the factors used in determining the consideration to afford to the pivotal science indicate full consideration is justified."
Comment: Commenter (6141) states that instead of imposing an absolute ban on the use of past studies in all cases, EPA should develop reasonable rules and guidelines on when EPA may consider these past studies in future rulemakings.
Response: EPA clarifies that the rule does not impose a ban on the use of any studies regardless of when they took place. Under the final rule no studies are categorically excluded from consideration, even studies where the underlying dose-response data are not available for independent validation. EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for significant regulatory actions and influential scientific information using the factors outlined in § 30.5(b) of the final rule. The EPA will also consider the degree to which pivotal science is available and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation.
Comment: Commenter (6360) recommends that, if EPA elects a retrospective application, EPA should develop a process by which stakeholders could petition EPA based on objective criteria for the retrospective application of this rule to an existing administrative record for a final agency action. The commenter recommends that the criteria require a demonstration that the lack of transparency in the past undermines confidence in policies that significantly and adversely impact today's consumers, economy, or environment. Commenter states that this process could draw from the existing petition for rulemaking processes under the Administrative Procedures Act (APA) and requests for data correction under the Data Quality Act.
Commenter (6143) suggests that requirements apply on a case-by-case basis to retrospective assessment of research information to the extent that such actions are based or depend on research information.
 Response: This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all significant regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data.
<IP_ADDRESS> Support for Retrospective Application to Past Studies Used as Pivotal Regulatory Science
Comment: Commenter (6362) states that the rule should generally apply prospectively to EPA decision making. The commenter also states that, in cases where EPA has developed analytical tools and models, e.g., ECOSAR, in the past that incorporate dose response data, it may be valuable to apply this rule retrospectively. The commenter notes that, in other cases, such as Integrated Risk Information System (IRIS) assessments, where the Agency has yet to articulate a periodic review schedule for updating scientific assessments dating back 10-20 years or longer, the EPA should develop appropriate mechanisms for application of the rule.
Response: EPA agrees with the commenter that this rule should apply prospectively to EPA decision making. This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. For future significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. In the case of tools and models (e.g. ECOSAR) or IRIS assessments, this rule will only apply to those if they are used as pivotal science in future significant regulatory actions and influential scientific information.
Comment: Commenter (6449) states that in many cases the EPA relies upon toxicological assessments that have already been published by the Agency. The commenter recommends that the Rule make clear that for major or significant regulatory actions, the requirements of this rule will apply at the regulatory phase regardless.
Response: EPA clarifies that for future significant regulatory actions and influential scientific information, this final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data.
<IP_ADDRESS> Oppose Retrospective Application
<IP_ADDRESS>.1 Regulatory Uncertainty
Comment: Commenters (6116, 6125, 6141, 6360, 6866, 6905, 6918) suggest that the EPA require only prospective application of the Proposed Rule and express concern that the Proposed Rule could increase regulatory uncertainty for industry.
Commenter (6125) states that even though limited by time and resources, our assessment shows that, if the proposed rule were to apply retroactively with few or no exceptions/exemptions, most of the EPA cancer classifications and reference values would be vacated. The commenter suggests that, given the magnitude of the issue, EPA must address the potential damages to public health and the environment before any final action. The commenter adds that, to issue a valid rule, EPA would have to analyze this issue on its own, including what studies the proposal will exclude, present the results for public comment, and explain why the benefits of the per se rule justified the public health sacrifice and regulatory confusion that it would cause.
Commenters (6141, 6360) recommend that the EPA require only prospective application of the reforms. According to the commenters, a forward-looking process that does not disrupt any previously published proposed or final rule strikes a reasonable balance between EPA's positive efforts to increase transparency and the need for certainty, finality, and reasonable implementation burdens. Commenter (6360) states that reopening existing administrative records of final agency actions could result in significant unintended consequences that could undermine EPA's ability to implement the proposed rule.
Commenter (6866) states that retrospective application would put in doubt all current regulations  -  rules that provide business with certainty about requirements and that protect the public  -  even though there is no reason to assume they are faulty. The commenter expresses that the EPA can always reopen rules on a case-by-case basis if there is reason to do so, and some environmental statutes require periodic reviews of the latest science.
Commenter (6905) understands that this rule would only be used prospectively and urges EPA to retain that limitation. The commenter notes that the Proposed Rule, if implemented, would present increased litigation risk for states who rely on existing rules and standards set by the EPA and would increase regulatory uncertainty.
Commenter (6918) supports a forward-looking process in which EPA applies its new regulatory procedures to new proposed rules but does not disturb already-issued proposed or final rules. According to the commenter, a forward-looking process that does not disrupt any previously issued proposed or final rule strikes a reasonable balance between EPA's efforts to increase transparency and the need for certainty, finality, and reasonable implementation burdens.
Response: EPA agrees with the commenters, and this final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. For future significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. Since this rule applies only prospectively to significant regulatory actions it is unnecessary to assess potential damages associated with a retrospective application of the requirements of this rule.
Comment: Commenter (6117) does not recommend any retroactive application of this regulation. The commenter states that the EPA has already embarked on a well-thought-out plan to require and promote research transparency, as described in the EPA's 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research ("Plan"). The commenter provides that, although the preamble to the proposed regulation cites and "applies concepts and lessons learned" from the Plan, there are some concerning differences. The commenter states that the Plan indicates that it does not apply to "scientific research data collected before its implementation." The commenter states that, in contrast, the preamble and the proposed regulation suggest that the regulation may apply retrospectively.
Commenter (6141) suggests that EPA focus the new rules for scientific transparency on future studies rather than on past studies that are already designed and published with terms that may not fully comply with transparency requirements of the Proposed Rule. The commenter states that it should be noted that the epidemiologic science community has been making significant efforts in recent years to make data available where possible and to develop studies based on publicly available data where appropriate. The commenter contends that the Proposal would strengthen and expand upon this trend by further encouraging researchers to make increased efforts toward transparency so that the results of their research are eligible to be considered in future EPA rulemakings or other regulatory proceedings.
Response: EPA disagrees with the commenters that all past studies should be exempt from the requirements of this rule. This final rule applies prospectively to significant regulatory actions or influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information, but applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. Under the final rule no studies are categorically excluded from consideration, even studies where the underlying dose-response data are not available for independent validation. EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for significant regulatory actions and influential scientific information. The EPA will also consider the degree to which pivotal science is available and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation.
<IP_ADDRESS>.2 Legal Considerations
Comment: Commenters (6117, 6133, 6137) assert that it is well established that agency rules cannot be applied retroactively unless Congress expressly grants the agency that power. The commenters cite Bowen v. Georgetown Univ. Hospital, 488 U.S. 204, 208 (1988). Commenter (6137) also cites Sierra Club v. Whitman, 285 F.3d 63, 68 (D.C. Cir. 2002) (referring to "unusual ability to implement rules retroactively"). Commenters (6133, 6137) contend that EPA has not identified any such congressional intention in any of the statutes at issue, and thus retroactive application of the Rule would be unlawful.
Commenter (6117) states that there is no specific grant of power to apply this proposed regulation retroactively. The commenter provides that the two bills upon which this proposed regulation is modeled, the Honest and Open New EPA Science Treatment (HONEST) Act of 2017 (H.R. 1430  -  115th Congress, 2017-2018), and the Secret Science Reform Act of 2015 (H.R.1030  -  114th Congress 2015-2016), were not enacted.
Commenters (6133, 6137) assert that the Supreme Court strongly disfavors retroactive application of rules and cite the following Court decision:
      "Retroactivity is not favored in the law. Thus, congressional enactments and administrative rules will not be construed to have retroactive effect unless their language requires this result. [] By the same principle, a statutory grant of legislative rulemaking authority will not, as a general matter, be understood to encompass the power to promulgate retroactive rules unless that power is conveyed by Congress in express terms. [] Even where some substantial justification for retroactive rulemaking is presented, courts should be reluctant to find such authority absent an express statutory grant." Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 - 09 (1988) (internal citations omitted).
Commenter (6133) states that the Proposal ignores an entire body of case law that has considered and roundly rejected both retroactivity in rulemakings and limiting data that underlies rulemakings to "publicly available data." That commenter adds that, in so doing, the Proposal is arbitrary and capricious, and should be rejected. The commenter notes that the suggestion in the Proposal, for example, that EPA may invoke the Proposal's approach to review all prior health and scientific studies underlying the national ambient air quality standards (NAAQS) is illegitimate, arbitrary and capricious, and contrary to caselaw. The commenter provides that Bowen and its progeny do not permit agency rules to have retroactive effect to disallow health studies and regulatory science generated prior to, or relied upon by EPA prior to, adoption of any final rule based on the Proposal. The commenter asserts that this caselaw does not entertain any such exception and accepting any such exception for these circumstances would circumvent the holdings and reasoning of this case law.
Response: EPA agrees with the commenters that this rule should not apply retroactively. This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. For future significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. EPA also notes that despite proposing to promulgate this rule under the substantive environmental statues EPA administers, EPA is finalizing the rule solely under its authority to promulgate procedural regulations governing its internal affairs (or "housekeeping authority").
Comment: Commenter (6133) states that, despite its assertion that the rulemaking is "intended" to apply prospectively, the Proposal contemplates prohibiting EPA -- or will prohibit EPA --  from relying on studies generated prior to rulemakings that fail to meet the Proposal's ill-defined criteria for "publicly available data." According to the commenter, this approach is arbitrary and capricious, runs counter to the specific language of many statutes the agency is tasked with administering, and would destroy the agency's ability to promulgate health-based standards to protect the American public using the best available science.
Commenter (6137) states that the statutes upon which EPA relies do not support retroactive application. The commenter notes, for example, the CAA does not allow -- and, as the D.C. Circuit has held, certainly does not require, e.g., American Trucking, 283 F.3d at 372 -- applying the so-called transparency provisions of the Proposed Rule at all in rules subject to the procedural requirements of CAA§ 307(d). The commenter provides that such rules include NAAQS. The commenter states that, far from suggesting that EPA could lawfully reopen long-settled NAAQS to apply a new and novel standard of review, the CAA requires EPA to review and revise air quality criteria and NAAQS at least every five years and to "promulgate such new standards as may be appropriate." 42 U.S.C. § 7409(d)(1). The commenter asserts that this carefully chosen language confirms that Congress did not intend for EPA to apply rules like the Proposed Rule to undo existing NAAQS, but instead intended for regular reviews of scientific information to result in new NAAQS.
Commenter (6137) states that, even if EPA had statutory authority to apply the Proposed Rule retroactively, it could not do so rationally. The commenter cites Sierra Club, 285 F.3d at 68 (if EPA had authority to implement a rule retroactively, "retroactivity must be `reasonable,'"). According to the commenter, retroactive application of the Proposed Rule would undo well-settled rules in a tremendously unfair and irrational way and would lead to widespread confusion about countless environmental and public health policies and protections.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. EPA also notes that this final rule is relying exclusively on the Agency's housekeeping authority to promulgate this purely procedural rule. In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers. The EPA will undertake such efforts in forthcoming actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule. Some of these subsequent rulemakings will be substantive rules issued under the associated environmental statutes and will be subject to judicial review. By contrast, in this action, the EPA finalizes a rule of internal agency procedures, including how the Agency will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information for independent validation.
<IP_ADDRESS>.3 Retrospective Application May Not Be Practical
Comment: Commenters (2171, 2426, 6126, 6866, 6895) express that retrospective application of the proposed rule may not be feasible or practicable within a reasonable timeframe, both because of the volume of significant environmental rules already in place and because of the expertise that would be needed to reanalyze rules and supporting studies underpinning those rules. Commenter (2426) states that there was insufficient time and expertise to reanalyze the technical and legal aspects of these rules while maintaining oversight of ongoing agency business.
Commenter (6866) states that a retroactive application would be practically impossible to achieve in a timely manner and would impose unnecessary burdens on the agency while achieving little. The commenter provides that data access and sharing plans developed by National Institutes of Health (NIH), NSF, and EPA for their own funded research have all been prospective.
Commenter (6895) states that applying the proposed rule retroactively to health studies, potentially initiated decades ago, would provide no additional protection and would be difficult and time consuming, if not impossible.
Commenter (6141) asserts that there are many reasons why it is not feasible or practicable for EPA to require retroactive application of its proposed transparency policy in the case of existing EPA regulations.
Commenter (6126) states that EPA will not likely have the resources or capability to assess the entire suite of regulations and the evidence-base retrospectively. The commenter notes, for example, that the EPA is technically required to evaluate every regulation promulgated under the Resource Conservation and Recovery Act (RCRA) on a triennial basis; recent research suggests that statutory requirement has been largely unfulfilled due to a lack of resources to comply with the decades-old mandate. The commenter states that, in the absence of a major influx of new resources, EPA would be unlikely to engage in such meaningful and transparent reviews while also complying with statutory obligations.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. EPA also notes that this final rule does not require that EPA, a member of the public or other entity to independently validate a study through reanalysis before it can be considered to be pivotal science.
Comment: Commenters (1449, 6141, 6907) state that there are situations where public access to data and analytic methods used in past published studies may infringe on legitimate confidentiality and/or privacy interests, and where exceptions from the requirement to provide full public access is justified and therefore appropriate.
Commenters (6141, 6191) state that the cost and effort of redoing or updating these past studies also may be too onerous and costly in the case of large and complex existing data sets used in many cases. Commenter (6191) states that enforcement of data sharing for previously completed projects would introduce undue financial burden on principal investigators and may be largely impossible. The commenter provides that Institutional Review Board (IRB)-approved studies include provisions regarding disposal of data following study completion. The commenter states that researchers abiding by these provisions would have securely deleted and disposed of all raw data in the allotted time following project completion.
Commenter (6119) states that the requirements laid out in the rulemaking may not be practicable and/or feasible in the development of toxicity values, which rely heavily on epidemiology studies, case reports and clinical control settings. The commenter asserts that epidemiology studies and case reports are not reproducible as they come from uncontrolled public environmental settings. The commenter explains that uncontrolled public environmental settings are real life exposure scenarios and ultimately what "pivotal regulatory science" is trying to protect. The commenter adds that trying to reproduce the conditions in which a release is occurring or according to conditions 50 years ago is not practicable nor feasible. The commenter further adds that clinical controlled settings can also contain confidential data that cannot always be released for public viewing.
Commenter (6909) states that this proposed rule could have the devastating effect of undermining the scientific bases underpinning many of EPA's key regulatory regimes if it is applied retroactively  -  as the language of the proposed rule indicates it may be. The commenter provides that many older epidemiological studies that have provided support for numerous of EPA's key CAA and Clean Water Act (CWA) programs utilized confidential health data that may not be possible to make public at this point.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions and influential scientific information, this final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. Under the final rule no studies are categorically excluded from consideration, even studies where the underlying dose-response data are not available for independent validation. EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for significant regulatory actions and influential scientific information. The EPA will also consider the degree to which pivotal science is available and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation.
 Further, the EPA is finalizing the approach that gives greater consideration to pivotal science whose underlying dose-response data are publicly available or available through restricted access. Restricted or tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism (e.g., Data Use Agreements) that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information.
<IP_ADDRESS>.4 Retrospective Application is Complicated
Comment: Commenter (6362) states that retrospective application of any regulation (and its underlying scientific evaluations) is rife with complication, confusion, and significant ambiguity for EPA and stakeholders alike. Commenter states that, for example, it is unclear which administrative NAAQS records would be covered by the proposal and how far back it would apply.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions (e.g. a future NAAQS regulation) and influential scientific information, this final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data.
<IP_ADDRESS>.5 Retrospective Application Would Undermine Existing Public Health Protections
Comment: Commenters (1012, 2171, 6191, 6895, 6907, 6909, 8281-PH6) oppose retroactive application because it could undermine existing public health protections.
Commenter (1012) states that retroactive application of this proposed rule would open a tremendously convoluted process that could undermine existing public health protections. Commenter (2171) states that this rule must not be applied retrospectively; such application would only serve to create confusion with the intent of undermining existing public health regulations. Commenter (6191) states that the retroactive imposition of this rule would invalidate well-conducted research to the detriment of public health. Commenter (6895) states that retroactive application of the Proposed Rule would be detrimental to public health. Commenter (8281-PH6) states that retroactive application would severely undermine existing public health and environmental protections that keep the public safe and healthy. Commenter (6907) expresses concern that, under the proposed rule, if applied retrospectively, older studies on pesticides may be not be considered. The commenter notes that this is of concern for older pesticides which are now unregistered where there are older studies that indicate that these pesticides pose harm to humans or the environment.
Commenter (6909) states that, if EPA applies the proposed rule to studies retroactively, the core programs of the CAA and CWA may suddenly be left without any scientific basis that the agency will recognize. The commenter expresses that the prospect of the agency promulgating a rule that it can use to selectively hollow out core programs that not only protect public health but provide huge economic benefits (in the form of prevented lost workdays and hospital admissions, for example) is extremely troubling.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions and influential scientific information, this final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. Under the final rule no studies are categorically excluded from consideration, even studies where the underlying dose-response data are not available for independent validation. EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for significant regulatory actions and influential scientific information. The EPA will also consider the degree to which pivotal science is available and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation.
<IP_ADDRESS> Bias in the Quality of Scientific Information Available
Comment: Commenters (0671, 4590, 6126, 6137, 6152, 6191, 6895) express concern that retroactive application could result in the exclusion of studies that currently represent the "best available science" and, thus, reduce the quality of scientific information available for EPA's regulatory decision-making.
Commenter (6137, 6191) states that retrospective application of the provision would directly introduce bias regarding the quality of the scientific information available, as applying the rule would exclude most data/scientific information from consideration.
Commenter (4590) expresses concern that an incomplete pool of scientific evidence could skew regulatory decision-making toward studies that are less rigorous and trustworthy. The commenter states that, often, research that provides real insight into the impact of pollution on individuals and communities requires precisely the types of data most at risk of exclusion from EPA consideration under this rule.
Commenter (0671) states that the proposed regulatory change should not cover past or future dose response data or models. The commenter asserts that the previous rules were created using the best available science when they were promulgated. According to the commenter, science doesn't disappear because the EPA now wants to apply an unreasonable standard of evidence.
Commenter (6152) states that it appears that EPA may prohibit the use of older scientific studies that were developed before this rule was proposed and therefore may not conform to the requirements in this proposal. The commenter asserts that this arbitrary exclusion and potential retroactive culling of studies would surely undermine the quality of science used in rulemakings. The commenter states that this would impact worker epidemiology studies that often take years and sometimes decades to complete.
Commenter (6895) opposes the rule as an impediment to examination of the current state of the science and strongly opposes any retroactive application of the rule to an existing record. The commenter states that such application will arbitrarily introduce bias into previous decisions to the detriment of public and environmental health. The commenter states that applying the proposed rule retroactively would de facto preclude EPA's reliance on previously validated scientific findings from published, peer-reviewed research.
Commenter (6373) states that both the prospective and retrospective application of the proposed rule requirements will impact the quality of the scientific information that would be available to EPA. The commenter asserts that the Rule would require researchers to spend significant extra time and funds preparing public-use data, which would likely compromise EPA's ability to review and incorporate the most up-to-date relevant epidemiological and toxicological evidence of the health effects of pollutants into its regulations.
Commenter (1012) states that retroactive or prospective application of this proposed rule would ultimately bias the quality of the scientific information available by only allowing studies that support industry positions, which could bias the EPA towards that position.
Commenters (0569, 4590) express concern that the proposed language at subparts §30.2 and §30.9 could impact the quality of the science available because it could allow the EPA to selectively choose studies to meet its agenda. Commenter states that subpart §30.2 contains an a priori criterion of "pivotal regulatory science" while §30.9 gives the EPA Administrator discretion to issue exemptions from the policy on a case-by-case basis. Commenter states that these sections are vague on how and by what measures determinations would be made, opening the door for drawing upon studies driven by unknown interests or by political considerations rather than, as EPA's Mission Statement notes, "...the best available scientific information." Commenter (4590) states that empowering the Administrator with the discretion to implement case-by-case exemptions risks arbitrary policymaking, untethered from clearly established principles regarding when it is appropriate to rely on non-publicly available data as the best available scientific evidence.
Commenter (6362) states that bias should not be presumed. According to the commenter, if EPA uses a weight-of-the-evidence approach (as required under TSCA) and EPA has concerns about bias having been introduced, it can assess this using a sensitivity analysis by evaluating the impact of each study and/or model on the overall outcome of the analysis. The commenter asserts that bias should not be inferred if newer, more scientifically robust studies based on modern, up to date knowledge of biology and dose response are determined to be of better quality, relevance, and evidentiary value.
Commenter (6375) states that, in general, if the right processes and systems are in place to manage the public sharing of dose-response studies, then no unintended bias will occur for any prospective application of the rule. The commenter recognizes the challenge this may present and recommends that EPA consider a process ensuring that new dose-response studies are identified and assessed when they are completed and not wait until the rulemaking process begins. The commenter states that the NAAQS process is an example where EPA could develop a continual review process. The commenter asserts that continual assessment of new dose-response studies to determine if they have the potential to be pivotal regulatory science is key to ensuring that this rule does not cause bias or otherwise slow the rulemaking process. According to the commenter, this will allow enough time for independent verification to be completed prior to the rulemaking process, thus minimizing unnecessary delays.
Commenter (6449) states that there may be bias against the following:
 high quality studies published in the past where underlying data is not available;
 studies published outside the U.S;
 studies performed by authors or in a journal not informed by the rule; and
 proprietary models.
Commenter (6375) states that, regarding retrospective application, if EPA does not ensure that data and models from past dose-response studies are made publicly available when reviewing a previously finalized rule or creating a new rule, EPA could be giving the same weight to studies that may not have the same level of quality or veracity. The commenter notes that this could bias the rulemaking decisions toward results which do not represent the best available science. The commenter suggest that the Agency should release underlying data from older studies including methodologies so that strength and weaknesses of these data sets can be identified and that bias toward lower quality studies can be identified and constrained going forward.
Commenter (9227) notes that EPA's proposal would regulate not the scientists, but EPA itself and that the EPA would "ensure" that data and models underlying scientific studies "pivotal" to regulatory action are publicly available simply by barring EPA's own use in regulatory actions of any studies for which the authors do not make the data and models publicly available. The commenter asserts that the "mechanism" mentioned in the preamble is not technical assistance or funding to encourage greater availability of data; it is simply the pressure generated by EPA's refusal to consider the results of a study if the authors do not release publicly the underlying data and models. The commenter states that most of the significant barriers to release data and models are not a matter of the researcher's preference, but rather take the form of legal and ethical constraints, significant costs, large time investments, or the loss of proprietary data critical to a researcher's future career prospects. The commenter suggests that while it seems plausible that having their research applied in a regulatory context would be viewed as an incentive by some, or perhaps many, researchers, there is no reason to believe that such an incentive would be sufficient to overcome the significant barriers to public release of data where those barriers exist. The commenter contends that the party most likely to be incentivized by EPA's proposed requirements is the regulated community which has vested financial interests in regulatory actions the agency may take -- a situation that almost certainly will lead to significant bias and conflicts of interests in the scientific evidence that the agency considers.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions and influential scientific information, this final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data.
EPA disagrees with the commenters that this rule will result in the exclusion of studies from consideration for EPA significant regulatory actions and influential scientific information.
Under the final rule no studies are categorically excluded from consideration, even studies where the underlying dose-response data are not available for independent validation. EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for significant regulatory actions and influential scientific information. The EPA will also consider the degree to which pivotal science is available and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation.
EPA disagrees with the commenter that the Administrator's exemption outlined in proposed 40 CFR 30.9 will result in arbitrary policymaking. The EPA believes that retaining the Administrator's exemption provision because there are conditions under which compliance with the requirements in 40 CFR part 30 might be impracticable. For example, the underlying dose-response data for some studies, particularly older studies, may not be readily publicly available because of the technological barriers to data sharing (e.g., differences in data storage devices or data retention practices) that existed when they were developed, such as the age of the study. As a result, the EPA is finalizing the Administrator's exemption provision as proposed in the 2020 SNPRM, with additional conditions described here. Due to other changes in the final rule, the Administrator's exemption provision, which was previously in 40 CFR 30.9 in the 2018 proposed rule and the 2020 SNPRM, is now 40 CFR 30.7 in the final rule. To ensure that the Administrator's decision is appropriately transparent, in the final rule the EPA has included a provision in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. This documentation would typically be provided as part of the proposed rulemaking given this will be part of the decision of what is the pivotal science for the rule. Regardless, the final rulemaking will provide clear documentation. The EPA is also including criteria that may be used by the Administrator when he or she is determining whether greater consideration should be afforded to pivotal science for which the underlying dose-response data are not available in a manner sufficient for independent validation. As a result, the Administrator may determine that greater consideration is warranted when:
 Technological or other barriers render sharing of the dose-response data infeasible;
 The development of the dose-response data was completed or updated before the effective date of the final rule;
 Making the dose-response data would conflict with laws and regulations governing privacy, confidentiality, CBI, or national security;
 Third-party independent validation of the study's underlying dose-response data through reanalysis has been conducted; or
 The factors in 40 CFR 30.5 used in determining the consideration to afford to the pivotal science indicate full consideration is justified.
To assist the Administrator in determining whether to grant an exemption, the EPA program or Region responsible for the significant regulatory action or influential scientific information and public commenters can provide input when the Administrator is considering an exemption. The EPA will document the rationale for the Administrator's exemption in the significant regulatory action or influential scientific information. The EPA is confident that the above criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
Finally, EPA disagrees with the commenters that by taking into consideration the availability of data and models underlying pivotal science, EPA will be biased against considering the best available science. The EPA does not agree that its approach will be biased. As discussed in the preamble, the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. When characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect, the EPA will identify pivotal science and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation. Including this review of dose-response data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by independent third parties. This approach will result in significant regulatory actions and influential scientific information that are based on the highest quality, most relevant studies and ensure adequate human health and environmental protections, while maximizing transparency and maintaining consistency with the statutes the EPA administers.
<IP_ADDRESS> Bias in the Timeliness of Scientific Information Available
<IP_ADDRESS>.1 Analysis Paralysis and Data Dredging
Comment: Commenter (6446) expresses concern that there are no criteria or ad hoc methods that would prevent stalling vital decisions to protect public health and the environment by "analysis paralysis." The commenter contends that the proposed rule, if adopted, would inevitably delay setting protective standards through prolonged evaluation of the sufficiency of the public availability of research data and methods, rather than evaluation of the actual quality and import of scientific research.
Commenter (6122) states that the decision to delay action in favor of more refined data or models is a decision in-of-itself, and often has real consequences for ecosystems and endangered species. The commenter contends that forcing EPA to consider virtually every possible model in any decision will not lead to better decision-making, but instead will lead to regulatory paralysis, and EPA will defer taking life-saving steps to address pollution.
Response: The EPA disagrees with the commenters that requirements of this rule will result in any meaningful delay in promulgating regulations. While this rule does require the Agency to evaluate the availability of data and models for pivotal science, the incremental burden to the Agency to carry out these requirements is expected to be small given (1) the extensive scientific review EPA already conducts regularly and (2) that the requirement is limited to pivotal science (i.e., typically a small, though highly important, subset of all the studies the EPA would review). See section III.J of the rule preamble for further explanation.
Comment: Commenter (6897) states that the proposed rule would encourage data dredging and deconstruction that are the antithesis of good science. The commenter notes that epidemiological studies consider a huge number of variables and can relate them to a variety of outcomes in order to determine one significant association, such as the impact of poor air quality and asthma. The commenter explains that data dredging involves systematically retesting data sets such as those underlying epidemiologic studies through multiple models and statistical tests in order to produce desired outcomes. The commenter states that the proposed rule would allow regulated industries to request data and subject it to endless dredging to slow or entirely forestall regulation that would hurt their economic interests. The commenter adds that, similarly, data "deconstruction" is a term that has been used to describe a variety of sophisticated attacks on data, including reconsidering raw data through unreliable models and confounding data to obscure findings of harm. By explicitly requiring that the EPA consider a vast array of alternative models, which may be prepared by outside stakeholders, the commenter states that the proposed rule has the potential to buoy well-financed stakeholders who benefit from undermining good science and stalling sound policy by enforcing their ability to endlessly test and manipulate data.
Response: EPA disagrees with the commenter. Because of the potential impact of final significant regulatory actions, independent validation of studies that are pivotal to the EPA's final significant regulatory actions and influential scientific information will increase public confidence in the findings and conclusions presented in those studies. As noted in preamble to the final rule, the EPA's Science Advisory Board (SAB) noted that it "recognizes the importance of this rule and its purpose, establishing transparency of the influential scientific information used for significant regulations and enhancing public access to scientific data and analytical methods to help ensure scientific integrity, consistency and robust analysis. Strengthening transparency by improving access to data can lead to an increase in the quantity and the quality of evidence that informs important regulatory and policy decisions. The scientific community is moving toward adopting the precept of sharing accurate data and information to increase credibility, high-quality outcomes and public confidence in science. The SAB supports the adoption of this precept." The scientific community has also embraced greater data transparency, as evidenced by data sharing and availability requirements for many high-impact journals and the emergence of organizations, such as the Center for Open Science, and international initiatives like Findable, Accessible, Interoperable, and Reusable (FAIR) data principles; Facilitate Open Science Training in European Research (FOSTER); and Guidelines for Transparency and Openness Promotion (TOP) in Journal Policies and Practices that incentivize greater transparency in research.,
<IP_ADDRESS>.2 Barrier to Timely EPA Rulemaking
Comment: Commenter (1012) states that retroactive or prospective application of this proposed rule would ultimately bias the timeliness of the scientific information available by introducing procedural hurdles to the Agency's review process which could bias the EPA towards industry positions.
Commenter (6373) states that the prospective and retrospective application of these requirements will impact the timeliness of the scientific information that would be available to EPA. The commenter states that, even if it were feasible to recreate past studies so that they use a new data set that may be made public, it would be neither time-efficient nor cost-effective to repeat these studies merely to create a public data set for an "independent validation" in order that they be considered in the regulatory process.
Commenter (6119) states that it is their assessment that the proposal could further delay development and update of toxicity values or reference values published in the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), Toxic Substances Control Act (TSCA), CWA, Safe Drinking Water Act (SDWA) and other federal acts authorized by EPA. The commenter notes that states, EPA and the public are already struggling to respond to emerging contaminants for which toxicity values and risk-based standards have yet to be developed. There are currently more than 129 million organic and inorganic substances identified with a chemical abstracts service number in the open scientific literature. Yet, the commenter notes that only a handful have been studied and even fewer with "dose response data and models" (reference values (reference dose and/ or reference concentrations)) used for "pivotal regulatory science" as noted in the proposed rule. In Alaska, for example, the commenter states that a cleanup level for sulfolane has yet to be set, awaiting a National Toxicology Program (NTP) study on the public health impacts of long-term exposure to the environmental contaminant.
Commenter (6119) recommends that, if finalized, the rule should be applied only going forward and not retroactively due to the disruption that would cause. The commenter states that making it retroactive would lead to a lengthy and expensive hiatus in environmental management (protection and permitting) while the past decisions are explored, and the public provided notice.
Commenter (1012) states that retroactive application of this proposed rule would cause needless delays in the already beleaguered NAAQS review process. Commenter (6125) asserts that the proposed rule would likely impair significantly the Agency's ability to meet regulatory deadlines for the NAAQS or other programs.
Commenter (1012) states that retroactive application of this proposed rule would open a tremendously convoluted process that could undermine existing public health protections and set the Agency up for years of legal challenges. Commenter (5170) states that retroactive application of this proposed rule would make the Agency vulnerable to an onslaught of legal challenges while public health is held in limbo.
Commenter (6116) states that this proposal would slow the EPA's work to a near standstill or leave it open to criticism in terms of credibility, leaving states with data gaps that they cannot fill. The commenter adds that delays and lack of data due to convoluted, ill-defined requirements to achieve "independent validation" will cause harm to tribal governments who need quick, reliable information to address their environmental protection needs.
Commenter (6373) states that the Rule would require researchers to spend significant extra time and funds preparing public-use data, which would likely cause critical delay in the publication of findings and compromise EPA's ability to review and incorporate the most up-to-date relevant epidemiological and toxicological evidence of the health effects of pollutants into its regulations.
Response: EPA notes that this final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions and influential scientific information, this final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data.
Further, EPA disagrees with the commenters that requirements of this rule will result in any meaningful delay in promulgating regulations. While this rule does require the Agency to evaluate the availability of data and models for pivotal science, the incremental burden to the Agency to carry out these requirements is expected to be small given (1) the extensive scientific review EPA already conducts regularly and (2) that the requirement is limited to pivotal science (i.e., typically a small, though highly important, subset of all the studies the EPA would review). See section III.J of the preamble for further explanation.
Comment: Commenter (6119) states that the proposal could further delay development and update of toxicity values or reference values published in the CERCLA, TSCA, CWA, SDWA and other federal acts authorized by EPA. The commenter asserts that states, EPA and the public are already struggling to respond to emerging contaminants for which toxicity values and risk-based standards have yet to be developed. The commenter provides that, while there are currently more than 129 million organic and inorganic substances identified with a chemical abstracts service number in the open scientific literature, only a handful have been studied and even fewer with "dose response data and models" used for "pivotal regulatory science" as noted in the proposed rule. According to the commenter, unnecessarily restricting the data currently in practice or potentially used for regulatory development would do little to rectify this situation in a timely or "transparent" manner.
Response: EPA disagrees with the commenter that requirements of this rule will result in any meaningful delay in promulgating regulations. While this rule does require the Agency to evaluate the availability of data and models for pivotal science, the incremental burden to the Agency to carry out these requirements is expected to be small given (1) the extensive scientific review EPA already conducts regularly and (2) that the requirement is limited to pivotal science (i.e., typically a small, though highly important, subset of all the studies the EPA would review). Further, EPA notes that this final rule does not restrict the science that EPA can consider in its final significant regulatory actions and influential scientific information. Under the final rule no studies are categorically excluded from consideration, even studies where the underlying dose-response data are not available for independent validation. EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for significant regulatory actions and influential scientific information. The EPA will also consider the degree to which pivotal science is available and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation. See section III.J of the preamble for further explanation.
Comment: Commenter (6137) asserts that the provisions in the proposed rule related to independent peer review of all pivotal regulatory science used to justify regulatory decisions is inconsistent with the provisions in the Office of Management and Budget (OMB) Bulletin that state agencies should "ensure peer review does not unduly delay the release of urgent findings." The commenter asserts that, if EPA wants to independently peer review all pivotal science, then it must clearly outline how it will ensure the process will not lead to undue delay. According to the commenter, the EPA has failed to do so. The commenter notes, for example, there is nothing in the Proposed Rule outlining how EPA will conduct an independent review of the studies underlying the NAAQS standard, which they state will require review of hundreds if not thousands of science documents, within the NAAQS review cycle. The commenter provides that the standard review period in the independent peer review process (i.e., from submission of a manuscript to final review) is time intensive. The commenter states that, if it can take months to review one manuscript, it is difficult to envisage how EPA could subject every piece of pivotal regulatory science to the same standard of review and still complete scientific assessments in a timely manner.
Commenter (6137) also asserts that the absence of a provision in the proposed rule to account for time-sensitive health and safety disseminations is inconsistent with such provisions in the OMB Peer Review Bulletin. The commenter contends that this encompasses most of the studies that EPA intends to review, including but not limited to, IRIS assessments, TSCA risk evaluations, and National Emissions Standards for Hazardous Air Pollutants (NESHAP) risk assessments. The commenter states that, in each of these cases, EPA utilizes scientific data to make safety determinations for chemical pollutants and impacts on human health and the environment, and thus, timely review is tantamount to protecting public health. The commenter argues that the Proposal adds another layer of review  -  one that is wholly unnecessary and duplicative  -  that is antithetical to the time sensitive nature of these reviews.
Response: EPA disagrees with the commenters that requirements of this rule will result in any meaningful delay in promulgating regulations. While this final rule requires the Agency to evaluate the availability of dose-response data for pivotal science, the incremental burden to the Agency to carry out these requirements is expected to be small given (1) the extensive scientific review EPA already conducts regularly and (2) that the requirement is limited to pivotal science (i.e., typically a small, though highly important, subset of all the studies the EPA would review). See section III.J of the preamble for further explanation. The EPA further notes that the requirements of this final rule do not apply to influential scientific information or pivotal science that is part of a time-sensitive health or safety dissemination. See 40 CFR 30.3 "The provisions of this part do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses, and influential scientific information or pivotal science that meet one or more of the exemptions identified in Section IX of the OMB Final Information Quality Bulletin for Peer Review." Implementation guidlines and statute-specific transparency regulations or programmatic regulations are forthcoming.
Comment: Commenter (6147) states that the requirement to review past decisions may delay or halt the normal process of EPA decisions. The commenter provides that much of the early data may not be easily obtained and there may be no new data. The commenter expresses that the debate over what is "sound science" has become politicized and has raised a barrier to releasing information in a timely manner. The commenter contends that this attempt to focus on the uncertainties that are inherent in any complex analysis tends to detract from the purpose of seeking a solution to environmental problems. According to the commenter, while it is important to assure the public that regulatory decisions are based on the best available science, it is also important to seek resolution and begin the activities that will restore or protect the environment.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions and influential scientific information, this final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. EPA disagrees with the commenters that requirements of this rule will result in any meaningful delay in promulgating regulations.
Comment: Commenter (6446) expresses concern that a related likely consequence of the proposed rule, even if it contains ad hoc mechanisms for exceptions, is a reduction in EPA's ability to respond quickly to emerging challenges, when data and models take time to be made publicly available and/or redacted and otherwise prepared in a format appropriate for public review. Commenter (6903) states that the Proposed Rule would be a barrier to effective and timely EPA rulemaking and would make it nearly impossible for the Agency to expediently respond to existing and emerging issues and uphold its statutory mandates to protect the public's health.
Response: EPA disagrees that this rule will reduce EPA's ability to respond quickly to emerging challenges. The rule contains no requirement that dose-response data underlying pivotal science be made publicly available. Instead, it governs internal agency procedures for how the EPA will give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation when promulgating significant regulatory actions or developing influential scientific information for which the conclusions are driven by the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect.
<IP_ADDRESS>.3 Other Comments Regarding Prospective or Retrospective Application
Comment: Commenter (0559) encourages EPA to clarify how historical and new studies will be treated under the proposed rule, including how model uncertainty will treat studies demonstrating low-dose effects.
Commenter (6191) states that proposed rule does not describe the process for retrospective application within the text of the rule.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on either significant regulatory actions or influential scientific information. Such retroactive application would be time consuming and impracticable to do for all regulatory actions EPA has promulgated and influential scientific information EPA has developed. For future significant regulatory actions and influential scientific information, this final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. 40 CFR Part 30.5 discusses uncertainty, "The EPA shall also describe critical assumptions and methods used in its dose-response assessment and shall characterize the variability and uncertainty of the assessment. The EPA shall evaluate the appropriateness of using default assumptions on a case-by-case basis. The EPA shall clearly explain the scientific basis for critical assumptions used in the dose-response assessment that the EPA relied on for the significant regulatory action or influential scientific information."
Comment: Commenter (6373) asserts that EPA should state whether it will decline to consider contemporaneous and future scientific studies that rely in part on past scientific work for which certain data were not or are not currently available.
Response: Under the final rule no studies are categorically excluded from consideration, even studies where the underlying dose-response data are not available for independent validation. EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for significant regulatory actions and influential scientific information. The EPA will also consider the degree to which pivotal science is available and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation.
6.1.3 How Does What this Rule Would Require Compare to Requirements of Environmental Statutes?
Comment: Commenter (0671) states that the proposed regulatory change will force the EPA to ignore the best available science on dose response and models, which is counter to the intent and text of the CAA and amendments, and which will introduce bias by preventing the EPA from using what are often the most relevant and well-designed studies.
Response: Under the final rule no studies are categorically excluded from consideration and the EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for final significant regulatory actions and influential scientific information. The EPA will also consider the degree to which pivotal science is available and give greater consideration to those studies with greater data and model availability. Further, as discussed in the final rule preamble in section III.A, this internal procedural rule does not interpret or apply any provisions of the statutes that EPA administers, and the EPA is maintaining language in 40 CFR 30.3 stating that the statutes EPA administers, or their implementing regulations, will control in the event of any conflicts with the requirements of this rule. When implementing this procedural rule in forthcoming statute-specific transparency regulations or programmatic regulations, the Agency will continue to comply with and abide by the requirements in those statutes and implementing regulations, including regulatory deadlines.
Comment: Commenters (6117, 6133, 6137) assert that it would be unlawful for this rule to have a retrospective effect.
Response: See discussion and response in section 15.2 of this Chapter (Could Prospective or Retrospective Application Introduce Bias Regarding the Timeliness and Quality of Scientific Information Available?) subsection B.3 (Oppose Retroactive Application; Legal Considerations) of this Chapter (15. Strengthening Transparency in Regulatory Science  -  Pivotal Regulatory Science).
Comment: Commenter (6133) states that the Proposal conflicts with the statutes that EPA administers. The commenter provides that the Proposal unlawfully restricts EPA's consideration and use of "dose response data and models that underlie" what the Proposal calls "pivotal regulatory science." 83 FR 18770/2.
      Pivotal regulatory science' is the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated. In other words, they are critical to the calculation of a final regulatory standard or level, or to the quantified costs, benefits, risks and other impacts on which a final regulation is based. Id.
Commenter (6133) asserts that, by restricting EPA's implementation of its federal organic statutes and the APA in this fashion, and by defining "pivotal regulatory science" in this manner, the Proposal violates federal laws. The commenter states that the Proposal does so by requiring EPA to implement federal laws based on the Proposal's criteria and concept of "pivotal regulatory science," rather than on the congressional criteria and requirements in federal statutes that contradict, disallow, or fail to include those criteria and concepts in the Proposal.
Response: EPA disagrees that this final rule conflicts with the statutes EPA administers. As a threshold matter, and as discussed in the final rule preamble in section III.A, this internal procedural rule does not interpret or apply any provisions of the statutes that EPA administers. Furthermore, 40 CFR 30.3 states that the statutes and regulations will control in the event of any conflicts, and EPA clarifies that the requirements in this final rule set the overarching structure and principles for science transparency in the EPA's final significant regulatory actions and influential scientific information. The EPA intends to develop internal implementation guidance and promulgate either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule, which will clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes EPA administers.
Comment: Commenter (6133) complains that EPA not only fails to provide a passable definition for its invented term, "pivotal regulatory science," the agency also fails to provide its rationale for limiting the scope of the rule to so-called "pivotal regulatory science." The commenter asks (1) why is the "public availability of science and data in a manner sufficient for independent validation" any less important or necessary or justified when the science is not "pivotal" or "critical" to a regulatory decision, (2) why should not all science, studies, data and information considered by EPA meet the standards for transparency, verifiability, independent validation, and trustworthiness that are the abiding concerns of the Proposal, and (3) why is it not arbitrary and capricious for EPA to continue to consider science and data that are unavailable and insufficient for independent validation in areas outside the reach of the Proposal? The commenter states that EPA offers no explanation for this disparate treatment; the agency's reasoning, such as it is, is entirely conclusory. The commenter provides that, by way of explanation for the limitation, EPA only suggests that the imposed standards "are of paramount importance when the government relies on science to inform its significant regulatory decisions." According to the commenter, this explanation is hopelessly circular and ultimately incoherent. The commenter states that EPA does not explain why it believes this explanation to be true. The commenter adds that the Proposal just substitutes the word, `paramount,' for the word, `critical,' that it substitutes for the word, `pivotal.' The commenter asserts that this failure to thoroughly explain both the term "pivotal regulatory science" in a way that meaningfully defines the scope of the regulation, and the rationale behind limiting the application only to pivotal (critical, paramount) science, makes it impossible for interested parties to comment fully and meaningfully on the Proposal. The commenter suggests that, should EPA intend to finalize this unlawful proposal, the EPA first must withdraw the Proposal, then issue a supplemental proposal with the necessary definitions and explanations.
Response: EPA agreed that there was value in issuing a supplemental proposal to make clarifications, modifications and additions to certain provisions in the rulemaking and therefore issued a supplemental notice of proposed rulemaking in March 2020. In the supplemental, EPA clarified, that "EPA would continue to use standard processes for identifying, evaluating, and reviewing available data, models, and studies. When the Agency has potentially identified multiple key studies or models of similar quality that could drive its subsequent decisions, the Agency will investigate the availability of the underlying data." EPA has limited the primary requirements of this rule to pivotal science, which is one or two studies, for two primary reasons. First, although this rulemaking does not require reanalysis of studies, it is informative to evaluate published findings on the patterns of such attempts since journal data sharing policies have been adopted. Lewandowsky et al. (2020) evaluated the cost-effectiveness of reanalysis studies under various scenarios and concluded that reanalysis studies are most cost-effective when they are focused on studies of the greatest interest to the scientific community (in this study, the number of citations was a surrogate for interest) (Ref. 43). This finding is consistent with results in other studies that found and encouraged narrowing the focus of attempted reanalysis studies to those studies of greater significance (Refs. 70, 72, 73, 74). Consistent with the recommendations of these studies and commenters and the EPA's commitment to cost-effective government practices, it is logical to narrow the applicability of this rule to those studies that are most pivotal or "key" to the development of final significant regulatory actions and influential scientific information. Second, though it was never the Agency's intent, the EPA finds that implementing the data and model availability requirements of this final rule for all the studies EPA considers in final significant regulatory actions and influential scientific information may be infeasible.
Finally, EPA disagrees that the Agency should not consider science where the underlying data and models are not publicly available. The EPA will continue to consider all peer-reviewed science evaluated in the EPA's influential scientific information and final significant regulatory actions, consistent with existing study quality assessment factors and the statutory mandates specific to that rulemaking.
Comment: Commenter (6133) states that the EPA does not and cannot identify any statutory basis -- in federal environmental statutes, the APA or otherwise -- to apply the Proposal's approach. The commenter provides that EPA's preambular explanation says that "pivotal regulatory science" is "critical to the calculation of a final regulatory standard or level, or to the quantified costs, benefits, or risks and other impacts on which a final regulation is based." According to the commenter, the Proposal nowhere explains what these "other impacts" are. The commenter states that the Proposal does not limit or bound these "other impacts," nor link them to the sentence's incoherent notion of what is "critical" and what is not. Commenter states that the preambular gloss is inconsistent with the proposed CFR definition. According to the commenter, the former says "pivotal regulatory science" is critical to vague "other impacts" on which a final rule is based. The commenter states that the proposed CFR definition, by contrast, says "pivotal regulatory science" "drive[s] the requirements and/or quantitative analysis of EPA final significant regulatory decisions." The commenter contends that the Proposal does not square the contradictions between science that drives a final rule's requirements and science that is "critical" to "other impacts" in a final rule.
Response: The EPA intends to promulgate regulations under the environmental statutes EPA implements to further clarify how the Agency will apply the definition of pivotal science in specific programs authorized under those statutes (e.g., CAA, CWA, SDWA, RCRA, FIFRA, TSCA, Emergency Planning and Community Right-to-Know Act (EPCRA)). The specific criteria for determining pivotal science may necessarily be specific to the authorizing statute, as well as the final significant regulatory action or the influential scientific information. The EPA intends to explain in each final significant regulatory action and for each influential scientific information how the pivotal studies were identified.
6.1.4 Recommended Changes to the Definition of Pivotal Regulatory Science at §30.2
<IP_ADDRESS> Pivotal Regulatory Science
<IP_ADDRESS>.1 Support for the Proposed Definition
Comment: Commenters (6150, 6180) support the Proposed Rule's definition of pivotal regulatory science as referring to the specific studies or analyses that drive the requirements and/or quantitative analysis of EPA's significant regulatory decisions. Commenter (6150) states that, as noted in the Preamble, this includes scientific studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated.
Commenter (6375) concurs with the general definition of "pivotal regulatory science" in the Proposed Rule. Commenter states that the definition of "pivotal regulatory science" could be further clarified, however, to include examples that illustrate situations in which the definition would and would not apply. The commenter suggests that examples where the rule would apply should include:
 Studies cited as the basis for Causal or Likely Causal determinations in a NAAQS Integrated Science Assessment, if they are not part of a generalized weight-of-evidence approach that incorporates a broader literature base;
 Studies EPA uses for its mortality or morbidity projections in a NAAQS Health Risk and Exposure Assessment, or the specification of a definitive concentration-response function upon which projections are based; and
 Studies EPA cites as a basis for quantifying a NAAQS.
Response: EPA acknowledges the commenters' support for the definition of pivotal regulatory science, and notes that the term has been combined with the term "pivotal science," proposed in the 2020 supplemental notice of proposed rulemaking. This final rule establishes how the EPA will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. An integrated science assessment would be considered influential scientific information, but the final rule focuses on only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information.
<IP_ADDRESS>.2 Do Not Support the Proposed Definition
General Comments
Comment: Commenter (0671) states that EPA should not attempt to define the concept of "pivotal regulatory science," because the premise of this proposed regulatory change is flawed.
Commenter (3971) suggests that EPA assemble small groups of dedicated scientists in order to produce a definition of "pivotal regulatory science" and how to implement such definition.
Response: When promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data, the Agency shall follow best practices to evaluate potential links between exposure to a pollutant, contaminant, or substance and the effect and the nature of the dose-response relationship. The EPA will use the following factors to assess the quality of studies identified in the systematic review: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. The EPA will rely on the highest quality, most relevant studies in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well-substantiated evidence of a relationship between exposure and effect, the EPA will identify those studies based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints that would inform a dose-response assessment for those effect endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements, quantitative analyses, or both of an EPA significant regulatory action or influential scientific information will be identified as pivotal science. The EPA intends to issue implementation guidelines and statute-specific rulemakings that will further describe these criteria and how the EPA will identify pivotal science in its assessments and rulemakings.
Definition Not Adequate and Lacks a Scientific or Legal Foundation
Comment: Commenters (1011, 1272, 4881, 6114, 6116, 6131, 6133, 6144, 6361, 6362, 6373, 6909, 6924, 8281-PH20) express concern that the term "pivotal regulatory science" is not adequately defined. Commenter (4881) states that a central element of the proposed rule is the vague definition of "pivotal regulatory science" to which the rule would apply. Commenter (6114) states that it is difficult to understand why the agency would publish a rule with such an obvious flaw, as this could leave the interpretation of this term up to the courts, which may not turn out the way the EPA intended. Commenter (6133) states that the term "pivotal regulatory science" is perhaps the most vague, unexplained and internally inconsistent term used in the Proposal. Commenter (6144) states that the term used in the proposed rule, "pivotal regulatory science" has no precise meaning in science and seems to be contrived to cover an arbitrary set of information without clear articulation and basis. Commenters (6114, 6116, 6131, 6361) state that although the term "pivotal regulatory science" is used several times in the notice and appears to be a focus for this rule, it is not adequately defined in the Federal Register notice.
Commenter (1272) states that the Food and Drug Administration (FDA) describes "regulatory science as a science-based decision-making process needed to fulfill the responsibilities of a public health agency", while the dictionary describes pivotal as "of crucial importance in relation to the development or success of something else". The commenter provides that, using these two in conjunction, pivotal regulatory science would mean any using science-based decision making whenever there is importance in the developing regulation, which they state that one could argue is every decision the EPA makes.
Commenters (1011, 6133, 6362) express concern that, in the proposed rule, EPA variably defines pivotal regulatory science as "the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated," and "the specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions." Commenter (1011) states that these designations are vague and without further guidance for what constitutes pivotal regulatory science, EPA will introduce uncertainty into its decision-making process. The commenter adds that it is unclear why EPA is choosing to create a new class of scientific information and holding it to a standard of data access that the rulemaking does not require for "non-pivotal" regulatory science.
Commenters (4839, 4881, 6924) express concern that "pivotal regulatory science" is not a phrase defined in or widely used in scientific literature.
Commenter (4839) states that the draft regulation embraces a policy agenda that lacks a foundation in scientific research, peer review and application to regulatory policy. The commenter asserts that the proclamation of new terms such as "pivotal regulatory science" is more rhetorical than real and demonstrates no connectivity to probabilistic risk assessment or other well-established methodologies that guide public health and environmental policies. The commenter contends that the term "pivotal regulatory science" is un-peer reviewed and lacks transparency regarding key decision factors used to weigh the role and utility of data used in linear or non-linear dose response functions, cost benefit analysis, identification of policy options or regulatory impact analysis. The commenter adds that pivotal regulatory science is presented as a cornerstone "to change agency culture and practices," an agenda that embodies a political objective rather than a scientific purpose.
Commenter (6924) states that "pivotal regulatory science" is not scientific terminology and is not used in the scientific literature. According to the commenter, the proposed rule's definition appears to attempt to delineate a smaller subset of relevant studies that would be "pivotal regulatory science", but the term is not useful because the entire body of relevant scientific evidence would meet the definition of pivotal regulatory science. The commenter adds that this is because a properly conducted assessment considers the entire body of evidence in the evaluation, integration and development of conclusions. The commenter provides that, for example, though there may be one study or several studies that contribute to the numerical calculation of a point of departure, the rest of the body of scientific evidence is used to make determinations that also are important in the magnitude of the benefit-cost calculation, including: (1) uncertainty factors used in calculations of risk; (2) whether particular sub-populations are susceptible and need greater protections; (3) the modeling of dose-response; (4) the likely occurrence and severity of potential health effects; (5) population exposure levels, etc. The commenter adds that a typical EPA assessment draws upon hundreds to thousands of studies, and according to this definition all the underlying data of those studies would need to be made publicly available.
Commenters (4881, 6114, 6116, 6131, 6361) assert that although the term "pivotal regulatory science" is used several times in the notice and appears to be a main focus for this rule, it does not appear anywhere else in the legal records, court decisions, or rules that address environmental protection or the role of the EPA.
Commenters (6116, 6131, 6361) state that, with no grounding in the law, it is unclear what EPA is trying to achieve by designating certain research as "pivotal regulatory science."
Commenter (6133) states that the term has no statutory basis in any statute cited by EPA, or otherwise. Commenter states that, beyond having no statutory underpinning, the meaning of the phrase is neither self-evident nor adequately defined in the Proposal.
Response: EPA disagrees that the term pivotal science (which encompasses the proposed term pivotal regulatory science in this final rule) is inadequately defined. 40 CFR Part 30.2 clearly defines pivotal science as meaning "the specific dose-response studies or analyses that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information."
In the 2020 SNPRM, the EPA introduced the term "pivotal science," defined in proposed 40 CFR 30.2 as "the specific scientific studies or analyses that underly [sic] influential scientific information." This term was proposed as a parallel to "pivotal regulatory science," defined in 40 CFR 30.2 of the 2018 proposed rule as "the specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA significant regulatory decisions." The EPA received comment on the use of "regulatory" in "pivotal regulatory science." Some commenters contended that there is no such thing as science that is regulatory; rather, there is science used to support regulation. Some commenters also noted that the terms "pivotal science" and "pivotal regulatory science" have similar scopes. The EPA acknowledges that no scientific study is inherently regulatory; rather, the EPA uses science to inform its significant regulatory actions. In order to increase the clarity of this final rule, to take into account the similarities between the two definitions, and to more accurately describe the science that the EPA uses, the EPA is removing the term "pivotal regulatory science" and combining the definitions of "pivotal science" and "pivotal regulatory science" under the single term "pivotal science" in 40 CFR 30.2. The EPA is responding to comments on both terms together.
The EPA also acknowledges that the term "regulatory science" may be confusing because it suggests either the term refers to a scientific discipline of regulatory decision-making (akin to FDA), or that some science the EPA considers is inherently regulatory. Neither of these interpretations reflects the Agency's intent in defining this term. The EPA considers the breadth of scientific evidence in its rulemakings; while this scientific evidence informs policy decisions, the EPA's consideration of the science does not make it "regulatory science." To reflect this fact, in the final rule the EPA is changing the proposed term "regulatory science" to "science that serves as the basis for informing a significant regulatory action."
In this final rule, rather than considering all studies that support the assessment of the relationship of a dose or exposure of a pollutant, contaminant, or substance to the magnitude of a predicted health or environmental impact as "pivotal science," the EPA is balancing transparency and feasibility by focusing on those studies that inform the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect. Thus, "pivotal science" includes only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. In the context of this rule, studies informing the dose-response modeling (e.g., benchmark response selection), studies identifying data for toxicokinetic adjustments, or studies informing the selection of uncertainty factors do not drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. Future statute-specific rulemakings may interpret "pivotal science" more broadly.
Definition Does Not Clarify Pivotal Regulatory Science Applicability
Comment: Commenters (6114, 6116, 6131, 6361) state that it is impossible to determine exactly what the ramifications of this rule would be.
Commenters (6114, 6116, 6131) state that, for example, it is unclear whether the term "pivotal regulatory science" would apply to studies or modeling conducted by industry groups, meaning that the research performed by these groups could be held to a lower standard than research performed by reputable scientists around the world.
Commenter (6133) states that EPA's choice to modify "regulatory science" with the adjective "pivotal" does nothing to clarify the scope of scientific studies and information encompassed by the Proposal. The commenter states that it is arbitrarily vague, and unexplained under the Proposal which science would be considered "pivotal," and under what conditions. The commenter adds that, because the term was created out of thin air to serve EPA's purposes and has no statutory grounding or intuitive meaning, this ambiguity-ridden definition is woefully inadequate. The commenter further adds that it is also arbitrary and capricious and an abuse of EPA's discretion and that EPA is well aware of the insufficiency of the definition, as is evident in the agency's solicitation of comments on the definitions of "pivotal regulatory science" and "dose response data and models" within the Proposal.
Response: In the 2020 SNPRM, the EPA introduced the term "pivotal science," defined in proposed 40 CFR 30.2 as "the specific scientific studies or analyses that underly [sic] influential scientific information." This term was proposed as a parallel to "pivotal regulatory science," defined in 40 CFR 30.2 of the 2018 proposed rule as "the specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA significant regulatory decisions." The EPA received comment on the use of "regulatory" in "pivotal regulatory science." Some commenters contended that there is no such thing as science that is regulatory; rather, there is science used to support regulation. Some commenters also noted that the terms "pivotal science" and "pivotal regulatory science" have similar scopes. The EPA acknowledges that no scientific study is inherently regulatory; rather, the EPA uses science to inform its significant regulatory actions. In order to increase the clarity of this final rule, to take into account the similarities between the two definitions, and to more accurately describe the science that the EPA uses, the EPA is removing the term "pivotal regulatory science" and combining the definitions of "pivotal science" and "pivotal regulatory science" under the single term "pivotal science" in 40 CFR 30.2. The EPA is responding to comments on both terms together.
The EPA also acknowledges that the term "regulatory science" may be confusing because it suggests either the term refers to a scientific discipline of regulatory decision-making (akin to FDA), or that some science the EPA considers is inherently regulatory. Neither of these interpretations reflects the Agency's intent in defining this term. The EPA considers the breadth of scientific evidence in its rulemakings; while this scientific evidence informs policy decisions, the EPA's consideration of the science does not make it "regulatory science." To reflect this fact, in the final rule the EPA is changing the proposed term "regulatory science" to "science that serves as the basis for informing a significant regulatory action."
The EPA notes that implementation guidelines and statute-specific transparency regulations or programmatic regulations are forthcoming. At that time, the agency will be better able to determine and assess potential ramifications of implementing this procedural rule.
Comment: Commenter (6909) states that EPA has not made it clear in the proposed rule how or even whether the rule would apply in a variety of frequently encountered situations. The commenter notes that, for example, EPA is openly unsure whether the rule would apply to a study underlying a guidance document; whether it would apply to a study that merely affirms an existing EPA standard; whether it would apply to a study underlying an individual party adjudication, or an enforcement action, or a site-specific permitting action.
Response: The EPA has considered the public comments and finalized the scope of this rule to apply to significant regulatory actions and influential scientific information. The EPA notes that implementation guidelines and statute-specific transparency regulations or programmatic regulations are forthcoming.
Comment: Commenter (6909) states that many of the central terms that will dictate how and to what studies the rule would apply are undefined or unclear.
Response: The EPA agrees that some terms were unclear. The final rule, in response to comments, defines the following terms: "data," "dose-response data," "independent validation," "influential scientific information," "pivotal science," "publicly available," "reanalyze," "science that serves as the basis for informing a significant regulatory action," and "significant regulatory actions." Each definition is discussed further in the preamble to the final rule.
Definition Allows for Limitless Discretion
Comment: Commenter (4881) states that there is no useful guidance in the language of the proposed rule for an EPA Administrator to apply in deciding which issues fit and which do not fit the fluid definition of "pivotal." According to the commenter, this ambiguity invites intrusion of political preference and prejudice into the essential scientific process of public health risk assessment.
Commenter (6137) states that the EPA's Proposed Rule lacks the requisite standards and principles that are the hallmark of lawful agency decision-making. The commenter asserts that the vague definitions proposed in 40 CFR §30.2 invite limitless agency discretion to decide when the Rule's requirements apply. The commenter notes that the Proposed Rule defines "pivotal regulatory science" as studies that "drive the requirements and/or quantitative analysis" of EPA's action, but this lacks any understandable meaning. The commenter states that there is no standard governing what science does or does not "drive" the regulatory action. According to the commenter, the lack of regulatory standards here means that EPA staff will impermissibly determine applicability of the rule "based upon their own unwritten personal standards." White v. Roughton, 530 F.2d 750, 754 (7th Cir. 1976). The commenter adds that these provisions allow for arbitrary application of the Rule, rendering the Proposed Rule arbitrary and thus unlawful.
Commenter (6373) states that the Rule does not clarify who will be determining which studies are considered "pivotal regulatory science" or at what stage or stages of EPA's review process this determination will be made. According to the commenter, this is particularly concerning given the former EPA Administrator's directive last year to remove or refuse to consider for membership former and current recipients of EPA grants from the Clean Air Scientific Advisory Committee (CASAC) and other advisory committees. Commenter states that, unless EPA has in place a fair review process for determining "pivotal regulatory science," the Rule can be misused to disregard or discredit relevant studies.
Response: The EPA notes that implementation guidelines and statute-specific transparency regulations or programmatic regulations are forthcoming. The EPA has clarified in this final rule that in general, the EPA will rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well substantiated evidence to support a relationship between exposure and effect, the EPA will identify a subset of those studies based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints that would inform a dose-response assessment for those effect endpoints and drive the requirements and/or quantitative analyses of an EPA final significant regulatory action or influential scientific information will be identified as pivotal science. The EPA disagrees that designating a set of key studies as "pivotal science" will necessarily be biased or without accountability. The EPA follows an objective, unbiased process for identifying and evaluating scientific studies and already identifies key or pivotal studies in some of its actions (e.g., IRIS assessments).
<IP_ADDRESS>.3 Recommendations for Specific Changes to the Definition
Comment: Commenter (0567) recommends the EPA delete the words "final" and significant" in the proposed definition of pivotal regulatory science. The commenter interprets that the Agency identifies pivotal regulatory science as the key scientific data and methods used to translate research results into application in the regulatory process. The commenter asserts that there is no reason not to apply appropriate processes in all regulations.
Commenter (4932) recommends that EPA alter the definition of "pivotal regulatory science" by striking the word "final" from the proposed definition to make the Transparency Proposal fully consistent with Executive Order 12866. The commenter notes that "regulatory action" under Executive Order 12866 means "any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking." The commenter adds that the necessary (and seemingly unintended) implication of including the word "final" in the definition is that the transparency objective (i.e., the disclosure of pivotal regulatory science) does not apply to advanced notices of proposed rulemaking or proposed rulemaking. According to the commenter, the public must have access to pivotal regulatory science at these earlier steps in the rulemaking process in order to assess effectively the merit of the Agency's regulatory science. The commenter contends that disclosure of pivotal regulatory science when final agency action is issued is too late in the rulemaking process as any opportunity for public comment will have ended.
Commenter (6155) states that the following language from EPA's regulations adopted under the Data Quality Act may help further clarify the terms "pivotal regulatory science" and "significant regulatory actions" as defined in §30.2 of the proposed rule. The commenter provides that EPA will generally consider the following classes of information to be influential, and, to the extent that they contain scientific, financial, or statistical information, that information should adhere to a rigorous standard of quality:
 Information disseminated in support of top Agency actions (i.e., rules, substantive notices, policy documents, studies, guidance) that demand the ongoing involvement of the Administrator's Office and extensive cross-Agency involvement; issues that have the potential to result in major cross-Agency or cross-media policies, are highly controversial, or provide a significant opportunity to advance the Administrators priorities. Top Agency actions usually have potentially great or widespread impacts on the private sector, the public or state, local or tribal governments. This category may also include precedent-setting or controversial scientific or economic issues.
 Information disseminated in support of Economically Significant actions as defined in Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), Agency actions that are likely to have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, Tribal, or local governments or communities.
 Major work products undergoing peer review as called for under the Agency's Peer Review Policy. Described in the Science Policy Council Peer Review Handbook, the EPA Peer Review Policy regards major scientific and technical work products as those that have a major impact, involve precedential, novel, and/or controversial issues, or the Agency has a legal and/or statutory obligation to conduct a peer review. These Major work products are typically subjected to external peer review. Some products that may not be considered "major" under the EPA Peer Review Policy may be subjected to external peer review but EPA does not consider such products influential for purposes of these Guidelines.
 Case-by-case: The Agency may make determinations of what constitutes "influential information beyond those classes of information already identified on a case-by-case basis for other types of disseminated information that may have a clear and substantial impact on important public policies or private sector decisions.
Commenter (6356) suggests EPA remove the word "significant" from the proposed definition of "pivotal regulatory science" or it should simply remove the term from the final rule and replace it with the definition of another proposed term "regulatory science" -- from which it also should delete the word "significant." According to the commenter, it does not appear that both terms are necessary, and they make cryptic distinctions between data and assumptions that drive the agency's regulatory decisions.
Commenter (6362) states that, assuming the intent is to define and distinguish the subset of scientific studies and analyses that form the scientific foundation for EPA's regulatory decisions from the larger universe of all the scientific information reviewed and considered by the agency, a more precise word than "pivotal" would be "material." The commenter provides that those scientific studies and analyses that are material to its regulatory decision must be or be made publicly available in a manner sufficient for independent validation.
Commenter (6449) states that it is not clear whether "pivotal regulatory science" means studies and analyses performed by the EPA, or those studies published by others in peer-reviewed journals that might support EPA's analysis. The commenter suggests that EPA consider that pivotal studies may also be those that determine qualitatively the weight of evidence (WOE) that a specific toxic endpoint is of relevance to human health or the species of concern. The commenter contends that selection of the appropriate toxic endpoint based on WOE after systematic review of the literature is as important as appropriate quantitative analysis.
Response: The EPA has removed the word "final" from the definition, so that pivotal science applies to EPA significant regulatory actions. The EPA also notes that this action also requires the EPA to identify and make publicly available the science that serves as the basis for informing a significant regulatory action at the proposed or draft stage to the extent practicable. Pivotal science is defined as the specific dose-response studies or analyses that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. Therefore pivotal science is not limited only to the science developed by the EPA.
<IP_ADDRESS>.4 Need More Clarity in the Definition
Comment: Commenter (1011) states that they do not interpret the proposed rule's classification of pivotal regulatory science as a change to the current understanding of what constitutes "best available science". The commenter urges EPA to continue to use the best available science when building the foundation for regulatory actions. The commenter asserts that the studies used by EPA should adhere to good laboratory and field practices, with results being peer-reviewed and any associated methods, models, and data made available for further review and analysis. The commenter recommends that, in cases where patient confidentiality or other circumstances prevents the dissemination of data, EPA should continue to follow the guidelines set forth in the OMB's Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies. These guidelines appropriately state that the worthwhile goal of allowing public access to data and methods "does not override other compelling interests such as privacy, trade secrets, intellectual property, and other confidentiality protections." The commenter further recommends that, if any aspect of the proposed rule is intended to alter EPA's definition and use of the best available science, the Agency should issue further guidance clarifying these changes and allow for public comment and consultation with the scientific community prior to implementation.
Commenter (6448) states that it is unclear how "pivotal regulatory science" differs from "best available science", if at all, and when well understood "best available science" would become "pivotal regulatory science." The commenter contends that the introduction of an additional ill-defined term would only lend towards confusion and inconsistency in regulatory decisions. The commenter recommends that EPA reconsider this approach and utilize the existing "best available science" standard along with solicitation of public comment and consultation with the EPA SAB and/or broader scientific community.
Commenter (6126) suggests that EPA reduce the vagueness and ambiguity in the definitions. The commenter asserts that the lack of clarity about the definitions cited here limits the ability to interpret intent and potential impact of the proposal. The commenter states that, after EPA clarifies definitions, a new round of public comment will likely be needed to address the basic questions raised by EPA in the proposed rule on other matters. The commenter asserts that "pivotal regulatory science" is a new term, undefined and unused in the existing text of Title 40 of the Code of Federal Regulations. The commenter notes that the meaning appears to hinge on whether a study or analysis "drives" EPA's actions. According to the commenter, this appears to be a dichotomous designation ("drives"/ "doesn't drive"), which may not reflect how many individual studies or analyses are factored into the development of regulation. The commenter adds that, in practice, the use of evidence involves different types of use considerations., The commenter states that further clarification is needed about how EPA intends to interpret this term.
Response: This purely internal procedural rulemaking is not intended to modify the Agency's interpretations of "best available science." "Pivotal science" is a statutorily neutral term and therefore is more generally applicable. The EPA will continue to consider all peer-reviewed science, consistent with existing study quality assessment factors and corresponding statutory mandates. The EPA will then identify and consider "pivotal science in accordance with the provisions of this rule," unless the implementation of the rule conflicts with statutory requirements and associated implementing regulations. It should also be noted that under the final rule no studies are categorically excluded from consideration, even studies where the underlying dose-response data are not available for independent validation. EPA will continue to assess the full body of science to evaluate the quality and transparency of available science for significant regulatory actions and influential scientific information. The EPA will also consider the degree to which pivotal science is available and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation.
<IP_ADDRESS>.5 "Drives the Requirements" Phrase
Comment: Commenter (2169) states that, because there is no mechanism in the regulation for assuring that the science drives the decision, there is no means for judging the term pivotal. The commenter asserts that, without transparent consideration of all the information available and public comment on whether all pertinent information was considered, it is pointless to promulgate rules on the availability of the information.
Commenter (6133) states that the use of the phrase "drive the requirements" within the CFR definition is particularly incoherent. The commenter asks the following questions:
 What does "drive the requirements" mean?
 Does the definition apply only to scientific studies that were outcome determinative?
 Does it encompass any scientific study that was considered in making the requirements?
 What about studies that were useful but not determinative? Something else entirely?
 Can more than one study be "pivotal" to the regulatory decision, or does the term "drive the requirements" imply that only one study could be "pivotal" to a given decision?
 Are most of the studies used by EPA considered to "drive the requirements" or is this term limited in some fashion, unrevealed to the public?
 Will EPA "know it when it sees it," making it up as the agency goes along?
Commenter (6137) asserts that the Proposed definition of "pivotal regulatory science", as studies that "drive the requirements and/or quantitative analysis" of EPA's action, lacks any understandable meaning. The commenter notes that there is no standard governing what science does or does not "drive" the regulatory action. According to the commenter, the lack of regulatory standards here means that EPA staff will impermissibly determine applicability of the rule "based upon their own unwritten personal standards." White v. Roughton, 530 F.2d 750, 754 (7th Cir. 1976). The commenter contends that these provisions allow for arbitrary application of the Rule, rendering the Proposed Rule arbitrary and thus unlawful.
Response: The EPA clarifies that "pivotal science" includes only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. In the context of this rule, studies informing the dose-response modeling (e.g., benchmark response selection), studies identifying data for toxicokinetic adjustments, or studies informing the selection of uncertainty factors do not drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. With regard to the meaning of "drive the requirements and/or quantitative analysis," these are the studies that are integral to quantitatively characterizing dose-response relationships for the toxicity endpoints that underlie the requirements or analyses of EPA significant regulatory actions or influential scientific information. The EPA may further interpret the meaning of "drive," and describe the process for designating key studies as pivotal science in subsequent implementation guidelines and/or statute-specific rulemakings.
<IP_ADDRESS>.6 Significant Regulatory Decisions
Comment: Commenter (6909) states that there are numerous ways in which the proposed rule is unacceptably vague. The commenter notes that many of the central terms that will dictate how and to what studies the rule would apply are undefined or unclear, including "pivotal regulatory science". The commenter provides that, even though the proposed rule offers a limited definition of "pivotal regulatory science," that definition hinges on the phrase "significant regulatory decisions." The commenter states that there is no explanation of how EPA would decide which regulatory decisions are significant and which are not.
Commenter (6137) argues that the EPA's Proposed Rule lacks the requisite standards and principles that are the hallmark of lawful agency decision-making. The commenter notes that the Proposed Rule defines "regulatory science" as "scientific information . . . that provide the basis for EPA final significant regulatory decisions." The commenter adds that there are no standards or definitions for what subset of "regulatory decisions" should be deemed "significant." According to the commenter, these provisions allow for arbitrary application of the Rule, rendering the Proposed Rule arbitrary and unlawful.
Response: The EPA notes that the operable definition in the final rule is for "significant regulatory actions," not "significant regulatory decisions." Significant regulatory actions are defined in the final rule as "final regulations determined to be `significant regulatory actions' by the Office of Management and Budget pursuant to Executive Order 12866." The EPA disagrees that this term is vague, arbitrary, or unlawful.
<IP_ADDRESS> Pivotal Regulatory Science and Regulatory Science
Comment: Commenters (1427, 6133, 6362) express that the proposed definitions of pivotal regulatory science and regulatory science lack clarity and overlap.
Commenter (1427) states that the proposed definitions of pivotal regulatory science and regulatory science are not sciences, overlap each other and obscure any legitimate need to distinguish between regulation and pivotal regulation. The commenter clarifies that, for example, there is no difference between chemistry and regulatory chemistry. According to the commenter, if this regulation is ultimately deemed necessary, the EPA might want to define pivotal regulation.
Commenter (6362) states that the proposed definitions of "pivotal regulatory science" and "regulatory science" can be interpreted as simultaneously referencing something identical as well as one being a subset of the other. The commenter asserts that, therefore, the definitions are vague and need clarification.
Commenter (6133) states that, as proposed, the terms "regulatory science" and "pivotal regulatory science" are vague, even incoherent terms with definitions that lend no assistance to commenters in understanding the Proposal. The commenter argues that the terms lack statutory authority and are vague, inconsistent, unexplained, and otherwise arbitrary and capricious.
Commenter (6133) expresses concern that the Proposal is internally confusing through the workings of its proposed regulatory text. Commenter states that EPA alternates between explaining the Proposal in terms of "regulatory science" and "pivotal regulatory science." The commenter cites, for example, in proposed §30.1, the Proposal "directs EPA to ensure that the regulatory science underlying its actions is publicly available . . . " and, later, in proposed §30.3, the Proposal indicates that the provisions apply "to dose response data and models underlying pivotal regulatory science that are used to justify significant regulatory decisions." The commenter adds that, in the subsequent section, proposed §30.4, the Proposal references "all studies (or regulatory science) relied upon . . .." According to the commenter, the Proposal is arbitrarily vague and incoherent concerning whether "regulatory science" that is relied upon is the same as "pivotal regulatory science," or whether it is a new category of science entirely. The commenter asks: (1) if this phrasing implies that the definition of "regulatory science" does not already include science that is "relied upon"? and, if so, (2) does EPA mean that the phrase, "provides the basis," is not synonymous with "relied upon"? The commenter states that the Proposal provides no answers to these questions.
Commenter (6133) expresses concern that the Proposal makes no attempt to clarify how "pivotal regulatory science" is distinct from the separately defined, "regulatory science," a term integral to proposed §30.1, which states the Proposal's very purpose. The commenter provides that the definition of "regulatory science" is almost identical to that of pivotal regulatory science, with the exception that "regulatory science" encompasses information that "provide the basis for EPA final significant regulatory decisions," while "pivotal regulatory science" "drives the requirements." The commenter states that the phrase "provides the basis" in the proposed "regulatory science" (§30.2) definition could mean that science was one of many studies considered, that it was the bedrock study upon which regulation was grounded, that EPA relied on the study, or that the study was critical to EPA's determination. According to the commenter, the Proposal nowhere addresses or explains whether or how these possible meanings are distinct from the possible meanings of the "drive the requirements" phrase of the "pivotal" definition. The commenter concludes that it is entirely unclear from these definitions what makes science that "provides the basis" distinct from science that "drive the requirements," and that neither of these terms meaningfully distinguishes "pivotal" regulatory science from ordinary regulatory science.
Response: Through its 2020 supplemental notice of proposed rulemaking and this final rule, the EPA has sought to increase the clarity surrounding "science that serves as the basis for informing a significant regulatory action" (proposed as regulatory science) and "pivotal science" (proposed as pivotal regulatory science). The EPA clarifies that the two terms are distinct; while "pivotal science" is a subset of "science that serves as the basis for informing a significant regulatory action," the two sets are not identical. The EPA has further clarified the use of these two terms within the regulatory text, and is finalizing the rule so that "science that serves as the basis for informing a significant regulatory action" is only defined in 40 CFR 30.2 and used in 40 CFR 30.4.
The EPA disagrees that the proposed definition for regulatory science was without meaning, but in response to comments is altering the final definition to increase clarity. For example, the EPA notes that the proposed definition for "regulatory science" combined both general categories of scientific information, such as assessments and models, with specific examples of EPA scientific products, such as criteria documents and regulatory impact analyses. The EPA acknowledges that this may increase confusion and is therefore limiting the final definition to general categories. As such, the EPA is altering the definition of "science that serves as the basis for informing a significant regulatory action" in 40 CFR 30.2 to mean "studies, analyses, models, and assessments of a body of evidence that provide the basis for EPA significant regulatory actions." Examples of models include those used in regulatory impact analyses. Examples of assessments of a body of evidence include risk assessments, hazard identifications, IRIS assessments, and criteria documents.
Other commenters expressed confusion over the scope of what constitutes science that serves as the basis for informing a final significant regulatory action, as defined in the proposed rule. One commenter asserted that the phrase "provides the basis" means that science that serves as the basis for informing a final significant regulatory action could be all the science considered, relied upon, and included in the administrative record of a rulemaking by the EPA. The EPA agrees with this and clarifies in the final rule that the scope of science that serves as the basis for informing a significant regulatory action is equivalent to the science included in the public docket as part of a rulemaking, but not all of that body of science would typically be considered "pivotal science."
On the other hand, "pivotal science" includes only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. In the context of this rule, studies informing the dose-response modeling (e.g., benchmark response selection), studies identifying data for toxicokinetic adjustments, or studies informing the selection of uncertainty factors do not drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. Future statute-specific rulemakings may interpret "pivotal science" more broadly.
6.2 SNPRM Pivotal Science
6.2.1 Need for Additional Clarity/Specificity
Comment: Commenters (10866, 10972, 11332, 11360, 11381, 11391, 11484, 11576, 11894, 12645, 12688, 12715, 12720, 12727, 14397) express that the proposed rule, and specifically the terms "pivotal regulatory science" and "pivotal science," are unclear, as EPA did not detail a list of criteria or specific process that will be used to determine which studies fall under these categories. Commenters (11391, 12720, 12727) also note that this need for additional specificity was identified by the SAB. Specific areas pointed out by commenters as needing clarification include the following:
 How will EPA determine whether science is "pivotal" or "scientifically influential" and how this will be communicated to the public (9362, 11360, 11332, 12645, 12715, 12720, 12727). Commenter (12645) argues that this can only be accurately known in retrospect.
 Who determines whether a study is "pivotal" or "scientifically influential" and whether this is considered final or there will be opportunity to revisit the determination if underlying circumstances change (12720).
 How to interpret the word "underly," as different studies and analyses may inform key scientific information "to differing degrees, depending on study quality, regulatory context, and EPA interpretation of scientific studies" (12720, 12727).