Response: The EPA considered these and other similar comments when developing the final rule. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions and finalizing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider the availability of underlying dose-response data when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available for independent validation. 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. 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. 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 does not believe that this final approach will lead to bias towards any party.
The EPA intends for the final rule to be implemented in a transparent manner. The final rule requires 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 in the significant regulatory action or influential scientific information. Additionally, the EPA expects to identify pivotal science in proposed significant regulatory actions or external review drafts of influential scientific information, which will allow the public, if they so choose, to independently validate the pivotal science and provide comment to the EPA.
<IP_ADDRESS> Research Will Not be Pursued or Will Be of Less Value
Comment: Commenters (1012, 2336, 2431, 4594, 4840, 4844, 4878, 5170, 5418, 6114, 6121, 6131, 6132, 6145, 6152, 6188, 6361, 6373, 6877, 6894, 6909, 6924, 6937, 8274, 9227) express concern that the Proposal will result in research not being pursued and/or it would be of less value. Comments include:
 It is likely that fewer scientists or research institutions will want to participate in EPA funded research if they are concerned that the personal health information, they collect may have to be publicly disclosed. The commenter adds that scientists and researchers may also find it difficult to recruit participants for long-term, large-scale studies that are needed to understand air and water quality issues if the participants are concerned that their medical records may be made publicly available. (1012)
 To satisfy a blanket disclosure requirement, a blanket redaction will become necessary. The commenter states that the resulting increase in costs will substantially reduce the number of future studies that can be conducted under a given level of spending. (2336)
 Individuals may be dissuaded from participating in new studies if privacy information commitments are not assured, and the quality of future science would suffer. (2431)
 The proposed rule could force scientists to disclose the health records of the families and children who suffer from asthma or are sickened by polluted water or to not conduct scientific studies at all. (2909)
 A failure to protect privacy data will hinder future scientific investigations as people will refuse to participate in research studies if they are not confident that their most personal information is protected. (4594)
 The proposal will impose costs and impediments that will discourage scientists from undertaking studies of great importance. (4840)
 In terms of future studies, researchers may have difficulty recruiting participants if they fear that their confidential information will be made public. (4844)
 Persons willing to participate in studies may be different as a result of the proposal in ways we cannot currently predict or describe, which could introduce confounding variables and bias that may question the study's results. (4878)
 If the proposed rule were to be implemented as currently written, it is highly likely that fewer scientists or research institutions will participate in EPA funded research because of concerns that the personal health information collected as part of research may have to be publicly disclosed. Consequently, the commenter suggests that researchers will find it difficult to recruit participants for long-term, large-scale studies that are needed to understand the health impacts of environmental quality issues as few participants are willing to have their medical records made public. (5170)
 Without the ability to protect and respect patient/human subject privacy and confidentiality, signatories and other researchers would not be able to conduct the studies that are pivotal to their work and to EPA's ability to fulfill its statutory duty to protect public health. (5418)
 While the language of the proposed rule would allow personal data to be redacted, it would also allow that data to be unredacted by the EPA Administrator. The commenters state that no information is given about how the Administrator would reach this kind of decision. Therefore, the commenters believe that participants from academia, industry, and members of the public would likely be hesitant to participate in studies, not knowing if or when confidential information could be released. (6114, 6131, 6361)
 The proposal will damage the ability of researchers to conduct future studies. The commenter suggests that researchers' ability to recruit potential research participants will be severely undermined if they fear that their personal information may be made available for public scrutiny. The commenter notes that this is particularly true for vulnerable communities that are both disproportionately exposed to hazardous chemicals and have historical reasons to distrust researchers. (6121)
 The proposal could result in lost publications (loss of intellectual property) and academic career derailment. The commenter adds that, when people no longer wish to enroll for fear their medical data will be released, new scientific studies could be inhibited, thereby damaging future scientific research. (6132)
 Commenter suggests that the release of data underlying scientific studies will limit the level of participation in future studies. (6145)
 Concerned that the proposal would undermine the quality of science that EPA uses to promulgate regulations. (6152)
 The proposed rule would impede the development and utilization of new science. (6894)
 Proposed rule has the potential to have significant negative impacts on the conduct of human health research in the United States. The commenter states that privacy concerns may begin to influence what science gets done and what does not. The commenter states that lines of scientific inquiry that would have been pursued may not be. The commenter states that the quality of data that is obtained may be poorer than it otherwise would have been. (6909)
 The rule's emphasis on publicly available data would have the perverse effect of discouraging individual participation in scientific studies due to personal privacy concerns. The commenter notes that potential study subjects, uncertain about EPA's willingness or ability to protect their identities and sensitive health information, would be more likely to be hesitant about participating in any study that could inform an EPA regulation. As a result, the commenter states that researchers could face increased difficulty in attracting subjects for crucial studies, reducing the availability of scientific information upon which to base EPA's decisions. The commenter contends that studies upon which EPA would be forced to rely could be less rigorous and trustworthy; the fact that a study's underlying data is publicly available has no bearing on the quality of the data or the study, and ground-breaking research on the health and environmental effects of pollution often relies upon the very kinds of highly sensitive data that would be most likely to be excluded from EPA review if the Proposed Rule were to be implemented. (6188)
 If EPA requires the distribution of identifiable data (i.e., individual data elements such as date of admission and residential zip code, a combination of which can identify a person), participants would have to sign agreements allowing the release of their private information and, as a result, they may decline to participate. According to the commenter, resulting impacts on participation rates could greatly increase the cost of studies and in the worst case, render research inconclusive because of a lack of representation. The commenter notes that researchers may have to redesign studies in a way that would reduce invasion of privacy, which could affect the accuracy or nuance achievable in a study, or account for the time and expense necessary to redact private information. The commenter contends that both of these consequences could damper studies' ability to answer critical research questions. (6373)
 Public health research, specifically observational cohort studies, can't be conducted without the cooperation and trust of study participants. Knowledge that their private data may be released to the public may severely impact the information study participants are willing to share. This in turn will compromise the quality of the research I and other public health researchers can conduct. There could be spillover effects from this proposed rule into other research studies that won't necessarily be considered for regulatory purposes, also compromising the quality of those studies. (6378)
 New studies may be discouraged for privacy and/or cost considerations. The commenter explains that the need to provide data will make it harder to obtain consent from subjects worried about personal identification and that it is possible that even very expensive measures such as use of the Federal Research Data Centers may not be adequate to maintain adequate privacy. The commenter adds that, with the stringent data requirements, and the increased concern about privacy, it is likely that the costs of compliant research would go up and that this may discourage researchers from undertaking future studies. (6877)
 Commenter is concerned that researchers would choose not to pursue research with human subjects, stifling scientific discovery; or that they will forgo compliance with the EPA proposed rule to obtain IRB approval and their research will be ignored by EPA because: (1) the researcher would have to make participant data publicly available and would not be able to ensure privacy/confidentiality; and (2) the researcher would have no control over how data they make publicly available would be used -- it could very well be used in a way that adversely impacts research subjects through privacy invasions or weakening of protections that safeguard communities. (6924)
 Under the proposed regulation, there will be pressure to submit protected data to third party partners, federally sanctioned privately managed data centers, and/or federal repositories. The commenter notes that this will be a Catch‐22 for researchers. The commenter provides that the researcher's choice will be to submit data to unproven or untrusted repositories, risking catastrophic release or misuse  -  or to not participate at all in research and grants that touch on policy‐relevant issues. (6937)
 Communities with lower socioeconomic status have been shown to be underrepresented in studies for various reasons. The commenter adds that restriction of evidence based upon data that is reliant on public access will certainly further confound this matter in these communities. The commenter notes that when community members are fearful that identification could lead to job loss or other negative personal impacts they are much less likely to participate in studies that examine personal health and environmental impacts linked to an employer., The commenter suggests that trust of confidentiality of and restriction to data accessibility increases study representation by reducing the exposure risk factors based upon individual identity. The commenter contends that restricting representation of communities that would result from these data accessibility issues leads to bias in a study's evidence by misrepresenting the community group that is being studied. (8274)
 Commenter (2478) expresses that the extent to which efforts to "strengthen transparency in regulatory science" would have led to a reduction in sponsored research into climate science, the EPA should have the burden of proving that this proposed rule was not designed to prejudice any particular area of scientific inquiry germane to the charge of the EPA. In other words, the commenter states that the EPA should have to demonstrate that this proposed rulemaking is not a pretext to de-prioritize research into climate science.
 Commenter (9227) states that the proposed rule does not disclose the cost -- highlighted on the very first page of a NAS report on data access -- that "perceived risks to privacy and confidentiality reduce survey participation," a cost that the NAS explains is "borne out by research." The commenter notes that NAS explains that this "threatens the research enterprise itself, because concerns about privacy and confidentiality are among the reasons often given by potential respondents for refusing to participate in surveys, and those concerns have been shown to affect behavior as well. The commenter adds that the NAS panel emphasized: "Any confidentiality breach that became known would be likely to heighten such concerns and, correspondingly, reduce survey response rates. Efforts to increase researchers' access to data must, therefore, take into account the need to avoid increasing the actual and perceived risks of confidentiality breaches."
      The commenter (9227) provides that this confidentiality risk has a further cost: it affects the quality of the data collected. As the NAS explained:
            The reason for confidentiality pledges and for stringent procedures to prevent disclosure is that they improve the quality of data collected from individuals, households, and firms. It is essential that respondents believe they can provide accurate, complete information without any fear that the information will be disclosed inappropriately. Indeed, if the information was disclosed, harm might come to an individual respondent.
      The commenter (9227) asserts that the proposal's only acknowledgment of this complex problem and cost is its statement that "EPA believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government." Remarkably, the commenter adds that the EPA does not cite a single example of these common solutions, citing only vaguely to "examples from the U.S. Department of Health and Human Services, National Institute of Standards and Technology, U.S. Department of Education, and the U.S. Census Bureau" and some hyperlinks not in the Proposal added to the docket almost a month into the comment period. Accordingly, the commenter states that, not only does the Proposal include no analysis of these alleged solutions and their costs and benefits, it does not even explain what the solutions are that EPA believes address this concern.
Response: The EPA considered these comments when finalizing this rulemaking, and the EPA does not believe the final rule will result in research not being pursued and/or research having less value. The provisions of this rulemaking are not restricted to any particular scientific discipline, but apply to all pivotal science used in significant regulatory actions and influential scientific information. As discussed in the final rule, underlying data or models 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 (e.g., Data Use Agreements) that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. The EPA would like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedure and does not direct or require any outside entity or the EPA to establish data sharing mechanisms. Further, the rule does not require the EPA to collect, store, or publicly disseminate data and models underlying pivotal science.
<IP_ADDRESS> Competitive Nature of Scientific Funding
Comment: Commenter (1170) expresses that the proposed rule is that it also ignores the intrinsically competitive nature of scientific funding, which means that even when there is no legal barrier to making data public, groups are strongly incentivized to keep some data non-public at least in the short term, so that they may carry out further analysis. The commenter notes that this is particularly true of data that takes months or years to obtain.
Response: The EPA considered this comment and similar comments when finalizing this rulemaking. 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 are unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, a study with underlying dose-response data that are not available 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. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. The EPA would also like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedure and does not direct or require any outside entity or the EPA to establish data sharing mechanisms. Further, the rule does not require the EPA to collect, store, or publicly disseminate data and models underlying pivotal science.
<IP_ADDRESS> Proposal Would Result in Fundamental Changes in the Use of Scientific Data and Research
Comment: Commenter (5170) states that the proposed rule would result in fundamental changes in the use of scientific data and research by the EPA, which they note is one of the most significant users of scientific data in the federal government. The commenter adds that there is a great deal at stake, in human health, lives and economic benefits and costs in such a significant change to the use of science as is being proposed in this rule and should, therefore, have a compelling, demonstrated need.
Response: The EPA considered this and other similar comments when developing the final rule and believes the approach used in the final rule will result in final significant regulatory actions and influential scientific information based on the highest quality studies that maximize transparency. The final rule also clarifies how the EPA will consider studies when developing final significant regulatory actions and influential scientific information. As more fully described in the preamble to the final rule, the EPA will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider the availability of underlying dose-response data when evaluating pivotal science and give greater consideration to pivotal science where the underlying dose-response data are available for independent validation. 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> Benefits of Environmental Protection Standards
Comment: Commenters (0017, 1331, 1424, 5120) suggest the economic benefits of environmental rules are greater than the implementation costs. Commenter (1331) asserts the public health costs of its implementation severely outweigh its benefits.
Commenter (0017) states the proposal will have a tremendous negative impact on the U.S. economy. The commenter states that, according to a 2011 EPA study, the estimated annual economic benefits of air quality improvements are estimated to be nearly $2.0 trillion in 2020 if they were to be fully implemented as laid out under the CAA. The commenter states that, in comparison, the cost of this benefit due to regulatory compliance actions would be approximately $65 billion. The commenter states that the EPA report estimates that the economic benefits of clean air to human health and environmental improvement exceed the costs by more than 30 to one.
Commenter (1424) states that all cost-effective studies show that protective environmental regulations save money, as they save billions in health care costs caused by toxic chemicals that cause cancer (PCBs), neurological deficits (lead), lung disease (PM2.5) and others. Commenter (5120) states that air quality legislation, culminating in amendments to the CAA in 1990, has produced an estimated $59-140 billion in health savings.
Response: This rule sets the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information. The final rule provides that if implementing the rule results in any conflict between this rule and the environmental statutes that the EPA administers, and their implementing regulations, this rule will yield and the statutes and regulations will be controlling. This is a rule of internal procedure promulgated under the EPA's housekeeping authority. This rule exclusively pertains to the internal practices of the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the federal government. Additionally, this rule does not require the EPA or other parties to disclose or host data. Hence, this rule does not impose costs on the EPA or any other party to make such data available. The EPA recognizes there will be some incremental review and administrative costs to the Agency but anticipates these will be small. As discussed in the preamble to 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.
<IP_ADDRESS> Proposed Rule Could Further Delay Development and Update of Toxicity Values/Reference Values/Guidelines/Policies/Rules
Comment: Commenters (0476, 2171, 5977, 6119, 6127, 6130, 6142, 6168, 6446, 6872, 6881, 6905, 6935, 6941, 8272) object to the proposal because it could delay needed federal action, development of protective standards, and development/update of toxicity values or reference values. Comments include the following:
 Properly implementing this rule will require EPA to first address many legal aspects surrounding public and nonpublic data, significantly expand database tools and peer review capacity, and develop guidelines for the use of "independent validation" -- all of which require considerable time and financial resources. The commenter states that, as a result, the proposed rule will delay the adoption of human health-based pollution standards for the foreseeable future. (2171)
 The proposal could further delay development and update of toxicity values or reference values published in the CERCLA, TSCA, CWA, SDWA and other federal acts authorized by EPA. The commenter provides that states, EPA and the public are already struggling to respond to emerging contaminants for which toxicity values and risk-based standards have yet to be developed. There are currently more than 129 million organic and inorganic substances identified with a chemical abstracts service number in the open scientific literature. Yet, the commenter notes that only a handful have been studied and even fewer with "dose response data and models" (reference values (reference dose and/ or reference concentrations)) used for "pivotal regulatory science" as noted in the proposed rule. The commenter contends that unnecessarily restricting the data currently in practice or potentially used for regulatory development would do little to rectify the situation in a timely or "transparent" manner. (6119)
 The added administrative barriers resulting from the proposed rule are likely to significantly delay the development of EPA guidelines and policies. The commenter adds that such delays are expected due to decreased access to industry claimed CBI, exclusion of relevant peer reviewed scientific studies, and the need for researchers to prepare publicly disclosable datasets. (6130)
 The proposed rule, if adopted, would inevitably delay setting protective standards through prolonged evaluation of the sufficiency of the public availability of research data and methods, rather than evaluation of the actual quality and import of scientific research. The commenter adds that the fact that the public would be able to de-anonymize much epidemiological data, after de-identification processes have been applied, would almost certainly have a chilling effect on voluntary public participation in important research, and would also prevent EPA from relying on the "best available science" in carrying out its work. (6446)
 Overly prescriptive and poorly defined list of modeling approaches will not either decrease or illuminate uncertainty and will not provide the basis for the specific decisions that confront the Agency; they are merely a recipe for obfuscation and delay. (6881)
 Commenter suggests EPA consider the impact of this proposed process on the pace of regulatory action and ensure the proper balance is struck between the potential value of independent validation -- which could take substantial time and, if so, be at odds with statutory requirements -- and the certainty and efficiency of regulatory decision making. The commenter states that, for example, if new transparency requirements cause delays in implementation of statutory provisions that cause statutory deadlines to be missed, then consequences can include deadline suits. (6935)
 Commenter is concerned that excluding data that cannot be made publicly available would slow the development and implementation of test methods and strategies to replace animal testing. The commenter states that such alternative methods and strategies can provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment, and their increased acceptance is one of TSCA's goals. (6941)
Response: The EPA disagrees that the requirements of this rule will result in any meaningful delay in promulgating regulations. While this final rule requires the Agency to evaluate the availability of dose-response data for pivotal science, the incremental burden to the Agency to carry out these requirements is expected to be small given (1) the extensive scientific review the EPA already conducts regularly and (2) that the requirement is limited to pivotal science (i.e., typically a small, though highly important, subset of the studies the EPA would review). Additionally, this rule does not require the EPA to disclose or host data, but to determine if the dose-response data underlying pivotal science are available and to give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation.
<IP_ADDRESS> Proposal Will Not Increase the Public's Understanding
Comment: Commenter (6046, 6133, 6168) contend that the proposed rule would not result in more transparency to the public. Commenter (6046) suggests that, instead of the proposed rule, the EPA could greatly improve its transparency by making its documents and memos (particularly those cited by pivotal science EPA documents) more easily accessible to the public.
Commenter (6133) suggests that the Proposal utterly fails to demonstrate or even support the claim that its approach ensures the information relied upon by EPA would be more understandable to the public. According to the commenter, the EPA fails to establish or even support the premise of its wrongheaded belief: that the best available, peer-reviewed, independent, credible science is not understandable already to the public, or the informed, knowledgeable members of the public versed in the scientific, technical, legal, economic or policy matters relevant to EPA's regulations, actions and mission. Additionally, the commenter notes that the proposal's claim about enhanced public understanding suffers from a fundamental internal contradiction and logical failing inherent to its approach: nothing in the Proposal requires that (1) publicly available data be actually considered, addressed, verified or replicated by EPA prior to the agency being allowed to consider the study based on that data; (2) publicly available data be actually considered, addressed, verified or replicated by any other person or party prior to EPA being allowed to consider the study based on that data; and (3) publicly available data be actually considered, addressed, verified or replicated by EPA, any person, or any party ever, before or after EPA is allowed to consider the study based on that data. Accordingly, the commenter contends that it is false and unsupported to suggest that the proposal ensures greater public "understanding" than the longstanding regulatory landscape where the Proposal's prescriptions and proscriptions do not exist.
Commenter (6168) notes that, if the EPA intends transparency in how research informs regulations, it must devote substantial resources to improving explanations of research utilized and their various caveats and not require dumps of "raw" data and algorithms without context. The commenter contends that "raw" data and algorithms are largely unintelligible, so this rule gives the appearance of transparency without actually enhancing science or participation. According to the commenter, as any scientist knows, data is never just data -- it is never really "raw" because it is always shaped by techniques of sampling, collection, entry, storage, and so forth. Because the proposed rule fails to acknowledge this basic fact about scientific data, the commenter states that the rule fundamentally misrepresents the practice and applications of research. The commenter notes that this is one sense in which the proposed rule impedes meaningful public understanding and engagement.
Response: The EPA disagrees with these comments. The final rule will result in final significant regulatory actions and influential scientific information based on the highest quality studies that maximize transparency. Additionally, the EPA intends for the final rule to be implemented in a transparent manner and expects to identify pivotal science in proposed significant regulatory actions or external review drafts of influential scientific information, which will allow the public, if they so choose, to independently validate the pivotal science and provide comment to the EPA.
<IP_ADDRESS> Proposal Would Constrain EPA's Consideration of a Regulation's Public Health Benefits
Comment: Commenter (6922) expresses concern that the proposal, if finalized, would constrain EPA's consideration of a regulation's public health benefits. The commenter notes that environmental statutes often call on EPA to evaluate the benefits and costs of a rulemaking when determining the most appropriate standard, control technology, and other regulatory requirements. In addition, the commenter adds that Executive Order 12866 requires agencies to conduct a cost-benefit analysis of major regulations. The commenter provides that the proposal, if finalized, would have the effect of precluding EPA's consideration of CBI and epidemiological studies for which underlying data is protected from public disclosure in EPA's development of the regulations and in assessing the costs and benefits of those regulations. Historically, the commenter notes that the EPA has been able to monetize only the public health benefits of reducing pollutants for which large-scale epidemiological studies are available and epidemiological studies, which predict mortality risks and other health effects, often rely on data that are not public, for various legitimate reasons.
Commenter (6922) contends that prohibiting reliance on epidemiological studies and/or CBI in analyzing benefits or costs would reduce the likelihood that EPA could consider the full suite of costs and benefits of regulation. The commenter is concerned that this would have the effect of elevating some considerations, such as cost of compliance, over other considerations, to the detriment of reasoned decision-making. The commenter concludes that both benefits and costs must be based on the best data in order to have reasoned decision-making.
Commenter (6915) states that restricting the use of studies that underlie emission standards for criteria pollutants could significantly impact the cost-benefit analyses for various other health-related rules by failing to account for all the benefits, making it far more likely that the costs will be predicted to exceed the benefits and that the regulatory standards will, accordingly, be lowered. The commenter states that, for example, in calculating the costs and benefits of rules to reduce air emissions, in some cases the majority of the benefit estimates are attributable to reductions in one or more criteria pollutants that are not the primary objective of the rule. The commenter states that these reductions are referred to as co-benefits, and the health impacts and monetized benefits are based on studies used in the air quality standards-setting process for criteria pollutants. The commenter states that, for example, in promulgating the Mercury and Air Toxics Standard rule governing air emission standards for hazardous air pollutants (including mercury) from power plants, EPA states "[i]t is important to note that the monetized benefits include many but not all health effects associated with PM2.5 exposure." 77 Fed. Reg. 9304, 9431 (Feb. 16, 2012); see also id. at 9305.
Response: The EPA considered this and other similar comments when developing the final rule and believes the approach used in the final rule will result in final significant regulatory actions and influential scientific information based on the highest quality studies that maximize transparency. The final rule also clarifies how the EPA will consider studies when developing final significant regulatory actions and influential scientific information. As more fully described in the preamble to the final rule, the EPA will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider the availability of underlying dose-response data when evaluating pivotal science and give greater consideration to pivotal science where the underlying dose-response data are available 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 final significant regulatory actions and finalizing 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. 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.
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> Proposal will Lead to Increased Litigation
Comment: Commenter (6937) suggests that the most likely outcome of the proposed regulation is not an improvement in the regulatory process or outcomes, but that every major regulation will be litigated on the topic of whether regulatory standards of transparency and replicability were met. The commenter notes that trying to write a regulatory one size fits all "bar" for transparency and replicability is an impossible task, given the incredible heterogeneity of scientific data and "the array of workflows across scientific fields" as well as "the case for data sharing at different levels of stringency" (quotations from source in footnote 10 of the Federal Register Notice). For example, the commenter provides that they can easily imagine lawsuits where EPA is challenged with the accusation that it did not work hard enough to meet the following proposed requirement: "where data is controlled by third parties, EPA shall work with those parties to endeavor to make the data available..." (§30.5, page 18774). Or that EPA could be EPA challenged over the degree of "access" and "use restrictions" (§30.5, page 18774), since these are left very vague in the proposal.
Response: The EPA disagrees that implementation of this rule will necessarily lead to increased litigation. 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. 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. The EPA would also like to emphasize that the final rule does not require the EPA to collect, store, or publicly disseminate data and models underlying pivotal science.
<IP_ADDRESS> Credibility/Public Trust of the Agency
Comment: Commenter (8913) suggests that an unintended consequence of the proposal is the inevitable negative impact the Transparency Rule would have upon commerce and American industry. The commenter contends that the disregard of sound science and the drastic constriction of evidence considered by the EPA, will greatly reduce the credibility of the agency. In short order, the commenter adds that this will result in reduced confidence in businesses and industries which manufacture or use toxic agents. The commenter notes that it will also damage the credibility of industries involved in containment activity and fabrication of products and structures designed to control or mitigate the release of chemicals, radioactivity, and other harmful substances. Thus, according to the commenter, the products and services even of companies and industries which perform careful robust safety studies will be suspect. Lastly, the commenter states that the EPA imprimatur will also cease to have strong force globally, resulting in less competitive export industries.
Commenter (5165) asserts that transparency concerns must not override EPA's obligation to consider the full range of peer-reviewed, sound scientific research that is available and relevant to its regulatory decisions. In the commenter's view, the proposal would likely hinder, rather than promote, EPA's use of best-available science and it would tend to diminish public confidence in the integrity of EPA's scientific decision making.
Conversely, commenters (1971, 5185, 5891, 6150, 6376) suggest that the proposed rule could be a step that increases public trust in and support for EPA itself. Commenter (5185) states that, while the agency's proposed reforms are clearly controversial, they are grounded in an accepted democratic principle: citizens have a right to the data and information that are used in the development of public policy. Commenter (5891) states that refusing to disclose the studies, surveys, etc., upon which any rule is based, is disheartening, dishonest and in-American.
Commenter (6150) states that new causal analytical techniques can be used to test validity of existing data thereby increasing public confidence in results. The commenter states that, by relying on data, models and processes subject to rigorous disclosure, the Agency will better inform the public and enhance the public's ability to understand and meaningfully participate in the regulatory process. Commenter (6176) states that the public should not be expected to just trust the EPA (or any agency) to promulgate any rule it wants and draw its own conclusions without the public knowing how those conclusions were reached. Commenter (6376) states that creating and codifying a standard of scientific transparency should result in better regulations and strengthen public trust in the regulatory agenda.
Response: 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. 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 of the assessment. 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. The EPA's continued progress toward maximizing transparency is vital to building and maintaining trust with the public and credibility in the Agency's decisions. The 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.
Finally, 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> Unable to Fully Assess Likely Impacts on EPA and State Programs
Comment: Commenter (6126) suggests that given the vague nature of certain definitions, the commenter states that they are unable to fully assess the likely impacts on EPA programs.
Commenter (5181) states that it is unknown how the proposed rule would impact development of Water Quality Standards for wetlands. The commenter notes that many states include pollutant and toxic discharge standards among those that are applied to wetlands. The commenter states that the proposal should clearly address and answer this question, and also clarify the impact on grants to states.
Commenter (6915) states that, based on EPA's complete failure to consider or discuss the effects of its action on state programs, the proposal should be withdrawn so that EPA can adequately consult with state officials to analyze these important impacts. See Exec. Order 13132 § 6(a) (instructing agencies to "ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications"); Chem. Mfrs. Ass'n v. U.S. Envtl. Prot. Agency, 870 F.2d 177, 203 (5th Cir. 1989).
Response: The EPA clarified in the final rule that the requirements in 40 CFR part 30 apply to significant regulatory actions and influential scientific information. 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.
2.2 Purpose/Basis and Effects (SNPRM Comments)
 2.2.1 Purpose/Basis for Rule
 <IP_ADDRESS> Alternative Purpose for Rule Besides Transparency
Comment: Commenters (10974, 10975, 11339, 11361, 11391, 11392, 11401, 11920, 13788) contend that the rulemaking is not an intention to improve transparency in EPA decision-making, but instead an attempt by EPA to undermine the scientific basis of the process. Specific concerns include:
 Commenter (10974) states that EPA's revisions do not clarify how this proposed rule enhances the public's ability to understand or meaningfully participate in the regulatory process and questions who represents "the public" in the context of independent validation. The commenter suggests that the limitation of reanalysis to individuals with expertise contradicts EPA's broader argument that the rule would benefit "the public's" understanding of science and EPA's rulemaking process. Further, the commenter contends that reanalysis by "subject matter experts" is redundant of current practices and that EPA is overstepping its authority to determine how individuals and organizations share their data, in turn confusing rather than clarifying the public's understanding and participation in the rulemaking process.
 Commenter (10975) states that the purpose of the proposed rule is to allow EPA to bypass its statutory duties and congressional mandates to enact restrictive rules in the first place, even when the evidence of potential public harm is clear. According to the commenter, this proposed rule does not come from rational public administrative concerns, nor from science, but from what political scientists call "Agency capture." The commenter also queries how this proposed rule can avoid the legal and moral taint of a highly partisan de-regulatory agenda for cutting back on public protections.
 Commenter (11339) states that the proposal is the cornerstone in a large-scale attack on health science at EPA, specifically, the scientific process of CAA rulemaking. The commenter provides examples of changes to the NAAQs rulemaking process including: disbanding advisory panels, lessen scientific review without adequate expertise, barring EPA funded scientists from serving on advisory panels, while creating no equivalent limits on the appointment of industry funded scientists.
 Commenter (11361) asserts that the "clarifications" offered in the SNPRM demonstrate the intention to undermine science through the façade of increasing transparency and that the framing of the rule around "recent innovations and policies surrounding information access" is actually disingenuous to the spirit of that spirit. The commenter contends that the data disclosure requirements in the 2020 SNPRM "allow stakeholders to reanalyze the data and models and explore the sensitivity of the conclusions to alternative assumptions" would make it easier for outside parties to cast doubt on peer-reviewed science. The commenter states that similarly, EPA's statement that the Proposed Rule does not "require that EPA, a member of the public or other entity must independently validate a study before it can be considered" indicates that the Proposed Rule would not improve the quality of the scientific information relied upon by EPA by ensuring it is independently verified, but would instead advance tactics used by industry to avoid regulation.
 Commenter (11392) states that this proposed rulemaking undermines the ability of EPA to protect human health and the environment and contravenes the Agency's statutory responsibility to use the best available science in promulgating health-protective regulations. The commenter contends that this rulemaking is not only dangerous, but is fundamentally flawed by failing to justify a legitimate purpose beyond arbitrary, political manipulation of the Agency's science-based work.
 Commenter (13788) contends that the suggestion that the rule could apply to studies retroactively if the Administrator does not grant an exemption further illustrates the intention to undermine longstanding reliance on the human health studies that have done the most to advance air quality and public health. The commenter states that the EPA has provided no reasoning to explain how retroactive application to past studies -- including the Harvard Six Cities and American Cancer Society particulate matter health studies and subsequent work that links exposures to air pollution with declines and damages to human health -- is justified. The commenter states that it certainly has not provided any information to suggest that this rule would encourage the release of more data from those studies. The commenter states that this proposal's focus is clearly on arbitrarily excluding or diminishing the value of quality scientific research rather than any real commitment to transparency.
Response: Because of the potential impact of the EPA's significant regulatory actions and influential scientific information on American lives and livelihoods, the American people deserve environmental decisions and policies that are based on the best scientific information. Only through continuous improvement to its procedures, especially those focused on transparency, can the EPA fully demonstrate that commitment. Data transparency is vital for individuals who have not contributed to the study to be able to verify the quality and strength of published studies and the opportunity to independently validate the pivotal science that the EPA relies upon is important in furthering scientific understanding and the Agency's mission. Increasing the availability of the underlying dose-response data upon which the EPA makes its decisions is integral to demonstrating accountability and this dedication to public health and the environment. Therefore, 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. 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. 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 reanalyses, 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 final rule does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science.
As discussed in the preamble of the final rule, the rule is designed to build upon open data initiatives in the federal government and scientific community. The rule is not targeted to a particular set of rulemakings or scientific studies, but rather intends to increase transparency in the pivotal science used in significant regulatory actions and influential scientific information. The EPA believes that the implementation of this final rule will increase the transparency of pivotal science for significant regulatory decisions and influential scientific information, while still ensuring that the highest quality, most relevant studies are considered in the development process.
Comment: Commenters (11190, 12720) contend that the rule is designed as an avenue to allow polluters to provide legal challenge to regulations under the new data availability requirement.
Commenter (11920) contends that through restricting the use of relevant and high-quality scientific information, the EPA is seeking to protect polluters and regulated industries, rather than carry out its statutory mandate to protect the environment and American citizens.
Response: The EPA disagrees that this rule is intended to benefit industry. The EPA is committed to its mission of protecting public health and the environment through sound policy decisions that are informed by robust scientific and technical research. Because of the potential impact of the EPA's significant regulatory actions and influential scientific information on American lives and livelihoods, the American people deserve environmental decisions and policies that are based on the best scientific information. Only through continuous improvement to its procedures, especially those focused on transparency, can the EPA fully demonstrate that commitment. Data transparency is vital for individuals who have not contributed to the study to be able to verify the quality and strength of published studies and the opportunity to independently validate the pivotal science that the EPA relies upon is important in furthering scientific understanding and the Agency's mission. Increasing the availability of the underlying dose-response data upon which the EPA makes its decisions is integral to demonstrating accountability and this dedication to public health and the environment. Therefore, 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. The EPA is finalizing the approach that gives greater consideration to pivotal science whose underlying dose-response data are publicly available or available through restricted access.
<IP_ADDRESS> Rule Does Not Have Adequate Basis or Justification
Comment: Commenters (11332, 11392, 11490 11894, 12430, 12455, 12456, 12727, 13788) assert that the Proposal and subsequent SNPRM do not have adequate basis or justification for the need to alter EPA's rulemaking process. Specifically:
Commenter (11332) states their concern considering EPA's lack of justification for this sweeping reach of the supplemental proposal, which is all-encompassing compared to even the original proposed rule. The commenter states that EPA's rule would apply to any data and models used by the Agency to craft its regulations, and that the change is significant. The commenter notes that it is an expansion of the net cast in the original proposal, which was limited to dose response data and models, and that this change could weaken a wider range of current pollution controls all across this country. The commenter contends that this major change in scope was never justified in the proposal.
Commenter (11392) notes that they agree with the members of EPA's handpicked SAB that this rule "risks serious and perverse outcomes" and that the Agency has not justified "why existing procedures and norms utilized in the U.S. scientific community, including the federal government, are inadequate, and how the Proposed Rule will improve transparency and the scientific integrity of the regulatory outcomes."
Commenter (11894) states that since EPA has failed to justify any per se, a priori restrictions based on data availability, any proposals for relief from those restrictions are proposals for relief from something that should not exist in the first place. The commenter asserts that as such, they are both unnecessary, and unable to increase in any way the legal defensibility of those restrictions, since they still allow the Agency, to the exact extent that the relief provisions do not apply, to unjustifiably refuse to consider certain studies. Furthermore, the commenter queries what possible sense does it make to exclude, arbitrarily and without justification, categories of studies that can contribute to understanding of particular problems that EPA is directed by statute to manage. The commenter agrees that EPA should be sure that regulatory decisions with binding legal effect rest on information whose quality has been tested, but the studies themselves have no binding effect; they are building blocks and evidence that the Agency uses to reach a conclusion. The commenter contends that process is debased when science is excluded for reasons that have nothing to do with its quality and probity, and to do so violates well-developed understandings of how science works. The commenter notes that the cure is not arbitrary exclusion, but, as John Milton said in a different context, to "Let [Truth] and Falsehood grapple; who ever knew Truth put to the worse, in a free and open encounter?" The commenter questions what EPA is so afraid of that it proposes to exclude these studies from the decision process as EPA manages major, consequential public health issues?
Commenter (12430) contends that as part of its notice-and-comment rulemaking requirements, the APA requires an Agency to provide notice of a proposed rulemaking, and to "disclose in detail the thinking that has animated the form of a proposed rule and the data upon which that rule is based." The commenter provides that the D.C. Circuit Court of Appeals has noted, "a prerequisite to the ability to make meaningful comment is to know the basis upon which the rule is proposed.", yet EPA has not provided a justification, let alone a detailed disclosure of its reasoning and data, for either the Proposal or the dramatic expansion proposed in the SNPRM. According to the commenter, the proposals merely assume and assert that: transparency is the determinant of scientific quality; transparency is presently lacking; public data availability is the only guarantor or indicator of transparency; and there exist no less disruptive means of increasing transparency that EPA could consider. The commenter states they have discussed EPA's failure to explain the basis of its NPRM in their 2018 comments and that the SNPRM fails to rectify this issue. The commenter notes that as in the NPRM, the SNPRM provides no references to U.S. EPA regulatory science or influential scientific information that subsequent review suggests were falsified or otherwise problematic, or instances in which public unavailability of data or models has resulted in irrational or arbitrary regulations or other harms. The commenter also contends that instead of providing a justification for profoundly expanding the scope of the Proposal in the SNPRM, EPA references only unspecified public comments and uncomplicated requests for clarification of the Proposal. The commenter provides that for example, the Proposal's preamble clearly explained the proposal's applicability only to dose-response data and models, but one provision of the proposed regulatory text was ambiguous on this point. The commenter asserts that EPA now cites this single ambiguity as its basis for the SNPRM's dramatic expansion of the proposal to all types of data and models. Additionally, the commenter contends that the citation of the OMB Memorandum does not provide basis for the proposed rule. Ultimately, the commenter states that EPA provides no reasoned basis for the SNPRM's drastic expansion of the Proposed Rule and that instead, the Agency summarily announces its intent to expand the provisions of the rule, which does not comprise the detailed disclosure of basis and data that the APA requires.
Commenter (12727) states that EPA does not explain or acknowledge its departure from existing approaches for assessing the weight of scientific evidence. The commenter notes that EPA's Risk Assessment Forum recommends weighting evidence based on relevance, strength, and reliability. Even within reliability, the commenter provides that the Forum observes that "scoring the most important component properties" is useful. According to the commenter, transparency is only one such component, and it is merely "presumed to increase reliability by reducing the likelihood of hidden faults." The commenter contends that EPA offers no reason to give overwhelming importance to one component of reliability in this framework, and, in turn, to reliability over the strength and relevance of a study. In fact, the commenter states EPA does not discuss existing approaches to weighting evidence at all and has therefore failed to acknowledge that it is changing policies or to provide a good reason for doing so, rendering a final rule that is similarly deficient and unlawful.
Additionally, commenters (12455, 12456) request that EPA provide specific examples to justify the 2018 proposed rule and the SNPRM.
Commenter (13788) asserts that EPA has provided no reasoning to explain how retroactive application to past studies -- including the Harvard Six Cities and American Cancer Society particulate matter health studies and subsequent work that links exposures to air pollution with declines and damages to human health -- is justified. The commenter notes EPA has not provided any information to suggest that this rule would encourage the release of more data from those studies
Response: As discussed in the preamble of the final rule, the rule is designed to build upon open data initiatives in the federal government and scientific community and advances 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. Having a better understanding of the underlying data will 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, there will be no categorical exclusion of studies based on the availability of their underlying dose-response data and the applicability of the rule is focused on dose-response data to provide incremental progress toward the Agency's goal of greater transparency. Briefly, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information, consistent with existing Agency practice. The EPA will continue to use the following, established factors to assess the quality of studies used to develop significant regulatory actions and influential scientific information: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. 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 -- in 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. 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. The EPA believes that the implementation of this final rule will increase the transparency of pivotal science underlying significant regulatory actions and influential scientific information, while still ensuring that the highest quality, most relevant studies are considered in the development process.
The EPA expects to identify pivotal science, and the consideration afforded to pivotal science, in proposed significant regulatory actions and external review drafts of influential scientific information, which will allow the subject matter experts, if they so choose, to independently validate the pivotal science and provide comment to the EPA. The EPA believes that this approach will allow the public to more effectively comment, engage, and hold the EPA accountable during the future development of specific significant regulatory actions and influential scientific information.
Finally, the EPA is maintaining that the rule provisions apply equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. 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 are unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, a study with underlying dose-response data that are not available 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. The EPA could also give pivotal science with underlying dose-response data that are unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator, as detailed under 40 CFR 30.7. One of the criteria the Administrator may use in his/her determination to grant a waiver is that the development of the dose-response data was completed or updated before the effective date of the rule. 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 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>.1 Provided Citations Do Not Provide Solid Backing
Comment: Commenters (11894, 12645, 12727) provide that the SNPRM's citations are unable to be used to provide firm support for the rulemaking. Specific concerns include:
Commenter (11894) states that the memorandum cited in the supplemental proposal says nothing about precluding use of, or downgrading consideration given to, scientific information for which raw data are not publicly accessible. The commenter notes that the memorandum in fact continues to recognize (at p. 5) that agencies must "ensure that privacy and confidentiality are fully protected and that data are properly secure so that open data do not disclose personally identifiable information." The commenter asserts that it does discuss circumstances under which tiered access to data is appropriate (p. 9), a discussion that does nothing to support the sweeping scope of this supplemental proposal. Further, the commenter provides that the supplemental proposal also cites a NAS report entitled "Principles and obstacles for sharing data from environmental health research." The commenter contends that that assertion rests on a generic reference to an unspecified portion of a 148-page document. According to the commenter, the Agency is apparently unaware (or, worse, failed to disclose) that the NAS document in question is merely a workshop report even though its own citation clearly states just that. The commenter states that workshop reports are assembled to represent all divergent points of view, and have no other purpose; these are not NAS consensus recommendations and contain a very strong disclaimer to this effect.
Commenter (12645) contends that the most authoritative citation is to a Workshop on Principles and Obstacles for Sharing Data from Environmental Health Research. According to the commenter, this Workshop is cited 9 times, all within the Federal Register section on Definitions, which addresses the central issues raised by the proposal. The commenter notes that none of the other 9 references within this section is cited more than once. The commenter states that the U.S. NAS is perhaps the most respected source of unbiased scientific opinion in the world, so citation to the NAS would seem to provide authoritative backing for EPA's proposal, but not if it is to a workshop. The commenter provides that speakers are chosen by the NAS to accurately and fairly represent divergent points of view rather than to present a recommendation obtained through the consensus of an expert scientific committee. The commenter asserts that in this case, industry representatives were involved in the planning committee for this Workshop and three were speakers, including the industry consultant who controversially heads EPA's CASAC. Additionally, the commenter provides that the NAS report has a very strong disclaimer that EPA chose to ignore:
      The statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the [NAS] and they should not be construed as reflecting any group consensus.
According to the commenter, individual opinions summarized by rapporteurs in the Workshop report, as well as specific quotations, are citable, but only to the individual who made the comments.
Commenter (12727) notes that the original proposal's cited support proved to be either inapplicable, irrelevant, or contrary to EPA's proposed action. The commenter states that further, EPA's failure to explain its proposed departure from current Agency policies and its reversal of prior Agency conclusions on data availability are a hallmark of arbitrary decision-making. The commenter provides that the supplemental proposal drastically expands the scope of the original proposal, yet it rectifies neither its earlier citation of inapplicable, non-supportive authorities nor its failure to acknowledge or explain contradictions with current policies and prior conclusions. The commenter also states that the supplemental proposal does not cite any new authorities that support its approach aside from OMB memorandum M-19-15, which the commenter asserts does not provide support for the proposal. According to the commenter, EPA's failure to provide adequate support for its proposed course of action is the antithesis of reasoned decision making.
Response: As discussed in the preamble of the final rule, the rule is designed to build upon open data initiatives in the federal government and scientific community. Additional discussion and citations for the rationale are provided. In addition, 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 (e.g., Data Use Agreements) that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information.
Further, the EPA would like to clarify that the rule does not prevent the Agency from using research with confidential data and does not rely on an Administrator's exemption to be able to consider such research. As explained in the preamble for the final rule, the EPA did not finalize the 2018 proposal or the proposed option in the 2020 SNPRM that would have categorically required that the underlying dose-response data be available for independent validation in order for studies to be considered pivotal science. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Also as discussed in the preamble to the final rule, the EPA is retaining the Administrator's exemption provision with some added considerations in response to public comments. To ensure that the Administrator's decision is appropriately transparent, in the final rule the EPA has included a provision in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. This documentation would typically be provided as part of the proposed rulemaking given this will be part of the decision of what is the pivotal science for the rule. Regardless, the final rulemaking will provide clear documentation. The EPA is confident that the criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
The EPA has also clarified references to the 2016 NAS workshop report entitled Principles and obstacles for sharing data from environmental health research: Workshop summary (Ref. 26) in the preamble text of the final rule. All references to this report in the final preamble clearly state that this was a workshop report.
<IP_ADDRESS> The EPA Has Not Sufficiently Articulated the Problem the Rule Is Intended to Fix
Comment: Several commenters (10742, 10974, 11332, 11339, 11390, 11391, 11395, 11396, 11404, 11408, 11473, 11479, 11484, 11497, 11576, 11579, 11892, 11894, 11920, 12403, 12412, 12427, 12464, 12546, 12617, 12645, 12688, 12692, 12707, 12716, 12720, 12727, 13549) express that EPA has not sufficiently articulated the problem that the EPA is intending to fix by its proposal/supplemental proposal. These commenters generally also note that EPA has not sufficiently justified their purported effort to address "transparency," and that sufficient peer review and other mechanisms already exist to validate studies and ensure transparency. Examples of some of the specific comments include:
Commenter (11390) contends that the proposed rule disregards settled scientific standards and drums up a transparency problem that does not exist, focusing on data availability instead of study reliability. According to the commenter, it adds nothing to -- and in fact completely ignores -- the complex discussions within the scientific community about how best to achieve additional transparency and enhance replicability while maintaining commitments to patient confidentiality and production of high-quality science.
Commenter (11473) states that the rulemaking is needless regulation seeking to solve a purported problem that does not exist. According to the commenter, sufficient safeguards already exist in the present peer review system, and the approach put forward by this proposed regulation will not achieve the Agency's claimed goals of "transparency."
Commenter (12720) contends that it is problematic that, two years since the original proposed rule, EPA has not identified any reasons to introduce such drastic changes to the Agency's science activities through the supplemental proposal.
Commenter (11497) states that multiple steps of independent scientific review already ensure the integrity and objectivity of science. The commenter notes that soundness of scientific methodology is thoroughly reviewed at many points in the process of designing, conducting and publishing research. The commenter adds that the competitive grant process; IRB requirements; peer-review prior to publication; the expertise and judgment of career EPA scientists when considering the strength and relevance of studies included in EPA decisions; and finally, the review of those decisions and the science they are based on by EPA's SAB all provide more than sufficient opportunities to assess the soundness of scientific studies.
Commenter (11894) expresses that the Agency suggests that it might consider studies for which the underlying data were unavailable due to concerns about privacy, confidentiality, CBI, or national security. The commenter notes that you will search the proposal in vain for any reference to considering studies because they had repeatedly been confirmed by other studies, or because their quality had been assured by other means, or because analysis could adjust for any likely flaws, or because they were the only data available to address a pressing regulatory issue.
Commenter (10742) notes that after a careful review of the supplemental notice of proposed rulemaking, the commenter found that the Agency has failed to fully identify the problem that finalizing this rule will solve. The commenter asserts that it is, therefore, difficult to analyze the individual components of the rule and if they will solve any problems.
Commenter (11920) contends that, quite simply, this rulemaking addresses a problem that does not exist, and would dramatically undermine the ability of the EPA to make use of best available scientific information to protect the environment and public safety.
Commenter (10974) states that there is no information-based demonstration of either the need for additional procedural transparency, or for furthered public understanding of EPA's critical rulemakings. The commenter contends that this proposed rule, if enacted, would provide no such clarity  -  it is a solution looking for a problem. The commenter also notes the SNPRM's reference to OMB M-19-15, and notes that the memo addresses, for all Federal executive agencies, what EPA is trying to do with this internally focused rulemaking. The commenter provides that the EPA says that this SNPRM is partly intended to "ensure consistency" with M-19-15, but, at the expense of duplicating work, and doing so to the detriment of "[e]nsuring and [m]aximizing the [q]uality, [o]bjectivity, [u]tility, and [i]ntegrity of [i]nformation", EPA has not established the need to take further action beyond following M-19-15 and the underlying guidance document. According to the commenter, the argument could be made that publishing this SNPRM in order to align a previous attempt at rulemaking to a new memo further confuses the issues at hand, rather than providing clarity.
Commenter (11332) provides that EPA has not in the original proposed rule or in the SNPRM adequately identified any particular problem to be addressed by this unprecedented Agency action. According to the commenter, the concern was identified earlier by EPA's own SAB. The commenter notes that this was months ago in regards to the original proposal, but the Agency did not address that concern in the supplemental proposal. The commenter contends that EPA has not meaningfully engaged with the SAB in assembling its supplemental proposal, and in the supplemental proposal, EPA has not responded in any meaningful way to the major questions and concerns identified by the SAB about this rushed effort. Additionally, the commenter states that the recently finalized ISA for Fine PM, Soot Air Pollution demonstrates that the existing scientific review processes are fully functioning to capture and characterize the best available science as mandated by law and that the health and economic benefits to the American public using the current approach to parsing the best available science over the past fifty years provide no reasonable legal or scientific rationale for the SNPRM. In summary, the commenter asserts that the Agency has not adequately shown the need for this proposed regulation. To the contrary, the commenter provides that the SNPRM would ignite cascading waves of unnecessary, unworkable, and hugely expensive implementation issues and also directly enable selective interference in the science.
Commenter (11350) states that EPA science assessments generally include an exhaustive and critical review of relevant studies and a full explanation of how they are being interpreted and adds that extensive information about each study is typically part of the public record even if all underlying data may not be included. The commenter notes that EPA assessments are normally subject to public comment and independent peer review and members of the regulatory community are free at any time to replicate studies they deem flawed, or to independently seek access to underlying data and reanalyze them. The commenter suggests that the so-called problem that the proposal seeks to fix is largely imaginary and asserts that the stakes for EPA science and the protection of public health are simply too high to finalize this deeply problematic and unnecessary proposal.
Commenters (12412, 13549) state that proposed 40 C.F.R. § 30.5 remains a poorly formed scheme in search of a problem that would ultimately force EPA to arbitrarily make public health and environmental decisions based on incomplete or improperly weighted information.
Commenter (11395) contends that the SNPRM does not address the need for the regulation and does not provide evidence that implementation of the proposed rule would improve regulatory outcomes. The commenter provides that appropriate data sharing mechanisms already exist and major funding sources, including the NIH and EPA, require scientists to establish a data sharing plan as part of the scientific granting process. Additionally, the commenter notes that the NIH currently operates multiple data repositories and that major journals, including Lancet, the Journal of the American Medical Association, and the New England Journal of Medicine, require researchers to specify a mechanism for sharing data with other scientists consistent with NIH policies and the FAIR (findable, accessible, interoperable, reusable) principles as part of their manuscript submission to facilitate replication of findings, or pooling of data from multiple studies. The commenter asserts that EPA should focus on implementing existing initiatives and guidelines for improving data sharing and transparency at federal agencies rather than promulgating a regulation that requires additional data sharing as a condition for consideration of a study.
Commenter (11404) provides that there is already a robust scientific information vetting process outlined in the executive orders and guidance documents referenced in the background document for this rulemaking. According to the commenter, these include Executive Order 12866: Regulatory Planning and Review; Executive Order 13563: Improving Regulation and Regulatory Review; EPA's Scientific Integrity Guidance; OMB's Guidelines Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information.
Commenter (11576) contends that the request for comment on how to improve information availability over time and how to incentivize researchers is a request for solutions to a problem that does not exist. The commenter states that EPA has not shown that its regulatory decisions and scientific analyses have been at all compromised due to the public not having access to the models and data underlying scientific studies.
Commenter (12688) provides that this proposal is both unnecessary, and inferior to current practices. The commenter notes that FOIA, including the Shelby Amendment, already serves the purpose of transparency, and Agency reliance on the best available science and considering all information available in rulemaking records is both a superior practice, and required by law.
Commenter (12546) contends that the proposal continues to have fundamental flaws and this supplement will not improve the use of science for decision-making; EPA has failed to provide a reasonable science or policy rationale supporting these actions. The commenter provides that EPA and numerous other agencies (such as the FDA) routinely make regulatory decisions without having access to "all data and models." According to the commenter, lacking "access to part or all of the data and Models" or "not hav[ing] the authority to provide access to part or all of the data and models," does not prevent EPA from determining the validity of scientific methods and conclusions and using science to inform decisions, as EPA repeatedly states in its own plan to increase access to results of EPA-funded scientific research. The commenter states that overall, the proposed rule and supplemental proposal is not consistent with the principles of open science,, and continues to lack a scientific basis or policy rationale.
Commenter (12727) states that EPA has failed to articulate a defensible rationale for this proposal or to describe what effects the proposal might produce. The commenter notes that the SAB recently observed that "[c]osts of processing and documenting data will be difficult to assess in advance until EPA has developed a system for dealing with the requirements of the rule." The commenter asserts that basic ambiguities in the proposal might further obscure potential costs, as the SAB noted with respect to the definition of "data." The commenter contends that a reasoned decision-making process would have generated more information upon which to analyze costs and benefits, rather than the near-total absence of information that we now face. According to the commenter, this lack of information is not carte blanche to forego an analysis, but rather an indication that this rulemaking is arbitrary and unsupported.
Similarly, another commenter (11579) states that EPA has yet to offer any evidence or substantial arguments in their defense of why the proposed restrictions on science are necessary. The commenter provides that the Agency's own SAB recently noted in its comments on the proposal, "[t]here is minimal justification provided in the Proposed Rule for why existing procedures and norms utilized across the U.S. scientific community, including the federal government, are inadequate, and how the Proposed Rule will improve transparency and the scientific integrity of the regulatory outcomes in an effective and efficient manner." According to the commenter, the EPA's continued failure to provide such "justification" has significant substantive and procedural implications. Substantively, the commenter contends that the Agency's unwillingness to address the implications of its proposal has disguised the severe problems the regulation would cause. The commenter notes that, in the words of the SAB (11579):
      It is plausible that in some situations, the Proposed Rule will decrease efficiency and reduce scientific integrity, [and] determining if in fact that will be the case requires a thorough and thoughtful examination that is currently absent in the Proposed Rule. Moving forward with altered transparency requirements beyond those already in use, in the absence of such a robust analysis, risks serious and perverse outcomes.
Commenter (12716) states that as the Agency points out, there are numerous laws and policies that already govern the requirements that must be met for the Agency to use science in its rulemaking, including OMB's Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies and Memorandum 13-13: Open Data Policy  -  Managing Information as an Asset, EPA's 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research to Significant Regulatory Decisions Plan; EPA Open Government Plan 4.0; (3) Open Data Implementation Plan; and EPA's Scientific Integrity Policy; Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency.
The commenter (12716) contends that an examination of the EPA's Information Quality Guidelines demonstrates that EPA is already required to have transparency in its reliance on scientific studies used in the establishment of regulations. For example, the commenter notes that in regard to ensuring and maximizing the quality of "influential" information (which includes information in support of Agency actions including rules), EPA states:
      EPA recognizes that influential scientific, financial, or statistical information should be subject to a higher degree of quality (for example, transparency about data and methods) than information that may not have a clear and substantial impact on important public policies or private sector decisions. A higher degree of transparency about data and methods will facilitate the reproducibility of such information by qualified third parties, to an acceptable degree of imprecision. For disseminated influential original and supporting data, EPA intends to ensure reproducibility according to commonly accepted scientific, financial, or statistical standards. It is important that analytic results for influential information have a higher degree of transparency regarding (1) the source of the data used, (2) the various assumptions employed, (3) the analytic methods applied, and (4) the statistical procedures employed. It is also important that the degree of rigor with which each of these factors is presented and discussed be scaled as appropriate, and that all factors be presented and discussed. In addition, if access to data and methods cannot occur due to compelling interests such as privacy, trade secrets, intellectual property, and other confidentiality protections, EPA should, to the extent practicable, apply especially rigorous robustness checks to analytic results and carefully document all checks that were undertaken. Original and supporting data may not be subject to the high and specific degree of transparency provided for analytic results; however, EPA should apply, to the extent practicable, relevant Agency policies and procedures to achieve reproducibility, given ethical, feasibility, and confidentiality constraints.
In addition to all of the already existing laws and guidance under which EPA is directed to review scientific information in its promulgation of regulations, the commenter (12716) notes that EPA also has "several mechanisms for vetting science through several expert panels, including the EPA SAB, the EPA CASAC and the EPA [Federal Insecticide, Fungicide and Rodenticide] FIFRA Scientific Advisory Panel . . .." Altogether, the commenter asserts that these safeguards are sufficient to ensure that the science relied upon by EPA is the best available science and that it is subject to peer review and available to the public.
Commenter (12427) states that EPA is trying to "solve" a "problem" that doesn't exist. According to the commenter, there is not a problem with "transparency" in current scientific practice; reputable journals encourage or require complete disclosure of data and models, with the reasonable exception in cases where disclosure would infringe on patient right to privacy or would disclose confidential information. Thus, the commenter contends that EPA is attempting to solve a problem that doesn't exist. The commenter provides that PLOS One requires full disclosure but also instructs that "All efforts should be made to protect patient privacy and anonymity." Additionally, the commenter states that EPA should address the following questions:
 What is the current practice among scientific journals regarding "transparency"? (answer: journals already promote this)
 What is the actual problem? What actual harm has been done because of lack of transparency? In what ways have existing peer review mechanisms failed to address studies that lack "transparency" but that are otherwise rigorous?
  If there is a problem, is a regulation the best approach? Why not do some test cases? Why not a white paper? Why not develop an internal guidance document?
Commenter (12727) contends that there is a plethora of evidence that EPA's existing approaches to evaluation of scientific studies, models, and other information underlying influential scientific information are not only functioning well, but are exemplary. The commenter states that EPA's requirement of peer review of all influential scientific information assures that influential scientific information and underlying information are rigorously examined both within and without the Agency before dissemination or other utilization. Furthermore, the commenter asserts that EPA's Scientific Integrity Policy successfully promotes use of best science by not imposing a priori constraints on which information is to be used, but rather by considering data on its individual merits, unconstrained by political or other interference. The commenter notes that although the policy recognizes the importance of the ability to independently validate scientific information and methods, as well as the importance of access to data and non-proprietary models used to support Agency action, these values are not absolute rules barring or downgrading consideration of legitimate data and information. The commenter contends that EPA's traditional weight-of-evidence approach to data evaluation has express judicial imprimatur, as does its decision to consider studies for which not all underlying data are publicly available for legitimate reasons.
Response: The final rule provides more detail explaining the EPA's rationale for this rule. In brief, 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. This rule is designed to build upon OMB M-19-15, which highlights the need to characterize the sensitivity of an agency's conclusions to analytic assumptions, as well as other federal guidance documents that require greater data transparency. The EPA's attention to data transparency is also responsive to the broader interest in greater data and model transparency observed in the numerous transparency initiatives in the scientific community and federal government, as well as the criticism the EPA has received from members of the public, scientific community, and Congress on the transparency of the scientific basis for EPA's decisions in previous influential scientific information assessments and regulatory actions. The EPA's continued progress toward maximizing transparency is vital to building and maintaining trust with the public and credibility in the Agency's decisions. Further, although the scientific community and government agencies are making great strides in data transparency, improvements can still be made over existing policies and mechanisms. Therefore, the rule requirements for the EPA's independent evaluation of the availability of data are necessary and critical to prioritizing data transparency in the pivotal science underlying its significant regulatory actions and influential scientific information. Although current methods and processes do allow for public comment and, where appropriate, peer review in the development of significant regulatory actions and influential scientific information, subject matter experts and peer reviewers (including the SAB and other science advisory panels) generally have not had access to the underlying data necessary to fully evaluate scientific conclusions. 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 promulgation of these internal Agency procedures in this rulemaking highlights the Administration's commitment to ensuring transparency in the EPA's most impactful regulatory actions and influential scientific information.
In addition, as explained in the preamble for the final rule, the EPA did not finalize the 2018 proposal or the proposed option in the 2020 SNPRM that would have categorically required that the underlying dose-response data be available for independent validation in order for studies to be considered pivotal science. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. 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.
The EPA agrees that data sharing mechanisms already exist. The preamble to the rule clarifies that restricted or tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. The rule does not prescribe a particular mechanism but does require the EPA to independently verify that such a mechanism exists for dose-response data underlying pivotal science.
The EPA received comments from the SAB on the 2018 NPRM and 2020 SNPRM on April 24, 2020. The EPA considered these comments in development of the final rule. In brief, the SAB consensus was that it supported the precept of enhancing public access to scientific data and analytical methods to ensure scientific integrity, consistency, and robust analysis and their consensus recommendations were that the EPA develop additional policy and/or guidance documents; further describe how pivotal science would be selected, made available, and peer reviewed; consider establishing an office on data sharing with the support of a peer review panel; provide greater clarity in the definitions of key terms, including data, independent validation, and publicly available; develop specific criteria for the Administrator's exemptions under the rule; consider applying rule requirements only to information developed after the effective date of the rule; seeking input from experts to identify best practices to ensure efficiency, utility, and protection of data that are made available; and consider funding reanalysis work.
As noted in the preamble for the final rule, this rule sets the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information and technical considerations, including those noted by the SAB, could be addressed in subsequent implementation guidelines and/or statute-specific rulemakings. Further, in response to comments from SAB and the public, the EPA clarified and modified several key definitions, including data, independent validation, and publicly available, in the final rule. The EPA also provided criteria for the Administrator's exemption in 40 CFR 30.7 of the final rule. The EPA would like to clarify that this rule does not direct or require any outside entity or the EPA to establish data sharing mechanisms and does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science. Comments related to making data available and future funding opportunities are not within the scope of this rulemaking. Finally, the EPA is maintaining that the rule provisions apply equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. However, in consideration of instances where data cannot be made available, the EPA amended the rule to provide technical considerations (40 CFR 30.5(d)) that can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability in the absence of maximum transparency and included an exemption criterion -- that the development of the dose-response data was completed or updated before the effective date of the rule -- to 40 CFR 30.7 to account for the concerns raised by the SAB and other public commenters.
Comment: Commenter (12427) asserts that the need to establish the quality of published information described in the proposed rule is accomplished through peer view, as discussed in the following sentence from the 2004 OMB Information Quality Bulletin for Peer Review: "Peer review is one of the important procedures used to ensure that the quality of published information meets the standards of the scientific and technical community." The commenter asserts that science should be evaluated by the scientific and technical community, not by political appointees of EPA. The commenter contends that the transparency rule and SNPRM vest decisions about what studies to exclude from these proposals solely with the politically-appointed Administrator and do not include any science-based criteria for making such decision, nor are such decisions vested in a scientific advisory committee. Furthermore, the commenter states that there are existing scientific Federal advisory committees that serve EPA that already review, evaluate, and assess scientific knowledge pertinent to regulatory and other decision making. The commenter notes that yet, EPA is silent regarding the important role of peer review and fails to explain why existing peer review mechanisms are inadequate.
The commenter asserts that peer review related to scientific rigor and not the narrow definition of "transparency" that EPA is attempting to codify into a regulation. Additionally, the commenter asserts that the lack of consideration for CBI and intellectual property in the proposed rule is inconsistent with current practice in scientific journals, and OMB's Information Quality Bulletin for Peer Review. The commenter also expressed concern for patient privacy.
Response: The EPA agrees that existing mechanisms within the EPA, the federal government, and in the scientific community are increasingly pushing towards greater data sharing and increasing scientific rigor. 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. Although current methods and processes do allow for public comment and, where appropriate, peer review in the development of significant regulatory actions and influential scientific information, subject matter experts and peer reviewers (including the SAB and other science advisory panels) generally have not had access to the underlying data necessary to fully evaluate scientific conclusions. The final rule also provides that 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. The EPA believes that 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.
Also as discussed in the preamble to the final rule, the EPA is retaining the Administrator's exemption provision with some added considerations in response to public comments. To ensure that the Administrator's decision is appropriately transparent, in the final rule the EPA has included a provision in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. This documentation would typically be provided as part of the proposed rulemaking given this will be part of the decision of what is the pivotal science for the rule. Regardless, the final rulemaking will provide clear documentation. The EPA is confident that the criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
Commenter (12427) contends that EPA has failed to justify that its existing peer review mechanisms fail to address scientific rigor in assessing science relevant to regulatory decision making. The commenter provides that peer review mechanisms already available to EPA include but are not limited to scientific Federal advisory committees (e.g., EPA SAB, EPA's CASAC, EPA FIFRA Scientific Advisory Panel), as well as ad hoc reviews (organized as panels or based on reviews from multiple individuals). Furthermore, the commenter states that for changes that may broadly affect the scientific enterprise, EPA has routinely sought advice from the NASEM, including but are not limited to, Risk Assessment in the Federal Government: Managing the Process; Review of EPA's Integrated Risk Information Systems; Science and Judgment; Science and Decisions; and many others. According to the commenter, EPA has failed to engage CASAC, the SAB, or any other of its advisory committees on the transparency rule or its supplement, has not engaged external experts to review any scientific work products for this proposed rule and supplement, and has not engaged NASEM.
Response: The EPA agrees that existing mechanisms within the EPA, the federal government, and in the scientific community are increasingly pushing towards greater data sharing and increasing scientific rigor. 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. Although current methods and processes do allow for public comment and, where appropriate, peer review in the development of significant regulatory actions and influential scientific information, subject matter experts and peer reviewers (including the SAB and other science advisory panels) generally have not had access to the underlying data necessary to fully evaluate scientific conclusions. This rule provides that 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. The EPA believes that 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.
The EPA's SAB provided advice and comments on mechanisms for secure access to PII and CBI under the proposed rule on September 30, 20 and the proposed and supplemental rulemakings on April 24, 2020. All of these comments were considered in developing the final rule. In brief, the SAB consensus was that it supported the precept of enhancing public access to scientific data and analytical methods to ensure scientific integrity, consistency, and robust analysis and their consensus recommendations were that the EPA develop additional policy and/or guidance documents; further describe how pivotal science would be selected, made available, and peer reviewed; consider establishing an office on data sharing with the support of a peer review panel; provide greater clarity in the definitions of key terms, including data, independent validation, and publicly available; develop specific criteria for the Administrator's exemptions under the rule; consider applying rule requirements only to information developed after the effective date of the rule; seeking input from experts to identify best practices to ensure efficiency, utility, and protection of data that are made available; and consider funding reanalysis work.
As noted in the preamble for the final rule, this rule sets the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information and technical considerations, including those noted by the SAB, could be addressed in subsequent implementation guidelines and/or statute-specific rulemakings. Further, in response to comments from SAB and the public, the EPA clarified and modified several key definitions, including data, independent validation, and publicly available, in the final rule. The EPA also provided criteria for the Administrator's exemption in 40 CFR 30.7 of the final rule. The EPA would like to clarify that this rule does not direct or require any outside entity or the EPA to establish data sharing mechanisms and does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science. Comments related to making data available and future funding opportunities are not within the scope of this rulemaking. Finally, the EPA is maintaining that the rule provisions apply equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created. Scientific transparency is important regardless of the age of the study or the dose-response data. However, in consideration of instances where data cannot be made available, the EPA amended the rule to provide technical considerations (40 CFR 30.5(d)) that can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability in the absence of maximum transparency and included an exemption criterion -- that the development of the dose-response data was completed or updated before the effective date of the rule -- to 40 CFR 30.7 to account for the concerns raised by the SAB and other public commenters.
Comment: Commenter (12430) notes that congressional directives already require U.S EPA to consider whether scientific information is reasonable, clear, and complete and whether it has been peer reviewed. The commenter states that existing mechanisms complement these directives, including: the SAB, established by Congress in 1978 to advise on scientific matters; existing independent peer review of much of the scientific research relied on for regulatory action and publication; legal requirements that prohibit U.S. EPA's adoption of regulations that are arbitrary, capricious, or unsupported by substantial evidence; and procedures to request reconsideration of Agency decisions and correction of Agency information. Additionally, the commenter contends that the process for setting the NAAQS illustrates the scientific review procedures that are already in place for EPA's regulatory actions. The commenter provides that after determining weight by independent peer review, EPA staff and their contractors review the literature and subject it to further internal review, they develop a staff report. The commenter states that CASAC, which consists of internationally recognized experts in their scientific disciplines, reviews the EPA staff report, and in turn provides advice to the Administrator regarding the adequacy of current standards and recommendations for revisions, if necessary, for the protection of public health. Additionally, the commenter states that the reports receive public comment, including from independent and industry scientists, and the CASAC review includes consideration of those public comments. According to the commenter, the EPA NAAQS documents typically receive multiple rounds of expert scientific review before they are finalized.
Commenter (12715) states that EPA never explains, in either the initial proposal or the SNPR, how its new approach will improve the Agency's scientific decision-making and references a 2019 joint statement of the editors of leading scientific journals. The commenter contends that the scientific bases of EPA risk and policy assessments are already peer reviewed by panels such as the EPA SAB panels, CASAC, FIFRA Science Advisory Panels, and the TSCA Science Advisory Committee to ensure that the evaluation of studies is performed using appropriate scientific criteria. According to the commenter, these reviewers have ample tools to evaluate the merit and robustness of scientific studies and information, including assessing: the quality of a study's design; the reasonableness of any assumptions; whether sample sizes are sufficient; whether the evidence is strong enough to support a conclusion; and how the study compares with other studies in the same subject matter area. The commenter asserts that EPA does not explain why these existing review criteria are insufficient or how its new, arbitrary requirements will add "transparency" or improve EPA's decision-making.
Response: The EPA agrees that existing mechanisms within the EPA, the federal government, and in the scientific community are increasingly pushing towards greater data sharing and increasing scientific rigor. 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. Although current methods and processes do allow for public comment and, where appropriate, peer review in the development of significant regulatory actions and influential scientific information, subject matter experts and peer reviewers (including the SAB and other science advisory panels) generally have not had access to the underlying data necessary to fully evaluate scientific conclusions. This rule provides that 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. The EPA believes that 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
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 promulgation of these internal Agency procedures in this rulemaking highlights the Administration's commitment to ensuring transparency in the EPA's most impactful regulatory actions and influential scientific information.
Comment: Commenter (11391) states that in its notice announcing the 2018 proposed rule, EPA claimed that it is needed to ensure the validity of the scientific information relied upon by the Agency, and enhance the transparency of regulatory processes, and while the earlier comments submitted by the commenter and others clearly show that is not the case, EPA has doubled-down on its claim, but again offered no evidence to support it.
The commenter (11391) notes that it is well established that Agency actions must be based on a consideration of relevant evidence and accompanied by a clear statement of how that evidence supports the action taken. The commenter states that as the Supreme Court explained in Federal Commissions Commission v. Fox Television Stations, Inc., an Agency must supply "good reasons" for reversing a previously held position, and that those reasons must be especially compelling where, as here, the agency's new position "rests on factual findings that contradict its prior policy." In such cases, the commenter provides that the Agency must provide "a more detailed justification than what would suffice for a new policy created on a blank slate," including a "reasoned explanation" for disregarding the facts and circumstances on which its prior policy was based. According to the commenter, in the absence of such an explanation, the Agency's action must be considered arbitrary and capricious in violation of the APA.
As such, the commenter (11391) states that EPA has not provided any justification for its newfound view that the validity of scientific research can only be assessed if the underlying data are disclosed. The commenter contends that this view is at odds with the widespread consensus within the scientific community that existing peer review processes, which do not require data disclosure, are sufficient to ensure the validity of scientific research. The commenter notes that recognizing this, in 2016 EPA concluded that the availability of underlying data "does not affect the validity of the scientific conclusions from peer-reviewed research publications." Now, less than four years later, EPA has suddenly changed its view. According to the commenter, neither the 2018 Notice nor the 2020 SNPRM acknowledge the change, much less provide a reasoned explanation for it.
Furthermore, the commenter (11391) states that in the 2020 SNPRM, EPA baldly asserts that the Proposed Rule is needed to ensure Agency practices are consistent with new guidance from the OMB, but does not explain why, nor could it, since the referenced guidance -- an April 2019 Memorandum on Improving Implementation of the Information Quality Act -- does not require EPA to adopt the Proposed Rule or even support its stated reasons for doing so. The commenter asserts that whereas EPA claims that access to underlying data is needed to ensure the validity of scientific research, the memorandum indicates that this can be achieved through peer review.