Not only would the Proposal impede EPA's fulfillment of its statutory duties, it would also be contrary to judicial precedent, which holds that "best available science" includes "all existing scientific evidence relevant to the [agency] decision [in question]." Ecology Ctr., Inc. v. U.S. Forest Serv., 451 F.3d 1183, 1194 n.4 (10th Cir. 2006) (quoting Heartwood, Inc. v. U.S. Forest Serv., 380 F.3d 428, 436 (8th Cir. 2004)). While agencies need not produce new evidence, they must seek out information and "cannot ignore existing data." Id. (emphasis added). Even if an agency is anticipating the arrival of better evidence, it must act on the basis of the evidence it currently has. Many of the fundamental public health studies on which EPA has based key rules and standards under the statutes are studies for which the raw data was not or could not have been released. Nonetheless these studies have been examined and validated, as will future studies. Arbitrarily cutting off consideration of a category of science is inconsistent with EPA's statutory obligations.
Comment [9217-3560]: Commenter (9225) writes that the proposed rule is not authorized by any authority delegated to EPA by Congress and is contrary to a number of statutes under EPA's authority. This includes, but is not limited to, the CAA; CWA; TSCA; LCSA; SDWA; FIFRA; and more.
Comment [9283-3584]: Commenter (8281-PH6) writes that the proposed rule is inconsistent with the Agency's statutory obligation to use the best available science as required in the TSCA, SDWA, and CWA.
Comment [9290-3814]: Commenter (8281-PH24) writes that the EPA has administered successfully, the CWA, and the CAA, and these acts should be expanded based on scientific research. The EPA should not be working to undermine scientific research. Instead, this EPA should be working to provide running water to the 630,000 American families who do not have running water in their homes.
Comment [9316-5014]: Commenter (8281-PH85) supports the application of this rule to EPA's environmental impact analyses, particularly Total Maximum Daily Loads (TMDL), and the NPDES permits under the CWA.
These legally binding permits include ethylene limits for wastewater treatment facilities for pollutants such as lead, mercury, or phosphorus. Slight alterations in these permit limits can cost a single wastewater facility tens of millions of dollars, the cost of which is passed on to individual local rate bearers. These permit limits are supposed to be derived in a manner similar to dose-response relationships as mentioned in the rule where, for example, a lower level of the pollutant in the discharge will result in a measurable increase in receiving water quality working with health. However, we have dealt with instances throughout the country where environmental agencies have based regulations on publicly unavailable data, outdated science or faulty science, even in the face of data or studies which indicate stringent permit limits imposed by these agencies are not anticipated to result in any quantifiable environmental or human health benefit despite the cost. We hope that this rule would remedy these shortcomings.
We also strongly support the use of independent expert peer reviews as an additional level of review for fiscal regulatory science. Our firm has been involved in independent peer reviews of various CWA-related EPA regulations which have concluded that the technical basis for EPA's regulations and permit limits were scientifically indefensible. Had no peer reviews occurred, these regulations would have imposed hundreds of millions of dollars of wastewater treatment costs to rate bearers with no anticipated benefit. As a science-based Agency applying science-based statutes it is critical to both receiving water quality and rate payers throughout the country that these permits, and regulations are based on sound science and not speculation. In this regard, we support application of EPA's proposed rule to CWA regulations.
Comment [6141-2554]: Commenter (6166) writes that the proposed rule is not authorized by any authority delegated to EPA by Congress and is contrary to a number of statutes under EPA's authority. This includes, but is not limited to, the CAA; CWA; TSCA; LCSA; SDWA; FIFRA; and more. Substantively, the rule violates numerous public health and environmental provisions contained in these laws, as well as requirements to use the best available science or to consider all available information.
Comment [6168-4099]: Commenter (6168) raises the following concerns with the Transparency Rule proposed by the NPRM:
 The Agency cites specific sections of statutes it administers as the basis of the Agency's authority to adopt the Transparency Rule; including CWA sections 104, 501, 33 U.S.C. 1254, 1361. The Agency rightly cites acts of Congress in an attempt to support the NPRM as such authority is necessary for the Agency to adopt regulations pursuant to the above listed Acts.
 However, Congress, in each of the Acts' sections 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 any of the Acts. 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 Acts, rendering the Transparency Rule arbitrary and capricious under the APA.
 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 Acts Congress requires the EPA to enforce. This provides additional cause for finding the Transparency Rule arbitrary and capricious under the APA.
Comment [7869-3372]: Commenter (8272) writes that the proposed rule is not authorized by any authority delegated to EPA by Congress and is contrary to a number of statutes under EPA's authority. This includes, but is not limited to, the CAA; CWA; TSCA; LCSA; SDWA; and the FIFRA. The rule violates numerous public health and environmental provisions contained in these laws, as well as requirements to use the best available science or to consider all available information.
Comment [6163-1276]: Commenter (6133) writes that the Proposal's peer review provision lacks any statutory basis, is vague and contrary to existing requirements for peer review.
In addition to addressing how and whether the agency will consider science, the Proposal also contains a seemingly unrelated provision regarding agency peer review. The Proposal, in § 30.7, reads:
      What role does independent peer review in this section?
      EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein.
      Because transparency in regulatory science includes addressing issues associated with assumptions used in models, EPA shall ask peer reviewers to articulate the strengths and weaknesses of EPA's justification for the assumptions applied and the implications of those assumptions for the results.
      83 Fed. Reg. at 18,774.
There is no statutory authority for EPA to "conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." The federal statutes that EPA lists as putative authority for the Proposal provide no authority for proposed § 30.7. See CWA sections 104, 501, 33 U.S.C. 1254, 1361. The claimed authorities that EPA lists do not mention peer review or even allude to the concept. Id. Neither the Proposal nor accompanying docket materials identify any provision of any federal statute that authorizes EPA to promulgate proposed § 30.7. Our own research revealed no provision of any federal statute that authorizes EPA to promulgate proposed § 30.7.
When Congress writes federal statutes, Congress knows how to create legal authority for peer review, who shall conduct that peer review, what role, if any, that EPA or other parties will play, and how that peer review may be conducted. None of the provision in the law authorize EPA's Proposal in § 30.7. Instead, the statutes require that EPA use peer-reviewed science, regardless of whether it would meet EPA's definition of the term in § 30.7. And in cases where the law requires EPA to conduct the review, the statutes often spell out specifically how that should happen. For example, for the CWA:
      CWA
      § 1321. Oil and hazardous substance liability
      (a) Definitions (27) the term "best available science" means science that--(A) maximizes the quality, objectivity, and integrity of information, including statistical information; (B) uses peer-reviewed and publicly available data; and (C) clearly documents and communicates risks and uncertainties in the scientific basis for such projects;
      33 U.S.C. § 1321 (emphasis added).
Under longstanding federal case law, when Congress authorizes an approach in one section of a statute using specific language but does not do the same in other sections of a statute, courts presume that Congress acted purposefully and did not mean to address or authorize that approach in those other statutory sections. See, e.g., Dean v. United States, 556 U.S. 568 (2009) ("It is generally presumed that Congress acts intentionally when including particular language in one section of a statute but not in another." (citing Russello v. United States, 464 U.S. 16, 23 (1983)). Not only are there no implied grants of authority to an agency in the other statutory sections, but the congressional decisions to authorize the approach elsewhere in the statute give even greater force to the conclusion that the agency has not been given authority where Congress did not use the same or similar authorizing language.
The EPA approach proposed in § 30.7 is even more unlawful than would be the case, independently, under this case law. Proposed § 30.7 says "EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." 83 Fed. Reg. at 18,774/2 (emphasis added). EPA proposes to bind itself ("shall") to conduct a particular form of peer review on "all pivotal regulatory science" based on an unenforceable, non-binding OMB bulletin that has never been the subject of notice and comment rulemaking and that itself is not authorized by any federal law. To the contrary, treating the content of the unenforceable bulletin as a binding regulation would itself violate the federal statutes that EPA implements, because those statutes do not codify the bulletin, and EPA would be unlawfully codifying a mere policy preference. This EPA may not do.
This Proposal is unlawful, arbitrary, and capricious, and an abuse of EPA discretion. To reiterate, the Proposal identifies no statutory authority for EPA to conduct independent peer review for any, much less all, "pivotal regulatory science" consistent with the dense content (and exceptions) of the OMB bulletin. The Proposal identifies no statutory authority for EPA to bind itself, and future administrations, to conduct peer review only in this fashion, unless and until future notice-and-comment rulemaking is undertaken. The Proposal identifies no suggestion in statutory language or legislative history that Congress intended EPA to conduct binding peer review consistent with this OMB bulletin, notwithstanding that Congress has known about this bulletin since 2005. EPA has simply made up proposed § 30.7 -- with its the link to the OMB bulletin, and the putative authority for the Proposal -- out of whole cloth. This EPA may not do.
[6857-2945] Commenter (6879) notes that EPA rules and regulations have been critical to the protection of wildlife, natural habitats, and the ecosystem services they provide to communities and the economy. This includes protection of wetlands under the CWA.These laws require EPA to use the "best available" science, or all "reasonably available" science and information. By excluding high-quality peer-reviewed and validly published science from the regulatory decision-making process, the proposed regulation directly contravenes the specific mandate of these statutes. And by deliberately excluding the best science available, the rule also contravenes the Congressional mandates for these statutes and undermines their public health and environmental protection purposes.
<IP_ADDRESS> CWA (SNPRM Comments)
Comment [48-1947]: Commenter (12727) notes that the Supplemental Notice adds a reference to the CWA, and amends its references to the CERCLA and RCRA, but these additions provide no additional support or authorization for the proposal.
The references to CWA and CERCLA cite to the general authorities of the EPA Administrator to issue regulations to fulfill the respective requirements of the statutes. These authorities cannot authorize the proposal's efforts to violate those statutes or act beyond the scope of their requirements. Similarly, the cited provision of RCRA contains the Administrator's general authorities to promote research and training, offering no basis for the proposal's requirements or reconciliation of where it may conflict with RCRA's obligations -- even requirements in the very same subsection it presumes to cite for authority.
[48-2184] Commenter (12727) notes that just as EPA is required to consider all available science when making its regulatory decisions, governing environmental and public health statutes likewise require EPA to consider all available science when releasing ISI, which often forms the basis for the agency's regulatory decisions. For example, for the CWA:
 The CWA instructs that EPA's water quality criteria must "accurately reflect[] the latest scientific knowledge" on a variety of factors.
A rule that prohibits EPA from considering (or that downgrades) valid, high quality scientific studies when generating ISI such as the products identified above would contravene the above- noted statutory directives regarding EPA's obligation to consider all available science.
Comment [73-415]: Commenter (11576) writes that in its supplemental notice, the EPA also points to Section 501 of the CWA, a provision that was first referenced in the agency's original proposal. Like Section 115 of CERCLA, Section 501 grants general rulemaking authority, authorizing the administrator "to prescribe such regulations as are necessary to carry out" the agency's functions under the CWA.
For the reasons explained above, and as previously noted, Section 501's general grant of rulemaking authority does not provide support for the proposed rule. Once again, the EPA has failed to explain why the regulation would be "necessary" for implementing the CWA. It plainly is not, as it would rather undermine the EPA's ability to protect public health and the environment by limiting the scientific studies the agency could consider when setting critical limits for toxic pollutants. And the agency has failed to provide any evidence that its current process for reviewing scientific evidence has been failing it. Limiting the science the EPA can rely on would compromise, not help, the agency's ability to "restore and maintain the chemical, physical, and biological integrity of the Nation's waters" -- the very purpose of the CWA. If the proposed rule is finalized, the EPA will undermine its ability to consider what may be the best or only scientific evidence available. The language of Section 501 does not provide authority for rules that are arbitrary and contrary to the statute -- and it accordingly offers no support for the proposed rule.
Comment [81-2188]: Commenter (12715) writes that whether EPA is arbitrarily barring consideration of scientific studies or information with nonpublic underlying data or data that are not able to be independently validated, or arbitrarily ascribing less weight to such studies or information, neither approach constitutes "housekeeping," and neither comports with statutory requirements that EPA use the best available science. To reiterate from the 2018 Comments, EPA's obligation with respect to the use of scientific information is clear: it must base its decisions on such criteria as the latest scientific knowledge, the best available, peer-reviewed science, and/or generally accepted scientific principles or laboratory tests. To cite just a few examples, in performing its duties, EPA must rely on: "the latest scientific knowledge," CWA of 1977, 33 U.S.C. § 1314(a)(1). EPA has repeatedly emphasized the importance of this fundamental precept, including in its 2018-2022 strategic plan, which states that one of the agency's priorities is to "identify, assess, conduct, and apply the best available science to address current and future environmental hazards."
These statutory requirements apply to all aspects of EPA's decision-making, including its scientific evaluations, adoption of regulatory standards, and development of policies. They do not permit what EPA proposes here: to either exclude or give less weight to scientific studies or information based on criteria -- availability of the underlying data and ability to independently validate underlying data -- that are not determinative of whether the studies or information constitute the best available science. Agencies may not adopt or implement regulations that conflict with the statutes under which they are promulgated, and an agency's interpretation of those statutes must always at least be reasonable. See Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 842-44 (1984). Furthermore, neither 5 U.S.C. § 301 nor any other purported housekeeping authority allows EPA to negate these statutes' fundamental, substantive, and common-sense commands. And even assuming EPA has some inherent housekeeping authority, it cannot rely on a general grant of rulemaking authority to promulgate regulations or develop policies that are otherwise inconsistent with more specific statutory directives. Glob. Van Lines, Inc. v. Interstate Commerce Comm'n, 714 F.2d 1290, 1293-97 (5th Cir. 1983).
Finally, EPA acknowledges that the statutes it administers would control in the event of a conflict between the proposed rule and those statutes, see 85 Fed. Reg. at 15,398, but that caveat cannot save the proposed rule. First, the core principle of the proposed rule is facially invalid, i.e., there is no circumstance in which it would be acceptable for EPA to exclude or give less weight to relevant, probative scientific studies, models, or other information that have been validated through peer review, on the sole basis that the underlying data are not publicly available or are not able to be independently validated. EPA cannot save an invalid rule by including what amounts to a waiver procedure, because the "essence of waiver is the assumed validity of the general rule." Alltel Corp. v. Fed. Commc'n Comm'n, 838 F.2d 551, 561 (D.C. Cir. 1988). Second, the agency's essential duty in rulemaking is to exercise its subject matter expertise to enact rules that implement and further the purposes of the statutes Congress has assigned it to administer. Chevron, 467 U.S. at 842-44. This does not include proposing rules without first determining the source of legal authority but instead asking commenters to supply that information. Third, the agency must propose its rules with specificity and be clear as to the programs, regulations, and information to which they will apply. 5 U.S.C. § 553(b)(3); Home Box Office, Inc., supra, 567 F.2d at 35-36.
Comment [82-856]: Commenter (12464) notes that section 501 of the CWA, 33 U.S.C. § 1361, does not authorize the Proposal for the same reasons. First, like Section 115 of CERCLA, Section 501(a) of the CWA only authorizes the EPA administrator to promulgate regulations "as are necessary to carry out his functions under this chapter." 33 U.S.C. § 1361(a). The EPA Administrator's discretion to promulgate regulations is limited by the goal of the CWA to "restore and maintain the chemical, physical, and biological integrity of the Nation's waters." EPA, however, makes no effort to explain why the Proposal is necessary to further the CWA's goals. On the contrary, the Proposal will limit the agency's ability to rely on the best available science in promulgating regulations under the CWA.
Second, the Proposal is contrary to the broader statutory scheme of the CWA. Like many other environmental statutes, the CWA embraces science and seeks to incorporate the best available science into EPA's decision-making. For example, in developing water quality criteria under the CWA, EPA must "accurately reflect[] the latest scientific knowledge." 33 U.S.C. § 1314(a)(1). The Proposal, by arbitrarily blocking EPA from considering relevant scientific studies, is inconsistent with this mandate.
Comment [82-2081]: Commenter (12464) writes that none of the other statutory provisions identified by the Supplemental Notice authorize EPA to promulgate the Proposal. The Supplemental Notice asserts that RCRA Section 8001, 42 U.S.C. § 6981, CERCLA Section 115, 42 U.S.C. § 9615, and CWA Section 501, 33 U.S.C. § 1361, empower EPA to promulgate the Proposal. 85 Fed. Reg. at 15,397. However, there are two major problems with these assertions of statutory authority. First, the Supplemental Notice does not provide any explanation for how these provisions purportedly authorize the Proposal. Second, an examination of the cited provisions demonstrates that they provide no support for the Proposal; indeed, the Proposal would actively hinder, rather than promote, the statutory purposes of RCRA, CERCLA, and the CWA.
Comment [82-2082]: Commenter (12464) argues that the Supplemental Notice makes no effort at all to tie the Proposal to the statutory schemes of RCRA, CERCLA, or the CWA. Instead, it merely asserts that the cited provisions authorize the Proposal without any explanation of how the Proposal relates to the language or purposes of the three statutes. Additionally, both the Initial Proposal and the Supplemental Notice refer to a range of different provisions from different statutes. 83 Fed. Reg. at 18,769; 85 Fed. Reg. at 15,397. EPA must explain how distinct provisions in multiple statutes can authorize the agency to promulgate precisely the same rule for its review of science under all of these schemes, as well as how the Proposal would comply with each statutory scheme.
Comment [82-2083]: Commenter (12464) writes, "[I]t is `axiomatic' that `administrative agencies may act only pursuant to authority delegated to them by Congress.'" None of the cited provisions, however, provide EPA with authority to ignore relevant scientific information. The CWA only authorizes rulemakings that are necessary to achieve the statutes' broader purposes. The Proposal, however, is not related to EPA research or research funding, and will actively hinder EPA's ability to achieve the statutes' underlying goals by limiting EPA's ability to rely on the best available science.
EPA has long accepted that its decisions must be guided by the best available science. For example, in 2002, EPA issued Information Quality Guidelines in which it took the position that the standard set forth in the SDWA -- to use "the best available, peer-reviewed science" -- should apply to all of the agency's risk assessments. EPA even reiterated its commitment to this standard in the Initial Proposal. 83 Fed. Reg. at 18,769. However, the Proposal would directly undermine this longstanding commitment to use the best available science. As we pointed out in a comment letter in response to the Initial Proposal, the Proposal would prevent EPA from relying on crucial studies that underlie a number of past, present, and future regulations. This radical departure from EPA's standard practice cannot be justified by any of the statutes EPA identifies because it is contrary to the goals of those statutes.
Comment [89-2199]: Commenter (11403) writes that EPA's 2018 version of this rule cited a hodgepodge of statutory authority, none of it valid. EPA at least corrected the obvious typographical errors from the previous version. However, those edits still do not grant EPA the authority to restrict science from all regulatory decision-making processes within the agency. EPA is attempting to use general grants of authority to create a completely novel approach to assessing science. However, as the Supreme Court has stated, "Congress . . . does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions -- it does not, one might say, hide elephants in mouseholes." EPA does not have the authority to alter the fundamental details of all of its regulatory schemes based on such vague provisions of law.
As an example, the commenter states that Section 501 of the CWA states, "The Administrator is authorized to prescribe such regulations as are necessary to carry out his functions under this chapter." This catch-all provision provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is "necessary" to carrying out functions under the CWA.
In short, the commenter notes that none of the statutory provisions cited by EPA provide authority for the proposed rule. The proposed rule fails at step one under Chevron v. Natural Resources Defense Council since it is unreasonable to believe that any statutory general grant of authority or any mention of EPA's oversight of other science or research programs would enable EPA to conduct rulemaking in a way that is altogether inconsistent with the rule of law. None of the cited provisions provide the authority sought by EPA, and as such the proposed rule should be withdrawn.
Comment [125-2203]: Commenter (11495) notes that EPA's Supplemental Notice is at odds with provisions of multiple environmental statutes which require the Agency to consider certain high-quality scientific information. The CWA and the CAA require that water and air quality criteria determinations be based on the "latest scientific knowledge."
Each of these provisions directs EPA to incorporate a certain quality of scientific information into its rulemaking decisions made pursuant to the statute. In particular, these requirements are designed to ensure the scientific validity of the information upon which EPA bases its actions. Mandating a high-quality scientific basis for regulatory actions is necessary to guarantee the best possible protections for public health and welfare and to minimize partisan influence in scientific decision-making.
The Supplemental Notice, however, would impermissibly prohibit the agency from considering of relevant and high-quality scientific studies whenever the data underlying the study are not publicly available -- in direct contravention of the statutory directives that mandate, for example, consideration of the "best available science." None of the provisions requires, or even suggests, that EPA only consider information that is publicly available. It strains the plain meaning of words like "best," "latest," and even "appropriate" to suggest that they permit the unscientific requirement that all data be publicly available.
EPA "cannot ignore available . . . information." Courts have held that "best available data" requirements "prohibit[] [an agency] from disregarding available scientific evidence that is in some way better than the evidence [it] relies on." Furthermore, a plaintiff may establish a violation of a "best available science" requirement by "point[ing] to any scientific evidence that the agency failed to consider." The Supplemental Notice would undoubtedly preclude EPA from considering certain studies and scientific information that is "better" or the "best available," simply because the study's underlying data is not publicly available, thereby failing to satisfy Congressional directives and undermining the quality of regulatory decisions.
Likewise, EPA cannot avoid the statutory directives to consider high-quality scientific information simply by assigning a lesser weight to such information when the underlying data are not publicly available, as the Agency alternatively proposes. The Supplemental Notice's alternative proposal is designed to have largely the same pernicious effects as flatly prohibiting consideration of studies lacking publicly available data. Just as with the primary proposal, EPA's alternative proposal would limit the agency's consideration of the best available science in making important regulatory decisions, and is, therefore, arbitrary, and capricious.
The effect of the Proposed Rule is inconsistent with EPA's view that the Supplemental Notice is "intended to be consistent with the statutes that EPA administers and EPA plans to implement this procedural rulemaking in accordance with all applicable statutory and regulatory requirements." EPA attempts to resolve this inconsistency by stating that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." However, as discussed below, EPA lacks the statutory authority to issue a rule this broad, even when it claims that it will avoid statutory conflicts.
Comment [133-1194]: Commenter (11894) writes that the CWA requires states, or, if they default, EPA, to establish "total maximum daily [pollution] loads" for individual water bodies to specify the pollution levels that they can tolerate. About 65,000 such TMDL have been established, mostly by states, but some by EPA. TMDL rest on extensive bodies of scientific information and modeling in several different technical fields. Once again, EPA has completely failed to even specify whether or not its new requirements would apply to this program.
The question whether these new requirements would apply to TMDL raises a fundamental issue that goes far beyond the TMDL program itself. Perhaps the new requirements would not apply to EPA-issued TMDL because of the specific regulatory language exempting EPA actions. But would they apply to the extensive technical guidance that EPA issues to states on how to write TMDL? And if they did, how could EPA exempt its own requirements from the same standards?
These questions are relevant, not just to the TMDL program, but to the entire structure of "cooperative federalism" under several EPA statutes. They would apply, for example, in almost exactly the same form, to permit decisions under the CWA or to permit and state implementation plan decisions under the CAA. Typically, under each of these statutes, EPA issues extensive technical guidance to state programs even though they retain the power to make regulatory decisions. Yet EPA's proposal does not mention this issue in any way. Nor does it discuss the impact of these new requirements on the TMDL program or how the agency might address them.
Comment [133-1238]: Commenter (11894) notes that the CWA requires each state to develop TMDL for every waterbody the state identifies as having uses impaired because of pollution. The objective of the TMDL is to determine the pollutant loading capacity of the waterbody and to allocate that load among the pollutant sources so that the appropriate control actions can be taken to achieve the state's water quality standards. States are responsible for developing TMDL and submitting them to EPA for approval. Even if a third party develops the TMDL with a proprietary model, the state is responsible for submitting that TMDL to EPA. If EPA disapproves a state TMDL, EPA must develop a replacement TMDL. TMDL are developed using a range of techniques from simple mass balance calculations to complex fate and transport mathematical models. To date, over 65,000 TMDL have been developed and approved for use in regulating point sources of pollution and controlling pollutant discharges from nonpoint sources. If the final science transparency rule applies retroactively to ISI, every one of the TMDL will have to be re-examined. If the model underlying a TMDL fails to meet the new tests of transparency and reproducibility, the enforceability of the state's point source permit limits and nonpoint source controls based on that TMDL will be undermined. If the science transparency rule applies only prospectively to new TMDL, EPA will need to disapprove any new TMDL based on a proprietary model since such a model would not meet the new transparency and reproducibility requirements. Whether the science transparency rule applies retroactively or prospectively, EPA will incur significant costs and time replacing TMDL. Despite this major impact, the supplemental notice provides no estimation of the costs and benefits.
Comment [159-1414]: Commenter (12430) notes that the SNPRM cites to one additional CWA provision  -  33 U.S.C. section 1361. The most arguably relevant subdivision simply states that "[t]he Administrator is authorized to prescribe such regulations as are necessary to carry out his functions under this chapter." It does not address the use of science, and the SNPRM fails to explain how the proposed regulation would be "necessary to carry out" the CWA, particularly when another section of the Act requires that water quality criteria "accurately reflect[] the latest scientific knowledge."
Comment [159-2091]: Commenter (12430) writes that in the SNPRM, U.S. EPA proposes to consider only (or, in the alternative, more heavily weight) studies and models with publicly available data. However, restricting agency consideration of scientific studies and models would run afoul of U.S. EPA's obligations under many of its operating statutes to rely on the best available science. For example, The CWA requires that water quality criteria "accurately reflect[] the latest scientific knowledge."
Comment [161-1464]: Commenter (12434) writes that the Proposal directly conflicts with requirements under the core federal environmental laws, each of which requires that decisions be made using the "best available science" or some similar restriction. By requiring that publicly available data be prioritized over other scientific data, regardless of any other merits, the EPA is arbitrarily constrained and will be unable to comply with the statutory requirements to meet the "best available science."
The CWA, for example, requires that the EPA develop water quality criteria "accurately reflecting the latest scientific knowledge." 33 U.S.C. § 1314(a)(1). In fact, throughout the CWA, the Agency is required to look at a broad range of scientific information when promulgating the numerous regulatory decisions, it entails. When reviewing states' water quality standards, the EPA must review any submitted "general information which will aid the Agency in determining the adequacy of the scientific basis of the standards." 40 C.F.R. § 131.6(f). The CWA does not limit the review of this information and other scientific information by whether the data set is publicly available anywhere in the statute. In fact, given that many of these regulatory decisions directly consider "public health or welfare," such as is the case for water quality standards, 33 U.S.C. § 1313(c)(2)(A), it is possible that the relevant scientific studies include data sets that are not fully publicly available because of public health data involved. The Proposal does not provide any such justification, beyond a stated intent of transparency, as to why a robust, and even peer-reviewed, scientific study that reflects the "latest scientific knowledge" could be insufficient or even ignored when making such critical decisions such as the establishment of water quality standards.
Public health data, most vulnerable to the Proposal's exclusions, are used for the development of water quality standards, which are critical for protecting the health of communities in the Long Island Sound region. For example, NYC has developed a Long-Term Control Plan in order to reduce combined sewer overflow events. The success of the Long-Term Control Plan is matched against New York State's water quality standards. If the latest scientific knowledge is not used when establishing these water quality standards because of confidential public health data sets, then NYC might work towards an inadequate standard that is not properly protective of public health, a serious consideration when speaking of the frequent overflow of raw sewage into local waterways during storm events.
Comment [187-1703]: Commenter (12720) notes that EPA cites sections 104, 33 U.S.C. § 1254, and 501, 33 U.S.C. § 1361, of the CWA as putative authority for the Proposal. Nothing in these sections authorize the Proposal's limitations on scientific evidence.
With respect to section 104, the Proposal tellingly fails to specify which of its 22 subsections supposedly supports the restrictions EPA has proposed. This deficiency reflects a lack of authority for the Proposal in section 104. And even if EPA thinks that it can cobble together language in section 104 to support the Proposal, the agency's complete failure to identify in the Proposal how section 104 authorizes this rulemaking means that EPA did not provide sufficient notice for the public to comment on the Proposal.
None of the subsections in section 104 states or suggests that, in promulgating regulations under the CWA, EPA may limit its consideration of "regulatory science underlying its actions" to studies or analyses that "are publicly available in a manner sufficient for independent validation." See 83 Fed. Reg. at 18,773 (proposed § 30.5) (and modified at 85 Fed. Reg. at 15,402). To the contrary, several subsections indicate that Congress intended EPA to consider available scientific evidence in order to carry out the Act.
First, subsection (b) authorizes EPA to collect and publicize results and information related to studies about water pollution but does not say anything about limiting consideration of science simply because data cannot be made public, either as part of rulemakings or otherwise. Nor does it draw any distinction between dose-response data and other types of data.
Second, subsection (c) directs EPA to "conduct research on, and survey the results of other scientific studies on, the harmful effects on the health or welfare of persons caused by pollutants." It provides no authority whatsoever for limiting consideration of studies, models or data, dose-response or otherwise, during rulemakings; indeed, by directing EPA to "survey the results of other scientific studies," rather than the publicly-available dose-response data underlying those results, this subsection contradicts the Proposal's (and Supplemental Proposal's) limitations and conditions.
Third, subsection (l)(1) indicates that EPA should be inclusive with respect to considering evidence, as it directs EPA to "develop and issue to the States for the purpose of carrying out this Act the latest scientific knowledge available in indicating the kind and extent of effects on health and welfare which may be expected from the presence of pesticides in the water in varying quantities. He shall revise and add to such information whenever necessary to reflect developing scientific knowledge."
Fourth, subsection (n) directs EPA to cooperate with various entities to "conduct and promote, encourage contributions to, continuing comprehensive studies of the effects of pollution, including sedimentation, in the estuaries and estuarine zones of the United States on fish and wildlife, on sport and commercial fishing, on recreation, on water supply and water power, and on other beneficial purposes." Importantly, subsection (n)(2) reveals Congress's intention that EPA will consider information broadly, by instructing the agency to "assemble, coordinate, and organize all existing pertinent information on the Nation's estuaries and estuarine zones. . ."
EPA also cites 33 U.S.C. § 1361 as a basis for the Proposal, but it does not provide the agency with the authority it desires. Subsection (a) merely states that the "Administrator is authorized to prescribe such regulations as are necessary to carry out his functions under this chapter." As explained above, that general grant of authority cannot support the rule, especially when the rule conflicts with the Act. Moreover, EPA casually invokes this provision, but does not make any effort to justify the proposed restrictions as necessary to any particular CWA statutory function, so it has not made the case that this provision provides authority to adopt the Proposal's limits.
The Act contains other indications that Congress intended EPA's consideration of science to be inclusive. In particular, section 304(a)(1) of the Act states:
The Administrator, after consultation with appropriate Federal and State agencies and other interested persons, shall develop and publish, within one year after the date of enactment of this title (and from time to time thereafter revise) criteria for water quality accurately reflecting the latest scientific knowledge (A) on the kind and extent of all identifiable effects on health and welfare including, but not limited to, plankton, fish, shellfish, wildlife, plant life, shorelines, beaches, esthetics, and recreation which may be expected from the presence of pollutants in any body of water, including ground water; (B) on the concentration and dispersal of pollutants, or their byproducts, through biological, physical, and chemical processes; and (C) on the effects of pollutants on biological community diversity, productivity, and stability, including information on the factors affecting rates of eutrophication and rates of organic and inorganic sedimentation for varying types of receiving waters.
As the italicized language above reveals, Congress refused to limit EPA's consideration of available evidence in discharging one of its core functions aimed at protecting the nation's waters. EPA provides no reason in the Proposal why the any other action under the CWA the Proposal targets should be any different.
1.3.8 National Environmental Policy Act (NEPA) (SNPRM Comments)
Comment [Comment 20-1294]: Commenter (10753) cited comments as stating that NEPA requires preparation of an Environmental Impact Statement (EIS) before EPA adopts the Rule and/or the SNPRM. This is especially true because the SNPRM expressly extends the Rule's coverage to rules and models that may not have been otherwise covered. EPA states:
      This SNPRM proposes that the scope of the rulemaking apply to ISI as well as significant regulatory decisions. This notice proposes definitions and clarifies that the proposed rulemaking applies to data and models underlying both pivotal science and pivotal regulatory science. In this SNPRM, EPA is also proposing a modified approach to the public availability provisions for data and models that would underly significant regulatory decisions and an alternate approach. Finally, EPA is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.
      https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-9322
Put another way, by expanding the Rule's reach, the SNPRM requires an EIS more (and a more thorough EIS) than does the Rule by itself.
Response: NEPA does not apply to this rulemaking because the rule is not a "major Federal action significantly affecting the quality of the human environment." NEPA section 102(2)(c); 42 USC § 4332(2)(c). The rule is one of internal agency procedure that describes the consideration the agency will give to studies based on data availability and the factors EPA uses to evaluate studies that may be used for regulatory purposes and ISI and, as such, will not affect the quality of the human environment.
Comment [Comment 89-814]: Commenter (11403) states that section 7(a)(2) of the ESA requires that "each federal agency shall, in consultation with and with the assistance of the Secretary, insure that any action authorized, funded, or carried out by such agency is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of habitat of such species which is determined by the Secretary . . . to be critical." Under the Services' joint regulations implementing the ESA, EPA is required to review its actions "at the earliest possible time" to determine whether the action may affect listed species or critical habitat. EPA must initiate consultation under Section 7 whenever its action "may affect" a listed species or critical habitat. The phrase "may affect" has been interpreted broadly to mean that "any possible effect, whether beneficial, benign, adverse, or of an undetermined character, triggers the formal consultation requirement." Because this proposed rule would prevent EPA from utilizing the best available science, EPA would be unable to sufficiently determine if one of its decisions, regulations, or policies would harm a threatened or endangered species or its critical habitat. EPA must at a minimum engage in a programmatic consultation with the services to determine if this action is likely to adversely affect endangered species.
While some of EPA's actions are exempt from the NEPA, this proposed rule is clearly not exempt. By EPA's own tortured logic, this proposal encompasses virtually every aspect of EPA's statutory mandate, and most of these still fall under the ambit of NEPA. Accordingly, the EPA must prepare an EIS for the proposed rule because the net effect of the changes to the existing regulations will mean more environmental harm due to delayed decisions, under-regulation of harmful pollutants, and the rejection of the best available science. By every definition, this will have a massive impact on the human environment and therefore requires review under NEPA.
NEPA requires every federal agency to prepare an EIS for all "major Federal actions significantly affecting the quality of the human environment." EPA may forego a NEPA analysis only if a categorical exclusion applies, and EPA has not indicated that it believes a categorical exclusion applies. If EPA does indeed believe that one applies, EPA must provide the public with notice and the opportunity for the public to provide comment. If EPA does not believe that a categorical exclusion applies, EPA must at the very least elect to first complete an Environmental Assessment (EA) to determine if an EIS is needed or complete a full EIS. It is highly likely, if not a certainty, that this proposal will have negative environmental impacts. A "reasonable person" reviewing this proposal could only conclude that the proposal is designed to weaken and hamstring EPA's ability to properly regulate harmful pollutants, resulting in significant harm to human health and environmental quality. Therefore, a finding of no significant impact from an EA would be highly suspect and would almost certainly be arbitrary and capricious. EPA must prepare a complete EIS on this proposed rule and provide a reasonable period to provide public comment consistent with the requirements of NEPA.
Response: An ESA section 7(a)(2) consultation is not required for this rule because it does not affect listed species or critical habitat. Further, contrary to the commenter's assertion, the rule does not prevent EPA from using the best available science. The rule is one of internal agency procedure that describes the consideration the agency will give to studies based on data availability and the factors EPA uses to evaluate studies that may be used for regulatory purposes and ISI.
See response to Comment 20-1294 regarding NEPA applicability.
1.3.9 Other Environmental Statutes (NPRM Comments)
Comment [37-32]: Commenter (0046) writes that EPA must also submit its proposal to the Science Advisory Board pursuant to the requirements of 42 U.S.C. §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 (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 SAB approval for any final action. See H. Rep. No. 95-722 (95th Cong. 1st Sess. (1977) (Conference Report).
Response: EPA sought SAB review of aspects of the proposed rule and received the SAB's comments on April 24, 2020. See https://yosemite.epa.gov/sab/sabproduct.nsf/2DB3986BB8390B308525855800630FCB/$File/EPA-SAB-20-005.pdf.
Comment [993-4238]: Commenter (1008) states that they are in favor of all federal agencies promoting public access to research results, including to the data supporting research conclusions that inform regulatory decisions. Commenter further appreciates the previous Administration's memorandums and orders that require federal agencies to make their data publicly accessible (e.g. Increasing Access to the Results of Federally Funded Scientific Research" - OSTP Memo Feb 22, 2013, "Open Data Policy-Managing Information as an Asset" - OMB Memo M-13-13). However, no agency (including the EPA), in its push towards research transparency and public access to research data, should compromise or disregard its Congressional mandated mission.
Response: EPA intends to implement this rule consistent with its mission to protect human health and the environment. Implementation of the final rule will not result in EPA compromising or disregarding its mission.
Comment [1320-4331]: Commenter (1335) notes that there may be articles in the EPA legislation, such as those cited in the proposed Rule, which exhort the EPA to use the best science available to reach regulatory conclusions, but the overarching intent and thrust of the Environmental Protection Act is to actually protect the environment. It would be extremely unwise to weaken the ability of the EPA to protect the environment to the best of its ability, to protect Americans from pollution and climate change (whatever the cause). In fact, any effort to thwart that central intent of the Act by the Agency must be in its core illegal.
Response: The Agency has no knowledge of the Environmental Protection Act referenced by the commenter. The final rule does not rely on or interpret the substantive environmental statutes that EPA cited in the 2018 and 2020 proposals. EPA's implementation of this rule will not weaken the Agency's ability to protect human health and the environment. The EPA is issuing this final rule to help strengthen the transparency of the dose-response data underlying certain EPA actions. As EPA states in the preamble, "codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the public's access to the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety."
Comment [1412-4472]: Commenter (1427) writes that the proposal asserts existing statutes and regulations governing the application of science in regulatory processes burden EPA, constrain its ability in the fulfillment of its mission where it must forthrightly (transparently) interface with the public. EPAs proposed remedies include weakening its duty to comply with legal, i.e., statutory and regulatory, and ethical obligations; defining new sciences unique to EPA administration; and assigning new authorities to non-scientist administrators to referee determinations that science applied to EPA regulations is valid and credible. Such remedies should be rejected.
Response: EPA disagrees with the commenter's assertion that the statutes and implementing regulations constrain EPA in the manner described by the commenter. EPA states clearly in § 30.3, that were there are conflicts between this rule and the substantive provisions of the statutes and regulations the Agency administers, this rule will yield. EPA is relying on its housekeeping authority to promulgate this purely procedural rule. It is well within the authority of the Administrator to develop procedures that govern the internal affairs of the Agency. See the response to Comment 31-135. The rule includes reasonable factors for the Administrator to consider when deciding whether to exempt a study from the rule requirements.
Comment [2322-157]: Commenter (2337) urges EPA not to finalize the Proposed Rule. The Proposed Rule is inconsistent with EPA's statutory mandate under various environmental laws to use the best available scientific data to protect public health and welfare and the environment.
Response: EPA disagrees that the final rule is inconsistent with its statutory mandates. EPA intends to continue relying on the high-quality studies to support its significant regulatory decisions and influential scientific information. See response to Comments 1320-4331 and 1412-4472.
Comment [2322-159]: Commenter (2337) expresses that the Proposed Rule requires that underlying data supporting scientific studies concerning the environmental or health impacts of pollutants be made publicly available for independent validation in order for EPA to use such data in making regulatory decisions. The Proposed Rule further provides that EPA will conduct independent peer review on all data it uses to justify its regulatory decisions. While commenter supports EPA's goal of basing its rulemaking on the strongest scientific evidence possible and fostering transparency, they are concerned that the Proposed Rule unduly limits the scientific data EPA can consider and conflicts with EPA's statutory obligations.
Response: The final rule does not prevent the agency from considering any particular studies. Nor does the rule authorize violations of the statutes and regulations. EPA will not categorically exclude any studies from consideration when promulgating significant regulatory decisions or developing influential scientific information. EPA has explained that this procedural rule has limitations on its scope in terms of conflicts with other substantive requirements and that, in situations where this rule applies, EPA will give greater consideration to those studies where the underlying dose-response data are available for independent validation. That means that the agency will consider all relevant studies when taking covered actions.
The final rule does not require EPA to conduct independent peer review of all the studies it uses to justify regulatory decisions. Section 30.6 provides, in pertinent part, that the "EPA shall conduct independent peer review consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review and the exemptions described therein. The EPA will evaluate whether or not to conduct additional peer review of individual studies identified as pivotal science if the studies have already undergone peer review." If adequate peer review has occurred under those guidelines, additional peer review may not be warranted.
Comment [2322-161]: Commenter (2337) writes that this repeated statutory requirement that EPA use the "latest," "best available," and "peer-reviewed" science conflicts with EPA's proposal to use only publicly available scientific data. None of the environmental statutes restrict reliable scientific evidence to studies where all underlying data has been made publicly available. Indeed, there are many reasons why data cannot, or cannot easily, be made public, including privacy and individual confidentiality concerns, particularly when related to personal health information. All high quality scientific research, regardless of the public availability of its raw data, should equally be used by EPA in establishing regulatory standards. Were EPA to reject otherwise reliable epidemiological or similar health evidence because underlying data could not be made available without violating privacy or confidentiality, EPA would not be using "the latest scientific knowledge" or "the best available peer reviewed science" in violation of its statutory obligations. Further, EPA would be ignoring data that would ensure its ability to meet its obligations to establish standards protective of public health, with "an adequate margin of safety."
Response: The final rule does not restrict EPA to using only publicly available scientific data. Additionally, the final rule does not categorically exclude any relevant studies from consideration. EPA will evaluate and weight studies determined to be pivotal science, using the criteria in § 30.5, which will allow all high-quality studies to be factored into the agency's development of significant regulatory decisions and influential scientific information. Also see the response to Comments 1320-4331, 1412-4472 and 2322-159.
Comment [2322-205]: Commenter (2337) contends that the Proposed Rule's provisions allowing data to be made public in controlled processes (section 30.5) and EPA to grant exemptions to the rule's requirements (section 30.9) do not resolve the rule's inconsistencies with environmental statutes. Where all underlying data cannot be made publicly available, the Proposed Rule requires the Administrator to make a case-by-case determination whether to exempt the data from disclosure requirements. This exemption will not ensure that EPA considers the latest or best available data, lacks consistent standards, and in any event will likely be difficult and time consuming to administer.
Response: EPA states clearly in § 30.3, that were there are conflicts between this rule and the substantive provisions of the statutes and regulations the Agency administers, this rule will yield. The final rule does not categorically exclude any relevant studies from consideration. See response to Comments 2322-159 and 2322-161.
EPA disagrees that the exemption provision lacks consistent standards. The final rule includes reasonable factors for the Administrator to consider when deciding whether to exempt a study from the rule requirements. The additional procedures required by this rule only apply to pivotal science, which is a subset of the total number of studies that the EPA would evaluate. Given the current robust process for identifying and reviewing scientific studies and documentation that are existing Agency practice, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions and influential scientific information, the EPA disagrees that implementation will be difficult or time-consuming.
Comment [2412-206]: Commenter (2427) writes that EPA's proposed rule that claims to strengthen transparency in science supporting regulations, would in fact prevent the Agency using the best available science  -  and therefore would keep EPA from complying with environmental laws.
Response: See response to Comments 2322-159 and 2322-161.
Comment [2772-2255]: Commenter (2787) argues that the proposed rule suffers from significant procedural flaws including lack of supporting evidence, insufficient detail in the proposal itself, and conflicts with EPA's statutory obligations.
Response: EPA disagrees that the final rule suffers from significant procedural flaws. See responses to comments in RTC section 1.5.
Comment [3117-104]: Commenter (3132) asserts that the proposal is void ab initio because the EPA has violated the National Environmental Policy Act. This is because the EPA is preparing the proposed rule without first preparing the necessary Environmental Impact Statement. See generally, NE_PA. With a few strictly limited exceptions, NEPA's Environmental Assessment and EIS requirements apply to EPA action. 40 CFR §6:204. Obviously, none of the exceptions apply here and any rational Environmental Assessment would find an EIS necessary. See generally CFR §§6:200-210.
Response: NEPA does not apply to this rulemaking because the rule is not a "major Federal action significantly affecting the quality of the human environment." NEPA section 102(2)(c); 42 USC § 4332(2)(c). The rule is one of internal agency procedure that describes the consideration the agency will give to studies based on data availability and the factors EPA uses to evaluate studies that may be used for significant regulatory actions and influential scientific information and, as such, will not affect the quality of the human environment.
Comment [3118-3141]: Commenter (3133) suggests that the proposal is void ab initlo because the EPA has violated the NEPA. This is because the EPA is preparing the proposed rule without first preparing the necessary Environmental Impact Statement. NEPA. With a few strictly limited exceptions, NEPA's Environmental Assessment and EIS requirements apply to EPA actions. 40 CFR §6:204. Obviously, none of the exceptions apply to the proposal and any rational EA would find an EIS necessary. See generally 40 CFR §§6:200-210.
Response: See response to Comment 3117-104.
Comment [4831-2080]: Commenter (4842) states that there is no basis in existing bedrock environmental laws that authorizes EPA to limit science considered in rulemaking processes. EPA cites several foundational environmental laws as a justification for this proposal. 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, this proposal undermines the use of best available science called for in environmental statutes including the Clean Air Act. Further, there is no basis for politically appointed administrators to choose which science will be considered and which may not be.
Response: The final rule does not rely on or interpret the substantive environmental statutes that EPA cited in the 2018 and 2020 proposals. Also see response to Comments 1412-4472 and 2322-205.
Comment [4832-283]: Commenter (4843) contends that this mandate directly undermines the agency's mission to protect health and human safety by purposefully creating more bureaucratic red tape to potentially prevent peer-reviewed scientific studies from having an effect on policy, without limiting the exposure of study participants. It works to undermine the scientific community as a whole by limiting the scope, type, character, and data from having any effect on policy unless researchers follow an arbitrarily limited state mandated and controlled scientific study format.
It is up to the agency to hire qualified people to read and interpret the most up to date science, to judge its value, and make recommendations based off the broader research as a whole to define and quantify potential hazards in the environment. This is a part of the EPA's core mandate and any decision that hinders it will directly increase the risk to everyone that the agency is sworn to protect. The mandate of the agency supersedes the current political climate.
Response: EPA disagrees that the final rule will undermine the Agency's mission. See the response to Comments 1320-4331 and 2322-205.
Comment [4868-4076]: Commenter (4879) suggests that given that there is no non-frivolous argument that any categorical NEPA exclusion could apply (see commenter's attached joint comment dated May 24, 2018), an EIS that fully discloses the environmental impact of the proposal is required by NEPA.
Response: See response to Comment 3117-104.
Comment [4873-2103]: Commenter (4884) asserts that EPA governance is not meant to be a profitable enterprise. It is meant to serve the public interests in good health and environmental quality. The Clean Air, Pure Waters, Toxic Substances Control, Resource Recovery, and Hazardous Waste laws all direct EPA to use the best science to achieve these ends without regard to cost. Why should EPA consider clean air cost free? Dirty air imposes poor health that the public must suffer and pay for. Dirty air soils clothes and buildings. Acidic deposition dissolves infrastructure, kills biota, and diminishes visibility. These impairments are costs to the public and the planet that cradles our lives and lively hood.
Response: Nothing in the final rule requires EPA to consider costs in a manner inconsistent with statutory requirements.
Comment [5153-4079]: Commenter (5164) writes that their letter adds to the abundant evidence that the NEPA requires the preparation of a proper EIS before the regulation can be adopted.
Response: See response to Comment 3117-104.
Comment [5170-382]: Commenter (5181) notes that the Administration is currently engaged in a multi-year effort to streamline NEPA and recommends that the proposed rule not undermine that initiative either by excluding information that does not meet the requirements or by requiring more time for the required transparency standards to be met.
Response: Nothing in the final rule is related to the Administration's efforts to streamline NEPA. This is a rule of internal agency procedure that applies only to EPA.
Comment [5410-4088]: Commenter (5421) states that EPA's success and the success of the existing regulations in handling RCRA problems with current scientific studies (studies that EPA would be compelled to ignore under the proposed regulation) provides further evidence that NEPA requires EPA to prepare a thorough EIS before it adopts the proposed regulation. Adopting the regulation without an EIS would violate NEPA.
Response: EPA disagrees that NEPA applies to this rulemaking. See response to Comments 3117-104, 2322-159 and 2322-161.
Comment [5865-695]: Commenter (6111) contends that the proposed rule would prohibit the continued and future use of these studies by EPA thereby obstructing EPA's statutory duty to consider the "best," "reasonably" available information in its decision-making processes. The resulting information vacuum would occur for no other reason than that the underlying human subject data is private and cannot be publicly disseminated.
Response: See response to Comments 1320-4331, 2322-157, 2322-159, 2322-161, 2322-205 and 5410-4088.
Comment [5985-4090]: Commenter (5995) suggests that even assuming arguendo that a non-frivolous scientific argument in favor of the proposed regulation could be made, the NEPA requires the preparation of a proper EIS before the proposed regulation can be adopted.
As the agency necessarily concedes, EPA has responsibility to prepare its own NEPA documents for compliance . https://www.epa.gov/nepa Significantly, EPA regulations also expressly recognize that NEPA compliance is necessary if [t]he proposed action is known or expected to cause significant public controversy about a potential environmental impact of the proposed action. 40 C.F.R. Sect. 6.204(b)(8), https://www.ecfr.gov/cgi-bin/text-idx?SID=e62b352cfd49343307deaef7f6cdc0db&mc=true&node=se40.1.6_1204&rgn=div8 (stating that, in such circumstances, a categorical NEPA exclusion is not applicable). In the present case, EPA must prepare a thorough EIS before it adopts the proposed regulation.
Response: EPA disagrees that NEPA applies to this rulemaking. See response to Comment 3117-104.
Comment [6093-543]: Commenter (6103) writes that commenters with legal expertise may note that there is no basis in the cited statutes for demanding access to raw data.
Response: Nothing in the final rule requires EPA to demand access to raw data. The rule does not require EPA to obtain dose-response data from researchers nor does it require researchers to submit dose-response data to the Agency. EPA has explained that the Agency will give greater consideration to studies where the underlying dose-response data are available for independent validation. Also note that the Agency is not relying on any of the environmental statutes cited in the proposal as legal authority for the final rule.
Comment [6097-3146]: Commenter (6107) writes that by purporting to limit EPAs consideration of important data, the proposed rule would cripple EPA efforts to comply with NEPA.
Response: EPA disagrees that NEPA applies to this rulemaking. Also see response to Comments 2322-159 and 3117-104.
Comment [6099-563]: Commenter (6109) notes that EPA states "the best available science must serve as the foundation of EPA's regulatory actions," citing Executive Order No. 13563. EPA could have also cited multiple laws that already mandate EPA's use of "best available science," including the TSCA and SDWA. According to the U.S. 10th Circuit Court of Appeals decision in Ecology Ctr., Inc. v. U.S. Forest Service., (451 F.3d 1183, 1194 (10thCir. 2006)), "best available science" means that agencies "should seek out and consider all existing scientific evidence relevant to the decision" and "cannot ignore existing data." EPA is proposing precisely the opposite and providing for itself a mechanism by which the agency could ignore existing data and turn a blind eye to existing scientific evidence.
Response: See response to Comments 2322-159 and 2322-161.
Comment [6102-480]: Commenter (6112) writes that the objectives are consistent with EPA's authority under numerous statutes that emphasize the need for sound science and public participation in regulatory decisions.
Response: EPA appreciates your comment in support of the final rule.
Comment [6103-516]: Commenter (6113) states that by forcing EPA to ignore such private (and appropriately non-public) data, the proposed anti-environment rule is fiendishly calculated to block the EPA staff from considering the best data available. This scheme has at least three devastating flaws.
First, the proposed rule will nonsensically bar EPA from considering the best scientific data available disabling EPA rulemaking. This rule would violate the agency's common sense and statutory duty to consider the sound scientific data.
Response: See response to Comments 2322-159 and 2322-161.
Comment [6105-520]: Commenter (6115) writes that the objectives are consistent with EPA's authority under numerous statutes that emphasize the need for sound science and public participation in regulatory decisions.
Response: EPA appreciates your comment in support of the rulemaking.
Comment [6107-4015]: Commenter (6117) provides that the EPA has already embarked on a well-thought-out plan to require and promote research transparency, as described in the EPA's 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research ("Plan"). Although the preamble to the proposed regulation cites and "applies concepts and lessons learned" from the Plan, there are some concerning differences.
First, the Plan indicates that it does not apply to "scientific research data collected before its implementation." In contrast, the preamble and the proposed regulation suggest that the regulation may apply retrospectively:
      ...EPA seeks comments on how the prospective or retrospective application of the provisions for dose response data and models or pivotal regulatory science could inadvertently introduce bias regarding the timeliness and quality of the scientific information available.
The commenter does not recommend any retroactive application of this regulation. It is well established that agency rules cannot be applied retroactively unless Congress expressly granted the agency that power. There is no specific grant of power to apply this proposed regulation retroactively. Moreover, the two bills upon which this proposed regulation is modeled, the Honest and Open New EPA Science Treatment (HONEST) Act of 2017 (H.R. 1430  -  115th Congress, 2017-2018), and the Secret Science Reform Act of 2015 (H.R.1030  -  114th Congress 2015-2016), were not enacted.
Response: This rule does not change any existing EPA regulations. It only applies prospectively to significant regulatory actions and influential scientific information, based on dose-response data, that are developed after the effective date of the rule. However, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created.
Comment [6112-1605]: Commenter (6137) states that not only does the Proposed Rule contravene the statutes upon which EPA relies as statutory authority, but its limitations on science likewise conflict with core provisions of other environmental statutes. For example, the Food Quality Protection Act ("FQPA"), which regulates pesticide residue in conjunction with FIFRA, sets safety standards based on the consideration of all available data. Limiting the data available to conduct studies necessary to evaluate the harmful effects of pesticides runs counter to this mandate.
Specifically, the commenter notes that Congress overhauled our food safety laws when it unanimously passed the FQPA, amending both the Federal Food, Drug, and Cosmetics Act ("FFDCA") and FIFRA. The overhaul responded to a seminal 1993 National Academy of Sciences ("NAS") report criticizing EPA for treating children like "little adults" by failing to address the unique susceptibility of children to pesticide exposures based on the foods they eat, their play, metabolism, and sensitive stages of their development. NAS, Pesticides in the Diets of Infants and Children (1993). The NAS recommended that EPA revamp and strengthen its pesticide regulations to account for children's vulnerabilities, consumption patterns, and exposures. Because it would take time to fill gaps in knowledge, safeguards and methodologies, the NAS recommended that additional protection be afforded in the form of "uncertainty" or "safety factors." The NAS first described how EPA has regularly used uncertainty factors and then proposed an additional uncertainty factor for fetal developmental toxicity and where data are incomplete: "In the absence of data to the contrary, there should be a presumption of greater toxicity to infants and children. To validate this presumption, the sensitivity of mature and immature individuals should be studied systematically to expand the current limited data base on relative sensitivity." Id.
The FQPA strengthened the food safety standard in several ways. First, under the FQPA, the EPA Administrator "may establish or leave in effect a tolerance for a pesticide chemical residue in or on food only if the Administrator determines that the tolerance is safe. The Administrator shall modify or revoke a tolerance if the Administrator determines it is not safe." 21 U.S.C. § 346a(b)(2)(A)(i). In other words, the absence of sufficient information to find a pesticide safe means it cannot be allowed in or on our food.
Second, safe "means the Administrator has determined there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information." Id. § 346a(b)(2)(A)(ii). The FQPA, therefore, requires that EPA conduct an assessment based on aggregation of all exposures to a pesticide whether from eating foods, drinking water with residues of the pesticide, or uses of the pesticide in and around the home or other places where people can be exposed. 21 U.S.C. § 346a(b)(2)(A)(ii), (C)(i)(I) & (ii). The FQPA also requires EPA to assess and protect against unsafe risks posed by cumulative exposures to pesticides that share a "common mechanism of toxicity," as is the case with pesticides in the organophosphate, carbamate, and pyrethroid families. See 21 U.S.C. § 346a(b)(2)(C)-(D).
Third, EPA must make specific safety determinations for infants and children. Id. § 346a(b)(2)(C)(ii)(I) & (II). It must consider available information concerning "the special susceptibility of infants and children," including "neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals." Id. § 346a(b)(2)(C)(i)(II). EPA must also base its tolerance decisions on available information about food "consumption patterns among infants and children." Id. § 346a(b)(2)(C)(i)(I) & (III).
Fourth, EPA must account for children's sensitivities, scientific uncertainty, and gaps in available data. The statute requires that "an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre -and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children." Id. § 346a(b)(2)(C). EPA can depart from this requirement and use a different margin of safety "only if, on the basis of reliable data, such margin will be safe for infants and children." Id.; see Nw. Coal. for Alts. to Pesticides v. EPA, 544 F.3d 1043, 1046 (9th Cir. 2008) (reversing EPA's shrinkage of the safety factor in the absence of supporting data).
As an over-arching mandate, the FQPA directs EPA to make its tolerance determinations based on its assessment of the pesticide's risk. 21 U.S.C. § 346a(b)(2)(C)(i). And throughout its mandates to assess the full effects of a pesticide, the FQPA directs EPA to base its risk assessment on "available information" about consumption patterns, special susceptibility of infants and children, and cumulative effects. Id. The FQPA also expressly directs EPA to consider the validity, completeness, and reliability of the available data from studies, the nature of the toxic effect, available information about the relationship between study results and human risk, and available information about aggregate and cumulative effects. Id. § 346a(b)(2)(C)(ii).
The Proposed Rule upends these mandates by requiring EPA to put on blinders and ignore a huge and important subset of the available data. It collides squarely with the congressional direction to consider all available data and information in order to protect our food and children in particular. It also conflicts with the congressional mandate to afford greater protection to children and our food when gaps in data prevent a full quantitative assessment and establishment of a dose-response. It thus undermines EPA's ability to carry out its obligations under the FQPA.
Response: EPA disagrees that the final rule will undermine EPA's ability to comply with the FQPA. See response to Comments 1320-4331, 1412-4472, and 2322-159.
Comment [6112-4017]: Commenter (6137) notes that EPA also requested "comment on how the prospective or retrospective application of the provisions for dose response data and models or pivotal regulatory science could inadvertently introduce bias regarding the timeliness and quality of the scientific information available." 83 Fed. Reg. at 18,772. Like much of the rest of the Proposal, it is unclear what exactly EPA is asking or suggesting. Certainly, to the extent EPA uses the Proposed Rule to exclude important, valid scientific information, it will bias the quality of the scientific information available.
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 Clean Air Act 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 Clean Air Act § 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 Clean Air Act 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.
Even if EPA had statutory authority to apply the Proposed Rule retroactively, it could not do so rationally. See Sierra Club, 285 F.3d at 68 (if EPA had authority to implement a rule retroactively, "retroactivity must be `reasonable,'"). Indeed, retroactive application of the Proposed Rule would undo well-settled rules in a tremendously unfair and irrational way, and would lead to widespread confusion about countless environmental and public health policies and protections.
Response: See response to Comment 6107-4015.
Comment [6127-2240]: Commenter (6152) states that the proposal is also neither required nor authorized under any statute that authorizes the EPA. Commenter strongly urges EPA to withdraw this proposed rule.
Response: EPA disagrees that it lacks authority to promulgate this rule. See the response to comment 31-135.
Comment [6133-2173]: Commenter (6158) suggests that importantly, the critical actor under the best available science standard is the agency  --  the standard requires the use of the best science that is available to the agency, not necessarily available to the public. Excluding science that is available to the agency but not available to the public would thus be a violation of "best available science" provisions.
Under federal law, the agency must find a way to continue using the best available scientific data and models available to it, regardless of whether those data and models are publicly available. Excluding science whose raw data are not in the public domain runs counter to the "best available science" doctrine and is thus illegal.
Response: See response to Comments 2322-159 and 2322-161.
Comment [6152-654]: Commenter (6122) asserts that the proposed rule violates the Endangered Species Act (ESA) and the NEPA.
Section 7(a)(2) of the ESA requires that "each federal agency shall, in consultation with and with the assistance of the Secretary, insure that any action authorized, funded, or carried out by such agency is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of habitat of such species which is determined by the Secretary . . . to be critical." Under the Services' joint regulations implementing the ESA, the EPA is required to review its actions "at the earliest possible time" to determine whether the action may affect listed species or critical habitat. The EPA must initiate consultation under Section 7 whenever its action "may affect" a listed species or critical habitat. The phrase "may affect" has been interpreted broadly to mean that "any possible effect, whether beneficial, benign, adverse, or of an undetermined character, triggers the formal consultation requirement." Because this proposed rule would prevent the EPA from utilizing the best available science, as discussed above, the EPA would be unable to sufficiently determine if one of its decisions, regulations, or policies would harm a threatened or endangered species, or their critical habitat. EPA must at a minimum engage in a programmatic consultation with the Services to determine if this action is likely to adversely affect endangered species.
While some of the EPA's actions are exempt from the National Environmental Policy Act (NEPA), this proposed rule is clearly not. By EPA's own tortured logic, this proposal encompasses virtually every aspect of EPA's statutory mandate, and most of these still fall under the ambit of NEPA. Accordingly, the EPA must prepare an Environmental Impact Statement ("EIS") for the proposed rule because the net effect of the changes to the existing regulations will mean more environmental harm due to delayed decisions, under-regulation of harmful pollutants, and the rejection of the best-available science. By every definition, this will have a massive impact on the human environment.
NEPA requires every federal agency to prepare an EIS for all "major Federal actions significantly affecting the quality of the human environment" and the Council for Environmental Quality's general NEPA regulations, which guide the EPA dictate whether or not an EIS must be prepared. The EPA may forego a NEPA analysis only if a categorical exclusion applies  --  the EPA has not indicated one way or another if it believes a categorical exclusion applies and if it does so, has not provided the public with notice of that belief or the opportunity to comment. If a categorical exclusion does not apply, the EPA must complete an Environmental Assessment (EA) or an EIS. To determine whether an EIS is required, the EPA may elect to prepare an EA first. If they do so, they must provide a period of notice and comment on the EA. It is highly likely, if not a certainty, that this proposal will have negative environmental impacts on the environment. A "reasonable person" reviewing this proposal could only conclude that the proposal is designed to weaken and hamstring the EPA's ability to properly regulate harmful pollutants, resulting in significant harm to human health and environmental quality, and that an EA/FONSI would be completely arbitrary and capricious. Accordingly, the EPA must prepare a complete EIS on this proposed rule and provide a reasonable period to provide public comment.
Response: An ESA section 7(a)(2) consultation is not required for this rule because it does not affect listed species or critical habitat. Further, contrary to the commenter's assertion, the rule does not prevent EPA from using the best available science. The rule is one of internal agency procedure that describes the consideration the agency will give to studies based on data availability and the factors EPA uses to evaluate studies that may be used for regulatory purposes and influential scientific information.
EPA disagrees that this rulemaking is subject to NEPA. See response to Comment 3117-104.
Comment [6152-3730]: Commenter (6122) notes that EPA's proposal represents the most significant rejections of science in the agency's nearly 50-year history. If finalized, the rule would allow political appointees to reject the best-available science for virtually any reason and delay taking critical, life-saving actions in order to benefit special interests and corporate polluters. Simply put, EPA is proposing to formally adopt the mindset of flat-earthers and climate deniers, adopting the worst tactics of the tobacco industry, all in an effort to reward the Trump administration's political benefactors. If finalized, this proposal will kill Americans, more people will go to hospitals because of pollution-induced illness, it will degrade our environment, and it will cause wildlife to go extinct. This profoundly senseless proposal must be withdrawn in its entirety.
The scientific process has always provided transparency through the peer review process and other measures designed to ensure the accuracy of scientific studies. In contrast, the proposed rule will prevent EPA from relying on the best available science because, as the EPA is well aware, underlying data are sometimes unavailable and not essential to peer review. This does not diminish the credibility, veracity, or importance of a particular study or paper. Deliberately ignoring science in order to tip the scales in favor of regulatory inaction violates every law that the EPA is charged with administering. The EPA's proposed rule adds insult to injury by allowing the Administrator to cherry pick which studies to consider based entirely on his or her whims, including studies that are favorable to industry  --  or even authored by industry  --  where underlying data will inevitably be withheld on CBI grounds, while disallowing the public health studies that have long been the bedrock of EPA decision-making.
EPA may only act within the constraints of the authority delegated to it from Congress. There is no statutory authority that supports the proposed rule. For example, with regard to regulations under the CAA, the proposed rule refers to Sections 103 and 301(a). However, neither of these sections contains any language even remotely supporting this proposal  -  which is presumably why the proposed rule does not cite any specific statutory language. Agencies are not free to take actions unmoored from their statutory mandates. Rather, as the Courts have explained, "EPA is a federal agency  -  a creature of statute. It has no constitutional or common law existence or authority, but only those authorities conferred upon it by Congress." Here, since EPA's mandates under the CAA and all the other cited statutes plainly require that the agency consider the best available science, even where underlying data may not be publicly available, it could not be clearer that EPA may not proceed with its proposed regulation.
Response: EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In this final procedural rule, EPA does not rely on, interpret or apply provisions of a particular statute or statutes that it administers. EPA will undertake such efforts in forthcoming substantive actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule. Also see response to Comments 31-135, 2322-159, 2322-161, 2322-205, 1320-4331, 1412-4472
Comment [6155-865]: Commenter (6125) writes that the policy justification for the proposal is inadequate. The proposal would apparently change the workings of all of the EPA's cited regulatory statutes, making key parts of regulatory decisions under each of them in advance. Accordingly, it must be justified as an exercise of regulatory authority under each such statute.
It is the agency's job, not EPN or any other commenter's, to provide that justification. However, to show how far short the proposal falls, the next section of EPN's comments explores in detail the deficiencies in the justification of this proposal under the cited statutes, and then examines in more detail three of the agency's most important regulatory mandates - the ambient air quality standards provisions of the CAA, the drinking water standards provisions of the SDWA, and the general chemical regulatory provisions of the TSCA.
Response: EPA disagrees that the final rule lacks justification. EPA described in the preamble of both the 2018 and 2020 proposals that the purpose of the rule is to increase the transparency of the science underlying significant regulatory actions and influential scientific information. The final rule would not result in the Agency making key parts of regulatory decisions in advance of a rulemaking. The studies considered by the Agency will be included in the rulemaking docket pursuant to § 30.4. For pivotal science, the weight assigned to the studies under § 30.5 and the rationale for the weighting will also be included in the docket. This will allow the public to comment on how the Agency evaluated the studies underlying the significant regulatory action before a rule is promulgated.
Comment [6155-2475]: Commenter (6125) contends that there is neither a legal basis nor a need for this rule. It would require that EPA violate explicit statutory provisions and would undermine environmental protection and critical health protections the public has come to rely on. It unlawfully shifts the basis for deciding what science to use in rulemaking away from the statutory goals of scientific reliability and environmental protection to so-called transparency, a term not used in the relevant EPA statutory provisions.
Response: See response to Comments 31-135, 1320-4331, and 1412-4472
Comment [6163-1118]: Commenter (6133) writes that the Proposal conflicts with the statutes that EPA administers.
The Proposal unlawfully restricts EPA's consideration and use of "dose response data and models that underlie" what the Proposal calls "pivotal regulatory science." 83 Fed. Reg. at 18,770/2. The Proposal goes on to state:
      Pivotal regulatory science' is the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated. In other words, they are critical to the calculation of a final regulatory standard or level, or to the quantified costs, benefits, risks and other impacts on which a final regulation is based.
Id. By restricting EPA's implementation of its federal organic statutes and the Administrative Procedures Act in this fashion, and by defining "pivotal regulatory science" in this manner, the Proposal violates federal laws. The Proposal does so by requiring EPA to implement federal laws based on the Proposal's criteria and conception of "pivotal regulatory science," rather than on the congressional criteria and requirements in federal statutes that contradict, disallow, or fail to include those criteria and concepts in the Proposal.
Response: See response to Comments 1320-4331, 1412-4472 and 2322-159.
Comment [6163-1143]: Commenter (6133) writes that the Food Quality Protection Act (also known as the Food, Drug, and Cosmetics Act or FFDCA) governs pesticide tolerances. Section 408 of the FFDCA requires EPA to set tolerances, which are maximum residue limits, for pesticide residues on foods. In setting tolerances, EPA must find that the tolerance is "safe." 21 U.S.C. § 346a. Safe is defined as meaning that there is a "reasonable certainty that no harm will result from aggregate exposure to the pesticide residue." Id. § 346a(b)(2)(a)(ii). To make this finding, EPA considers, among other things: the toxicity of the pesticide and its break-down products, aggregate exposure to the pesticide in foods and from other sources of exposure, and any special risks posed to infants and children. Id. § 346a(b). For threshold effects, EPA is required to add an additional tenfold margin of safety to protect infants and children, unless the administrator finds based on reliable data that a different safety factor will ensure the pesticide is safe. Id. § 346a(b)(2)(C)(ii). The statute contains specific provisions regarding the type and availability of data that must be considered. Id. § 346a(b)(2)(D), (E), (F).
The Proposal does not cite to the FFDCA, and apparently EPA never considered whether the Proposal is consistent with the law. It is not. First, the Act defines "safe" to mean that "there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information." Id. § 346a(b)(2)(A)(ii). As part of this determination, EPA must "ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure." Id. § 346a(b)(2)(C). EPA cannot do this if it excludes relevant studies solely because the underlying data cannot be made public.
The FFDCA specifically speaks to how threshold and non-threshold effects shall be considered. Id. § 346a(b)(2)(B). The Proposal cannot override the specific Congressional mandates in the FFDCA for how to conduct a tolerance assessment. In determining whether there is a reasonable certainty of no harm to infants and children, EPA must consider "available information" on consumption patterns among infants and children, special susceptibility of infants and children (including for example neurological and in utero effects), cumulative effects on infants and children. Id. § 346a(b)(2)(C). Likewise, the Act specifies numerous scientific factors that must be considered in evaluating safety, including considering "available data" on these factors. Id. § 346a(b)(2)(D). The Proposal plainly contradicts these mandates. Obviously, published, peer-reviewed literature is "available" and must be considered. As with studies considered under other statutes, EPA fails to explain the arbitrariness of excluding published peer-reviewed studies while allowing industry studies considered CBI to be considered.
Finally, the FFDCA contains certain procedural requirements for "establishing general procedures and requirements to implement this section." Id. § 346a(e). Yet EPA failed to cite the FFDCA -- either its substantive or procedural requirements -- at all in its Proposal.
Response: EPA disagrees that the final rule will undermine EPA's ability to comply with the FQPA. See response to Comments 1320-4331, 1412-4472, and 2322-159.
Comment [6163-1146]: Commenter (6133) provides the following:
      The Atomic Energy Act (AEA), 42 U.S.C. § 2011 et seq., is not a typical environmental law, as the original act established the Atomic Energy Commission (AEC) just after World War II to promote the "utilization of atomic energy for peaceful purposes to the maximum extent consistent with the common defense and security and with the health and safety of the public." The concern found in the final clause of its original organic act, "the health and safety of the public," has at no point disappeared in subsequent iterations of the act and this Proposal runs contrary to its clearly stated intent.
      The AEC was abolished in the 1970s, and since that then, most of the functions of the AEA are carried out by the Nuclear Regulatory Commission and the U.S. Department of Energy. However, when EPA was formed in the early 1970s, it assumed the AEC's authority to issue generally applicable environmental radiation standards to protect the health and safety of the public. Other federal and state organizations must follow these standards when developing requirements for their areas of radiation protection. EPA also implements the Federal Radiation Council's authority under the AEA, developing guidance for federal and state agencies containing recommendations for their use in developing radiation protection requirements and working with states that have radiation protection programs.
      There are several specific statutory requirements that EPA executes under the AEA, which states that "the purpose of this [Act is] to effectuate the policies set forth above by providing for  -  (d) a program to encourage widespread participation in the development and utilization of atomic energy for peaceful purposes to the maximum extent consistent with the common defense and security and with the health and safety of the public." 42 U.S.C. § 2013(d) (emphasis added).
      The following regulations are health-based standards, and as we discuss supra section III.G., EPA bases its regulatory limits and nonregulatory guidelines for population exposures to low-level ionizing radiation on the linear no-threshold (LNT) dose-response model, which uses the premise that any radiation dose carries some risk, and that risk increases directly with dose. The viability of each of these longstanding health-based protections will be undercut by promulgation of a final rule that resembles this draft for the reasons discussed supra section III.G., and in direct conflict with the AEA's requirement that the utilization of atomic energy for peaceful purposes be "to the maximum extent consistent with the common defense and security and with the health and safety of the public."
      Environmental Radiation Protection Standards for Nuclear Power Operations (40 C.F.R. Part 190); these standards limit radiation releases and doses to the public from the normal operation (non-emergency) of nuclear power plants and other uranium fuel cycle facilities.
      Environmental Radiation Protection Standards for Management and Disposal of Spent Fuel, High Level and Transuranic Wastes (40 C.F.R. Part 191); this regulation sets environmental standards for the disposal of highly radioactive spent nuclear fuel and certain kinds of highly toxic and radioactive wastes produced from the nuclear weapons program that must ultimately be disposed of in a deep geologic repository.
      Health and Environmental Protection Standards for Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings (40 C.F.R. Part 192); this regulation sets standards for the protection of the public health, safety, and the environment from radiological and non-radiological hazards associated with uranium and thorium ore processing, and disposal of associated wastes. In May of 2015, EPA proposed revisions to 40 C.F.R. 192 that would establish groundwater restoration and monitoring requirements at in-situ recovery facilities, and then in January 2017, EPA re-proposed those revisions. We await final agency action on the matter.
      Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with the 40 C.F.R. Part 191 Disposal Regulations (40 C.F.R. 194); these criteria apply to the certification and recertification of compliance with the radioactive waste disposal standards at the Waste Isolation Pilot Plant (WIPP) in New Mexico, the world's only deep geologic repository, which is operated by the U.S. Department of Energy (DOE) for permanent disposal of transuranic waste from the nation's nuclear defense program.
      Public Health and Environmental Radiation Protection Standards for Yucca Mountain, Nevada (40 C.F.R. Part 197); these regulations, last promulgated in 2008 (after a Federal Appeals Court found an earlier version unlawful, see, e.g., Nuclear Energy Inst., Inc. v. EPA, 373 F.3d 1251 (D.C. Cir. 2004)), establish public health and environmental standards for storage and disposal of spent nuclear fuel at the proposed repository at Yucca Mountain, Nevada. The U.S. Nuclear Regulatory Commission would implement these regulations at Yucca Mountain if a repository were to be established there.
      As discussed above, the Clean Air Act requires EPA to regulate airborne emissions of hazardous air pollutants (HAPs) from a specific list of industrial sources called "source categories." Standards known as the "National Emission Standards for Hazardous Air Pollutants" (NESHAPs) dictate specific regulatory limits for source categories that emit radionuclides. In 40 C.F.R. Part 61: the National Emission Standards For Hazardous Air Pollutants, EPA sets health based standards in a number of settings, such as Subpart B: Radon Emissions from Underground Uranium Mines; Subpart H: Emissions of Radionuclides Other than Radon from Department of Energy Facilities; Subpart I: Radionuclide Emissions from Federal Facilities Other than Nuclear Regulatory Commission Licensees and Not Covered by Subpart H; Subpart K: Radionuclide Emissions from Elemental Phosphorus Plants; Q: Radon Emissions from Department of Energy Facilities; R: Radon Emissions from Phosphogypsum Stacks; Subpart T: Radon Emissions from the Disposal of Uranium Mill Tailings; and Subpart W: Radon Emissions from Operating Mill Tailings.
      And last, under the Safe Drinking Water Act (SDWA), discussed above, EPA sets health-based standards on the levels of certain radionuclides in drinking water. After much litigation, in 2000 EPA revised an outdated set of standards that had been in place since the late 1970s and set new monitoring provisions for community water systems (CWS). The current standards are: Combined radium 226/228 of 5 pCi/L; a gross alpha standard for all alphas of 15 pCi/L (not including radon and uranium); a combined standard of 4 mrem/year for beta emitters; and a the MCL for uranium at 30 ug/L.

In short, the Proposal could seriously damage EPA's ability to administer the AEA and protect the public from radiation. Yet the Proposal fails to cite the statute at all.
Response: EPA disagrees that the final rule will damage the Agency's ability to administer the AEA or any other environmental statutes. See response to Comments 1320-4331, 1412-4472, and 2322-159.
Comment [6163-3475]: Commenter (6133) contends that the Proposal's retroactivity provisions are arbitrary and capricious.
In the Proposal, EPA states that the proposed regulation "is intended to apply prospectively." 83 Fed. Reg. at 18,771. However, a few pages later, the agency "solicits comments on how the prospective or retrospective application of the provisions for dose response data and models or pivotal regulatory science could inadvertently introduce bias regarding the timeliness and quality of the scientific information available." Also, the Proposal states that "for regulatory programs . . . in which future significant regulatory actions may be based on the administrative record from previous reviews . . . , EPA seeks comment on the manner in which this proposed rule should apply to that previous record." Id. at 18,772.
In short, despite its assertion that the rulemaking is "intended" to apply prospectively, the Proposal contemplates prohibiting EPA -- or will prohibit EPA --  from relying on studies generated prior to rulemakings that fail to meet the Proposal's ill-defined criteria for "publicly available data." This approach is arbitrary and capricious, runs counter to the specific language of many statutes the agency is tasked with administering, and would destroy the agency's ability to promulgate health-based standards to protect the American public using the best available science.
The Proposal ignores an entire body of case law that has considered and roundly rejected both retroactivity in rulemakings and limiting data that underlies rulemakings to "publicly available data." In so doing, the Proposal is arbitrary and capricious, and should be rejected. The Supreme Court strongly disfavors retroactive application of rules. The Court has stated that:
      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. [] Even where some substantial justification for retroactive rulemaking is presented, courts should be reluctant to find such authority absent an express statutory grant.
Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 - 09 (1988) (internal citations omitted). Notably, the Proposal does not identify a single provision in a single statute that EPA administers, or any other federal law, that requires or even authorizes any final rule based on the Proposal to have retroactive effect. See generally 83 Fed. Reg. at 18,768 - 74. There has been no power conveyed by Congress in express terms to promulgate retroactive rules related to any element of the Proposal; it is unsurprising that the Proposal does not and cannot identify any express or even implied grant of authority. See Bowen, 488 U.S. at 208 - 09.
The Proposal claims prospective application, while nonetheless noting that in some circumstances EPA may desire to apply the rule retroactively. 83 Fed. Reg. at 18,771. This, too, is unlawful and fails to meet the high burden in the Supreme Court's Bowen decision and its progeny concerning retroactive application of agency rules. The suggestion in the Proposal, for example, that EPA may invoke the Proposal's approach to review all prior health and scientific studies underlying the NAAQS is illegitimate, arbitrary and capricious, and contrary to caselaw. Bowen and its progeny do not permit agency rules to have retroactive effect to disallow health studies and regulatory science generated prior to, or relied upon by EPA prior to, adoption of any final rule based on the Proposal. This caselaw does not entertain any such exception and accepting any such exception for these circumstances would circumvent the holdings and reasoning of this case law.
Response: See response to Comments 1412-4472, 2322-159, 2322-161 and 6107-4015.
Comment [6340-1647]: Commenter (6362) writes that implementation of the rule should be statute-specific.
EPA requested comment on the effect this proposed rule may have on individual EPA programs. Each of the federal environmental statutes referenced by EPA as a source for its authority to propose this rule, was enacted and designed to achieve a specific environmental goal and purpose (e.g., TSCA regulates new and existing chemicals, CAA controls air pollution on a national level, and SDWA regulates public drinking water supplies across the nation). Each statute confers its unique authority upon the agency, requiring agency review according to different scientific standards; each has its own regulations designed to effectuate the specific corresponding program's mission; and, in many cases, each statute relies on different and variable scientific disciplines. As such, ACC believes that this rule, while applicable to all the statutes identified, should be implemented by regulations specific to the objectives and scientific disciplines of each statute. ACC believes that just as the FOIA, which is overseen by the US DOJ, is implemented by each agency with specific and separate regulations relevant to the requirements of each statute, this policy rule should be implemented by each EPA program office charged with implementing a given statute in a manner consistent with the authorities granted and requirements unique to that statute.
Response: EPA appreciates your comment. In this rule, EPA does not rely on, interpret or apply provisions of a particular statute or statutes that it administers. EPA will undertake such efforts in forthcoming substantive actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule.
Comment [6894-3611]: Commenter (6915) writes that because the proposed rule would run afoul of these provisions and potentially others, EPA's citation to general rulemaking authorities such as CAA § 301(a), 42 U.S.C. § 7601(a), and CWA § 501, 33 U.S.C. § 1361, is unavailing. Such general provisions of rulemaking authority cannot override more specific statutory directives. Global Van Lines, 714 F.2d at 1293-97. Nor can EPA's reliance on 5 U.S.C. § 301 in the notice extending the comment period save its ultra vires proposal. 83 Fed. Reg. at 24,256. Known as the "housekeeping statute," 5 U.S.C. § 301 is "simply a grant of authority to the agency to regulate its own affairs," not a general, independent basis for deviating from a specific statutory directive or limiting the scope of other statutes. See Chrysler Corp. v. Brown, 441 U.S. 281, 308-12 (1979).
Thus, as a general matter, EPA's obligation is clear: it must base its decisions on such criteria as the latest scientific knowledge, the best available, peer-reviewed science, and/or generally accepted scientific principles or laboratory tests. No statute suggests that EPA, in setting standards, can reject scientific evidence that meets those criteria solely because the underlying data are not public or because the evidence is based on models that otherwise follow long-accepted scientific guidelines. In short, EPA lacks sufficient legal authority to either adopt or implement the proposed rule, and its proposed action conflicts with the statutes it must follow.
Response: See response to Comment 31-135 on EPA's authority to promulgate this rule. Also see response to Comments 1412-4472, 2322-159 and 2322-161.
Comment [6894-3624]: Commenter (6915) writes that the proposal provides no analysis of its environmental impacts and fails to explain how EPA has addressed the requirements of the NEPA, 42 U.S.C. § 4321 et seq.
Response: EPA disagrees that this rulemaking is subject to NEPA. See response to Comment 3117-104.
Comment [6906-3976]: Commenter (6927) agrees that this proposed rule is consistent with the Administrative Procedures Act (APA) as well as programmatic statutes that EPA administers to disclose to the public the bases for agency rules and to rationally execute and adequately explain agency actions.
Response: EPA appreciates your comment in support of the rulemaking.
Comment [7775-4127]: Commenter (8178) objects to the proposal to limit the use of scientific evidence in rulemaking proceedings.
In general, before approving the proposed regulation, NEPA requires EPA to prepare a thorough EIS for the project. In a discussion entitled: What is included in an EIS?, EPA outlines the EIS requirements. https://www.epa.gov/nepa/national-environmental-policy-act-review-process#EIS The requirements include: Alternatives: Consideration of a reasonable range of alternatives that can accomplish the purpose and need of the proposed action.
Although the documents that EPA presented in support of the proposed regulation fall far short of what NEPA requires in many ways, the most obvious deficit may be the EPA's failure to meaningfully discuss reasonable alternatives to the proposed action. In the present case, as a consequence of Anti-Environment regulation's extraordinary breadth, NEPA requires EPA to prepare an EIS which reviews and discusses the many reasonable (and often patently superior) alternatives to the proposed regulatory action.
While courts sometimes differ on the necessary scope of alternatives, it is clear that even a minimal EIS should discuss several alternatives. The proposed regulation lists 8 different statutes (i.e., CAA, CWA, SDWA, RCRA, CERCLA, EPCRTKA, FIFRA, and TSCA) it will impact. See proposed regulation Federal Register, Vol. 83, No. 83 pg. 18769. Clearly, a reasonable discussion of alternatives would compare the proposed actions impacts with an alternative that impacts only 1 statute. Another alternative would apply to two of the listed statutes. Put simply each permutation of these statutes less than 8 statutes ought to be fully discussed in the EIS as a reasonable alternative. The EPA only has itself to blame for the complexity of the requisite EIS because it alone proposed a regulation that would affect 8 important statutes in one regulation.
Response: EPA disagrees that this rulemaking is subject to NEPA. See response to Comment 3117-104.
Comment [7876-4130]: Commenter (8279) argues that in addition to being bad for the environment, SDWA and TSCA lists mark the starting points for the required EIS that EPA must prepare, as required by NEPA, before the regulation is approved.
Response: EPA disagrees that this rulemaking is subject to NEPA. See response to Comment 3117-104.
Comment [8750-1427]: Commenter notes that the Proposal acknowledges that "[t]he best available science must serve as the foundation of EPA's regulatory actions." But it then requires EPA to systematically ignore the best available science when it regulates to protect human health and welfare. This is counter to EPA's statutory mandates to use "best available science," and the proposal is a transparent attempt not to strengthen science, but rather to censor science that is inconvenient to the current Administration's political goals.
Since EPA was established nearly half a century ago, the Agency and its leadership --  under Administrations of both parties -- have recognized the central role that rigorous science plays in fulfilling the Agency's mission of protecting human health and the environment. EPA's obligation to consider the best available science is not only a policy commitment that flows from the Agency's mission; it is a legal obligation enshrined in many of the fundamental public health and environmental statutes that EPA is charged with administering. The agency has established an array of mechanisms over the last five decades -- including "rigorous review" by its scientific advisory boards "that goes beyond the typical journal peer review procedures" -- to ensure that the Agency's decisions are grounded in the best available science.
Response: See response to Comments 2322-159, 1320-4331 and 1412-4472.
Comment [8750-1435]: Commenter (9227) writes that EPA's statutory authorities generally require the agency to consider all available data when undertaking significant rulemakings.
As just noted, EPA's statutory authorities mandate a variety of requirements for what scientific information EPA must consider in rulemaking. These statutes are discussed in detail, infra at Section I.B.3. To take one example that appears in numerous statutes, including TSCA, CAA, SDWA, and the Endangered Species Act, Congress has often required agencies to act on the "best available science." For an agency to comply with this obligation, the agency must at least consider all available scientific information. "Best" means "of the most excellent, effective, or desirable type or quality." "Available" means "able to be used or obtained." And "science" means "the intellectual and practical activity encompassing the systematic study of the structure and behavior of the physical and natural world through observation and experiment." Assessing which science is "best" requires consideration of the overall quality of the science, and the public availability of underlying data is, at best, one of many aspects that should inform that assessment of overall quality.
An agency "cannot ignore available. . . information." Numerous courts have indicated that a plaintiff or petitioner can establish a violation of the "best available science" requirement by "point[ing] to any scientific evidence that the agency failed to consider." "The best available data requirement. . . prohibits [an agency] from disregarding available scientific evidence that is in some way better than the evidence [it] relies on.'" "An agency does. . . have an obligation to deal with newly acquired evidence in some reasonable fashion." EPA's proposal will result in EPA precluding itself from considering certain studies that are "available," thus violating the requirement that EPA rely on the best available science.
In addition, the requirement that agencies use "best available" science or information often means that the agency must act even if the available science or information is imperfect.
"Even if the available scientific and commercial data were quite inconclusive, [the agency] may -- indeed must -- still rely on it" when the agency has a duty to act. "[W]here the information is not readily available, we cannot insist on perfection." Just as the Courts have recognized that they cannot expect perfection, agencies cannot choose to ignore certain studies or sources of information based solely on whether the data is publicly available -- especially where the validity of those studies has been established using techniques that do not rely on public availability of underlying data.
EPA cannot reasonably elevate the interest in public availability of all underlying information above all other factors in assessing the "best available science." Textually, EPA's approach is unlawful.
Response: See response to Comments 1412-4472, 2322-159 and 2322-161.
Comment [8750-1450]: Commenter (9227) suggests that even the Proposal appears to concede that studies for which data is not publicly available could constitute the "best available science" that EPA is statutorily required to consider. The proposed exemption provision in section 30.9 makes it clear that EPA does not consider a study to be invalid or unsuitable for EPA's consideration based only on the public unavailability of underlying data or models. Specifically section 30.9 would give the Administrator discretion to authorize consideration of a scientific study where "[i]t is not feasible to ensure that all dose response data and models underlying pivotal regulatory science is publicly available." Of course, EPA could not have intended for proposed section 30.9 to provide the Administrator with discretion to take a study that is not "best available science" into consideration when promulgating a rulemaking. If the Administrator has discretion to allow consideration of a study for which it is infeasible to make the study's underlying data and models publicly available, then it obviously is not necessary for such underlying data and models to be publicly available for a scientific study to constitute "best available science." Yet, unless the Administrator elects to exercise his discretion under proposed section 30.9 and find that it is "infeasible" to make a study's underlying data and models publicly available, proposed section 30.5 broadly prohibits EPA from relying on the study in support of "significant regulatory actions."
Moreover, while proposed section 30.5's prohibition would apply to "pivotal regulatory science" used for "significant regulatory actions," the proposed rule says nothing to prohibit EPA's reliance on these studies for other agency purposes, such as in permitting, enforcement, or regulatory actions that do not qualify as "significant." Thus, EPA clearly does not believe that a study cannot be "best available science" based solely on the fact that underlying data and models are not publicly available.
In sum, if finalized, EPA's proposed rule would restrict EPA's ability to consider "best available science" when undertaking significant rulemakings, contrary to the numerous statutory directives discussed in detail below.
Response: The Administrator's exemption provision in §30.7 is needed because there are conditions under which compliance with the requirements of the final rule might be impracticable, such as the age of the study. EPA finalized the exemption provision with reasonable factors for the Administrator to consider when granting an exemption. In addition, the final rule requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information.
Also see responses to Comments 2322-161, 2322-159 and 2322-161.
Comment [8750-1812]: Commenter (9227) asserts that EPA failed to submit the proposal to the SAB or to consult with the scientific and technical community.
There is no indication that EPA consulted with the scientific and technical community --  or even its own Science Advisory Board -- before proposing to require that the underlying data and models be made publicly available for all pivotal regulatory science regardless of ethical, feasibility, or confidentiality constraints. As detailed in a June 28, 2018 letter from the chair of the SAB, the SAB learned of the rule only through a press event, Federal Register notice, and news articles. The letter further explained that the proposed rule "was not identified as a major action in either of the Spring 2017 or Fall 2017 semi-annual Regulatory Agendas," and that SAB members "had no information regarding the timeline for finalizing the rule . . . ." The letter also points out that "the precise design of the proposed rule appears to have been developed without a public process for soliciting input specifically from the scientific community," even though the proposed rule raises important scientific questions.
Not surprisingly, the SAB concluded in its May 31, 2018 meeting that the Proposal merits SAB review because it "deals with issues of scientific practice and proposes constraints to the use of scientific studies in particular contexts." Moreover, the SAB chair's June 28 letter raises a number of questions that echo the concerns we have detailed in our comments, including the feasibility of providing access to data and methods for already-completed studies; "legitimate confidentiality and privacy interests" that would counsel against providing "complete public access"; the costs and effort associated with implementing the Proposal; the relationship between the Proposal and previous EPA efforts to encourage transparency; and the need to consider "the multiple existing methods to assess the validity of prior epidemiologic studies" that "do not provide public access to data and analytic methods."
EPA's failure to consult with the SAB is contrary to statute and to EPA's well established practice. EPA must submit its Proposal to the SAB pursuant to the requirements of 42 U.S.C. § 4365(c)(1) (the Environmental Research Development Demonstration Authorization Act or "ERDAA"), 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 (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 must then review and comment on the proposal. While the Administrator need not receive the SAB's final approval, the Administrator must consider the SAB's advice and comments.
As the SAB chair's letter notes, EPA's "usual process" is to inform the SAB about the publication of the agency's semi-annual regulatory agenda and provide descriptions of actions that are contained in the agenda, including "available information regarding the science that is informing these agency actions." That procedure was not followed here. In its evident zeal in the name of purported "transparency," EPA has ignored major statutory and regulatory requirements that provide actual transparency to the CAA's scientific review process. Should EPA decide to move forward with this Proposal, it must first allow the SAB to complete its review and take into account the SAB's recommendations in any final rule.
Response: EPA disagrees that it violated the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA). EPA did seek and obtain SAB review of aspects of the proposed rule. See https://yosemite.epa.gov/sab/sabproduct.nsf/LookupWebProjectsCurrentBOARD/2DB3986BB8390B308525855800630FCB/$File/EPA-SAB-20-005.pdf.