Both EPA and the U.S. Department of Housing and Urban Development (HUD) regulate similar residential sources of lead (paint, soil, and dust) - EPA in private housing, and HUD in Federally supported housing, including Federally supported units in private buildings. This policy shift increases the potential for disparate treatment and public confusion stemming from those situations. The identical risks addressed by the two programs should be analyzed consistently. HUD has already acted to incorporate CDC's statement into its programs by making its policy on dust-lead clearance levels more stringent; is still considering its response. But under this proposal, EPA might not be able to rely on as wide a range of studies as would be available to the rest of the federal family, which could result in different risk assessments and regulatory outcomes for similar, and possibly even adjacent, dwellings.
Response: As discussed in the preamble of the final rule, the transparency provisions in this final rule are intended to build upon existing federal government efforts and provide incremental progress toward the Agency's goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. For example, in 2002 the OMB released its Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, which includes discussion of the importance of the reproducibility of analyses underlying influential information. The EPA's 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research noted that "transparency is a core EPA value" and that increased availability of research data would accelerate scientific breakthroughs that support the Agency's mission and policymaking efforts. The EPA's Open Government Plan 5.0 also details the EPA's progress in implementing the tenets of the numerous data transparency initiatives in the federal government prior to 2018, including OMB M-10-06 , the Office of Science and Technology Policy Memorandum of February 22, 2013, and OMB M-13-13. In 2019, Congress passed the Foundations for Evidence-Based Policymaking Act of 2018 (or OPEN Government Data Act, Pub. L. 115-435) into law, which included requirements for federal agencies to prioritize making their data available to the public, and OMB has released additional guidance for implementing the act.
Further, as discussed in the final rule, underlying dose-response data are considered available if they can be accessed 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 that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information.
The EPA agrees with commenters that it is important to consider the totality of relevant, quality research. Therefore, the EPA did not finalize the 2018 proposal or the 2020 SNPRM proposed option that would have categorically required that the underlying data and models be available for independent validation in order for studies to be considered pivotal science. However, given that transparency is an important aspect of EPA's regulatory actions and assessments it should be an important consideration in how the Agency considers pivotal science. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the Agency also recognizes that there will be instances where the underlying dose-response data of pivotal science is unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
<IP_ADDRESS> Different Federal Definitions of Science
Comment: Commenters (6125, 8913) express concern that the proposed rule would create different federal definitions of science.
Commenter (6125) states that the proposal on its face does not apply to other federal agencies or to states and tribes (or for that matter, even to EPA outside of major rulemaking). The commenter provides that the proposed rule does not acknowledge that this would result in two different federal definitions of science, nor does it address the potential confusion this would create. The commenter explains one of the definitions is applicable only to major rulemaking and the other for everything else; in other words there would be two different EPA definitions of science for actions addressing the same subject, the risk from the conduct, under the same statute. The commenter asserts that this is the very definition of arbitrary.The commenter contends that EPA has not attempted to explain how the different federal definitions of science would work, nor has it identified it as a source of potential problems for EPA or other agencies.
Commenter (6125) asks: How would EPA address such a situation? The commenter notes that the proposal says nothing about this, despite the obvious potential for confusion. For example, the commenter asks, would a decision whether to enforce a regulation based on the constricted new rule on science be based on all relevant science, including data not considered in developing the rule in the first place? What about permitting, licensing and registration decisions? What about evaluating a grant proposal under traditional science, for activities governed by a regulation using censored science? The commenter states that none of these serious concerns are addressed in the proposal. The commenter suggests that, if the agency insists on attempting to promulgate this flawed rule, there should be no distinction made between application of its provisions to major rules and to all other regulatory actions with regard to the consideration of the science in the development of such decisions. The commenter states that, if it is appropriate for one category of rules, then it is appropriate for all of them.
Commenter (6125) states that both EPA and HUD regulate similar residential sources of lead (paint, soil, and dust) - EPA in private housing, and HUD in federally supported housing, including federally supported units in private buildings. The commenter asserts that the EPA's proposed policy shift increases the potential for disparate treatment and public confusion stemming from those situations. According to the commenter, the identical risks addressed by the two programs should be analyzed consistently. According to the commenter, HUD has already acted to incorporate CDC's statement into its programs by making its policy on dust-lead clearance levels more stringent. The commenter states that, under the proposed rule, EPA might not be able to rely on as wide a range of studies as would be available to the rest of the federal family, which could result in different risk assessments and regulatory outcomes for similar, and possibly even adjacent, dwellings.
Commenter (8913) states that an ill-considered consequence of the proposal is the degree to which the rule would sow chaos in government and research domains. The commenter states that governmental record-keeping/information-sharing would be fractured and thrown into confusion. The commenter states that many other regulatory bodies would continue to follow law and rely on best available science. For example, according to the commenter, the FDA, NIH and CDC would be funding research, evaluating medical findings, and focusing on public health values quite differently from EPA. The commenter contends that state and local officials acting to protect the air and water of their regions and the health of the families and children in their communities would no longer be able to rely on EPA standards for guidance.
Commenter (1973) contends that the proposal would put EPA in direct opposition to the standards for considering evidence of health effects of smoking, high cholesterol, etc. by the CDC, of the studies considered for issuing guidelines generated by the NIH, and of the FDA reliance on non-publicly available studies to approve drugs for use by people.
Response: As discussed in the preamble of the final rule, the transparency provisions in this final rule are intended to build upon existing federal government efforts and provide incremental progress toward the Agency's goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. For example, in 2002 the OMB released its Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, which includes discussion of the importance of the reproducibility of analyses underlying influential information. The EPA's 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research noted that "transparency is a core EPA value" and that increased availability of research data would accelerate scientific breakthroughs that support the Agency's mission and policymaking efforts. The EPA's Open Government Plan 5.0 also details the EPA's progress in implementing the tenets of the numerous data transparency initiatives in the federal government prior to 2018, including OMB M-10-06 , the Office of Science and Technology Policy Memorandum of February 22, 2013, and OMB M-13-13. In 2019, Congress passed the Foundations for Evidence-Based Policymaking Act of 2018 (or OPEN Government Data Act, Pub. L. 115-435) into law, which included requirements for federal agencies to prioritize making their data available to the public, and OMB has released additional guidance for implementing the act.
This is a rule of internal procedure promulgated under the EPA's housekeeping authority. The rule does not impose requirements on parties external to the EPA, including other agencies within the federal government. External users of EPA scientific assessments can still use these assessments. There are also provisions in the final rule (e.g., requirements for the EPA to document critical assumptions and methods used in its dose-response assessment, studies considered pivotal science, the rationale for the level of consideration for studies in the significant regulatory action or influential scientific information, and any Administrator exemption) that will make it clear how the provisions of this rule may have impacted the significant regulatory action or influential scientific information and will help external users determine whether the product is fit for their purpose. The EPA also disagrees that implementation of this rule would limit the scientific record. The final rule does not categorically exclude any studies from EPA's consideration, so the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
2.1.6 EPA Would be at Odds with Other National and International Bodies
Comment: Commenters (1973, 4827, 4878, 6906) contend that the proposal would create an approach to the use of scientific evidence on the adverse health effects of air pollution by EPA that would be at odds with the World Health Organization (WHO), the Royal Society for Medicine, and other national review bodies and law. Several commenters (4840, 4878, 6906) express concern that this could result in the EPA being unable to use beneficial studies conducted in compliance with other national and international bodies. Specific comments include:
Commenter (4840) states that some of the findings on which our public health protections are based are the result of studies done across the globe. The commenter suggests that it is unlikely that Canadian or European scientists would turn over their raw data to a U.S. agency for "independent validation."
Commenter (4878) states that there is little currently known about air pollution and its impacts on the brain. The commenter provides that recent studies have linked particulate exposures to Parkinson's disease including a large study done in Denmark. The commenter states that this study used several thousand people with and without a current diagnosis of Parkinson's disease. Using extremely specific (within 5-50 meters of the front door) geo-coding to estimate participant's exposure to contaminants, the commenter notes that the study estimated that ambient air pollution from traffic increased risk of developing Parkinson's disease by 9 percent. The commenter adds that researchers found an increased risk of Parkinson's disease after exposure to particulate matter in studies from Taiwan and South Korea, as well.
The commenter (4878) expresses that, in addition to concerns about the usefulness of data if enough information is redacted to protect privacy, these studies raise additional challenges because they were performed internationally. The commenter provides that, in the Danish study participants are protected by European Union (EU) law. Going forward, the commenter notes that an EU study's compliance with the proposed rule will need to be reconciled with the new General Data Protection Regulation, which is seen as more restrictive than HIPAA.The privacy directive raises many issues for science not discussed here, but it is clear that many studies that involve people located in the EU will have a difficult time both complying with the new directive and providing enough information to EPA to be considered.
The commenter (4878) contends that studies coming from other countries are vital to health determinations in the U.S. because people in other countries are exposed to chemicals at different rates than in the U.S. The commenter states that the ability to compare and contrast exposure to health outcome can be enlightening; average particulate matter concentrations in South Korea and China are several times higher than in the United States, making relatively subtle effects stand out more easily. The commenter asserts that studies done in other countries can also help researchers tease out whether an effect is dose or length of exposure dependent and the inability to review and use international research in determinations will virtually guarantee EPA is missing major findings and important data.
Commenter (6906) also adds that recognition of internationally available data reduces EPA's burden in performing evaluations and allows for the consideration of hazard and risk assessments from other jurisdictions for Risk Evaluations under TSCA (§§ 4 and 6). According to the commenter, it also reduces industry's burden by allowing industry to rely on and/or provide data across countries. The commenter asserts that this promotes a uniform international market by coming to a common understanding of risk.
Specifically, commenter (6906) states that Effects and Environmental Fate of Chemicals Access to hazard characterizations, exposure assessments and environmental fate analysis in the EU, Canada and other jurisdictions assists with risk evaluation and new chemical review as required under the TSCA (§§ 4 and 6). The commenter is concerned that the new rule could limit recognition of analysis conducted and information available in foreign jurisdictions.
Commenter (6906) notes that many manufacturers of paint, coatings, sealants and adhesives operate at an international scale, importing raw materials and exporting products to foreign jurisdictions. The commenter states that the U.S. exports of paint and coatings totaled $2.3 billion in 2017, the second-highest level in more than a decade. An analysis of exports to 20 EU member countries, out of 28 EU countries, including Germany, France, United Kingdom, Spain and Portugal shows exports of 86.8 million to EU members. Being the U.S.' most important trade partner, Canada consumed the largest amount of U.S. paint and coatings exports at 1.034 billion, accounting for 45% of all U.S. exports globally.
Response: As discussed in the preamble of the final rule, the rule requirements build upon open data initiatives in the federal government and scientific community and advance the EPA's mission and commitment to the public by prioritizing transparency of the underlying dose-response data in pivotal science for the most impactful of EPA's assessments and regulatory actions. Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. Such independent reanalyses will subsequently enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or influential scientific information. Implementation of this rule will more effectively share pivotal science for external consideration and increase the opportunity for independent validation of pivotal science by subject matter experts. As data are better understood through independent reanalysis, the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information. The incremental progress made possible by this rule provides an important step towards prioritizing transparency in particularly impactful EPA rules and assessments and will inform future statute-specific rulemakings.
As discussed further in the preamble of the final rule, the EPA will 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. Where there is convincing and well substantiated evidence to support 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 or quantitative analyses of an EPA significant regulatory action or influential scientific information will be identified as pivotal science. Although the EPA is prioritizing transparency in pivotal science, the Agency also recognizes that there will be instances where the underlying dose-response data of pivotal science is unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. The EPA provides these factors in 40 CFR 30.5(d) and they are discussed more fully in the preamble of the final rule.
Further, as discussed in the final rule, underlying dose-response data are considered available if they can be accessed 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 that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. The EPA would also like to clarify that the rulemaking does not require the EPA to collect, store, or publicly disseminate data and models underlying pivotal science.
Comment: Commenter (6873) notes that, not only are there well-established requirements and procedures for protecting the privacy rights of research participants (45 CFR, Pub. L. 93-348, etc.), but that these rights are also encoded in the international Helsinki Declaration of the World Medical Association. The commenter contends that, coming up with new guidelines for releasing private data, even if the intent is to mask this data and make it available only to government scientists, will require review and approval by the U.S. (the FDA and other agencies) and the global research community.
Response: The EPA would like to clarify that this is a rule of internal procedures and does not direct or require any outside entity or EPA to establish data sharing mechanisms or create new guidelines for releasing data. Further, the rulemaking does not require the EPA to collect, store, or publicly disseminate data and models underlying pivotal science.
2.1.7 Proposed Rule is Flawed and Needs to Be Withdrawn/Redone with Feedback from the Scientific Community/Stakeholders
 <IP_ADDRESS> Feedback from the Scientific Community/Stakeholders
Comment: Commenters (0055, 0057, 1742, 2907, 3644, 3971, 4594, 4831, 4894, 5165, 5181, 6115, 6119, 6125, 6126, 6144, 6373, 6894, 6904, 6924, 8272) urge the EPA to not implement the proposed rule and instead to consult with the stakeholders before issuing the rule, including scientists, medical researchers and health professionals, universities, hospitals, peer-reviewed journals/publishers, science advisory panels, and communities who participate in research studies. Commenters (2472, 2904, 4595, 4839, 5011, 5165, 6117, 6119, 6144, 6163, 6595, 6909, 6915, 8272, 9225) states that the EPA has failed to get adequate input from the scientific community in developing this proposed rule. Commenter (1006) suggests that EPA "take down" the proposal and come back with something that takes in mind the countless feedback that the scientific community has given in response to the Proposed Rule. Commenter (6158) states that the proposed rule appears to have been written by government officials who do not understand the scientific process and thus there is a glaring lack of analysis and rationale in the Federal Register announcement. In particular, the commenter adds that no formal scientific argument or policy rationale is made that would justify the need for this rule.
Commenter (6117) asserts that it is inappropriate to establish major changes in research priorities through insertion of additional language in a proposed regulation ostensibly on another topic, as was done here, rather than to use the normal channels of consultation with stakeholders, advisory boards, and reference to prior commissioned studies from the NAS.
Commenter (6144) states that it is clear both from the number of questions posed by the agency during its comment period about how the rule might be implemented and from the outcry of the scientific community that the agency did not consult with scientists or respected national scientist organizations as it crafted this rule.
Commenter (6126) states that the EPA's proposed rule raises complex and multifaceted issues, and its implementation would likely have meaningful consequences for environmental regulation and, therefore, public health and the environment. The commenter expresses that they (BPC) are disappointed EPA did not engage in a more deliberate and robust effort to engage stakeholders while initially developing the proposed regulation. While the commenter appreciates EPA's efforts since publication of the proposed rule to gather public input, the lack of foresight to engage in meaningful public discourse about the proposed activities prior to publication is troubling. According to the commenter, the now partisan debate over this rule's motives and meaning could have been diminished if EPA had taken time to more meaningfully and transparently engage the public.
Commenter (6126) notes that, as EPA determines whether or how to move forward in developing this regulation, they encourage a much more robust and thorough consultative process. The commenter states that this process should include direct consultation and dialogue with key stakeholders and experts likely to be impacted by the issues of the regulation, including scientists, industry, academic institutions, states, other federal agencies, and EPA's relevant advisory boards. The commenter contends that such a process will likely necessitate a new notice of proposed rulemaking for public comment prior to developing a final rule. The commenter suggests that EPA engage in much more extensive public and interagency dialogue, then subsequently issue a new Notice of Proposed Rulemaking on data sharing and use issues. The commenter suggests that the EPA could either (1) withdraw the rule and issue a new Notice of Proposed Rulemaking informed by a robust dialogue or (2) issue a new Notice of Proposed Rulemaking that supersedes the proposed rule published on April 30, 2018.
Commenters (4595, 5165) recommend that EPA withdraw this proposed rule until a more thorough examination by an independent scientific organization/scientific community can be completed. Commenter (4595) urges EPA to consider carefully and deliberately, in concert with the scientific community and other stakeholder communities, any policy changes that could diminish the important role of scientific evidence in helping to make decisions that impact the health of Americans. Commenter (5165) suggests that a regulation with such significant ramifications for EPA's science-based decision making should be thoroughly vetted by the scientific community and other key stakeholders, including the state and local air agencies that rely on the scientific integrity of EPA's regulations to protect public health and the environment from the harmful effects of air pollution. Commenter (5165) adds that EPA should also consult from the earliest stages with the state and local agencies that are responsible for implementing our nation's environmental laws.
Commenter (5181) expresses that, given the broad scope and potential effect of the proposed rule, they recommend that an additional step be added for EPA to hold discussions with impacted states and tribes and other stakeholders to provide supplemental information to the current proposal. The commenter also requests that EPA provide a supplement to the rule to explain more fully how the proposed rule would increase transparency without delaying decision-making or excluding consideration of traditionally acceptable data and publications, given the numerous federal provisions already in place to achieve the goal of ensuring transparency.
Commenter (3971) states that the proposed approach, if carefully designed with input from all stakeholders (which will require a series of science advisory panels), can be brought into rulemaking. The commenter states that possible benefits of bringing to the table both classic toxicologists (who embrace historical in-vivo, whole animal, testing), as well as "modern era" toxicologists and physicians (who are well versed in predictive structure activity models, in-silico models, and low-dose modeling) could take rulemaking to a new level of sophistication. The commenter states that doing so would allow all reasonable scientific approaches to be given serious consideration when working toward a final recommendation for a particular conclusion. The commenter states that NAS and numerous respected scientific bodies, as well as trade associations, have made many proposals as to how this approach could be carried out, and these are well documented within EPA files. The commenter states that one unfortunate aspect of this proposed regulation is that the possible published papers that may help guide the Agency are not listed in the appendix.
Typically, according to the commenter (6125), these actions rely heavily on work done by the career staff in ORD and/or program offices and consultation with the SAB, the FIFRA Science Advisory Panel (SAP), and/or the NAS and others before proposing a regulation. The commenter notes that none of this was done here. The commenter states that multiple reports based on emails and other documents obtained by the Union of Concerned Scientists (UCS) indicate that the idea of developing a policy memorandum or a rule based on legislation developed by Congressman Lamar Smith of the House Science, Space, and Technology Committee began in January 2018. Serious work on drafts took place during February under some deadline pressure, as evidenced by email traffic mainly involving EPA political staff. The commenter provides that the Administrator's first public mention of the effort appeared in a March 19 story in the Daily Caller, which was linked in an official EPA news release.
Commenter (6125) contends that the agency was in such a rush to judgment that it did not provide a role for its own career scientific and science/policy experts in crafting the policy/regulation or assessing potential unanticipated impacts, never included the rule in its regulatory agenda, did not follow its guidance for how to develop agency rules, did not notify or consult with or request a review of the proposal by its SAB, SAP, or the Department of Agriculture (USDA) as required by law, did not solicit the advice of the NAS on provisions that would change dose-response models used in risk assessment from those previously recommended by the NAS.
The commenter (6125) notes that the EPA initially allowed only a 30-day comment period, which would close one day before a long-scheduled meeting of the full SAB. According to the commenter, this rushed and largely secret process, antithetical to any standard of reasoned consideration or transparency, shows that EPA is not really concerned about transparency in public policy, much less in science.
Commenter (5022) states that the Proposal violates fundamental tenets of transparent rulemaking. The commenter suggests that the EPA apparently failed to consult with relevant stakeholders such as scientific, research, or health professional associations, did not consult with other federal agencies, and did not even make the proposed rule available to its own SAP for review.
Similarly, commenter (6163) notes that the proposed rule was published without input from internal or external scientific experts, including the EPA SAB and the NASEM. According to the commenter, as a policy that would significantly impact the use of science at the agency and the clear solicitation of input about process and data management infrastructure included in the notice, experts in science and data management would have greatly informed the agency's actions.
Commenter (4831) states that they (The National Academies) have carried out numerous studies that advise EPA on the scientific bases of regulatory decisions related to human health and the environment. The commenter notes that examples of relevant reports that advise on dose-response analysis and models, as well as how to perform literature-based reviews, include:
 Application of Systematic Review Methods in an Overall Strategy for Evaluating Low-Dose Toxicity from Endocrine Active Chemicals (NASEM, 2017a; ),
 Review of EPA's IRIS Process (NRC, 2014; http://dels.nas.edu/Report/Review-Integrated-Risk/18764),
 Critical Aspects of EPA's IRIS Assessment of Inorganic Arsenic: Interim Report (NRC, 2013; http://dels.nas.edu/Report/Critical-Aspects-IRIS/18594),
 Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde (NRC, 2011; http://dels.nas.edu/Report/Review-Environmental-Protection-Agency/13142),
 Finding What Works in Health Care: Standards for Systematic Reviews (IOM, 2011; http://www.nationalacademies.org/hmd/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx),
 Science and Decisions: Advancing Risk Assessment (NRC, 2009; http://dels.nas.edu/Report/Science-Decisions-Advancing-Risk-Assessment/12209), and
 Models in Environmental Regulatory Decision Making (NRC, 2007; http://dels.nas.edu/Report/Models-Environmental-Regulatory-Decision-Making/11972).
According to the commenter (4831), these reports encourage EPA to consider all available science in the rule-making process and provide guidance about how the agency could be more transparent in describing how evidence is gathered and evaluated. Specifically, the commenter suggests that systematic-review methods be adopted to ensure objectivity, rigor, and transparency in performing literature-based reviews (IOM, 2011; NRC, 2011, 2014). The commenter states that NASEM, 2017a, includes four case examples of systematic reviews.
Commenters (2907, 4438, 4831, 4839, 5022, 5165, 5178, 6126, 6373, 8272) suggest EPA work with the National Academies. Commenter (4839) asserts that the design and content of the proposal contradicts credible and well-established scientific principles and methods used across academia, the business community and the public sector. The commenter requests that EPA withdraw the proposed rule and suggests that, if EPA wishes to re-engage in evaluating the topic of transparency in regulatory science, the EPA seek an independent review of key issues from the NAS/NRC and invite the input of other established, competent and credible professional bodies. Commenter (5022) asserts that heeding the advice provided by the National Academies to use the best and most current science to support and revise default assumptions, make implicit defaults explicit, and provide clear standards for the level of evidence needed to depart from default assumptions, taking into account data-sharing guidelines already developed by NIH. Commenter (4438) suggests that subsequent EPA transparency initiatives, if any, be based on consultation with the NAS and should not restrict EPA's ability to rely on the universe of best available science when promulgating regulations.
Commenter (5011) states that crafting the rule without consulting with the scientific community is a fatal error for this proposal. According to the commenter, even the agency's own SAB has noted the need to consult with scientists in any further development of this proposal. Commenters (1012, 2427, 2472, 3135, 5178, 6144, 6447, 6897, 6915, 6916, 6943, 8272, 8281-PH10, 9225) suggest that the SAB should have been given the opportunity to review the rule and make recommendations. Comments include:
 From a process standpoint, the SAB should have been given the opportunity to consider the EPA's proposed rule before it was released for public input. The commenter notes that the SAB has advised the EPA about the quality of the scientific information utilized in policymaking and EPA research programs and plans for over 40 years. The commenter adds that this Board has an ethical responsibility to remain impartial, consider public input, and consider the best scientific evidence available when making decisions. The commenter notes that SAB's analysis would have provided unparalleled insight into the potential effects of the proposed rule. (6897)
 It seems to reason that when you propose a rule which directly affects how the EPA uses science, you'd want to consult with scientists. The commenter states that they hope that EPA will heed their advice and consult, not just with your SAB, but with the many scientific organizations and societies which have previously expressed concerns about the "Secret Science Act." In the meantime, the commenter strongly urges the EPA to withdraw the proposed rule. (1012)
 Commenter (3135) supports the SAB workgroup's May 12 memo recommending that the SAB review the agency's April proposed rulemaking, "Strengthening Transparency in Regulatory Science." The commenter notes that the workgroup points to a number of complex scientific issues for which the Agency should seek expert advice from the SAB. According to the commenter, the proposed rule suffers from lack of involvement of the scientific community, either within or outside of the EPA. The commenter urges the SAB to recommend that the Administrator:
 Not use the agency's regulatory authority to prescribe specific risk assessment processes;
 Not adopt any major changes to EPA's foundational policies on the use of science in rulemaking without thorough advice and consultation with the SAB, and other authoritative scientific bodies.
 The EPA has failed to consult its own SAB about this proposed rule despite the SAB's assessment that "this rule deals with a myriad of scientific issues for which the Agency should seek expert advice." The commenter contends that proposing a rule that limits the use of scientific data without even notifying, let alone consulting, the Agency's own expert scientific advisors is a text book example of an arbitrary and capricious failure to consider "relevant factors." Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42-43 (1983). The commenter adds that the EPA offers no explanation for its inexplicable failure to consult with science experts, including the SAB, on this proposal, and it is beyond question that this highly consequential proposal demanded such consultation. The commenter argues that, not only is this statutorily required, see 42 U.S.C. §4365(c)(1), but as the SAB Work Group Memo states, "[t]he proposed rule deals with issues of scientific practice and proposes constraints that the [A]gency may apply to the use of scientific studies in particular contexts. As such, this rule deals with a myriad of scientific issues for which the Agency should seek expert advice from the [SAB]." SAB Work Group Memo at 2. The commenter provides that, underscoring the importance of the issue, the full 44-member SAB followed up on the Work Group's Memo with a unanimous vote to review the proposal and urged EPA to proceed no further until EPA does what it should have done in the first place: "request, receive and review scientific advice from the SAB." SAB June 28 Letter at 1. The commenter asserts that the EPA's effort to rush this proposed rule out the door without any input from the SAB or other scientists violates basic principles of good government and policymaking as well as EPA's legal duty. We urge EPA to withdraw this ill-conceived proposal and to consult with the SAB, the NAS, and the broader scientific community before determining if any rule is needed. (6915)
 The EPA failed even to confer with its chartered SAB, and seek its input, as required under the Environmental Research Development and Demonstration Authorization Act (ERDDAA), 42 U.S.C. § 4365(c)(1), even though EPA claims authority under the CAA, and admits in the Proposal that it is a "significant regulatory action" submitted to OMB for review. As EPA's SAB recently wrote to the Administrator, the commenter notes that a proposal like this, which "focus[es] on the EPA's foundational policies related to the use of science in rulemaking and policy development," is within the SAB's purview and should have been submitted to it for review." According to the commenter, EPA's failure even to submit the Proposal to SAB review, never mind take account of the SAB review results, is evidence of the arbitrary and capricious nature of this whole undertaking. (6916)
 Of particular concern, the EPA's own SAB was not given the opportunity to review the proposed rule before it was announced. The commenter provides that a June 28, 2018, letter from SAB Chair Dr. Michael Honeycutt explained that the SAB only found out about the proposed rule after the related press event and subsequent announcement in the Federal Register. "SAB members had no information regarding the timeline for finalizing the rule and the proposed rule was not identified as a major action in either of the Spring 2017 or Fall 2017 semi-annual Regulatory Agendas." The commenter adds that the letter goes on further to explain that, "the precise design of the proposed rule appears to have been developed without a public process for soliciting input specifically from the scientific community." The SAB consists of EPA-appointed members of the scientific community whose role is to review this type of rule prior to proposal. According to the SAB website, one of the roles of the SAB is to, "...advise the agency on broad scientific matters." The commenter contends that the proposed rule on "transparency" in science surely fits under the umbrella of a "broad scientific matter." (6919)
 The SAB should have been given the opportunity to thoroughly review the proposed rule and make recommendations that would serve to identify and address the specific problems inherent with the implementation of this rule. The commenter notes that this step would have allowed the acknowledged scientific leaders in their respective fields to consider elements in the proposed rule that may be either too far-reaching or otherwise inconsistent with current scientific protocol. (6943)
 The EPA SAB has asked to review the rule under the authority vested in it by the Environmental Research, Development and Demonstration Authorization Act. The commenter provides that the SAB sent a letter to the EPA administrator, raising many of the same scientific issues of confidentiality, feasibility, and the need for a clearer definition of crucial concepts, such as replication and validation. The commenter urges the EPA to fully consult with the SAB before moving forward with this rule. After the SAB review is complete, the commenter suggests that EPA either withdraw the proposal, or provide an additional opportunity for public comment based on that SAB review. (8281-PH10)
 EPA's SAB, tasked with reviewing the Agency's regulatory agenda and recommending actions that merit independent review, only learned about the rulemaking after it was already proposed. As a result, the commenter provides that an SAB workgroup recommended that the advisory body review the merits of the rule because "it deals with a myriad of scientific issues for which the Agency should seek expert advice from the Science Advisory Board." After a nearly unanimous vote concurring with the memo, the commenter notes that the SAB wrote in a June 28 letter to former Administrator Scott Pruitt that "[t]he SAB urges the Agency to ... request, receive, and review scientific advice from the SAB before revising the proposed rule." (9225)
Response: Public input was an important part of shaping the final rulemaking. The EPA accepted public comment on the proposed rule from April 30, 2018 to August 16, 2018, and held a public hearing on July 17, 2018. In response to public comments, the EPA released a supplemental NPRM and took public comment from March 18, 2020 to May 18, 2020. In addition, the EPA's SAB provided advice and comments on mechanisms for secure access to PII and CBI under the proposed rule on September 30, 2020, and the proposed and supplemental rulemakings on April 24, 2020. All of these comments were considered in developing the final rule.
As discussed more fully in the preamble of the final rule, the rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making.
Comment: Commenter (3971) states that, in an ideal world, a "middle ground" proposal would come from balanced committees of experienced professionals. Specifically, the commenter suggests that EPA return to its historical (pre-2000 era) position that these groups have representatives from nongovernmental organizations (NGOs), the private sector (corporations), academia, consultants, trade associations, as well as others who are genuine experts on the topic. The commenter adds that, in the future, it would be good to include at least one or two experts from countries outside the United States. Hopefully, the commenter contends, such committees would contain persons who have not been heavily influenced by forces that are stubbornly wedded to certain positions.
Commenter (3971) expresses that the demand that professionals cannot have ever worked in a corporation that has an interest (knowledge) in a topic, or that someone must be disqualified because he or she has performed research funded by the regulated community, or served as an expert in court for "one side or the other," is not appropriate criterion for exclusion. Often, the commenter notes, special interest groups claim that certain experts are unable to serve on various advisory boards because of claims of bias or conflict of interest. According to the commenter, the result is that SAB often convenes committees that lack persons who have spent a lifetime studying a particular issue.
Commenter (3971) contends that banning true experts because they have served as experts in litigation or conducted studies for the regulated community (often having QC and rigor far higher than studies in universities or government labs) is not an optimal or appropriate policy. Again, the commenter claims that, as this regulation attempts to address, "transparency" is important. The commenter states that if all SAB participants share their possible conflicts and bias with the ethics lawyers at EPA and the public, I believe the public deserves to hear their views.
Commenter (3971) expresses that, as noted in many published papers of the past 5 years, the trial lawyers have had a significant impact on the views of government employees, NGOs, and some experts. The commenter asserts that the SAB group within EPA needs to be more sensitive to possible or likely conflict of interest. According to the commenter, it is no surprise that trial lawyers write many letters complaining of conflicts of interest when consultants or corporate scientists (who often conducted the original studies) are nominated for appointment. The commenter provides that when university professors who receive government grants intended to highlight adverse effects (at any dose) of a chemical, no questions are raised. According to the commenter, it is well known that scientists who report an adverse effect, even if not a physiologically or environmentally dose (with a factor of 1,000), are more likely to get funding than those who do not. Currently, the commenter claims that there is no opportunity for an expert to rebut the claims of parties who have a vested interest in the outcome of the committee process (which should occur to insure proper "due process").
As has been noted by others, commenter (3971) notes that when EPA uses the new "conflict of interest" criterion, sometimes committees of persons who don't know the topic in an in-depth manner are convened, and they reach very poor scientific conclusions. The commenter contends that Committees of well-meaning volunteers who have not "labored in the field" for decades on a particular topic cannot recognize shortcomings in various studies that are brought before them because it does take 10-20 years of study of a particular topic to recognize such flaws. For example, the commenter notes that the presumption that all research that is conducted under a federal grant is valid, while that conducted by the regulated community is compromised, is not appropriate. Although the public and many NGOs believe that research conducted by universities surely must be objective and weighed more heavily than an industry sponsored study, the commenter states that is not a valid assumption. The commenter provides that few universities, if any, perform their work using GLP, or meet the expectations for analytical testing quality that the regulated community must meet. The commenter notes that studies by non-industry groups often have fewer animals, fewer doses, less quality control, improper statistical analyses, and other shortcomings. Future committees should reflect the expertise necessary to weigh the quality of the studies and evaluated the studies objectively.
Commenter (6104) provides contact information for any questions on their comments and requests that EPA periodically meet with states to share information the agency has learned, and to consider any intended and unintended impacts to state programs. The commenter notes that their members, the directors of state surface water quality programs, possess unique knowledge and insight into those clean water program areas that rely most heavily on data, scientific studies, and models. The commenter asserts that, as with all of their comment letters, they encourage the agency to also consider recommendations provided by individual states.
Response: Comments related to conflicts of interest reviews for members of the SAB or other advisory committees are outside the scope of this rulemaking. The EPA agrees that a thorough study quality evaluation should be conducted for all studies used in significant regulatory actions and influential scientific information. Studies are not considered more or less credible based on the affiliation of the authors. The rule requirements also direct the EPA to evaluate the availability of the underlying dose-response data for any subject matter expert, regardless of author's affiliation or funding status.
<IP_ADDRESS> Proposal Did Not Include Cost Benefit Analyses/Impacts Assessments
Comment: Commenters (2171, 2335, 2430, 2902, 5011, 5021, 5022, 5170, 5172, 5178, 5181, 6046, 6125, 6126, 6133, 6168, 6185, 6358, 6446, 6447, 6874, 6877, 6879, 6893, 6915, 6916, 6919, 6920, 6924, 8272, 8281-PH20, 8801, 9227) assert that the proposal fails to conduct appropriate costs and/or benefits analyses/impacts assessments. Comments include:
 The EPA provide more information about the potential impacts of this proposal in order for the public to fully weigh the proposed rule's implications. (2335)
 Requests that the EPA publicly define the potential data and policy impacts of the proposed rule. (2430)
 The Proposal is fatally flawed because it provides almost no analysis of the impacts of the proposed change in policy. (5011)
 Despite its professed fealty to cost effectiveness in rulemaking, the proposed rule provides no cost-effectiveness analysis whatsoever. According to the commenter, the proposal simply asserts blithely that "EPA believes the benefits of this proposed rule justify the costs." (5022)
 While the proposed rule states that EPA "believes the benefits of this proposed rule justify the costs," EPA offers no estimation or calculation of either the potential costs or benefits. The commenter states that, for such a significant change in policy, a statement of belief is not adequate. (5170, 6125)
 Although this proposal would do real harm to EPA's ability to protect public health and the environment, the proposed rule does not include any assessment of its impact on public health and the environment. (5172)
 Commenter (6879) states that the EPA is proposing to make significant changes to long-standing policies without adequate analysis of the costs and benefits of the proposal. Commenters (6877, 6879) note that EPA has failed to demonstrate that the purported benefits of this regulation would outweigh the costs, including costs in compliance as well as increased risks to human health and the environment.
 Proposal fails to acknowledge the costs from delays in rulemaking proceedings while EPA performs the additional review called for above and beyond the extensive scientific peer review to which scientific studies have already been subjected. (6915)
 The proposed rule has not provided any supporting information to justify why the rule is beneficial. Moreover, the commenter adds that the EPA has not fully evaluated the costs and benefits of the rule. The commenter states that the costs of the rule could be significant, especially if EPA decides to apply the rule retrospectively, and use the rule as a tool to revise existing health-based air quality standards. The commenter urges EPA to include an evaluation the costs and benefits. The commenter also requests that EPA evaluate what data would be available for setting health-based air quality standards if the rule was applied retroactively and prospectively and consider how it would impact the EPA's ability to protect public health and the environment. (6920)
 The analysis of costs and benefits should include an examination of the studies that have previously informed regulation and the extent to which they will meet the proposed criteria; an analysis of regulations that would not have been promulgated, would have included less-protective limits, or that could be weakened in the future under the proposed criteria; an analysis of the time and costs required to bring all relevant studies into compliance with the criteria; and a calculation of the foregone public-health benefits and associated costs to the U.S. economy when regulations are delayed or are less protective due to this rule. Commenters assert that the analysis of benefits is also lacking, given that EPA failed to present convincing evidence that insufficient data access has caused a problem, or that addressing the purported problem would improve public health, including reproductive health and the health of children. (5178, 6893)
 EPA has completely failed to evaluate the costs and benefits of this action. The commenter asserts that it is a basic tenet and requirement of reasoned decision-making that an agency must provide a reasoned explanation of its action that considers both the advantages and disadvantages of issuing a rule [Michigan v. EPA, 135 S. Ct. 2699, 2707 (2015)]. The commenter states that there is no question that the proposed rule could have profound consequences on the regulatory process at EPA, and ultimately on human health and environmental quality. (6447)
 Commenters (6153, 6358, 6874) note that the EPA the proposal does not contain a thorough analysis of costs and benefits and EPA could have obtained information to inform a robust cost-benefit analysis by issuing an advanced notice of proposed rulemaking (ANPRM) and seeking SAB input, but it did not do so. Commenter (6358) suggests that the analysis of benefits is lacking, given that EPA failed to present convincing evidence that insufficient data access has caused a problem, or that addressing the purported problem would improve public health, including reproductive health and the health of children. Commenters (6153, 6874) contends that such an analysis should include an examination of the studies that have previously informed regulation and the extent to which they will meet the proposed criteria; an analysis of regulations that would not have been promulgated, would have included less-protective limits, or that could be weakened in the future under the proposed criteria; an analysis of the time and costs required to bring all relevant studies into compliance with the criteria; and a calculation of the foregone public-health benefits and associated costs to the U.S. economy when regulations are delayed or are less protective due to this rule.
 In the background section of this proposed rule, the cost of compliance with "significant regulations" is provided as justification for the proposed rule. The commenter states that, subsequently, it is suggested that dose response modeling used by EPA scientists for "pivotal regulatory science" is overly protective of health and the environment and therefore places unnecessary regulatory and financial burdens on industry. The commenter states that this justification for the proposed rule does not account for the short and long-term costs to individuals and communities from environmental degradation and the resulting population health impacts. (6130)
 The proposed rule does not include any assessment of its impact on public health and the environment. The commenter asks: "Where is the EPAs risk assessment that shows that the proposed changes will have a positive impact on, and not unintended consequences of doing harm to, the groups it is purportedly intended to protect?" The commenter asserts that there are important questions that must be answered before EPA proceeds. The commenter notes that sound scientific information is crucial to creating regulations and policies that protect the health and well-being of us all and that they are is concerned that there is little evidence to suggest that the proposed changes would not adversely affect the quality of the resulting policies. (8801)
 The EPA does not present any analyses of benefit-cost, children's environmental health risks or environmental justice in support of the rule, which are required under Executive Orders 12291, 13045, and 12898. (6924, 8281-PH20) Commenter (6450) states there has been no environmental justice analysis conducted.
Response: The EPA agrees that neither the 2018 proposed rule nor the 2020 SNPRM included a characterization of costs or benefits of the proposed action. As discussed in the preamble to the final rule, this is a rule of internal procedure promulgated under the EPA's housekeeping authority and a benefit-cost analysis is not required. However, the EPA has included a discussion of costs and benefits in the preamble of the final rule.
Briefly, the additional procedures required by this rule only apply to pivotal science, which is a subset of the total number of studies that the EPA would evaluate. Given the costs of the current robust process for identifying and reviewing scientific studies and documentation that are existing Agency practice, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions and influential scientific information, the EPA anticipates that the incremental costs of this rule will be small. The Agency may also incur other administrative costs to perform analyses and evaluations to support activities such as exemption decisions made by the Administrator, and documenting these or other decisions made pursuant to the requirements of the final rule. Again, the Agency anticipates that the incremental costs for these activities will be small relative to current administrative costs for developing significant regulatory actions or influential scientific information. Finally, this final rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to pivotal science for which the underlying dose-response data are available. Hence, this rule does not impose costs on the EPA or any other party to make data available, including costs to ensure that PII and CBI are not disclosed. The Agency may opt, at its discretion, to incur the costs associated with making data available when it is in the public interest to do so, but that will be decided on a case-by-case basis and is not a requirement of the final rule.
The main benefits of this rule spring from greater transparency in significant regulatory actions and influential scientific information. By placing greater emphasis on the availability of dose-response data underlying pivotal science, the rule will allow for greater scientific scrutiny as EPA decision makers are developing significant regulatory actions and influential scientific information and increases the likelihood that any errors will be identified and corrected. Greater transparency is also inherently valuable as a principle of good government and provides benefits to the public at large, including reducing the risk of errors in EPA analyses and in the science such analyses rely upon. The ability for independent subject matter experts to validate pivotal science will facilitate more effective comment and engagement with the public during development of future significant regulatory actions and influential scientific information.
Comment: Commenter (6125) asserts that reasoned decision making requires an agency to identify and address the impact of its proposed actions on its ability to perform its Congressionally mandated functions, State Farm, 463 U.S. at 43, because the likely impacts of the proposal are a critical issue in deciding whether to proceed with the rule. Nevertheless, the commenter states that the proposal outright fails to consider any impacts at all  --  literally none at all! The commenter argues that the failure to consider potential environmental impacts in a proposal that fundamentally affects each of EPA's core statutory responsibilities is fatally arbitrary. See Sierra Club v. Costle, 657 F.2d 298, 326 (D.C. Cir. 1981) ("[W]e can think of no sensible interpretation of the statutory words `best technological system' which would not incorporate the amount of air pollution as a relevant factor.") See also N.L.R.B. v. Creative Food Design Ltd., 852 F.2d 1295, 1306 (D.C. Cir. 1988) (noting that agencies "may not ignore relevant factors" in making decisions); Small Refiner Lead Phase-Down Task Force v. U.S.E.P.A., 705 F.2d 506, 521 (DC. Cir. 1983) ("Arbitrary and capricious" review generally refers to the requirement that an agency "must consider all the relevant factors" and reach a "reasonable" conclusion; Sierra Club v. Costle,657 F.2d at 323."); Environmental Defense Fund, Inc. v. Costle, 657 F.2d 275, 283 (DC Cir. 1981) ("Thus, we must be assured that the agency action was "based on a consideration of the relevant factors," Citizens to Preserve Overton Park, Inc. v. Volpe, supra, 401 U.S. at 416, 91 S. Ct. at 823; and that "the agency has exercised a reasoned discretion, with reasons that do not deviate from or ignore the ascertainable legislative intent," Ethyl Corp. v. EPA, supra, 541 F.2d at 35-36, quoting Greater Boston Television Corp. v. F.C.C., 444 F.2d 841, 850 (1970), cert. denied, 403 U.S. 923, 91 S.Ct. 2229, 29 L.Ed.2d 701 (1971).)"
Moreover, commenter (6125) argues that as in CMA v. EPA, 217 F. 3d 861, 865-66 (D.C. Cir 2000), EPA's assertion of potential benefits without demonstrating their existence or providing any quantitative comparison of their value as compared to costs and disbenefits to public health is yet another clear indicator of arbitrariness and lack of support in the evidence before the agency. Id. (citing State Farm, 463 U.S. at 43).
Response: Based on a consideration of these and similar comments, the EPA has included a discussion of the effects of the final rule on the studies the EPA uses to support final significant regulatory actions and influential scientific information in the preamble of the final rule. Briefly, consistent with existing Agency practice, the EPA will use existing factors (including soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review) to evaluate study quality. When evaluating potential links between exposure to a pollutant, contaminant, or substance and effects and the nature of the dose-response relationship, the EPA will follow best practices and 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 (consistent with Agency guidelines on hazard identification and dose-response assessment) to support a relationship between exposure and effect, the EPA will identify a subset of those studies for use in characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect. This will be based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements, quantitative analyses, or both will be identified as pivotal science. Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. In compliance with the rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or propriety information, available through restricted access in a manner sufficient for independent validation. Including this review of data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and scrutiny by independent third parties. This approach will result in final 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. When the dose-response data underlying pivotal science are not publicly available in a manner sufficient for independent validation, the EPA will give less consideration to the studies' evidence, findings, and conclusions unless the Administrator grants an exemption request. Although the EPA is prioritizing transparency in pivotal science, the Agency also recognizes that there will be instances where the underlying dose-response data of pivotal science is unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. The EPA provides these factors in 40 CFR 30.5(d) and they are discussed more fully in the preamble of the final rule.
The EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety. As discussed more fully in the preamble of the final rule, the rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making.
The EPA agrees that neither the 2018 proposed rule nor the 2020 SNPRM included a characterization of costs or benefits of the proposed action. As discussed in the preamble to the final rule, this is a rule of internal procedure promulgated under the EPA's housekeeping authority and a benefit-cost analysis is not required. However, the EPA has included a discussion of costs and benefits in the preamble of the final rule.
Briefly, the additional procedures required by this rule only apply to pivotal science, which is a subset of the total number of studies that the EPA would evaluate. Given the costs of the current robust process for identifying and reviewing scientific studies and documentation that are existing Agency practice, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions and influential scientific information, the EPA anticipates that the incremental costs of this rule will be small. The Agency may also incur other administrative costs to perform analyses and evaluations to support activities such as exemption decisions made by the Administrator, and documenting these or other decisions made pursuant to the requirements of the final rule. Again, the Agency anticipates that the incremental costs for these activities will be small relative to current administrative costs for developing significant regulatory actions or influential scientific information. Finally, this final rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to pivotal science for which the underlying dose-response data are available. Hence, this rule does not impose costs on the EPA or any other party to make data available, including costs to ensure that PII and CBI are not disclosed. The Agency may opt, at its discretion, to incur the costs associated with making data available when it is in the public interest to do so, but that will be decided on a case-by-case basis and is not a requirement of the final rule.
The main benefits of this rule spring from greater transparency in significant regulatory actions and influential scientific information. By placing greater emphasis on the availability of dose-response data underlying pivotal science, the rule will allow for greater scientific scrutiny as EPA decision makers are developing significant regulatory actions and influential scientific information and increases the likelihood that any errors will be identified and corrected. Greater transparency is also inherently valuable as a principle of good government and provides benefits to the public at large, including reducing the risk of errors in EPA analyses and in the science such analyses rely upon. The ability for independent subject matter experts to validate pivotal science will facilitate more effective comment and engagement with the public during development of future significant regulatory actions and influential scientific information.
Comment: Commenter (6133), without support, provides that the Proposal states that "EPA believes the benefits of this proposed rule justify the costs." 83 Fed. Reg. at 18,772. Commenters (6133, 6446, 6916) assert that the only further discussion in the proposal that the benefits of the proposed rule justify the costs is a reference to the Mercatus Paper. Commenters (6133, 6446) note that the proposal (83 FR 18772) includes the following quote from the Mercatus paper:
      One recent analysis found that: "[i]mprovements in reproducibility can be thought of as increasing the net benefits of regulation because they would avoid situations in which costs or benefits are wrongly estimated to occur or in which regulatory costs are imposed without corresponding benefits. . . ." They concluded that "an increase in existing net benefits from greater reproducibility, which, if it occurred, would cover the costs of obtaining the data and making the data available."
Id. (quoting Randall Lutter and David Zorn, On the Benefits and Costs of Public Access to Data Used to Support Federal Policy Making, Mercatus Working Paper, September 2016).
The commenter (6133) asserts that this quote is not close to a sufficient cost-benefit analysis. First, according to the commenter, the Working Paper's plausibility analysis is dubious. Among other problems, the commenter states that the analysis examines the time it takes for chemical manufactures, processors, and distributors to identify and provide studies in their possession related to a specific chemical and equates that to the time it would take EPA to obtain, review, process, redact, and publicly maintain data for any study it considers. Lutter and Zorn, at 21 - 22 (citing (40 C.F.R. pt. 716)). The commenter provides that the chemical study Health and Safety Data Reporting Rule and the cost estimate the Working Paper's analysis is based on does not require submission of underlying data unless requested by EPA. 40 C.F.R. § 716.10(a)(4). The analysis also does not include time or costs to the researchers outside of the agency. Lutter and Zorn, at 21 - 22. Further, the commenter notes that the Working Paper assumes that EPA would only receive the underlying data for 20% of the requested scientific studies EPA relies on. Id. at 25. Therefore, the commenter asserts that the Working Paper lowers the already questionable cost estimate by eliminating costs associated with collecting and preparing data for the other 80% of studies. Id. The commenter adds that the Working Paper does not explain what the authors expect EPA to do about 80% of studies EPA currently relies on for which it does not receive the underlying data, but the Proposal would require the agency to unlawfully ignore those studies in regulatory decision making.
Importantly, the commenter (6133) contends that even the partial quote the Proposal presents does not provide results of a cost-benefit analysis nor conclude the costs outweigh the benefits. Instead it says that if an increase in benefits occurred, the costs would be covered. The commenter provides that the same article states this point explicitly:
      Of course, our estimates of the benefits of public access to data supporting federal regulatory decisions fall short of proving that the benefits outweigh the associated costs. They do show, however, the plausibility of such a claim.
Lutter and Zorn, at 29.
According to the commenter (6133), the Proposal does nothing to address this or try to determine how plausible such a claim is. The commenter argues that the EPA has not provided a defined Proposal, nor done any cost analysis of its Proposal, that could be analyzed. The commenter adds that the fact that this is the best support the EPA could provide for its baseless belief that the Proposal's benefits justify its costs further shows that EPA must withdraw the Proposal.
Similarly, commenter (6916) notes that the Agency fails to provide analysis accompanying the Proposal, as required by Executive Order 12866, "assess[ing] both costs and benefits" to assure "a reasoned determination that the benefits of the intended regulation justify its costs." Instead, the commenter states that the EPA makes unsupported statements about its "belie[f that] the benefits of the proposed rule justify the costs." The commenter adds that the only further discussion on this point is a reference to the industry-funded Mercatus Paper, which rejects a CBO projection that proposed legislation, with terms similar to the Proposed Rule here, would cost the country $250 million a year. The commenter provides that the Mercatus Paper, however does not find the new policy to be cost-free. Instead the commenter states that it reports that compliance with the proposed legislation would add $2,558 to the costs of each study  -  and EPA never explains how that compares with the $250 million price tag from the CBO.
According to the commenter (6916), EPA baldly asserts that the benefits will outweigh the costs because the Proposal "will improve the data and scientific quality of the Agency's actions and facilitate expanded data sharing and exploration of key data sets," citing only a 2005 NRC report. But the commenter notes that the NRC report does not assess the cost of eliminating peer-reviewed quality science from consideration, it merely discusses the tension between providing more transparency and access to data while continuing to protect confidentiality. Indeed, the NRC explicitly states that its work does not "weigh[] the potential harm posed by disclosure against the benefits potentially foregone."
There is, moreover, according to the commenter (6916), no attempt made by the Agency to quantify or qualify lost benefits, were the new policy to take effect. The commenter asserts that there is no analysis of the number of studies that could be affected by the Proposal, the effects of the Proposal on research, the potential for weakening of environmental regulations, and the resulting environmental or public health costs, or any other costs for that matter associated with eliminating dose-response studies and methods from regulatory decision making because the underlying data cannot be released. In fact, the commenter notes that the EPA does not even seem to understand that there could be such costs associated with its Proposal  -  it asserts (without support) only that making underlying data available "will improve the data and scientific quality of the Agency's actions."
Commenter (6919) expresses that, on the whole, the proposed rule attempts to make a case for the need for open and transparent data and models, yet the notice solicits information and comments from the public without providing any analysis of the impact of the EPA's proposed action. The commenter asserts that this is the type of significant federal action that should have an accompanying regulatory impact analysis. The commenter states that a cost analysis for this proposed action is unavailable, but a comparison can be made with the projected costs from the CBO's review of the HONEST Act of 2017, on which this proposal is based. The commenter notes that the CBO analysis found that the EPA would, "...need to spend at least $100 million dollars per year to upgrade the format and availability of those studies' data to the level required by H.R. 1430." Under Executive Order 12866, the commenter provides that a significant regulatory action is one that may, "[h]ave 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, local, or tribal governments or communities."
Commenter (6919) expresses that the lack of sufficient analysis before publishing the proposed rule makes it extremely difficult, if not impossible, for commenters to provide meaningful and in-depth comments. According to the commenter, this fact, together with the extraordinary number and complexity of the questions that the EPA asks of its commenters, could make the ultimate rule vulnerable to challenges for insufficiency of notice and insufficient consideration of comments received.
Response: The EPA agrees that neither the 2018 proposed rule nor the 2020 SNPRM included a characterization of costs or benefits of the proposed action. As discussed in the preamble to the final rule, this is a rule of internal procedure promulgated under the EPA's housekeeping authority and a benefit-cost analysis is not required. However, the EPA has included a discussion of costs and benefits in the preamble of the final rule. The analysis by CBO noted by the commenters is not applicable to this rule because the analyses were not for this rule and the requirements analyzed are not the same as those in this rule.
Briefly, the additional procedures required by this rule only apply to pivotal science, which is a subset of the total number of studies that the EPA would evaluate. Given the costs of the current robust process for identifying and reviewing scientific studies and documentation that are existing Agency practice, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions and influential scientific information, the EPA anticipates that the incremental costs of this rule will be small. The Agency may also incur other administrative costs to perform analyses and evaluations to support activities such as exemption decisions made by the Administrator, and documenting these or other decisions made pursuant to the requirements of the final rule. Again, the Agency anticipates that the incremental costs for these activities will be small relative to current administrative costs for developing significant regulatory actions or influential scientific information. Finally, this final rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to pivotal science for which the underlying dose-response data are available. Hence, this rule does not impose costs on the EPA or any other party to make data available, including costs to ensure that PII and CBI are not disclosed. The Agency may opt, at its discretion, to incur the costs associated with making data available when it is in the public interest to do so, but that will be decided on a case-by-case basis and is not a requirement of the final rule.
The main benefits of this rule spring from greater transparency in significant regulatory actions and influential scientific information. By placing greater emphasis on the availability of dose-response data underlying pivotal science, the rule will allow for greater scientific scrutiny as EPA decision makers are developing significant regulatory actions and influential scientific information and increases the likelihood that any errors will be identified and corrected. Greater transparency is also inherently valuable as a principle of good government and provides benefits to the public at large, including reducing the risk of errors in EPA analyses and in the science such analyses rely upon. The ability for independent subject matter experts to validate pivotal science will facilitate more effective comment and engagement with the public during development of future significant regulatory actions and influential scientific information.
Comment: Commenter (6125) asserts that the proposed rule is mute regarding its impacts on rules across each of EPA's core environmental statutes, both as to how this rule would apply and how it would affect existing regulations. The commenter notes that the proposal does not even identify the relevant statutory provisions, much less potentially affected regulations. According to the commenter, if the proposal would leave those rules in place, it would accomplish little. The commenter adds that, if the proposal would repeal some or all of them, either directly or by requiring them to be redone, EPA should say so and describe the scope of the proposal's impact. Instead, the commenter states that the proposal is completely silent about whether any existing rules would be affected, and does not even identify any such rules, much less describe how this rule would affect them. Thus, the commenter concludes that it provides no basis for informed public comment.
Response: Based on consideration of this comment and similar comments, the EPA clarified in the 2020 SNPRM the relationship between this rulemaking, the environmental statutes and their implementing regulations by adding language to proposed 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations would control in the event of any conflicts. With this final rule, the EPA is maintaining language from the 2020 SNPRM in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict, and clarifying in this preamble that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
<IP_ADDRESS> No or Insufficient Basis for Rule
 <IP_ADDRESS>.1 EPA Fails to Provide Support for Proposal
Comment: Commenters (2171, 2561, 5011, 6046, 6125, 6133, 6137, 6164, 6879, 6916, 8771, 9227) suggest that the EPA has failed to provide the required reasoning/basis to support for why there is a need to change longstanding Agency practice/need for the rule or why other alternatives are not sufficient. Comments include:
 Based on the lack of meaningful information and articulated or demonstrated need for the proposed rule, EPA has not made the case for a new regulation at 40 CFR Part 30. (2171)
 EPA needs to provide the legal authority to impose the proposed rule (they find EPA's legal authority citations to be uncompelling and incomplete). (6109)
 The proposed rule is written with limited explanation, as stated by the Union of Concerned Scientists, limiting the ability for an effectively administered rule. (2561)
 The Proposal is fatally flawed because it provides almost no justification for the proposed change in policy. (5011)
 Neither the Proposal nor docket contains any factual, scientific, technical, logical, or legal support for the suggestion that science and data that are "publicly available in a manner sufficient for independent validation" are necessary elements for the "validity," "reliability," or "transparency" of scientific information. (6133)
 The EPA alludes to "transparency" multiple times, but the without defining what that concept means, or explaining why it believes existing statutes, regulations, guidelines and protocols fail to meet it. (6916)
 Commenter expresses concerns that the EPA is proposing to make significant changes to long-standing policies without adequate justification. The commenter adds that EPA has failed to show any compelling need or justification for the proposed regulation. (6879)
 There is insufficient justification for the proposed rule and portions of it are seriously flawed (e.g., no solutions for confidential data or costs and responsibility for such measures; one person determining exceptions). (6046)
 The proposed rule is predicated on irrational and unsupported conclusions. According to the commenter, a close examination of generally applicable data access policies and guidelines  -  including policies and recommendations of third party organizations and major scientific journals upon which EPA allegedly relies  -  reveals that EPA's Proposed Rule is not based on a reasoned explanation and has no rational connection to facts in the record, but rather is entirely baseless. The commenter adds that the EPA has not demonstrated that it is consistent with scientific principles to categorically exclude peer-reviewed scientific information from all consideration in a rulemaking, as EPA proposes to do. (6137)
 The EPA fails to adequately describe the justification behind this policy change, how it builds upon current policies regarding transparency, such as the IQA and EPA's Information Quality Guidelines, or what the potential impacts of restricting science will be on current and future decision-making. The commenter urges the agency to elaborate on these substantive details and provide the science community and the public the opportunity to provide feedback. (6164)
 EPA has completely failed to follow well-established principles for establishing the legal need for reasoned agency decision-making generally, and in particular for any change to a prior position. According to the commenter, to comply with these requirements, an agency must, among other things:
 Explain why the agency is rejecting policy judgments or factual determinations underlying the prior rule or position.
 Provide a "reasoned explanation" for changing course;
 Demonstrate that the new policy is itself consistent with the governing statute;
 Ensure that the new policy is itself supported by the record, "based on consideration of the relevant factors," and supported with "rational connection[s] between the facts found and the choice made"; and
 Consider relevant alternatives reflected in the prior rule's record, in particular, alternatives most consistent with statutory goals and purposes, and explain why the agency is not adopting them in the new rule  (6125)
 There are "significant and viable and obvious alternatives" to this Proposal, which the Agency has failed to adequately consider, nor has the Agency explained why it believes such alternatives are not sufficient. The EPA has not supported why releasing confidential health and business information is necessary. Nor, according to the commenter, is the Agency's rationale completely clear in the Proposal. When commenters are left to guess, the commenter notes that is not lawfully sufficient notice of the subjects and issues involved. (6916)
 The failure to adequately justify a changed agency position is one of the hallmarks of arbitrary and capricious decision making The commenter adds that the Agency must "provide a more detailed justification than would suffice for a new policy...when, for example, its [revised] policy rests upon factual findings that contradict those which underlay its prior policy; or when its prior policy has engendered serious reliance interests that must be taken into account. It would be arbitrary and capricious to ignore such matters." The Proposal fails to engage with the reasoning or facts underlying the Agency's longstanding policy position, which respected the confidentiality of underlying data and accounted for all relevant science. (6916)
 Little use of the FOIA to obtain research data has been made over the years, as far as the Congressional Research Service could ascertain. The commenter states that this is an indication that the EPA proposal may impose burdens on researchers, making them produce products that will never be used, except in rare cases. Thus, if EPA proceeds with the rule, the commenter asserts that the EPA needs to justify the requirement that all studies on which it relies must provide public access, rather than requiring public access only in situations where EPA receives a request. (6955)
 The EPA must offer a detailed justification for the premise that there is a "reanalysis crisis" to solve, and a detailed analysis of how its refusing to look at studies that don't do the skeptics' work for them could provide incremental benefits -- otherwise, the proposal must be withdrawn for utter lack of purpose. The commenter states that the EPA has not yet even provided a single anecdotal example of a study whose meaningful reanalysis is hampered. (8771)
 EPA appears to leap to the conclusions (again without any supporting evidence) that the only way to strengthen the validity of the science is by enhancing transparency, that no other possible steps to enhancing integrity are worth considering, and that enhancing transparency means making underlying data and models publicly available. According to the commenter, this is all before EPA even gets to its obviously illogical conclusion that threatening exclusion of studies without publicly available data will "increase access to dose response data and models underlying pivotal regulatory science," rather than simply bar EPA from considering a vast universe of useful and rigorously vetted studies. The commenter adds that the evidence cited by EPA in support of the need to strengthen science through its proposed approach is so vague and perfunctory that it is largely impossible even to tell which conclusions various sources are supposed to support. The commenter provides that the EPA's rationale for its data availability requirements consists of a few conclusory statements by EPA itself, a reference to "the replication crisis," and citations to a handful of articles and guidance issued by EPA and OMB. The commenter contends that none of these provide a rational basis of support for the Proposal. (9227)
Response: In response to public comments, the EPA clarified many aspects of the proposed rule in the 2020 supplemental notice of proposed rulemaking and final rule, including the purpose, legal authority, and definitions of key terms. The purpose of the rule is detailed in the preamble of the final rule. In brief, the transparency provisions in this final rule are intended to build upon existing efforts and provide incremental progress toward the Agency's overarching goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. 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 several international organizations and initiatives focused on increased transparency and data sharing in science. The EPA supports these efforts and believes that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety. The incremental progress made by this rule provides an important step towards prioritizing transparency in particularly impactful rules and assessments and will inform future statute-specific rulemakings.
The EPA is relying exclusively on its 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.
Further, in consideration of public comments, the EPA is also finalizing the alternative approach presented in the SNPRM, rather than providing for the exclusion of studies based on the availability of their underlying data. As described in the final rule, 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.
The EPA would also like to clarify that the rule does not impose requirements on parties external to the EPA, including researchers. The rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making. The incremental progress made possible by this rule provides an important step towards prioritizing transparency in particularly impactful EPA rules and assessments and will inform future statute-specific rulemakings.
Comment: Commenter (9227) asserts that the EPA has provided no explanation or justification for targeting dose response studies in particular or for not including other types of studies or scientific information. The commenter adds that the EPA has not suggested that these studies are inherently less reliable than other studies, that they more commonly fail to publicly disclose data and modeling information, that replication is more necessary for these studies than others, or any other conceivable reason. Absent any explanation from the agency, the commenter contends that it is impossible to comment on the factual predicates for EPA's proposed decision, or the reasonableness of EPA's justification, except to state that it appears completely arbitrary in the absence of any rationale. See, e.g., Transactive Corp., v. United States, 91 F.3d 232, 237 (D.C. Cir. 1996) ("A long line of precedent has established that an agency action is arbitrary when the agency offered insufficient reasons for treating similar situations differently.").
Response: As explained above, in response to public comments, the EPA clarified many aspects of the proposed rule in the 2020 supplemental notice of proposed rulemaking and final rule, including the purpose, legal authority, and definitions of key terms. As discussed more fully in the preamble of the final rule, the rule is designed to build upon data initiatives across the federal government and scientific community. The rule is not intended to fix a particular error, but rather to pursue an incremental approach to maximizing transparency in the science that EPA relies upon to ensure that implementation is done in a thoughtful and deliberate way that focuses on the EPA's most impactful actions, minimizes unintended consequences, and informs future transparency requirements. The EPA is focusing on the underlying dose-response data for this rulemaking because of the influence these data have on particularly impactful decisions at the Agency. Risk assessments and regulations that target emissions and risk reduction of one or more pollutants, contaminants, or substances are integral to the Agency's mission and the underlying dose-response data that inform the quantitative value used to evaluate and mitigate potential risk are critical to understanding the assessment or regulatory action. In addition, the data underlying the dose-response assessment are more distinct than the broad range of data informing an entire risk assessment. Therefore, the EPA is concentrating its current efforts to increase transparency on a well-defined step in the quantitative assessment of risk supporting specific Agency actions. This final rule provides an important step in furthering the progress already being made toward maximizing transparency and will provide important insight for developing future statute-specific requirements.
Further, in consideration of public comments, the EPA is also finalizing the alternative approach presented in the SNPRM, rather than providing for the exclusion of studies based on the availability of their underlying data. As described in the final rule, 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>.2 Materials Cited/Administrative Record Do Not Support Proposal
Comment: Commenters (5022, 6133, 6447, 6450) express that materials cited/administrative record do not support proposal. Comments include:
 The proposal lacks critical citations and documentation. According to the commenter, rather than furnishing the evidentiary support required for administrative action, the agency has merely adopted a legislative initiative that failed to pass despite support from the energy, chemical, manufacturing, and other key industries. (5022)
 Materials cited by EPA also do not provide any support for the Proposal, on scientific, technical, policy, logical, or legal grounds, and in fact, the materials actually undermine the Proposal. According to the commenter, the cited materials demonstrate that the Proposal is unsupported, arbitrary, capricious, and otherwise inconsistent with law. The commenter contends that the fact that EPA cites many of these materials because they contain, from different contexts, options EPA could enact as part of the proposed rule further demonstrates that the Proposal must be withdrawn as it fails to provide fair notice to the public of what is being proposed. (6133)
 The administrative record before the Agency offers no evidence of Congressional intent that the EPA should consider transparency of underlying data and models that inform the scientific research the Agency relies on when adopting regulations pursuant to the Acts. The commenter states that, without such Congressional intent, the EPA has no basis to adopt the Transparency Rule as proposed. The commenter states that to do so very likely would contradict the Congressional intent evident in the cited sections of the Acts. (6178)
 The Proposal is not supported by the administrative record. (6447)
 Many of the relevant documents underlying the proposal have been excluded from the record, meaning there is not sufficient specificity to allow for a sound response. (6450)
Response: As explained above, in response to public comments, the EPA clarified many aspects of the proposed rule in the 2020 supplemental notice of proposed rulemaking and final rule, including the purpose, legal authority, and definitions of key terms. As further discussed in the preamble of the final rule, the rule is designed to build upon open data initiatives across the federal government and scientific community developed over the last several years. The rule is not intended to fix a particular error, but rather to increase transparency in the pivotal science used in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
<IP_ADDRESS>.3 No Basis for Assumption that Science or Studies for Which Data are Publicly Available Yield More Valid Results
Comment: Commenters (6125, 6133, 6361) suggest that EPA has not provided support for their assertion that the proposal will "improve the data and scientific quality of the agency's actions."
Commenter (6133) asserts that the EPA provides no basis for its assumption that science or studies for which data are publicly available yield more valid or reliable results than the best available, peer-reviewed, independent, credible science, for which the underlying data are not publicly available. The commenter adds that the proposal arbitrarily fails to address, much less explain, why prior EPA regulatory actions that relied upon studies, data, or other information did not reflect the "best available science" or why they were otherwise unreliable, despite failing to meet the Proposal's standards.
Commenter (6133) states that the Proposal fails to explain how the term, "in a manner sufficient for independent validation," and the proposed §30.5 definition will increase transparency in science or why it is necessary to ensure that EPA will consider the best available science. To the contrary, the commenter contends that the Proposal's approach would preclude EPA from considering the best available science that is relevant to EPA's responsibilities. The commenter also states that the EPA also fails to explain why data underlying peer-reviewed studies must be publicly available "in a manner sufficient for independent validation" when independent researchers can verify science without making the underlying data, which is often confidential, publicly available.
Commenter (6133) notes that the Proposal does not require that any information actually be independently validated before EPA may consider it or base regulatory decisions on such verification. Accordingly, there is an irrational disconnect between EPA's insistence that information be "publicly available for independent validation" and the Proposal's claim that this ensures EPA will consider and use the "best available science." See 83 Fed. Reg. at 18,769. The commenter adds that the EPA itself has not outlined a process by which "dose response data and models" would be validated, and the Proposal does not seriously consider the methodological complications of partial redaction of underlying study data.
Commenter (6361) suggests that the EPA also does not explain how the Proposed Rule approach will ensure the application of "best available science" which is the standard in all environmental laws. According to the commenter, it is possible that EPA's proposed regulation will result in a failure to rely on the "best available science" as EPA arbitrarily disqualifies important scientific studies if the underlying data cannot be disclosed to the public or cannot be independently validated.
Commenter (6125) states that the proposed rule directs EPA to make all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making dose response models and data underlying pivotal regulatory science used in significant regulatory decisions available to the public in a manner sufficient for independent validation, consistent with law and protection of privacy, confidentiality, and national and homeland security. However, it does not compel the Agency to make that information available where it concludes after all such reasonable efforts that doing so in way that complies with the law and appropriate protections is not possible.
Commenter (6125) adds that, while it is not flatly untrue that the proposal "does not compel" EPA to make the information available, it is worse than disingenuous not to mention also that unless the information is publicly available it cannot be used as a basis for the rulemaking decision unless EPA grants an exemption. See at 18770 n. 7. The commenter contends that, even though limited by time and resources, their assessment shows the magnitude of the issue and the absolute need for EPA to address the potential damages to public health and the environment before any final action. To issue a valid rule, the commenter states that the 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.
Response: As detailed in the preamble to the final rule, the purpose of this action is to increase transparency by codifying internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. These requirements build upon open data initiatives in the federal government and scientific community and advance the EPA's mission and commitment to the public by prioritizing transparency of the underlying dose-response data in pivotal science for the most impactful of EPA's assessments and regulatory actions. Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. Such independent reanalyses will subsequently enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or influential scientific information. Implementation of this rule will more effectively share pivotal science for external consideration and increase the opportunity for independent validation of pivotal science by subject matter experts. As data are better understood through independent reanalysis, the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information.
As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information and does not modify the Agency's interpretations of "best available science." 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. The EPA also wishes to clarify that the rule does not require the EPA to collect, store, or publicly disseminate data and models underlying pivotal science.
<IP_ADDRESS>.4 No Support for Assertion that the EPA has Not Consistently Followed EPA Policies
Comment: Commenter (6133) adds that the Proposal provides no support for the idea that EPA has not consistently followed previous EPA policy that encouraged the use of non-proprietary data and models. To the extent EPA believes this is a problem, the commenter suggests that the EPA withdraw the Proposal and explain what policies it has not followed and how it has not followed those policies. The commenter notes that EPA should then present options to address those alleged shortcomings.
Commenter (6133) argues that if EPA decides to move ahead with this reckless, unjustified, and unlawful effort to censor the science that EPA may consider, and must consider, to protect Americans' health and environment, the agency must first issue a supplemental proposal and actual administrative record to cover the multitude of issues, evidence, and specific regulatory text for which EPA fails to provide fair notice. According to the commenter, the Proposal fails to provide fair notice or justifications addressing numerous issues that our comments detail -- from an absence of any statutory authority, to failures to address statutory authorities that the Proposal squarely contravenes, to failures to provide reasoned explanations, including basic justifications for EPA's numerous departures from past practices. The commenter adds that the proposal fails to propose specific regulatory text addressing numerous implementation elements, as well as issues that are touched upon only in passing in the preamble (e.g., non-linearity and LNT). Apart from all of the significant substantive and procedural defects from which the Proposal suffers, the commenter contends that it still manages to be a shockingly shoddy effort missing actual regulatory text and supporting legal, factual, scientific, and technical information that would provide fair notice to the public.
Response: The purpose of the rule is detailed in the preamble of the final rule. In brief, the transparency provisions in this final rule are intended to build upon existing efforts and provide incremental progress toward the Agency's overarching goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. 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 several international organizations and initiatives focused on increased transparency and data sharing in science. The EPA supports these efforts and believes that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety. The incremental progress made by this rule provides an important step towards prioritizing transparency in particularly impactful rules and assessments and will inform future statute-specific rulemakings.
Further, in consideration of public comments, the EPA is also finalizing the alternative approach presented in the SNPRM, rather than providing for the exclusion of studies based on the availability of their underlying data. As described in the final rule, 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.
Finally, the EPA clarified many aspects of its rulemaking in the 2020 SNPRM and the final rule, including its authority. The EPA is relying exclusively on its 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.
 <IP_ADDRESS>.5 Mismatch Between Problem Identified and Solution Adopted
Comment: Commenter (6933) suggests that, in general, the NPRM should be withdrawn because to the extent it can be understood what it requires -- through the haze of vague definitions and exceptions -- it both fails to address the issue which it purports to be concerned with, and is inconsistent with EPA's obligations to use best available science under both statutory requirements and caselaw. In essence, the commenter notes that the rule identifies the goal of improving the quality and transparency of EPA's science and uses it as an excuse to adopt policies that actually reduce the quality, and likely the transparency, of EPA's scientific decision-making. The commenter contends that there is a fundamental mismatch between the problem identified and the solution adopted.
Commenter (6933) asserts that the contradiction between purpose and means that lies at the core of the NPRM is clearly exposed by the fact that on the one hand it purports to be a proposal "to provide a mechanism to increase access" to scientific information, 81 FR 18770, and other hand it purports to impose no requirements on outside parties at all. See 81 FR 18772 (noting that the rule is not covered by Executive Order 13771 because "it relates to `agency organization, management, or personnel"); id. (stating the action does not contain any paperwork collection activities); id. (Regulatory Flexibility Act (RFA) certification that the action "will not impose any requirements on small entities"). According to the commenter, the agency cannot maintain on the one hand that the proposal simply governs what science the agency can review, and is not intended to change the behavior of outside parties, and at the same time assert that imposing these requirements will lead to greater access to data by the public.
The commenter (6933) contends that it is apparent that any handwaving the NPRM makes in the direction of the idea that the proposal will ultimately encourage investigators to make data more available are merely window dressing for the rule's actual purpose and effect -- to reduce the scope of scientific information considered by the agency by making public access to data the sole criterion of the quality of scientific research.
Commenter (6933) states that, by failing to wrestle with significant dimensions of the problem and explanation on how its suggested solution will actually improve them, the agency fails to satisfy basic requirements of administrative law. In addition, the commenter notes that the rule is so vague that it fails to provide any basis on which the public can comment. The commenter adds that it is not mere happenstance that section II of the NPRM is labeled "background" and section III is "request for comment." The commenter argues that the NPRM spends some time discussing the alleged problem, almost no time describing what the rule actually does, and then has a long section identifying all of the issues which the NPRM does not address but on which comment is solicited, including such fundamental issues as to what data and models it should apply to, what rules it should apply to, how it applies to reviews of the NAAQS, whether or how to apply it retrospectively, whether and which exemptions are appropriate, etc. etc. In the absence of any information as to the agency's proposed course of action on these fundamental questions, the commenter asserts that the opportunity for public comment has been rendered meaningless just as much as if the agency had limited the scope of comment to a narrow subset of issues.
Commenter (6933) asserts that, even for things that are actually proposed, the NPRM is too vague to support a final rule. For example, proposed §30.2 ("Definitions") states that "all terms not defined herein shall have the meaning given them in the Act or in subpart A." But the commenter notes that given that there is no subpart A, how is anyone supposed to comment on the definitions? And the commenter adds that the definition of "pivotal regulatory science" is "the specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions." The commenter states that often there is no single "specific" scientific study that "drive[s]" a regulatory decision. The commenter provides that ISAs for NAAQS may be thousands of pages long and cite many thousands of studies and that the scientific record for the Clean Water Rule was likewise a myriad of studies constituting thousands of pages. According to the commenter, it is reductivist and scientifically inaccurate to identify any single study as "the" specific study, so what are the criteria EPA will use to implement this definition? The commenter contends that without adequate information, the proposal could mean anything to everything and that is an inadequate basis for public comment.
Commenter (6194) asserts that notices of proposed rulemakings must also include "the terms or substance of the proposed rule or a description of the subjects and issues involved." 5 U.S.C. § 553(b)(3). The commenter notes that the purpose of this requirement is to "provide sufficient factual detail and rationale for the rule to permit interested parties to comment meaningfully." Honeywell International, Inc. v. EPA, 372 F.3d 441, 445 (D.C. Cir. 2004). The commenter asserts that the Federal Register notice of the Proposal is too vague to allow for fully meaningful and targeted comments. Given the ambiguities of the rule, the commenter states that the public cannot adequately assess what EPA thinks the Proposal means or how it will implement it. Nevertheless, for purposes of these comments, the commenter assumes EPA intends a broad interpretation that would preclude a swath of scientific studies and information from use and consideration in regulatory proceedings.
Moreover, commenter (6194) notes that many of the sources cited in the Proposal either do not support the text of the proposed regulation, do not support the proposition for which they are cited, or are so broad that the public does not have fair notice of, and therefore cannot evaluate, EPA's rationale for the Proposal. The commenter adds that the overall lack of clarity is illustrated by EPA's own solicitation of feedback; it covers so wide a range of issues -- posing over two dozen questions -- that it makes clear EPA has not identified a proposed path forward on which the public can comment. The commenter asserts that the Proposal would be more appropriately posited as an Advanced Notice of Proposed Rulemaking; it does not meet the APA's standards for proposed rules.
Response: In response to public comments, the EPA clarified many aspects of the proposed rule in the supplemental notice of proposed rulemaking and final rule. As further discussed in the preamble of the final rule, the rulemaking establishes internal Agency procedures and does not intend to change the behavior of external parties. Further, in response to public comments, the EPA did not finalize the 2018 proposal or the 2020 SNPRM proposed option that would have categorically required that the underlying data and models be available for independent validation in order for studies to be considered pivotal science. However, given that transparency is an important aspect of EPA's regulatory actions and assessments it should be an important consideration in how the Agency considers pivotal science. Because the final rule does not categorically exclude any studies from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating final significant regulatory actions and finalizing influential scientific information. As clarified in the preamble to the final rule, the EPA is pursuing an incremental approach to maximizing transparency in the science that it relies upon to ensure that implementation is done in a thoughtful and deliberate way that focuses on the EPA's most impactful actions, minimizes unintended consequences, and informs future transparency requirements. The rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making. The incremental progress made possible by this rule provides an important step towards prioritizing transparency in particularly impactful EPA rules and assessments and will inform future statute-specific rulemakings.
<IP_ADDRESS> Proposed Rule's Requirements Insufficient
Comment: Commenters (0057, 0556, 2876, 2907, 4831, 4838, 4881, 4884, 5021, 5165, 5170, 5178, 5287, 6046, 6104, 6109, 6110, 6125, 6126, 6133, 6142, 6146, 6147, 6152, 6163, 6164, 6185, 6188, 6194, 6233, 6351, 6447, 6450, 6875, 6909, 6915, 6916, 6919, 6920, 6924, 6933, 9224, 9225, 9227) oppose the proposed rule because the process it prescribes is too vague/lacking in detail, flawed, or illegal. Comments include:
 The proposed regulation is too vague to be meaningfully evaluated and successfully implemented. For example, according to the commenter, it is unclear whether §30.7 requires EPA to conduct its own peer review of all pivotal regulatory science and, if so, whether EPA has the capacity or capability to perform those reviews. See 83 Fed. Reg. at 18774. Likewise, the commenter states that the exemption process does not provide sufficient standards to ensure that the Administrator makes consistent determinations. (4838)
 The consequences of the proposed rule, significant they may be, are indeterminate in light of the proposal's vagueness. (5021)
 The proposal fails to clearly articulate the specific proposed requirements, impairing informed public comment. (5021, 6185)
 EPA needs to first propose a rule for using studies confirmed by peer-led and noted duplicate study confirmation. According to the commenter, the regulation as it stands is highly incomplete and highly questionable. (5287)
 A detailed operational structure for implementation needs to be developed. (6142)
 The specific actions of the proposed rule are difficult to identify in the docket due to being intermingled with reasoning for why the proposed rule should be implemented. (6046)