expectancy for those living in the most polluted areas.
These results, and the methodologies underlying them, were then validated by the original Harvard Six Cities researchers, in collaboration with a team funded by the American Cancer Society, using new cohort data  -  a combined data sample of more than 500,000 adults. The collaborative work was peer-reviewed and published. That work then became the focus of new debate over the 1997 PM NAAQS standard-setting, including new industry attacks based on industry's asserted lack of access to the health data in which they were grounded  -  raising the same questions that are still underlying this 2018 Proposal  -  namely, arguing that EPA needed to make public the data underlying any study on which it relied. Again, however, HEI was brought in to validate the results, and the resulting work was published in 2000. The D.C. Circuit Court reviewing the 1997 standard determined in 2002 that releasing the data was neither required by the Act, nor was it practical or necessary.
 The HEI review validated the previous work, and "demonstrated the robustness of the PM-mortality risk estimates to many alternative model specifications....[and] also made a number of innovative methodological contributions that...substantially contributed to subsequent analyses."
Comment [6895-3185]: Commenter (6916) states that the EPA's Proposal to limit the scientific basis for the Agency's decision making is not authorized by the CAA.
EPA, like all federal agencies, is a creature of statute, and "may act only pursuant to authority delegated ... by Congress." But the Proposal fails to state clearly under what authority EPA is proposing these rules, providing only a list of statutes that require the Agency affirmatively to take scientific information into account, but not explaining why they would offer the Agency authority to disregard certain relevant studies.  Indeed, EPA seems unsure of its authority, requesting comment on "additional or alternative sources of authority."
Nor does the EPA Administrator's authority "to prescribe such regulations...as are necessary to carry out the Agency's functions" present an opening to disregard relevant information, as EPA suggests. To the contrary, courts have held that the Administrator must take into account all relevant studies in the record. Other CAA sections, not cited by the Agency, lay out and define some of the Administrator's rulemaking "functions under the Act" as requiring for example, the use of "the latest scientific knowledge useful in indicating the kinds and extent of all identifiable effects on public health or welfare..." So, the Proposal to permit him to disregard some studies is contrary not only to his general rulemaking authority, but to his specific authority to, inter alia, set NAAQS based on the "latest scientific knowledge."
The seminal CAA air quality standard-setting provisions have twice been held not to require the release of data underlying studies relied on by the Agency, as discussed above. Indeed, in both situations, the court has described such release as "unnecessary and unjustified."
The Proposal also is inconsistent with the overall precautionary nature of the CAA. Congress did not intend EPA to limit itself to considering only `sure things' but asks the Administrator to protect the public against uncertain dangers due to exposure to air pollution. Primary NAAQS are to be set with an "adequate margin of safety," meaning that "the Administrator need not regulate only the known dangers to health but may `err' on the side of overprotection." This precautionary approach is reflected also in the various technology-forcing sections of the Act, which Senator Muskie said "may [require] that people and industries will be asked to what seems to be impossible at the present time." Under this scheme, the Administrator must consider all relevant studies placed in the record, and "may apply his expertise to draw conclusions from suspected, but not completely substantiated, relationships between facts, from theoretical projections from imperfect data, from probative preliminary data not yet certifiable as `fact' and the like," in order to protect public health as Congress intended. This context simply does not authorize the Administrator to decline to consider any studies  -  but particularly not those representing the best available science  -  because the underlying data is confidential.
Comment [6895-3204]: Commenter (6916) states that CAA section 307(d)(6)(B) requires that when finalizing a proposed rule, and after taking comment, an Agency must "respon[d] to each of the significant comments, criticism, and new data submitted in written or oral presentations during the comment period." And, while both proposed and final rules under the CAA must be accompanied by a statement of basis that summarizes studies and data on which the Agency relies, in no way does that requirement authorize the public release of the raw data. Nor does the Act's requirement that the record underlying rules include a "summary of ... the factual data on which the ... rule is based," require the public release of such data. Nor does the Act elsewhere require or allow data to be released to the public. Where "new data" is submitted by commenters, that must be responded to by the Agency and that response made part of the record, but the statute does not require public release of new data either. Indeed, Agency proposals, including this one, describe measures by which commenters can submit so-called CBI  -  which the Agency can consider but protect from public release.
Therefore, to the extent that the Proposal envisions authorizing EPA to ignore or disregard or not to consider some studies submitted during a rulemaking comment period, whether or not the data is publicly released, such agency action would be taken in direct violation of the CAA. Nor is there any basis elsewhere in the CAA for EPA to decide to exclude or prohibit the consideration of otherwise relevant matter because it is based on confidential information not available to the general public.
The Proposal does not meet CAA procedural requirements. As noted supra, the CAA requires, with any proposed rule, 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." But this Proposal is not accompanied by any record in support. Nor has the Agency even attempted to explain in the preamble why current statutes and guidelines do not adequately provide for the public to question scientific studies, seek validation, replication (or reproducibility) of study results, and to comment on methodologies, without "public" release of confidential data. It therefore does not satisfy the CAA's requirements or provide the public with a meaningful opportunity to fully comment on the proposal.
Comment [6895-3227]: Commenter (6916) contends that the Proposal does not clearly identify the authority under which EPA has promulgated it. As discussed above, the CAA does not authorize the Proposal, which is clearly aimed at limiting the studies EPA can rely on and consider in CAA rulemaking. Certainly that is the case for the CAA sections listed by the Agency in the Proposal, including the general rulemaking authority under the Act which requires the evaluation of all material in the record. EPA's suggestion that it has "general authority" to make rules to comply with its obligations is similarly unavailing here, as the general authority does not exist to make rules that are outside EPA's statutory obligations, or in violation of them  -  and a rule that would enable EPA to disregard relevant studies in a CAA rulemaking record is clearly outside the Agency's authority. Nowhere does the Act permit EPA to limit its own access to relevant science.
The Proposal's terms are so vague as to fail to afford an opportunity for meaningful comment. Significant issues are presented in the Proposal only in the broadest terms, and with enough specificity "to permit interested parties to comment meaningfully." As noted supra, we assume (as we must, given no other information from the Agency), that the Proposal is aimed at precluding EPA's reliance on studies for which the data are not made public. That is the natural reading of the proposed regulatory language, which is the most choate information offered in the Proposal. But even that reading is not certain, given the very broad discretionary nature of the exemptions provided for in the rule text (see, e.g., 83 Fed. Reg. 18,774, proposed 40 C.F.R. § 30.9, giving the Administrator the ability to grant an exemption to the data publication requirement if that is "impracticable," which is undefined in the Proposal). As a result, it is unclear how this rule would apply to EPA decision making, and how it would be different than the Agency's current protocol for considering studies relevant to specific rulemaking proposals.
As one example, EPA alludes to "transparency" multiple times, but without defining what that concept means, or explaining why it believes existing statutes, regulations, guidelines and protocols fail to meet it. While asserting an interest in "ensur[ing] that the data and models underlying science is [sic] publicly available in a manner sufficient for validation and analysis," there is no more specific statement explaining how that would be implemented or why releasing confidential health and business information is necessary. Nor is the Agency's rationale completely clear in the Proposal. When commenters are left to guess, that is not lawfully sufficient notice of the subjects and issues involved.
Comment [6895-3296]: Commenter (6916) states that the EPA has failed to follow required and customary rulemaking process in issuing this Proposal. 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 Environmental Research, Development and Demonstration Authorization Act of 1976 (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.
As discussed above, however, 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 Office of Information and Regulatory Affairs (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.
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.
Comment [6897-1893]: Commenter (6918) supports the Proposed Rule's underlying values, which originate from EPA's statutory authority and principles of good government.
Transparency, validity, and public participation are especially important when EPA issues rules under the CAA. Section 307(d)(3) of the Act, which applies to certain important categories of EPA rules as well as to other rules to which the EPA Administrator decides to apply it, imposes even more stringent requirements than does the APA, 5 U.S.C. § 553, which specifies general requirements for notice-and-comment rulemaking. Specifically, CAA section 307(d)(3) requires:
      In the case of any rule to which this subsection applies, notice of proposed rulemaking shall be published in the Federal Register, as provided under section 553(b) of Title 5, shall be accompanied by a statement of its basis and purpose and shall specify the period available for public comment . . . . The notice of proposed rulemaking shall also state the docket number, the location or locations of the docket, and the times it will be open to public inspection. The statement of basis and purpose shall include a summary of --
      (A) the factual data on which the proposed rule is based;
(B) the methodology used in obtaining the data and in analyzing the data; and
(C) the major legal interpretations and policy considerations underlying the proposed rule.
As the D.C. Circuit has explained, section 307(d) requires EPA to issue a proposed rule and to provide a detailed explanation of its reasoning at the proposed rule stage. See, e.g., Small Refiner Lead Phase-Down Task Force v. EPA, 705 F.2d 506, 519 (D.C. Cir. 1983). CAA § 307(d)(3) "requires a much more detailed notice of rulemaking" than the APA. Id. at 518; see also Union Oil Co. v. EPA, 821 F.2d 678, 681-82 (D.C. Cir. 1987) (noting that Congress's 1977 amendments to the CAA "provide new procedural requirements for EPA rulemaking" that are "more stringent than those previously applicable under the Administrative Procedure Act," including a requirement that "EPA . . . establish a detailed `rulemaking docket' that . . . must provide the entire basis for the final rule.") (quoting 42 U.S.C. § 7607(d)(3) (1982)). The public process values that underlie notice-and-comment rulemaking, both under the CAA and under the APA, amply justify the notice requirement. If poor notice is given, "[t]he agency will not get the informed feedback it needs, the parties will feel unfairly treated, and there will be a meager record for [the courts] to review." Small Refiner Lead Phase-Down Task Force, 705 F.2d at 550.
The Proposed Rule represents another instance of EPA seeking to build on its existing policies, principles, and statutory obligations. EPA recognizes that "[m]eaningful public participation requires much more than simply holding public meetings or hearings or collecting public comment." And, consistent with EPA's long history of seeking to increase transparency, promote public participation, and ensure validity of its rules, increasing access to underlying data and models will help satisfy EPA's specific obligations under the CAA.
Comment [6901-4441]: Commenter (6922) provides that, in the CAA:
      The Administrator shall issue air quality criteria for an air pollutant within 12 months after he has included such pollutant in a list under paragraph (1). Air quality criteria for an air pollutant shall 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, in varying quantities.
Comment [8750-1431]: Commenter (9227) asserts that, not only is there no authority for EPA's pan-statutory Proposal, but the Proposal would also violate explicit statutory commands. Though EPA admits that "[t]he best available science must serve as the foundation of EPA's regulatory actions," proposed section 30.5 would prohibit EPA from considering high quality and critically important scientific studies -- precisely that "best available science" -- when undertaking regulatory actions. Specifically, section 30.5 would prevent EPA from considering any scientific study for which the underlying "dose response data and models" are not "publicly available in a manner sufficient for independent validation." The commenter notes that in CAA, 42 U.S.C. § 7408(a), EPA shall establish air quality criteria that "shall 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, in varying quantities."). And, by excluding science that meets these statutory criteria from supporting regulations to protect public health and welfare, the Proposal would frustrate Congress's policy in these statutes and frustrate EPA from achieving its fundamental mission.
Comment [8750-1432]: Commenter (9227) states that the EPA's statutory authorities generally require the agency to consider all available data when undertaking significant rulemakings. The EPA's statutory authorities mandate a variety of requirements for what scientific information EPA must consider in rulemaking. These statutes are discussed in detail, infra at Section I.B.3. To take one example that appears in numerous statutes, including TSCA, CAA, SDWA, and the ESA, Congress has often required agencies to act on the "best available science." For an agency to comply with this obligation, the agency must at least consider all available scientific information. "Best" means "of the most excellent, effective, or desirable type or quality." "Available" means "able to be used or obtained." And "science" means "the intellectual and practical activity encompassing the systematic study of the structure and behavior of the physical and natural world through observation and experiment." Assessing which science is "best" requires consideration of the overall quality of the science, and the public availability of underlying data is, at best, one of many aspects that should inform that assessment of overall quality.
An agency "cannot ignore available. . . information." Numerous courts have indicated that a plaintiff or petitioner can establish a violation of the "best available science" requirement by "point[ing] to any scientific evidence that the agency failed to consider." "The best available data requirement. . . prohibits [an agency] from disregarding available scientific evidence that is in some way better than the evidence [it] relies on.'" "An agency does. . . have an obligation to deal with newly acquired evidence in some reasonable fashion." EPA's proposal will result in EPA precluding itself from considering certain studies that are "available," thus violating the requirement that EPA rely on the best available science.
In addition, the requirement that agencies use "best available" science or information often means that the agency must act even if the available science or information is imperfect.
"Even if the available scientific and commercial data were quite inconclusive, [the agency] may -- indeed must -- still rely on it" when the agency has a duty to act. "[W]here the information is not readily available, we cannot insist on perfection." Just as the Courts have recognized that they cannot expect perfection, agencies cannot choose to ignore certain studies or sources of information based solely on whether the data is publicly available -- especially where the validity of those studies has been established using techniques that do not rely on public availability of underlying data.
EPA cannot reasonably elevate the interest in public availability of all underlying information above all other factors in assessing the "best available science." Textually, EPA's approach is unlawful.
Comment [8750-1448]: Commenter (9227) notes that, as EPA acknowledges in footnote 3 of the Proposal, in at least two instances the D.C. Circuit Court of Appeals has recognized that studies for which underlying data is not publicly available may constitute "best available science." The D.C. Circuit's decisions in these cases further demonstrate that the public unavailability of a study's underlying data does not render a study incapable of constituting "best available science" otherwise unworthy of EPA's consideration.
In American Trucking Associations v. EPA, the petitioner challenged EPA's reliance on scientific studies for which underlying data was not publicly available in deciding to strengthen the NAAQS for PM. The Court held that the CAA did not require EPA to make public underlying data where EPA relied on the study itself and not the raw data underlying the study. The Court agreed with EPA's position that requiring agencies to obtain and publicize the data underlying all studies on which they rely "would be impractical and unnecessary." Importantly, the Court concluded that:
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. . . . Such 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].
The court accordingly recognized that ignoring relevant scientific information simply because the underlying data is not available would violate EPA's obligations to consider "best available science." Coalition of Battery Recyclers Association v. EPA involved another challenge to EPA's reliance on a scientific study for which the underlying data was not publicly available.In that case, EPA had relied upon the study in question to determine the "concentration-response relationship between blood lead levels and IQ changes." The D.C. Circuit again upheld EPA's reliance on studies without making the underlying data publicly available and explained, "raw data often is unavailable due to proprietary interests of a study's scientific investigators or confidentiality agreements with study participants." Likewise, in City of Waukesha v. EPA the D.C. Circuit concluded that agency peer review satisfies the requirement to use best, peer reviewed science and supporting studies.
Comment [8750-1453]: Commenter (9227) notes that, by prohibiting EPA from considering all valid and relevant studies when undertaking significant rulemakings, the proposed rule would prevent EPA from complying with an array of statutory provisions governing EPA's consideration of available science.
Under CAA section 108(a), EPA must establish air quality criteria for each air pollutant that serves as the basis for setting the NAAQS. Such criteria "shall 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, in varying quantities." As explained above, the scientific community, EPA, and the courts have all concluded that lack of public availability of underlying data does not render the study invalid. And consideration of such studies can be essential for EPA to fulfill CAA section 108(a)'s directive that it consider "the latest scientific knowledge" in establishing air quality criteria, that it consider studies "useful" in indicating effects of pollutants on ambient air, and in providing an adequate margin of safety in the standard itself. Thus, EPA's proposal to bar EPA from considering such studies would prevent EPA from complying with its statutory obligation under CAA section 108(a).
Section 108(a)(2) says nothing about excluding information -- its evident purpose is to be inclusive as to information to be considered. EPA's historic practice reflects this broad directive: each NAAQS review evaluates virtually all studies in the area, excluding none, but assigning appropriate weight based on study-by-study evaluation. Since the NAAQS provisions were enacted in 1970, EPA has conducted many NAAQS rulemakings. The agency does not establish per se, a priori rules regarding study inclusion or exclusion, but rather evaluates each of the individual studies -- and there are thousands typically evaluated for each NAAQS review -- on their merits based on reasoned criteria. While details of the development and review of the criteria and standards have evolved over time, in practice, EPA has endeavored to include all relevant scientific studies in the process, even providing provisional assessments of relevant literature that appears after the formal scientific review has been completed. Over the years, tens of thousands of peer-reviewed studies of health effects, exposure, and atmospheric interactions, and monitoring have been included in reviews of criteria and standards. A requirement that they must be excluded from consideration unless the raw data and full methodologies are made available for all of them is inconsistent with the legislative mandate and EPA's practice over the last 40 years.
Thus, a science regulation that applies to the NAAQS is unlawful unless EPA can show that the new standard can be established and implemented consistent with the applicable statutory requirements. To do so, EPA must prove that public unavailability of data means that a study does not constitute "latest scientific knowledge useful" in indicating effects on human health or welfare. EPA's Proposal neither acknowledges this requirement nor explains how the Proposal would not violate this statutory command.
For example, in past NAAQS reviews, EPA has considered the Harvard Six Cities study and American Cancer Society studies, despite the fact that the data underlying these studies is not publicly available. These studies, however, are plainly "useful in indicating the kind and extent of all identifiable effects on public health or welfare." These seminal studies have been part of the air quality criteria since the mid-1990s -- they have thus been accepted as "useful" by separate panels of CASAC, and by EPA, in three separate NAAQS reviews. Their use has been upheld by the D.C. Circuit. Both studies have been reanalyzed and validated by highly competent third-party reviewers (the HEI) with access to the underlying data. The study results have been reproduced many times over. Extended follow-up analyses of the ACS and Harvard Six Cities studies provide consistent and stronger evidence of an association with PM 2.5 and mortality at even lower air quality distributions than had previously been observed. This type of cumulative weight of evidence is highly probative in assessing both causality and in establishing the level of the NAAQS. The proposal says almost nothing about any of these other attributes that not only make these studies "useful," but indeed make them particularly high quality and reliable. The primary ozone NAAQS provides further examples of the pernicious effects the proposal would have. Among the key controlled human exposure studies demonstrating that exposure to ozone causes adverse health effects in even healthy subjects at levels below the level of the then-current NAAQS are Adams (2006) and Schelegle (2009). These studies were sponsored by the American Petroleum Institute, which controls access to the underlying data. The American Petroleum Institute refused an EPA researcher access to the data of a related Adams study it sponsored (Adams (1998)). So not only would these evidently "useful" (under CAA section 108(a)(1)) studies be barred from consideration under the Proposal, but the Proposal creates a perverse incentive for industry to refuse access to study data. The published studies --  peer reviewed -- would obviously be providing information "useful" in indicating effects of air pollution, but the Proposal would not only bar their consideration but create an incentive for industry never to provide underlying data for any industry-sponsored study with a result not to industry's liking.
The most recent premiere long-term cohort study for PM is Domenici (2017) which found even greater effects of fine particles at levels below EPA's current standards. This study used a Medicare database available to any research group that can guarantee confidentiality of personal data. Yet the proposal could evidently bar consideration of this powerful study.
NAAQS must be requisite to protect the public health, and to provide an "adequate margin of safety" in doing so. The proposal violates this central statutory requirement. NAAQS are required to provide this margin of safety "to build a buffer to protect against uncertain and unknown dangers to human health." EPA's Proposal would build a buffer against using the very studies necessary to guard against these dangers.
Comment [8750-1770]: Commenter (9227) contends that the proposed rule fails to meet even the most basic procedural and substantive obligations. The APA requires that the "opportunity for comment must be a meaningful opportunity," and "[t]hat means enough time with enough information to comment and for the agency to consider and respond to the comments." Prometheus Radio Project v. FCC, 652 F.3d 431, 450 (3d Cir. 2011) (internal citation and quotation marks omitted). See also Am. Hosp. Ass'n v. Bowen, 834 F.2d 1037, 1044-45 (D.C. Cir. 1987) (noting the "obvious importance of the [APA's] policy goals of maximum participation and full information."). For its part, the CAA "requires a much more detailed notice of proposed rulemaking than does the APA." Union Oil Co. of Cal. v. EPA, 821 F.2d 678, 682 (D.C. Cir. 1987); see Small Refiner Lead Phase-Down Task Force v. EPA, 705 F.2d 506, 550 (D.C. Cir. 1983) ("[T]he additional notice requirements in § 307(d)(3) suggest that Congress intended agency notice under the CAA to be more, not less, extensive than under the APA."). Executive Order 13563 underscores these obligations requiring that to promote "open exchange of information and perspectives among State, local, and tribal officials, experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole," agencies "shall endeavor to provide the public with an opportunity to participate in the regulatory process."
Moreover, notice has to be provided by the agency; it cannot be bootstrapped from the public comments. The reasons are evident: there is no requirement for parties to monitor all of the thousands or tens of thousands of submitted comments in order to guess the issues on which to comment. A contrary rule "would turn notice into an elaborate treasure hunt, in which interested parties, assisted by high-priced guides (called `lawyers'), must search the record for the buried treasure of a possibly relevant comment."
Drafting these comments has entailed a great deal of guesswork. The comments of EDF or any other commenter on a particular issue thus should not be taken to mean that EPA provided sufficient notice of that issue.
The proposed rule lacks essential elements needed to understand it, rendering the opportunity for comment meaningless. The Proposal contains vague and contradictory statements about its actual substance and effect, fails entirely to analyze and disclose its costs and benefits, and is littered with vague references to entire websites and executive branch departments. The cursory reasoning and wholly inadequate record offered in support of the proposed rule prevents stakeholders from engaging with the agency on its rationale for the proposed action and its costs and benefits or offering contrary evidence. Finally, EPA has not provided any basis whatsoever to warrant the gross inadequacies of the proposed rule and the process to consider it. With such a deeply deficient basis for action, the only legally viable course is to withdraw the Proposal.
Comment [8750-1777]: Commenter (9227) Section 307(d) applies to "such. . . actions as the Administrator may determine." EPA claims to take this action under "authority of the statutes it administers. . . including CAA sections 103, 301(a)." By issuing this Proposal through notice and comment procedures, Administrator Pruitt appears to have determined that 307(d) procedures apply.
Even without that invocation, the proposed rule is subject to these procedural requirements because it materially impacts many of the actions delineated in 307(d)(1) to which the CAA rulemaking procedures explicitly apply. The Proposal applies to "significant regulatory actions," which many of these actions are. The CAA requires science-based decision-making that the Proposal will materially affect. For example, by restricting the science EPA may rely on in regulatory actions, the Proposal materially impacts residual risk determinations for HAP (§ 307(d)(1)(C)), standards for mobile source air toxics (§ 307 (d)(1)(K)), and residual risk standards for municipal solid waste combustors (§ 307(d)(1)(D)).
This proposed rule directly affects EPA's setting and review of NAAQS, the promulgation or revision of which is subject to the CAA rulemaking requirements. Section 108(a) of the CAA requires the Administrator to set air quality criteria for air pollutants that "reflect the latest scientific knowledge." This Proposal amends the science EPA can consider for air quality criteria. Under CAA section 109 EPA must use the air quality criteria to set primary and secondary NAAQS and periodically review them --  which EPA is currently doing for PM. In the Proposal, EPA cites Am. Trucking Ass'ns v. EPA, 283 F.3d 355, 358 (D.C. Cir. 2002) as an example of an instance where EPA relied on a scientific study where the underlying data was not publicly available. EPA states that under the Proposal use of such science would be "preclude[d]" In Am. Trucking Ass'ns the Court upheld EPA's use of key studies underlying the NAAQS for PM. Under the Proposal, EPA would not have been permitted to use those studies, and it is unclear how the Proposal will affect EPA's reliance on these studies as it undertakes its review. This demonstrates how this Proposal would have an immediate impact on EPA NAAQS-setting under the CAA. EPA is thus subject to the CAA 307(d) procedural requirements for this Proposal.
Comment [8750-1778]: 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.
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."
The commenter notes that the 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. This does not meet the standards of the APA and CAA.
Additionally, 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 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 EPA (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).
This clearly is not enough to meet the 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 the discusses elsewhere in 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.
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.
Comment [8750-1804]: Commenter (9227) states that the CAA requires 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. As discussed above, 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 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 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.
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, 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 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 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.
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 of the proposal, 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. 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.
This amount of information is wholly insufficient to allow a public commenter to provide meaningful comments about these issues.
Comment [8750-1807]: Commenter (9227) states that the Proposal impacts EPA's process for setting NAAAQs in material ways by amending the scientific information that can be used as air quality criteria. Under the CAA air quality criteria cannot be amended without review by the Clean Air Science Advisory Committee (CASAC). Thus, EPA must submit this proposal to CASAC for review, consider their recommendations, and provide reasonable explanation for deviation from those recommendations.
Comment [8750-1943]: Commenter (9227) contends that the EPA arbitrarily failed to consider the far-reaching implications this Proposal could have on inter-agency coordination and consultation given that other agencies normally rely on research potentially excluded by the Proposal and cites consultation provisions in the CAA.
Comment [8750-2635]: Commenter (9227) notes that the EPA cites CAA, § 301, 42 U.S.C. § 7601, as purportedly granting authority for the Proposal. The authority granted by section 301(a), however, applies only to the CAA and, in any event, is not broad enough to encompass this Proposal. Section 301 provides that "[t]he Administrator is authorized to prescribe such regulations subject to section 307(d) as are necessary to carry out his [or her] functions under this Act." The courts have consistently "decline[d] to read ... open-ended power into section 301," and instead have required that regulations promulgated under section 301 be both necessary and appropriate. As discussed in more detail below, EPA's Proposal here is not necessary, and instead directly conflicts with several other provisions of the CAA. It is axiomatic that a "general grant of authority cannot trump specific statutory provisions."
[9066-1932] Commenter (6188) contends that the Proposed Rule contradicts the requirements of Federal environmental law, including cited authority for the rulemaking. The Proposed Rule's requirements are at odds with statutory mandates contained in the very same environmental laws it points to as providing a basis for the rule. They also directly controvert authority it cites as support for the rulemaking.
The requirements of the Proposed Rule conflict with EPA's statutory obligations under federal environmental laws. CAA § 109 mandates that EPA set air quality standards based on "air quality criteria," which must "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare." 42 U.S.C. §§ 7409, 7408(a)(2).
Exclusion of relevant studies from consideration based not on the quality of the science but on the public availability of underlying data directly contradicts mandates. EPA itself has defined "best available science" without reference to the public availability of data:
Use of best available science involves the use of supporting studies conducted in accordance with sound and objective scientific practices, including, when available, peer reviewed science and supporting studies and data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data).
Simply put, the "best available science" is science that follows standards accepted by the scientific community, not science that EPA arbitrarily selects based upon the public availability of data -- a criterion irrelevant to scientists' standards for determining whether research represents the best science.
Specifically, scientists have observed that the best quality science oftentimes relies upon data that is not publicly available due to significant privacy considerations. It is for that very reason that courts have recognized EPA's need to rely upon studies based on publicly undisclosed underlying data when considering the best science. American Trucking Ass'ns, 283 F.3d at 372 (explaining that curtailing EPA's ability to rely on published studies would exclude "plainly relevant scientific information" from regulatory decision-making processes); see also Coalition of Battery Recyclers Ass'n, 604 F.3d at 623 (finding that EPA is entitled to rely on published study results as "raw data is often unavailable due to proprietary interests of a study's scientific investigators or confidentiality agreements with study participants"). Forcing EPA to ignore high quality science controverts EPA's statutory obligations and will impair EPA's ability to protect public health and the environment.
Comment [9066-1894]: Commenter (6188) states that the EPA purports to derive authority for the Proposed Rule from CAA § 103. That provision simply authorizes EPA to establish a national research and development program for the prevention and control of air pollution and, as part of that program, to conduct and promote the coordination of research and studies relating to the causes, effects, extent, prevention, and control of air pollution. 42 U.S.C. § 7403(a)(1). The section authorizes specific activities of the Administrator in establishing such a program, none of which includes limiting the scope of reviewable data, research, or studies when undertaking regulatory action. The section has no bearing on how or to what extent EPA utilizes research in regulatory decision-making processes.
Comment [9217-3559]: Commenter (9225) contends that the proposed rule is not authorized by any authority delegated to EPA by Congress and is contrary to a number of statutes under EPA's authority. This includes, but is not limited to, the CAA; CWA; TSCA; LCSA; SDWA; FIFRA; and more.
Comment [9287-3739]: Commenter (8281-PH16) Because of the importance of having access to such scientific data in order to protect the public's health, we oppose the "Strengthening Transparency and Regulatory Science" proposed rule. Research and evidence are the foundation of EPA's policies and has been necessary for success of laws like the CAA and improving and in saving lives from the dangers of air pollution.
Congress intentionally directed EPA to consider peer reviewed research under the CAA and mandates regular reviews of the science to ensure that EPA is reviewing and considering the most up to date science. The commenter believes that the proposal would prevent EPA from using the best science to inform decision-making, and the result would be weaker standards at the expense of American's health. For example, the proposal would exclude several landmark air quality studies from the evidence base that EPA is permitted to consider, largely on the basis that these studies include confidential patient information that would make them less transparent under the constructs of the proposed rule.
Comment [9290-3812]: Commenter (8281-PH24) states that the EPA has administered successfully, the CWA, and the CAA, and these acts should be expanded based on scientific research. The EPA should not be working to undermine scientific research.
Comment [5167-4751]: Commenter (5178) provides that the CAA requires that EPA set NAAQS to protect the public health, and to do so with an adequate margin of safety. NAAQS must be based on air quality criteria 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." EPA must comprehensively consider the state of scientific knowledge, and set standards to "protect individuals who are particularly sensitive to the effects of pollution." These susceptible groups include children; the elderly; and those with heart disease, lung disease, or asthma. Recently, Patricia Koman and colleagues have suggested that pregnant women should be considered an at-risk population due to physiological changes, noting, "Women with preexisting conditions, women experiencing poverty, and groups that suffer systematic discrimination may be particularly susceptible to cardiac effects of air pollutants during pregnancy."
Two landmark prospective cohort studies have informed the NAAQS for fine particulate pollution (PM2.5). The Harvard Six Cities Study followed 8,111 residents of six U.S. cities from recruitment in 1974-1977 through 1991 and collected air sampling data and health information. After adjusting for other health risk factors, the investigators found that mortality rates were associated with the level of air pollution, and that the association was particularly strong for fine particulate pollution. The American Cancer Society (ACS) study linked air pollution data from 151 U.S. metropolitan areas to data on risk factors and mortality in 552,138 adults residing in these areas who enrolled in 1982 and were followed through 1989. The authors found increased mortality to be associated with sulfate and fine particulate air pollution "at levels commonly found in U.S. cities."
Both studies were instrumental in setting the 1997 NAAQS, and some stakeholders called for the data to be made public. However, study participants had been assured confidentiality. Instead of making data public, investigators agreed to supply it to the HEI, which used a competitive process to select a team to reanalyze the data. In 2000, HEI reported that the re-analyses "assured the quality of the original data, replicated the original results, and tested those results against alternative risk models and analytic approaches without substantively altering the original findings of an association between indicators of PM air pollution and mortality."
Since publication of these two landmark studies, dozens of additional peer-reviewed studies, as well as follow-up research involving the Six Cities and ACS cohorts, have replicated and expanded upon their findings and provided insights into specific effects of particulate pollution on certain groups, In a look back at the evolution of research on the health effects of particulate pollution, lead Six Cities investigator Douglas W. Dockery commented:
True replication requires not reanalyzing existing work but independent investigators producing independent data. The HEI process made important contributions in evaluating, advancing, and applying new methods which led to significant additional analyses. But the HEI work reanalyzing an existing body of evidence was time-consuming and expensive. It would not be a good use of resources to require this approach for all studies contributing to the regulatory actions, or even to a few key studies.
EPA's 2011 policy assessment for review of the particulate NAAQS noted that in addition to epidemiologic studies, toxicological and controlled human exposure studies identify potential biological pathways for cardiovascular and respiratory effects associated with particulate exposures. The analysis also summarizes research on susceptible populations: "the currently available epidemiological and controlled human exposure evidence expands our understanding of previously identified susceptible populations (i.e., children, older adults, and individuals with pre-existing heart and lung disease) and supports the identification of additional susceptible populations (e.g., persons with lower socioeconomic status (SES), genetic differences)." It reports that evidence is accumulating on the effects of PM2.5 on low birthweight and infant mortality.
Some of the most recent research adds to knowledge on susceptible populations. For example, Qian Di and colleagues analyzed 2000-2012 data on 61 million Medicare beneficiaries and zip-code level information on PM2.5 and ozone pollution. They found increased mortality risks  --  including higher risks for black beneficiaries and those eligible for Medicaid, who are disproportionately women with low incomes  --  at pollutant levels below the current limits.
Mingyu Zhang and colleagues analyzed local air pollution data as well as data from the Boston Birth Cohort, which began recruiting pregnant women in 1998 and followed their children for several years after birth. They found that the children of women who were exposed to the highest PM2.5 levels during their third trimesters had a greater risk of elevated blood pressure at ages three to nine. Both of these studies involve data that can be obtained by investigators who apply to use it and are approved by the relevant IRB or Privacy Board,, but their data sets are not publicly available. Such an approach recognizes recent advances in identifying individuals from data that do not appear to contain PII. For decades, public release of data collected on individuals has relied on anonymization to protect privacy, but researchers have demonstrated the potential of "reidentification" techniques, which combine seemingly innocuous data from multiple publicly available sources, to identify individuals.,
Failure to consider these studies and others like them in setting NAAQS because their data are not publicly available would conflict with responsibilities to advance children's environmental health and environmental justice, as well as the requirement that EPA set standards that protect susceptible subgroups.
Comment [6141-2554]: Commenter (6166) asserts that the proposed rule is not authorized by any authority delegated to EPA by Congress and is contrary to a number of statutes under EPA's authority. This includes, but is not limited to, the CAA; CWA; TSCA; LCSA; SDWA; FIFRA; and more. Substantively, the rule violates numerous public health and environmental provisions contained in these laws, as well as requirements to use the best available science or to consider all available information,
Comment [6857-2945]: Commenter (6879) notes that EPA rules and regulations have been critical to the protection of wildlife, natural habitats, and the ecosystem services they provide to communities and the economy. This includes protection of people from air pollution and climate disruption under the CAA.
These laws require EPA to use the "best available" science, or all "reasonably available" science and information. By excluding high-quality peer-reviewed and validly published science from the regulatory decision-making process, the proposed regulation directly contravenes the specific mandate of these statutes. And by deliberately excluding the best science available, the rule also contravenes the Congressional mandates for these statutes and undermines their public health and environmental protection purposes.
Comment [6873-1712]: Commenter (6895) states that by mandating this irrelevant requirement, the proposed rule will restrict the use of best available science in public health and environmental protection decision making, which contradicts EPA's own "Peer Review Handbook." For example, EPA is required to use the "latest scientific knowledge" in setting NAAQS and historically EPA follows that requirement in making risk management decisions based on the best available science. The Presidential/Congressional Commission on Risk Assessment and Risk Management was mandated by Congress in the CAA Amendments of 1990 "to make a full investigation of the policy implications and appropriate use of risk assessment and risk management in regulatory programs under various Federal laws to prevent cancer and other chronic human health effects which may result from exposure to hazardous substances"., After years of work the Commission proposed a systematic, comprehensive framework that can address various contaminants, media, and sources of exposure, as well as public values, perceptions, and ethics, and that keeps the focus on the risk management goals. For this framework to be successful, the use of science cannot be restricted or limited. EPA should adhere to the well-reasoned process which the Commission on Risk Assessment and Risk Management developed.
Comment [7869-3372]: Commenter (8272) asserts that the proposed rule is not authorized by any authority delegated to EPA by Congress and is contrary to a number of statutes under EPA's authority. This includes, but is not limited to, the CAA; CWA; TSCA; LCSA; SDWA; and the FIFRA. The rule violates numerous public health and environmental provisions contained in these laws, as well as requirements to use the best available science or to consider all available information.
Comment [6106-875]: Commenter (6116) notes that, on April 30, 2018, the EPA published a notice in the Federal Register of a proposed rule that would drastically reduce the types of scientific studies that can be used to inform EPA regulations protecting public health under the guise of improving transparency. The commenter notes that they are troubled by this proposal, as we believe it would vastly undermine the mission of the EPA, which is to protect human health and the environment. It is curious that this proposal champions "transparency" when it seems certain to serve the opposite purpose. The commenter opposes this proposal for several reasons, including, but not limited to the following:
 The EPA itself seems to question whether it has the authority to promulgate this rule. The FR notice asks commenters to provide information on what areas of the CAA they feel may demonstrate this type of authority. The EPA should have a solid foundation before it proposes rules and should not have to seek answers for questions about its own authority.
Comment [6116-1117]: Commenter (6141) states that Ground the New Regulatory Framework based on the Agency's Statutory Authority and Longstanding Values and Principles of Good Government.
The Proposal for scientific transparency is consistent with the objectives and requirements of existing federal environmental statutes and administrative policies. Most importantly, the CAA and other major federal environmental statutes provide EPA with broad authority to establish procedures, requirements, and criteria for adopting rules, regulations, and policies for how the Agency adopts new regulations, rules, and guidance. For example, section 301(a) of the CAA provides the EPA Administrator with broad authority to establish regulations "as are necessary to carry out ... the functions" under the CAA, while section 307(d) provides extensive authority on the manner in which EPA may conducting notice and comment rulemakings, including provisions for ensuring a robust rulemaking record and adequate opportunities for public participation. The other relevant federal environmental statutes also provide EPA broad authority for the establishment of procedures, requirements, and criteria for how it establishes implementing rules, regulations, and policies. Oglethorpe Power [the commenter] supports EPA's proposal to use this authority to establish new rules for ensuring the transparency and public availability of the underlying scientific data and other important supporting documentation used by EPA in its regulatory actions.
Comment [6163-1276]: Commenter (6133) notes that, in addition to addressing how and whether the agency will consider science, the Proposal also contains a seemingly unrelated provision regarding agency peer review. The Proposal, in § 30.7, reads:
      What role does independent peer review in this section?
      EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein.
      Because transparency in regulatory science includes addressing issues associated with assumptions used in models, EPA shall ask peer reviewers to articulate the strengths and weaknesses of EPA's justification for the assumptions applied and the implications of those assumptions for the results.
      83 Fed. Reg. at 18,774.
There is no statutory authority for EPA to "conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." The federal statutes that EPA lists as putative authority for the Proposal provide no authority for proposed § 30.7. See 83 Fed. Reg. at 18,769/2 (citing CAA sections 103, 301(a), 42 U.S.C. 7403, 7601(a)). The claimed authorities that EPA lists do not mention peer review or even allude to the concept. Id. Neither the Proposal nor accompanying docket materials identify any provision of any federal statute that authorizes EPA to promulgate proposed § 30.7. Our own research revealed no provision of any federal statute that authorizes EPA to promulgate proposed § 30.7.
When Congress writes federal statutes, Congress knows how to create legal authority for peer review, who shall conduct that peer review, what role, if any, that EPA or other parties will play, and how that peer review may be conducted. None of the provision in the law authorize EPA's Proposal in § 30.7. Instead, the statutes require that EPA use peer-reviewed science, regardless of whether it would meet EPA's definition of the term in § 30.7. And in cases where the law requires EPA to conduct the review, the statutes often spell out specifically how that should happen.
The commenter cites statute provisions on Peer Review under the CAA (as well as other statutes):
      § 7511b. Federal ozone measures
      (g) Ozone design value study The Administrator shall conduct a study of whether the methodology in use by the EPA as of November 15, 1990, for establishing a design value for ozone provides a reasonable indicator of the ozone air quality of ozone nonattainment areas. The Administrator shall obtain input from States, local subdivisions thereof, and others. The study shall be completed, and a report submitted to Congress not later than 3 years after November 15, 1990. The results of the study shall be subject to peer and public review before submitting it to Congress.
      42 U.S.C. § 7511b (emphasis added).
      § 7412. HAP
      (p) Mickey Leland National Urban Air Toxics Research Center (NUATRC) (3) Scientific Advisory Panel (SAP) The Board of Directors shall be advised by a SAP, the 13 members of which shall be appointed by the Board, and to include eminent members of the scientific and medical communities. The Panel membership may include scientists with relevant experience from the NIEHS, the CDC, the EPA, the National Cancer Institute (NCI), and others, and the Panel shall conduct peer review and evaluate research results. The Panel shall assist the Board in developing the research agenda, reviewing proposals and applications, and advise on the awarding of research grants.
      42 U.S.C. § 7412 (emphasis added).
Under longstanding federal case law, when Congress authorizes an approach in one section of a statute using specific language but does not do the same in other sections of a statute, courts presume that Congress acted purposefully and did not mean to address or authorize that approach in those other statutory sections. See, e.g., Dean v. United States, 556 U.S. 568 (2009) ("It is generally presumed that Congress acts intentionally when including particular language in one section of a statute but not in another." (citing Russello v. United States, 464 U.S. 16, 23 (1983)). Not only are there no implied grants of authority to an agency in other statutory sections, but the congressional decisions to authorize the approach elsewhere in the statute give even greater force to the conclusion that the agency has not been given authority where Congress did not use the same or similar authorizing language.
<IP_ADDRESS> CAA (SNPRM Comments)
Comment [29-2180]: Commenter (11184) states that, by way of example, in CAA. Section 108(a)(2), Congress requires EPA to issue air quality criteria for air pollutants to "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." 42 U.S.C. § 7408(a)(2). The SNPRM does not claim that studies that have not publicly released all their underlying data, such as those linking air pollution to mortality and disease, do not 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 exclude such studies from consideration when issuing air quality criteria, it would be in violation of the CAA.
Comment [48-518]: Commenter 12727 states that the expanded proposal would irreconcilably conflict with EPA's obligation to regulate emissions of HAP under the CAA. Section 112 of the Act requires EPA to set emission standards for existing major sources of HAP that are typically no less stringent than "the average emission limitation achieved by the best performing 12 percent of the existing sources (for which the Administrator has emissions information)." This provision does not allow EPA to ignore information that the agency possesses but that qualifies as CBI. Indeed, EPA has historically taken such CBI into account in calculating the minimum limitation. Now, however, EPA has proposed to define "data and models" to encompass "data on environmental releases" and to eliminate any such data that would underlie pivotal regulatory science driving the level of a standard, such as emission standards under section 112. EPA's proposed rule, as expanded, patently conflicts with the CAA's well established requirements and cannot be finalized.
Comment [48-2181]: Commenter (12727) Several environmental statutes require EPA to ground its decision-making in scientific evidence. The CAA, for example, mandates that "[a]ir quality criteria . . . accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare," 42 U.S.C. § 7408(a)(2), and the TSCA requires the Administrator to "make decisions . . . based on the weight of the scientific evidence," 15 U.S.C. § 2625(i)."
The originally proposed regulatory language (§§ 30.3, 30.5) violated these statutory commands by preventing EPA from relying on a study as "pivotal regulatory science . . . used to justify significant regulatory decisions" if dose-response data or models underlying the study were not publicly available, without regard to whether the study had been validated by other means. The Supplemental Notice exacerbates these violations by expanding the proposed regulation's scope (§§ 30.3, 30.5) to not just pivotal regulatory science used to justify significant regulatory decisions, but also "pivotal science supporting influential scientific information."
Comment [38-40]: Commenter (12727) Just as EPA is required to consider all available science when making its regulatory decisions, governing environmental and public health statutes likewise require EPA to consider all available science when releasing ISI, which often forms the basis for the agency's regulatory decisions. For example:
      CAA section 108 instructs EPA to establish air quality criteria that "accurately reflect the latest scientific knowledge," which criteria, in turn, must inform NAAQS.
A rule that prohibits EPA from considering (or that downgrades) valid, high quality scientific studies when generating ISI such as the products identified above would contravene the above- noted statutory directives regarding EPA's obligation to consider all available science.
Comment [53-2006]: Commenter (11360) Congress intentionally and wisely embedded peer-reviewed research in the foundation of the CAA, including requiring regular reviews of the science, explicitly recognizing that EPA needs the most current, peer-reviewed data to protect the public health. Limiting scientific evidence does not strengthen regulations or policies; rather, it is paramount that the full suite of relevant science, vetted through peer-review, inform the landscape of decision-making. Excluding relevant studies simply because they do not meet unnecessarily rigid transparency standards will adversely affect decision-making processes.
Comment [73-421]: Commenter (11576) notes that, as previously explained, the current rulemaking process has also violated the requirements of other statutes the EPA may or may not be relying on in attempting to issue the proposed rule. Under the CAA, the EPA is directed to "give interested persons an opportunity for the oral presentation of data, views, or arguments, in addition to an opportunity to make written submissions[,]" and to "keep the record of such proceeding open for thirty days after completion of the proceeding to provide an opportunity for submission of rebuttal and supplementary information." The EPA's refusal to satisfy these requirements cannot be allowed to stand.
Comment [81-2189]: Commenter (12715) asserts that the EPA is arbitrarily barring consideration of scientific studies or information with nonpublic underlying data or data that are not able to be independently validated, or arbitrarily ascribing less weight to such studies or information, neither approach constitutes "housekeeping," and neither comports with statutory requirements that EPA use the best available science. To reiterate from the 2018 Comments, EPA's obligation with respect to the use of scientific information is clear: it must base its decisions on such criteria as the latest scientific knowledge, the best available, peer-reviewed science, and/or generally accepted scientific principles or laboratory tests. To cite an example, in performing its duties, EPA must rely on: "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices," CAA of 1970, 42 U.S.C. § 7408(a)(2). EPA has repeatedly emphasized the importance of this fundamental precept, including in its 2018-2022 strategic plan, which states that one of the agency's priorities is to "identify, assess, conduct, and apply the best available science to address current and future environmental hazards."
These statutory requirements apply to all aspects of EPA's decision-making, including its scientific evaluations, adoption of regulatory standards, and development of policies. They do not permit what EPA proposes here: to either exclude or give less weight to scientific studies or information based on criteria -- availability of the underlying data and ability to independently validate underlying data -- that are not determinative of whether the studies or information constitute the best available science. Agencies may not adopt or implement regulations that conflict with the statutes under which they are promulgated, and an agency's interpretation of those statutes must always at least be reasonable. See Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 842-44 (1984). Furthermore, neither 5 U.S.C. § 301 nor any other purported housekeeping authority allows EPA to negate these statutes' fundamental, substantive, and common-sense commands. And even assuming EPA has some inherent housekeeping authority, it cannot rely on a general grant of rulemaking authority to promulgate regulations or develop policies that are otherwise inconsistent with more specific statutory directives. Glob. Van Lines, Inc. v. Interstate Commerce Comm'n, 714 F.2d 1290, 1293-97 (5th Cir. 1983).
Finally, EPA acknowledges that the statutes it administers would control in the event of a conflict between the proposed rule and those statutes, see 85 Fed. Reg. at 15,398, but that caveat cannot save the proposed rule. First, the core principle of the proposed rule is facially invalid, i.e., there is no circumstance in which it would be acceptable for EPA to exclude or give less weight to relevant, probative scientific studies, models, or other information that have been validated through peer review, on the sole basis that the underlying data are not publicly available or are not able to be independently validated. EPA cannot save an invalid rule by including what amounts to a waiver procedure, because the "essence of waiver is the assumed validity of the general rule." Alltel Corp. v. Fed. Commc'n Comm'n, 838 F.2d 551, 561 (D.C. Cir. 1988). Second, the agency's essential duty in rulemaking is to exercise its subject matter expertise to enact rules that implement and further the purposes of the statutes Congress has assigned it to administer. Chevron, 467 U.S. at 842-44. This does not include proposing rules without first determining the source of legal authority but instead asking commenters to supply that information. Third, the agency must propose its rules with specificity and be clear as to the programs, regulations, and information to which they will apply. 5 U.S.C. § 553(b)(3); Home Box Office, Inc., supra, 567 F.2d at 35-36.
Comment [82-2192]: Commenter (12464) Third, both alternatives are inconsistent with the statutes directing which data EPA must consider in certain contexts. As we explained in a previous comment letter, many statutes require EPA to consider science in its decision-making, without any reference to whether such science is based on studies with raw data that is publicly available. For example, under the CAA, EPA must set and review the NAAQS for six common pollutants. In setting these standards, the CAA instructs EPA to use "the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects [of air pollution] on public health or welfare." Thus, a conflict would arise between the statutory language and the reduced-weight alternative if EPA gave less weight to a study that was "the latest scientific knowledge" on a relevant question merely because the raw data from that study is not publicly available. The same conflict would exist with the proposed tiered-access system, if the "latest scientific knowledge" came from a study with raw data to which researchers have not or could not grant restricted access.
Comment [89-2193]: Commenter (11403) states that the EPA's 2018 version of this rule cited a hodgepodge of statutory authority, none of it valid. EPA at least corrected the obvious typographical errors from the previous version. However, those edits still do not grant EPA the authority to restrict science from all regulatory decision-making processes within the agency. EPA is attempting to use general grants of authority to create a completely novel approach to assessing science. However, as the Supreme Court has stated, "Congress . . . does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions -- it does not, one might say, hide elephants in mouseholes." EPA does not have the authority to alter the fundamental details of all of its regulatory schemes based on such vague provisions of law.
Section 103 of the CAA directs EPA to "conduct, and promote the coordination and acceleration of, research, investigations, experiments, demonstrations, surveys and studies" on air pollution. Curtailing the use of science based on arbitrary notions of transparency does the opposite of what Section 103 requires.
Section 301(a) of the CAA gives the Administrator authority to "prescribe such regulations as are necessary to carry out his functions" relating to the CAA. This catch-all provision certainly provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is "necessary" to the carrying out of functions under the CAA
In short, none of the statutory provisions cited by EPA provide authority for the proposed rule. The proposed rule fails at step one under Chevron v. Natural Resources Defense Council since it is unreasonable to believe that any statutory general grant of authority or any mention of EPA's oversight of other science or research programs would enable EPA to conduct rulemaking in a way that is altogether inconsistent with the rule of law. None of the cited provisions provide the authority sought by EPA, and as such the proposed rule should be withdrawn.
Comment [93-2088]: Commenter (11395) states that while similar language does not specifically appear in the CAA, American Trucking Assns. v. EPA [283 F.3d 355 (D.C. Cir. 2002)] supported EPA's reliance on peer-reviewed scientific studies, without conducting an independent analysis of the raw data underlying those studies, in setting the 1997 ozone and fine PM ambient air quality standards 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].
Comment [97-2149]: Commenter (11479) states that the proposed rule, as modified in the supplemental notice, would clearly interfere with the agency's use of the best available science. The commenter notes that the CAA has requirements to update pollution standards that provide for an "adequate margin of safety" to protect public health. This determination can only be reliably made using the best available science. This proposal would, however, prevent EPA from using the best available science to set pollution standards that would provide for an adequate margin of safety, because the proposal excludes studies where the raw data and other underlying information cannot be made public. Because of this, EPA should not cite the CAA as a source of statutory authority. Further, the CAA encourages a close partnership with the NAS and other independent scientific institutions. When EPA is considering a proposal to reinterpret how it uses science in regulatory decisions, it should first and foremost consider comments from and engage with NAS and similar bodies, which, for this rule, EPA did not.
In fact, virtually all of EPA's statutory mandates require the use of the best available scientific evidence. Congress did not state in any of these laws that the agency shall only consider scientific evidence derived from studies where the underlying unanalyzed data is publicly available, nor that the evidence considered should be solely at the Administrator's discretion.
Comment [115-1431]: Commenter (11393) appreciates the SNPRM's recognition that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." 85 Fed. Reg. at 15398. This statement alone should lead EPA to withdraw the proposed rule and SNPRM; the requirements conflict with every statute EPA administers and would cause EPA to unlawfully exclude valid scientific research from its work.
By way of example, in CAA Section 108(a)(2), Congress requires EPA to issue air quality criteria for air pollutants to "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." 42 U.S.C. § 7408(a)(2). The SNPRM does not claim that studies that have not publicly released all their underlying data, such as those linking air pollution to mortality and disease, do not 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 exclude such studies from consideration when issuing air quality criteria, it would be in violation of the CAA.
Comment [118-1437]: Commenter (11407) states that they appreciate the SNPRM's recognition that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." 85 Fed. Reg. at 15398. This statement alone should lead EPA to withdraw the proposed rule and SNPRM; the requirements conflict with every statute EPA administers and would cause EPA to unlawfully exclude valid scientific research from its work.
By way of example, in CAA Section 108(a)(2), Congress requires EPA to issue air quality criteria for air pollutants to "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of a4 identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air." 42 U.S.C. § 7408(a)(2). The SNPRM does not claim that studies that have not publicly released all their underlying data, such as those linking air pollution to mortality and disease, do not 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 exclude such studies from consideration when issuing air quality criteria, it would.be in violation of the CAA.
Comment [125-1091]: Commenter (11495) notes that the EPA attempts to support the Supplemental Notice, in part, with the same environmental statutes that require it to consider the best available science. For example, in the Proposed Rule, EPA cites section 103 of the CAA, which provides that the Administrator shall "conduct . . . research . . . and studies relating to the causes, effects (including health and welfare effects), extent, prevention, and control of air pollution" and is authorized to "collect and make available . . . the results of and other information . . . pertaining to such research and other activities." EPA also cites CAA section 301(a), which provides that the Administrator is authorized to "prescribe such regulations as are necessary" to carry out EPA's functions under the Act.] EPA points to similar provisions for all major environmental statutes, each of which contain the same requirement that regulations promulgated under the Administrator's general rulemaking authority must be necessary.
Courts have consistently "decline[d] to read open-ended power" into general statutory grants of rulemaking authority, such as CAA section 301(a). Rather, the authority imparted by such provisions is limited to actions that are necessary and appropriate for enforcing and carrying out the specific statutory mandates enacted by Congress. In the case of the CAA, this means that any rule promulgated under the authority of section 301(a) must be connected back to the actual purpose and goals of the Act -- to protect and enhance public health and welfare through air pollution prevention. Although EPA relies on such grants of general rulemaking authority, it fails to articulate any connection between the Strengthening Transparency in Regulatory Science Rule and the purposes or goals of each individual substantive statute.
EPA fails to -- and indeed cannot -- demonstrate that the Strengthening Transparency in Regulatory Science rule is both necessary and appropriate for carrying out a particular statutory directive. As discussed in detail above, the rule is not only unnecessary to carry out EPA's functions, but also in direct opposition to a number of specific statutory "quality of information" provisions. It is well established that agencies may not rely on general statutory grants of rulemaking authority to promulgate regulations that are inconsistent with more specific statutory
Comment [125-2202]: Commenter (11495) states that the EPA's Supplemental Notice is at odds with provisions of multiple environmental statutes which require the Agency to consider certain high-quality scientific information. The commenter notes that the CWA and the CAA require that water and air quality criteria determinations be based on the "latest scientific knowledge."]
Each of these provisions directs EPA to incorporate a certain quality of scientific information into its rulemaking decisions made pursuant to the statute. In particular, these requirements are designed to ensure the scientific validity of the information upon which EPA bases its actions. Mandating a high-quality scientific basis for regulatory actions is necessary to guarantee the best possible protections for public health and welfare and to minimize partisan influence in scientific decision-making.
The Supplemental Notice, however, would impermissibly prohibit the agency from considering of relevant and high-quality scientific studies whenever the data underlying the study are not publicly available -- in direct contravention of the statutory directives that mandate, for example, consideration of the "best available science." None of the provisions requires, or even suggests, that EPA only consider information that is publicly available. It strains the plain meaning of words like "best," "latest," and even "appropriate" to suggest that they permit the unscientific requirement that all data be publicly available.
EPA "cannot ignore available . . . information." Courts have held that "best available data" requirements "prohibit[] [an agency] from disregarding available scientific evidence that is in some way better than the evidence [it] relies on." Furthermore, a plaintiff may establish a violation of a "best available science" requirement by "point[ing] to any scientific evidence that the agency failed to consider." The Supplemental Notice would undoubtedly preclude EPA from considering certain studies and scientific information that is "better" or the "best available," simply because the study's underlying data is not publicly available, thereby failing to satisfy Congressional directives and undermining the quality of regulatory decisions.
Likewise, EPA cannot avoid the statutory directives to consider high-quality scientific information simply by assigning a lesser weight to such information when the underlying data are not publicly available, as the Agency alternatively proposes. The Supplemental Notice's alternative proposal is designed to have largely the same pernicious effects as flatly prohibiting consideration of studies lacking publicly available data. Just as with the primary proposal, EPA's alternative proposal would limit the agency's consideration of the best available science in making important regulatory decisions, and is, therefore, arbitrary, and capricious.
The effect of the Proposed Rule is inconsistent with EPA's view that the Supplemental Notice is "intended to be consistent with the statutes that EPA administers and EPA plans to implement this procedural rulemaking in accordance with all applicable statutory and regulatory requirements." EPA attempts to resolve this inconsistency by stating that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." However, as discussed below, EPA lacks the statutory authority to issue a rule this broad, even when it claims that it will avoid statutory conflicts.
Comment: Comment [151-1349]: Commenter (12405) notes that the CAA authorizes EPA to establish NAAQS to protect public health and to regulate emissions of HAP. EPA works with local governments to reduce air pollution and uses scientific studies that could be impacted by the proposed rule to revise its national air quality standards and NAAQS on a regular basis.
In addition to concerns stated in the previous section about the usefulness of data if enough information is redacted to protect privacy, these studies raise additional challenges because they were performed internationally. In the Danish study, participants are protected by EU law. Going forward, an EU study's compliance with the proposed rule will need to be reconciled with the new General Data Protection Regulation, which is seen as more restrictive than the United States' HIPAA of 1996. The privacy directive raises many issues for science not discussed here, but it is clear that many studies involving people located in the EU will have a difficult time both complying with the new directive and providing enough information to EPA to be considered.
Studies coming from other countries are vital to health determinations in the Unites States because people in other countries are exposed to chemicals at different rates than in the U.S. The ability to compare and contrast exposure to health outcomes can be enlightening. For example, average PM concentrations in South Korea and China are several times higher than in the United States, making relatively subtle effects stand out more easily. Studies done in other countries can also help researchers more clearly understand whether an effect is dependent on dose or length of exposure. The inability to review and use international research in determinations will guarantee EPA is missing major findings and important data.
Comment [157-1390]: Commenter (12422) states that many of laws authorizing the activities of the EPA require the agency to use the best science in protecting the public's health and environment. For example, the CAA mandates that air quality criteria "accurately reflect" the "latest scientific knowledge." In the past, the EPA has considered all available studies in issuing these criteria without consideration of the availability of the underlying data. Promulgation of this proposed rule would be an arbitrary and capricious violation of the provisions of these laws.
Comment [159-2089]: Commenter (12430 notes that, in the SNPRM, U.S. EPA proposes to consider only (or, in the alternative, more heavily weight) studies and models with publicly available data. However, restricting agency consideration of scientific studies and models would run afoul of U.S. EPA's obligations under many of its operating statutes to rely on the best available science.
For example:
The CAA requires, "Air quality criteria for an air pollutant shall 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, in varying quantities."
The CAA and other statutes require U.S. EPA to make decisions based on many of the kinds of science that the SNPRM would prevent U.S. EPA from considering. The SNPRM, if finalized, would violate these statutes, and would prevent U.S. EPA from discharging its duties under the related laws.
Comment [161-2094]: Commenter (12434) states that the Proposal directly conflicts with requirements under the core federal environmental laws, each of which requires that decisions be made using the "best available science" or some similar restriction. By requiring that publicly available data be prioritized over other scientific data, regardless of any other merits, the EPA is arbitrarily constrained and will be unable to comply with the statutory requirements to meet the "best available science."
Similarly, the CAA requires that air quality criteria "shall accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare . . ." 42 U.S.C. 7408(a)(2). The Supreme Court ruled that NAAQS must be based on "published air quality criteria that reflect the latest scientific knowledge." American Trucking v. Whitman, 531 U.S. 457, 457 (2001). Like the CWA, the CAA details the information that should be considered when making regulatory decisions but does not limit this scientific information to only that which is publicly available. Again, the Proposal would eliminate key scientific information that informs the public health impacts of air pollution and allows the EPA to properly establish guidelines and restrictions.
The standards set under the CAA necessarily rely on public health data. Significant environmental justice impacts will result if confidential or only partially publicly available public health data is ignored. For example, in Connecticut v. Pruitt, in which Save the Sound (then known as Connecticut Fund for the Environment) was an intervenor, a district court judge required the EPA to hold a hearing to determine whether a Pennsylvania coal-fired power plant should install controls. Connecticut v. Pruitt, No. 3:17-cv-00796 (D. Ct. Feb. 7, 2018). Pollution from the facility contributed to Connecticut's greenhouse gas and ozone pollution, resulting in nonattainment of NAAQS, which are set based on public health studies. Consequently, the burning of coal will be limited to emergencies by 2023 and phased out by 2028. Similarly, it is these data sets that can inform our understanding of disparate impacts of the siting of polluting activities. NAAQS are used by EPA and state agencies when conducting cumulative impact modeling to determine the additional public health impacts of the siting of a new facility on a community that is already burdened with pollution. These standards cannot be appropriately set or the impacts of the siting of polluting activities properly examined if these studies are ignored, potentially aggravating the disparate impacts on communities. In order to conduct robust public health studies, it is common for members of the public to be assured that the data sets will remain partially or fully confidential so as to protect the sensitive health information of study participants, allowing for large data sets from which to draw conclusions.
Comment [162-1475]: Commenter (12435) states that the proposed framework under which the EPA Administrator would have discretion to exempt certain studies from these requirements lacks criteria tied to the actual scientific merit of the studies and/or the Acts that EPA administers. This is inconsistent with existing statutes, including the CAA 109(d), which specifies that an independent scientific review committee shall "advise the Administrator of areas in which additional knowledge is required to appraise the adequacy and basis of existing, new, or revised NAAQS" and "describe the research efforts necessary to provide the required information." This independent scientific review should not be limited in the research efforts reviewed by the Administrator.
Comment [177-1595]: Commenter (12596) states that the Administrators have used this authority to make substantive decisions regarding consideration of scientific studies when setting NAAQS. In the same way, this discretion would allow an Administrator to consider transparency assessments arising from a procedural framework during NAAQS reviews.
In these circumstances, a procedural framework would not be interpretative of the CAA's substantive authority. It would not modify the use or criteria for consideration of scientific studies under the statute, nor would it implicate public rights to participate under the CAA's rulemaking processes. Indeed, the public would retain the opportunity to provide input on transparency assessments, and EPA's substantive determinations concerning them, through a CAA rulemaking's notice-and-comment process. Transparency assessments produced under a procedural framework would simply be a data point for the Administrator to consider within the confines of the CAA and its jurisprudence.
Furthermore, the Final Transparency Rule would not affect requirements in the CAA to predicate regulatory action on the best science available. The opposite is true. In the face of growing concerns about the replicability of scientific studies, the absence of a transparency assessment framework undermines the reasonableness of future CAA rulemakings, and validity of underlying claimed health benefits.
One survey of 1,500 scientists found that 52% agreed that there is a significant "crisis" of reproducibility. These challenges could implicate the Administrator's ability to make a reasonable determination of adverse impacts under the CAA. Without a formal framework, assessments of scientific replicability, and therefore the transparency of pivotal regulatory science, could be arbitrary and capricious. The Final Transparency Rule would increase replicability and verification in the scientific process, thereby allowing the testing of critical methodological assumptions and mitigating biases in key studies that inform significant regulations. In other words, it would foster review of best science.
Comment [181-1623]: Commenter (12699) notes that a further scan through these statutes would find additional language that would suggest a need for accurate information. Looking at just the criteria pollutant language in the CAA, "[a]ir quality criteria for an air pollutant shall accurately reflect the latest scientific knowledge." [Emphasis added]. The NAAQS shall be "based on such criteria and allowing an adequate margin of safety, are requisite to protect the public health." It is impossible to know if something is "requisite" (or "necessary") if that decision is based on inaccurate science. The science in a given situation very well may be accurate, but it is incumbent upon the EPA (and other agencies) to take necessary steps to ensure this accuracy.
Beyond the specific statutory sections, the need for accuracy should be simply inferred. After all, did Congress delegate regulatory power to the EPA so that it can develop regulations that are based on inaccurate information?
Comment [181-2207]: Commenter (12699) states that, to put it succinctly, the answer is yes. The EPA should rely on both the substantive environmental statutes and the housekeeping authority.
The EPA would not be implementing these statutes properly if it were using flawed science in the promulgation of its rules. To highlight one example, it is useful to reexamine the U.S. Supreme Court case Michigan v. EPA. In discussing the "appropriate and necessary" language in 112(n)(1)(A) of the CAA, the U.S. Supreme Court argued "[o]ne would not say that it is even rational, never mind "appropriate," to impose billions of dollars in economic costs in return for a few dollars in health or environmental benefits."
Similarly, it would not be rational for the EPA to use science for these very costly policies without even knowing whether the science is credible. Nor would it be rational for the agency to fail to take every possible step to ensure scientific accuracy, including making underlying information available to the public (especially since the EPA is well aware of the problems that pervade the science). Making the information available to the public is not some nice gesture to appease the public. It is a critical step to help the agency itself get necessary feedback to better assess the science.
Comment [184-2093]: Commenter (12707) notes that the supplemental proposal undermines the use of best available science as called for in numerous environmental statutes including the CAA.
The CAA, for example, has requirements to update pollution standards that provide for an adequate margin of safety for public health. This determination can only be reliably made using the best available science. However, this proposal would prevent EPA from using that information to set science-based pollution standards that would provide for an adequate margin of safety. EPA should not cite the CAA as an appropriate source of statutory authority. The added confusion of the supplemental proposal, including so-called tiered access or EPA's ability to consider some research over what has long been considered "best available science" based upon the availability of data, does not legitimize the proposal.
In sum, there is no statutory authority, with or without the Housekeeping Statute, for EPA to rely on to censor or constrain science. Further, finalizing this effort will only serve to undermine EPA's essential role and create confusion over which studies will be considered and how they will be valued to set standards that directly impact public health and the quality of our air and water. Many of these uncertainties are recognized in EPA's own SAB's April 28, 2020 letter.
Comment [187-1702]: Commenter (12720) provides that the EPA cites 42 U.S.C. § 7601(a) of the CAA as one basis for the Proposal. But that section merely authorizes the Administrator to "prescribe such regulations as are necessary to carry out his functions under this chapter." The courts have made clear that "EPA cannot rely on its gap-filling authority to supplement the CAA's provisions when Congress has not left the agency a gap to fill." NRDC v. EPA., 749 F.3d 1055, 1064 (D.C. Cir. 2014); see also American Petroleum Institute v. EPA, 52 F.3d 1113, 1119 (D.C. Cir. 1995) ("the general grant of rulemaking power to EPA cannot trump specific portions of the CAA"); NRDC v. Reilly, 976 F.2d 36, 41 (D.C. Cir. 1992) (EPA cannot use its general rulemaking authority as justification for adding to a statutorily specified list); Sierra Club v. EPA, 719 F.2d 436, 453 (D.C. Cir. 1983) (same); Gonzales v. Oregon, 546 U.S. 243, 264 - 65 (2006) ("It would go . . . against the plain language of the text to treat a delegation for the `execution' of [the Attorney General's] functions as a further delegation to define other functions well beyond the statute's specific grants of authority."). Here, not only is there no statutory gap to fill, as explained further below, the Proposal and Supplemental Proposal are in direct conflict with other provisions of the Act. EPA cannot rely on 42 U.S.C. § 7601(a) to support any final rule.
EPA also cites 42 U.S.C. § 7403, which requires the Administrator to establish a national research and development program for air pollution, among other things. EPA does not state specifically which of the many subsections it believes authorizes this proposed rule. Thus, the citation fails to provide sufficient notice for the public to comment on the rulemaking.
Nothing in the Proposal (or Supplemental Proposal) establishes or even purports to establish the type of national research and development program for air pollution discussed in subsection (a). But that subsection is nonetheless revealing about congressional intent concerning "studies relating to the causes, effects (including health and welfare effects) extent, prevention, and control of air pollution." 42 U.S.C. § 7403(a)(1). There is no indication that Congress intended to allow EPA to ignore or refuse to consider studies on the health and welfare effects of air pollution only if raw data or `regulatory science underlying EPA's actions [were] publicly available in a manner sufficient for independent validation." See 83 Fed. Reg. at 18,773 (proposed §§ 30.1 - 30.3). Indeed, the absence of any such congressional conditions or criteria makes it all the more obvious that EPA invented and added those criteria and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do.
Subsection (b) authorizes EPA to collect and make available information about such research, but nothing in that subsection allows EPA to restrict which types of data it considers in regulatory decisions. Nor does subsection (b) draw any distinction between dose-response data, "data and models underlying pivotal regulatory science and pivotal science," and other types of data. Again, the absence of any such congressional distinction makes it all the more obvious that EPA invented and added that distinction as a matter of its own policy preferences, contrary to the Act. This EPA may not do. None of the other subsections in 42 U.S.C. § 7403 address this issue either. There is no support in the CAA for the Proposal or the Supplemental Proposal.
Comment [198-2211]: Commenter (13549) states that the SNPRM changes the authority EPA claims to rely on for the proposal, however either way, the proposal remains unlawful. The text of the SNPRM proposes to rely solely on 5 U.S.C. § 301. 85 Fed. Reg. at 15404. The preamble says EPA is taking comment on whether to use 5 U.S.C. § 301, which the SNPRM calls EPA's housekeeping authority, independently or in conjunction with statutory provisions cited in the proposed rule and corrected in the SNPRM's preamble. 85 Fed. Reg. at 15398. The fact that EPA is still considering and asking what authority it can rely on for the proposed rule, twenty-two months after the initial proposed rule, shows that EPA does not have such authority. The SNPRM's statements on authority continues EPA's pattern of making rules first and searching for a justification later (which it still has not provided for this rulemaking). As the NTAA explained in its 2018 comments: In order to protect human health and environment, EPA must have a solid foundation before it proposes rules and rulemaking as such portrays the agency's naiveté in seeking answers for questions about its own authority.
First, none of the initial or corrected environmental statutes provide EPA authority for the proposed rulemaking. In most cases, EPA simply cites its general authority for rulemaking under the statutes. Still that general authority alone cannot provide a basis for the rule, especially when, as here, the rule would conflict with the requirements of each of the statutes. Courts have made clear that "EPA cannot rely on its gap-filling authority to supplement [a statute's] provisions when Congress has not left the agency a gap to fill." NRDC v. EPA, 749 F.3d 1055, 1064 (D.C. Cir. 2014); see also New York v. U.S. EPA, 413 F.3d 3, 40-42 (D.C. Cir. 2005). EPA otherwise cites to statutes describing research programs established by the agency, with no relation to or authorization for the requirements the SNPRM seeks to create. The Band also disagrees with EPA's reliance on 5 U.S.C. § 301 because 1) it is questionable whether § 301 applies to EPA as EPA is not one of the fifteen "Executive Departments" listed at 5 U.S.C. § 101, and 2) the proposed rule and SNPRM are not merely internal rules of agency procedure -- they would significantly impact every aspect of EPA's scientific and regulatory work, the individuals who contribute to that work, and the Tribes and communities who rely on it.
The Band appreciates the SNPRM's recognition that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." 85 Fed. Reg. at 15398. This statement alone should lead EPA to withdraw the NPRM and SNPRM; the requirements conflict with every statute EPA administers and would cause EPA to unlawfully exclude valid scientific research from its work.
By way of example, in CAA Section 108(a)(2), Congress requires EPA to issue air quality criteria for air pollutants to "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." 42 U.S.C. § 7408(a)(2). The SNPRM does not claim that studies that have not publicly released all their underlying data, such as those linking air pollution to mortality and disease, do not 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 exclude such studies from consideration when issuing air quality criteria, it would be in violation of the CAA.
Comment [199-2213]: Commenter (12403) notes that the proposal would hamper implementation of CAA requirements.
Comment [200-2214]: Commenter (12412) notes that the SNPRM changes the authority EPA claims to rely on for the proposal, however either way, the proposal remains unlawful. The text of the SNPRM proposes to rely solely on 5 U.S.C. § 301. 85 Fed. Reg. at 15404. The preamble says EPA is taking comment on whether to use 5 U.S.C. § 301, which the SNPRM calls EPA's housekeeping authority, independently or in conjunction with statutory provisions cited in the proposed rule and corrected in the SNPRM's preamble. 85 Fed. Reg. at 15398. The fact that EPA is still considering and asking what authority it can rely on for the proposed rule, twenty-two months after the initial proposed rule, shows that EPA does not have such authority. The SNPRM's statements on authority continues EPA's pattern of making rules first and searching for a justification later (which it still has not provided for this rulemaking). As the NTAA explained in its 2018 comments: In order to protect human health and environment, EPA must have a solid foundation before it proposes rules and rulemaking as such portrays the agency's naiveté in seeking answers for questions about its own authority.
First, none of the initial or corrected environmental statutes provide EPA authority for the proposed rulemaking. In most cases, EPA simply cites its general authority for rulemaking under the statutes. Still that general authority alone cannot provide a basis for the rule, especially when, as here, the rule would conflict with the requirements of each of the statutes. Courts have made clear that "EPA cannot rely on its gap-filling authority to supplement [a statute's] provisions when Congress has not left the agency a gap to fill." NRDC v. EPA, 749 F.3d 1055, 1064 (D.C. Cir. 2014); see also New York v. U.S. EPA, 413 F.3d 3, 40-42 (D.C. Cir. 2005). EPA otherwise cites to statutes describing research programs established by the agency, with no relation to or authorization for the requirements the SNPRM seeks to create. The commenter disagrees with EPA's reliance on 5 U.S.C. § 301 because 1) it is questionable whether § 301 applies to EPA as EPA is not one of the fifteen "Executive Departments" listed at 5 U.S.C. § 101, and 2) the proposed rule and SNPRM are not merely internal rules of agency procedure -- they would significantly impact every aspect of EPA's scientific and regulatory work, the individuals who contribute to that work, and the Tribes and communities who rely on it.
The commenter appreciates the SNPRM's recognition that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." 85 Fed. Reg. at 15398. This statement alone should lead EPA to withdraw the proposed rule and SNPRM; the requirements conflict with every statute EPA administers and would cause EPA to unlawfully exclude valid scientific research from its work.