First, under SDWA, the peer-reviewed science used must qualitatively be the "best available"; no discretion is given to the Administrator to further limit the science used on the ambiguous grounds of "appropriate[ness]," much less the non-statutory basis of "transparency" put forward in the proposal. Most important, the core objective of the proposal  -  "to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation" (proposed § 30.1 "What is the purpose of this subpart?") is one that the Administrator does not have authority to pursue under this SDWA provision.
Tellingly, the authority under SDWA cited for the proposal, SDWA §1442, simply authorizes research, technical assistance, information and research facilities, and training. That section cannot be read to authorize in any way the changes in the use of "regulatory science underlying [agency] actions" in this proposal, especially in the face of the terms and stated intentions of §1412(b)(3)(A)(i). (The other SDWA provision cited in the proposal as "authority", §1450(a)(1), is simply a general rulemaking authority and cannot be used to bootstrap the lack of direct authority in SDWA for this proposal).
The principal cases interpreting this provision have defined and maintained the strict requirements of this authority. EPA observes the "best available science" requirement where it uses newer, peer-reviewed data rather than older data developed by an EPA scientist for the regulatory determination (re filtration avoidance, City of Portland v. EPA, 507 F.3d 706, 716 (D.C. Cir. 2007)), and where the agency explained and provided "substantial scientific support" for the model and data it used (City of Waukesha v. EPA, 320 F.3d 228, 250-51, 256-57 (D.C. Cir. 2003), but not where it rejected the evidence that was the "best available" at the time of the rulemaking (Chlorine Chemistry Council v. EPA, 206 F.3d 1286, 1290-91 (D.C. Cir. 2000)). City of Waukesha v. EPA furthermore indicates that agency peer review satisfies the requirement to use best, peer-reviewed science and supporting studies, as noted above. 320 F. 3d at 247.
Comment [6155-2631]: Commenter (6125) writes that it is clear from even a brief look that these provisions require EPA to consider all the best available science, without authorizing, or even mentioning any of the per se restrictions based on "transparency" that EPA has proposed to use as a universal overriding rule. For these reasons, EPA must justify its proposal as a proper exercise of its authority under each of the statutory provisions whose operation it would affect - provisions that the agency does not even cite. It is the job of the proposer, not the commenters, to survey these provisions and provide the needed justification.
The SDWA 1412(b)(3)(A) addresses EPA's "use of science in decision-making" by providing that risk assessments "shall" use "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices."
This provision uses mandatory language directing EPA to use reliable and relevant scientific information -- and further specify how to do so. They all direct that decisions regarding protection of public health be based on the full range of relevant scientific information, in some cases specifying how to identify what information to use. None of them give EPA discretion to ignore such information for any of the reasons set forth in the proposal.
Comment [6163-1105]: Commenter (6133) notes that EPA cites 42 U.S.C. § 300j - 1 of the SDWA as authority for the rule. Subsection (a) of that section allows EPA to conduct some types of research on drinking water contamination and requires it to conduct other studies. But it says nothing about which types of studies EPA may consider in rulemakings and does not distinguish between dose-response studies and other types of studies. The absence of any such congressional distinction or restriction makes it all the more obvious that EPA invented and added the distinction and restrictions in the Proposal as a matter of its own policy preferences, contrary to the Act. This EPA may not do. The remainder of the subsections have nothing to do with data or research. At any rate, EPA does not state specifically which of the subsections in 42 U.S.C. § 300j - 1 it believes authorizes this proposed rule. Thus, the citation fails to provide sufficient notice for the public to comment on the proposed rule.
EPA also cites 42 U.S.C. § 300j - 9(a)(1), but that says only that the "Administrator is authorized to prescribe such regulations as are necessary or appropriate to carry out his functions under this subchapter." As explained above, that general grant of authority cannot support the rule, especially when the rule conflicts with the Act. The SDWA does not authorize the proposed rule.
Comment [6163-1136]: Commenter (6133) notes that the SDWA protects the nation's public drinking water supplies. The Act generally applies to "each public water system in each State," 42 U.S.C. § 300g, and requires EPA to set standards for drinking water contaminants that may have an adverse effect on human health and are known or anticipated to occur in such systems, id. § 300g-1(b)(1)(A).
For a given contaminant, the SDWA requires that EPA first establish a MCLG, which is "the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety." Id. § 300g-1(b)(4)(A). EPA must then set a MCL "as close to the [MCLG] as is feasible." Id. § 300g-1(b)(4)(B).
EPA also must, every five years, "publish a list of contaminants" that "are not subject to any proposed or promulgated national primary drinking water regulation, which are known or anticipated to occur in public water systems, and which may require regulation . . . ." Id. § 300g1(b)(1)(B)(i). The SDWA requires EPA to prioritize that list based on vulnerable subpopulations that are at risk and other factors. Id. § 300g-1(b)(1)(C). EPA must then decide whether to regulate at least five contaminants on the list based on the "best available public health information." Id. § 300g-1(b)(1)(B)(ii).
In making these determinations, the SDWA requires EPA to use "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices," and "data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data)." Id. § 300g1(b)(3)(A); see also id. § 300g-1(b)(12), (13) (similar); id. § 300j-19 (referring to best available science standard for risk assessment of algal toxins).
The Proposal would conflict with the SDWA by prohibiting EPA from using the "best available" science and "data collected by acceptable or best available methods" solely because that data could not be made public. Indeed, courts interpreting these requirements have already rejected this proposed limitation on dose-response studies, making clear that they can indeed be the "best available" science regardless of whether the underlying data are publicly available. In City of Waukesha v. EPA, the court approved EPA's use of "studies of Hiroshima and Nagasaki atomic bomb survivors" in setting limits for radium and uranium in drinking water. 320 F.3d 228, 248, 252 (D.C. Cir. 2003). But of course, these and similar studies would likely be excluded under the Proposal because the underlying data are not available. The court also upheld the agency's use of the LNT model used by EPA for both radium and uranium, id. at 249 - 50, 252, which is precisely the model that EPA now implies -- without citing any evidence -- is not scientifically justified.
Additionally, in carrying out its obligations to establish drinking water standards, the Act directs the agency to discuss "peer-reviewed studies known to the Administrator that support, are directly relevant to, or fail to support any estimate of public health effects and the methodology used to reconcile inconsistencies in the scientific data." 42 U.S.C. § 300g-1(b)(3)(b)(v). Moreover, the agency must identify the "[q]uantifiable and non-quantifiable benefits for which there is a factual basis in the rulemaking record" in establishing a drinking water standard. Thus, under the express provisions of the SDWA, the agency cannot simply ignore peer-reviewed studies or other information in the record that the Proposed Rule would disallow from consideration, simply because the underlying data may be unavailable. Id. § 300g-1(b)(3)(c)(i).
If Congress had intended for the data targeted by the Proposal to be excluded, it could have said so. Instead, Congress directed EPA to use "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices," and "data collected by accepted methods or best available methods." 42 U.S.C. § 300g1(b)(3)(A). EPA cannot ignore these commands to achieve its political goal of rolling back public health protections.
Comment [6333-2425]: Commenter (6355) strongly agrees that "the best available science must serve as the foundation of EPA's regulatory actions". While the proposed rule does not define what is meant by `best available science', and scientists and policy-makers may have different ideas on how the concept is defined and interpreted, the scientific community agrees that the `best available science' is the product of a process that includes clearly stated objectives and rationale, appropriate study design and data collection methods, logical analysis and interpretation of data, and rigorous documentation and explanation of findings, all of which are evaluated by independent peer-review.
The `best available science' provides an indispensable foundation for policy and regulatory decisions; yet the proposed rule restricts the science that can be used for regulatory decision-making to those data that conform to a list of constraints (i.e. , independence, objectivity, transparency, clarity, and reproducibility). The `best available science', as described above, is not bound by these criteria. Thus, the proposed rule would exclude relevant scientific evidence from the policy-making process. Ignoring relevant data would be in violation of those laws that mandate the use of `best available science' (e.g., SDWA).
Comment [6340-1455]: Commenter (6362) writes that the provisions cited by EPA under the CAA, the CWA, the SDWA, the CERCLA, and the EPCRA in support of its authority to develop and implement its proposed rule all provide broad regulatory authority to promulgate regulations "as are necessary to carry out [the Administrator's] functions" under the statute.
Comment [6353-2321]: Commenter (6375) notes that EPA solicits comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation. (pg. 18,771). EPA's statement concerning its legal authority could be enhanced by reference to statutory provisions that require it to rely on "accurate," "useful," or "best" data. For example, section 108(a)(2) requires that the Administrator issue air quality criteria that "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health and welfare . . .." 42 U.S.C. § 7408(a)(2). The SDWA requires the Administrator to assess risk using "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices." 42 U.S.C. § 300g1(b)(3)(A). Increasing the transparency of regulatory science and ensuring that it is reproducible helps in evaluating its accuracy and usefulness.
Comment [6425-2355]: Commenter (6447) writes that the proposal is not authorized by statute and is contrary to Law.
EPA purports to rely on general statutory authority for the proposal, but no statutes authorize EPA to ignore science. On the contrary, as multiple U.S. Senators have noted, EPA's proposal would violate several statutes, including the TSCA, the SDWA, and the APA, which require the Agency to use the best available science, and all information presented to the agency during a rulemaking. The current proposal would do the opposite, requiring EPA to ignore some of the best available science, and to ignore certain information submitted during rulemaking. In particular, the proposal would make it difficult or impossible to use most epidemiological studies, where the source data are almost always comprised of sensitive personal information. Epidemiological studies are fundamental to EPA policymaking, and a critical source of information about the effects of various risk factors on human health. The Agency does not the option of suppressing this information, and courts have held that EPA "cannot ignore existing data."
In short, the proposed action would be illegal, and would not survive a legal challenge.
Comment [6884-3033]: Commenter (6905) notes that like EPA's mission statement, several of the federal statutes that provide authority for the agency's work call for use of the best science without regard for data transparency. For example, the SDWA calls on the Administrator to use "the best available, peer reviewed science and supporting studies conducted in accordance with sound and objective scientific practices." SDWA specifically calls on the Administrator to make information on public health effects available including peer reviewed studies. But it qualifies the requirement with the phrase "to the extent practicable" and does not require that all the data underlying the studies be publicly available. It appears that the proposed rule could reject some of the best available science and may result in a finding that the rule contradicts the federal statutes.
Comment [6894-3605]: Commenter (6915) writes that the SDWA requires that findings which support a determination to regulate a contaminant "be based on the best available public health information," and that, in developing the NPDWR, "to the degree that an Agency action is based on science, the Administrator shall use the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices." §§ 1412(b)(1)(B)(ii)(II), 1412(b)(3)(A)(i), 42 U.S.C. §§ 300g-1(b)(1)(B)(ii)(II), 300g1(b)(3)(A)(i) (emphases added).
Comment [6901-4442]: Commenter (6922) notes that in the SDWA: "Use of science in decision-making. In carrying out this section, and, to the degree that an Agency action is based on science, the Administrator shall use:
      1) The best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and
2) Data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data)."
Comment: [7876-4129]: Commenter (8279) objects to the proposal to limit the use of scientific evidence in rulemaking proceedings.
The proposed regulation will undercut the ability of EPA (including future EPA administrators) to protect the public pursuant to the SDWA and TSCA. The breadth of the proposed regulation is shown in part by reviewing the chemicals covered by the two acts. See, e.g., The non-confidential list of 67951 TSCA chemicals, https://www.epa.gov/tsca-inventory/how-access-tsca-inventory, the list of hazardous waste, https://www.epa.gov/hw/defining-hazardous-waste-listed-characteristic-and-mixed-radiological-wastes, SDWA Regulations, https://www.epa.gov/ground-water-and-drinking-water/national-primary-drinking-water-regulations, PDF copy of list, https://www.epa.gov/sites/production/files/2016-06/documents/npwdr_complete_table.pdf
Comment [8750-1433]: Commenter (9227) notes 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, at section I. B.3. of the commenter's comment letter. To take one example that appears in numerous statutes, including TSCA, CAA, SDWA, and the ESA, Congress has often required agencies to act on the "best available science." For an agency to comply with this obligation, the agency must at least consider all available scientific information. "Best" means "of the most excellent, effective, or desirable type or quality." "Available" means "able to be used or obtained." And "science" means "the intellectual and practical activity encompassing the systematic study of the structure and behavior of the physical and natural world through observation and experiment." Assessing which science is "best" requires consideration of the overall quality of the science, and the public availability of underlying data is, at best, one of many aspects that should inform that assessment of overall quality.
An agency "cannot ignore available. . . information." Numerous courts have indicated that a plaintiff or petitioner can establish a violation of the "best available science" requirement by "point[ing] to any scientific evidence that the agency failed to consider." "The best available data requirement. . . prohibits [an agency] from disregarding available scientific evidence that is in some way better than the evidence [it] relies on.'" "An agency does. . . have an obligation to deal with newly acquired evidence in some reasonable fashion." EPA's proposal will result in EPA precluding itself from considering certain studies that are "available," thus violating the requirement that EPA rely on the best available science.
In addition, the requirement that agencies use "best available" science or information often means that the agency must act even if the available science or information is imperfect.
"Even if the available scientific and commercial data were quite inconclusive, [the agency] may -- indeed must -- still rely on it" when the agency has a duty to act. "[W]here the information is not readily available, we cannot insist on perfection." Just as the Courts have recognized that they cannot expect perfection, agencies cannot choose to ignore certain studies or sources of information based solely on whether the data is publicly available -- especially where the validity of those studies has been established using techniques that do not rely on public availability of underlying data.
EPA cannot reasonably elevate the interest in public availability of all underlying information above all other factors in assessing the "best available science." Textually, EPA's approach is unlawful.
Comment [8750-1437]: Commenter (9227) writes that the proposed rule violates EPA's statutory authorities.
Not only is there no authority for EPA's pan-statutory Proposal, but the Proposal would also violate explicit statutory commands. Though EPA admits that "[t]he best available science must serve as the foundation of EPA's regulatory actions," proposed section 30.5 would prohibit EPA from considering high quality and critically important scientific studies -- precisely that "best available science" -- when undertaking regulatory actions. Specifically, section 30.5 would prevent EPA from considering any scientific study for which the underlying "dose response data and models" are not "publicly available in a manner sufficient for independent validation." This is reflected "the best available public health information" in a SDWA rulemaking, 42 U.S.C. § 300g-1(b)(1)(B)(ii)(II). Accordingly, this proposed prohibition would contravene an array of statutes governing EPA's consideration of science when promulgating rules, such as requirements to consider the "best available science" when setting environmental protection standards. See, e.g., SDWA, 42 U.S.C. § 300g-1(b)(3)(A) (EPA must use "[t]he best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices" and "[d]ata collected by accepted methods or best available methods"). And, by excluding science that meets these statutory criteria from supporting regulations to protect public health and welfare, the Proposal would frustrate Congress's policy in these statutes and frustrate EPA from achieving its fundamental mission.
Comment [8750-1465]: Commenter (9227) writes that EPA's Proposal contravenes the SDWA.
The SDWA requires EPA to issue national drinking water regulations setting required purity levels for water from public water supply systems. Before regulating, the Administrator must conclude that the contaminant at issue "may have" an adverse effect on the health of persons. In regulating, the Administrator must consider "the best available public health information." The section adds that in setting regulations, the Administrator "shall use ...the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices" and in addition "data collected by accepted methods or best available methods." When Congress promulgated these statutory requirements in 1996, the Senate Committee on Environment and Public Works explained that the "Administrator has a duty to seek and rely upon the best available science and information to support.... [m]any of the most important activities including selecting contaminants for regulation, setting standards, designing analytical methods, and structuring waivers, variances and exemptions."
By restricting EPA to considering only those scientific studies for which underlying data, models, and other information is publicly available, EPA's proposal prevents EPA from complying with the SDWA directive that it consider the "best available" public health information and science when setting SDWA standards. Specifically, as explained above, the public will not necessarily have access to the underlying information used to produce the "best available, peer-reviewed science and supporting studies." Nowhere does the SDWA authorize EPA to ignore such studies based on the public unavailability of underlying information. Thus, regardless of the merits of the core objective of EPA's proposal -- "to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation" (proposed § 30.1 "What is the purpose of this subpart?"), EPA's attempt to elevate this objective above the agency's statutory obligation to consider the "best available" science when promulgating SDWA standards is unlawful.
Comment [8750-1817]: Commenter (9227) writes that EPA's proposal fails to meet the procedural requirements of the SDWA, 42 U.S.C. § 300f Et Seq.
EPA cites the SDWA as an authority for the Proposal but has failed to comply with the procedural requirements of the statute. The SDWA provides authority to promulgate regulations at 42 U.S.C. 300g-1(d). Though EPA does not cite this particular section, it is the only provision of the SDWA that provides EPA with rulemaking authority. The SDWA requires the Administrator to consult with the Secretary of HHS and the National Drinking Water Advisory Council (NDWAC) in proposing and promulgating regulations under this section. EPA has not met these requirements here, and as such cannot claim to be using SDWA authority to promulgate this rule.
Comment [8750-1965]: Commenter (9227) writes that EPA arbitrarily failed to consider the far-reaching implications this Proposal could have on inter-agency coordination and consultation given that other agencies normally rely on research potentially excluded by the Proposal.
Consultation Provisions in the SDWA
300g-1 (b)(1)(D)
Standards: Listing of Contaminants for Consideration, Urgent Threats to Public Health
The Administrator may promulgate an interim NPDWR for a contaminant without making a determination for the contaminant under paragraph (4)(C), or completing the analysis under paragraph (3)(C), to address an urgent threat to public health as determined by the Administrator after consultation with and written response to any comments provided by the Secretary of HHS, acting through the director of the CDC or the director of the NIH.
***
300g-1(d)
Regulations:
Regulations; public hearings; administrative consultations. Regulations under this section shall be prescribed in accordance with section 553 of title 5, United States Code (relating to rulemaking), except that the Administrator shall provide opportunity for public hearing prior to promulgation of such regulations. In proposing and promulgating regulations under this section, the Administrator shall consult with the Secretary and the NDWAC.
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300j-12(i)(2)
Funds: Indian Tribes: Use of Funds
(2) Use of funds. Funds reserved pursuant to paragraph (1) shall be used to address the most significant threats to public health associated with public water systems that serve Indian Tribes, as determined by the Administrator in consultation with the Director of the Indian Health Service and Indian Tribes.
***
300j-13(a)(5)
Source Water Quality Assessment
Demonstration project. The Administrator shall, as soon as practicable, conduct a demonstration project, in consultation with other Federal agencies, to demonstrate the most effective and protective means of assessing and protecting source waters serving large metropolitan areas and located on Federal lands.
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300j-5(b)
NDWAC
(b) Functions. The Council shall advise, consult with, and make recommendations to, the Administrator on matters relating to activities, functions, and policies of the Agency under this title [42 USCS §§ 300f et seq.].
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300j-3d
Water Supply Cost Savings
(a) Drinking water technology clearinghouse. The Administrator, in consultation with the Secretary of Agriculture, shall --
(1) develop a technology clearinghouse for information on the cost-effectiveness of innovative and alternative drinking water delivery systems, including wells and well systems; and
(2) disseminate such information to the public and to communities and not-for-profit organizations seeking Federal funding for drinking water delivery systems serving 500 or fewer persons.
***
300i-3(a)
Contaminant Prevention, Detection and Response
In general. The Administrator, in consultation with the CDC, after consultation with appropriate departments and agencies of the Federal Government and with State and local governments, shall review (or enter into contracts or cooperative agreements to provide for a review of) current and future methods to prevent, detect and respond to the intentional introduction of chemical, biological or radiological contaminants into community water systems and source water for community water systems, including each of the following:
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300j19(b)(2)(A)
Algal Toxin Risk Assessment and Management
(b) Information coordination. In carrying out this section the Administrator shall--
(2) as appropriate, consult with--
      (A) other Federal agencies that--
      (i) examine or analyze cyanobacteria or algal toxins; or
      (ii) address public health concerns related to harmful algal blooms.
Comment [9066-2646]: Commenter (6188) writes that the proposed rule contradicts the requirements of federal environmental law, including cited authority for the rulemaking.
The Proposed Rule's requirements are at odds with statutory mandates contained in the very same environmental laws it points to as providing a basis for the rule. They also directly controvert authority it cites as support for the rulemaking.
The requirements of the Proposed Rule conflict with EPA's statutory obligations under federal environmental laws. CAA § 109 mandates that EPA set air quality standards based on "air quality criteria," which must "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare." 42 U.S.C. §§ 7409, 7408(a)(2). The TSCA requires EPA to use the "best available science" when evaluating the testing and regulation of chemicals. 15 U.S.C. § 2625(h). Decisions are to be made using the "weight of the scientific evidence," and EPA is required to consider all information related to a chemical substance, including hazard and exposure information, "that is reasonably available to the Administrator." 15 U.S.C. §§ 2625(i), (k). Similarly, the SDWA mandates use of the "best available public health information" when EPA determines whether to regulate a contaminant, and reliance on the "best available, peer-reviewed science and supporting studies" when making regulatory decisions. 42 U.S.C. §§ 300g-1(b)(1)(B)(ii), 300g-1(b)(3).
Exclusion of relevant studies from consideration based not on the quality of the science but on the public availability of underlying data directly contradicts these mandates. EPA itself has defined "best available science" without reference to the public availability of data:
Use of best available science involves the use of supporting studies conducted in accordance with sound and objective scientific practices, including, when available, peer reviewed science and supporting studies and data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data).
Simply put, the "best available science" is science that follows standards accepted by the scientific community, not science that EPA arbitrarily selects based upon the public availability of data -- a criterion irrelevant to scientists' standards for determining whether research represents the best science.
Specifically, scientists have observed that the best quality science oftentimes relies upon data that is not publicly available due to significant privacy considerations. It is for that very reason that courts have recognized EPA's need to rely upon studies based on publicly undisclosed underlying data when considering the best science. American Trucking Ass'ns, 283 F.3d at 372 (explaining that curtailing EPA's ability to rely on published studies would exclude "plainly relevant scientific information" from regulatory decision-making processes); see also Coalition of Battery Recyclers Ass'n, 604 F.3d at 623 (finding that EPA is entitled to rely on published study results as "raw data is often unavailable due to proprietary interests of a study's scientific investigators or confidentiality agreements with study participants"). Forcing EPA to ignore high quality science controverts EPA's statutory obligations and will impair EPA's ability to protect public health and the environment.
Comment [9078-3549]: Commenter (6194) writes that the proposal is inconsistent with EPA's statutory obligations and conflicts with other applicable federal requirements.
The Proposal would prevent EPA from relying on the best available information in discharging its duties. EPA is charged with developing regulations that provide societal benefits by reducing harm to human health and the environment from the presence of chemicals in air, soil, drinking water, food, and consumer products. The Proposal implicates research that is central to making such determinations; creating an obstacle to the consideration of such science is contrary to both primary statutory directives and requirements to conduct cost benefit analyses. Likewise, EPA fails to address how it could implement a regulation that is inconsistent with federal requirements and standards governing the use of science across agencies.
A. Statutory Requirements to Develop Health Based Standards and Conduct Cost-Benefit Analyses EPA acknowledges that it must use the "best available science" in all of its regulatory actions.
This directive is embodied in multiple statutes implemented by EPA and is reflected in other environmental statutes, further illustrating Congress' conceptualization of "best" available science. Broadly speaking, there are three basic types of statutory requirements that the EPA and other agencies consider scientific information. First, there are requirements that the agency consider the "best available science." Second, there are requirements that the agency consider particular factors, including scientific factors. Third, there are requirements that the agency balance economic costs or technological feasibility against public health, environmental, or other benefits that must be scientifically assessed. The precise terminology regarding the required use of science may, as illustrated below, vary across statutes, but what these provisions have in common are requirements for EPA and other agencies to use scientific information that is "best," not simply adequate, and "available."
Table 1: Examples of Statutory Directives regarding Use of Science by EPA and other Agencies
 SDWA [42 U.S.C § 300g1(b)(3)(A)]: EPA must use "[t]he best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices," and "[d]ata collected by accepted methods or best available methods (if the reliability of the method and the nature of the excision justifies use of the data)."
 [42 U.S.C. § 300g1(b)(1)(b)(ii)]: EPA must use "best available public health information" in determining whether to regulate contaminants.
This statutory provisions link the concept of the "best available science" to the availability of underlying raw data, nor can such a limitation be read into the statutes. Where Congress wanted to direct EPA's decision regarding what science to consider or how -- it did so. When Congress wanted to link "best available science" to data being publicly available -- it did so. Thus, if Congress had wanted to put a blanket limitation on EPA's consideration of science for which underlying data is not publicly available, it clearly knew how to do so -- and it chose not to.
As EPA has previously explained, the agency would be unable to fulfill statutory mandates if it could not consider studies that follow federal laws and ethical standards regarding the privacy of patient and individual data:
If EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment. . . . [S]uch data are often the property of scientific investigators and are often not readily available because of the proprietary interests of the investigators or because of arrangements made to maintain confidentiality regarding personal health status and lifestyle information of individuals included in such data. Without provisions of confidentiality, the possibility of conducting such studies could be severely compromised.
The Proposal would also cut EPA off from information needed to complete the cost-benefit analysis of regulations required under certain statutes and government-wide requirements.
Not only would the Proposal impede EPA's fulfillment of its statutory duties, but 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 [9217-3562]: 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 [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 [6168-4099]: Commenter (6178) notes that the NPRM proposes to establish a new EPA regulation that will `ensure the data and models underlying the science pivotal to what the Agency deems `significant regulatory actions' is publicly available in a manner sufficient for validation and analysis', hereinafter referred to as the `Transparency Rule' or `Rule'. Specifically, they wish to raise the following concerns with the Transparency Rule proposed by the NPRM:
      1. The Agency cites specific sections of statutes it administers as the basis of the Agency's authority to adopt the Transparency Rule; specifically SDWA sections 1442. 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.
      2. 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.
      3. Further, not only does the Transparency Rule lack sufficient Congressional intent to avoid being deemed arbitrary and capricious, implementing the Rule would actually contradict Congressional instruction to conduct scientific research with a focus on `promotion' and `coordination' among itself and other institutions that produce scientific research material to the objectives of the Acts Congress requires the EPA to enforce. This provides additional cause for finding the Transparency Rule arbitrary and capricious under the APA.
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 [8750-1661]: Commenter (9227) writes that EPA arbitrarily failed to consider the implications of this proposal on interagency coordination.
Additionally, EPA arbitrarily failed to consider the far-reaching implications this Proposal could have on inter-agency coordination and consultation given that other agencies normally rely on research potentially excluded by the Proposal. In the numerous environmental statutes that EPA cites, there are dozens of provisions that require EPA to coordinate or consult with other Federal entities -- especially when implementing research programs and issuing information or guidelines. The Proposal would almost certainly frustrate and impair this coordination and consultation, either by forcing EPA to ignore the science provided by other agencies or by severely restricting the science that EPA itself would be able to share with other agencies in these statutorily required processes. The Proposal arbitrarily ignores these potential impacts.
In addition to the many examples of statutorily required consultation that are identified in Appendix B of the commenter's comment letter, other federal agencies routinely incorporate and rely upon EPA science assessments in their own efforts to carry out their mandates to protect human health and safety. As with statutorily required consultations, the Proposal utterly fails to acknowledge or consider what impacts restricting EPA's own use of dose-response studies would have on the work of these other agencies. Indeed, there is no evidence that these other agencies were even permitted to comment on the Proposal as part of the usual process of interagency review.
Some selected examples of other federal agency programs that rely on EPA science include:
 FDA also regulates contaminants in bottled water under the FFDCA Section 410 of the Act requires that FDA regulations for bottled water be issued in coordination with the effective date of NPDWR issued under the SDWA and be no less protective of public health than those standards. If the Proposal impedes EPA's work to establish drinking water standards, this may affect FDA's own ability to justify protective bottled water standards.
Comment [6428-1351]: Commenter (6450) writes that the proposed rule is not merely a disastrous policy choice, given its threats to public health and the integrity of EPA decision-making, but it is plainly unlawful. EPA clearly lacks the authority to issue the proposal. EPA cites to various provisions in federal law to justify its authority but, in virtually every case, the agency refers to sections that authorize or mandate EPA to undertake research, not to impose arbitrary limitations on the scientific data that informs public health decisions. EPA also cites to statutory provisions authorizing it to promulgate rules "necessary" to achieving the goals of relevant statutes but restricting the use of sound science is neither necessary nor consistent with the statutory goals of protecting clean air, clean water, and a safe environment. Indeed, the proposed rule directly contradicts the specific mandate of numerous federal laws, such as the SDWA and the TSCA, which require EPA to use the "best available" science or all "reasonably available" science and information in its decision-making.
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. The SDWA sections 1442, 1450(a)(1), 42 U.S.C. 300j - 1, 300j -  9(a)(1). 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.
Statute Provisions on Peer Review
SDWA
§ 300g-1. National drinking water regulations

(b) Standards

(3) Risk assessment, management, and communication
(A) Use of science in decision-making in carrying out this section, and, to the degree that an Agency action is based on science, the Administrator shall use--
(i) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and(ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data).

(B) Public information
In carrying out this section, the Administrator shall ensure that the presentation of information on public health effects is comprehensive, informative, and understandable. The Administrator shall, in a document made available to the public in support of a regulation promulgated under this section, specify, to the extent practicable--
(i) each population addressed by any estimate of public health effects;
(ii) the expected risk or central estimate of risk for the specific populations;
(iii) each appropriate upper-bound or lower-bound estimate of risk;
(iv) each significant uncertainty identified in the process of the assessment of public health effects and studies that would assist in resolving the uncertainty; and
(v) peer-reviewed studies known to the Administrator that support, are directly relevant to, or fail to support any estimate of public health effects and the methodology used to reconcile inconsistencies in the scientific data.
[...]

(12) Certain contaminants
(B) Sulfate
(i) Additional study Prior to promulgating a national primary drinking water regulation for sulfate, the Administrator and the Director of the CDC shall jointly conduct an additional study to establish a reliable dose-response relationship for the adverse human health effects that may result from exposure to sulfate in drinking water, including the health effects that may be experienced by groups within the general population (including infants and travelers) that are potentially at greater risk of adverse health effects as the result of such exposure. The study shall be conducted in consultation with interested States, shall be based on the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices, and shall be completed not later than 30 months after August 6, 1996.

42 U.S.C. § 300g-1 (emphasis added).

§ 300j-2. Grants for State programs

(d) New York City (NYC) watershed protection program
(1) In general The Administrator is authorized to provide financial assistance to the State of New York for demonstration projects implemented as part of the watershed program for the protection and enhancement of the quality of source waters of the NYC water supply system, including projects that demonstrate, assess, or provide for comprehensive monitoring and surveillance and projects necessary to comply with the criteria for avoiding filtration contained in 40 C.F.R. 141.71. Demonstration projects which shall be eligible for financial assistance shall be certified to the Administrator by the State of New York as satisfying the purposes of this subsection. In certifying projects to the Administrator, the State of New York shall give priority to monitoring projects that have undergone peer review.

42 U.S.C. § 300j-2 (emphasis added).
<IP_ADDRESS> SWDA (SNPRM Comments)
Comment [23-84]: Commenter (10973) writes that additional review of alignment to statutory requirements is needed.
On 85 FR 15398, the proposal indicates that "this internal agency procedure is intended to be consistent with the statues that EPA administers and EPA plants to implement this procedural rulemaking in accordance with all applicable statutory and regulatory requirements." This statement is appreciated, and we encourage EPA to provide additional analysis to confirm alignment with these requirements.
As noted in our 2018 comments, the SDWA requires that regulatory decisions be based upon "(i) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and (ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data)." (Sec. 1412 (b)(3)(A)). SDWA does not distinguish peer-reviewed science that has data and models that are publicly available from those where data and models may not be publicly available. Other environmental statues have similar provisions which should also be carefully considered.
The current proposal in general is more flexible than the 2018 version in providing additional guidance on situations where "tiered access" can be established and/or EPA can waive the requirements for publicly available information, which will help to reduce potential conflicts between this Agency policy and statutory requirements. In finalizing this rule, a more formal assessment of potential conflicts between this policy and statutory language should be completed to assure that this policy does not hamper important regulatory decisions in SDWA or elsewhere. Additionally, by using EPA's alternate approach for prioritizing publicly available data and models but not eliminating those that are not, potential conflicts can be reduced further.
Comment [48-2185]: 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 the SDWA generally requires EPA to use "the best available, peer-reviewed science,"
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 [81-2187]: Commenter (12715) writes that the proposed rule conflicts with fundamental statutory requirements to use the best available science and citation to "housekeeping" authority cannot cure that defect.
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 best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices," SDWA of 1996, 42 U.S.C. § 300g-1(b)(3)(A)(i). 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 [82-2084]: Commenter (12464) writes that the cited provisions do not authorize EPA to promulgate the proposal.
"[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 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 [89-2194]: Commenter (11403) writes that the proposed rule is not based on any valid statutory authority and is arbitrary and capricious.
a. The environmental statutory provisions cited by EPA do not authorize the proposed rule
EPA's 2018 version of this rule cited a hodgepodge of statutory authority, none of it valid. EPA at least corrected the obvious typographical errors from the previous version. However, those edits still do not grant EPA the authority to restrict science from all regulatory decision-making processes within the agency. EPA is attempting to use general grants of authority to create a completely novel approach to assessing science. However, as the Supreme Court has stated, "Congress . . . does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions -- it does not, one might say, hide elephants in mouseholes." EPA does not have the authority to alter the fundamental details of all of its regulatory schemes based on such vague provisions of law. Section 1442 of the SDWA generally authorizes the Administrator to "conduct research, studies, and demonstrations relating to the causes, diagnosis, . . . and other impairments of man resulting directly or indirectly from contaminants in water, or to the provision of dependably safe supply of drinking water . . ." This section does not authorize EPA to exclude science based on a perceived lack of transparency or support any other aspect of the proposed rule.
Section 1450(a)(1) of the SDWA states, "The Administrator is authorized to prescribe such regulations as are necessary or appropriate to carry out his functions under this subchapter." 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 the functions under the SDWA.
In short, none of the statutory provisions cited by EPA provide authority for the proposed rule. The proposed rule fails at step one under Chevron v. Natural Resources Defense Council since it is unreasonable to believe that any statutory general grant of authority or any mention of EPA's oversight of other science or research programs would enable EPA to conduct rulemaking in a way that is altogether inconsistent with the rule of law. None of the cited provisions provide the authority sought by EPA, and as such the proposed rule should be withdrawn.
Comment [93-2087]: Commenter (11395) notes that the SDWA stipulates that, in risk assessment, management and communication actions that are based on science, "the Administrator shall use the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices" and defines "best available science," as "science that is reliable and unbiased ... conducted in accordance with sound and objective science practices, including, when available, peer reviewed science and supporting studies and data collected by accepted methods or best available methods." (40 CFR 300g-1) Again, a rule that precludes that use of high-quality peer reviewed studies in significant actions would contradict the SDWA language.
Comment [97-2150]: Commenter (11479) writes that the proposed rule, as modified in the supplemental notice, would clearly interfere with the agency's use of the best available science. For example, the policy violates laws like the TSCA and the SDWA because of the statutory requirement to use the "best available science." That requirement does not make exception for the agency to effectively ignore certain scientific information of high quality simply because the unanalyzed data cannot be made public for reasons of privacy, confidentiality, or intellectual property. According to judicial precedent, "best available science" is defined as "all existing scientific evidence relevant to the decision" and a body of evidence that "cannot ignore existing data."
In fact, virtually all of EPA's statutory mandates require the use of the best available scientific evidence. Congress did not state in any of these laws that the agency shall only consider scientific evidence derived from studies where the underlying unanalyzed data is publicly available, nor that the evidence considered should be solely at the Administrator's discretion.
Comment [125-2200]: Commenter (11495) writes 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. For example, the SDWA requires that the issuance of national drinking water regulations be based on the "best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices."
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 [156-1380]: Commenter (12418) writes that making regulatory determinations based on whether a study has publicly available data and models instead of on the quality of the study conflicts with existing statutory mandates.
Giving more consideration to studies where "underlying data and models are available" does not fulfill EPA's requirement to protect public health from harmful substances in air, water, and other media using the best available science. The laws that EPA administers to protect the public from harmful substances in the environment provide guidance on how scientific evidence is incorporated into rulemaking. Under the statutory text of the SDWA, EPA must identify whether drinking water contaminants present a threat to public health using "the best available, peer-reviewed science" and the decision to regulate a contaminant must be based on the "best available public health information." In the context of developing MCL, this process involves an extensive literature review of the available evidence, identification of the highest quality studies for sensitive health effects, and selection of a critical study that will serve as the basis of regulatory values.
In the Supplemental Notice of Proposed Rulemaking (SNPR), EPA has failed to identify how relying more heavily on data and models that are publicly available fulfills these statutory mandates to use the best available science in decision making. EPA presents no evidence that studies in which the underlying data and models are publicly available are more valid or credible in a manner sufficient to justify greater consideration than studies where the underlying data are not available. Lacking in empirical support, the proposed rule conflicts with legal requirements for EPA's use of science in regulatory decision-making.
Comment [159-2090]: Commenter (12430) notes that in the SNPRM, U.S. EPA proposes to consider only (or, in the alternative, more heavily weight) studies and models with publicly available data. However, restricting agency consideration of scientific studies and models would run afoul of U.S. EPA's obligations under many of its operating statutes to rely on the best available science. For example:
 The SDWA requires that findings which support a determination to regulate a contaminant "be based on the best available public health information" and that, in developing the NPDWR, "to the degree that an Agency action is based on science, the Administrator shall use the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices."
Comment: [187-1704]: Commenter (12720) notes that EPA cites 42 U.S.C. § 300j - 1 of the SDWA as authority for the rule. Subsection (a) of that section allows EPA to conduct some types of research on drinking water contamination and requires it to conduct other studies. But it says nothing about which types of studies EPA may consider in rulemakings and does not distinguish between dose-response studies and other types of studies. The absence of any such congressional distinction or restriction makes it all the more obvious that EPA invented and added the distinction and restrictions in the Proposal and Supplemental Proposal as a matter of its own policy preferences, contrary to the Act. This EPA may not do. The remainder of the subsections have nothing to do with data or research. At any rate, EPA does not state specifically which of the subsections in 42 U.S.C. § 300j - 1 it believes authorizes this proposed rule. Thus, the citation fails to provide sufficient notice for the public to comment on the proposed rule.
EPA also cites 42 U.S.C. § 300j - 9(a)(1), but that says only that the "Administrator is authorized to prescribe such regulations as are necessary or appropriate to carry out his functions under this subchapter." As explained above, that general grant of authority cannot support the rule, especially when the rule conflicts with the Act. The SDWA does not authorize the proposed rule.
Comment [198-2210]: Commenter (13549) writes that as a baseline, whether working on "significant regulatory actions," ISI, or anything requiring the consideration of science, EPA must base its decisions on the best available science. Anything less is nonsensical, arbitrary, and in violation of the environmental laws EPA is charged with implementing. The SNPRM does not maintain this baseline, but instead provides for ways EPA would exclude and lessen consideration of the best available science. Therefore, the SNPRM, along with the proposed rule, must be withdrawn. See, e.g., 42 U.S.C. § 300g-1(b)(1)(B)(ii), (3)(A) (SDWA provisions requiring regulation of contaminants based on best available science); 15 U.S.C. § 2625(h) (TSCA provision requiring the use of best available science); see also 83 Fed. Reg. at 18,769 ("The best available science must serve as the foundation of EPA's regulatory actions.").
1.3.4 Toxic Substances and Control Act (TSCA) (NPRM and SNPRM Comments)
Comment: Sections <IP_ADDRESS> and <IP_ADDRESS> of this Chapter present comments received on the NPRM (Section <IP_ADDRESS>) and SNPRM (Section <IP_ADDRESS>) related to the EPA's legal authority for the rule under the TSCA. The EPA provides the following general response to these comments:
Response: EPA appreciates your comments. As discussed in the Section I.C of the final rule preamble and in this RTC document in Section 1.2, EPA has decided it is most appropriate to rely on its authority to promulgate housekeeping regulations, rather than any of the substantive environmental statutes cited in the 2018 proposal or the 2020 supplemental proposal as legal authority for the rule. EPA intends to promulgate future science transparency rules under its substantive environmental statutes. Additionally, the final rule states in § 30.3 that "[i]n the event the procedures outlined in this rule conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control."
<IP_ADDRESS> TSCA (NPRM Comments)
Comment [37-33]: Commenter (0046) writes that while TSCA Section 26 is not identified in the proposal, it includes provisions that raise questions about EPA's authority for and potential application of the proposal. Section 26(h), "Scientific Standards", states that "to the extent that the Administrator makes a decision based on science, the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science." EPA must consider each of these factors "as applicable." The availability of sufficient underlying data to "validate" or "reproduce" study results is not among the relevant factors that EPA must consider.
Similarly, section 26(i) addresses WEIGHT OF SCIENTIFIC EVIDENCE directing that:" -- The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence." This requires the Administrator to evaluate the totality of available scientific evidence and make a judgment about its "weight"  -  not excluding evidence based solely on the availability of data sufficient for its validation.
These subsections indicate, at a minimum, that this proposal to require that "dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation...[w]hen promulgating significant regulatory actions" may not be consistent with the scientific standards and methodology for decision-making Congress prescribed for such actions under TSCA Section 26.
Comment: [996-3804]: Commenter (1011) believes that the proposed rule would create unnecessary difficulties for EPA and its ability to comply with statutes that rely upon the assessment of the best scientific data currently available. This includes the LSCA, which updates the TSCA and requires the Administrator to use "scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science." EPA should reconsider this proposed rule to ensure that any new guidelines comply with applicable laws and encourage the use of all relevant scientific information, even if the underlying data cannot be made public.
Comment [2322-2720]: Commenter (2337) notes that EPA's core mission, reflected in numerous environmental statutes, is to protect public health and the environment. These same statutes require that EPA, in fulfilling this mission, support and rely on the best available science. While the specific terms of each statute vary, their direction is similar: EPA is charged with conducting and supporting research into the impacts of pollutants on human health and the environment, using available scientifically accepted data to determine when pollutants pose a danger to human health or the environment, and establishing standards with a sufficient margin of safety to protect public health. Indeed, this requirement that EPA use the latest or best available science is repeated in numerous environmental statutes. The TSCA directs the Administrator, when making decisions based on science, to act "in a manner consistent with the best available science" and consider a number of factors, including the reasonableness of the methods used to develop the information, the completeness of the data, the extent of uncertainty, and independent verification or peer review. Notably, public availability or independent verification are not disqualifying requirements.
Comment [2533-4926]: Commenter (2548) writes that they have spent the past eighteen years of their career as a faculty member at highly ranked research universities (The University of North Carolina at Chapel Hill and Duke University) and have devoted the majority of this time to studying the potential health effects of exposures in the natural and built environments. They have served as President of the largest professional organization of biostatisticians in North America, as Chair of the Biometrics Section of the American Statistical Association, and as a standing member of numerous review groups at the NIH. They are currently a member of the National Academies' Committee on Applied and Theoretical Statistics and have recently chaired selection committees for two of the top prizes in statistical science worldwide.
Their major concern regarding the proposed rule is that it violates the reformed TSCA, and indeed more importantly the best principles of science, in eliminating from consideration a class of studies that offer both large-scale population coverage and careful exposure assessment. These studies often provide our best information regarding potential health effects of environmental contaminants. In environmental health research, many research questions (e.g., health effects of smoking, exposure to high levels of other air pollutants) cannot be evaluated in randomized controlled trials of humans for ethical reasons. In such cases, large observational cohort studies typically provide the best "real world" data on associations between environmental contaminant levels and health outcomes like heart attack, stroke, asthma, and premature death.
Comment [2772-2263]: Commenter (2787) writes that the proposed rule is inconsistent with EPA's statutory obligations to ground its actions on scientific evidence. The TSCA and the SDWA require that EPA use the "best available science."
Comment [2887-4671]: Commenter (2902) writes that many questions remain as to whether the proposed rule violates existing laws, such as the TSCA. The rule, as written, appears poorly designed and without the mission of the EPA in mind.
Comment [4582-4139]: Commenter (4593) writes that if EPA had adopted this data transparency limitation in past risk assessments, EPA would not have been able to take many of its historic actions to protect children, families, and the environment such as reducing or eliminating the exposure of children to lead in paint, gasoline and drinking water and promulgating protective air quality standards for PM and other air pollutants.
The proposed policy would affect assessments that will soon be carried out under TSCA Section 6. TSCA gives EPA the authority to regulate the manufacture, processing, distribution in commerce, use and disposal of chemicals. The problem formulation documents which set forth EPA's approach for assessing the first 10 chemicals under the amended TSCA are open for public comment now. How these chemicals are assessed will be the model for future assessments. The proposed policy would in fact make it impossible for EPA to consider the full array of well conducted and peer reviewed scientific studies of the health and environmental effects of pollution. It would bias the body of information in favor of industry supplied studies since they would have the means to provide the underlying data. Assessment of all relevant scientific information is essential in making sound judgments about protecting public health and the environment and is a legal requirement in all major environmental legislation.
TSCA also contains provisions to require chemical manufacturers to test the chemicals that they manufacture or process. To require industry to test chemicals under Section 4, EPA must make a set of legal findings.
It is the data inadequacy finding that we are interested in today for it is the nexus between TSCA and the proposed transparency policy. To make this finding, EPA conducts a thorough literature search and usually issues a rule to require studies that have not been published be submitted to the Agency. The bulk of the information considered, however, is typically studies published in peer-reviewed scientific journals. Despite being accepted by the scientific community, these studies do not meet the proposed transparency requirements of the proposed rule, since it requires that all raw underlying data and the models used to analyze data supporting the study are available for public review. Thus, if the transparency rule were in effect, EPA would have to judge studies from peer reviewed journals as inadequate. Ignoring this large category of information would cost industry hundreds of millions of dollars to repeat perfectly good, scientifically acceptable studies, which the public would ultimately pay for through higher prices. And it would significantly delay or, in some cases, preclude assessment and regulation of risks to human health and the environment.
Comment [4827-2074]: Commenter (4838) writes that the proposed rule violates several environmental statutes because it hinders EPA's ability to rely on best available science, or the most up-to-date information, as they require. The CAA, CWA, SDWA, TSCA, and EPCRA all require certain decisions or regulatory criteria be based on the most up-to-date science. These criteria are described as "best available science," "latest scientific knowledge," and "best available public health information." The proposed rule would illegally limit EPA's ability to rely on best available science in violation of these statutes.
Comment [4837-3059]: Commenter (4848) notes that administrative procedure requires that EPA consider data submitted by the public in evaluating regulations. Scientific studies submitted have always been of uneven quality. EPA has processes in place (including use of a scientific advisory board, testimony and written and oral public notice and comment) using both internal and external peer review to evaluate data. Depending on context, some studies are given greater weight than others. Some studies are disregarded entirely.
It is inappropriate, and likely unlawful under the APA and the express language of numerous environmental statutes including the SDWA and the TSCA, for EPA to categorically eliminate certain types of studies, and hence certain types of data, without considering context.
Comment [4867-2026]: Commenter (4878) notes that the TSCA is EPA's primary authority for regulating non-pesticide chemicals. Under TSCA, EPA can secure information on new and existing chemicals and regulate chemicals it determines pose an unreasonable risk to public health or the environment. All studies used would be subject to the proposed rule.
In late 2016, the EPA moved to ban toxic chemical trichloroethylene (TCE) due to health risks, including a risk of Parkinson's disease, though this action is still pending. The original recommendation was based on hundreds of studies, many of which would not be considered under the proposed rule.
For example, one study sent questionnaires to 134 people who had formerly worked on a site with heavy and long-term exposure to TCE. Fourteen had signs of Parkinson's disease, and an additional thirteen showed mild features of the condition, far more than expected given the population. Another asked twin pairs about exposure to solvents including TCE and showed a significant association between TCE exposure and Parkinson's disease risk.
In these relatively small studies, a distinctive characteristic  --  people who all worked together, and twins  --  respectively, combined with the most basic additional medical information could render the participants identifiable. Both of the TCE studies are highly cited and the findings have been replicated. To exclude this evidence that TCE exposure is a risk factor for Parkinson's disease is illogical and does not serve the best health interests of the American public.
Furthermore, the proposed rule does not comply with the letter of TSCA. TSCA and other statutes administered by EPA requires the agency use the "best available science" and none require the agency to access to raw data. TSCA additionally requires that EPA consider all information that is reasonably available to the administrator. As drafted, the proposed rule violates these statutes because it would force the agency to ignore some of the best information available.
Comment [5865-330]: Commenter (6111) writes that EPA's historic position is consistent with the Statutes. The TSCA requires that regulation of chemical substances be "consistent with the best available science" and that EPA make decisions "based on the weight of the scientific evidence."
Furthermore, because EPA is required under the Statutes to assess the public health benefits of its regulations, it must take into account all relevant science and cannot arbitrarily exclude certain studies demonstrating those benefits.
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 were not or could not have been released. Attachment 1 to this letter contains a partial list of studies [note: included under a separate excerpt] that likely contain confidential data; these are all studies on which EPA has relied and cited as the basis for its actions under some of the Statutes. Until now, release of the underlying raw data was not an EPA criterion for determining the "best available" reports, studies, analyses, or models. Indeed, none of the Statutes invoked by EPA as support for the proposed rule limits EPA in this fashion; none of the Statutes requires EPA to make raw data publicly available.
EPA's proposed new approach, which conflicts with the agency's obligations and curtails its authority, is irrational at best and detrimental to public health and safety at worst.
Comment [6093-532]: Commenter (6103) writes that the rule is counter to mandates in the reformed TSCA and other authorizing laws to use the best available science. Many of the statutes implemented by the EPA require the use of "best available science." This rule would actually undermine the use of best available science as called for in the statutes. As a result, the policy as drafted would be in violation of laws like the TSCA and the SDWA because the proposal would allow for the agency to ignore some of the best information that could help implement these laws.
Comment [6112-1557]: Commenter (6137) writes that EPA's reliance on the TSCA, 15 U.S.C. § 2609, as authority for the Proposed Rule, fares no better. Indeed, much like many of the other statutory provisions upon which EPA relies, this provision governs EPA's authority to conduct and support research and does not address EPA's authority to use scientific data or research in support of regulatory decisions.
Specifically, section 2609 grants EPA authority to "conduct such research, development, and monitoring as is necessary to carry out the purposes of this chapter. [EPA] may enter into contracts and may make grants for research, development, and monitoring under this subsection." 15 U.S.C. § 2609(a). Section 2609 grants EPA additional related authorities, including authority to:
 Create and operate information systems to store data relevant to chemical substances, id. § 2609(b);
 Develop "screening techniques for carcinogenic, mutagenic, teratogenic, and ecological effects of chemical[s]," id. § 2609(c);
 Establish a research program to develop chemical "monitoring techniques and instruments," id. § 2609(d);
 Conduct "basic research" on chemical screening and monitoring, id. § 2609(e), and train federal scientists on chemical screening and monitoring, id. § 2609(f); and
 Develop systems for information sharing among "Federal, state, and local authorities," id. § 2609(g).
Notably absent from the list of authorities under section 2609 is EPA's authority to determine what science it can consider when making regulatory decisions. Instead, the provision solely focuses on EPA's ability to conduct research or to fund research, independent of whether that research will or may be used by EPA to make regulatory decisions. Thus, section 2609 does not provide any basis for the authority claimed in the Proposed Rule.
Moreover, § 2625 of TSCA governs how EPA uses science when exercising its main regulatory powers under the statute and establishes detailed criteria that EPA must use when "the Administrator makes a decision based on science" when carrying out its regulatory powers. 15 U.S.C. § 2625(h). Thus, this provision, and not those cited by EPA, would theoretically govern a rule related to the use of science. See Bennett v. Islamic Republic of Iran, 618 F.3d 19, 25 (D.C. Cir. 2010) ("`where Congress includes particular language in one section of a statute but omits it in another section of the same Act, it is generally presumed that Congress acts intentionally and purposefully in the disparate inclusion or exclusion.'" (quoting Russello v. United States, 464 U.S. 16, 23 (1983)). However, and as discussed more fully infra, Section IV.A, the Proposed Rule contravenes the requirements of § 2625 that EPA consider all "reasonably available information" when making regulatory decisions, and thus is not authorized by this provision either.
Comment [6112-1600]: Commenter (6137) writes that EPA's proposed refusal to consider or use science relevant to decisions that will affect public health directly contravenes the newly enacted revisions to TSCA. Numerous provisions of TSCA make clear that EPA may not prohibit the consideration of non-public data in regulatory decision-making under TSCA. Indeed, when viewed as a whole, TSCA establishes a comprehensive scheme for how EPA is to evaluate and use science in making regulatory decisions that forecloses the Proposed Rule.
First, TSCA requires EPA to consider all "reasonably available information" when making any regulatory decisions under sections 2603, 2604, and 2605. 15 U.S.C. § 2625(k) (emphasis added) (EPA "shall take into consideration information relating to a chemical . . . that is reasonably available to [the Agency]"); also, id. § 2605(c)(2)(A). Thus, the statute mandates that if a study is reasonably available to EPA, EPA must consider it when making a significant regulatory decision under these provisions of the statute. Whether the data underlying a scientific study is publicly available has no bearing on whether the study itself is reasonably available to EPA. Because the Proposed Rule purports to apply to all significant regulatory decisions made by EPA under TSCA  -  including those made under these provisions  -  it is unlawful.
Second, when making any regulatory decision under sections 2603, 2604, and 2605, TSCA requires EPA to make an individualized evaluation of any information reasonably available to the Agency, and thus, prohibits the blanket ban erected in the Proposed Rule. Section 2625(h) establishes five statutory factors that EPA must consider when "mak[ing] a decision based on science." 15 U.S.C. § 2625(h)(1)-(5). One of these statutory factors expressly addresses situations in which non-public scientific data is before the Agency and requires the Agency to "consider . . . the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models." Id. § 2625(h)(5). In addition, EPA must consider whether the methodologies used to collect the data are "reasonable," id. § 2625(h)(1), and the "degree of clarity and completeness" with which the methods used were documented, id. § 2625(h)(3). In sum, Section 2625(h) requires EPA to review each scientific study on a case-by-case basis to determine whether and how to use it. This case-by-case evaluation requires EPA to consider the public or non-public nature of the underlying data as one of many factors and prohibits EPA from implementing a blanket ban on the use of non-public data in significant regulatory decisions under TSCA.
Third, the Proposed Rule is at odds with the requirement that EPA act "consistent with the best available science." Id. § 2625(h) (emphasis added). Although Congress did not define the term in TSCA, it is clear from other statutes that an agency cannot lawfully act consistent with the best available science when it categorically bars consideration of any science based on non-public data. For example, the ESA requires federal agencies to consider the "best scientific and commercial data available," see 16 U.S.C. § 1536(a)(2), and courts have held that this provision requires an agency to consider "all relevant data . . . even when it is imperfect, weak, and not necessarily dispositive." League of Wilderness Defenders/Blue Mountains Biodiversity Project v. Connaughton, 752 F.3d 755, 763-64 (9th Cir. 2014) (emphasis added); see also Bldg. Indus. Ass'n of Superior Cal. v. Norton, 247 F.3d 1241, 1246 (D.C. Cir. 2001) (an agency "must utilize the `best scientific . . . data available,' not the best scientific data possible") (emphasis in original). EPA itself acknowledged that this sort of restriction on science is contrary to the requirements of TSCA; when analyzing the same restrictions proposed in the HONEST Act, EPA recognized:
Provisions under the newly amended TSCA . . . would be significantly impacted by the HONEST Act. First, a number of provisions in section 26 could not be upheld under the HONEST Act. Section 26(h) requires the Agency to "use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with best available science." . . . [T]he HONEST Act would not allow EPA to use the best available science. Section 26(i) requires the Agency to use the "weight of scientific evidence" in making decisions under TSCA, and EPA believes this would not be possible given that the provisions of the HONEST Act would prohibit the use of some data. Finally, section 26(k) requires the Agency to "take into consideration information relating to a chemical substance or mixture, including hazard and exposure information, under the conditions of use, that is reasonable available." EPA would be in violation of the HONEST Act when upholding these provisions under TSCA, namely instead of using the best available science and all reasonable available data for chemical regulations, EPA would be restricted to selecting information based on availability. This approach would introduce research bias that would compromise the quality of the Agency's work.
EPA, EPA Analysis of HONEST Act to CBO at 3-4 (2016), https://www.scribd.com/document/344731162/EPA-analysis-of-Honest-Act-to-CBO (emphasis added).
Indeed, where Congress has sought to qualify a best available science requirement by implementing a total bar on particular types of science, it has done so expressly. For example, in the Consumer Productive Safety Improvement Act of 2008, Congress directed a panel studying phthalates to use "the most recent, best-available, peer-reviewed, scientific studies." 15 U.S.C. § 2057c(b)(2)(B) (emphasis added). The absence of any such prohibition in TSCA is further proof that the Proposed Rule is prohibited by the statute's best-available-science requirement.
Fourth, the Proposed Rule is inconsistent with the TSCA requirement that EPA make regulatory decisions using a "weight of the scientific evidence" approach. Id. § 2625(i). As EPA has itself recognized, this approach requires the Agency to individually evaluate the strengths and weakness of any study reasonably available to the Agency. 40 C.F.R. § 702.33 (defining "weight of scientific evidence" as "comprehensively, objectively, transparently, and consistently, identify[ing] and evaluat[ing] each stream of evidence, including strengths, limitations, and relevance of each study and "integrat[ing] evidence as necessary and appropriate based upon strengths, limitations, and relevance" for purposes of risk evaluations under 15 U.S.C. § 2605 (emphasis added)). Thus, the Proposed Rule's outright ban on consideration of scientific studies that rely on non-public data is prohibited by the weight of the scientific evidence approach required under TSCA.
In sum, these provisions  -  considered together and in light of other provisions of the statute  -  establish a comprehensive scheme for how EPA is to consider scientific data, and this scheme prohibits the Proposed Rule's ban on the consideration of non-public data. Together, they require EPA to consider all reasonably available scientific information; evaluate each piece of information, including the methods by which it was acquired and analyzed; use each piece of information in a manner consistent with the best available science; and give each piece of information its due weight.
In addition, in deciding whether or not "there may be a reasonable basis to conclude that a chemical substance or mixture presents a significant risk of serious or widespread harm to human beings," EPA must consider "any . . . information available to the Administrator." 15 U.S.C. § 2603(f). And other provisions of TSCA expressly address certain types of non-public data and authorize EPA to consider it in making regulatory decisions. See 15 U.S.C. §§ 2604(b), 2613.
In light of the numerous provisions of TSCA addressing the consideration of scientific data, it is evident that if Congress had intended to allow EPA to bar the consideration of nonpublic data, it surely would have said so expressly. Given the comprehensiveness of these provisions providing otherwise, there is simply no room for a blanket ban on science that relies on non-public data. The Proposed Rule is therefore unlawful.
Comment [6112-1625]: Commenter (6137) writes that EPA failed to follow the procedural requirements under TSCA.
Pursuant to section 2609 of TSCA, prior to promulgating any rules, EPA must "consult[] and cooperate[] with the Secretary of Health and Human Services and with other heads of appropriate departments and agencies." 15 U.S.C. § 2609(a); see also id. § 2609(b)(2)(A), (c), (d), (e), (g). Therefore, to the extent EPA relies on TSCA as authority for the Proposed Rule, it must consult and cooperate with the Secretary of HHS. Yet nowhere in the Proposed Rule does EPA indicate that it has done so. Failure to comply with this requirement would render any final rule unlawful. See 5 U.S.C. § 706(2)(D) (a reviewing court "shall . . . hold unlawful and set aside agency action . . . found to be . . . without observance of procedure required by law").
Comment [6118-1732]: Commenter (6143) notes that EPA has issued its proposed rule on Strengthening Transparency in Regulatory Science pursuant to its authority under several environmental statutes that that it implements, including the CAA; CWA; SDWA; RCRA; CERCLA; EPCRA; FIFRA; and TSCA. This proposed action is fully consistent with the authorities and objectives laid out in those statutes. EPA must ensure that any final action it takes on this proposal continues to respect the balance reflected in those statutes between sound, transparent science, and legitimate privacy interests.
Comment [6118-1733]: Commenter (6143) notes that in its proposal, the Agency recognizes that "[t]he best available science must serve as the foundation of EPA's regulatory actions." This is true not only as a matter of good governance, but as a statutory requirement. In particular, TSCA requires EPA to "use scientific information, technical procedures, measures, methods, protocols, methodologies, or models . . . in a manner consistent with the best available science" when making regulatory decisions that are based on science. Further, Congress directed EPA to consider the following five specific factors in doing so:
 the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information;
 the extent to which the information is relevant for the Administrator's use in making a decision about a chemical substance or mixture;
 the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented;
 the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and
 the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models.
Comment [6118-1734]: Commenter (6143) writes that EPA's proposed action will help the Agency to carry out TSCA's requirements regarding the use of the "best available science." By ensuring greater transparency into the data, assumptions, and methodologies used in the studies on which EPA relies, this proposed rule will facilitate EPA's analysis of the factors specified in TSCA §26(h) -- particularly with respect to suitability, documentation, and consideration of uncertainty and variability.
The concern that some opponents of this proposed action have expressed -- that it will inhibit or preclude use of certain studies that they believe to be relevant and useful, but for which data sufficient to permit independent verification are not publicly available -- should be offset by recognizing that it is an explicit intent of the Agency to rely on the best available science. Science, studies, and conclusions from data that are not available for independent verification do not meet this requirement. They are not suitable for use as a basis for rulemaking insofar as they cannot be independently inspected and verified.
As the Agency recognizes in its proposal, this greater transparency serves a dual function in EPA's efforts to implement its statutory duties. Greater transparency can help to "[strengthen] the integrity of EPA's regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions." By supporting application of the "best available science" analysis, the proposed rule will help EPA reach regulatory decisions grounded in sound, quality science that will withstand judicial review -- which, in the TSCA context, means decisions that are supported by "substantial evidence." At the same time, greater transparency will "enhanc[e] the public's ability to understand and meaningfully participate in the regulatory process." Public input is a fundamental part of the administrative process, and TSCA provides for public comment at multiple steps of the decision-making process under several of its provisions. The proposed rule will improve the public's access to data necessary to make informed comments on the science underpinning EPA's actions.
Comment [6119-1358]: Commenter (6144) writes that the policy, as drafted, is in apparent violation of laws like the TSCA and the SDWA because of the statutory requirement to use the "best available science" and allow the agency to effectively ignore certain information regardless of the quality of that work, that would help implement these science-based laws. According to judicial precedent, "best available science" is defined as "all existing scientific evidence relevant to the decision" and a body of evidence that "cannot ignore existing data." In addition to the "best available science" requirements, TSCA also requires EPA to take into consideration information "that is reasonably available to the Administrator." EPA's own regulations define that term as "information that EPA possesses or can reasonably generate, obtain, and synthesize . . . , whether or not that information is confidential business information, [sic] that is protected from public disclosure...." Not only would this proposed rule conflict with TSCA's mandate to consider the best available science, it would challenge the method by which EPA can review the weight of the scientific evidence which in rulemaking for TSCA is defined by a systematic review method. These reviews consider the entire body of scientific evidence, so the exclusion of certain studies based on whether the raw data and models are publicly available would render these reviews, as mandated, impossible.
Comment [6127-2244]: Commenter (6152) writes that the focus on reproducibility and limiting studies that contain personal health data would undermine worker health studies. Under the 2014 updates to the TSCA, EPA is required to assess worker exposures when the agency is evaluating the safety of chemicals. However, this proposal would essentially prohibit the use of epidemiology studies in that process because they are not considered reproducible in the same way as animal or toxicological tests.
Historically, epidemiology studies have been vital to identifying and protecting against harmful workplace exposures. An example from our union's history is the body of epidemiology research initiated through a labor and management partnership that identified the high incidence of bladder cancer among workers in the rubber industry. Subsequently those workers and employers worked together to reduce and eliminate the harmful chemical exposures causing occupational cancer.
Comment [6133-2162]: Commenter (6158) writes that the proposed rule likely violates federal laws that require the EPA to use the best scientific information available to it. EPA has a duty to use the best scientific information available under several laws. For example, the TSCA requires EPA to operate "in a manner consistent with the best available science" and make regulatory decisions based on the weight of the scientific evidence.
Comment [6143-2594]: Commenter (6168) writes that EPA's focus on transparency in dose-response science is inconsistent with its recent turn to secrecy.
Some brief examples include:
 As Environmental Data and Governance Initiative (EDGI) has documented, EPA has made less accessible or removed extensive information about climate change that had been available on EPA's website.
 EPA has failed to provide the information necessary for independent evaluation of its decisions under TSCA, e.g. EPA's recent decision to green light a new fragrance chemical despite a range of health concerns.
 EPA has pushed to delay releasing reports documenting harms of chemicals, e.g. formaldehyde and Per- and Polyfluoroalkyl Substances (PFAS).
 EPA has reduced opportunities for public participation by creating short comment periods and trying to circumvent public comment entirely.
 EPA's procedure for implementing TSCA is designed to limit the range of information included in regulatory decisions by limiting the sorts of uses/exposures that will be analyzed.
 EPA has drastically shifted influence away from the broader public and toward business interests, for example in private meetings and in appointments to SABs.
Especially under Scott Pruitt -- who was Administrator when this proposed rule was written and published -- EPA has been secretive, for example denying FOIA until required to release documents by courts. Pruitt's secrecy was famous: not telling reporters where he was speaking, not letting the press into events, hiding, and even changing his calendars, etc.
The litany of ways the EPA under the current administration has been secretive and has sought to limit information and evidence of chemical harms suggests that the idea of "transparency" grows not out of commitment to openness and public participation. Rather, it is being used here strategically, in bad faith, to limit the evidence used in regulatory decision-making and to undermine moves toward protective regulations.
Comment [6152-652]: Commenter (6122) writes that the proposed rule is not based on any valid statutory authority and is arbitrary and capricious.
EPA cites multiple statutory provisions in an attempt to support the proposed rule that it believes authorize this type of rulemaking, "including provisions providing general authority to promulgate regulations necessary to carry out the Agency's functions under these statutes and provisions specifically addressing the Agency's conducting of and reliance on scientific activity to inform those functions . . ." None of the specific statutory provisions provided by EPA provide specific authority for EPA to fundamentally rework the foundational processes it uses to assess and include/reject science. Indeed, if such authority existed, one would have expected EPA to have discovered this authority many decades earlier. Instead, EPA is attempting to use general grants of authority to create a completely novel approach to assessing science. However, as the Supreme Court has stated, "Congress...does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions -- it does not, one might say, hide elephants in mouseholes." And if this is true, neither can the EPA alter the fundamental details of all of its regulatory schemes based on such vague provisions of law. We review each of the provisions listed by EPA, none of which discuss transparency, dose response, pivotal regulatory science, benefit-cost calculation, or changing "agency culture," the stated goals of this rulemaking.
Section 10 of the TSCA grants the Administrator authority on research, development, collection, dissemination, and utilization of data. There is no mention of any type of research or data that should be excluded in order to carry out the purposes of the statute.
In short, none of the statutory provisions cited by EPA provide authority for the proposed rule. The proposal fails at step one under Chevron v. Natural Resources Defense Council and should be withdrawn as beyond the authority of the EPA.
Comment [6155-638]: Commenter (6125) notes that TSCA, in section 26(h), provides that in regulating "[t]he Administrator shall make decisions...based on the weight of the scientific evidence" and shall "take into consideration information...that is reasonably available to the Administrator." id at (j). The law grants EPA broad authority to act against any "unreasonable risk of injury to health or the environment" created by the use of a chemical substance or mixture. Congress directed EPA to make this unreasonable risk determination without considering costs, though costs become relevant later at the stage of regulation. This directive to consider health impacts alone makes science of even more relevance to an unreasonable risk determination than it might be under a different statutory approach, such as cost benefit balancing.
Congress addressed in detail the types of science that EPA should use. Specifically, Congress directed that to the extent the Administrator based a regulatory decision on science, the agency use information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science, and [to] consider as applicable --
 the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information;
 the extent to which the information is relevant for the Administrator's use in making a decision about a chemical substance or mixture;
 the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented;
 the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and
 the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models. 15 U.S.C. §2025 (h)
As noted above, Congress added that "[t]he Administrator shall make [regulatory] decisions...based on the weight of the scientific evidence," id at (i), and shall "take into consideration information...that is reasonably available to the Administrator." id at (j). Nowhere is the Administrator barred from considering studies for which underlying data may be unavailable. Quite the contrary. The Administrator is to evaluate studies based on a range of factors  --  including peer review, internal consistency of study methodology and how well uncertainties are characterized.
The proposed rule is inconsistent with and would lead to decisions that violate these provisions, since it substitutes an a priori requirement of data availability to the public in place of the statutory factors. The availability of sufficient underlying data for the public to `validate' or `reproduce' study results is not even among the factors the agency is to consider, much less a determinative factor nullifying all those enumerated. The proposal is likewise at odds with the requirement that decisions be based on the "weight of the scientific evidence" since it bars evidence from the weighting process. In sum, EPA has not identified a lawful basis for applying this rule to regulatory decisions under TSCA. The general regulatory and research authorities cited in the proposal do not provide such a basis.
Small wonder, then, that the proposal, having failed to identify any substantial legal basis for limiting science under the various affected programs "solicits public comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation." 83 FR at 18771. But it is not the job of commenters to identify the legal sources of authority for the proposal, and the proposal fails to do so. That failure alone precludes adopting a final rule based on the proposal.
Comment [6155-2634]: Commenter (6125) writes that it is clear from even a brief look that these provisions require EPA to consider all the best available science, without authorizing, or even mentioning any of the per se restrictions based on "transparency" that EPA has proposed to use as a universal overriding rule. For these reasons, EPA must justify its proposal as a proper exercise of its authority under each of the statutory provisions whose operation it would affect - provisions that the agency does not even cite. It is the job of the proposer, not the commenters, to survey these provisions and provide the needed justification.
In several of the listed statutes Congress has explicitly told EPA how to use science in decision-making.
 TSCA 15 USC Section 2605 (h) provides that "the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science."
These provisions all use mandatory language directing EPA to use reliable and relevant scientific information -- and further specify how to do so. They all direct that decisions regarding protection of public health be based on the full range of relevant scientific information, in some cases specifying how to identify what information to use. None of them give EPA discretion to ignore such information for any of the reasons set forth in the proposal.
Comment [6163-1112]: Commenter (6133) notes that EPA cites 15 U.S.C. § 2609 under the TSCA as support for this rule. But that section states only that the "Administrator shall, in consultation and cooperation with the Secretary of Health and Human Services and with other heads of appropriate departments and agencies, conduct such research, development, and monitoring as is necessary to carry out the purposes of this chapter." It does not allow EPA to limit the type of data considered in regulatory decisions, nor does it draw a distinction between dose-response data and other types of data. TSCA does not support the proposed rule. The absence of any such congressional distinction or restriction makes it all the more obvious that EPA invented and added the distinction and restrictions in the Proposal as a matter of its own policy preferences, contrary to the Act. This EPA may not do.
Comment [6163-1142]: Commenter (6133) writes that under TSCA, EPA has broad authority to protect the public from harm from chemical substances and mixtures. TSCA authorizes EPA to issue regulations designed to gather information on, require testing of, and control exposure to chemical substances and mixtures. EPA must restrict or ban any chemical substance that presents an unreasonable risk of injury to human health or the environment. See, e.g., 15 U.S.C. §§ 2603, 2604, 2605.
TSCA contains specific provisions regarding EPA's use and consideration of science in rulemakings. "In carrying out sections 2603, 2604, and 2605," EPA must "use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science." Id. § 2625(h). EPA must further consider the following:
 the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information;
 the extent to which the information is relevant for the Administrator's use in making a decision about a chemical substance or mixture;
 the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented;
 the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and
 the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models.
Id. After consideration of these matters, EPA must make decisions "based on the weight of the scientific evidence." Id.
In short, EPA must examine the reliability of a study on a case-by-case basis by weighing several indicators of scientific validity. Noticeably absent from Congress's enumerated factors in § 2625(h) is whether the underlying data can be made available to the public. While § 2625(h)(4) provides that EPA should take into account "the extent of independent verification or peer review" of scientific information, this language indicates that peer review of a study could provide sufficient assurance of its reliability even without additional verification.
TSCA further directs EPA to make available to the public, among other things, "a list of the studies considered by the Administrator in carrying out each such risk evaluation, along with the results of those studies" and "each designation of a chemical substance . . . along with an identification of the information, analysis, and basis used to make the designations." Id. § 2625(i). Again, the statute, despite calling out specific information to be made publicly available, does not state that the underlying data for these studies must be made publicly available. Thus, the rule is flatly inconsistent with TSCA.
Finally, even if it were not already clear from the above provisions that EPA cannot bar consideration of studies as provided in the Proposal, TSCA also states that EPA "shall take into consideration information relating to a chemical substance or mixture, including hazard and exposure information, under the conditions of use, that is reasonably available to the Administrator." Id. § 2625(k). EPA has defined "reasonably available" to mean "information that EPA possesses or can reasonably generate, obtain and synthesize for use . . . for prioritization and risk evaluation. Information that meets such terms is reasonably available information whether or not the information is CBI that is protected from public disclosure under 15 U.S.C. 2613." 40 C.F.R. § 702.3. Thus, if the studies covered by the rule are "reasonably available" to EPA, the agency must consider them, regardless of whether the raw data can be made public. EPA cannot create a double standard where studies withheld from the public as CBI must be considered but studies for which the underlying data cannot be made publicly available cannot be considered. The Proposal is unlawful under TSCA and cannot be promulgated.
Comment [6340-1462]: Commenter (6362) writes that EPA's reference to section 10 under the TSCA also does not appear on-point. American Chemistry Council (ACC) believes EPA's authority to implement this rule is derived from TSCA Section 26(h), which speaks directly to scientific information and standards to which the Agency must adhere in the administration of its work under TSCA Sections 4, 5, and 6.
Comment [6343-2705]: Commenter (6365) writes that they are committed to meeting their obligations to operate in a responsible manner to avoid adversely impacting the environment and public health and safety. Both lead itself and the production of lead are extensively regulated by the EPA, including under the TSCA, CAA, CWA, and RCRA. As a result of these programs and other actions taken by industry, "[t]he United States have made tremendous progress in reducing lead concentrations in the outdoor air," with the national average concentrations dropping "more than 90 percent since 1980," and "EPA expects that most of the areas previously designated as nonattainment will have attained or are on track to attain by the end of 2016."
In order to ensure that the regulatory standards that the ABR's members are subject to are supported by the best possible science, the ABR supports EPA's objective of strengthening transparency in regulatory science by ensuring that the data and models underlying regulatory science is publicly available in a manner sufficient for validation and analysis. Furthermore, EPA should establish clear criteria for data and model availability so that stakeholders can effectively determine whether the data and models underlying each regulatory proposal are available for review.
Comment [6353-2330]: Commenter (6375) notes that EPA solicits comment on whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles at the programmatic or statutory level would be appropriate as alternative or additional steps the agency may take to further the policies articulated in Section II. (pg. 18,771).
The regulatory language that EPA proposes provides general requirements that apply to the Agency's use of science under the many statutes that it implements. The generality of the proposed regulations may be a function of the diverse purposes of those statutes Specifically, some of these statutes focus on the introduction of new substances into the marketplace (e.g., FIFRA and TSCA). The scientific analyses required for these different programs and the sources of the scientific information underlying those analyses differ. The Agency should consider supplementing the general language that it has proposed with statutory specific regulations. A statutory-specific rulemaking would provide greater certainty going forward.
Comment [6424-2640]: Commenter (6446) writes that the proposed rule also deviates from accepted practices that EPA routinely uses, and is required to use, to evaluate science it relies on for regulatory decisions. EPA has long recognized that proprietary CBI submitted to it cannot be shared with the public, yet it routinely relies on that information, including scientific studies and other scientific information, as the foundation for important regulatory decisions. (See, e.g., CBI protection provisions in the TSCA at 15 U.S.C. § 2613, subd. (c). EPA also adheres to specific Congressional directives regarding the science it should consider for regulatory action, including directives to consider whether the scientific information is reasonable, clear, complete and whether it has been peer reviewed. (See, e.g., the TSCA at 15 U.S.C. § 2625, subds. (h) and (i), requiring EPA to consider several factors to evaluate science relating to toxic chemicals and requiring that decisions be based on "the weight of the scientific evidence."
Comment [6425-2641]: Commenter (6447) writes that the proposal is not authorized by statute and is contrary to Law.
EPA purports to rely on general statutory authority for the proposal, but no statutes authorize EPA to ignore science. On the contrary, as multiple U.S. Senators have noted, EPA's proposal would violate several statutes, including the TSCA, the SDWA, and the APA, which require the Agency to use the best available science, and all information presented to the agency during a rulemaking. The current proposal would do the opposite, requiring EPA to ignore some of the best available science, and to ignore certain information submitted during rulemaking. In particular, the proposal would make it difficult or impossible to use most epidemiological studies, where the source data are almost always comprised of sensitive personal information. Epidemiological studies are fundamental to EPA policymaking, and a critical source of information about the effects of various risk factors on human health. The Agency does not the option of suppressing this information, and courts have held that EPA "cannot ignore existing data."
In short, the proposed action would be illegal, and would not survive a legal challenge.
Comment [6833-3415]: Commenter (6855) writes that the requirements should apply specifically to risk evaluations performed under Section 6(b) of TSCA; to assessments (including certain retrospective assessments), models, criteria documents, and regulatory impact analyses that provide the basis for EPA's policies, procedures, guidance, and proposed and final regulatory decisions; and to individual party adjudications, enforcement activities, and permit proceedings.
Comment [6852-2770]: Commenter (6874) writes that a recent analysis tallied the costs to the U.S. economy of a set of endocrine-disrupting chemicals (EDCs) for which robust exposure, toxicity, and epidemiologic data exist. Teresa Attina and colleagues calculated that these EDCs cause annual losses of $340 billion, or 2% of the 2010 U.S. GDP, with the majority of that due to IQ point loss and intellectual disability from in-utero exposure to polybrominated diphenyl ethers (PBDEs). The total also includes costs associated with 86,000 cases of endometriosis attributable to the phthalate DEHP and 37,000 cases of uterine fibroids attributable to DDT exposures; uterine fibroids are both more common and more severe in African American women. The authors note that although the LSCA's update of the TSCA gives EPA the authority to limit production of chemical hazards and protect vulnerable populations, it does not provide the kind of funding necessary to adequately assess the safety of the many chemicals that are in use despite a lack of sufficient safety data. Given this combination of insufficient federal funding for testing and the substantial potential benefits of regulations that reduce EDC exposure, as well as reformed TSCA's requirement to make decisions based on the "weight of the scientific evidence," EPA should be using the best available science to guide regulation rather than restricting the pool of science that can inform its regulatory work.
Comment [6884-3029]: Commenter (6905) writes that states understand EPA's desire to be transparent with the public and we work hard to achieve this where possible. However, states are concerned that requiring all data used in scientific studies that underpin environmental and public health protection regulations be publicly available will lead to issues. For example, under the TSCA, EPA regularly relies on industry testing and data to make decisions on whether a chemical presents an unreasonable risk to human health or the environment. But some of this data is protected from public access under CBI claims.
Comment [6884-3032]: Commenter (6905) notes that like EPA's mission statement, several of the federal statutes that provide authority for the agency's work call for use of the best science without regard for data transparency. For example, TSCA as amended under the LSCA requires the EPA Administrator to use "scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science." The statute states that this best available science should be clear and complete, but it does not require it to be publicly available. It appears that the proposed rule could reject some of the best available science and may result in a finding that the rule contradicts the federal statutes.