Comment [6885-2986]: Commenter (6906) writes that in effect, EPA's proposal could be interpreted in a manner that is overly restrictive. EPA might also interpret this proposal in a manner that screens science studies using narrower criteria than congress indicated for risk evaluations under TSCA, where EPA is required to use the "best available science." The concept of "best available science" also applies to EPA decision-making generally and in other statutory programs, as explained in E.O. 13563. TSCA § 26(h) (as recently amended by the LSCA) requires that "in carrying out sections 4,5, and 6, 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" (italics added). The phrase "best available science" incorporates evaluation of similar supporting studies, objectivity, consistency with intended use of information, relevance, variability, and independent verification. Under this standard, EPA is not only required to evaluate the clarity of data, but also assumptions, methods, protocols, methodologies and/or models. In effect, the standard requires the broader set of considerations used in the scientific community when evaluating studies. [...]
American Coatings Association [the commenter] (ACA) recognizes that proposed 40 CFR §30.5 (requiring disclosure of dose response data and models) and §30.7 (requiring peer review and comment to EPA) are designed to give the public enough information to evaluate whether EPA has used the "best available science." The proposal and existing "best available science" standard are not necessarily mutually exclusive, but ACA suggest that EPA amend its proposal, so it more clearly incorporates consideration of factors that constitute "best available science."
These changes would allow EPA to continue considering data from the EU and Canada during TSCA risk evaluations. Suggested changes also promote industry participation in TSCA risk evaluations.
Comment [6893-2964]: Commenter (6914) writes that they have been integrally involved with both the passage and the implementation of the original 1976 TSCA and the 2016 LSCA, which amended the 1976 TSCA law. The TSCA law requires EPA to rely on the "best available science" and specifies that the agency "cannot ignore existing data." This proposal is contradictory in that it allows the agency to ignore some of the best available information that could help implement these laws. The proposal would limit exactly the kind of information Congress intended the agency to collect related to workplace chemical exposures and work-related disease.
Comment [6894-3607]: Commenter (6915) writes that the TSCA requires the Administrator, in decisions based on science, to "use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science," and, in carrying out certain sections of the Act, to "take into consideration information relating to a chemical substance or mixture . . . that is reasonably available to [him or her]." § 26(h), (k), 15 U.S.C. § 2625(h), (k) (emphases added).
Comment [6901-4445]: Commenter (6922) notes that in the TSCA: "In carrying out sections 2603, 2604, and 2605 of this title, 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[.]
Comment [6903-1997]: Commenter (6924) writes that the rule is counter to mandates in the reformed TSCA to use the best available science and systematic reviews for chemical evaluations.
Reformed TSCA requires the use of the "best available science" for decision-making under the Act. In contrast, this proposed rule mandates EPA to ignore well-conducted, relevant studies simply because all the data are not publicly available and/ or may not conform to the rule's invalid assumptions about GLP/Guideline and dose-response modeling; this is inconsistent with the TSCA statute and the Agency's legal mandate.
Further, EPA's rule delineating risk evaluation procedures under TSCA mandates the use of systematic review methods. Systematic reviews consider the entire body of scientific evidence and provide the most comprehensive, accurate and transparent evaluations of chemicals. In a systematic review, the quality and strength of all relevant individual studies is considered to reach an overall conclusion about the body of evidence, without requirements for data re-analysis or public access to data. This proposed rule would prevent EPA from completing systematic reviews as its regulation mandates for chemical evaluations because it would prohibit the Agency from considering studies where the data were not publicly available and downgrade studies based on criteria not related to actual study quality, such as GLP.
Comment [6912-3758]: Commenter (6933) writes that for all of these reasons, and many more beside (including the blatant inconsistency with requirements of the CAA, TSCA and other statutes to use best available science), they ask that you withdraw this proposal.
Comment [8750-1434]: Commenter (9227) writes that EPA's statutory authorities generally require the agency to consider all available data when undertaking significant rulemakings.
As just noted, EPA's statutory authorities mandate a variety of requirements for what scientific information EPA must consider in rulemaking. These statutes are discussed in detail, infra at Section I.B.3. To take one example that appears in numerous statutes, including TSCA, CAA, SDWA, and the 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 [8750-1438]: 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 would be true even if that scientific study constituted "information available to the Administrator" in a TSCA § 4(f) rulemaking. 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., TSCA, 15 U.S.C. § 2625(h) ("[T]he Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science."). 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 [8750-1447]: Commenter (9227) notes that EPA has previously stated in several different forums that a scientific study can be valid even if the underlying dose response data and models are not publicly available. For example, EPA recently explained in its own Plan to Increase Access to Results of EPA-Funded Scientific Research that even though "some research data cannot be made fully available to the public but instead may need to be made available in more limited ways," the lack of full public availability "does not affect the validity of the scientific conclusions from peer-reviewed research publications." Under the plan, EPA must make publications resulting from EPA-funded research publicly accessible on NIH's PubMed Central (PMC). The plan aims to "maximize access, by the general public and without charge, to digitally formatted data resulting from EPA funded research, while protecting confidentiality and personal privacy, recognizing proprietary interests, business confidential information and intellectual property rights, and preserving the balance between the relative benefits and costs of long-term preservation and access." The plan recognizes important exceptions for when "the research data cannot be released due to one or more constraints, such as requirements to protect confidentiality, personal privacy, proprietary interest, or property rights." It specifically declares: "The validity of scientific conclusions drawn from research publications or their associated research data, or EPA's ability to consider those conclusions and data in its actions, does not depend on compliance with this Plan."
Likewise, EPA's Science Policy Council explains in A Summary of General Assessment Factors for Evaluating the Quality of Scientific and Technical Information that EPA's determination as to the quality and reliability of a particular scientific study does not depend on one single factor (e.g., the public availability of underlying data), but instead turns on the agency's consideration of five general factors. Congress implicitly endorsed this approach by including a directive for EPA to use these same five factors in evaluating science under the TSCA Amendments passed in 2016, and just last year this Administration included these same factors in a recent regulation implementing TSCA. The factors comprise: (1) soundness; (2) applicability and utility; (3) clarity and completeness; (4) uncertainty and variability; and (5) evaluation and review. Of these, the only ones with any possible direct relevance to EPA's proposed approach are the third and fifth factors, but neither supports the elevation of public availability of data above all other considerations or the exclusion of studies with non-public data. The third factor, "clarity and completeness" requires EPA to consider "[t]he degree of clarity and completeness with which the data, assumptions, methods, quality assurance, sponsoring organizations and analyses employed to generate the information are documented." The fifth factor, "evaluation and review," requires EPA to consider "[t]he extent of independent verification, validation and peer review of the information or of the procedures, measures, methods or models." Even clear and complete "documentation" of the data used does not require that the data be made publicly available. Nor does factor five require either that a study's findings must have been replicated using the same data, or that the data must be available to allow for such replication. Moreover, these are only portions of two of five key factors to consider.As discussed at Section I. B.3. b) ii of the commenter's comment letter, even this Administration, in the context of promulgating regulations under TSCA, has adopted a regulatory definition of "best available science" expressly incorporating a multi-factor analysis, and that definition recognizes that public unavailability of data does not render a study incapable of being "best available science."
Comment [8750-1464]: Commenter (9227) writes that EPA's Proposal contravenes the TSCA.
i. TSCA expressly requires that EPA consider reasonably available information and EPA's proposal would preclude EPA from considering some reasonably available information.
When Congress amended TSCA through passage of the LSCA, Congress provided a number of detailed instructions on how EPA should consider scientific information with respect to chemical substances; EPA's proposal contradicts Congress's carefully crafted scheme. In particular, Congress included a provision specifically requiring that EPA consider all "reasonably available information." When making decisions about testing or the risk evaluation or regulation of new or existing chemicals, "the Administrator 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." 15 U.S.C. § 2625(k) (emphases added). But under EPA's proposed rule, EPA would often be precluded from considering such reasonably available information if all the underlying data and models were not publicly available. See 83 Fed. Reg. at 18,769 n.3 (stating that proposal "would preclude [EPA] from using [non-public] data in future regulatory actions"). EPA's proposal violates the plain language of TSCA § 26(k), as well as Congress's clear purpose of ensuring that EPA consider all reasonably available information relating to a chemical when making a decision about the chemical.
Under its plain language, "available" means "able to be used or obtained; at someone's disposal." Congress chose this standard to ensure that EPA would make decisions based on all reasonably available information. S. Rep. No. 114-67 at 9 (June 18, 2015) ("The section ... requires EPA to consider reasonably available information about potential hazards and exposures of a chemical substance under the conditions of use when making decisions under TSCA.... The Committee intends that EPA systematically search for and identify relevant information that is available to inform safety assessments and determinations."); Oversight of the EPA's Progress in Implementing Inspector General and Government Accountability Office Recommendations: Hearing before the Subcomm. on Superfund, Waste Management, and Regulatory Oversight of the S. Comm. on Environment and Public Works, 114th Cong. at 63 (June 14, 2016) ("[F]or the EPA to properly evaluate and regulate toxic substances, it is essential that they have the most up-to-date chemical and toxicity data available."). Congress also selected this standard to avoid paralysis by analysis -- Congress wanted EPA to act on available information and not to postpone action waiting for new or perfect information to become available. See, e.g., 162 Cong. Rec. S3511, S3517 (daily ed. June 7, 2016) (referring to "information reasonably available to EPA" as "ensur[ing] that such considerations do not require additional information to be collected or developed"). "Congress recognized the need to use available studies, reports and recommendations for purposes of chemical assessments rather than creating them from whole cloth." Id. at S3522. And Congress intended for EPA to consider studies even when they had not undergone all possible forms of vetting. "[I]n instances where there were other studies and reports unavailable at the time of the [NAS] recommendations, EPA should take advantage of those studies and reports in order to ensure that the science used for chemical assessments is the best available and most current science." Id. at S3522. Congress intended for EPA to consider all reasonably available information, and EPA's proposal would thwart that clear purpose.
Notably, this Administration has adopted two regulations under the amended TSCA defining reasonably available information. These regulations generally provide that:
Reasonably available information means information that EPA possesses or can reasonably generate, obtain, and synthesize for use in risk evaluations, considering the deadlines specified in TSCA [for action]. Information that meets the terms of the preceding sentence is reasonably available information whether or not the information is CBI, that is protected from public disclosure under TSCA section 14.
40 C.F.R. § 702.33; see also 40 C.F.R. § 702.3 (similar definition for prioritization decisions). This bears no resemblance to the limitations put forward in the Proposal. Indeed, EPA has defined "reasonably available information" to include information EPA withholds as CBI under TSCA § 14. 15 U.S.C. § 2613. If the proposed rule forecloses EPA from considering information that cannot be fully disclosed, as it appears to do, then EPA cannot comply with both these regulations and the proposed rule.
EPA's proposal also violates other provisions of TSCA that expressly require EPA to act on "available information." For example, in preparing risk evaluations for existing chemicals, EPA "shall integrate and assess available information on hazards and exposures for the conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed or susceptible subpopulations identified as relevant by the Administrator." Under the proposed rule, EPA would not be able to integrate and assess available information where all underlying data has not been disclosed. Similarly, when developing regulations for existing chemicals, EPA "shall consider and publish a statement based on reasonably available information with respect to" a number of factors, including the effects of the chemical on health and the environment. But under the proposed rule, EPA cannot consider all reasonably available information when assessing those health and environmental effects.
Indeed, TSCA § 4(f) imposes a duty upon EPA to initiate regulation in response to any available information that meets certain substantive standards. However, if all the underlying information were not available, EPA's proposed rule would then foreclose EPA from considering that information during the resulting rulemaking. Congress would not have created a scheme where EPA must act in response to certain information but then cannot consider that information in taking action. Specifically, under TSCA § 4(f):
Upon the receipt of -- (1) any information required to be submitted under this Act, or (2) any other information available to the Administrator -- which indicates to the Administrator that 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, the Administrator shall, ... initiate applicable action under section 5, 6, or 7 to prevent or reduce to a sufficient extent such risk or publish in the Federal Register a finding, made without consideration of costs or other non-risk factors, that such risk is not unreasonable.
Thus if "any ... information available" to EPA provides a reasonable basis to conclude that a chemical "presents a significant risk of serious or widespread harm to human beings," then EPA must initiate action to regulate the chemical. But under EPA's proposed rule, EPA would then be required to ignore the information triggering this duty when crafting the final regulation unless the source of the information fully disclosed all underlying data. That result clearly contradicts Congress's intent, which was to create a duty for EPA to react to any available information meeting the substantive standard of TSCA § 4(f).
In sum, Congress repeatedly directed EPA to consider all reasonably available information when making decisions under TSCA. The proposed rule would illegally preclude EPA from considering available information. The two cannot be reconciled, and the rule is unlawful.
ii. TSCA requires an agency to act on the "best available science," meaning that EPA must consider all available science and assess the quality of the science based on a variety of factors.
EPA's proposed blanket prohibition against basing a rulemaking on science for which underlying data or models are not publicly available would be particularly hard to reconcile with the "best available science" standard as articulated in TSCA, which clearly contemplates a case-by-case analysis in which EPA weighs a variety of factors when identifying the best available science. The relevant provision of TSCA requires that:
(h) Scientific standards. In carrying out sections 4, 5, and 6, 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, and shall consider as applicable --
(1) 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;
(2) the extent to which the information is relevant for the Administrator's use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented;
(4) 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
(5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models.
Thus, Congress provided EPA with factors to guide its consideration of the "best available science," and Congress did not make the public disclosure of all underlying data a requirement for material to be the "best available science." Quite the opposite; Congress included aspects of disclosure and independent review as parts of factors to be considered when weighing scientific information. But these are just aspects of five different factors to be weighed "as applicable," and Congress clearly contemplated that EPA would sometimes rely on science that does not meet the proposed rule's requirement of full disclosure of all underlying data.
First, Congress directed EPA to consider these factors when weighing particular information; Congress specifically did not develop (or direct EPA to develop) bright-line criteria for eliminating information from consideration entirely. Thus, each factor includes the phrase "degree of" or "extent to which," without identifying any threshold that would be disqualifying. This shows that Congress intended these factors to help EPA assess the weight information should be given based on its relative scientific reliability, not to create minimum thresholds of reliability below which information must be ignored by EPA altogether. For EPA to insert a screen on top of these factors -- excluding information where the underlying data and models are not publicly available as required by the proposed rule -- contradicts Congress's unambiguous intent about how EPA should approach its assessment of the best available science.
Second, Congress made the "degree of clarity and completeness" with which the underlying data is documented to be part of one factor for EPA to consider in evaluating whether a particular study is the "best available science." But EPA must also consider "the degree of clarity and completeness" with which "assumptions, methods, quality assurance, and analyses" are documented as well. Thus, Congress contemplated that EPA would still rely on some studies that did not document completely all the underlying data, much less disclose all of that information.
Third, Congress made "the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models" another factor to be weighed when considering whether information is the "best available." Notably, Congress's choice of the disjunctive "or" reflects that "peer review" can be an adequate alternative to "independent verification," and Congress did not require that either "independent verification or peer review" be accomplished through public availability of data as required in the proposed rule. Moreover, Congress contemplated scenarios where EPA would give more weight to evidence even if the "information" had not undergone "independent verification or peer review" based on the extent to which the "procedures, measures, methods, protocols, methodologies, or models" had done so.
Fourth and most importantly, EPA cannot rationally elevate the interest in public disclosure of all underlying data above all the other factors that Congress expressly required EPA to consider in evaluating science. Congress required EPA to consider these five factors "as applicable" when weighing information, and Congress did not make full public availability of underlying data one of the factors, much less a decisive or absolute one.
This administration recently adopted a regulatory definition of "best available science" for purposes of TSCA which expressly incorporated consideration of these five factors and was otherwise inspired by use of the term in the SDWA. EPA defined the phrase:
Best available science means science that is reliable and unbiased. Use of best available science involves the use of supporting studies 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 (if the reliability of the method and the nature of the decision justifies use of the data). Additionally, EPA will consider as applicable:
[TSCA § 26(h)(1)(5) factors]
According to EPA in selecting this definition, "the Agency is remaining consistent with the current approach already used Agency-wide, while also acknowledging the specific standards under TSCA." Notably, this definition does not require public disclosure of all underlying data for science to be the "best available science," yet many studies that meet this definition of "best available science" would be excluded under EPA's proposed rule.
EPA's Proposal cannot be reconciled with EPA's existing definition of best available science, with decades of court and agency precedent, or with text of the statute. When a statute requires the agency to make a decision based on the "best available science," it would be unlawful to follow EPA's proposed rule.
iii. EPA's proposed rule also contradicts TSCA's requirement that decisions be made based on the weight of the scientific evidence.
TSCA § 26(i) requires EPA to make decisions regarding testing and regulating new and existing chemicals "based on the weight of the scientific evidence." If EPA excludes certain information, as proposed, then EPA will not be able to weigh the evidence as a whole.
Indeed, this administration recently adopted a regulation defining "weight of scientific evidence" to mean "a systematic review method ... that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance." Systematic reviews consider the entire body of scientific evidence, but EPA's proposed rule would prevent EPA from conducting true systematic review because it would prohibit the Agency from considering studies where the data were not publicly available and it would eliminate studies based on criteria other than their "strengths, limitations, and relevance." If the proposed rule forecloses EPA from considering information that cannot be fully disclosed, as it appears to do, then EPA cannot comply with this regulation and the proposed rule.
In sum, EPA's proposed rule is inconsistent with TSCA's plain text. EPA should not adopt the proposed rule because it cannot be reconciled with the agency's duties under TSCA.
iv. Section 10 of TSCA does not authorize this proposal.
Nothing in TSCA § 10 authorizes EPA to exclude scientific information during rulemakings on any basis. Section 10 authorizes EPA to research and develop information for purposes of carrying out TSCA. Section 10 also authorizes EPA to develop systems to collect and disseminate information about chemical substances. But TSCA § 10 is silent regarding rulemaking or EPA's use of scientific information in rulemaking. It does not authorize EPA to exclude scientific information on any basis; if anything, TSCA § 10 reflects a congressional judgment that EPA should be prepared to use any and all "toxicological and other scientific information which could be useful to the Administrator in carrying out the purposes of this [Act]."
Comment [8750-1818]: Commenter (9227) writes that EPA unlawfully failed to consult with other agencies as required by TSCA.
When promulgating the Proposal, EPA unlawfully failed to consult with other entities as required by TSCA. For example, consider the sole statutory authority EPA cites under TSCA -- § 10. To the extent EPA acts under TSCA § 10, TSCA § 10 repeatedly directs EPA to consult, cooperate, and/or coordinate with the Secretary of HHS, and sometimes other agencies as well. EPA has not identified any specific provision of TSCA § 10 that authorizes the proposed rule, and as noted above, no provision does. But if EPA acts under TSCA § 10, then EPA needs to comply with the requirements of whichever provision EPA considers relevant. Most of the provisions of TSCA § 10 expressly require that EPA consult, coordinate, or cooperate with, at least, the Secretary of HHS (section 10(a), 10(b)(2)(A), 10(b)(2)(B), 10(c), 10(d), 10(e), 10(g)). For example, the provision that mentions "research and development results" states that EPA shall act "in consultation with the Secretary of Health and Human Services and other heads of appropriate departments and agencies." EPA does not appear to have complied with any of the procedural requirements of TSCA § 10.
Comment [8750-1819]: Commenter (9227) writes that EPA has failed to consult with the Science Advisory Committee on Chemicals (SACC).
As discussed above, this proposed rule has severe implications for the implementation of TSCA. The SACC's purpose is "to provide independent advice and expert consultation, at the request of the Administrator, with respect to the scientific and technical aspects of issues relating to the implementation of this subchapter." This rulemaking specifically involves "the scientific and technical aspects of issues relating to the implementation of [this Act]," yet there is no indication that the Administrator has consulted with the committee. Congress specifically created this Committee to consult on these types of issues, and thus EPA is abusing its discretion to not consult with this Committee about a proposal that will so radically affect the scientific and technical aspects of issues relating to the implementation of TSCA.
Comment [8750-2711]: 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 under the TSCA
2609(a)
Research, Development, collection, dissemination, and utilization of data
(a) Authority. The Administrator shall, in consultation and cooperation with the Secretary of HHS 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 Act. The Administrator may enter into contracts and may make grants for research, development, and monitoring under this subsection. Contracts may be entered into under this subsection without regard to sections 3648 and 3709 of the Revised Statutes
***
2609(b)(1), (2)
Research, development, collection, dissemination, and utilization of information: Information Systems
Administrator shall Consult and cooperate with Secretary of HHS and other heads of appropriate departments and agencies, to establish an efficient system for retrieval of toxicological and other scientific information which could be useful
***
2609(c)
Research, development, collection, dissemination, and utilization of information: Screening Techniques
Administrator shall coordinate with Assistant Secretary for HHS to develop screening techniques
***
2609(d)
Research, development, collection, dissemination, and utilization of information: Monitoring
Administrator shall, in consultation and cooperation with the Secretary of HHS, establish and be responsible for research aimed at the development, in cooperation with local, State, and Federal agencies, of monitoring techniques and instruments which may be used in the detection of toxic chemical substances and mixtures and which are reliable, economical, and capable of being implemented under a wide variety of conditions
***
2609(e)
Research, development, collection, dissemination, and utilization of information: Basic Research
The Administrator shall, in consultation and cooperation with the Secretary of HHS, establish research programs to develop the fundamental scientific basis of the screening and monitoring techniques described in subsections (c) and (d), the bounds of the reliability of such techniques, and the opportunities for their improvement.
***
2609(g)
Research, development, collection, dissemination, and utilization of information: Exchange of research and development results
The Administrator shall, in consultation with the Secretary of HHS and other heads of appropriate departments and agencies, establish and coordinate a system for exchange among Federal, State, and local authorities of research and development results respecting toxic chemical substances and mixtures, including a system to facilitate and promote the development of standard information format and analysis and consistent testing procedures.
***
2608(d)
Coordination
"Coordination. In administering this Act [15 USCS §§ 2601 et seq.], the Administrator shall consult and coordinate with the Secretary of Health and Human Services and the heads of any other appropriate Federal executive department or agency, any relevant independent regulatory agency, and any other appropriate instrumentality of the Federal Government for the purpose of achieving the maximum enforcement of this Act . . ."
***
2608(e)
Exposure Information
If the Administrator obtains information related to exposures or releases of a chemical substance or mixture that may be prevented or reduced under another Federal law, including a law not administered by the Administrator, the Administrator shall make such information available to the relevant Federal agency or office of the EPA.
***
2604(f)(5)
Manufacturing and Processing Notices: Protection Against Unreasonable Risks
Consult with Assistant Secretary of Labor prior to adopting any restriction of chemical substance for workplace exposures
***
2604(h)(2)(B)(ii)
Manufacturing and Processing Notices: Exemptions
Consult with AG of the Federal Trade Commission about exempting persons from information requirements.
Comment [9066-1929]: Commenter (6188) writes that the TSCA already expressly dictates the information that EPA must make publicly available, including a list of the studies EPA considers in carrying out risk evaluations and the results of those studies. 15 U.S.C. § 2625(j). Nowhere does the statute require that the data underlying those studies be made publicly available or limit the use of data or studies in making evaluations or regulatory decisions. Once again, EPA has declined to cite the provision within the TSCA that deals most directly with data disclosure and has not explained how other provisions of the TSCA unrelated to data disclosure support a rule imposing additional data disclosure requirements.
Comment [9066-2647]: 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. 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). 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 [9078-3551]: 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
 TSCA [15 U.S.C. § 2625(h)]: "In carrying out sections 2603, 2604, and 2605 of this title, 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".
This statutory provision does not 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 [9217-3561]: 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 [9289-3793]: Commenter (PH20) writes that the rule is counter to the mandates in the reformed TSCA to use the best available science and systematic reviews for chemical evaluations.
Comment [9310-4993]: Commenter (PH84) writes that they played a key role in the reform of the TSCA which requires that EPA use the best available science in the review and management of toxic chemicals. As EPA begins to review the tens of thousands of chemicals already on the market, they are concerned that they be able to take into consideration all information that is reasonably available.
Comment [9312-5004]: Commenter (PH46) writes that the rule is counter to mandates in the amended TSCA, to use the best available science and systematic reviews for chemical evaluations. Specifically, the proposed rule inappropriately codifies particular data analysis approach such as dose response modeling that should be made based on empirical considerations.
The rule is counter to the mandates in the amended TSCA to use the best available science and systematic reviews for chemical evaluations. In contrast, this proposed rule will have EPA ignore well-conducted, relevant studies simply because all the data are not publicly available and/or may not conform to the rule's invalid assumptions about good laboratory practices and guidelines, studies, and dose response modeling. This is inconsistent with modern science and the TSCA statutory mandates. Further, EPA's risk evaluation framework rules under TSCA mandate the use of systematic review methods. Well conducted systematic reviews consider the entire body of scientific evidence and the quality and strength of all relevant individual studies are considered to reach the overall conclusion.
Comment [6857-2945]: Commenter (6879) writes that EPA rules and regulations have been critical to the protection of wildlife, natural habitats, and the ecosystem services they provide to communities and the economy. This includes protection of endangered and other wildlife from pesticides and other toxic substances under the FIFRA and the TSCA.
These laws require EPA to use the "best available" science, or all "reasonably available" science and information. By excluding high-quality peer-reviewed and validly published science from the regulatory decision-making process, the proposed regulation directly contravenes the specific mandate of these statutes. And by deliberately excluding the best science available, the rule also contravenes the Congressional mandates for these statutes and undermines their public health and environmental protection purposes.
Comment [6163-1276]: Commenter (6133) writes that the proposal's peer review provision lacks any statutory basis, is vague and contrary to existing requirements for peer review.
In addition to addressing how and whether the agency will consider science, the Proposal also contains a seemingly unrelated provision regarding agency peer review. The Proposal, in § 30.7, reads:
What role does independent peer review in this section?
EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein.
Because transparency in regulatory science includes addressing issues associated with assumptions used in models, EPA shall ask peer reviewers to articulate the strengths and weaknesses of EPA's justification for the assumptions applied and the implications of those assumptions for the results.
83 Fed. Reg. at 18,774.
There is no statutory authority for EPA to "conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." The federal statutes that EPA lists as putative authority for the Proposal provide no authority for proposed § 30.7. See TSCA, as amended, section 10, 15 U.S.C. 2609, and the APA). 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
TSCA
§ 2625. Administration
(h) Scientific standards In carrying out sections 2603, 2604, and 2605 of this title, 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, and shall consider as applicable-- (1) 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; (2) the extent to which the information is relevant for the Administrator's use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) 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 (5) 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. § 2625 (emphasis added).
§ 2617. Preemption
(b) New statutes, criminal penalties, or administrative actions creating prohibitions or other restrictions (1) In general Except as provided in subsections (c), (d), (e), (f), and (g), beginning on the date on which the Administrator defines the scope of a risk evaluation for a chemical substance under section 2605(b)(4)(D) of this title and ending on the date on which the deadline established pursuant to section 2605(b)(4)(G) of this title for completion of the risk evaluation expires, or on the date on which the Administrator publishes the risk evaluation under section 2605(b)(4)(C) of this title, whichever is earlier, no State or political subdivision of a State may establish a statute, criminal penalty, or administrative action prohibiting or otherwise restricting the manufacture, processing, distribution in commerce, or use of such chemical substance that is a high-priority substance designated under section 2605(b)(1)(B)(i) of this title.
(f) Waivers (2) Required exemptions Upon application of a State or political subdivision of a State, the Administrator shall exempt from subsection (b) a statute or administrative action of a State or political subdivision of a State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that-- (A)(i) compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; (ii) compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and (iii) the State or political subdivision of the State has a concern about the chemical substance or use of the chemical substance based in peer-reviewed science; or (B) no later than the date that is 18 months after the date on which the Administrator has initiated the prioritization process for a chemical substance under the rule promulgated pursuant to section 2605(b)(1)(A) of this title, or the date on which the Administrator publishes the scope of the risk evaluation for a chemical substance under section 2605(b)(4)(D) of this title, whichever is sooner, the State or political subdivision of the State has enacted a statute or proposed or finalized an administrative action intended to prohibit or otherwise restrict the manufacture, processing, distribution in commerce, or use of the chemical substance.
15 U.S.C. § 2617 (emphasis added).
§ 2605. Prioritization, risk evaluation, and regulation of chemical substances and mixtures
(b) Risk evaluations (E) Metals and metal compounds In identifying priorities for risk evaluation and conducting risk evaluations of metals and metal compounds, the Administrator shall use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated March 2007, or a successor document that addresses metals risk assessment and is peer reviewed by the SAB.
15 U.S.C. § 2605 (emphasis added).
Under longstanding federal case law, when Congress authorizes an approach in one section of a statute using specific language but does not do the same in other sections of a statute, courts presume that Congress acted purposefully and did not mean to address or authorize that approach in those other statutory sections. See, e.g., Dean v. United States, 556 U.S. 568 (2009) ("It is generally presumed that Congress acts intentionally when including particular language in one section of a statute but not in another." (citing Russello v. United States, 464 U.S. 16, 23 (1983)). Not only are there no implied grants of authority to an agency in the other statutory sections, but the congressional decisions to authorize the approach elsewhere in the statute give even greater force to the conclusion that the agency has not been given authority where Congress did not use the same or similar authorizing language.
The EPA approach proposed in § 30.7 is even more unlawful than would be the case, independently, under this case law. Proposed § 30.7 says "EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." 83 Fed. Reg. at 18,774/2 (emphasis added). EPA proposes to bind itself ("shall") to conduct a particular form of peer review on "all pivotal regulatory science" based on an unenforceable, non-binding OMB bulletin that has never been the subject of notice and comment rulemaking and that itself is not authorized by any federal law. To the contrary, treating the content of the unenforceable bulletin as a binding regulation would itself violate the federal statutes that EPA implements, because those statutes do not codify the bulletin, and EPA would be unlawfully codifying a mere policy preference. This EPA may not do.
This Proposal is unlawful, arbitrary, and capricious, and an abuse of EPA discretion. To reiterate, the Proposal identifies no statutory authority for EPA to conduct independent peer review for any, much less all, "pivotal regulatory science" consistent with the dense content (and exceptions) of the OMB bulletin. The Proposal identifies no statutory authority for EPA to bind itself, and future administrations, to conduct peer review only in this fashion, unless and until future notice-and-comment rulemaking is undertaken. The Proposal identifies no suggestion in statutory language or legislative history that Congress intended EPA to conduct binding peer review consistent with this OMB bulletin, notwithstanding that Congress has known about this bulletin since 2005. EPA has simply made up proposed § 30.7 -- with its the link to the OMB bulletin, and the putative authority for the Proposal -- out of whole cloth. This EPA may not do.
<IP_ADDRESS> TSCA (SNPRM Comments)
Comment [48-1959]: Commenter (12727) notes that several environmental statutes require EPA to ground its decision-making in scientific evidence. The TSCA requires the Administrator to "make decisions . . . based on the weight of the scientific evidence," 15 U.S.C. § 2625(i)."
The originally proposed regulatory language (§§ 30.3, 30.5) violated these statutory commands by preventing EPA from relying on a study as "pivotal regulatory science . . . used to justify significant regulatory decisions" if dose-response data or models underlying the study were not publicly available, without regard to whether the study had been validated by other means. The SNPRM exacerbates these violations by expanding the proposed regulation's scope (§§ 30.3, 30.5) to not just pivotal regulatory science used to justify significant regulatory decisions, but also "pivotal science supporting influential scientific information."
Comment [48-2183]: Commenter (12727) writes 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 TSCA directs that, in implementing the Act's testing requirements, manufacturing and processing notice requirements, and requirements for the prioritization, risk evaluation, and regulation of chemical substances and mixtures, EPA must make its decisions "based on the weight of the scientific evidence." Likewise, in carrying out EPA's responsibilities under TSCA, "the Administrator shall use scientific information . . . employed in a manner consistent with the best available science." Numerous other TSCA provisions emphasize EPA's obligation to consider all reasonably available scientific information when implementing TSCA's requirements.
A rule that prohibits EPA from considering (or that downgrades) valid, high quality scientific studies when generating ISI such as the products identified above would contravene the above- noted statutory directives regarding EPA's obligation to consider all available science.
Comment [53-2007]: Commenter (11360) writes that Congress intentionally and wisely embedded peer-reviewed research in the foundation of the CAA, including requiring regular reviews of the science, explicitly recognizing that EPA needs the most current, peer-reviewed data to protect the public health. These expectations also are reflected in other public health laws that support the EPA's mission, including the TSCA. Limiting scientific evidence does not strengthen regulations or policies; rather, it is paramount that the full suite of relevant science, vetted through peer-review, inform the landscape of decision-making. Excluding relevant studies simply because they do not meet unnecessarily rigid transparency standards will adversely affect decision-making processes.
Comment [81-2191]: 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 science," TSCA, 15 U.S.C. § 2625(h). 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 [89-2198]: 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 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 warrants exclusion in order to carry out the purposes of the statute.
In short, the statutory provision cited by EPA does not 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 [93-2086]: Commenter (11395) notes that TSCA specifies that "(h)azard information related to potential health and environmental hazards of the chemical substance will be reviewed in a manner consistent with best available science and weight of scientific evidence" (40 CFR 702.41(d)(2)). The TSCA definition of "best available science" goes on to list five criteria that should be considered, as applicable, one of which is "(t)he extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies or models." While this definition acknowledges the merit of independent verification, that criterion is only one of several listed and peer reviews is identified as another method of review of data quality. This is inconsistent with the SNPRM, which stipulates that studies for which data cannot be made available for reanalysis will not be considered or will be considered as less valid, even when the validity of those studies is supported by other avenues, including peer review.
Comment [97-2148]: 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 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.
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 [101-2085]: Commenter (11482) 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. Numerous court cases have weighed in on the best available science standard in the context of numerous different federal laws. For example, courts have found that the agency must use the best science that is available to it at the time of the decision, not the best that might be available to it at some time in the future.
Importantly, the critical actor under the best available science standard is the agency  --  the standard requires the use of the best science that is available to the agency, not necessarily available to the public. Excluding science that is available to the agency but not available to the public would thus be a violation of "best available science" provisions.
Under federal law, the agency must find a way to continue using the best available scientific data and models available to it, regardless of whether those data and models are publicly available. Excluding science whose raw data are not in the public domain runs counter to the "best available science" doctrine and is thus illegal.
Comment [125-2201]: Commenter (11495) writes that EPA's SNPRM is at odds with provisions of multiple environmental statutes which require the Agency to consider certain high-quality scientific information. The TSCA requires the EPA Administrator to ensure that evaluation and regulation of toxic substances is "consistent with the best available science" and to use all scientific information that is "reasonably available" when making related decisions.
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 SNPRM, 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 SNPRM 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 SNPRM'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 SNPRM is "intended to be consistent with the statutes that EPA administers and EPA plans to implement this procedural rulemaking in accordance with all applicable statutory and regulatory requirements." EPA attempts to resolve this inconsistency by stating that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." However, as discussed below, EPA lacks the statutory authority to issue a rule this broad, even when it claims that it will avoid statutory conflicts.
Comment [133-1187]: Commenter (11894) notes that TSCA §5 requires EPA to review the likelihood that a new chemical will present an unreasonable risk to human health or the environment before it can be marketed. At present, much of the information that EPA reviews rests on CBI or otherwise would not meet the requirements of the proposal. To fill some of these gaps, EPA relies on models that likewise would often not meet those requirements.
Once again, EPA has failed to address how it can refuse to apply these new requirements to data and models used to support PMNs given express direction from Congress to the agency to consider data quality. Indeed, yet again, EPA has not addressed the issue of applicability to this program at all or addressed the impacts on the public health or the environment if it did. Nor, once again, has EPA explored the resources that would be needed to respond.
Comment [151-1348]: Commenter (12405) discusses Parkinson's disease research in TSCA determinations.
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 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.
In these relatively small studies, a distinctive characteristic  --  people who worked together and twins  --  respectively, combined with the most basic additional medical information could render the participants identifiable. Both TCE studies are highly cited, and scientists have replicated the findings. To exclude 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 [158-1398]: Commenter (12423) writes that EPA has already developed and employed the systematic review process to screen and prioritize studies used in TSCA risk assessments. Like this proposed rule, that process discounts or excludes studies for which underlying data are not publicly available. Consequently, whether intended or not, many studies providing tribally relevant data are likely to be excluded. Like in the current rule, reporting issues are conflated with study quality. The process is inconsistent with best practices in systematic review, is unscientific and arbitrary, and open to bias.
As the EPA tribal partnership group that works on TSCA related issues, the National Tribal Toxics Council (NTTC) would like to know how this rule would and could affect risk evaluations and use limits done under TSCA authority. Together with the systematic review process, this rule would multiply bias against studies with relevant tribal data and increase the likelihood that studies with relevant tribal information may not be considered. Much of tribal data is published in various reports and grey literature that is already discounted via systematic review. With generally fewer studies and data available that are relevant for tribes and the myriad unique exposures to begin with, how might excluding valid studies impact the agency's ability to estimate risk to tribes?
NTTC requested a briefing from EPA on these points on 04/20/2020 and the request was not met. We are left to assume that this rule will apply to TSCA risk evaluations and other TSCA activities and, if so, this rule will be extremely detrimental to ongoing efforts by the Office of Pollution Prevention and Toxics (OPPT) and the Office of Research and Development (ORD) to represent tribes in risk assessment, as per TSCA mandate to consider potentially exposed and susceptible subpopulations.
Conclusion 3: The rule will significantly impact EPA's capacity to carry out the TSCA protections for potentially exposed and susceptible subpopulations, as mandated by Congress in its 2016 bipartisan amendment.
Comment [160-1456]: Commenter (1431) remains concerned that in its desire to ensure that the data underlying its significant regulatory actions and ISI are publicly available, EPA may exclude information that is most relevant to its assessment of risks to human health and the environment. In particular, excluding information that cannot be made publicly available would slow the development and implementation of alternative test methods and strategies to replace animal testing. Such approaches can provide information of equivalent or better scientific quality and relevance for risk assessment, and their development and implementation are mandated by the TSCA. This potential conflict between public accessibility and continued progress in regulatory science has been recognized by EPA's OPPT. In its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program, OPPT states that public access to the datasets used to build models that predict human outcomes may not be possible in some cases, because OPPT uses CBI to update and refine its models, and these activities are critical to its mission of evaluating chemicals under TSCA. Under the proposed rule and SNPRM, OPPT could be limited to using only publicly accessible information and open source models. As Robert DeWoskin, etioLogic LLC, notes in his comments on the proposed rule, in some cases, results from commercially available models can be used without the need to release proprietary code, and requiring commercial model developers to release this intellectual property would likely restrict their ability to continue developing and supporting their models. In addition, sponsors of new industrial chemicals and agrochemicals sometimes submit chemical and toxicological information derived from proprietary alternatives in lieu of certain animal tests. Under the proposed rule and SNPRM, EPA may be unable to consider this information, resulting in animal testing that would, in the case of industrial chemicals at least, be conducted in violation of TSCA provisions to use available nonanimal test methods and strategies. Finally, as numerous stakeholders have commented, the proposed rule could force EPA to exclude from its consideration epidemiologic studies that use confidential health data. Such studies are frequently the most relevant to protecting public health as they assess outcomes in humans following real world exposures. The exclusion of this information may lead EPA to increase its reliance on information from less relevant animal toxicity studies.
Comment [172-1551]: Commenter (12465) writes that while the supplemental proposal notes 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," therein lies significant ambiguity as to the applicability and scope of regulation designed to underlie the basis of EPA regulatory science decisions. The details on how the Agency would navigate these potential regulatory conflicts should be considered and advanced concurrently with the current proposal to effect maximum stakeholder input. For example, EPA needs to fully understand the potential vulnerability this transparency rule would create for regulatory decisions made under the TSCA and the FIFRA that rely on CBI as well as the extent to which models relied on by both programs comply with the rule as proposed. It is possible that a significant number of EPA decisions under FIFRA and TSCA could be successfully challenged if this rule were finalized as proposed.
Comment [187-1709]: Commenter (12720) 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 and Supplemental Proposal as a matter of its own policy preferences, contrary to the Act. This EPA may not do.
Comment [198-2209]: 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., 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.").
Comment [199-2212]: Commenter (12403) writes that the proposal is also inconsistent with provisions in the TSCA.
1.3.5 Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)/ Resource Conservation and Recovery Act (RCRA) (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 CERCLA and RCRA. The EPA provides the following general response to these comments:
Response: EPA appreciates your comments. As discussed in 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> CERCLA/RCRA (NPRM Comments)
<IP_ADDRESS>.1 CERCLA
Comment [6112-1554]: Commenter (6137) provides that EPA also cites to provisions under the CERCLA as authority for its Proposed Rule. However, upon examination, these provisions likewise provide no legal support for the Proposal.
The first provision upon which EPA relies  -  Section 115  -  is inapposite. It merely sets out goal dates for EPA to begin assessment and remediation of facilities on the NPL and is entirely irrelevant to the issues of the Proposed Rule. See 42 U.S.C. § 9616. While the second provision upon which EPA relies  -  Section 311  -  is at least relevant to the issues of the Proposed Rule, it nonetheless conflicts with the proposition that the Proposed Rule espouses. It requires the Department of HHS, in consultation with EPA, to establish and support a research program consisting of:
Basic research (including epidemiologic and ecologic studies) which may include each of the following:
(i) Advanced techniques for the detection, assessment, and evaluation of the effects on human health of hazardous substances.
(ii) Methods to assess the risks to human health presented by hazardous substances.
(iii) Methods and technologies to detect hazardous substances in the environment and basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.
42 U.S.C. § 9660(a)(1)(A); see also id. § 9660(c) (authorizing EPA to conduct research on the "detection, assessment, and evaluation of the effects on and risks to human health of hazardous substances and detection of hazardous substances in the environment"). These provisions say nothing about authorizing EPA to adopt rules at all, much less rules limiting reliance on studies that do not meet the criteria of the Proposed Rule. Section 311(a) merely provides for the Department of HHS to establish and support certain research programs. It does not give EPA any authority at all, much less authority to limit the type of studies that can be relied upon for purposes of implementing CERCLA's operative provisions. Accordingly, CERCLA provides no support for EPA's actions here.
Comment [6112-1591]: Commenter (6137) contends that under CERCLA, Congress created a hazardous substance research and classification regime based largely on studies that "determine relationships between exposure to toxic substances and illness" -- the very dose response studies that the Proposed Rule would stifle. 42 U.S.C. § 9604(i)(1). The statute requires EPA and ATSDR to annually update a list of hazardous substances commonly found at facilities on the NPL that the agencies determine "pos[e] the most significant potential threat to human health due to their known or suspected toxicity to humans and the potential for human exposure to such substances . . ." Id. § 9604(i)(2)(A), (B). EPA must also develop guidelines for ATSDR's toxicological profiles of each listed substance, which must include "available toxicological information and epidemiologic evaluations . . . to ascertain the levels of significant human exposure for the substance and the associated acute, subacute, and chronic health effects." Id. § 9604(i)(3)(A). For any substance for which adequate information is unavailable, EPA and ATSDR must create a program of toxicological and epidemiological research to develop that information. Id. § 9604(i)(5).
Congress specified that CERCLA health assessments include:
preliminary assessments of the potential risk to human health posed by individual sites and facilities, based on such factors as the nature and extent of contamination, the existence of potential pathways of human exposure (including ground or surface water contamination, air emissions, and food chain contamination), the size and potential susceptibility of the community within the likely pathways of exposure, the comparison of expected human exposure levels to the short-term and long-term health effects associated with identified hazardous substances and any available recommended exposure or tolerance limits for such hazardous substances, and the comparison of existing morbidity and mortality data on diseases that may be associated with the observed levels of exposure.
42 U.S.C. § 9604(i)(6)(F). And when assessing alternate remedial actions under CERCLA, EPA must "at a minimum, take into account . . . the persistence, toxicity, mobility, and propensity to bioaccumulate of such hazardous substances and their constituents [and] short- and long-term potential for adverse health effects from human exposure." Id. § 9621(b)(1).
EPA's Proposed Rule would prevent the Agency from using the very types of health assessments that Congress mandates. It undermines both the letter and spirit of the statute and is therefore unlawful.
Comment [6118-1728]: Commenter (6143) asserts 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 [6152-642]: Commenter (6122) 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 115 of the CERCLA and Executive Order 12580 authorize the president to delegate duties under CERCLA and designate EPA as the statute's Administrator. This delegation provision provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is "necessary" to the carrying out functions under CERCLA. EPA points to another section as a parallel citation, which addresses assessment, listing, and evaluation of facilities, and directs commencement of remedial investigations and feasibility studies and commencement of remedial actions. This provision is irrelevant to the proposed rule, we will assume that the inconsistency is a mere typographical error and not intended to cite additional statutory authority.
Section 311 of the CERCLA directs the Administrator in the use and development of research and training tools. The section does not mention transparency or any of the other undefined terms that EPA uses like "dose response" and "benefit-cost calculation."
Comment [6155-2632]: Commenter (6125) asserts 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 statutes Congress has explicitly told EPA how to use science in decision-making. The commenter notes that the 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 [6155-2724]: Commenter (6125) asserts that other provisions prescribe factors EPA must use in making decisions. The CERCLA requires that EPA rules setting cleanup priorities "shall be based upon relative risk or danger to public health or welfare or the environment... taking into account to the extent possible" seven enumerated factors related to risk.
Like the express science provisions discussed above, both of these provisions are mandatory and prescribe specific factors EPA must assess. Neither offers any basis for failing to consider such factors or evidence regarding such factors because it is supported by science that is not "transparent." When Congress wished to limit available science to information that is publicly available, it has done so. See CWA Section 311(a)(27), 33 USC 1321(a)(27) (for purposes of addressing oil and hazardous substance liability, "best available science" is defined as evidence that "uses peer reviewed and publicly available data"). Its failure to impose such limits on the use of data or science in the provisions discussed above is thus purposeful. As noted, the proposal does not even mention any of these relevant statutory requirements governing the use of science or data or information, much less explain how any of them could authorize EPA to make a decision without using information that is relevant to decision-making, solely for lack of transparency and regardless of reliability or relevance. None of these statutes provide EPA with any authority to pick and choose what reliable and useful science to use or ignore specific studies based on transparency. While the proposal misleadingly pays lip service to using the best available science, it would expressly "preclude" the use of reliable and available science that is not, in its characterization, "transparent," regardless of whether it is the best available science. The proposal does not even mention the governing statutory requirements, much less explain how its approach is consistent with them.
Comment [6163-1107]: Commenter (6133) contends that under the CERCLA, EPA cites 42 U.S.C. § 9616 as authority, but that section merely provides a schedule for the assessment and remediation of Superfund sites. It is entirely unclear what this has to do with the subject matter of the Proposal. EPA does not state specifically which provision of 42 U.S.C. § 9616 it believes authorizes the Proposal, nor does the Proposal even explain the reference. Thus, the citation fails to provide sufficient notice for the public to comment on the proposed rule.
EPA also cites 42 U.S.C. § 9660, which has many subsections. This broad citation also fails to provide sufficient notice for the public to comment on the proposed rule. Subsections (a), (b), and (c) require the Secretary of Health and Human Services (HHS) and the Administrator of EPA to establish research programs on the effects of hazardous substances on human health. But nothing in those sections limits EPA's consideration of studies in which the data can be made public or draws a line between dose-response data and other types of data. 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. CERCLA does not authorize the Proposal.
Comment [6163-1139]: Commenter (6133) provides that under CERCLA, EPA has power to clean up sites that are contaminated with hazardous substances, and to assure that responsible parties pay for such clean up. CERCLA requires EPA to issue regulations that identify hazardous substances that "present substantial danger to the public health or welfare or the environment," and that specify the quantities of such substances that trigger the Act's notification requirements. 42 U.S.C. § 9602(a). The Proposal contradicts this statutory mandate because it allows EPA to arbitrarily exclude some studies solely because the underlying data cannot be made public. Under the statute, EPA is required to use all relevant studies in determining whether a substance presents a substantial danger to people or the environment.
CERCLA also requires the President to promulgate and revise the National Contingency Plan for the removal of hazardous substances. Id. § 9605(a), (b). The President has delegated that authority to EPA. Exec. Order No. 12580, 52 Fed. Reg. 2923 (1987); Exec. Order No. 12777, 56 Fed. Reg. 54757. The Plan must include criteria for determining priorities "based upon relative risk or danger to public health or welfare or the environment," taking into account enumerated factors. 42 U.S.C. § 9605(a)(8)(A). The Proposal conflicts with this section because it would direct EPA to disregard relevant studies solely because the underlying data could not be made public, even if those studies shed light on the enumerated factors.
CERCLA's non-rulemaking provisions also show that Congress did not intend for studies to be excluded from consideration simply because the underlying data cannot be made public. For example, CERCLA authorizes the President to address hazardous substance releases that pose an "imminent and substantial danger to the public health or welfare," and to "undertake such investigations, monitoring, surveys, testing, and other information gathering" as necessary to determine "the extent of danger to the public health or welfare or to the environment." Id. § 9604(a), (b). This shows that Congress's purpose in enacting CERCLA was to address the serious public health and environmental threats of hazardous substance releases. That purpose would be undermined if EPA could refuse to consider relevant studies only because the underlying data cannot be made public. EPA also has co-responsibility with the ATSDR to establish a registry of diseases relating to toxic substance exposure, as well as to create a list of hazardous substances found at Superfund sites, prepare a toxicological profile of those substances, and determine whether adequate information on the health effects of those substances exists. Id. § 9604(i). The statute specifically lists the types of studies and data that should be considered in determining whether adequate information exists and assessing the need for further research. Id. § 9604(i)(5); see also id. § 9604(i)(13). The statute does not exclude studies whose underlying data cannot be made public. In short, the Proposal contradicts both the statutory language and the purpose of CERCLA.
Comment [6340-1457]: Commenter (6362) states that the provisions cited by EPA under the CAA, the CWA, the SDWA, the CERCLA, and the EPCRA in support of its authority to develop and implement its proposed rule all provide broad regulatory authority to promulgate regulations "as are necessary to carry out [the Administrator's] functions" under the statute. [...]
Comment [6343-2722]: Commenter (6465) provides that they further support EPA's objective of implementing this policy in a robust and consistent manner across its regulatory determinations. In particular, in order to robustly and consistently implement its scientific transparency standards, EPA should clarify that the science that is used in establishing remedial action performance standards for response actions under the of 1980 and for RCRA corrective actions is subject to EPA's proposed standards for ensuring transparency in regulatory science.
Clean-up obligations under CERCLA and corrective action obligations under RCRA are among the most critical environmental issues that impact industrial manufacturing companies. Between 1980 and 2015, private parties committed more than $35 billion in cleanup costs, with several individual CERCLA matters having cleanup costs in excess of $1 billion. Consequently, many CERCLA clean-ups constitute the magnitude of significant regulatory actions under Executive Order 12866 for a "significant regulatory action."
Comment [6353-2323]: Commenter (6375) states 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). Increasing the transparency of regulatory science and ensuring that it is reproducible helps in evaluating its accuracy and usefulness.
Furthermore, making data and methods underlying regulatory decisions publicly available is not new. Guidelines issued by both the OMB and EPA implementing the IQA, Treasury and General Government Appropriations Act for Fiscal Year 2001, § 515, P.L. No. 106-554, 114 Stat. 2763 (Dec. 21, 2001), emphasize the importance of reproducibility in assessing the quality and utility of data used in making regulatory decisions. It appears the OMB's IQA guidelines recognize that the reproducibility of underlying science helps to ensure the integrity of agency decisions and explain that, "[m]aking the data and methods publicly available will assist in determining whether analytic results are reproducible." 67 Fed. Reg. 8452, 8460 (Feb. 22, 2002) (OMB IQA Guidelines).
EPA's IQA guideline states: "A higher degree of transparency about data and methods will facilitate the reproducibility of such information by qualitied third parties, to an acceptable degree of imprecision. . .. It is important that analytic results for influential information have a higher degree of transparency regarding (1) the source of the data used, (2) the various assumptions employed, (3) the analytic methods applied, and (4) the statistical procedures employed."
EPA should also consider replacing some of the citations it provides for its legal authority with others that might be more relevant. For example, the Agency may want to cite 42 U.S.C. § 6981, on research, instead of 42 U.S.C. § 6979, which concerns "Labor standards." In addition, section 115 of CERCLA, 42 U.S.C. § 9615, which authorizes regulations, might be a more appropriate citation than section 116 of that Act, 42 U.S.C. § 9616, which specifies schedules for assessment and evaluation of facilities subject to the Act's requirements.
Comment [6353-2328]: Commenter (6375) states 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 of the NPRM FR notice).
The regulatory language that EPA proposes provides general requirements that apply to the Agency's use of science under the many statutes that it implements. The generality of the proposed regulations may be a function of the diverse purposes of those statutes Specifically, some of these statutes focus on removal from (e.g., CERCLA), the environment. The scientific analyses required for these different programs and the sources of the scientific information underlying those analyses differ. The Agency should consider supplementing the general language that it has proposed with statutory specific regulations. A statutory-specific rulemaking would provide greater certainty going forward.
Comment [6779-4123]: Commenter (6801) provides that the CERCLA, commonly known as Superfund, was enacted by Congress on December 11, 1980. This law created a tax on the chemical and petroleum industries and provided broad Federal authority to respond directly to releases or threatened releases of hazardous substances that may endanger public health or the environment. EPA, Superfund: CERCLA Overview, https://www.epa.gov/superfund/superfund-cercla-overview While the space allotted to this comment does not permit a thorough discussion of CERCLA's history, EPA discusses the many chemical spills that led to CERCLA and includes computerized graphics at this address: https://www.epa.gov/superfund/superfund-history
The EPA's numerous CERCLA regulations are in print in the CFR. Electronic versions can be found at https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR (official) or https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=d5cf8817453753f37820f1e458cfd52a&ty=HTML&h=L&mc=true&n=pt40.30.307&r=PART (unofficial, but more current).
The adoption or amendment of numerous EPA regulations require good scientific data including private medical data protected by privacy laws such as HIPAA, as well as data that is private and or difficult to reproduce for other reasons (for example, endangered wildlife surveys that may not be able to be repeated without impermissibly harming the wildlife or studies that require access to private land).
Examples of such good data and studies that led to CERCLA and/or the related regulations include: https://www.health.ny.gov/environmental/investigations/love_canal/lcreport.htm
https://www.health.ny.gov/environmental/investigations/love_canal/docs/report_public_comment_final.pdf https://archive.epa.gov/epa/aboutepa/love-canal-tragedy.html http://www.gendisasters.com/new-jersey/13273/logan-township-nj-chemical-explosion-dec-1977
An example of a regulation that may not have been adopted if the proposed regulation was in effect, 40 CFR Part 355 Sub Part C Section 355.33 provides:
      355.33What release quantities of EHSs and CERCLA hazardous substances trigger the emergency release notification requirements of this subpart?
      The release of a reportable quantity (RQ) of an EHS or CERCLA hazardous substance within any 24-hour period triggers the emergency release notification requirements. RQs for EHSs are listed in Appendices A and B of this part in the column labeled RQ. RQs for CERCLA hazardous substances are listed in Table 302.4 of 40 CFR 302.4 in the column labeled final RQ.
Obviously, any revision of the rule or of the RQs listed in Table 302.4 of 40 CFR 302.4 in the column labeled 'final RQ' would require a good scientific basis. That would include data protected by privacy laws such as HIPAA.
Unfortunately, virtually all EPA's CERCLA regulations suffer from the same defect.
Comment [8750-1968]: Commenter (9227) contends 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 CERCLA
§311(a)(1)
Research, Development, and Demonstration
The Secretary of HHS...in consultation with the Administrator, shall establish and support a basic research and training program...consisting of the following:
(A) Basic research (including epidemiologic and ecologic studies) which may include each of the following:
(i) Advanced techniques for the detection, assessment, and evaluation of the effects on human health of hazardous substances.
(ii) Methods to assess the risks to human health presented by hazardous substances.
(iii) Methods and technologies to detect hazardous substances in the environment and basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.
(B) Training, which may include each of the following:
(i) Short courses and continuing education for State and local health and environment agency personnel and other personnel engaged in the handling of hazardous substances, in the management of facilities at which hazardous substances are located, and in the evaluation of the hazards to human health presented by such facilities.
(ii) Graduate or advanced training in environmental and occupational health and safety and in the public health and engineering aspects of hazardous waste control.
(iii) Graduate training in the geosciences, including hydrogeology, geological engineering, geophysics, geochemistry, and related fields necessary to meet professional personnel needs in the public and private.
(a) sectors and to effectuate the purposes of this Act.
***
§311(a)(2)
Research, Development, and Demonstration
The Director of the NIEHS shall cooperate fully with the relevant Federal agencies referred to in subparagraph (A) of paragraph (5) in carrying out the purposes of this section.
***
§311(a)(5)
Research, Development, and Demonstration
To assist in the implementation of this subsection and to aid in the coordination of research and demonstration and training activities funded from the Fund under this section, the Secretary shall appoint an advisory council (hereinafter in this subsection referred to as the ``Advisory Council'') which shall consist of representatives of the following:
 The relevant Federal agencies.
 The chemical industry.
 The toxic waste management industry.
 Institutions of higher education.
 State and local health and environmental agencies.
 The general public.
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§311(a)(6)
Research, Development, and Demonstration
Within nine months after the date of the enactment of this subsection, the Secretary, acting through the Director of the NIEHS, shall issue a plan for the implementation of paragraph (1). The plan shall include priorities for actions under paragraph (1) and include research and training relevant to scientific and technological issues resulting from site specific hazardous substance response experience. The Secretary shall, to the maximum extent practicable, take appropriate steps to coordinate program activities under this plan with the activities of other Federal agencies in order to avoid duplication of effort. The plan shall be consistent with the need for the development of new technologies for meeting the goals of response actions in accordance with the provisions of this Act. The Advisory Council shall be provided an opportunity to review and comment on the plan and priorities and assist appropriate coordination among the relevant Federal agencies referred to in subparagraph (A) of paragraph (5).
***
§311(c)
Research, Development, and Demonstration
HAZARDOUS SUBSTANCE RESEARCH. -- The Administrator may conduct and support, through grants, cooperative agreements, and contracts, research with respect to the detection, assessment, and evaluation of the effects on and risks to human health of hazardous substances and detection of hazardous substances in the environment. The Administrator shall coordinate such research with the Secretary of HHS, acting through the advisory council established under this section, in order to avoid duplication of effort
***
§104(i)(4)
Response Authorities
The Administrator of the ATSDR shall provide consultations upon request on health issues relating to exposure to hazardous or toxic substances, on the basis of available information, to the Administrator of EPA
***
§104(i)(5)(A)
Response Authorities
For each hazardous substance listed pursuant to paragraph (2), the Administrator of ATSDR (in consultation with the Administrator of EPA and other agencies and programs of the Public Health Service shall assess whether adequate information on the health effects of such substance is available. For any such substance for which adequate information is not available (or under development), the Administrator of ATSDR, in cooperation with the Director of the National Toxicology Program (NTP), shall assure the initiation of a program of research designed to determine the health effects (and techniques for development of methods to determine such health effects) of such substance.
***
§104(i)(6)(C)
Response Authorities
In determining the priority in which to conduct health assessments under this subsection, the Administrator of ATSDR, in consultation with the Administrator of EPA, shall give priority to those facilities at which there is documented evidence of the release of hazardous substances, at which the potential risk to human health appears highest, and for which in the judgment of the Administrator of ATSDR existing health assessment data are inadequate to assess the potential risk to human health as provided in subparagraph (F). In determining the priorities for conducting health assessments
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§107(c)
Abatement Action
Within one hundred and eighty days after enactment of this Act, the Administrator of the EPA shall, after consultation with the Attorney General, establish and publish guidelines for using the imminent hazard, enforcement, and emergency response authorities of this section and other existing statutes administered by the Administrator of the EPA to effectuate the responsibilities and powers created by this Act.
***
§120(e)(1)
Federal Facilities
Not later than 6 months after the inclusion of any facility on the NPL, the department, agency, or instrumentality which owns or operates such facility shall, in consultation with the Administrator and appropriate State authorities, commence a remedial investigation and feasibility study for such facility.
***
§120(e)(6)
Federal Facilities
Administrator, after consultation with other departments, may determine that remedial efforts should be done by another potentially responsible party and may enter into a settlement agreement with such party.
Comment [9066-1934]: Commenter (6188) asserts that the CERCLA § 311 requires EPA to carry out a research program to develop and demonstrate "alternative or innovative treatment technologies" for potential use in response actions. 42 U.S.C. § 9660(b). Information gathered as part of that research program is already required to be made publicly available, with the express exception of trade secrets or personal proprietary information, two categories of data that the Proposed Rule does not protect on its face. Indeed, in requiring that all studies' supporting data be made publicly available, the Proposed Rule's language contradicts this statutory mandate. In sum, the authority EPA has cited for the rulemaking not only fails to confer upon EPA the power to promulgate the rule, but also is inconsistent with the rule's requirements.
Comment [9078-3554]: Commenter (6194) states that 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.
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."
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.)
Examples of EPA statutory mandates that could be impeded by the Proposal include (i) the development of standards to control emissions from burning hazardous waste fuels under the RCRA "as may be necessary to protect human health and the environment," 42 U.S.C. § 6924(q)(1); and (ii) determinations of whether hazardous sites need to be placed on the CERCLA NPL. With respect to the latter, CERCLA provides that, if a health assessment indicates that a release or threatened release may pose a serious threat to human health, the ATSDR shall "notify the Administrator of EPA who shall promptly evaluate such release or threatened release in accordance with the hazard ranking system . . . to determine whether the site shall be placed on the National Priorities List." 42 U.S.C. § 9604 (i)(6)(H). As referenced in footnote 41 of the commenter's comment letter, health assessments provided by ATSDR to EPA on a scheduled basis are exempt from peer review as a prerequisite to submission.
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 [6168-4099]: Commenter (6178) raises the following concerns with the Transparency Rule proposed by the NPRM:
1. The Agency cites specific sections of statutes it administers as the basis of the Agency's authority to adopt the Transparency Rule; specifically CERCLA (as delegated to the Administrator via Executive Order 12580) sections 115, 311, 42 U.S.C. 9616, 9660. 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 [6163-1276]: Commenter (6133) states that the Proposal contains a seemingly unrelated provision regarding agency peer review. The Proposal, in § 30.7, reads:

What role does independent peer review in this section?
EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein.

Because transparency in regulatory science includes addressing issues associated with assumptions used in models, EPA shall ask peer reviewers to articulate the strengths and weaknesses of EPA's justification for the assumptions applied and the implications of those assumptions for the results.

83 Fed. Reg. at 18,774.

There is no statutory authority for EPA to "conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." The federal statutes that EPA lists as putative authority for the Proposal provide no authority for proposed § 30.7. See CERCLA (as delegated to the Administrator via Executive Order 12580) sections 115, 311, 42 U.S.C. 9616, 9660. 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.