It is beyond cavil that general rulemaking provisions do not "`provide [EPA] Carte blanche authority to promulgate any rules, on any matter relating to the CAA, in any manner that the [EPA] wishes.'" North Carolina v. EPA 531 F.3d 896, 922 (D.C. Cir. 2008), on reh'g in part, 550 F.3d 1176 (D.C. Cir. 2008) (citing Citizens to Save Spencer County v. EPA, 600 F.2d 844, 873 (D.C. Cir. 1979)). Rather, such regulations must be "necessary" to carry out another statutory duty. See, e.g., id. ("EPA cannot claim retiring excess Title IV allowances is `necessary' for EPA to ensure SIPs [State Implementation Plans] comply with section 110(a)(2)(D)(i)(I)."); 42 U.S.C. § 7601(a). And "`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' -- i.e., `when there is statutory language on point.'" WildEarth Guardians v. EPA, 830 F.3d 529, 539 (D.C. Cir. 2016) (citing Nat. Res. Def. Council v. EPA, 749 F.3d 1055, 1063 - 64 (D.C. Cir. 2014)); see also Nat. Res. Def. Council v. EPA, 749 F.3d 1055, 1063 - 64 (D.C. Cir. 2014) ("[W]e have consistently held that EPA's authority to issue ancillary regulations is not open-ended, particularly when there is statutory language on point." (citing Am. Petroleum Inst. v. EPA, 52 F.3d 1113, 1119 (D.C. Cir. 1995))).
EPA has not argued, nor could it, that the Proposed Rule is "necessary" for fulfilling the agency's rulemaking duties under the CAA. Rather, as discussed infra, Section IV.A of the commenters' comment letter, EPA's proposed exclusion of scientific data that is not publicly available is antithetical to the purposes of the CAA. Moreover, EPA itself has repeatedly determined, and the D.C. Circuit has affirmed, that disclosure of the data underlying studies on which the agency relies is not necessary to fulfill the Agency's transparency and public comment obligations under the CAA, 42 U.S.C. § 7607(d).
For example, when EPA set the 1997 PM NAAQS, "[s]everal commenters questioned EPA's ability to rely on studies demonstrating an association between PM and excess mortality without obtaining and disclosing the raw `data' underlying these studies for public review and comment." 62 Fed. Reg. 38,652, 38,689 (July 18, 1997); see also EPA, Responses to Comments on the 1996 Proposed Rule on the NAAQS for PM (July 1997), https://www3.epa.gov/ttn/naaqs/standards/pm/data/rtc_pm.pdf. EPA responded that "[i]t would be impractical and unnecessary for EPA to review underlying data for every study upon which it relies as support for every proposed rule or standard." 62 Fed. at 38,689. EPA made clear that disclosing such data was not its general practice, in part because EPA was not relying on the underlying data but rather on the study results themselves. Id. EPA recognized that "[i]f EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment." Id. EPA explained:
[S]uch data are often the property of scientific investigators and are often not readily available because of the proprietary interests of the investigators or because of arrangements made to maintain confidentiality regarding personal health status and lifestyle information of individuals included in such data. Without provisions of confidentiality, the possibility of conducting such studies could be severely compromised. Id.
And when the 1997 PM NAAQS was challenged, the D.C. Circuit affirmed EPA's consideration of relevant scientific epidemiological evidence without disclosure of all of the raw data. See Am. Trucking Ass'ns. v. EPA, 283 F.3d 355, 372 (D.C. Cir. 2002) (The court "agree[d] with EPA that requiring agencies to obtain and publicize the data underlying all studies on which they rely `would be impractical and unnecessary.'" (quoting 62 Fed. Reg. at 38,689) (emphasis added)).
In Coalition of Battery Recyclers Association v. EPA, 604 F.3d 613, 623 (D.C. Cir. 2010), petitioners again challenged EPA's failure to disclose underlying data for a study on the health effects of lead exposure, on which it relied to issue the 2008 Lead NAAQS. Specifically, the petitioners contended "the Lanphear study [on which EPA relied] contained such errors that EPA acted arbitrarily and capriciously in relying on results from the study without first obtaining and making public the underlying data for the study." Battery Recyclers, 604 F.3d at 622-23. EPA reiterated in its briefing that it would be "impractical and unnecessary" to disclose such data. See EPA Respondent Brief (Doc. No. 1230237) at 47 (Feb. 16, 2010) (citation and quotation marks omitted; emphasis added), Battery Recyclers, 604 F.3d at 623. The D.C. Circuit again agreed with and upheld EPA's determination that disclosure of underlying data is not necessary to consider the results of a health study to be relevant to a clean air rulemaking pursuant to 42 U.S.C. § 7607(d). The court applied its prior holding in American Trucking, that "`[t]he CAA imposes no such obligation' and that `requiring agencies to obtain and publicize the data underlying all studies on which they rely would be impractical and unnecessary.'" Battery Recyclers, 604 F.3d at 623 (quoting American Trucking, 283 F.3d at 372). Though petitioners "attempt[ed] to distinguish their request on the ground that in American Trucking the court was addressing requests for data underlying several studies, while they request only that EPA obtain and make public the data underlying the Lanphear study," id. at 623, the court found that argument unpersuasive, again "noting that raw data often is unavailable due to proprietary interests of a study's scientific investigators or confidentiality agreements with study participants." Id. at 623 (citing American Trucking, 283 F.3d at 372).
EPA also cannot argue that excluding studies from the Agency's consideration when the underlying data cannot be publicly disclosed is "necessary" for ensuring the Agency relies on the best available science. As an initial matter, nowhere in the Proposed Rule does EPA find that particular studies, much less all studies that rely in part on the collection of confidential raw data (such as people's names and health records), are bad science, or even less reliable science. Nowhere does EPA show how health studies that rely in part on confidential personal information can never be relevant in any way to CAA rulemakings. Nor could it, as EPA has found such studies relevant and has relied on such studies for decades, and they are commonly accepted and valued as important scientific information of health effects within the scientific community. See Section IV.A [of comment letter]. EPA cites no examples of situations where unsound, unlawful, or arbitrary decision-making resulted from an agency's reliance on studies that do not fit its newfound notions of "transparency" and "integrity." Rather, courts have repeatedly upheld actions that have relied on such studies, as cited above.
Moreover, EPA has not demonstrated that it is consistent with scientific principles to categorically exclude peer-reviewed scientific information from all consideration in a rulemaking, as EPA proposes to do. If EPA has any doubts or concerns regarding the merits of a particular study, it must address those doubts or concerns for that particular study in the context of a given rulemaking, where agency staff, internal scientific experts, scientific advisory committees, or commenters contend that study is relevant. EPA has provided no scientific justification for ignoring an entire class of health science simply because the underlying data has not been disclosed. Whether underlying data on which a study relies is made public or not simply has no bearing on whether a scientific study is good science, is accurate, is reliable, and is relevant to a scientific question (such as the health effects of air pollution). And to the extent EPA requires additional verification of a study, there are myriad ways it can do so without disclosing confidential data (for example, requesting an independent scientific body to conduct a confidential review). See Section IV.A, infra, of the commenters' comment letter.
Furthermore, there is no statutory gap with respect to what studies EPA should consider (nor does EPA attempt to identify any). As further discussed below, sections of the CAA that govern air standards and rulemakings specify the applicable standards and generally require consideration of all available science. EPA has been adopting rules under most of these provisions for decades without finding any need for restrictions of the sort EPA proposes here. The Agency provides no explanation, and none exists, for suddenly finding "gaps" in these provisions.
Finally, EPA fails to acknowledge that it has had a longstanding policy of considering health studies without requiring disclosure of all underlying raw data. Indeed, it tries to minimize its prior position in a footnote, stating that: "Historically, EPA has not consistently observed the policies underlying this proposal, and courts have at times upheld EPA's use [of] non-public data in support of its regulatory actions." 83 Fed. Reg. at 18,769, n.3. It ignores the fact that EPA itself has consistently considered and used health studies dependent on non-public information for clean air rulemakings. Further, the Agency's longstanding policy has been that "EPA does not generally undertake evaluations of raw, unanalyzed scientific data as part of its public health standard setting process." 62 Fed. Reg. at 38,689. Only in "extreme cases  -  for example where there are credible allegations of fraud, abuse or misconduct  -  would a review of raw data be warranted." Id. That EPA now finds this data so important that it must be publicly disclosed before the Agency will even consider a study represents a monumental shift in course.
EPA is not working on a blank slate. Therefore, it must do more than just explain the change. Rather, EPA must provide "a more detailed justification," FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicles Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 41-42 (1983), because its new policy directly contradicts the Agency's prior findings that such studies are relevant to clean air rulemakings and provide evidence of health effects that the Agency can and must consider. EPA has not provided any reasoned explanation for its departure, much less an explanation with the requisite detail to justify its about-face.
Comment [6112-1582]: Commenter (6137) states that Agency "regulations, in order to be valid, must be consistent with the statute under which they are promulgated." Decker v. Nw. Envtl. Def. Ctr., 568 U.S. 597, 609 (2013) (quoting United States v. Larionoff, 431 U.S. 864, 873 (1977)). As discussed below, the Proposed Rule violates a number of provisions in the statutes upon which EPA relies as statutory authority. For this reason, too, the Proposed Rule is invalid.
The CAA's specific rulemaking provisions do not allow EPA to create the restrictions on the consideration or use of health science that EPA proposes. Rather, these provisions govern each type of CAA rulemaking, and to the extent science can and must be considered under these provisions, EPA may not lawfully restrict the use of such science. The Proposed Rule contravenes a number of CAA provisions and is thus unlawful.
First, sections 108 and 109 of the CAA do not allow EPA to restrict science as proposed and demonstrate that the Proposed Rule cannot lawfully be applied to any NAAQS rulemakings. These provisions specify that EPA's air quality criteria (on which the NAAQS are based) must "accurately reflect the latest scientific knowledge." 42 U.S.C. § 7408(a)(2); id. § 7409(b) (requiring those "criteria" be used to set NAAQS). This language unambiguously requires EPA to consider "all identifiable effects on public health," not just some. Id. § 7408(a)(2). The criteria "shall include information" on defined factors, "to the extent practicable." Id. This provision leaves no room for EPA to ignore or exclude studies because underlying data is not disclosed.
EPA cannot possibly ensure its air quality criteria "accurately reflect the latest scientific knowledge" if it refuses to even read certain studies based on an arbitrary public disclosure test. EPA's past practice illustrates this: for decades, the Agency's practice has been to review all available scientific studies, including those relying on non-public data. See, e.g., Battery Recyclers, 604 F.3d at 616; see also EPA, ISA for PM (Final Report, Dec 2009) (2009), https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=216546; EPA, Air Quality Criteria for PM, Vols. II-III (1996), https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=2832. The legislative history of § 108 confirms that Congress's intent was for EPA to "establish such national goals on the basis of the best information available," not to sit idly by until industry representatives no longer dispute questions regarding health effects. S. Rep. No. 91-1196 (Sept. 17, 1970), CAA 70 Leg. Hist. 19, 110 (emphasis added).
In addition, the Proposed Rule would direct EPA to violate the statutory procedures that must be followed when the Agency sets NAAQS. This includes EPA's appointment of an independent scientific review committee, including certain defined members, see 42 U.S.C. § 7409(d)(2)(A), and consideration of the recommendations of that committee when setting the NAAQS, id. § 7409(d)(2)(B) -(C); see also, e.g., Mississippi v. EPA, 744 F.3d 1334, 1346 (D.C. Cir. 2013) (explaining NAAQS development process). That committee shall advise EPA regarding whether there are "areas in which additional knowledge is required." 42 U.S.C. § 7409(d)(2)(C). In promulgating NAAQS in the past, EPA has recognized that the CAA requires it to consider scientific advice and recommendations from such experts, including those that rely on health studies where underlying data is not disclosed. Directing the Agency to ignore scientific studies presented by CASAC, just because the underlying data is not public, contravenes these statutory requirements.
Second, section 7409 of the Act requires EPA to adopt NAAQS based on the criteria, at levels requisite to protect public health with an adequate margin of safety. "[T]he Act requires [a] . . . preventative and precautionary" approach to setting NAAQS, whereby EPA must protect public health from "not just known adverse effects, but those of scientific uncertainty or that research has not yet uncovered." Am. Lung Ass'n v. EPA, 134 F.3d 388, 389 (D.C. Cir. 1998) (citation and quotation marks omitted). Congress "specifically directed" EPA "to protect against . . . effects whose medical significance is a matter of disagreement." Lead Indus. Ass'n v. EPA, 647 F.2d 1130, 1154 (D.C. Cir. 1980); accord Nat. Res. Def. Council, Inc. v. EPA, 824 F.2d 1146, 1152 (D.C. Cir. 1987) (en banc) (discussing legislative history). EPA's proposal would flout these precedents by refusing to consider scientific studies  -  even those published in peer reviewed journals by reputable scientists  -  based on an arbitrary data transparency policy.
To the extent the CAA allows EPA to weigh particular studies based on its expert judgment, this does not authorize EPA to categorically exclude an entire class of studies from being considered when performing a rulemaking to fulfill the Agency's statutory directive to protect public health and welfare. 42 U.S.C. § 7409(b)(1) (requiring primary NAAQS to be standards "the attainment and maintenance of which in the judgment of the Administrator, based on such criteria and allowing an adequate margin of safety, are requisite to protect the public health"). EPA cannot rationally engage in its task of determining an appropriate level for the NAAQS if it entirely excludes relevant health studies from its consideration simply because underlying data has not been publicly released. Under the Proposed Rule, EPA would refuse to consider studies indicating that adverse health effects occur at a specific pollutant level -- even where multiple studies reach the same results -- where the studies fail to meet the agency's arbitrary disclosure tests. This would contradict the statutory requirement to assure public health protection by ignoring some of the most important health science relevant to that question and is the epitome of irrational agency action.
Third, the Proposed Rule violates section 7412 of the CAA, which includes myriad provisions that require EPA to evaluate health risks and effects of HAP and to set emission standards to reduce these risks and effects, based on certain science-based legal tests applicable to particular § 7412 rulemakings. See, e.g., 42 U.S.C. § 7412(a), (b)(1)-(4), (f)(1)-(2). In no place does the statute limit EPA's consideration of scientific studies on health effects or risks to those studies where underlying data is publicly disclosed, nor does it authorize EPA to so limit its consideration of such scientific information. Instead, § 7412 includes language repeatedly indicating the requirement, embodying Congressional intent, for EPA to consider all relevant scientific information regarding health risks and effects, actual or potential, of HAP.
For example, § 7412(f) requires EPA to investigate and report, among other things, on "the actual health effects with respect to persons living in the vicinity of sources," and "any available epidemiological or other health studies" regarding the effects of HAP, as part of the residual risk requirements. Id. § 7412(f)(1)(C) (emphasis added); id. § 7412(f)(1) (also providing other requirements for EPA's investigation and report to Congress). EPA submitted that report to Congress in 1999. Section 7412(f) further provides that, in the absence of Congressional action on recommendations provided in EPA's Residual Risk Report to Congress, EPA "shall . . . promulgate standards for [each air toxics] category or subcategory if promulgation of such standards is required in order to provide an ample margin of safety to protect public health in accordance with this section (as in effect before November 15, 1990)." Id. § 7412(f)(2)(A). This provision also directs that:
Emission standards promulgated under this subsection shall provide an ample margin of safety to protect public health in accordance with this section (as in effect before November 15, 1990), unless the Administrator determines that a more stringent standard is necessary to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect. If standards promulgated pursuant to subsection (d) and applicable to a category or subcategory of sources emitting a pollutant (or pollutants) classified as a known, probable or possible human carcinogen do not reduce lifetime excess cancer risks to the individual most exposed to emissions from a source in the category or subcategory to less than one in one million, the Administrator shall promulgate standards under this subsection for such source category.
Id. § 7412(f)(2)(A). It would not be possible for EPA to fulfill its statutory directives under § 7412(f) to ensure that air toxics emissions standards "provide an ample margin of safety to protect public health," and to assess and remove any unacceptable health risks, unless EPA considered all relevant scientific studies in assessing such health risks. Id. § 7412(f)(2).
Further, § 7412(f)(2) also explicitly refers to EPA's Benzene Rule, which interpreted the prior version of this provision and which itself relied on certain studies and guidelines for which underlying data was not disclosed. Id. § 7412(f)(2)(B) (citing 54 Fed. Reg. 38,044 (Sept. 14, 1989)). As EPA determined, and Congress, the D.C. Circuit, and EPA have affirmed through citation and reliance on that rule, § 7412(f) standards must be "based on the most current scientific knowledge," and on risk assessment guidelines and methods developed by EPA scientists and expert independent scientists. 54 Fed. Reg. at 38,062-63. EPA has repeatedly recognized this reliance on an expansive array of scientific support that includes information that relies on epidemiological and other health studies for which the underlying data is not published in later § 7412(f) rulemakings as well.
Indeed, EPA itself has interpreted its legal responsibility pursuant to this provision as "incorporating into our assessments the best available science with respect to dose-response information." To achieve that, EPA has followed scientific recommendations by the Office of Air Quality Planning and Standards, and has prioritized certain sources of such dose-response information according, in part, to "level of peer review received." These guidelines direct EPA to consult dose-response assessments such as a reference concentration (RfC, for inhalation), reference dose (RfD, for ingestion), and a unit risk estimate (URE, for cancer risk) and/or slope factor (SF, for cancer risk). EPA's scientific method is to consult and rely on IRIS (an EPA database containing peer-reviewed scientific health assessment information) as a top priority source of such information, due in part to the high level of peer review. As EPA's guidelines explain: "IRIS is a critical resource for risk assessors because the database contains toxicity information that reflects a consensus among EPA program offices." EPA also prioritizes dose response information from the U.S. ATSDR, and the California EPA Office of Environmental Health Hazard Assessment. Each of these recognizes the value of relevant scientific information without regard to whether full underlying data can be or has been publicly disclosed.
Section 7412(a)(11) likewise illustrates the constraints the CAA imposes on limiting consideration of science when establishing cancer risk. This provision defines "carcinogenic effect" as having "the meaning provided by the Administrator under Guidelines for Carcinogenic Risk Assessment as of the date of enactment." 42 U.S.C. § 7412(a)(11). These Guidelines for Carcinogenic Risk Assessment ("Cancer Guidelines"), in turn, direct that EPA shall rely on "established scientific peer review processes," and state that "[t]he cancer guidelines incorporate basic principles and science policies based on evaluation of the currently available information." The Cancer Guidelines also provide that EPA's Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens ("Supplemental Guidance") should be considered along with the Guidelines. Both the Cancer Guidelines and Supplemental Guidance cite as relevant and in some instances important some of the very types of scientific studies that EPA's Proposed Rule would categorically exclude: epidemiological studies which rely on private or confidential medical information, or assessments such as IRIS, California EPA's (Cal. EPA) assessments, and other health reference concentration information that rely on such studies. The Cancer Guidelines do not preclude the consideration of any "one kind of data" as relevant, but instead "cover the assessment of available data," explaining that "[i]t is very important that all analyses consider the basic standards of quality, including objectivity, utility, and integrity."
Thus, EPA's Proposal to ignore studies because underlying data is not disclosed is antithetical to the Guidelines upon which EPA relies when determining carcinogenic effects in § 7412(a)(11). The statute's text and incorporation of EPA's science guidelines on cancer risk are unambiguous and leave no gap to fill regarding what "carcinogenic" means. Thus, in regulating carcinogens EPA may not apply the Proposed Rule's exclusion of any relevant health science regarding carcinogens and carcinogenic risk from air pollutants in rulemakings.
Consistent with the reliance on all relevant health science to determine carcinogenic effects, for cancer and other health risks under § 7412(f), EPA has an existing policy of what it describes as using the "the best available science with respect to dose-response information. The recommendations are based on the following sources, in order of priority": (1) EPA IRIS values which have all gone through independent, external peer-review; (2) ATSDR values, which follow an approach similar to EPA's IRIS program; and (3) Cal. EPA values for which "[t]he process for developing these assessments is similar to that used by EPA to develop IRIS values and incorporates significant external scientific peer review." Likewise, for non-cancer health risks from air pollution, EPA's guidelines do not exclude science that is relevant, even if underlying data is not disclosed. Notably, the vast majority of health reference values that EPA uses in § 7412(f) come from EPA's IRIS program, which includes a scientific literature review of all available relevant studies, without excluding any due to a lack of disclosure of underlying data.
Fourth, the Proposed Rule is unlawful because EPA is considering costs and is relying on implementation costs as a basis for the Rule, in direct violation of § 7409, § 7412(f)(2), and other provisions of the CAA where cost is not a relevant or permissible factor in determining health and environmental impacts. See, e.g., 83 Fed. Reg. at 18,768 (indicating that Proposed Rule would apply to "regulations for which the public is likely to bear the cost of compliance"); see also id. at 18,774 (proposed § 30.8) (requiring agency to implement the Proposed Rule "in a manner that minimizes costs"). Section 7412(f)(2) prohibits consideration of economic costs in assessing and determining whether the health risks that a major air toxics source causes are "unacceptable," as it requires a determination of what is required to provide an "ample margin of safety to protect the public health." Nat. Res. Def. Council, Inc., 824 F.2d at 1164-65 (quotation marks omitted); Benzene Rule, 54 Fed. Reg. at 38,048-49 (citing Vinyl Chloride decision as prohibiting consideration of costs when determining a "safe" or "acceptable" emission level). Similarly, as EPA explained in the Cancer Guidelines: "Risk assessments may be used to support decisions, but in order to maintain their integrity as decision-making tools, they are not influenced by consideration of the social or economic consequences of regulatory action." Cancer Guidelines, supra n.59, at 1-5 to 1-6. It is therefore both unlawful and arbitrary to use cost as a justification to ignore and exclude health science from residual risk air toxics assessments, and thus as part of the determination of whether risk is acceptable or unacceptable, pursuant to § 7412(f)(2).
Fifth, section 7412(n) directs EPA to "perform a study of the hazards to public health reasonably anticipated to occur as a result of emissions by electric utility steam generating units of pollutants listed under subsection (b) after imposition of the requirements of this chapter," and to list such sources "after considering the results of [this] study." 42 U.S.C. § 7412(n)(1). This provision includes no limitation on the data EPA can or must consider for this question, based on EPA's own interpretation. Thus, previously, in fulfilling its duty pursuant to this provision, EPA considered a wide array of scientific studies as relevant, regardless whether underlying data was disclosed. Excluding consideration of relevant scientific material addressing such hazards solely because underlying data is not available would arbitrarily lead to an incomplete assessment of relevant information and flout the statute's preventative and health-protective intent. EPA may not apply the Proposed Rule under this provision, as EPA has already recognized  -  for example, in acting pursuant to § 7412(n)(1) to reach the determination that it is "appropriate and necessary" to regulate power plants due to their health hazards  -  but rather must consider the types of studies the Proposed Rule would ignore. EPA cannot depart from its decision to consider such studies relevant without meeting the State Farm and Fox tests, see supra at 23, which it unquestionably has not done here.
In addition, the listing and delisting provisions for HAP and source categories, and the requirements for the urban air toxics program, require EPA to assess particular and potential health effects and risks from HAP. See, e.g., 42 U.S.C. § 7412(b)(2)-(3), (c)(9), (k). EPA's Proposal to ignore relevant scientific information due to the lack of public disclosure violates these requirements.
Sixth, CAA § 7429 requires EPA to evaluate health risks and does not allow the exclusion of relevant scientific information. For example:
 § 7429(a)(3)  -  standards must include new unit siting requirements that, on a site-specific basis, minimize potential risks to public health or the environment;
 § 7429(e) requires permits to include site-specific provisions "if the Administrator or the State determines that emissions in the absence of such limitations or measures may reasonably be anticipated to endanger public health or the environment";
 § 7429 (h)(3) requires residual risk review under § 112(f), and § 129(b)(1) requires the inclusion of any residual risk standards in the guidelines for existing units.
Seventh, the Proposed Rule is antithetical to the very purpose of the CAA, which is "to protect and enhance the quality of the Nation's air resources so as to promote the public health and welfare and the productive capacity of its population." 42 U.S.C. § 7401(b)(1). A "primary goal" is "pollution prevention." Id. § 7401(c). Each of the above provisions must be read in a way that advances that goal; the Proposed Rule would do the contrary and is thus inconsistent with the statute and unlawful. EPA's Proposal runs directly counter to these goals and objectives by arbitrarily excluding consideration of science that discloses health impacts of air pollution. The Proposal is not neutral. It only excludes health-based science (dose-response studies, epidemiological studies) where underlying data is not disclosed, generally because it cannot or should not be disclosed to protect individual participants' privacy and confidentiality. EPA cannot exclude whole categories of scientific data untethered from a specific context or study, but rather must assess each health study on a case-by-case basis to determine whether or not it should be considered in a particular rulemaking, under EPA's long-standing scientific guidelines and policies and its regular approach in CAA rulemakings. Instead, this Proposed Rule excludes health studies from consideration as a class, up front, before EPA is even in the rulemaking stage under its authority. And it does so not for scientific reasons, but simply due to industry preferences  -  most notably because industry cannot pick them apart by replicating decades of air pollution health effects, or by contacting individuals who shared private medical information to replicate the collection of data.
While the CAA provides for protection of "public health and welfare," the Proposed Rule favors excluding science even if it is the most relevant and important evidence regarding how to protect public health. While the CAA aims for "pollution prevention" to protect public health, the Proposed Rule would prevent consideration of science relevant to these very goals. Therefore, EPA's Proposed Rule is unlawful and arbitrary. Thus, EPA cannot lawfully satisfy § 7429 for similar reasons as described above, unless it evaluates relevant information on risks.
Eighth, a number of important CAA provisions require EPA to act based on a finding that air pollution is reasonably anticipated to endanger health or the environment. See, e.g., 42 U.S.C. §§ 7415, 7422, 7521. The D.C. Circuit has ruled that such language "requires a precautionary, forward-looking scientific judgment about the risks of a particular air pollutant, consistent with the CAA's `precautionary and preventative orientation.'" Coal. for Responsible Regulation v. EPA, 684 F.3d 102, 122 (D.C. Cir. 2012) (citation omitted). Such a precautionary approach does not require scientific certainty. "If a statute is `precautionary in nature' and `designed to protect public health,' and the relevant evidence is `difficult to come by, uncertain, or conflicting because it is on the frontiers of scientific knowledge,' EPA need not provide `rigorous step-by-step proof of cause and effect' to support an endangerment finding." Id. at 121 (citation omitted). Thus, the court expressly rejected the notion that EPA can or should disregard uncertain or "difficult to come by" evidence under "endangerment" statutes. Indeed, the court rejected the notion that EPA could not rely on studies that synthesized the research of others:
It makes no difference that much of the scientific evidence in large part consisted of "syntheses" of individual studies and research. Even individual studies and research papers often synthesize past work in an area and then build upon it. This is how science works. EPA is not required to re-prove the existence of the atom every time it approaches a scientific question.
Id. at 120. Thus, in making endangerment determinations, there is no lawful or rational basis for EPA to automatically exclude reliance on any studies that synthesize and evaluate research by others.
The Courts have also rejected EPA's attempts to avoid endangerment determinations based on considerations other than the specific endangerment criteria. In Massachusetts v. EPA, the Court held that the endangerment language in section 7521(a)(1) required EPA to assess whether motor vehicle emissions cause or contribute to air pollution which may reasonably be anticipated to endanger public health and welfare due to climate change, and to so determine exclusive of any other policy considerations. Massachusetts v. EPA, 549 U.S. 497, 532-34 (2007). Likewise, here, EPA cannot avoid its duty to make endangerment findings by arbitrarily rejecting scientific studies to serve vague and disingenuous policy interests such as allegedly fostering greater public trust and greater transparency in agency decisions.
The Proposed Rule also conflicts with specific language in § 7415 requiring an endangerment finding notification,
      [w]henever the Administrator, upon receipt of reports, surveys or studies from any duly constituted international agency has reason to believe that any air pollutant or pollutants emitted in the United States cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare in a foreign country or whenever the Secretary of State requests him to do so with respect to such pollution which the Secretary of State alleges is of such a nature, the Administrator shall give formal notification thereof to the Governor of the State in which such emissions originate.
42 U.S.C. § 7415(a). This provision does not allow EPA to ignore any such "reports, surveys or studies," if they show "reason to believe" that an air pollutant endangers public health. Id.
Similarly, § 7422 directs that EPA "shall review all available relevant information," to determine whether to make an endangerment finding for certain radioactive pollutants (including source material, special nuclear material, and byproduct material), cadmium, arsenic and polycyclic organic matter. 42 U.S.C. § 7422(a) (emphasis added). This language expressly forecloses EPA's refusal to consider available studies based on an arbitrary transparency screen. See also 42 U.S.C.§ 7521(a)(1)-(a)(3)(B) (providing for EPA to promulgate revised standards for heavy duty trucks "[o]n the basis of information available to the Administrator concerning the effects of air pollutants emitted from heavy-duty vehicles or engines and from other sources of mobile source related pollutants on the public health and welfare, and taking costs into account").
Finally, the CAA's rulemaking provision for air standards and limitations does not allow EPA to ignore relevant scientific information, including information provided by Commenters, and likewise may not direct a court to ignore this data. Section 7607 of the CAA  -  which provides for judicial review of air rulemakings  -  prescribes more detailed rulemaking procedures than those provided by the APA for a designated list of air emission standards and rules. 42 U.S.C. § 7607(d)(1). These procedures protect the public's right to notice and comment, in part, by requiring EPA to place into the docket and to consider and respond to all such comments. Id. § 7607(d)(4)(B)(i) ("Promptly upon receipt by the agency, all written comments and documentary information on the proposed rule received from any person for inclusion in the docket during the comment period shall be placed in the docket."); id. § 7607(d)(5) ("In promulgating a rule to which this subsection applies (i) the Administrator shall allow any person to submit written comments, data, or documentary information; (ii) the Administrator shall give interested persons an opportunity for the oral presentation of data, views, or arguments, in addition to an opportunity to make written submissions . . ."); id. § 7607(d)(6)(B) ("The promulgated rule shall also be accompanied by a response to each of the significant comments, criticisms, and new data submitted in written or oral presentations during the comment period.").
EPA's Proposed Rule contravenes these requirements and is therefore unlawful because it allows EPA to decide, before even receiving comments, that it will not consider or respond through regulatory action to any comments that submit scientific material for which underlying information is not disclosed. Under § 7607(d), EPA may not lawfully decide to ignore an entire class of science; if submitted by commenters as relevant, EPA must consider and respond in the context of the statutory test that applies to its rulemaking. Failure to do so is unlawful and arbitrary. Id. § 7607(d)(9).
Relatedly, for certain rules where recommendations are provided from scientific experts, § 7607 requires additional material to be placed into the docket, without EPA discretion. Id. § 7607(d)(3) (requiring a "statement" that "shall also set forth or summarize and provide a reference to any pertinent findings, recommendations, and comments by the Scientific Review Committee established under section 7409(d) of this title and the NAS, and, if the proposal differs in any important respect from any of these recommendations, an explanation of the reasons for such differences."). EPA's Proposed Rule unlawfully violates this provision because it would direct EPA to refuse to consider or discuss such information if based on studies for which underlying data were not disclosed.
More generally, EPA may not attempt to restrict, before a rulemaking has even begun, the type of information it will consider in that rulemaking. Doing so impinges on the federal courts' authority to determine what scientific evidence is relevant to application of CAA requirements in rulemakings. Pursuant to § 7607, the relevant court of appeals, and most frequently the D.C. Circuit, has jurisdiction to consider a petition for review of an EPA air rule. 42 U.S.C. § 7607(b). This grant of jurisdiction includes a grant allowing the court to decide what record material is relevant. Id.; see also id. § 7607(c). Notably, the court rules provide that the record on review of an agency order or regulation must include, inter alia, "the pleadings, evidence, and other parts of the proceedings before the agency." D.C. Cir. R. 16 ("If necessary, the court may direct that a supplemental record be prepared and filed."); see also Fed. R. App. P. 16. Similarly, the Federal Rules of Evidence require courts, not EPA or any other federal agency, to determine what evidence is "relevant" and "admissible." See, e.g., Fed. R. Evid. 401402 (allowing courts, and Congress by statute, but not federal agencies, to prescribe rules of evidence and determine admissibility of evidence and expert testimony). Scientific information submitted by commenters undoubtedly qualifies as "evidence" that the court must consider, even if EPA refuses to do so. EPA may not lawfully prevent submission of such evidence, or attempt to exclude it from a rulemaking record. Id.
Where EPA previously attempted to restrict or change the statutory test and authority granted to courts to evaluate CAA cases, the D.C. Circuit rejected that as unlawful and outside of the bounds of EPA's authority. Nat. Res. Def. Council v. EPA, 749 F.3d 1055, 1062 (D.C. Cir. 2014) (vacating affirmative defense to civil penalties because it changed the standard set by statute for court's discretion in enforcement cases, and thus violated § 7604 and § 7413). For this reason, too, the Proposed Rule is invalid.
Comment [6112-1626]: Commenter (6137) contends that the EPA's Proposal is also deficient because it fails to follow particular procedural requirements under the CAA that are legally required for EPA to issue certain types of rules. Specifically, the CAA requires that the CASAC complete a review of air quality criteria and the NAAQS every five years. 42 U.S.C. § 7409(d)(2)(B). Because the Proposed Rule aims to "preclude [the Agency] from using [nonpublic] data in future regulatory actions," it would impact the CASAC's review of air quality criteria. 83 Fed. Reg. at 18,769, n.3. Accordingly, EPA was required to follow the path prescribed by the CAA  -  including submission of the proposed rule to CASAC for review, allowing CASAC to provide recommendations to the Administrator, and then requiring the Administrator to include a statement regarding the recommendations made by CASAC in the Proposed Rule. 42 U.S.C. §§ 7409(d)(2)(B), 7607(d)(3); see also 42 U.S.C. § 7607(b), (d). Yet, there can be no dispute that none of these steps were taken before issuance of the Proposed Rule.
Comment [6112-2470]: Commenter (6137) asserts that it would be irrational and impracticable to require EPA to seek out the underlying data for, and demand separate peer review of, all data and models the Agency uses for purposes of characterizing the quantitative relationship between dose or exposure and magnitude of a predicted health or environmental impact. For instance, in the last ozone NAAQS review, EPA reviewed more than 4,000 studies and references for the ISA, and cited more than 2,200 in the final ISA. See EPA, Health and Environmental Research Online, ISA Ozone (2013) (last updated July 2, 2018), https://hero.epa.gov/hero/index.cfm/project/page/project_id/1628. It is neither practicable nor necessary for EPA to demand production of underlying data from thousands or even hundreds of studies, and to require new peer reviews of each. EPA cannot construe the statute in a way that would render it impossible to complete the review and revision of the NAAQS that Congress mandated.
EPA further tries to justify the Proposed Rule as a way to ensure the Agency is not arbitrary and capricious in its conclusions. But as previously noted, the D.C. Circuit has twice rejected the notion that EPA must obtain and disclose data underlying the studies it relies on in NAAQS development.
Comment [6112-3473]: Commenter (6137) states that, to the extent EPA suggests the Rule may be applied retroactively, there is simply no basis for doing so. It is well-established that an agency cannot apply a rule retroactively absent clear congressional intention for such application. E.g., Sierra Club v. Whitman, 285 F.3d 63, 68 (D.C. Cir. 2002) (referring to "unusual ability to implement rules retroactively"); Bowen v. Georgetown Univ. Hospital, 488 U.S. 204, 208 (1988) ("Retroactivity is not favored in the law. Thus, congressional enactments and administrative rules will not be construed to have retroactive effect unless their language requires this result. By the same principle, a statutory grant of legislative rulemaking authority will not, as a general matter, be understood to encompass the power to promulgate retroactive rules unless that power is conveyed by Congress in express terms." (citations omitted)). EPA has not identified any such congressional intention in any of the statutes at issue, and thus retroactive application of the Rule would be unlawful.
Nor would the statutes upon which EPA relies support such an application. For example, as explained above, the CAA does not allow -- and, as the D.C. Circuit has held, certainly does not require, e.g., American Trucking, 283 F.3d at 372 -- applying the so-called transparency provisions of the Proposed Rule at all in rules subject to the procedural requirements of CAA § 307(d). Such rules include NAAQS. Further, far from suggesting that EPA could lawfully reopen long-settled NAAQS to apply a new and novel standard of review, the CAA requires EPA to review and revise air quality criteria and NAAQS at least every five years and to "promulgate such new standards as may be appropriate." 42 U.S.C. § 7409(d)(1) (emphasis added). This carefully chosen language confirms that Congress did not intend for EPA to apply rules like the Proposed Rule to undo existing NAAQS, but instead intended for regular reviews of scientific information to result in new NAAQS.
Comment [6112-4453]: Commenter (6137) expresses that, in addition, in performing certain CAA and other rulemakings, EPA may not consider the economic implications of considering or excluding certain science at all. See Section IV.A of the commenters' comment letter. Yet EPA's failure to provide any lawful or rational justification for its costs/benefits statement for the Proposed Rule suggests that economic cost may have impermissibly played a role in its analysis. Had EPA focused on health rather than cost, EPA could not possibly find that the benefits of ignoring health science outweigh the costs for public health rulemakings.
Comment [6116-2627]: Commenter (6141) states that, 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.
Comment [6118-1681]: Commenter (6143) states that the EPA has issued its proposed rule on Strengthening Transparency in Regulatory Science pursuant to its authority under several environmental statutes that that it implements, including the CAA; CWA; SDWA; RCRA; CERCLA; EPCRA; FIFRA; and TSCA. This proposed action is fully consistent with the authorities and objectives laid out in those statutes. EPA must ensure that any final action it takes on this proposal continues to respect the balance reflected in those statutes between sound, transparent science, and legitimate privacy interests.
Comment [6119-1360]: Commenter (6144) states 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 information to set science-based 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 for good reason. EPA should not cite the CAA as an appropriate source of statutory authority. Further, the CAA encourages a very 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, before moving forward in such a rushed manner. If EPA is arguing that it derives its authority from statutes like the CAA, it should only do so after consultation with independent scientific bodies and significant stakeholder engagement.
Comment [6128-2225]: Commenter (6153) notes 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."
Comment [6149-2755]: Commenter (6174) contends that there is no basis in existing bedrock environmental laws that authorizes EPA to limit science considered in rulemaking processes. EPA cites several key laws as a justification for this current proposal to limit or constrain the science it can consider. Nowhere in the cited statutes is there any basis for demanding access to raw data, nor does this relate sensibly to any definition of best available science. Rather it undermines the use of best available science as called for in numerous environmental statutes including the CAA. Further, there is no basis in the statutes for politically appointed administrators to choose which science will be considered and which may not be.
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 the best available 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.
In sum, there is no statutory authority for EPA to rely on to censor or constrain science. Indeed, quite the opposite. Further, such an effort would only serve to undermine EPA's essential role.
Comment [6152-637]: Commenter (6122) states that the proposed rule is not based on any valid statutory authority and is arbitrary and capricious.
EPA cites multiple statutory provisions in an attempt to support the proposed rule that it believes authorize this type of rulemaking, "including provisions providing general authority to promulgate regulations necessary to carry out the Agency's functions under these statutes and provisions specifically addressing the Agency's conducting of and reliance on scientific activity to inform those functions . . ." None of the specific statutory provisions provided by EPA provide specific authority for EPA to fundamentally rework the foundational processes it uses to assess and include/reject science. Indeed, if such authority existed, one would have expected EPA to have discovered this authority many decades earlier. Instead, 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." And if this is true, neither can the EPA alter the fundamental details of all of its regulatory schemes based on such vague provisions of law. We review each of the provisions listed by EPA, none of which discuss transparency, dose response, pivotal regulatory science, benefit-cost calculation, or changing "agency culture," the stated goals of this rulemaking.
Section 103 of the CAA directs the 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 functions under the CAA.
Comment [6155-632]: Commenter (6125) notes that Congress first established the legal standards that NAAQS must meet in the 1970 CAA. EPA must establish primary and secondary NAAQS for air pollutants, "emission of which ... cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare". CAA section 108 (a)(1)(A). For each such pollutant, the law requires NAAQS not just to "protect the public health" but to do so "with an adequate margin of safety." CAA § 109(b)(1) (emphasis added). In setting these standards, EPA cannot consider the costs of meeting them, see Whitman v. American Trucking, 531 U.S. 457, 464-71 (2001) (Scalia, J.) but must instead comprehensively consider the state of scientific knowledge. To make sure this happens, Congress required NAAQS to be based on "air quality criteria," CAA § 109 (b), which must "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." CAA §108(a)(2) (emphasis added). The Supreme Court agrees that NAAQS must be based on "published air quality criteria that reflect the latest scientific knowledge." Whitman, supra, at 457. Accord, State of Mississippi v. EPA, 744 F. 3d. 1344, 1346 (D.C. Cir. 2013).
Air quality criteria must include information on "variable factors...which of themselves or in combination with other factors may alter the effects on public health or welfare of such air pollutant"; the types of air pollutants which ... may interact with such pollutant to prove an adverse effect"; and "any known or anticipated adverse effects on welfare." CAA section 108 (a)(2) (A)-(C). To make sure that EPA based its decisions on this latest useful science, in 1997 Congress also required EPA to appoint a scientific review committee  -  the CASAC -- to review the scientific information to be embodied in the air quality criteria and used to determine NAAQS. CAA § 109(d).
These statutory provisions originated in the 1970 Senate version of the CAA. The Senate Report on them stated that: "Margins of safety are essential to any health-related environmental standards if a reasonable degree of protection is to be provided against hazards which research has not yet identified" Library of Congress. Environmental Policy Division, (197480). A legislative history of the Clean Air Amendments of 1970, together with a section-by-section index. Washington: U.S. Govt. Print. Off. at p. 410 (emphasis added). The courts agree. See, e.g. American Trucking Association v. EPA (ATA III), 283 F.3d. at 369 (D.C. Cir. 2002).
EPA could not obey these statutory commands unless it considered (1) all knowledge that met the standards of quality observed by the scientific community to establish health effects of pollution; (2) knowledge that, though it might not meet these standards, was nevertheless "useful in indicating" these effects or pointing to "hazards which research has not yet identified;" and (3) all the knowledge regarding the factors which may result in these pollutants' synergistic effects on public health and welfare.
 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 its merits based on reasoned criteria. While details of the development and review of the criteria and standards have evolved, in practice, over the last four decades, EPA has endeavored to include all relevant peer reviewed scientific studies in the process, even searching out relevant newer literature to be sure that what is considered in a regulatory context is comprehensive. During this period, EPA has included tens of thousands of peer reviewed studies of health effects, exposure, and atmospheric interactions, and monitoring in reviews of criteria and standards.
A requirement that any study must be excluded from consideration unless the raw data and full methodologies are made available for each of them is both impractical and inconsistent with the legislative mandate and EPA's practice over the last 40 years. Reasoned criteria that EPA has typically applied include:
 Are the study populations, subjects, or animal models adequately selected, and are they sufficiently well-defined to allow for meaningful comparisons between study or exposure groups?
 Are the statistical analyses appropriate, properly performed, and properly interpreted?
 Are likely covariates adequately controlled or taken into account in the study design and statistical analysis?
 Are the air quality data, exposure, or dose metrics of adequate quality and sufficiently representative of information regarding ambient conditions?
 Are the health, ecological or welfare effect measurements meaningful, valid, and reliable?
 Do the analytical methods provide adequate sensitivity and precision to support conclusions?
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, including those requiring the use of "scientific knowledge" and specifying how to use it. This proposal has neither acknowledged that such requirements exist nor explained how it can, under the regulation, produce scientific information and rulemaking records meeting them, and there is nothing in the record to demonstrate that it can. Thus, contrary to the implicit suggestion in the proposal that EPA is working with a blank slate when it puts a unique spin on science under the CAA, it is entering a field where Congress has provided expansive directives. Moreover, the agency and the congressionally mandated CASAC have long followed an inclusive approach to selecting and evaluating the relevant scientific literature, consistent with these directives.
Automatic disclosure of data underlying scientific studies, regardless of the obstacles, has never been a precondition to EPA consideration of those studies in setting NAAQS. In two cases cited in the proposal, plaintiffs challenged rules on the basis that there was no public access to underlying data. In each case, EPA declined to provide the data, and in each case, the court affirmed that denial, and endorsed EPA's reasoning in doing so.
Comment [6155-665]: Commenter (6125) states that even if the per se rule could satisfy the substantive requirements of the NAAQS  -- which it cannot  --  the proposal fails utterly to comply with procedural requirements for establishing NAAQS, and in particular, for amending the air quality criteria on which the NAAQS are based. The law requires EPA to set NAAQS (as well as virtually every other significant CAA rule) through a structured dialogue with the public. CAA § 307(d)(3). First, EPA must issue a proposal setting out the "factual data" relied on the "methodology used in obtaining the data and in analyzing the data," and the major legal and policy considerations underlying the proposal. The public can then comment on every aspect of this proposal and can submit its own data. When EPA takes final action, it must respond, "to each of the significant comments, criticisms, or new data submitted." Ib.
These provisions largely mirror the requirements of the APA though they are more elaborately stated. Other specific provisions, however, go well beyond APA requirements. Specifically, any change in criteria documents must by law be reviewed by CASAC. CAA §109(d). In addition, criteria documents must also be reviewed by EPA's SAB under 42 USC 42 USC section §4365 (c)(1) (the Environmental Research Development Demonstration Authorization Act).
EPA's proposal would specifically and indisputably amend the air quality criteria, adopted pursuant to section 108 (b) of the CAA, for PM and lead. See proposed rule footnote 3 final sentence which states that the proposed rule would "preclude" using the Lanphear study which is part of the criteria for the NAAQS for lead, and the Harvard Six Cities and American Cancer Society II studies which are part of the air quality criteria for the PM NAAQS, and presumably a number of informative studies that update and expand these original works by adding more recently collected health and air pollution information. For these reasons, the statement at proposal 18773 saying the rule "does not establish an environmental health or safety standard" is false.
The proposal furthermore affects the current review of the PM NAAQS by proposing to regulate -- in fact, dictate -- the type of science that can be used in that review, and removing studies which were part of the air quality criteria in the past reviews, which would again directly alter the air quality criteria. Air quality criteria cannot be amended without review by CASAC. See CAA §109 (d)(2)(B). EPA consequently must submit its proposal to CASAC for its review, following all procedural requirements for public meeting and deliberations in doing so. CASAC must then submit its recommendations to the Administrator (see §109 (d)(2)(B) final clause), and the Administrator must consider these recommendations and provide a reasonable explanation for any actions that deviate significantly from those recommendations (CAA §307(d)(3)).
EPA cannot proceed with this action until these requirements are satisfied. And EPA cannot short-circuit the role the law assigns CASAC by using this type of broad rulemaking, effectively dictating how science can be used in future rule makings, to restrict CASAC's authority.
The proposal would amend the substantive standards for decision-making for a host of actions covered by CAA section 307 (d), among them the NAAQS (§307 (d)(1)(A)), 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)). Therefore, CAA §307 (d)(5)(ii) and (iv)require the Administrator to hold a public hearing on his proposal and to keep the record open for an additional thirty days, "to provide an opportunity for submission of rebuttal and supplementary information."
EPA should have submitted its proposal to the SAB pursuant to the requirements of 42 USC§ 4365 (c)(1) (the Environmental Research Development Demonstration Authorization Act), which requires the Administrator to submit to the SAB any "proposed criteria document, standard, limitation, or regulation, together with relevant scientific and technical information in the possession of the Environmental Protection Agency (EPA) ... on which the proposed action is based" at the time it provides that proposal to another agency of the government for formal review. The SAB is then to review and comment on the proposal, which the Administrator is to consider, although the Administrator is not required to obtain Science Advisory Board approval for any final action. See H. Rep. No. 95-722 (95th Cong. 1st Sess. (1977) (Conference Report).
EPA and the SAB have adopted procedures to implement this statutory requirement, whereby EPA provides SAB with a description (including a pertinent summary of potential issues of scientific concern) of planned major actions not yet proposed and the SAB determines, in a public forum, which of these actions merits its consideration and comment. See Memorandum of December 27, 2012, "Identifying EPA Planned Actions for Science Advisory Board Consideration of the Underlying Science" from Michael Goo, Assistant Administrator for Policy, Glenn Paulsen, EPA Science Advisor, and Vanessa Vu, SAB Office Director, and Memorandum of November 12, 2013 from SAB Chair James Mihelic to Members of the Chartered SAB and Liaisons. EPA has failed to comply with its statutory obligations and the requirements of its internal procedures.
In short, in its evident zeal to advance purported "transparency," EPA has thus ignored a variety of statutory and regulatory requirements which provide actual transparency to agency rulemakings, including the CAA's scientific review process.
Comment [6155-2630]: Commenter (6125) states that it is clear from even a brief look that these provisions require EPA to consider all the best available science, without authorizing, or even mentioning any of the per se restrictions based on "transparency" that EPA has proposed to use as a universal overriding rule. For these reasons, EPA must justify its proposal as a proper exercise of its authority under each of the statutory provisions whose operation it would affect - provisions that the agency does not even cite. It is the job of the proposer, not the commenters, to survey these provisions and provide the needed justification.
In several of the listed statutes Congress has explicitly told EPA how to use science in decision-making. As an example, the commenter notes that CAA 108(a)(2) specifies that "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."
These provisions, and others, all use mandatory language directing EPA to use reliable and relevant scientific information -- and further specify how to do so. They all direct that decisions regarding protection of public health be based on the full range of relevant scientific information, in some cases specifying how to identify what information to use. None of them give EPA discretion to ignore such information for any of the reasons set forth in the proposal.
Comment [6161-1504]: Commenter (6131) notes that 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 [6163-1102]: Commenter (6133) notes 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 is in direct conflict with other provisions of the Act. EPA cannot rely on 42 U.S.C. § 7601(a) to support this 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 proposed rule.
Nothing in the 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 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.
Comment [6163-1128]: Commenter (6133) notes that in CAA section 101(b), Congress directs EPA "to protect and enhance the quality of the Nation's air resources so as to promote the public health and welfare and the productive capacity of its population." 42 U.S.C. § 7401(b). The Proposal prevents EPA from doing so by blocking the agency from considering information that also is the best available, peer-reviewed, independent, credible science that could persuade or cause the agency to better protect the "public health and welfare and the productive capacity of [the Nation's] population." In this way, the Proposal thwarts the leading purpose of the CAA. CAA section 101 shows the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
CAA section 103(a)(1) directs EPA to "conduct, and promote the coordination and acceleration of, research, investigations, experiments, demonstrations, surveys, and 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 nothing in these congressional directives restricting these tasks ("research, investigations, experiments, demonstrations, surveys, and studies") to materials based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in these congressional directives to distinguish between "research, investigations, experiments, demonstrations, surveys, and studies" that involves "dose response data and models," and science that does not, for imposing regulatory restrictions on what science EPA must consider. The absence of any such congressional restrictions, authorizations or distinctions makes it clear that EPA invented and added the Proposal's limitations and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do. CAA section 103(a)(1) shows that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
CAA subsection 103(a)(4) directs EPA to "establish technical advisory committees composed of recognized experts in various aspects of air pollution to assist in the examination and evaluation of research progress and proposals and to avoid duplication of research." 42 U.S.C. § 7403(a)(4). CAA section 103(a)(5) directs EPA to "conduct and promote coordination and acceleration of training for individuals relating to the causes, effects, extent, prevention, and control of air pollution." Id. § 7403(a)(5). There is nothing in these congressional directives restricting these tasks to materials based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in these congressional directives to distinguish between research or science that involves "dose response data and models" on the one hand, and science that does not, on the other hand, for imposing regulatory restrictions on what science EPA must consider. The absence of any such congressional restrictions, authorizations, or distinctions makes it clear that EPA invented and added the Proposal's limitations and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do. CAA subsections 103(a)(4) & (5) show that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
CAA section 103(b) is significantly titled "Authorized Activities of Administrator in Establishing Research and Development Program." 42 U.S.C. § 7403(b) (emphasis added). It states that:
In carrying out the provisions of the preceding subsection the Administrator is authorized to --
      (1) collect and make available, through publications and other appropriate means, the results of and other information, including appropriate recommendations by him in connection therewith, pertaining to such research and other activities;
      (2) cooperate with other Federal departments and agencies, with air pollution control agencies, with other public and private agencies, institutions, and organizations, and with any industries involved, in the preparation and conduct of such research and other activities;
      (3) make grants to air pollution control agencies, to other public or nonprofit private agencies, institutions, and organizations, and to individuals, for purposes stated in subsection (a)(1) of this section;
      (4) contract with public or private agencies, institutions, and organizations, and with individuals, without regard to section 3324(a) and (b) of title 31 and section 6101 of title 41;
      (5) establish and maintain research fellowships, in the EPA and at public or nonprofit private educational institutions or research organizations;
      (6) collect and disseminate, in cooperation with other Federal departments and agencies, and with other public or private agencies, institutions, and organizations having related responsibilities, basic data on chemical, physical, and biological effects of varying air quality and other information pertaining to air pollution and the prevention and control thereof;
      (7) develop effective and practical processes, methods, and prototype devices for the prevention or control of air pollution; and
      (8) construct facilities, provide equipment, and employ staff as necessary to carry out this chapter.
Id. There is nothing in these congressional directives restricting these tasks, research or data to materials based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in these congressional directives to distinguish between research, science, data, or models that involves "dose response data and models" on the one hand, and science that does not, on the other hand, for imposing regulatory restrictions on what science EPA must consider. The absence of any such congressional restrictions, authorizations or distinctions makes it clear that EPA invented and added the Proposal's limitations and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do. CAA subsections 103(b) shows that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
CAA section 103(d) addresses Environmental Health Effects Research:
      (1) The Administrator, in consultation with the Secretary of Health and Human Services (HHS), shall conduct a research program on the short-term and long-term effects of air pollutants, including wood smoke, on human health. In conducting such research program, the Administrator --
      (A) shall conduct studies, including epidemiological, clinical, and laboratory and field studies, as necessary to identify and evaluate exposure to and effects of air pollutants on human health;
      (B) may utilize, on a reimbursable basis, the facilities of existing Federal scientific laboratories and research centers; and
      (C) shall consult with other Federal agencies to ensure that similar research being conducted in other agencies is coordinated to avoid duplication.
      42 U.S.C. § 7403(d).
There is nothing in these congressional directives restricting these tasks, research, studies, or data to materials based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in these congressional directives to distinguish between research, science, data, or models that involves "dose response data and models" on the one hand, and science that does not, on the other hand, for imposing regulatory restrictions on what science EPA must consider. The absence of any such congressional restrictions, authorizations, or distinctions makes it clear that EPA invented and added the Proposal's limitations and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do. CAA subsection 103(d) shows that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
CAA subsection 103(d)(2) directs "[i]n conducting the research program under this subsection, the Administrator shall develop methods and techniques necessary to identify and assess the risks to human health from both routine and accidental exposures to individual air pollutants and combinations thereof." 42 U.S.C. § 7403(d)(2). Subsection 103(d)(2) then says, "such research program shall include the following elements," listing subsections (A)-(C). Id. Subsection 103(d)(2)(B) & (C) are especially relevant and revealing:
      (B) An evaluation, within 12 months after November 15, 1990, of each of the HAP listed under section 7412(b) of this title, to decide, on the basis of available information, their relative priority for preparation of environmental health assessments pursuant to subparagraph (C). The evaluation shall be based on reasonably anticipated toxicity to humans and exposure factors such as frequency of occurrence as an air pollutant and volume of emissions in populated areas. Such evaluation shall be reviewed by the Interagency Task Force established pursuant to subparagraph (A).
      (C) Preparation of environmental health assessments for each of the HAP referred to in subparagraph (B), beginning 6 months after the first meeting of the Interagency Task Force and to be completed within 96 months thereafter. No fewer than 24 assessments shall be completed and published annually. The assessments shall be prepared in accordance with guidelines developed by the Administrator in consultation with the Interagency Task Force and the SAB of the EPA. Each such assessment shall include --
      (i) an examination, summary, and evaluation of available toxicological and epidemiological information for the pollutant to ascertain the levels of human exposure which pose a significant threat to human health and the associated acute, subacute, and chronic adverse health effects;
      (ii) a determination of gaps in available information related to human health effects and exposure levels; and
      (iii) where appropriate, an identification of additional activities, including toxicological and inhalation testing, needed to identify the types or levels of exposure which may present significant risk of adverse health effects in humans."
      42 U.S.C. § 7403(d)(2)(B) & (C) (emphases added).
There is nothing in these congressional directives restricting these tasks, research, studies, or data to materials based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in these congressional directives to distinguish between research, science, data, or models that involves "dose response data and models" on the one hand, and science that does not, on the other hand, for imposing regulatory restrictions on what science EPA must consider. The absence of any such congressional restrictions, authorizations, or distinctions makes it clear that EPA invented and added the Proposal's limitations and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do. CAA subsection 103(d)(2) shows that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
Equally damning for the Proposal, when Congress directs EPA to evaluate pollutants and their health effects, Congress uses broad and capacious terms:
 "on the basis of available information" (§ 103(d)(2)(B), 42 U.S.C. § 7403(d)(2)(B));
 "available toxicological and epidemiological information for the pollutant to ascertain the levels of human exposure which pose a significant threat to human health and the associated acute, subacute, and chronic adverse health effects" (§ 103(d)(2)(C)(i), 42 U.S.C. § 7403(d)(2)(C)(i)); and
 "available information related to human health effects and exposure levels" (§ 103(d)(2)(C)(ii), 42 U.S.C. § 7403(d)(2)(C)(ii)).
These instructions to EPA are prefaced with the mandatory language, "[s]uch research program shall include the following elements." (§ 103(d)(2), 42 U.S.C. § 7403(d)(2)). Congress went out of its way not to authorize EPA to ignore "available toxicological and epidemiological information" to ensure that the agency would be "ascertain[ing] the levels of human exposure which pose a significant threat to human health and the associated acute, subacute, and chronic adverse health effects." (§ 103(d)(2)(C)(i), 42 U.S.C. § 7403(d)(2)(C)(i)).
This shows clear congressional concern with all available science related to human health effects from air pollution -- not some restricted, politicized subset of science where underlying, confidential data are "publicly available in a manner sufficient for independent validation." CAA subsection 103(d)(2) shows that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
When Congress directs EPA to conduct an ecosystem research program in subsection 103(e), Congress says that such program "shall include" "[e]valuation of risks to ecosystems exposed to air pollutants, including characterization of the causes and effects of chronic and episodic exposures to air pollutants and determination of the reversibility of those effects." 42 U.S.C. § 7403(e). Subsections (e)(3) -(e)(6) address other effects on water quality, crops, soils, and other elements of ecosystems.
There is nothing in these congressional directives restricting these tasks, research, studies, or data to materials based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in these congressional directives to distinguish between research, science, data, or models that involves "dose response data and models" on the one hand, and science that does not, on the other hand, for imposing regulatory restrictions on what science EPA must consider. The absence of any such congressional restrictions, authorizations, or distinctions makes it clear that EPA invented and added the Proposal's limitations and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do. CAA subsection 103(e) shows that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
In section 108(a)(2) of the CAA, Congress required 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," CAA § 108(a)(2), 42 U.S.C. § 7408(a)(2) (emphases added). In American Trucking v. Whitman, 531 U.S. at 457, the Supreme Court said that NAAQS must be based on "published air quality criteria that reflect the latest scientific knowledge."
The Proposal violates these statutory requirements by prohibiting EPA from considering available science to discharge the agency's statutory responsibility to "protect the public health," with "an adequate margin of safety." CAA § 109(b)(1), 42 U.S.C. § 7409(b)(1). The Proposal does this by subverting and supplanting the congressional criteria in CAA § 108(a)(2), 42 U.S.C. § 7408(a)(2) with a restrictive standard driven by whether raw data are "publicly available in a manner sufficient for independent validation," 83 Fed. Reg. at 18,773/2 (proposed § 30.1).
With this unlawful maneuver, the Proposal prevents EPA from adopting 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." CAA § 108(a)(2), 42 U.S.C. § 7408(a)(2) (emphases added). First, the Proposal thwarts the congressional directives for "accurate reflection" of the "latest scientific knowledge." It does so by compelling or allowing EPA to ignore the "latest scientific knowledge," and to fail to "accurately reflect" that science, if raw data are not "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1).
Moreover, the Proposal thwarts the congressional directives for science that is "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." CAA §108(a)(2), 42 U.S.C. § 7408(a)(2) (emphases added). It does so, again, by compelling or allowing EPA to ignore the "latest scientific knowledge," and to fail to accurately reflect that science, if raw data are not "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1).
Further, section 208 contains the mandatory term "shall" -- which does not give the agency latitude. It does not matter if that "scientific knowledge" is "publicly available" in the way EPA contemplates in the Proposal, it must simply inform the effects of air pollution on public health or welfare. Further, American Trucking considered the requirements of this section and specifically concluded that "the CAA imposes no" "general requirement that EPA obtain and publicize the data underlying published studies on which the Agency relies." 283 F.3d at 372.
In these statutory provisions, obviously there is no mention of the necessity, or even relevance, of raw data being "publicly available in a manner sufficient for independent validation" before EPA must consider studies based on that data. Equally plain, there is no authorization for EPA to fail to "accurately reflect" that science when issuing air quality criteria.
There is nothing in these congressional directives restricting EPA's responsibilities, or the research, studies, or data it must consider, to materials based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in these congressional directives to distinguish between research, science, data, or models that involve "dose response data and models" on the one hand, and science that does not, on the other hand, for imposing regulatory restrictions on what science EPA must consider. The absence of any such congressional restrictions, authorizations, or distinctions makes it clear that EPA invented and added the Proposal's limitations and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do. CAA subsection 108(a) shows that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
The Proposal also violates section 109 of the CAA and contravenes the Supreme Court decision in American Trucking v. Whitman. The Proposal's conception of "pivotal regulatory science" turns on, among other things, "analyses that drive the magnitude of the benefit-cost calculation," and "studies, models and analyses" that are "critical to the calculation of a final regulatory standard or level, or to the quantified costs, benefits, risks and other impacts on which a final regulation is based." 83 Fed. Reg. at 18,770/2; id. at 18,773/2 (proposed § 30.2 (dose response data and models)). CAA section 109(b)(1) requires EPA to promulgate or revise health-based NAAQS that are "requisite to protect the public health," "allowing an adequate margin of safety." 42 U.S.C. § 7409(b)(1).
As noted, in American Trucking v. Whitman, a unanimous Supreme Court said that NAAQS must be based on "published air quality criteria that reflect the latest scientific knowledge." 531 U.S. at 457. Moreover, the Court held that CAA section "109(b), interpreted in its statutory and historical context and with appreciation for its importance to the CAA as a whole, unambiguously bars cost considerations from the NAAQS-setting process." 531 U.S. at 471. The Court also squarely rejected arguments appealing to statutory language concerning "adverse public health, welfare, social, economic, or energy effects which may result from various strategies for attainment and maintenance" of NAAQS. The justices made clear such language and concerns have "no bearing upon whether cost considerations are to be taken into account in formulating the standards." Id.
The Proposal violates CAA section 109(b)(1) and the governing Supreme Court interpretation in American Trucking by purporting to allow the "magnitude of a benefit-cost calculation" and "quantified costs and benefits" to impact or govern (1) EPA's consideration of peer-reviewed science relevant to reviewing, setting or revising health-based NAAQS; and (2) EPA's review, revision or establishment of health-based NAAQS. This is unlawful.
CAA sections 109(b)(1), (2), & (c) require EPA to protect Americans' "public health" with an adequate margin of safety, and America's "welfare" from "any known or anticipated adverse effect." 42 U.S.C. § 7409(b)(1), (2) & (c). The Proposal prevents EPA from doing so by blocking the agency from considering information that also is the best available, peer-reviewed, independent, credible science that could persuade or cause the agency to better protect Americans' public health and welfare, based on the statutory criteria in section 109. In this way, the Proposal thwarts the central role and fundamental right to health-based air quality standards under the CAA. CAA section 109 shows the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
CAA section 111(a)(1) defines a standard of performance as:
      a standard for emissions of air pollutants which reflects the degree of emission limitation achievable through the application of the best system of emission reduction which (taking into account the cost of achieving such reduction and any non-air quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated." 42 U.S.C. 7411(a)(1).
There is nothing in these congressional directives restricting EPA's establishment of "standards of performance," or its determinations of "achievability" or "best system of emission reduction" or "adequate demonstration," to information based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in these congressional directives to distinguish between research, science, data, or models involving "dose response data and models" on one hand, and science that does not, on the other hand, for imposing regulatory restrictions on what science EPA must consider.
EPA cannot fulfill the congressional directive to establish the "best system of emission reduction" if EPA is artificially and unlawfully restricting its consideration of data and information to those that are "publicly available in a manner sufficient for independent validation." Id. Nor may EPA fulfill the "adequately demonstrated" directive if systems of emission reduction that have been adequately demonstrated require EPA to consider data, science, or information that are not "publicly available in a manner sufficient for independent validation." Id.
CAA section 111(b)(1)(A) requires EPA to establish a list of stationary sources to be subject to section 111 standards of performance:
      [The Administrator] shall include a category of sources in such list if in his judgment it causes, or contributes significantly to, air pollution which may reasonably be anticipated to endanger public health or welfare.
      42 U.S.C. 7411(b)(1)(A) (emphasis added).
There is nothing in the Act restricting EPA's consideration of which categories of sources "may reasonably be anticipated to endanger public health or welfare" to information based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). There is no indication of congressional intent that what "may reasonably be anticipated to endanger public health or welfare" may be modified or constrained by ignoring science and data concerning endangerment if that information is not "publicly available in a manner sufficient for independent validation."
The absence of any such congressional restrictions, authorizations, or distinctions concerning what EPA may consider makes it clear that EPA invented and added the Proposal's limitations and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do. CAA subsections 111(a)(1) and 111(b)(1)(A) show that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
CAA section 112(b) provides a list of toxic air pollutants for which industrial sources must limit their emissions. The statute then directs the Administrator to periodically review that list of HAP and, where appropriate, revise this list by rule. In particular, the Administer is directed to add pollutants which:
      present, or may present, through inhalation or other routes of exposure, a threat of adverse human health effects (including, but not limited to, substances which are known to be, or may reasonably be anticipated to be, carcinogenic, mutagenic, teratogenic, neurotoxic, which cause reproductive dysfunction, or which are acutely or chronically toxic) or adverse environmental effects whether through ambient concentrations, bioaccumulation, deposition, or otherwise, but not including releases subject to regulation under subsection (r) as a result of emissions to the air. 42 U.S.C. § 7412(b)(2).
There is nothing in these congressional directives restricting EPA's establishment of this list nor of the pollutants that should be added to it based only on data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in these congressional directives to distinguish between research, science, data, or models involving "dose response data and models" on one hand, and science that does not, on the other hand, for imposing regulatory restrictions on what science EPA must consider.
EPA cannot fulfill the congressional directive to establish section 112(b)(2)'s pollutant list if the agency is artificially and unlawfully restricting its consideration of data and information to those that are "publicly available in a manner sufficient for independent validation." Id. Nor will EPA be able to fully analyze pollutants for inclusion on this list if determining inclusion would require EPA to consider data, science or information that are not "publicly available in a manner sufficient for independent validation." Id.
Similarly, Section 112(b)(3) lays out a petition process to add chemicals to the Section 112 list that similarly require the petitioner to submit to EPA proof that "the substance is an air pollutant and that emissions, ambient concentrations, bioaccumulation or deposition of the substance are known to cause or may reasonably be anticipated to cause adverse effects to human health or adverse environmental effects." 42 U.S.C. § 7412(b)(3)(B). Here, the straitjacket that the Proposal would place on this statutory language would similarly prevent the agency from carrying out its statutory directive.
Section 112(b)(3)(C) provides criteria for delisting pollutants from the list. This section would nonetheless be hamstrung if the agency were limited exclusively to data that are "publicly available in a manner sufficient for independent validation." 83 Fed. Reg. at 18,773/2 (proposed § 30.1). Nor is there any authorization in the section's congressional directives to distinguish between research, science, data, or models involving "dose response data and models" on one hand, and science that does not, on the other hand, for purposes of listing or delisting pollutants from section 112's hazardous pollutant list.
Nearly every subsection of Section 112, including standards for major and area sources, reporting requirements, and accidental release provisions, touch on protecting "public health," weighing "risks," or assessing how "hazardous" a "substance" or "pollutant" may be. EPA cannot fulfill the congressional directives of any of these sections if the agency is artificially and unlawfully restricting its consideration of data and information to those that are "publicly available in a manner sufficient for independent validation." Id. Nor will EPA be able to fully analyze risks to or impacts on human health and set section 112 standards accordingly if making such determinations would require EPA to consider data, science, or information that are not "publicly available in a manner sufficient for independent validation." Id.
The absence of any such congressional restrictions, authorizations, or distinctions concerning what EPA may consider makes it clear that EPA invented and added the Proposal's limitations and conditions as a matter of its own policy preferences, contrary to the Act. This EPA may not do. CAA section 112 makes exceedingly clear that the Proposal is arbitrary and capricious and an abuse of EPA's discretion.
The sections listed above merely represent a sampling of some examples in Title 1 of the Act that exemplify the extent to which the Proposal is arbitrary, capricious, an abuse of EPA's discretion, and a violation of clear congressional directives. The Act's five other Titles are no different, and the list provided here is not exhaustive -- the CAA is rife with examples of statutory language that the Proposal would distort with its adherence to data that are "publicly available in a manner sufficient for independent validation" 83 Fed. Reg. at 18,773/2 (proposed § 30.1) and research, science, data, or models involving "dose response data and models."
Comment [6165-1550]: Commenter (6135) states that they agree with the findings of the U.S. Court of Appeals for the D.C. Circuit in American Trucking Associations v Environmental Protection Agency that the CAA imposes no obligation to obtain and make public the data underlying certain "key studies" and similarly reject arguments that a general requirement be imposed for EPA to obtain and publicize the data underlying published studies on which the agency relies. We also agree with the court's finding that "requiring agencies to obtain and publicize the data underlying all studies on which they rely 'would be impractical and unnecessary.'"
Comment [6168-4099]: Commenter (6178) raises the following concerns with the Transparency Rule proposed by the NPRM:
1. The Agency cites specific sections of statutes it administers as the basis of the Agency's authority to adopt the Transparency Rule; specifically CAA sections 103, 301(a), 42 U.S.C. 7403, 7601(a). The Agency rightly cites this act of Congress in an attempt to support the NPRM as such authority is necessary for the Agency to adopt regulations pursuant to the CAA.
2. However, Congress, in each section cited, never instructs the Agency to consider transparency to the public of supporting data and/or models of the scientific research when deciding to rely on such research as support for regulations passed pursuant to the CAA. Consequently, the Transparency Rule requires the EPA to rely on factors which Congress has not intended it to consider when promulgating regulations pursuant to the CAA, rendering the Transparency Rule arbitrary and capricious under the APA.
3. Further, not only does the Transparency Rule lack sufficient Congressional intent to avoid being deemed arbitrary and capricious, implementing the Rule would actually contradict Congressional instruction to conduct scientific research with a focus on `promotion' and `coordination' among itself and other institutions that produce scientific research material to the objectives of the CAA Congress requires the EPA to enforce. This provides additional cause for finding the Transparency Rule arbitrary and capricious under the APA.
Comment [6168-4102]: Commenter (6178) states that the CAA does not instruct the Agency to consider Transparency to the public when evaluating scientific data.
It is a basic principle of separation of powers enshrined in the American system of government that only Congress passes laws, and then only the executive branch enforces such laws. With respect to executive agencies like the EPA, this principle translates into limitations on such agencies: the agencies are inherently restricted by the specifics of the laws they enforce.
The EPA's NPRM violates this basic principle of separation of powers. This is evident when reviewing each of the Acts the Agency cited in the NPRM as each instruct the EPA to conduct scientific research with very specific goals in mind, none of which however concern transparency to the public of the underlying data and models supporting the conclusions of such research.
To illustrate this lack of Congressional intent, section 7403 of the CAA, one of two cited by the Agency to support the Transparency Rule as authorized by the CAA, Congress instructs the EPA administrator to "establish a national research and development program for the prevention and control of air pollution and as part of such program shall...conduct, and promote the coordination and acceleration of, research, investigations, experiments, demonstrations, surveys, and studies relating to the causes, effects (including health and welfare effects), extent, prevention, and control of air pollution; encourage [and] cooperate with... air pollution control agencies and other appropriate public or private agencies, institutions, and organizations, and individuals in the conduct of such activities; conduct investigations and research and make surveys concerning any specific problem of air pollution in cooperation with any air pollution control agency with a view to recommending a solution of such problem...; establish technical advisory committees composed of recognized experts in various aspects of air pollution to assist in the examination and evaluation of research progress and proposals and to avoid duplication of research; and conduct and promote coordination and acceleration of training for individuals relating to the causes, effects, extent, prevention, and control of air pollution." [emphasis added]
The other section cited, CAA section 7601, states "the Administrator [of the EPA] is authorized to prescribe such regulations as are necessary to carry out his functions under this chapter."
Each of the emboldened phrases above highlights Congress's instructions to the EPA on how to conduct scientific research when determining the appropriate regulations to adopt pursuant to the CAA. Nowhere in such instructions does Congress direct the Agency to consider whether the underlying data and/or models supporting the conclusions of such scientific research is transparent such that, in the words of the NPRM, "the data and models underlying the science [pivotal to its significant regulatory actions] is publicly available in a manner sufficient for validation and analysis." Therefore, the Transparency Rule does not follow from the Congressional instruction found in the CAA.
Furthermore, Congress instructs the EPA in the CAA to focus on `promoting cooperation' between it and other institutions, public and private, researching air pollution such that `acceleration' of necessary research is achieved, resulting in required EPA regulations being enacted as soon as possible. Focusing on transparency as described in the NPRM would very likely delay promulgation of such regulations as coordination between critical research institutions that utilize nonpublic information (i.e. research participant's personal data or proprietary research databases) would inevitably be hindered, if not entirely eliminated. Accordingly, not only would the Transparency Rule's adoption lack basis in the Congressional instructions cited by the Agency, it would also contradict the basic Congressional instructions that the Agency Administrator is only `authorized to prescribe such regulations as are necessary to carry out his functions'.
Each of the other Acts' sections cited by the Agency in support of the Transparency Rule contain substantially similar clauses, therefore the above analysis applies to each cited Act.
Comment [6334-3168]: Commenter (6356) asserts that the regulation should not be applied retroactively. EPA proposes on page 18,771 that this regulation, if finalized, would apply prospectively. But it solicits comment regarding how the proposed rule should apply to future rulemakings which are based on the administrative record from previous reviews  -  particularly where the governing statute requires repeated review on a fixed date-certain cycle and dose-response data and models underlying pivotal regulatory science if those were developed prior to the effective date of this rule. Id. at 18,772/col. 1. The commenter submits that to the extent that future regulations rely on old data and/or dose-response relationships, then the proposed regulation should be transparent on both sets of information--the data and/or dose-response models must be available for review and independent validation in the context of the new rulemaking. However, the information could not form the basis for a challenge of a standard or pollutant limitation that EPA promulgated prior to adoption of this final agency action. In other words, prior regulations should not be affected by this rulemaking, even if EPA has not made their basis available for independent validation. But if that information forms the basis for a new standard or pollutant limitation, then the data and dose-response relationships that were the foundation of the historic requirements would be subject to this regulation if adopted. To the extent that these methods of analyses have evolved or been replaced, and particularly if they are distinguishable, it may change the outcome of future regulations, even if the old regulations adopted prior to this rulemaking continue to be implemented.
EPA should explain, in the context of this rulemaking, that many environmental statutes, including but not limited to the CAA, contain anti-backsliding provisions regarding the relaxation of standards. See, e.g., CSS Section 172(e), 42 U.S.C. §7502(e). Courts have interpreted this CAA provision to mean that while EPA can revoke a NAAQS for a criteria pollutant, the non-backsliding provisions of the Act prohibit the agency from revoking regulatory requirements that were required for implementation of a prior standard. See South Coast Air Quality Management District v. EPA, 882 F.3d 1138 (D.C. Cir. (2018), petition for rehearing pending; South Coast Air Quality Management District v. EPA, 472 F.3d 882 (2006), rev'd. 489 F.3d 1245 (D.C. Cir. 2007). Both decisions involved revocation of a standard and its replacement with a more stringent standard, so NEDA/CAP expresses no opinion of revision of standard to a less stringent standard, because we consider that unlikely to happen. It may be helpful for EPA to flag similar statutory provisions in its final action on this Notice.
Comment [6340-1454]: Commenter (6362) states that the provisions cited by EPA under the CAA, the CWA, the SDWA, the CERCLA, and the EPCRA in support of its authority to develop and implement its proposed rule all provide broad regulatory authority to promulgate regulations "as are necessary to carry out [the Administrator's] functions" under the statute.
Comment [6343-2707]: Commenter (6365) expresses that they are committed to meeting their obligations to operate in a responsible manner to avoid adversely impacting the environment and public health and safety. Both lead itself and the production of lead are extensively regulated by the EPA, including under the CAA. As a result of this program and other actions taken by industry, "[t]he United States have made tremendous progress in reducing lead concentrations in the outdoor air," with the national average concentrations dropping "more than 90 percent since 1980," and "EPA expects that most of the areas previously designated as nonattainment will have attained or are on track to attain by the end of 2016."
In order to ensure that the regulatory standards that the commenter's members are subject to are supported by the best possible science, the ABR supports EPA's objective of strengthening transparency in regulatory science by ensuring that the data and models underlying regulatory science is publicly available in a manner sufficient for validation and analysis. Furthermore, EPA should establish clear criteria for data and model availability so that stakeholders can effectively determine whether the data and models underlying each regulatory proposal are available for review.
Comment [6353-2326]: Commenter (6375) notes that the EPA solicits comment on whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles at the programmatic or statutory level would be appropriate as alternative or additional steps the agency may take to further the policies articulated in Section II of the NPRM's preamble. (pg. 18771).
The regulatory language that EPA proposes provides general requirements that apply to the Agency's use of science under the many statutes that it implements. The generality of the proposed regulations may be a function of the diverse purposes of those statutes Specifically, some of these statutes focus on the introduction of new substances into the marketplace (e.g., FIFRA and TSCA), while others primarily concern regulation of emissions or releases to (e.g., CAA and CWA), or removal from (e.g., CERCLA), the environment. The scientific analyses required for these different programs and the sources of the scientific information underlying those analyses differ. The Agency should consider supplementing the general language that it has proposed with statutory specific regulations. A statutory-specific rulemaking would provide greater certainty going forward.
Comment [6355-2849]: Commenter (6377) notes that CAA Section 108(a)(2) requires NAAQS to be based on air quality criteria that "shall accurately reflect the latest scientific knowledge" useful in identifying potential health and welfare effects, including, "to the extent practicable," specific information on variable factors, pollutant interactions and welfare effects. These statutory provisions impose three distinct requirements for the scientific information contained in criteria documents (now known as ISA): (1) it must be accurate; (2) it must reflect the latest relevant information available; and (3) specific data must be provided where practicable.
In adopting these provisions in 1970, the Senate Committee expressly noted the absence of key scientific information relevant to NAAQS development and adopted an ambitious research program to fill the gaps, including research on: (1) the contribution of air pollution to the etiology of disease; (2) synergistic effects; (3) tissue accumulation; (4) functional impairment; (5) contributing factors such as age, occupation and smoking; and (6) improved predictive models. The Committee stated that "This effort should be directed toward the accelerated development of more comprehensive air quality criteria" (id.). Accordingly, as new information is developed, Congress directed EPA to include it in more comprehensive versions of the ISA.
This requirement was strengthened in the 1977 CAA Amendments, which included the rulemaking provisions that now appear in Section 107(d) of the Act. Those provisions originated in the House bill, and in adopting them the House Committee found that "appropriately broad administrative discretion to promulgate regulations to protect health or the environment must be restrained by thorough and careful procedural safeguards that ensure an effective opportunity for public participation in the rulemaking process." Two provisions were adopted to provide such assurance. With respect to proposed rules, Section 307(d)(3) provides:
All 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.
Section 307(d)(6)(C) imposes a similar requirement on final rules:
The promulgated rule may not be based (in whole or in part) on any information or data which has not been placed in the docket as of the date of such promulgation.
As the 1977 House Committee noted, these provisions were necessary because Congress gave EPA broad discretion in developing NAAQS, rejecting the "substantial evidence" standard for judicial review in favor of the more lenient "arbitrary and capricious" standard, under which courts give substantial deference to agency findings of fact. In adopting this approach, Congress wanted to be sure that all of the scientific information on which the agency relies is available for public review at the proposal stage and for judicial review in the wake of a final standard. The House Committee went on to state that "Of course, the agency has at least as great an obligation to include any such documents that contradict its position as it does to include those that support it" (p. 321).
To recap, Section 108(a) of the Act requires NAAQS to be based on scientific information that is accurate and the latest relevant information available, including specific data where practicable. Section 307(d) requires all data and information on which proposed and final rules are based to be placed in the underlying dockets. These provisions amount to a statutory requirement for EPA to provide scientific transparency to the maximum extent practicable in developing ISA and proposed and final NAAQS rules.
Comment [6355-2851]: Commenter (6377) states that the substantial costs of the NAAQS program have been documented extensively. In enacting the CAA Amendments of 1970 and 1977, Congress prohibited EPA from considering costs in establishing NAAQS, but also adopted a series of provisions designed to ensure that the potential benefits of the program would be justified by the scientific data in NAAQS rulemaking dockets. EPA's transparency proposal is a reasonable effort to implement those requirements while providing adequate protections for privacy, confidentiality, and other potential problem areas. Far from being inconsistent with the applicable CAA provisions, EPA's transparency proposal is required by them and is long overdue. The Coalition urges EPA to implement the proposal expeditiously and apply it to all currently pending NAAQS reviews.
Comment [6424-1252]: Commenter (6446) notes that the proposed rule deviates from accepted practices that EPA routinely uses, and is required to use, to evaluate science it relies on for regulatory decisions. EPA has long recognized that proprietary CBI submitted to it cannot be shared with the public, yet it routinely relies on that information, including scientific studies and other scientific information, as the foundation for important regulatory decisions. EPA also adheres to specific Congressional directives regarding the science it should consider for regulatory action, including directives to consider whether the scientific information is reasonable, clear, complete and whether it has been peer reviewed. (See, e.g., the TSCA at 15 U.S.C. § 2625, subds. (h) and (i), requiring EPA to consider several factors to evaluate science relating to toxic chemicals and requiring that decisions be based on "the weight of the scientific evidence," and the CAA at 42 U.S.C. § 7408, subd. (a)(2), requiring EPA to rely on "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices.")
Comment [6870-4001]: Commenter (6892) states that, in their view, the federal statutes not only fail to support the proposal but instead require consideration of all relevant scientific evidence. The provisions cited by the EPA proposal provide flimsy support  -  thus the plaintive cry for legal assistance from public commenters. More importantly, the proposal flies in the face of EPA's primary responsibility to base its decisions on consideration of all relevant scientific evidence.
It would be tedious to discuss the statutes in each of the different areas that EPA regulates, and not very useful, since the provisions cited by EPA in each area are similar. Air pollution is probably the most important area covered by the proposal in public health terms, so I will use that as an example.
The problem is not just that the CAA fails to provide clear authority for EPA's proposed exclusionary rule. There are also provisions in the Act that cut strongly against the proposal.
Like many recent EPA actions, the "transparency" proposal is an effort to elevate the concerns of regulated businesses at the expense of EPA's primary mission: protecting public health and safety. Transparency is a worthy goal, but it should not serve as an excuse to ignore inconvenient evidence or to compromise public safety.
Comment [6872-3439]: Commenter (6894) expresses that an unintended negative outcome, the community of scientists, which has increasingly grown to share the essential data used in research, would be thwarted by those who may be unable or unwilling to share their data, especially post-facto data that were part of the current publications already having gone through the peer review and publication process. The result would be a crippling, if not an elimination of the strong, crucial science that has been the backbone of existent, validated regulatory reviews per the CAA mandate.
Comment [6873-1716]: Commenter (6895) notes that, in one example of the need for valid science-based standards, the PM-2.5 NAAQS set limits based on daily and annual exposure to PM-2.5 in ambient air. The regulation was supported by studies that were performed in many communities by many scientists and those scientists were able to calculate similar linkages between a concentration of PM2.5 and an acute or chronic health effect.
The Health Effects Institute (HEI) examined two of the sentinel studies that were pivotal to the development of the PM-2.5 NAAQS. The Harvard Six Cities Study and the American Cancer Society Study of Particulate Air Pollution and Mortality were selected for independent validation because the development of the NAAQS relied on their findings. A team of independent analysts started from the individual health and air quality data to see if the author's conclusions were supported. They corroborated the findings of the original studies.
Further, as noted above the re-validation of the Harvard Six Cities Study and the American Cancer Society Study of Particulate Air Pollution and Mortality as well as the re-analysis of 40 studies all used to support the development of the PM-2.5 NAAQS shows clearly that the authors of these pivotal studies provided sufficient data so that the work could be replicated and validated. There is no need for revisiting these studies through the application of additional restrictions or requirements for public data availability nor from the release of personally identifying information.
In 1971 President Richard Nixon signed into law the ban on lead in paint in public housing, followed later by a ban in all paint sold in the United States. In 1973, the newly formed EPA reviewed blood lead levels among urban adults and children grouped by location and found blood lead levels which exceeded concentrations that were known to be associated with adverse health effects. The data was pooled and masked by sex, age, location, and potential exposure category. EPA's review led to the removal of lead from gasoline in 1995. All these actions directly resulted in lower ambient lead levels and the prevention of adverse neurological effects in children and adults from lead exposure. If this situation were to occur today, in accordance with this proposed rule EPA would be required to replicate these findings, making each individual's results available for further review by non-scientific individuals (lawyers and politicians), which would have further delayed the removal of lead from gasoline and jeopardized the health of millions of children living in urban areas across the United States. EPA requests comments on alternatives to redoing studies upon which current regulations are based. The Departments are strongly opposed to any retroactive application of the proposed rule. The pivotal studies used in many of the past regulatory actions including the promulgation of the PM-2.5 NAAQS provided sufficient data so that the work could be replicated and validated in a manner widely accepted by the scientific community in the lead in gasoline matter, an alternative would be to put lead back in gasoline. That would of course be unconscionable, however, EPA's reasoning could well lead to this type of result.
Comment [6891-2149]: Commenter (6921) states that numerous laws such as the CAA require the use of the best available science when implementing their provisions; the proposed rule would run afoul of such laws and hinder their proper implementation .
Comment [6894-3604]: Commenter (6915) states that the CAA requires that air quality criteria "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare." § 108(a)(2), 42 U.S.C. § 7408(a)(2) (emphases added).
Comment [6895-3068]: Commenter (6916) states that the EPA's attempt to justify its action on the basis that courts previously have found it has the discretion to rely on non-public data in decision making, see 83 Fed. Reg. 18,769 n.3, simply does not explain why this proposed action  -  to cut off access to studies based on non-public data - is justified. The cases, upholding earlier Agency decisions not to release sensitive data underlying regulatory decisions, were decided based on a hard look at the statute, on grounds "that `the CAA imposes no such obligation' and that `requiring agencies to obtain and publicize the data underlying all studies on which they rely would be impractical and unnecessary.'" Nor is EPA's suggestion that various third-party independent organizations have called for "open science" at all persuasive, as discussed below. This issue has been debated  -  and transparency has improved, over many years  -  but even commentators in the initial rounds of the conversation, noted that there is no empirical evidence supporting the idea that there is a "bad science" problem.
The commenter further states that the proposal is impractical and unnecessary because existing laws and guidelines provide for controlled release of underlying data to permit reanalysis where there are questions about study results.
Comment [6895-3151]: Commenter (6916) notes that, by statute, the public may not access raw underlying data - or protected intellectual property. To the extent that the Proposal would, if finalized, require the public release of such data, it is unlawful.
EPA's CAA rulemaking history illustrates that the Proposal is not necessary: scientific results and methods can be questioned and validated without exposing protected underlying data to public scrutiny.
The Proposal seeks comment on whether its new public data release paradigm should be applied even to "dose response data and models...developed prior to the effective date." To be clear (which the Proposal is not) this would have the potential effect, on CAA rulemakings, of prohibiting the use of the well-developed dose response information resulting from two landmark studies, the Harvard Six Cities Study and the American Cancer Society Study of Particulate Air Pollution and Mortality, that have been called "the poster children of good-science reforms." We strongly oppose such an outcome, as it would remove from EPA's rulemaking toolbox the "best available science" on the link between air quality and health. That is both unnecessary and unjustified.