The commenter (11391) also points to EPA's reference to OMB's 2002 Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies but, again, they do not support adoption of the Proposed Rule. The commenter contends that while the Guidelines do call for increased transparency in science, the provisions in the proposed rule that require disclosure are inconsistent with provisions in the Guidelines that indicate that transparency does not necessarily require disclosure of the data underlying research studies, that such disclosure can raise ethical and/or other issues, and that balances the need for transparency against "other compelling interests such as privacy, trade secrets, intellectual property, and other confidentiality protections." The commenter asserts that rather than attempt such a balance, EPA has declared a blanket standard, under which it must ignore or give lesser weight to studies for which the underlying data are not available, even if those studies have been independently verified (e.g., through peer review) and the researchers have valid reasons for withholding the underlying data.
Finally, the commenter (11391) notes that the 2018 Proposed Rule applied only to dose-response data and models underlying pivotal regulatory science that is used to justify significant regulatory decisions and that EPA is now proposing to expand the scope of the Proposed Rule in two ways:
      1. the Proposed Rule would apply not only to the science relied upon in promulgating significant regulatory decisions, but also in finalizing influential scientific information; and
      2. the Proposed Rule would apply to all data and models underlying such science, instead of only dose-response data and models.
The commenter (11391) contends that EPA offers no explanation for the first change. With respect to the second, the commenter provides that EPA asserts that "[t]ransparency of EPA's science should not be limited to dose-response data and dose-response models, because other types of data and models will also drive . . . significant regulatory decisions and influential scientific information." The commenter asserts that EPA has still not explained why its version of "transparency" is necessary or appropriate.
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 augments, but does not replace, existing Agency procedures for evaluating science underlying significant regulatory actions and influential scientific information. As further discussed in the preamble to the final rule, the EPA is focusing on dose-response data in this rule to pursue an incremental approach to maximizing transparency in the science that it relies upon to ensure that implementation is done in a thoughtful and deliberate way that focuses on the EPA's most impactful actions, minimizes unintended consequences, and informs future transparency requirements. When implemented, the 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 implementation of this final rule will 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, the EPA clarified 40 CFR 30.5 to give equal consideration to dose-response data that are publicly available or available through restricted access. As discussed in the final rule, underlying dose-response data are considered available if they can be accessed through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. The EPA believes that the final 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.
In the preamble to the final rule, the EPA clarifies that although the availability of dose-response data underlying a study in a manner sufficient for independent validation is an important component of determining the level of consideration to afford a study, the EPA agrees that availability by itself is not sufficient to determine study quality or validity. As explained in 40 CFR 30.5, the EPA will use existing factors (including soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review) to evaluate study quality. Subsequently, after identifying the highest quality, most relevant studies that would inform a dose-response assessment and identifying the availability of pivotal science, the EPA would consider additional applicable factors as described in 40 CFR 30.5(d) when determining the level of consideration to give pivotal science where the underlying dose-response data are not available for independent validation.
The EPA disagrees with commenters that peer review can achieve the goals of this rulemaking. Peer review does not typically include reanalysis of the underlying data (i.e., the proper stage of data where the data that are ready to be analyzed to extract relevant information) and, thus, peer review is not considered a replacement for the data availability requirements of this rule. Jamieson et al. (2019) state, "Journals play a key role in ascertaining the quality of the evidence in work submitted for publication through peer review. However, that practice is neither uniform nor free of exploitation. While it can select for trustable results, its existence alone is not sufficient to verify the quality of the evidence used to back claims." The authors go on to say that additional confidence could be gained from third-party reanalyses that independently validate the study results. In addition, as detailed in OMB's Final Information Quality Bulletin for Peer Review, "the intensity of peer review is highly variable across journals" and "prior peer review and publication is not by itself sufficient grounds for determining that no further review is necessary." The scientific community has also embraced greater data transparency, as evidenced by data sharing and availability requirements for many high-impact journals and the emergence of organizations, such as the Center for Open Science, and international initiatives like FAIR data principles; FOSTER; and Guidelines for TOP in Journal Policies and Practices that incentivize greater transparency in research.[,] The EPA supports these efforts and believes that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety.
<IP_ADDRESS> Basis for Proposal is Valid
Comment: Commenter (11401) states that they understand why EPA felt it necessary to supplement the rulemaking due to the Proposal's mischaracterization as an effort to block science. The commenter contends that this is not the case and that EPA is well within its authority to carry out the provisions of the SNPRM and it is a laudable effort to hold itself to scientific standards, as is only right and equitable as it holds companies and citizens to strict environmental standards that cost society billions of dollars every year.
Commenter (12692) contends that the Environmental Protection Network's assertion the rulemaking has no problem it is trying to solve is flawed. The commenter provides that it is a bit much to demand that EPA produce a list of its own "bad decisions" as any such determination would require a rulemaking of its own. The commenter states that the core thesis of the Transparency proposal is not that EPA knows the studies it relies on lead to "bad" decisions but that, in many cases, it cannot properly evaluate those decisions because the underlying studies incapable of independent validation. The commenter asserts that quality control via the "marketplace of ideas" has been precluded.
Additionally, the commenter (12692) states that the "replication crisis" is very real and that many studies published in prestige journals turn out to be junk. The commenter references The Economist, in an editorial cited by the Transparency proposal, that explained the problem as follows:
      A simple idea underpins science: "trust but verify." Results should always be subject to challenge from experiment. That simple but powerful idea has generated a vast body of knowledge. Since its birth in the 17th century, modern science has changed the world beyond recognition, and overwhelmingly for the better.
The commenter (12692) provides that success can breed complacency and that modern scientists are doing too much trusting and not enough verifying -- to the detriment of the whole of science, and of humanity. According to the commenter, too many of its findings that fill the academic ether are the result of shoddy experiments or poor analysis (see pages 26-30). The commenter asserts that a rule of thumb among biotechnology venture-capitalists is that half of published research cannot be replicated, even that may be optimistic. The commenter notes Amgen and Bayer have failed to reproduce many research projects, as well as the doubt of a leading computer scientist that frets that three quarters of papers in his subfield are bunk. The commenter also references that between 2000-10 roughly 80,000 patients took part in clinical trials based on research that was later retracted because of mistakes or improprieties.
According to the commenter (12692), The Economist identifies three main causes of replication failure: The publish-or-perish imperative of academic life; the associated career-related inducements to exaggerate, cherry pick results, and spin causality out of chance correlations; publication bias against studies finding negative results; and lax peer review. The commenter provides that for example, the article reports, "When a prominent medical journal ran research past other experts in the field, it found that most of the reviewers failed to spot mistakes it had deliberately inserted into papers, even after being told they were being tested." The commenter also reiterates Lutter and Zorn's concern over replicability.
Response: The EPA agrees with commenters on the importance of transparency and scientific scrutiny and debate in creating sound environmental policy. 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 information. Only through continuous improvement to its procedures, especially those focused on transparency, can the EPA fully demonstrate that commitment.
<IP_ADDRESS> Prior Basis for Rule
<IP_ADDRESS>.1 Previous Environmental Rulemakings Necessitate Transparency
Comment: Commenter (9335) points to CASAC's 2019 Draft Review of the Particulate Matter Policy Assessment (PM PA) as a basis for the Proposed Rule. The commenter states that their comments reflect the need for transparency as follows: 1) there is NO causal relationship between PM2.5 and total mortality in the US, 2) the PM PA cites `positive authors' and omits `null authors' and their criticism, 3) the PM PA does not address the PM2.5 deaths controversy, 4) analyses of underlying data for four key US cohorts, including the Harvard Six Cities Study and the American Cancer Society Cancer Prevention Study II, support the need for the proposed EPA Transparency Rule, and 5) the PM PA must be revised to incorporate the CASAC Review and the criticisms by the commenter and others.
Response: Although the rulemaking is not related to any specific EPA rulemaking or particular study, the EPA agrees with the commenter that transparency and scientific scrutiny and debate is integral to creating sound environmental policy.
Comment: Commenter (9588) states that there is a very real need to review science and notes the FDA's five-step process for drug approval, EPA's chemical review process under the TSCA, and the OMB's requirement for review of all new regulations as a need for review. The commenter also provides that peer-review is a necessity at most legitimate science journals and considered the question of grantees serving on review committees, siding with the financial independence of advisory committee members. Additionally, the commenter notes several critiques ofgovernment transparency rules and their importance as they relate to science and policymaking.[,][,][,][,]
Response: The EPA agrees with the commenter on the importance of transparency and scientific scrutiny and debate in creating sound environmental policy. 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. The EPA would also like to clarify that reviews conducted by other federal agencies and OMB are outside the scope of this rulemaking.
Comment: Commenter (11899) contends that past EPA rulemakings, including the Clean Power Plan and Endangerment Findings, were often not only secretive and arbitrary, but also adversely affected job creation and retention; the price and availability of the energy, food and consumer products needed in the daily lives of all Americans; and ultimately the health and welfare of millions of families, especially poor, minority and blue-collar families in states that rely on coal and natural gas for electricity, industries and factories for jobs and salaries  -  and on other activities that may have some adverse effects on environmental quality and human health and welfare, but also improve our environment, health and welfare in significant ways. The commenter provides that this negative impact provides a compelling case for the threat of EPA's rules on health, welfare, and pursuit of happiness, justice and civil rights progress of our members, the people we represent, and all Americans, than do the damages of any environmental contaminants being regulated, especially when based on secret science and pressure politics.
Response: Although the rulemaking is not related to any specific EPA rulemaking or particular study, the EPA agrees with the commenter that transparency and scientific scrutiny and debate is integral to creating sound environmental policy. 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 information. Only through continuous improvement to its procedures, especially those focused on transparency, can the EPA fully demonstrate that commitment.
<IP_ADDRESS>.2 Roots in Previous Legislation
Comment: Commenter (11392) states that the rulemaking's legacy lies in the failed Secret Science Reform Acts of 2014' and 20152 and the Honest and Open New EPA Science Treatment (HONEST) Act of 20173, bills that passed out of the House Committee on Science, Space, and Technology under Republican leadership but that the Senate did not see fit to consider. The commenter contends that this attempt to implement the provisions of failed legislation through rulemaking is an inappropriate circumvention of the authorities granted to the executive branch by the Constitution, and that the executive branch cannot exercise such legislative powers.
Response: The EPA disagrees that this rule is politically motivated, as transparency assumes no political ideology. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. The EPA is committed to furthering this effort with the implementation of this final rule. The EPA drafted this rulemaking independent of any external parties.
Comment: Commenter (11890) notes that many of the same arguments were made in support of the Shelby Amendment of 1999. Following passage, the commenter states that broad demand for this public access never materialized. According to the commenter, the amendment and subsequent OMB Circular A-110 included provisions for public access to data from federally funded research. The commenter states that the mechanism providing access included procedures established under the FOIA. The commenter provides that an investigation into requests to EPA made between 2002 and 2012 for underlying study data (beyond published findings) found only two such requests. Both were granted through the FOIA mechanism provided by the Shelby Amendment. The commenter contends that this is hardly evidence of broad public demand for underlying study data.
Conversely, commenter (11915) states that the underlying intent of these reforms is grounded in the broadly agreed upon principle that citizens should have a right to the data and information that are used in the development of public policy. The commenter contends that this spirit of openness with respect to the regulatory process is found throughout government; it is enshrined in statute (known as "the Shelby Amendment") and countless federal directives and EPA memos reinforce the principle and detail guidance for implementing it. The commenter notes that publicly available data and information is also supported by experts of all political stripes, referencing a 2012 congressional testimony where White House science advisor Dr. John Holdren stated that "absolutely, the data on which regulatory decisions and other decision are based should be made available to the Committee and should be made public."
Response: The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. 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.
2.2.2 Effects
<IP_ADDRESS> Limits Available Science
Comment: Several commenters (9372, 10045, 10055, 10740, 10748, 10749, 10751, 10752, 10753, 10865, 10944, 10969, 10973, 10974, 11176, 11183, 11192, 11330, 11339, 11340, 11347, 11349, 11350, 11354, 11359, 11360, 11377, 11387, 11390, 11392, 11395, 11396, 11402, 11403, 11404, 11408, 11479, 11484, 11489, 11490, 11495, 11496, 11497, 11498, 11576, 11894, 11903, 11911, 11918, 11919 , 11921, 12404, 12405, 12412, 12415, 12422, 12427, 12430, 12431, 12435, 12442, 12443, 12456, 12458, 12464, 12466, 12474, 12688, 12540, 12645, 12701, 12707, 12712, 12715, 12716, 12720, 12727, 13549, 13788) that oppose the proposed rule note that the proposed rule would limit the use of science (and/or "best available science") valuable research from being considered in the EPA rule making process and that the supplemental proposal compounds the problem by expanding the scope of science that the rule would apply to. Additional comments and responses to comments on the implications for health and environmental protections are included in Section <IP_ADDRESS> of this Chapter. Commenters claim that most of the best research does not use publicly available data. Several examples of specific comments follow:
Commenter (11403) notes that providing raw data is not often a requirement for scientific publication. The commenter states that this does not mean that scientists should ignore any study that does not provide raw data; it simply means the peer review process ensures that data analysis is done properly. The commenter provides that this has been the scientific standard for more than 100 years. As noted by many commenters, the commenter states that raw data from epidemiological studies are often not made public in order to protect patients' identities as required by federal law. The commenter notes that many epidemiological studies that measure exposure to and harm from pollutants look at vulnerable populations in order to get a sense of how these populations respond compared to the general population. For instance, the commenter states that exposure to sulfur dioxide in the air is particularly worrisome for young people who have asthma, and exposure to pesticides tend to have a greater effect on the farmworker population due to disproportionately high chronic exposures.
Commenter (12442) contends that the EPA's supplemental rule proposal unnecessarily modifies which studies can be considered and unscientifically reduces the consideration of valuable and necessary studies that aid the Agency in setting policy to protect public health and the environment.
Commenter (11484) states that while they agree in principle that the increase of transparency in regulatory science is beneficial, that increase cannot come at the expense of EPA's statutory requirement to rely on the best available science.
Commenter (12435) contends that past, current and proposed research would be stifled by the SNPRM, due in part to state privacy rules. The commenter states that the proposed regulations force a false, illegal and unreasonable choice between protecting privacy and protecting public health.
Commenters (12435, 12456) express concern that, if the current language proposed by the SNPRM is adopted, studies conducted by researchers in Colorado would no longer be given weight because the underlying data would not be publicly available in accordance with Colorado Board of Public Health Rules, regardless of the quality of the study and the relevance of the information. The commenters state that, although these studies can be useful and even essential when EPA considers new rules or changes to existing regulations, current Colorado Board of Public Health Rules limit the availability of data collected by health departments to protect privacy.
Commenter (12435) states that the proposed rule may unjustifiably exclude water sampling data collected by the Water Quality Control Division and entities within Colorado due to conflicts with the Colorado Open Records Act. The commenter states that the EPA should have access to all sampling data in Colorado while developing its guidance and rules, and the use of this data should not be at the discretion of the EPA Administrator, or excluded from consideration because the data was collected from drinking water system intakes or private wells.
Commenter (12456) states that high-quality research by Colorado Parks and Wildlife has been used by EPA to develop cadmium, copper, lead, silver and zinc criteria to protect aquatic life. The commenter states that the EPA should have access to all high-quality data, studies, and models while developing its guidance and rules, and the use of this data should not be at the discretion of the EPA Administrator, or excluded from consideration because all or part of study took place on private lands in Colorado. The commenter urges the EPA to change the 2020 proposed rule to promote the use of all high-quality data and studies in EPA's decision making, including studies that may include data that is not publicly available.
Commenter (11498) notes that the widening of the scope won't just limit EPA's use of science underpinning regulation, but also EPA's use of science underpinning other significant outputs of the Agency. According to the commenter, the changes mean EPA will likely be unable to cite important studies on topics relating to the levels of contaminants in water, air and land; epidemiological studies that describe clinical markers of exposure or effect; and many other studies that are fundamental in understanding and protecting human health.
Commenter (11894) states that, in short, adopting this proposal would do even more than adoption of the initial proposal to bar the Agency from basing its decisions on the best available science as the law requires.
Commenter (12707) states that the changes provided in the supplemental rule fail to clarify how EPA will approach long standing scientific studies  -  it only creates further confusion and broadens the scope of science that will be covered. According to the commenter, the initial proposal and this supplemental proposal are a next step in a very transparent effort to discredit and make unavailable certain seminal studies that establish the connection between exposure to air pollution and adverse public health impacts.
Commenter (12464) notes that in their comments on the initial proposal, they explained that the proposed rule would prevent EPA from relying on studies involving confidential human health data, thus violating the Agency's duty to rely on the best available science. The commenter states that the supplemental proposal offers two alternatives that purportedly address this concern, one allowing EPA to consider studies without publicly-available data "if there is tiered access to these data and models in a manner sufficient for independent validation," 85 Fed. Reg. at 15,399, and the other giving lesser weight to studies whose data are not publicly available, id. The commenter contends that while the supplemental proposal presents the proposed and alternate versions of 40 C.F.R. 30.5 as solutions to concerns that they and many others raised regarding the initial proposal, the new provisions are in fact no improvement.
Commenter (11330) states that the 2018 proposed rule would have allowed the EPA to selectively exclude studies with conclusions they found unfavorable. The commenter notes that he was joined by over one hundred members of Congress, a thousand scientists, and the leading scientific advocacy organizations in America in condemning the proposal. Clearly, according to the commenter, the EPA did not heed their call. The commenter contends that the path the EPA chose given this blowback was to release a supplemental rule that effectively does the same thing. The commenter adds that the supplemental proposal allows the EPA to prioritize studies, and not just for rulemaking, for all EPA activities.
Commenter (11489) states that the proposed rule and SNPRM serve only to limit the studies the EPA can consider to those in which the data is publicly available, regardless of quality and value. The commenter states that these efforts limit the EPA's own ability to engage in evidence-based policymaking and do not address a legitimate need, as the EPA already has the authority to determine which studies it will consider during rulemaking.
Commenter (11903) states that under its first option, the EPA is proposing rules forbidding the use of scientific evidence, including evidence from "high-quality studies", without regard to relevance, in a way that will obviously impose costs on others, by narrowing the indicia that scientists routinely use when determining what evidence is reliable. Under its second option, EPA proposes to bind itself to a complex decision-making contraption, requiring EPA and the public to interpret and apply at least ten newly promulgated regulatory definitions, all as a predicate to allow EPA to give "greater consideration" to certain data.
Commenter (12431) expresses concern that in its desire to ensure that the data underlying its significant regulatory actions and influential scientific information are publicly available, the EPA may exclude information that is most relevant to its assessment of risks to human health and the environment. In particular, the commenter states that excluding information that cannot be made publicly available would slow the development and implementation of alternative test methods and strategies to replace animal testing. The commenter adds that expanding the scope of this rulemaking would obviously compound the issue of potentially excluding information relevant to EPA's regulatory actions and scientific information.
Commenter (11183) states that the supplemental notice extends its reach. The commenter notes that the EPA's Risk Assessment paradigm has 3 components: Hazard Identification, Dose Response Analysis and Exposure Assessment, that then feed into the final Risk Characterization. The commenter notes that the proposal highlighted only the dose response data for limitation; the supplemental notice expands it to include all the components of the Risk Assessment. The commenter contends that limiting the use of the best science, viz human exposure and health data, throughout the Risk Assessment will eviscerate the science. Similarly, the commenter states that the supplemental notice expands the application of this policy from only regulatory decisions to include other `influential scientific information', that is, all the business of EPA.
Commenter (12427) states that the combination of the proposed rule and supplemental notice will have the effect of restricting the use of rigorous scientific studies with the following features:
 Health studies with PII
 CBI
 Intellectual property
 Older studies for which the data and models may no longer be available.
 International studies (e.g., because privacy and confidentiality restrictions in other countries may not enable full disclosure of raw data)
Commenter (10055) specifically asserts that the proposed supplement would throttle the science that supports standard-setting for the future and for the renewal of current standards. The commenter adds that it would greatly reduce the number of high-quality studies that could support environmental policy and regulation because these studies rely on confidential medical data and cannot be made publicly available or even posted on a tiered-access program.
Commenter (12701) expresses concern that if this rule goes into effect, the EPA might disregard premier peer-reviewed studies when revising air quality or drinking water regulations because confidential health information from study participants cannot be verified. Ultimately, the commenter is concerned that if what they believe is an this overly broad rule goes into effect, future EPA information and regulations intended to protect public and environmental health will not be informed by the best science.
Commenter (11402) states that the proposal would undermine EPA's ability to use the best available science in its policy-making process and thus impede EPA's mission to protect human health and the environment. The commenter states that the proposed supplemental rule would significantly undermine the ability of the EPA to use the best available science in setting policies and regulations if implemented. The commenter adds that it would result in a significant reduction in science that could be used by EPA, risking direct harm to our citizens and their environment. Therefore, the commenter contends that the effect of the rule would be to weaken the scientific underpinnings of federal policy and that standards created and enforced by the EPA should be based on ALL of the best available published science, data, and models. The commenter states that peer-reviewed literature is considered to be the gold standard for high quality research and that the use of such peer-reviewed scientific studies and conclusions in policy deliberations should not be restricted to studies with publicly available underlying data.
Commenter (12715) states that the supplemental proposal would eliminate or de-emphasize consideration of relevant, peer-reviewed scientific studies where the underlying data cannot all be made public or cannot be made available via the proposed complicated tiered access system. In addition, the commenter notes that the proposal gives complete discretion to the EPA Administrator to decide what studies with non-public data are subject to the rule. The commenter contends that this would likely eliminate from consideration any research studies that, for valid reasons, do not have underlying data that can be made publicly available, including public health studies that form the basis of many critical nationwide protections.
Commenter (12715) states that applying the public availability requirement to all studies, regardless of when they were generated would severely restrict the body of scientific literature that could be considered as the basis for a "pivotal" science decision. According to this requirement, the commenter expresses concern that studies based on data that is not available or obtainable -- which is the case for most older studies, many of which are crucial to the scientific issues considered by EPA -- would no longer be used by EPA in its decision-making processes unless the Administrator used his or her discretion to grant an exemption under section 30.9. For example, the commenter notes that the EPA is required to review its NAAQS for criteria pollutants every five years and, if necessary, revise them to protect public health and the environment. See 42 U.S.C. § 7409(d). The commenter provides that the NAAQS review process builds on the administrative record from prior rulemakings, including historic studies that are part of that record. Under the supplemental proposal, the commenter states that the EPA could refuse to consider these studies and others because they rely on data pertaining to the personal medical histories of participants that cannot, by the studies' terms or by law, be divulged. The commenter contends that restricting the use of such studies would significantly undermine current and future NAAQS reviews and other rulemakings and would flout EPA's duty to use the best available science when protecting public health and the environment.
Additionally, commenter (12715) notes that given that the requirements set forth in the supplemental proposal might also be applied to historical studies considered by the Agency in any actions it takes going forward, many groundbreaking studies conducted in accordance with accepted scientific research principles could be either excluded from consideration or accorded less weight under EPA's tiered hierarchy for consideration. The commenter states that environmental research also may rely on CBI or data collected on private land that owners may not want made public. In short, the commenter asserts that the proposed rule will limit the scientific research that can be used to protect public health and the environment, which in turn will have a material adverse effect on State, local, and tribal communities
Commenter (12715) states that the supplemental proposal's requirement that underlying data be available in a manner sufficient for independent validation is technically unworkable. The commenter notes that the potential problems with this approach include that the actual feasibility of making data and models available in a manner sufficient for independent validation is unclear, as studies may be formatted in a manner that makes the data difficult to share, the lab that has generated the data may not be willing or able to collate and release the data, data from studies generated in other countries may be difficult to obtain, and some important conclusions are drawn from meta-analysis of numerous other studies. The commenter concludes that these issues would preclude potentially relevant studies from being considered or would give them less weight without a valid scientific reason for such a restriction.
Commenter (12415) states that helpful, representative tribal data will be more difficult to generate and make available to inform regulatory processes if the rule is adopted. The commenter states that the rule would dismantle decades of precedent and sound practice involving acceptable science, studies, and their use in assisting with regulatory development. The commenter states that thousands of rigorous, peer-reviewed studies and analyses rely on private, confidential patient data -- medical studies, personal health data, and clinical reports -- which by law cannot be made public.
Commenter (11921) states that their experience makes clear that the EPA should use the broadest possible range of science for making decisions on risk, causality, and other important policy. The commenter notes that, while reproduction of the results of single studies is sometimes helpful in such systematic reviews, limiting evidence synthesis and assessment to only studies that have accessible data would seriously circumscribe the Agency's decision making and the robustness of such decisions.
Commenter (11390) states that even as the EPA expands the proposed rule to capture nearly all science the Agency considers --  while still exempting without explanation Agency adjudications and enforcement activities  -- it presents among these revisions an "alternative" approach that would, if adopted, allow EPA to consider studies based on non-publicly available data under certain circumstances. In reality, the commenter contends that the revised proposed rule further hamstrings EPA's ability to use the best science when it regulates. The commenter asserts that the proposed rule is not only unnecessary and antithetical to the goal of achieving regulatory transparency but would also severely constrain EPA's ability to use the best quality science to make critical decisions. According to the commenter, eliminating the consideration of relevant science from the decision-making process based solely on the availability of underlying data would compromise the EPA's ability to effectively carry out its mission to protect public health and the environment.
Commenter (11192) notes that while the supplemental proposal resolves some of the ambiguities of the original proposal, it exploits the concept of transparency, and provides an avenue for unwarranted dismissal of high-quality science. As a result, the commenter contends that the supplemental proposal further clarifies that this proposed rule would undermine science-based decision-making at the EPA. The commenter adds that, from ethical, legal, financial, and logistical considerations, it is clear that compliance with this proposed rule is untenable for existing public health studies, and the rule could cause the EPA to disregard studies crucial for the protection of human health.
Commenter (11192) asserts that it is an ill-conceived move by the EPA to put current researchers in the position of either complying with privacy laws or allowing their research to have real-world impacts by informing regulations. The commenter states that the effect of this is readily apparent: it will dramatically shift the balance of the kinds of studies that will be utilized in Agency decision-making, reducing the proportion of public health studies and increasing the proportion of assay-based and computational modeling studies. According to the commenter, this is likely to make the link between regulations and health protections less clear, not more.
Commenter (13788) provides that the expansion of the rule to apply to influential scientific information could either arbitrarily erode the usefulness of its peer-reviewed influential scientific information and limit the Agency's ability to rely on influential scientific information in situation where it is required to use the best available science, or, if the Agency chooses to rely on the influential scientific information despite the exclusion of the best available science, potentially allow the Agency to circumvent statutory requirements. According to the commenter, neither of these outcomes is justified.
Commenter (11491) states that both options presented in the SNPRM, which allow for prohibiting, discouraging, or differentially weighing agency use of non-public data, are inconsistent with 2019 guidance from the OMB. The commenter states that an approach most consistent with the OMB guidance would be to continue to use the best available science regardless of underlying PII or CBI, and then explore the extent to which that science (possibly through tiering) could be made more accessible. The commenter states, in contrast, the EPA is proposing to give lesser or no consideration to science where data are confidential. The commenter states that, rather than maximizing access to data supporting influential science, the EPA's proposed approach would limit the science on which it can rely to make decisions, capriciously favoring not the most relevant or carefully designed studies, but those with public data.
Response: As more fully discussed in the preamble to the final rule, the EPA is concentrating its efforts in the final rule to increase transparency on dose-response data, as the dose-response data are discrete and the dose-response assessment is a well-defined and impactful step in the quantitative assessment of risk. Specifically, the scope of dose-response data in this final rule is those studies consisting of the data integral to characterizing dose-response relationships. In some instances, this group will consist of a handful of studies. In other instances, where there are multiple toxicity endpoints, there may be more studies that are crucial to characterizing dose-response relationships. In some other cases, there may be a large number of studies that are used to characterize a dose-response relationship (e.g., where the dose-response is based on a meta-regression of epidemiology studies). However, not all of these studies would be considered pivotal science. This final rule provides an important step in furthering the progress toward maximizing transparency and will provide insight for future statute-specific requirements.
In addition, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA will continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well substantiated evidence to support a relationship between exposure and effect, the EPA will identify those studies --  based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints -- that would inform a dose-response assessment for those effect endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements or quantitative analyses of an EPA significant regulatory action or influential scientific information will be identified as pivotal science. When evaluating those scientific studies considered to be 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. Because the final rule does not categorically exclude any studies, including public 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.
In addition, 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.
Moreover, although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may be instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. 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. Again, because the final rule does not categorically exclude any studies, including public 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. Because of these considerations and exemption criteria, the EPA disagrees that implementing this rule will reduce the proportion of public health studies or increase the proportion of assay-based and computational modeling studies. The EPA maintains that this rule is designed to build upon OMB guidance.
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.
The EPA disagrees with the commenter that the rule is unworkable. Specifically, the commenter specifically stated that there was a feasibility issue with making data and models available. As discussed in the preamble to the final rule, the scientific community has already embraced greater data transparency, as evidenced by data sharing and availability requirements for many high-impact journals and the emergence of organizations, such as the Center for Open Science, and international initiatives like FAIR data principles; FOSTER; and Guidelines for TOP in Journal Policies and Practices that incentivize greater transparency in research. Data sharing mechanisms, like those provided for in the rule, already exist and provide a way to allow a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. Further, 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 making the dose-response data available would conflict with laws and regulations governing privacy, confidentiality, CBI, or national security -- to 40 CFR 30.7 to make the rule more flexible. Again, because the final rule does not categorically exclude any studies, including public health studies, from EPA's consideration, the Agency will not be precluded 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 believes that the approach described in the final rule will result in significant regulatory actions and influential scientific information 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 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.
Comment: Commenter (9372) states that it would be foolish not to consider the best research in the field on pollution, nearly all of which uses restricted data on individuals. For example, the commenter notes that the growing literatures in economics, public health and epidemiology have documented the contemporaneous health (Anderson and Thundilyil, 2011; Ransom and Pope, 1995; Pope and Dockery, 1999; Friedman et al., 2001; Moretti and Neidell, 2011; Schlenker and Walker, 2015) and mortality-related impacts among infants and the elderly (Anderson, 2016; Deryugina et al, 2016) of pollution, as well as linked it to bronchitis (Beatty and Shimshack, 2011), diabetes (Bowe et al, 2018) and missing school (Currie et al, 2008). The commenter adds that a growing literature also documents how in utero exposure to pollution affects health outcomes at birth such as infant mortality (Currie and Neidell, 2005; Chay and Greenstone, 2003), birth weight (Currie, Davis, Greenstone, and Walker, 2015) and the development of congenital anomalies (Currie, Greenstone, and Moretti, 2011). See also Jayachandran (2009), Currie and Walker (2011), Knittel, Miller, and Sanders (2015), ArceoGomez, Hanna, and Oliva (2015), and Almond and Currie (2011). Additionally, the commenter provides that some recent research also investigates how pollution exposure during gestation affects later human capital outcomes (Almond, Edlund, and Palme, 2009; Bharadwaj, Gibson, Graff Zivin, and Neilson, 2017; Black, Bütikofer, Devereux, and Salvanes, 2013; Ferrie, Rolphe and Troeskin, Persico, Figlio and Roth, 2016; Rau et al., 2015; Sanders, 2012). For example, Persico and Venator (2020), who find that pollution from local industrial sites opening affect students' academic achievement and behavioral incidents in nearby schools, as well as school rankings showing that there are community-wide effects of environmental policies. The commenter also adds that a few studies also document how acute, short term exposure to air pollution on testing days affects test score performance and performance in high-skilled occupations (Archsmith, Heyes, and Saberian, 2017). For example, Marcotte (2017) uses the variation in air quality on different testing days and finds that children who take tests on days on worse days for pollen and fine airborne particulate matter have worse outcomes. Similarly, the commenter provides that Roth (2016) finds that pollution on testing days affects college students' performance in the United Kingdom, and Ebenstein and Roth (2014) find that pollution affects performance on high school exit exams in Israel. Hernstadt and Muehlegger (2015) find that crime is higher downwind of highways than on the opposite upwind side, implying that pollution might have cognitive effects. As Almond, Currie and Duque (2016) point out in their recent literature review, even mild health shocks in early life can lead to substantial long-term negative outcomes.
Response: The EPA agrees that the Agency should consider all relevant scientific information when developing significant regulatory actions and influential scientific information and has clarified this point in the preamble of the final rule. As described in the preamble to the final rule, the EPA will continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well substantiated evidence to support a relationship between exposure and effect, the EPA will identify those studies --  based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints -- that would inform a dose-response assessment for those effect endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements or quantitative analyses of an EPA significant regulatory action or influential scientific information will be identified as pivotal science. The EPA intends to issue implementation guidelines and statute-specific rulemakings to further clarify and describe how the EPA will identify pivotal science in its assessments and rulemakings. The specific criteria for determining "pivotal science" may necessarily be specific to the authorizing statute, as well as the significant regulatory action or the influential scientific information. The EPA intends to explain in each significant regulatory action and for influential scientific information how the pivotal studies were identified. Once studies considered to be pivotal science are identified, 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. 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 believes that the approach described in the final rule will result in significant regulatory actions and influential scientific information 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.
Comment: Commenter (10740) cites that Professor Steinzor and Professor Wendy E. Wagner have written cogently on how science is normally considered during the regulatory process, when agencies must evaluate the scientific evidence that informs a significant policy decision about health or environmental hazards. The commenter provides that they outline four sequential steps that are normally taken and note that an elaborate version of such steps is mandated by the CAA for EPA to use when setting NAAQS.
The commenter (10740) asserts that the proposed rule, instead, advances a process that Steinzor and Wagner have called "deconstruction" of the evidence. The commenter provides that deconstruction is accomplished through a myriad of techniques, including undermining the validity of studies for nonscientific reasons, encouraging the reconsideration of raw data using unreliable models, and adding research engineered to confound a finding of harm.
Response: The EPA disagrees with the commenter and finds that evaluating the availability of underlying dose-response data for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by subject matter experts. 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. Additionally, the EPA believes that the approach described in the final rule will result in significant regulatory actions and influential scientific information 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.
Comment: Commenter (12715) states that although EPA rightly recognizes that it may not be possible to make data and models publicly available for many older studies, focusing the exemption solely on models and data developed before the effective date of the rule ignores the fact that academic researchers and others whose research is relevant to EPA's work may not conduct and report their studies in a way that satisfies the rule's requirements, and may not have the resources to change their protocols simply to comply with the rule's requirements. Moreover, the commenter notes that academic researchers who are focused on publishing their studies in peer-reviewed journals and on obtaining grants and other funding sources for their research have little reason or incentive to even consider whether their studies would qualify for EPA's use under this rule. The commenter adds that members of the academic community may have conducted and published a particular study with grant money that is long gone, may have moved on to other projects or endeavors, and may have utilized research participants who can no longer be found. By contrast, the commenter states that industry-generated studies are almost always funded and conducted for the purpose of being submitted for consideration by EPA and the industry sector has a strong incentive, as well as sufficient resources, to provide whatever is required to address any modified or additional "data transparency" requirements imposed by EPA in this new rule. It is therefore unreasonable, according to the commenter, for the EPA to expect that data generated and models used in academic research will be available in ways that comply with the proposed rule simply because they were developed after its effective date.
Response: 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.
These considerations, the Administrator's exemption, and the EPA's incremental approach to maximizing transparency by first focusing on dose-response data are intended to minimize potential unintended consequences, such as that noted by the commenter. In addition, 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. The EPA believes 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.
Comment: Commenter (12718) states that the EPA elected to broaden the applicability of the proposed regulation through the supplemental proposal. The commenter notes that one effect could be that restrictions may be placed even on industry-produced scientific evidence required under the country's chemical and pesticides laws, which has long been viewed as credible and necessary by EPA officials during both Republican and Democratic administrations. For example, how the SNPRM requirements align with the FIFRA and the TSCA expectations remains unspecified in the SNPRM.
Response: 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.
Comment: Commenter (11495) states that, in at least two instances the D.C. Circuit Court of Appeals has recognized that studies for which the underlying data are not publicly available may constitute the "best available science." In American Trucking Associations, Inc. v. EPA, the commenter notes that the court held that the CAA did not require EPA to make underlying data public where EPA relied on the study itself and not the raw underlying data. The commenter provides that the court agreed with the EPA's argument that requiring the Agency to obtain and publicize the relevant data "would be impractical and unnecessary." In Coalition of Battery Recyclers Association v. EPA, the court again upheld EPA's reliance on non-publicly available data, reasoning that EPA relies on studies and their results rather than the raw data underlying those results.
Response: As described in the preamble to the final rule, the EPA will continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well substantiated evidence to support a relationship between exposure and effect, the EPA will identify those studies --  based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints -- that would inform a dose-response assessment for those effect endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements or quantitative analyses of an EPA significant regulatory action or influential scientific information will be identified as pivotal science. When evaluating those scientific studies considered to be 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. 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.
Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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 like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedures 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 dose-response data underlying pivotal science
Comment: Commenter (12720) expresses that the EPA commonly relies on studies conducted outside of the United States, including environmental epidemiology studies of air pollution and health in Canada. Such studies provide relevant information to EPA but are unlikely to meet stringent data requirements in the proposal. The proposal does not engage with this issue at all or identify any ways in which the significant reduction in research input from international community would affect EPA's science activities. The Proposal does not address these difficulties and should be withdrawn.
Commenter (12430) states that the supplemental proposal could potentially screen out "high-quality studies" developed by a mixture of academic, governmental, and private researchers over several decades and skew the scientific record in favor of newer industry-funded studies. The commenter contends that existing studies would be less likely to comply with the supplemental proposal, and unless the Administrator applies an ad hoc and discretionary exemption, would be discounted relative to newer studies created after the adoption of the supplemental proposal. The commenter provides that academic and government researchers generally prefer, and only receive funding, to focus on expanding scientific knowledge and do not have the resources to revisit established scientific conclusions. The commenter points out, however, that industry-funded groups, may have an incentive to invest in additional research to disprove those scientific conclusions. The commenter contends that the potential effect of the supplemental proposal's new and arbitrary criteria for assessing the relative value of scientific studies and information, would unscientifically skew the weight of the evidence toward industry research and interests.
Response: As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. 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. Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation.
Although the EPA is prioritizing transparency in pivotal science, the EPA also acknowledges and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. 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. 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.
The considerations in 40 CFR 30.5, the Administrator's exemption in 40 CFR 30.7, and the EPA's incremental approach to maximizing transparency by first focusing on dose-response data are intended to minimize potential unintended consequences, such as the potential skew toward newer, domestic, and/or industry-funded studies suggested by the commenters. In addition, 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. The EPA believes 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.
Comment: Commenter (11396) states that the Agency has not articulated whether and how it will keep track of studies that are excluded from regulatory decision-making. In the interest of scientific transparency, the commenter suggests that the Agency at least develop a protocol for documenting and disclosing the reasons specific studies are excluded.
Response: As described in the preamble to the final rule, the EPA intends for the final rule to be implemented in a transparent manner. 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. Additionally, the final rule requires the EPA to document the rationale for exemptions granted by the Administrator in the significant regulatory action or influential scientific information.
Comment: Commenter (11176) states that the category of "non-federally funded and non-EPA data" likely makes up the largest category informing EPA's many actions. The commenter states that it is also the category that poses the most challenges for making data available. The commenter states that such studies generally provide important scientific contributions and should not be discounted because their data are not readily available. The commenter states that, while such work will not necessarily be excluded through the proposed rule with the SNPRM, it is likely to be de-emphasized to the detriment of evidence-based policymaking at EPA.
Response: As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. 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 underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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 considerations in 40 CFR 30.5, the Administrator's exemption in 40 CFR 30.7, and the EPA's incremental approach to maximizing transparency by first focusing on dose-response data are intended to minimize potential unintended consequences, such as the potential for non-federally funded and non-EPA studies to be de-emphasized as suggested by the commenter. In addition, 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. The EPA believes 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.
<IP_ADDRESS>.1 Specific Studies That Would Not Comply with Rule
Comment: The commenter (12465) provides the example of the Westat Survey. The commenter notes that the report entitled "Household Solvent Products: A National Usage Survey" (or the Westat Survey) is a survey of consumer usage for a wide variety of products to determine various attributes and inform exposure assessments. According to the commenter, while the report was completed in 1987, it remains in use today informing the EPA's Consumer Exposure Model and the Westat Survey informed several of the first 10 chemicals currently being evaluated under reformed TSCA. The commenter states that it is unclear in the proposal how the Westat Survey would be treated, let alone the multitude of exposure models that rely upon it.
Further, the commenter (12465) states that it is unclear that the supplemental proposal has adequately considered the numerous types of data and models EPA relies upon to support its regulatory decisions. The commenter provides that the 1987 report "Household Solvent Products: A National Usage Survey" remains in use today informing the EPA's Consumer Exposure Model and several of the first 10 chemicals currently being evaluated under reformed TSCA. According to the commenter, the supplemental proposal is unclear how this information would be treated, let alone the exposure models that rely upon it. Additionally, the commenter notes that this study is likely worthy of being updated, however it is not clear that respondents would be afforded sufficient privacy protections to elicit responses.
Response: As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. 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 underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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.
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.
Comment: Commenter (11894) states that the EPA's NAAQS established under the CAA were the primary target of EPA's original proposal. The commenter adds that the EPA's new proposal would further increase that impact in at least two ways: First, as noted it would extend the bar on the use of undisclosed data from dose-response models to all models. That would affect the many other models - for example, economic models, energy use models, and atmospheric models - on which NAAQS analysis relies. Second, many of the documents prepared in the course of setting a NAAQS are themselves "influential scientific information" or rely on other studies that would or could qualify as "influential scientific information."
Commenter (11894) suggests that the application of the bar on the use of undisclosed studies to these documents would further increase the cost and complexity of establishing NAAQS and diminish the quality of the decision-making record. The commenter provides that this would be particularly clear in the case of the Regulatory Impact Analysis that is prepared for every NAAQS. By law, the commenter notes that these documents play no part in EPA's decision, so the original proposal would not have covered them. However, the commenter states that they would unquestionably qualify as "influential scientific information." According to the commenter, the EPA's proposal does not analyze any of these issues. The commenter adds that it is ironic then, that developments since EPA's original proposal have further underlined the complete lack of justification for anything like EPA's proposal where NAAQS establishment is concerned.
Response: The rulemaking is intended to codify internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. These requirements build upon open data initiatives in the federal government and scientific community and advance the EPA's mission and commitment to the public by prioritizing transparency of the underlying dose-response data in pivotal science for the most impactful of EPA's assessments and regulatory actions.
Comment: Commenter (11921) provides that EPA should recognize that expectations for data access for studies have evolved over time and in many cases older studies that did not and are unable to comply after a prolonged interval still have substantial scientific merit and value for informing regulations. According to the commenter, some studies, e.g. the National Institute for Occupational Safety and Health/National Cancer Institute Diesel Exposed Miners Study (DEMS), have made their data available through federal RDCs, however other critical studies, e.g. the North American Rubber Workers Study (Delzell, 2006), which has played and continues to play a key role in assessment of risk from 1,3-butadiene and styrene, was designed and implemented at a much earlier time and would not be readily available. The commenter states that this supplemental proposal would require a significant delay in the use of a study that has been vetted and peer-reviewed by a wide range of scientists (including  -  in both these cases - the most recent update subjected to HEI project oversight and intensive independent peer review).
Response: Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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.
Comment: Commenter (12715) states that while the initial proposal applied only to studies that provide the dose-response data for human health risk assessment, the supplemental proposal expands the types of studies to which the proposed rule would apply and now includes "data and models underlying pivotal regulatory science and pivotal science used to support significant regulatory decisions and influential scientific information." 85 Fed. Reg. at 15,400-01. The commenter provides that the expanded scope would thus include the data from many other types of studies such as environmental fate and transport, bioaccumulation, and ecological toxicity studies and will severely curtail EPA's ability to consider studies that provide the most relevant data in many types of regulatory and non-regulatory scientific decision-making. For example, the commenter notes that while risk assessment evaluations performed under the EPA's IRIS are not regulatory in nature, the toxicity factors provided by IRIS are used as the basis for many regulatory standards developed by the EPA and numerous states, as well as federal and state guidance values and cleanup decisions. In fact, the commenter notes that some states' regulations require that IRIS toxicity factors be used as the basis for human health standards for environmental contaminants. The commenter states that the supplemental proposal would significantly limit IRIS's consideration of and reliance on many key studies that are crucial for the assessment of human health effects and development of toxicity factors for environmental contaminants.
Commenter (12456) states that the systematic review process in place for IRIS and other review processes already includes consideration of the quality of a research study and methods. The commenter asserts that the best professional judgement of data quality should be left to subject matter experts and not assigned solely on the basis of data availability.
Commenter (11349) provides that the EPA and National Institute for Environmental Health Sciences' (NIEHS's) Children's Environmental Health and Disease Prevention Research Centers may certainly be excluded by this supplemental proposal and that the expansion increases the studies that can be excluded even further.
Response: Based on a consideration of these and other similar comments, the preamble to the final rule describes the EPA's rationale for modifying the applicability of the rule to focus on dose-response data and clarifies how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. Briefly, the EPA is concentrating its efforts in the final rule to increase transparency on dose-response data, as the dose-response data are discrete and the dose-response assessment is a well-defined and impactful step in the quantitative assessment of risk. This final rule provides an important step in furthering the progress toward maximizing transparency and will provide insight for future statute-specific requirements. In addition, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available or not available in a manner sufficient for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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.
Including this review of dose-response data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by independent third parties.
Comment: Commenter (11482) states that the inherently interdisciplinary and connected nature of the ocean means that more information, from more sources, is critical to gaining an understanding of ocean issues and being prepared to act from a regulatory perspective. The commenter notes that the proposed rule, which would limit rather than increase actionable knowledge, is likely to harm ocean and coastal ecosystems. Additionally, the commenter states that given the vast amounts of ocean data held by the U.S. Navy and shared with ocean researchers  --  but with important redactions and aggregation of data for reasons of national security  --  this rule could limit the information available to the EPA from such sources, despite that information being trustworthy and the findings vetted through extensive peer review. Similarly, the commenter provides that the EPA would be barred from relying on information from the National Oceanic and Atmospheric Administration that may not withstand these overly burdensome standards. For example, the commenter states that many environmental studies, including those intentionally conducted in the ocean and those that are the result of accidents like the Deepwater Horizon, simply can't (or shouldn't) be replicated in any meaningful way -- yet they provide key insights that should be taken into consideration by federal regulators. The commenter suggests that the rule may also hamper the use of climate models.
In short, the commenter (11482) contends that public health studies related to the ocean would suffer under this rule; this is particularly worrisome at a time when warming waters and deoxygenation are combining to exacerbate the problem of harmful algal blooms, with potentially negative, far reaching health consequences.
Response: In the final rule the terms replicate and reproduce (or other forms of the word) are no longer used. The EPA is clarifying that the intent of the term in the proposed regulatory text at 40 CFR 30.5 was "reanalyze" rather than "replicate." In the 2020 SNPRM, the EPA proposed using the term "reanalyze" instead of "replicate" and proposed at 40 CFR 30.2 a definition for "reanalyze." In addition, the EPA is modifying the definition of "independent validation" in the final rule by replacing "capable of being substantially reproduced" with "produced." The EPA will not finalize the proposed 40 CFR 30.2 definition of "capable of being substantially reproduced" because the term is not used in the final rule's definition of "independent validation" or elsewhere in 40 CFR 30.
Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. 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 underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the Agency also recognizes that there will be instances where the underlying dose-response data of pivotal science 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 making the dose-response data available would conflict with laws and regulations governing privacy, confidentiality, CBI, or national security (emphasis added). 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.
The considerations in 40 CFR 30.5, the Administrator's exemption in 40 CFR 30.7, and the EPA's incremental approach to maximizing transparency by first focusing on dose-response data are intended to minimize potential unintended consequences, such as the potential unintended impact on ocean studies suggested by the commenter. In addition, 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. The EPA believes 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.
Comment: Commenter (11392) notes that past products designated influential scientific information, such as chemical draft risk evaluations, ISAs, IRIS toxicological reviews, and a scientific assessment of the impact of climate change on human health, would be undermined by imposing arbitrary limitations on the scientific studies that can be considered in the drafting of these products.
Response: The EPA disagrees that scientific assessments would be undermined by this rule. The approach outlined in this rule 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. Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. 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 underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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.
EPA would also like to clarify that the final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on existing significant regulatory actions or influential scientific information. Past products will not be impacted.
Including this review of dose-response data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by independent third parties.
Comment: Commenter (11576) states that the inclusion of "influential scientific information" will impede Agency scientists from relying on the best available science while also compromising scientific integrity. The commenter notes that EPA's Peer Review Agenda describes different types of highly influential scientific assessments developed by the Agency. and includes a list of influential assessments, including the ISA for Ozone and Related Photochemical Oxidants (Office of Research and Development), the Peer Review of EPA's Biologically Based Dose-Response Model for Perchlorate (Office of Water), and the EPA's Draft Risk Evaluation for 1-Bromopropane (Office of Chemical Safety and Pollution Prevention), all of which rely on studies that may be arbitrarily excluded if the proposed rule is finalized.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods.
As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. 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 underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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.
Including this review of dose-response data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by independent third parties.
Comment: Commenter (11890) provides that the rule would impair EPA's science assessments by excluding or downgrading high quality studies of human health impacts of environmental chemicals or agents. The commenter asserts that this is at odds with EPA's mission and duty to use the best available science and that critical evaluation programs impacted by the inclusion of "influential science" include drinking water health advisories, IRIS assessments, FIFRA re-registrations, children's lead hazard evaluation, and TSCA risk evaluations.
Response: The EPA does not agree that this rulemaking is counter to the Agency's mission. 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. Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. 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 underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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.
In addition, as clarified in the preamble to the final rule, this rulemaking is not intended to modify the Agency's interpretations of "best available science." The EPA will continue to consider all peer-reviewed science, consistent with existing study quality assessment factors and corresponding statutory mandates. The EPA will then identify and consider pivotal science in accordance with the provisions of this rule, unless the implementation of the rule conflicts with statutory requirements and associated implementing regulations.
The EPA believes that the approach described in the final rule will result in significant regulatory actions and influential scientific information 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.
Comment: Commenter (11894) notes that EPA has issued about 170 separate documents to establish scientific guidance for water quality. According to the commenter, these do not have regulatory effect but provide background for regulatory decisions that set actual water quality standards. The commenter states that these criteria are, therefore, an essential part of the water quality standards program which is, in turn, an essential part of the CWA, and taken by themselves, they would clearly qualify as "influential scientific information." As such, the commenter contends they would often rely on studies and models that would not meet the new requirements. The commenter questions whether these would be "agency actions" exempt from the new requirements despite their lack of legal effect, and if not, what would be the impact of the new requirements on human and environmental health, program functioning, and resource needs? The commenter also considers EPA and the National Highway Traffic Safety Administration's Heavy Duty Rule's inclusion of hundreds to thousands of references, each with sub-references, all of which appear to be "influential scientific information". The commenter questions whether or not these references are or would be covered by the rule, why, what the effects on EPA's authority to control emissions of pollutants under CAA sections 202 (a)(1), (2) and (3) are or would be, and EPA's reasoning for these findings. Additionally, the commenter suggests EPA should analyze how references in various significant rules would be impacted by this proposal.
Response: As described in the preamble to the final rule, the requirements in the final rule set the overarching structure and principles for transparency in the EPA's 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 EPA administers.
In addition, the preamble discusses that the EPA is pursuing an incremental approach to maximizing transparency in the science that it relies upon to ensure that implementation is done in a thoughtful and deliberate way that focuses on the EPA's most impactful actions, minimizes unintended consequences, and informs future transparency requirements. The EPA is focusing on the underlying dose-response data for this rulemaking because of the influence these data have on particularly impactful decisions at the Agency. Risk assessments and regulations that target emissions and risk reduction of one or more pollutants, contaminants, or substances are integral to the Agency's mission and the underlying dose-response data that inform the quantitative value used to evaluate and mitigate potential risk are critical to understanding the assessment or regulatory action. In addition, the data underlying the dose-response assessment are more distinct than the broad range of data informing an entire risk assessment. Therefore, the EPA is concentrating its current efforts to increase transparency on a well-defined step in the quantitative assessment of risk supporting specific Agency actions. This final rule provides an important step in furthering the progress already being made toward maximizing transparency and will provide important insight for developing future statute-specific requirements.
The EPA is also finalizing regulatory text in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict.
Comment: Commenter (12464) states that many assessments, reviews, and reports of EPA cite thousands of scientific papers. According to the commenter, it is unclear how many of those papers would be subject to the proposal. Additionally, the commenter notes that because the supplemental proposal would systematically exclude studies that do not meet EPA's criteria for reanalysis and independent validation, critical studies that would otherwise inform influential scientific information would not be incorporated into key documents, such as the Integrated Scientific Assessment for Particulate Matter. The commenter asserts that many of the studies cited in the assessment are epidemiological papers analyzing the numbers of patient hospital visits or other sensitive medical information. As such, the commenter provides that these studies cannot be made publicly available due to laws and contracts designed to protect patient and human subject privacy. Thus, the commenter contends that the supplemental proposal's expansion in scope would in many instances prohibit EPA from relying on the best available science when assessing and determining highly influential scientific information, depriving regulators, researchers, and academics of a valuable and objective source of information.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how pivotal science would be selected. As discussed in the preamble to the final rule, rather than considering all studies that support the assessment of the relationship of a dose or exposure of a pollutant, contaminant, or substance to the magnitude of a predicted health or environmental impact as "pivotal science," the EPA is balancing transparency and feasibility by focusing on those studies that inform the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect. Thus, "pivotal science" includes only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. In the context of this rule, studies informing the dose-response modeling (e.g., benchmark response selection), studies identifying data for toxicokinetic adjustments, or studies informing the selection of uncertainty factors do not drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information.
The final rule also clarifies how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. 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 underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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. 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.
Comment: Commenter (11894) notes that, as detailed in Appendix B of their comment letter, the supplemental proposal would either bar a majority of the key long-term cohort studies in the 2018 PM ISA from consideration, or perhaps merely downgrade them (the proposal is to too opaque to allow any certainty as to its intended result) -- all without reference to the studies' methodological quality, consistency with prior studies, or any other individual consideration.
Commenter (12435) provides that the current ozone standard relies on "controlled human exposure studies conducted over many decades" (Ozone Standards ISA). The commenter notes that these studies were conducted with the informed consent of human participants and most studies were published more than ten years ago. While the underlying raw data may not be available, the commenter states that these studies have gone through peer review and the relevant information is now retained in the published journal articles. The commenter adds that the consistency of findings across decades contributes to the weight of evidence used to set this standard to be protective of public health. The commenter expresses concern that, in Colorado, 3.9 million people live within the ozone nonattainment area. Without this standard, the commenter states that Colorado would be hindered in its ability to regulate emissions that contribute to ozone and the health of many would suffer without going through incredible expense and time of setting standards under State law that should be done properly by EPA under the CAA. The commenter provides that epidemiology studies find that ozone concentrations "are associated with a range of respiratory effects, including asthma exacerbation, chronic obstructive pulmonary disease (COPD) exacerbation, respiratory infection, and hospital admissions and emergency department (ED) visits for combined respiratory diseases" (Ozone Standards ISA, page ES-8). The commenter states that Colorado's health agencies rely on policy based on the types of studies that could be dismissed under this proposal.
Commenter (12720) expresses that, under the Supplemental Proposal, the EPA would not be able to rely on the best available science for its ISAs of air pollution which inform the NAAQS-setting process, while industry-funded research calling into question the air pollution-health link, would not be subject to similar data release requirements, or even peer-review and independent reevaluation.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. 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 underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. 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. 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 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.