Response: The EPA clarifies that this final rule only applies to dose-response data. Rather than having this final rule apply to all the 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, the EPA is focusing on those studies that describe the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect. Specifically, the scope of dose-response data in this final rule is those studies consisting of the data integral to characterizing dose-response relationships. These dose-response studies that constitute pivotal science may be used to identify candidate PODs that are then employed in the benefit-cost analysis, but not all studies informing the benefit-cost calculation would be considered pivotal science. The EPA further clarifies that this rule will not place any burden on researchers, as this rule exclusively pertains to the internal practices of the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the federal government.
Support Application to Modeling Used to Develop TMDLs
Comment: Commenter (6180) supports application of the Proposed Rule to modeling used to develop total maximum daily loads (TMDLs).
Response: The EPA clarifies that this final rule only applies to dose-response data. Rather than having this final rule apply to all the 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, the EPA is focusing on those studies that describe the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect. Specifically, the scope of dose-response data in this final rule is those studies consisting of the data integral to characterizing dose-response relationships. These dose-response studies that constitute pivotal science may be used to identify candidate PODs that are then employed in TMDLs, but not all studies considered in the TMDL would be considered pivotal science. Further, the EPA notes that a future statute-specific rulemaking made under the CWA may interpret "pivotal science" more broadly.

<IP_ADDRESS>.3 Oppose Applicability to Other Data and Models
Comment: Commenters (0671, 6191, 6915), in addition to opposing the applicability of the Proposal to dose response data and models underlying pivotal regulatory science, oppose expanding the applicability of the rule requirements to other data and models used by EPA to support regulatory decisions.
Commenter (6191) states that if economic and environmental impact data and models used to support a rule are developed by EPA scientists, they would seem to be subject to the federal Open Data Policy requirements. In general, the commenter notes that economic and environmental impact data do not necessarily include data from individual humans and therefore do not pose the same challenges as for dose response data and models. The commenter, adds, however, there are issues with mandating sharing when: (1) the research was conducted without intent to inform a rule; (2) was conducted without a pre-existing mandate to share data; iii) was conducted a long time ago and accessing the data for the research is impossible. According to the commenter, there will always be reasons why not all data can be shared and a strict mandate for public access will needlessly remove important research from consideration.
Commenter (6915) notes that, in developing regulations EPA uses other types of models in addition to dose response models. The commenter explains that these include toxicokinetic models that predict a chemical's absorption, distribution, metabolism, and excretion, as well as fate and transport models that predict a chemical's movement in the environment and distribution to environmental media. The commenter asserts that the Proposed Rule's provisions that could decrease protectiveness of dose response analysis (e.g., requiring justification of default assumptions and precluding consideration of relevant studies due to data disclosure requirements) could similarly result in decreased protectiveness of these other types of models. The commenter contends that, in regulations based on dose response analysis combined with toxicokinetic and/or fate and transport analyses, the overall decrease in protectiveness would be magnified.
Response: The EPA has not expanded the applicability of this final rule, but rather has narrowed it to only dose-response data underlying pivotal science. As codified in 40 CFR 30.5 of the final rule, the EPA will rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well substantiated evidence to support a relationship between exposure and effect, the EPA will identify 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 acknowledges, and agrees with commenters, that there may be pivotal science for which 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. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
<IP_ADDRESS> Impact on EPA Decision-Making
<IP_ADDRESS>.1 Need for Improvement in the Use of Scientific Evidence in Support of Regulatory Decision Making
Comment: Commenter (0068) expresses that they believe there are aspects of the proposal that, when properly revised and qualified, would represent an improvement in the use of scientific evidence in support of regulatory decision making that relies on dose-response data and models.
Commenter (0068) specifically endorses the requirement that EPA:
      ...describe and document any assumptions and methods used and should describe variability and uncertainty. EPA shall evaluate the appropriateness of using default assumptions, including assumptions of a linear, no-threshold dose response, on a case-by-case basis. EPA shall clearly explain the scientific basis for each model assumption used and present analyses showing the sensitivity of the modeled results to alternative assumptions. When available, EPA shall give explicit consideration to high quality studies that explore: A broad class of parametric dose-response or concentration-response models; a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the dose or exposure range; and models that investigate factors that might account for spatial heterogeneity.
The commenter asserts, however, in requiring such discussion of assumptions, and parametric analysis, EPA should simultaneously make clear that its statutory responsibility is to protect public health, and hence in making decisions based on such evidence it will adopt the public health decision rule, "when in doubt, act to protect public health and wellbeing," as opposed to the classic decision rule used in scientific publishing, "place greatest emphasis on avoiding false positives."
Commenter (6855) suggests that the Agency modernize its entire conceptual framework for making regulatory decisions, including how the Agency manages its risk assessment methods, assumptions, models, uncertainty, and non-risk factors at the risk management stage.
Response: Consistent with the requirements in the 2018 proposed rule, this final rule requires the EPA to describe critical assumptions and methods used in dose-response assessments conducted by the Agency that drive the requirements, quantitative analyses, or both of a significant regulatory action or influential scientific information. The final rule also requires the EPA to characterize the variability and uncertainty of such dose-response assessments.
The EPA does not agree that the Agency should codify the suggested public health decision rule or changes to the conceptual risk-based framework for making regulatory decisions in this final rule, as these activities are outside of the scope of the current rule. The purpose of this final rule is to increase transparency by codifying internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. The EPA believes the approach described in the final 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.
<IP_ADDRESS>.2 Limit Amount of Quality Data for Use in Support of Regulatory Decision-making
General Comments on Impacts of Limiting Data in Support of Regulatory Decision-making
Comment: Commenters (0501, 0945, 1077, 1203, 1281, 1306, 1310, 1311, 1331, 1355, 1363, 1369, 1373, 1375, 1385, 1388, 1395, 1400, 1445, 1797, 1879, 1883, 1946, 2003, 2107, 2157, 2171, 2361, 2430, 2907, 4595, 5011, 5022, 5165, 5180, 6111, 6121, 6125, 6153, 6181, 6355, 6373, 6376, 6378, 6446, 6801, 6880, 6894, 6896, 6915, 6919, 8275, 8281-PH38, 9227) oppose the rule and contend that the proposed rule will limit the use of science and quality data that can be used in EPA decision making and is contrary to statutory mandates/federal law. Science and quality data and studies that they note that EPA would not be able to consider in regulatory decision-making included, but were not limited to epidemiological studies, data/studies that rely on CBI and personal health information, and studies where the underlying data was no longer available.
Commenters (0501, 0569, 0844, 0945, 1077, 1203, 1272, 1281, 1306, 1310, 1311, 1331, 1355, 1363, 1369, 1373, 1375, 1385, 1388, 1395, 1400, 1445, 1797, 1883, 1946, 2003, 2107, 2157, 2361, 2428, 2431, 2479, 2746, 2899, 4848, 5164, 5165, 5180, 6121, 6133, 6153, 6157, 6185, 6355, 6373, 6378, 6446, 6874, 6884, 6895, 6896, 6909, 6915, 6939, 6955, 8275, 8276, 8281-PH38, 9171, 9227) note that the limitation of EPA's ability to use science and quality data will adversely affect policies/regulatory decisions (including, but not limited to, studies used as a basis for programs like the NAAQS Program, studies that link elevated lead levels to adverse health effects, and research into neurotoxicants and endocrine disruptors associated with adverse reproductive health outcomes) and the mission of the Agency to protect the environment and human health.
Some specific comments regarding the proposed rule regarding the inability to use quality data/studies and the adverse impacts that would have on regulatory decision-making include:
 The rule could lead to ignoring critical evidence and could only lead to adverse consequences as it weakens decision making processes and delays important action. (1373)
 The proposed push for all studies used in government regulations to be made publicly available is not applied consistently, e.g. companies are not required to make publicly available all information and studies on pesticides. The commenter asserts that, the proposed regulation will cater to smaller, less relevant studies and will result in less evidence-based regulations to the detriment of all US citizens. (2107)
 The implementation of this rule, and censoring studies from use in EPA work because they could not be "independently validated" because of privacy issues could result in regulatory records supporting unreliable, pre-determined outcomes or decisions. (2171)
 Rather than increasing the transparency of decision-making, this proposed rule would disallow and thus hide non-publicly available studies, regardless of their scientific quality. (2361)
 Regulatory agencies are most effective when they have the entirety of the best scientific literature at their disposal for rulemaking to set new standards and policies. (2431)
 EPA's failure to consider individual health data -- because it cannot be made public -- would miss important data regarding particularly vulnerable populations that the NAAQS were developed to protect. (6446)
 The Proposed Rule would have an effect opposite to its claimed purpose; it would suppress important and relevant science conducted in large part by the best minds in academia and government, thereby unduly restricting the evidence available to EPA and potentially favoring data developed by industry. (5022)
 Along with the changes to the NAAQS review process outlined in EPA's May 9, 2018, "Back to Basics" memo and the recent requirement that members of the Clean Air Science Advisory Committee and related panel members not receive any current EPA funding, the Proposed Rule would constrain both the range of expertise and body of scientific literature that is available to be considered in these reviews, undermining the NAAQS. (6185)
 Limiting the ability of the EPA to the use of only those studies that can make their data public will drastically reduce the accuracy of rulemaking and will not allow a for a full accounting of costs and benefits. The commenter states that this will lead the EPA to be blind to much of the information needed and widely concurred as valid by the scientific community. (9171)
 Commenter opposes the proposed rule because it would require discarding valid studies that have passed rigorous peer review, even if published in top journals like Nature or Science, and even if confirmed by independent research. The commenter states that a decision to not regulate is also a decision, just like a decision to regulate. The commenter asks why can a decision to not regulate be made with no supporting studies, but a decision to regulate must be supported solely by unrestricted-distribution studies? (2899)
 Sound science is critical to policy decision-making and provides a process that explores how to best answer questions through a carefully structured approach. The commenter states that it cannot replace good decision-making, but science does enable us to make well-informed decisions and to predict the consequences and outcomes of our choices. (6157)
 The proposed rule would limit consideration of science in decision making in a manner that is unjustified and arbitrary, and would lead to inadequate regulatory protections, inconsistent with federal law. The commenter states that existing law and precedent dictates that the EPA take action based on the weight of scientific evidence even in the face of some uncertainty. The commenter states that this requires that the agency consider all available scientific evidence in its decision making and not make arbitrary exclusions of research. (8275)
 The purpose and effect of the proposal would be to degrade the quality of science in EPA's decision making. The commenter contends that there is no reason to think that excluding relevant science merely because the underlying data are not publicly available would increase the net benefits of a regulation. The commenter states that, for example, it appears that under the proposed rule EPA would exclude a peer-reviewed, published study whose conclusion had been reproduced based upon numerous different datasets (and whose underlying data, though not publicly available, had been reevaluated by outside experts), while including a study that had had no peer review, was not published, had no corroborating studies, and had not actually been replicated or reproduced, merely because the underlying data was made publicly available. The commenter states that this is simply not a recipe for more accurate decision making. (9227)
 Commenter does not agree with the agency's assertion that the best available science is that for which underlying datasets are fully open to public inspection. The commenter states that, if the EPA restricts the science it relies upon to only those studies that publish open datasets, the outcomes and data from key areas of scientific inquiry related to EPA's decision-making will be put beyond the reach of agency staff. (6181)
 Commenter urges EPA to withdraw the proposed rule as it limits EPA's ability to use the best available science, such as studies produced by leading research institutions to protect construction workers and the public in future rulemaking proceedings. (6896)
 The proposed rule would directly contradict the mandates of many Acts that require that the scientific review draw upon the best available science. (6378)
 The proposed rule would violate the agency's common sense and statutory duty to consider the sound scientific data. The commenter states that the proposed regulation turns the statutory scheme of Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) upside down by forcing the Agency to ignore data that EPA can use to prevent Love Canal type disasters in the future. (6801)
 The proposed rule would prohibit the continued and future use of studies by EPA thereby obstructing EPA's statutory duty to consider the "best," "reasonably" available information in its decision-making processes. The commenter states that the resulting information vacuum would occur for no other reason than that the underlying human subject data are private and cannot be publicly disseminated. (6111)
 The proposed rule would in many instances prohibit EPA from relying on the best available science relevant to many of the regulatory issues that the agency faces. The commenter adds that this proposed requirement contravenes five decades of EPA practice in which EPA has repeatedly affirmed that its mission requires it to rely on the best available scientific evidence, without ever asserting that it should exclude from consideration studies for which the underlying data were not publicly available. (6111)
 When considering the likely consequences of EPA's proposal to base its regulations solely on studies for which data are publicly available or for which exceptions are made, it is instructive to consider examples of research into neurotoxicants and endocrine disruptors, which are associated with adverse reproductive health outcomes. The commenter notes that the EPA efforts to reduce lead and methylmercury exposure for pregnant women and children might not have been so successful if the agency had used the overly stringent definition of transparency it now proposes. The commenter adds that programs that might not exist, or exist in less-effective forms, include those to reduce lead exposure from paint, gasoline, and drinking water; limit mercury emissions; and advise pregnant women to steer fish consumption away from species that often contain high levels of methylmercury. (6939)
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, a modified version of the 2018 proposed rulemaking regulatory text at 40 CFR 30.5. In the 2020 SNPRM, the EPA proposed Agency consideration of studies where there is tiered access to data and models that have CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects. For all other studies, data and models should be publicly available if the studies are to be used as pivotal regulatory science or pivotal science. In the 2020 SNPRM, the EPA also proposed an alternative. Under alternative proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency would, other things equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access when the data include CBI, proprietary data, or PII and appropriate techniques have been used to reduce the risk of re-identification.
Based on a consideration of public comments received in response to the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing internal procedural requirements for how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
As described in the preamble to the final rule, the transparency provisions of the final rule apply to dose-response data underlying pivotal science. Under this rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. In cases where dose-response data underlying pivotal science are not available in a manner sufficient for independent validation, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule under 40 CFR 30.7.
The EPA believes that this approach will allow the public to more effectively comment, engage, and hold the EPA accountable during the future development of specific significant regulatory actions and influential scientific information.
Limiting Consideration of Epidemiological Data/Studies in Support of Regulatory Decision-making
Comment: Commenters (0039, 0501, 1331, 1388, 1424, 2064, 2171, 2495, 4537, 4828, 5981, 6113, 6125, 6133, 6144, 6153, 6174, 6181, 6874, 6884, 6895, 6915, 6919, 6932, 6939, 8272, 8281-PH38, 9227) express concern that this regulation would dramatically limit the consideration of epidemiological research data in future EPA regulations because patients' data must be kept confidential. Specific comments include:
 Commenters (1375, 1395, 2171, 5165, 6111, 6373, 6915, 6919, 8281-PH38) express specific concern that the rule would bar, due to confidential data, EPA's consideration of relevant scientific literature in the establishment of regulations designed to protect human health and the environment, including the Six Cities Study and related studies (e.g., American Cancer Society Study (ACS). Specific comments include:
 From a risk assessment perspective, not including epidemiology studies in regulatory science is not sound or prudent. According to the commenter, laboratory, toxicology, and epidemiology are complementary and necessary pieces of understanding and quantifying effects of a pollutant on human health and that excluding evidence from one of these three essential disciplines threatens the science basis for regulatory decisions and actions. The commenter contends that the proposed rule would put regulators tasked with protecting human health in an impossible situation of relying primarily on animal models or in-vivo models that cannot be directly extrapolated to human dose response estimates. (2171)
 Most of the cost-benefit analyses for air regulations are based on Six Cities and ACS studies because they present the best epidemiological data available for use in such analyses. According to the commenter, if the EPA determines that it cannot use the Six Cities and ACS studies in future regulatory action, this would also prevent their use for the EPA's cost-benefit analyses. The commenter argues that exposure and epidemiology studies have been fundamental to the policy through which public health agencies protect public health. The commenter points out that the EPA's proposal states that, "[f]or regulatory programs, like the National Ambient Air Quality Standards program, in which future significant regulatory actions may be based on the administrative record from previous reviews  -  particularly where the governing statute requires repeated review on a fixed, date-certain cycle  -  the EPA seeks comment on the manner in which this proposed rule should apply to that previous record." According to the commenter, this request for comment suggests that previous regulatory actions, like those using the Six Cities and ACS studies, are in peril because they were properly conducted in accord with health privacy regulations to protect sensitive personal data from the health studies on which these regulations are based. (6919)
 Commenter (1395) estimates that EPA cites approximately 50,000 studies each year, many of which are based on analyses of confidential medical records. The commenter states that, if this rule is put into effect, these studies, including the Six Cities Study, would not be able to be used and the rule could be used as a basis to undo rules protecting public health.
 Commenter (1375) states that this proposed regulation is an attempt to exclude the most impactful and important public health studies in history. The commenter states that public health research requires the collection of personal data from study participants in order to understand their lifestyle and environmental exposures. The commenter states that this data must be extensive and detailed to capture the many possible variables impacting health outcomes, precisely so that the actual cause of the observed health impact can be assessed while accounting for confounding variables. The commenter states that the personal data are often so extensive that even if the participants were anonymized, it would still be possible to determine from the information collected who the actual participant was.
 Commenter (5165) asserts that EPA should publicly confirm that it would consider existing literature such as the Six Cities Study in future rulemakings, should the proposed rule be enacted. The commenter notes that EPA suggests in footnote 3 of the proposal that it would exclude such studies from consideration.
 Commenter (6111) states that, contrary to EPA's stated goal of improving the basis for its regulatory decisions, requiring the public availability of all raw data will instead undermine EPA's ability to make reasonable decisions. The commenter states that this requirement will effectively prohibit EPA from considering studies that by design are based on data that cannot be made publicly available due to laws and contracts designed to protect patient and human subject privacy and ensure willingness of people to participate in research by sharing their private information with researchers. The commenter states that the proposed rule precludes consideration of studies based on confidential data, even when those results have been confirmed by other studies.
 Commenters (6373, 6915) assert that, if EPA excludes relevant studies because the underlying data cannot be made public, the efficacy of EPA regulations themselves will be threatened. The commenters suggest that, if EPA had disregarded the Six Cities and ACS Cohort Studies based on the lack of publicly released data, air quality standards would not have been tightened; they might have been relaxed to allow increased levels of pollution because relevant and reliable scientific evidence would not have been before EPA. The commenters state that this could have had significant negative public health implications, including greater excess morbidity and mortality attributable to air pollution. Commenter (6915) states that EPA estimates that reductions in ambient particulate matter under the 1990 CAA Amendments will prevent 230,000 adult deaths by 2020.
 Commenter (9227) expresses concern that EPA's proposed regulation would preclude the Agency from using key studies to support the proposed rule regarding methylene chloride in paint and coating removers. The commenter asserts that the effect would be to severely jeopardize the finalization of this life-saving rule. The commenter notes that EPA has proposed a ban on the use of methylene chloride in paint and coating removers and that methylene chloride is associated with a number of hazardous health effects, including impaired visual and motor functions, respiratory irritation, headaches, nausea, and death. The commenter provides that the scientific basis for the proposed regulation is provided in the Agency's 2014 risk assessment. According to the commenter, the raw data underlying key studies used to derive the benchmark margin of exposure for chronic exposure and acute exposures to methylene chloride are not publicly available.
 Commenters (6153, 6874, 6939, 8272) state that programs that might not exist, or exist in less-effective forms, include those to limit mercury emissions; and advise pregnant women to steer fish consumption away from species that often contain high levels of methylmercury.15 Commenters state that EPA efforts to reduce methylmercury exposure for pregnant women and children might not have been so successful if the Agency had used the overly stringent definition of transparency it now proposes.
 The lead rules are based on risk analyses conducted by EPA using epidemiology studies published in the 1990s that correlate childhood blood lead levels with impaired brain function and adverse behavioral effects. The commenter states that many of the published studies are longitudinal cohort studies that include measurements of lead in blood from children decades ago, and then follow them out over time to observe lasting effects. The commenter notes that it makes it impossible to replicate the exposure conditions at the time the original children in the study cohort had their blood lead levels measured, such as the Port Pirie cohort study population living near a lead smelter in the 1980s. The commenter asserts that longitudinal cohort studies, particularly those that capture exposures that may no longer occur -- are not reproducible. (6133). Some specific regulations cited by commenters that have been developed as a result of lead studies include:
 Regulations governing lead in paint. (1424, 5981, 6125, 6144, 6153, 6174, 6874, 6939, 8272)
 Regulations governing lead in gasoline. (1424, 5981, 6153, 6874, 6895, 6939, 8272)
 Regulations governing lead in dust and/or soil. (6125, 6144, 6174)
 EPA's drinking water standards for lead. (4828, 6125, 6144, 6153, 6174, 6874, 6939, 8272)
 EPA's Lead and Copper Rule (LCR) of 1991. (6133)
 EPA's 2006-2008 lead air standards. (6125)
 Commenters (6125, 9227) express concern that, if the proposed rule were applied retroactively or if EPA re-evaluates the maximum contaminant level (MCL) for arsenic, the proposed rule would likely mean that EPA could not rely on two key studies because the data are four to five decades old and include confidential individual health information. According to the commenter (9227), the MCL finalized by EPA was based on the two epidemiological studies, both of which were peer reviewed, published in prestigious health and environmental journals, and have been cited numerous times by other researchers.
 Commenters (6133, 6932) specifically express concern that regulation of chlorpyrifos could be impacted by the proposed rule because the epidemiologic studies of chlorpyrifos can no longer be reproduced. Commenters (6153, 6874, 8272) state that agricultural workers, the majority of whom are Hispanic, bear the greatest burden of current chlorpyrifos exposure. Failing to take regulatory action to reduce these exposures because individual-level data sets from high-quality research are not publicly available would allow the persistence of environmental injustice. Commenter (6113) states that a striking example of the risks posed by the proposed regulation were highlighted when the Ninth Circuit USCA released its decision in League of United Latin American Citizens v. Wheeler. The commenter provides that, in that case, the Ninth Circuit ruled that EPA had to ban the use of chloropyrifos on food products because of the studies indicating harm to humans. According to the commenter, in the event the EPA's regulation were in effect, chloropyrifos could not be banned despite the pesticide's documented risks to the brains of children.
 Commenters (0039, 4537, 6133) states that the reassessment of the LNT model for radiation could profoundly impact many regulations and non-regulatory guidance from multiple entities, including the EPA, the Nuclear Regulatory Commission, and others. A list of regulations and non-regulatory guidance that would be impacted is provided by commenter 6133 in their comments. Commenter (6133) notes that the epidemiologic science and associated studies that are the basis of adherence to the LNT and decades of protective radiation standards are likely to be expressly excluded from consideration by EPA by the terms of this Proposal. The commenter adds that NAS and other studies that EPA has long relied upon in the radiation standards setting process are epidemiological human cohort studies. The commenter states that the EPA's Proposal, if implemented, would limit EPA staff from basing regulatory actions on precisely these types of studies by requiring that the underlying data of these studies be publicly shared. Data for some of the radiation epidemiological studies are accessible to users,with a detailed description of how a user can access the information. However, the commenter notes that public sharing of PII is restricted because the studies rely on confidential health data. The commenter contends that these studies are profoundly important studies that have been peer reviewed for decades and the science that has emerged from them has been validated multiple times. (6133)
 Commenters state that EPA announced that the Agency will begin the process of developing, under the SDWA, maximum contaminant levels (MCLs) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), in addition to designating these chemicals as "hazardous substances," possibly under the CERCLA. The commenters assert that EPA's proposed rule would limit EPA's ability to protect the public from the health hazards associated with PFOA and PFOS. (6111, 6137, 6144, 9227)
 Researchers conducted exposure and health epidemiological studies consisting of nearly 70,000 participants to examine the health impacts of exposure to these chemicals. (6137)
 Commenters provide that when EPA issued health advisories for these two chemicals in 2016, the Health Effects Support Documents relied extensively on epidemiological studies generated by the C8 Health Project. According to commenters, through this work, the researchers identified probable links between exposure to these chemicals and six specific diseases: diagnosed high cholesterol, ulcerative colitis, thyroid disease, testicular cancer, kidney cancer, and pregnancy-induced hypertension. (6111, 6137, 6144, 9227)
 Commenter provides that these studies looked at "demographic data, medical diagnoses (both self-report and medical records review), clinical laboratory testing, and determination of serum concentrations of 10 perfluorocarbons (PFCs)," information that is both sensitive and confidential. The commenter states that, although the results of these studies have been published in numerous articles in scientific journals, under EPA's Proposed Rule this research would be excluded from consideration despite the clear evidence of harm these chemicals pose. (6137)
 Commenter (6137) states that turning a blind eye to this data would have dramatic public health consequences, as it would preclude evaluation of valuable evidence of harm from exposure that could and should form the foundation of protections under the statutes EPA is charged with executing for the benefit of the public and the environment. Commenter (9227) states that, in failing to consider such crucial case studies, EPA would be ignoring best available science, thereby undermining its own attempt to protect Americans from emerging health threats such as PFOA and PFOS.
 Commenter states that pyrethroid pesticides are classified by EPA as a "likely human carcinogen," and are linked in published studies to Parkinson's Disease and adverse behavioral problems in prenatally exposed children., The commenter provides that EPA convened a FIFRA Scientific Advisory Panel in October 2017 to assess its use of a Physiologically Based Pharmacokinetic Model (PBPK) used in its risk assessment for the pyrethroid pesticides. The commenter notes that, despite the central role of the pyrethroid PBPK model in EPA's regulatory approval for pyrethroid pesticides, scientific peer reviewers on the FIFRA Scientific Advisory Panel were unable to obtain the raw data necessary to provide a robust peer review of the model. According to the commenter, at this point, the EPA Scientific Advisory Panel meeting is postponed indefinitely. The commenter states that the stated reason is "due to the unavailability of experts," but that they believe that the more likely reason is to bias the panel with the addition of industry experts, as EPA has done recently with its Scientific Advisory Boards. According to the commenter, a model that underestimates exposures and health risks will lead to regulations that fail to protect Americans from harmful exposures to pyrethroid pesticides.(6133)
 Commenter (2064) notes that the EPA is currently reviewing the registration of an herbicide called paraquat, which, through peer-reviewed and validated research, is strongly associated with an increased risk of Parkinson's disease. The commenter provides that much of the research relies on large, population-based studies, which is the type of research most impacted by this rule. The commenter states that, without the ability to consider this research, the EPA will miss vital information needed to protect public health, thus placing Americans at risk. The commenter contends that many of the most important studies involving environmental exposures and Parkinson's disease would be excluded from future determinations for one or more of the following reasons:
 The authors did not previously obtain the needed consents to release the data and would thus be subject to criminal penalty if they did so.
 The data cannot be deidentified appropriately while complying with federal privacy protection laws.
 The cost to deidentify would be very high and many research institutions do not have people on staff who can perform the work needed to do so.
 Commenter (0501) states that epidemiological and observational studies that involve personal data are essential for identifying the links between pollution and health effects. The commenter states that it is difficult to make these data public because researchers need to protect the privacy of study participants and their data. The commenter states that the fact that the data will not be made public does not diminish the quality of these studies. The commenter states that this rule will limit the amount of quality data that can be used by the Agency and will adversely affect the mission of the Agency to protect the environment and human health.
 Commenter (1331) states that the proposed regulation underestimates the usefulness of environmental epidemiology in highlighting the areas of the environment that need remediation due to their negative effects on public health. The commenter states that, by implementing the proposed regulation, public transparency of data from studies looking at the connections between these two integral components of public policy would be illegal and ethically wrong.
 Commenter (6884) states that epidemiological studies produce vital and valid scientific information that is necessary to determine impacts on humans of various types of occupational and environmental exposures. The commenter states that, without these studies, real world impacts on individuals and communities would not be captured, and important data that could affect hundreds and thousands of people would be lost.
 Commenter (6915) states that the provisions of the proposed rule would essentially prohibit the use of such epidemiology data in human health risk-based assessment despite their clear superiority over animal data for use in risk assessment. The commenter states that, in general, and specifically in EPA's 2005 Guidelines for Carcinogen Risk Assessment, human (i.e., epidemiology) data are preferred to animal data as the basis for risk assessment toxicity factors when they are of sufficient quality and are amenable to dose response modeling. The commenter states that this is because animal data always carry inherent uncertainties in regard to their relevance to humans. The commenter notes that epidemiology data collected over at least the last 40 years, however, have been generated under the auspices of IRBs working to protect the patient or participant information obtained by academic institutions, government entities, hospitals, and other organizations, and thus disclosure of that data would be difficult, if not impossible. The commenter states that these factors would all preclude EPA's or researchers' ability to provide raw, unpublished data for re-analysis as required under the proposed EPA rule.
 Commenter (6915) states that, for older epidemiology data, such as data from studies on occupational exposures to workers in factories before the advent of strict IRB requirements, raw data are seldom if ever still available. The commenter states that such data, including high quality data generated by major corporations in conjunction with academic institutions, would not be available to EPA under the proposed rule. The commenter states that, effectively, the proposed rule would restrict the epidemiology data available for use by EPA, even where the weight of the evidence clearly supports a finding of causality and risk.
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, a modified version of the 2018 proposed rulemaking regulatory text at 40 CFR 30.5. In the 2020 SNPRM, the EPA proposed Agency consideration of studies where there is tiered access to data and models that have CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects. For all other studies, data and models should be publicly available if the studies are to be used as pivotal regulatory science or pivotal science. In the 2020 SNPRM, the EPA also proposed an alternative. Under alternative proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency would, other things equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access when the data include CBI, proprietary data, or PII and appropriate techniques have been used to reduce the risk of re-identification.
Based on a consideration of public comments received in response to the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing internal procedural requirements for how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
As described in the preamble to the final rule, the transparency provisions of the final rule apply to dose-response data underlying pivotal science. Under this rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. In cases where dose-response data underlying pivotal science are not available in a manner sufficient for independent validation, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule under 40 CFR 30.7.
The EPA believes that this approach will allow the public to more effectively comment, engage, and hold the EPA accountable during the future development of specific significant regulatory actions and influential scientific information.
Limiting Consideration of Studies that Use Confidential Data (Personal and Business Confidential Data) and Studies Where Underlying Data is No Longer Available in Support of Regulatory Decision-making
Comment: Commenters (1281, 1306, 1445, 5011, 6111, 6181, 6378, 6895, 6909, 6915, 6919, 8281-PH38) express concern that, in developing future regulations to protect human health and the environment, EPA would be precluded from considering relevant information that has been validated through peer review, on the sole basis that the underlying data are not publicly available. Specific comments include:
 The proposed rule fails to recognize or acknowledge the existence of many studies already designed and published with terms that make complete transparency difficult or impossible because of IRB requirements and other important confidentiality protections. (6915)
 Commenters (1310, 1311, 6865) express concern that, in developing future regulations, EPA would be precluded from considering relevant studies on the sole basis that the underlying data are not publicly available. Commenter (1311) states that, given that much key research relies on confidential health data from study subjects, this proposal risks severely restricting the number and quality of studies available for use when making critical decisions. Commenter (6865) states that, discarding the opportunity to engage important studies based on their use of private data would be a costly mistake given their potential to save lives and advance scientific understanding in policy decisions.
 Commenter states that, by prohibiting the usage of information derived from anonymous sources, this largely excludes many useful scientific sources of knowledge. The commenter states that, in order to receive IRB approval to conduct work with human subjects, assuring the anonymity of participants is an essential step. The commenter states that guaranteeing anonymity of subjects is considered the top standard for conducting research with human subjects when investigating sensitive topics such as negative health outcomes. The commenter states that excluding studies because they are upholding scientific standards is a very unwise decision. (1310)
 Commenter expresses concern that, under the misleading veil of "transparency," the proposed rule could force investigators to invade the confidentiality of research participants and make confidential and private data open to all. (5113)
 Commenter states that requiring a study's underlying datasets be fully open to public inspection would drastically limit EPA's ability to use the most up-to-date, peer-reviewed science. The commenter states that this standard conflicts with privacy protections and the confidentiality of personally identifying information. The commenter states that it is not possible for a host of epidemiological studies and long-term health studies to open their datasets without publishing sensitive information that cannot, by law, be made public. The commenter states that the cost of sanitizing such data would be immense and would be borne by researchers who do not necessarily have the resources or institutional support to complete the process. (6181)
 Commenter provides two examples of important studies that would not be available to the EPA review if the proposed rule were put in place: Kaufman et al 2016, based on the MESA Air study, and Miller et al 2007, based on the Women's Health Initiative study. The commenter states that both studies rely on human subject data that is protected. (6378)
 Concerns about protecting privacy may deter researchers from providing studies to the EPA. The commenter states that researchers have a responsibility to assure the confidentiality of data they collect from human subjects. The commenter states that combining or merging datasets can increase risk to confidentiality by increasing the likelihood of identifying individuals. The commenter states that researchers may therefore be reluctant to submit their research to the EPA because producing the required data may violate informed consent provisions. (6877)
 The proposal would effectively prevent the EPA from using many kinds of scientific studies vital to its decision-making, including studies that rely on personal health data, CBI, intellectual property, or older studies where the authors or data sources may not be accessible. The commenter asserts that EPA's proposed rule would do nothing to improve transparency for scientists, policymakers or the public. The commenter provides that scientists do not review the raw data for studies since that would reveal little; rather the scientist reviews the research questions, methods, summarized data, results and conclusions in order to assess the quality of the work. (5011)
 The proposed rule precludes consideration of studies based on confidential data, even when those results have been confirmed by other studies. The commenter provides that, in the professional scientific and medical research community, "transparency" means clear and detailed disclosure of all methods, data, assumptions, and uncertainties. The commenter states that studies are considered "transparent" when the study design and methodology are clear enough to allow other scientists to challenge assumptions, test hypotheses, and either reproduce or replicate the study to determine whether the results obtained are consistent with the original study. According to the commenter, the concept of transparency promoted by the draft rule is harmful to good decision-making, to implementation of the statutes, and, most of all, to protection of public health and safety. (6111)
 The Proposal could cull the use of research that includes CBI or older studies that has data stored on older technology that can't be recovered. (8281-PH38)
 The Proposal would affect protections currently in place, such as limits on certain toxic air emissions from tail pipes and smoke stacks, and information on the health effects of many of these; where more than 150 chemicals come from older studies built on confidential patient or private business data that cannot be made public. (8281-PH38)
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, a modified version of the 2018 proposed rulemaking regulatory text at 40 CFR 30.5. In the 2020 SNPRM, the EPA proposed Agency consideration of studies where there is tiered access to data and models that have CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects. For all other studies, data and models should be publicly available if the studies are to be used as pivotal regulatory science or pivotal science. In the 2020 SNPRM, the EPA also proposed an alternative. Under alternative proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency would, other things equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access when the data include CBI, proprietary data, or PII and appropriate techniques have been used to reduce the risk of re-identification.
Based on a consideration of public comments received in response to the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing internal procedural requirements for how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
As described in the preamble to the final rule, the transparency provisions of the final rule apply to dose-response data underlying pivotal science. Under this rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. In cases where dose-response data underlying pivotal science are not available in a manner sufficient for independent validation, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule under 40 CFR 30.7.
Additionally, the final rule does not require the EPA or other parties to make dose-response data underlying pivotal science available (publicly or through restricted access) in a manner sufficient for independent validation.
The EPA believes that the final rule will allow the public to more effectively comment, engage, and hold the EPA accountable during the future development of significant regulatory actions and influential scientific information.
<IP_ADDRESS>.3 Skew Regulatory Decision-making Toward Studies That are Less Rigorous and Trustworthy/Transparent
Decision-making Will be Less Scientific and More Arbitrary
Comment: Commenters (0569, 1203, 1355, 1879, 4595, 6895, 6909, 6916) assert that the proposed rule will deprive EPA of great amounts of useful information and will make EPA decision making less scientific and more arbitrary, by just that measure. Specific comments include:
Commenters (0569, 1203, 4595, 6880, 6895) express concern that an incomplete pool of scientific evidence could skew regulatory decision-making toward studies that are less rigorous and trustworthy even if data were available. Commenter (1203) states that a broad-brush rule that eliminates a lot of evidence is a recipe for weak, poorly informed policy that may exaggerate some public health threats and minimize others.
Specific comments include:
 By limiting the science EPA can use in policies and regulations, EPA will constrain itself to smaller groups of studies and risk biased outcomes. The commenter states that, if the pool of research is smaller--which is what this proposed rule will lead to--that smaller pool utilized creates an inherent bias and thus the rulemaking process will yield distorted results. (4595)
 Should EPA adopt this rule, established knowledge that has been through the scientific validation process will be ignored. The commenter states that acting as though established knowledge does not exist will lead to flawed decisions and threaten environmental and public health. (6895)
 Not only would that render the future substantive rules unlawful under the Act's requirements, but it would also make them arbitrary and capricious, as "failure to consider the evidence proffered renders [a decision] arbitrary and capricious" and the Agency may not "hastily discount[]" relevant studies. The commenter asserts that the Agency seems unaware that its new policy, if finalized, could lead to future rulemaking actions that are unlawful, arbitrary and capricious. (6916)
 The new rule is not an attempt to make environmental regulations more transparent, it is a rule to limit research on the impacts of deadly pollution and give free reign to deregulate industries in the direct contradiction of science. The commenter states that not including research that includes confidential information translates into not including health science. (1355)
 The provision of the rule allowing EPA to arbitrarily bypass the requirement for studies that they like is completely anti-scientific at its heart. The commenter states that the whole rigor of the enterprise is based on taking all available information into account, independent of prior preferences or ideas. The commenter states that, if to the exclusion is added the ability to include without justification some studies that would otherwise be excluded, the danger of circular self-confirmation in views already held becomes extreme. (1879)
 The proposed rule's attempt to exclude perfectly reliable scientific studies from EPA's consideration is a thinly veiled attempt to allow the EPA to ignore sound science at its discretion if that science does not conform with the current Administration's political agenda. (6909)
 The proposed rule would freeze the science in procedures that may or may not make sense today but will certainly not be scientifically defensible in the future. The commenter states that issuing regulations on risk assessment methodology is a slippery slope that potentially subjects the process to at best, control by risk managers and attorneys, and at worst, politicization. (3135)
 Commenter expresses concern that the rule could replace evidence-based decision-making with arbitrary determinations based on political considerations. (5113)
 While the Proposal would eliminate many studies from EPA consideration due to confidential data, this limitation is not equally imposed by the EPA on industry and academia. The commenter states that industry-funded studies could keep their data secret by claiming it is "CBI." The commenter asks what is the EPA justification for this unequal treatment of corporate and academic research? (2907)
 While many commenters have pointed out the potential harm from chemical exposures that could result by excluding studies from consideration in rulemaking, the proposal could also unfairly skew rulemaking against use of chemicals that would not result in an expectation of unreasonable harm. The commenter states that a recent paper based on findings of the NIH Agricultural Health Study (https://aghealth.nih.gov/) showed no association between exposure to glyphosate and any cancer. The commenter states that, in deciding how and whether to regulate glyphosate (e.g., setting tolerances), EPA would have to ignore this real-world study, thus giving disproportionate weight to other studies (some lab-based as opposed to conducted under real-world conditions) that suggest glyphosate could cause cancer under some circumstances. The commenter states that this could result in an unfair burden on the regulated community in terms of stricter regulation or the discontinued use of products. (6880)
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, a modified version of the 2018 proposed rulemaking regulatory text at 40 CFR 30.5. In the 2020 SNPRM, the EPA proposed Agency consideration of studies where there is tiered access to data and models that have CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects. For all other studies, data and models should be publicly available if the studies are to be used as pivotal regulatory science or pivotal science. In the 2020 SNPRM, the EPA also proposed an alternative. Under alternative proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency would, other things equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access when the data include CBI, proprietary data, or PII and appropriate techniques have been used to reduce the risk of re-identification.
Based on a consideration of public comments received in response to the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing internal procedural requirements for how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
As described in the preamble to the final rule, the transparency provisions of the final rule apply to dose-response data underlying pivotal science. Under this rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. In cases where dose-response data underlying pivotal science are not available in a manner sufficient for independent validation, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule under 40 CFR 30.7.
The EPA believes that this approach will allow the public to more effectively comment, engage, and hold the EPA accountable during the future development of specific significant regulatory actions and influential scientific information.
Comment: Commenter (1798) asserts that GLP compliant studies are not transparent. The commenter suggests that, while industry's GLP test raw data may be available to regulators, the industry does not allow regulators/agencies or academic scientists to access any data beyond what they make available in the GLP study. The commenter states that, in contrast, toxicity studies by academics will usually allow 3rd parties that they trust to access all raw data. The commenter states that the instances of secret industry occupational studies are too numerous to deny. According to the commenter, EPA evaluators should have the flexibility to make case by case reliability & relevance decisions.
Response: As described in the preamble to the final rule, the transparency provisions of the final rule apply to dose-response data underlying pivotal science. In cases where dose-response data underlying pivotal science are not available in a manner sufficient for independent validation, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption, on a case-by-case basis, from the requirements of the final rule under 40 CFR 30.7.
Joint Statement by Editors
Comment: Commenters (1306, 1797, 1883, 6111, 9227) note that the editors in chief of the world's top scientific journals have notified EPA that "[i]t does not strengthen policies based on scientific evidence to limit the scientific evidence that can inform them; rather, it is paramount that the full suite of relevant science vetted through peer review, which includes ever more rigorous features, inform the landscape of decision making." The commenters state that the editors conclude that EPA's proposal to exclude relevant studies from EPA's consideration based solely on the fact that underlying data or methods cannot be made available to the public "will adversely affect decision-making processes." Specific comments include:
 The stringent criteria of data availability proposed by the EPA fail to enhance currently accepted standards for quality of evidence and transparency, and most certainly would exclude significant research from consideration in policy decisions. The commenter states that, while they believe in the ideal of data transparency, they also believe that where such transparency is not justifiably possible, peer-reviewed science should not be excluded from informing policy decisions. (1797)
 The proposed rule fails to take into account the fact that studies are reliable and constitute the best available science when they comply with professionally-established best practices for describing the methodology, sampling size, sampling procedure and assumptions utilized and the results are consistent with those of other studies. (6111)
 Publication in a peer-reviewed scientific journal is the way that scientists communicate their findings to other scientists and is considered the hallmark of scientific quality. (9227)
 In response to EPA's Proposal, the editors-in-chief of Science and Nature, and other leading scientists explained that though "[d]ata sharing is a feature that contributes to the robustness of published scientific results. . . in not every case can all data be fully shared." For example, full sharing is not possible when data sets include "personal identifiers." The commenter states that the editors confirm that even under circumstances where underlying data cannot be made generally available, it is possible to evaluate the merits of a study, explaining: "Importantly, the merits of studies relying on data that cannot be made publicly available can still be judged. Reviewers can have confidential access to key data and as a core skill, scientists are trained in assessing research publications by judging the articulation and logic of the research design, the clarity of the description of the methods used for data collection and analysis, and appropriate citation of previous results." (9227)
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, a modified version of the 2018 proposed rulemaking regulatory text at 40 CFR 30.5. In the 2020 SNPRM, the EPA proposed Agency consideration of studies where there is tiered access to data and models that have CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects. For all other studies, data and models should be publicly available if the studies are to be used as pivotal regulatory science or pivotal science. In the 2020 SNPRM, the EPA also proposed an alternative. Under alternative proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency would, other things equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access when the data include CBI, proprietary data, or PII and appropriate techniques have been used to reduce the risk of re-identification.
Based on a consideration of public comments received in response to the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing internal procedural requirements for how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
As described in the preamble to the final rule, the transparency provisions of the final rule apply to dose-response data underlying pivotal science. Under this rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. In cases where dose-response data underlying pivotal science are not available in a manner sufficient for independent validation, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule under 40 CFR 30.7.
The requirements included in the final rule provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations in order to ensure the EPA maintains a strong scientific basis for its decision-making. The incremental progress made possible by the final rule provides an important step towards prioritizing transparency in particularly impactful EPA rules and assessments.
PLOS Medicine Editorial
Comment: Commenters (2906, 6133) note that in an editorial in PLOS Medicine, Professor John Ioannidis states "[i]f the proposed rule is approved, science will be practically eliminated from all decision-making processes. Regulation would then depend uniquely on opinion and whim." Commenter (2906) asserts that EPA is a non-partisan organization that needs the best available research & minimal political interference in order to create regulations that balance safety with vigorous commercial growth. Commenter (6133) suggests that, instead of restricting the pool of available science by instituting an unworkable requirement for a broad category of scientific inquiry, EPA should focus on identifying weaknesses in the available evidence and targeting future investigations towards addressing specific deficiencies. The commenter adds that, assessing whether any particular study is reliable is not contingent on whether the underlying data can be made public, a fundamental point made clear in a report that EPA itself cited in the Proposal. The commenter includes the following additional quotes from the PLOS Medicine editorial:
      Ioannidis explains that "we should recognize that most of the raw data from past studies are not publicly available," and "[s]ome deficiencies may be unavoidable. For example, researchers cannot ethically randomize people to harmful exposures in order to tackle confounding, nor violate informed consent agreements that prohibit open sharing of private data from past studies." Ioannidis goes on to say that "simply ignoring science that has not yet attained such standards, is a nightmare," and "we would see governments discarding science at massive scale because of perceived imperfections and impurities." Ioannidis also notes that "we have extremely strong evidence that the tobacco pandemic is devastating; that the MMR vaccine is generally safe; that climate change is happening; and that air pollution is a major health hazard," in contrast to "most dietary advice one might hope to give about specific nutrients." The subjects that Ioannidis explains have strong evidence are the issues EPA is responsible for addressing that the Proposal seeks to discredit. Ioannidis further notes:
            For example, the pivotal research on the health effects of air pollution is particularly strong. The Six Cities and American Cancer Society studies are exemplary large-scale investigations, with careful application of methods, detailed scrutiny of measurements, replication of findings, and, importantly, detailed re-analysis of results and assessment of their robustness by entirely independent investigators. The re-analysis and sensitivity analyses were conducted by the Health Effects Institute that was funded by stakeholders some of whom may have desired to see opposite conclusions. It would be wonderful, if in the future the same rigorous re-analysis and replication standards could become the standard for all important areas of research that can inform policy.
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, a modified version of the 2018 proposed rulemaking regulatory text at 40 CFR 30.5. In the 2020 SNPRM, the EPA proposed Agency consideration of studies where there is tiered access to data and models that have CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects. For all other studies, data and models should be publicly available if the studies are to be used as pivotal regulatory science or pivotal science. In the 2020 SNPRM, the EPA also proposed an alternative. Under alternative proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency would, other things equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access when the data include CBI, proprietary data, or PII and appropriate techniques have been used to reduce the risk of re-identification.
Based on a consideration of public comments received in response to the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing internal procedural requirements for how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
As described in the preamble to the final rule, the transparency provisions of the final rule apply to dose-response data underlying pivotal science. Under this rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. In cases where dose-response data underlying pivotal science are not available in a manner sufficient for independent validation, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule under 40 CFR 30.7.
The requirements included in the final rule provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations in order to ensure the EPA maintains a strong scientific basis for its decision-making. The incremental progress made possible by the final rule provides an important step towards prioritizing transparency in particularly impactful EPA rules and assessments.
<IP_ADDRESS>.4 Impacts on Addressing New and Emerging Environmental and Public Health Concerns
Comment: Commenter (1363) states that limiting scientific studies that can be used in forming the EPA's regulations to only those in which all information is "publicly available" is unreasonable and will place unnecessary constraints on scientists and slow the speed in which studies can be conducted and findings presented. The commenter states that this hurts the agency's ability to consider and form regulations and policies quickly in response to the changing environment. The commenter states that, if testing cannot be done quick enough to prove new regulations must be put in place to protect environmental and individual health, then unwanted harm will come to the people and the planet. The commenter states that the government must ensure a fine balance between accountability and efficiency. The commenter contends that this proposed rule will ruin the current balance by placing an unwarranted emphasis on accountability, hurting the efficiency of scientists and EPA policy makers. The commenter states that, while Republicans are constantly calling for a smaller government with less interventions and paperwork, so that it functions more efficiently, this rule goes against these values and will only cause more problems and delays in the future policy-making process.
Response: The EPA disagrees that the requirements of the final rule will result in any meaningful delay in promulgating regulations. While the final rule requires the Agency to evaluate the availability of dose-response data for pivotal science, the incremental burden to the EPA to carry out these requirements is expected to be small given (1) the extensive scientific review the EPA already conducts regularly and (2) that the requirement is limited to pivotal science (i.e., typically a small, though highly important, subset of the studies the EPA would review).
Comment: Commenter (6111) states that the proposed rule would impede EPA's ability to address new and emerging public health risks in future rulemakings, including actions for two fluorochemicals, perfluorooctanoic acid ("PFOA") and perfluorooctane sulfonate ("PFOS")., The commenter states that, if finalized, the proposed rule would prevent these EPA actions. The commenter notes that when EPA issued health advisories for these two chemicals in 2016, the Health Effects Support Documents relied extensively on epidemiological studies generated by the C8 Health Project. The commenter states that a key component of the evidence for the harmfulness of these chemicals consists of epidemiological studies based on data that are not publicly available. The commenter states that researchers published more than three dozen papers based on these data, identifying probable links between PFOA exposure and "diagnosed high cholesterol, ulcerative colitis, thyroid disease, testicular cancer, kidney cancer, and pregnancy-induced hypertension." The commenter states that this situation underlines the arbitrariness and irrationality of the proposed rule: on the one hand, EPA is proposing to take regulatory action to protect the American people from emerging health threats and on the other -- through the proposed rule -- it is simultaneously undermining its own ability to follow through on those proposals.
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, a modified version of the 2018 proposed rulemaking regulatory text at 40 CFR 30.5. In the 2020 SNPRM, the EPA proposed Agency consideration of studies where there is tiered access to data and models that have CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects. For all other studies, data and models should be publicly available if the studies are to be used as pivotal regulatory science or pivotal science. In the 2020 SNPRM, the EPA also proposed an alternative. Under alternative proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency would, other things equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access when the data include CBI, proprietary data, or PII and appropriate techniques have been used to reduce the risk of re-identification.
Based on a consideration of public comments received in response to the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing internal procedural requirements for how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
As described in the preamble to the final rule, the transparency provisions of the final rule apply to dose-response data underlying pivotal science. Under this rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. In cases where dose-response data underlying pivotal science are not available in a manner sufficient for independent validation, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule under 40 CFR 30.7.
The EPA believes that this approach will allow the public to more effectively comment, engage, and hold the EPA accountable during the future development of specific significant regulatory actions and influential scientific information.
Comment: Commenter (6903) states that the data disclosure requirements in the Proposed Rule would make it impossible for the EPA to issue or update its rules and standards, preventing the EPA from fulfilling its statutory duties. The commenter states that EPA has an explicit mandate to protect the public's health from "known or anticipated" harm and must rely on science to establish the evidence or potential for harm. The commenter states that, by requiring that the EPA use only the science where data can be made publicly available, the Proposed Rule would create an undue burden on the Agency that would effectively prevent the Agency from passing new or updating existing standards and rules.
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, a modified version of the 2018 proposed rulemaking regulatory text at 40 CFR 30.5. In the 2020 SNPRM, the EPA proposed Agency consideration of studies where there is tiered access to data and models that have CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects. For all other studies, data and models should be publicly available if the studies are to be used as pivotal regulatory science or pivotal science. In the 2020 SNPRM, the EPA also proposed an alternative. Under alternative proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency would, other things equal, give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access when the data include CBI, proprietary data, or PII and appropriate techniques have been used to reduce the risk of re-identification.
Based on a consideration of public comments received in response to the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing internal procedural requirements for how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information.
As described in the preamble to the final rule, the transparency provisions of the final rule apply to dose-response data underlying pivotal science. Under this rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. In cases where dose-response data underlying pivotal science are not available in a manner sufficient for independent validation, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule under 40 CFR 30.7.
The EPA believes that this approach will allow the public to more effectively comment, engage, and hold the EPA accountable during the future development of specific significant regulatory actions and influential scientific information.
<IP_ADDRESS> Recommended Changes to and Clarifications of the Language in §30.5
<IP_ADDRESS>.1 Revise §30.5 to Require Documentation of "All Reasonable Efforts" of Making Data Available Before Concluding that it is Not Possible
Comment: Commenter (6143) requests that EPA make the following revision to the proposed text under §30.5 (underlined text reflects suggested text additions):
      The agency shall make and thoroughly document all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making such data available before it concludes that doing so in a manner consistent with law and protection of privacy, confidentiality, national and homeland security is not possible.
Response: The EPA is not finalizing the commenter's suggested language in 40 CFR 30.5. The EPA acknowledges that there may be pivotal science for which 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. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator. In instances where the EPA gives the pivotal science lesser consideration, the rule requires the Agency to document why lesser consideration was given per 40 CFR 30.5(c).
<IP_ADDRESS>.2 Revise §30.5 to Clarify How EPA Will Work with Third Parties to Make Data Available
Comment: Commenter (6125) states that the Proposal fails to explain how it is meant to function for third party-conducted studies (for example, the text of the Proposal says, "[w]here data is controlled by third parties, EPA shall work with those parties to endeavor to make the data available in a manner that complies with this section" and does not explain "how" (§30.5)).
Response: The EPA has removed this language from the final rule.
<IP_ADDRESS>.3 Supports EPA Granting Greater Weight to Studies, Data, and/or Models Where Underlying Data are Publicly Available
Comment: Commenter (6918) agrees that, as a general principle, where practicable, EPA should grant greater weight to studies, data, and/or models for which the underlying data are publicly available. The commenter states that the EPA's preference for these studies is another way for EPA to increase transparency and enhance the value of public participation without violating data access limitations, such as privacy or confidentiality. The commenter adds that such a preference also encourages third parties, when they design their studies or data-collection efforts, to make all reasonable efforts to ensure their data and models can be made public, perhaps in masked or anonymized form. The commenter suggests that incentivizing third parties to do so also demonstrates EPA's commitment to transparency, public participation, and validity.
Response: The EPA agrees with the commenter and in this final rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation.
<IP_ADDRESS>.4 Revise §30.5 to Clarify What Constitutes "Independent Validation"
Comment: Commenters (6126, 6137, 6185, 6447, 6906) provide that §30.5 of the Proposal states: "the Agency shall ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation," and that "independent validation" is defined as "information necessary for the public to understand, assess, and replicate findings." Commenter (6137) asserts that the EPA provides no indication what this means or how it will "ensure" or what EPA will do if it is not possible to ensure this. Similarly, commenter (6164) states that the term "validation" and is not defined and suggests that what EPA means be clarified.
Commenters (6126, 6185, 6447) state that the approach for "independent validation" is not described and that the definition for "independent validation" needs to be further clarified. Commenters (6185, 6447) assert that EPA already has procedures in place for allowing independent validation that work and it is unclear what additional measures EPA is now proposing. Commenter (6126) requests that the EPA be clear about the intent and the goal for addressing independent validation.
Commenters (6125, 6126, 6162) also state that the Proposal does not define "replicate." Commenter (6126) notes that the Proposal uses both the terms "replicate" and "reproduce" and that, in scientific practice, replication and reproducibility can be interpreted as different practices where one relies on the precise data used in an initial analysis and another relies on similar methods and data. Commenter (6125) asserts that, not defining "replicate" in the rule is yet another instance of a failure to provide adequate notice. The commenter states that, in context, EPA is using replicate not in the sense of conducting a new study to determine if the original conclusions also are supported by analyses of new data, but whether the results are "reproducible" by other analysts using the original data. According to the commenter, read literally, requiring studies be reproducible as well as `transparent' would exclude the use of the following:
 Studies of the effects of natural or human-induced disasters and interventions on health and the environment
 Studies of human exposures to historically high concentrations of environmental pollutants or to occupational exposures that could not ethically be reproduced.
Response: The EPA has defined "independent validation" in 40 CFR 30.2 as: "the reanalysis of study dose-response data by subject matter experts who have not contributed to the development of the study to evaluate whether results similar to those reported in the study are produced."
<IP_ADDRESS>.5 Revise §30.5 to Clarify Primary Data Record Needed for Independent Validation and Analysis
Comment: Commenter (5419) states that §30.5 specifies the type of information that would be made public to allow independent validation. The commenter expresses concern that for complete independent validation and analysis, as stated in the Proposal, the primary data record would be required. According to the commenter, notwithstanding privacy concerns, which is covered under other sections of the Proposal, public posting of such large quantities of data would be unwieldly. The commenter contends that the interpretation of the term "data" has critical implications and requests that the EPA clarify its intent.
Response: The EPA has clarified in this final rule that 40 CFR 30.5 only concerns the availability of dose-response data underlying pivotal science in significant regulatory actions or influential scientific information. 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.
<IP_ADDRESS>.6 Revise §30.5 to Clarify Circumstances Where a Study Can be Used When Underlying Data Cannot be Made Publicly-Available
Comment: Commenter (6362) states that §30.5 refers specifically to the requirements that apply when "EPA uses dose response data and models underlying "pivotal" (which the commenter believes is more aptly expressed as "material") regulatory science." The commenter interprets this to mean that in these specific circumstances, the dose response data and models must be "publicly available in a manner sufficient for independent validation," which EPA defines as in a manner "consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security." The commenter states that information is considered "publicly available in a manner sufficient for independent validation" when it includes the information "necessary for the public to understand, assess, and replicate findings." The commenter asserts that, for environmental safety, exposure-response is the more appropriate relationship to evaluate because most of the environmental test guidelines require quantifying concentrations in media external to the organism for use as the exposure metric. The commenter requests that the EPA provide greater clarity regarding what it intends to do in circumstances where raw data cannot be made publicly available.
Commenter (6918) supports enhanced transparency in EPA rulemakings but recognizes the vital importance of privacy, confidentiality or personal and business information, and national and homeland security as limits on data access. The commenter recommends that EPA more-clearly detail an objective and consistent process that would determine when release of data underlying pivotal studies would be deemed inappropriate because it would impair privacy, confidentiality, and/or national security. The commenter also recommends that EPA specify the conditions under which it could rely on studies for which the underlying data cannot appropriately be released.
Commenter (0562) states that not all confidential or proprietary information is needed for qualified reviewers to make their weight of evidence (WOE) calls on the merits of the science, the study, or model results.
Response: The EPA disagrees with the commenter that the EPA should consider the availability of exposure-response data. 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.
In this final rule, the EPA has described how it will consider studies for which the underlying data cannot appropriately be released. The EPA will evaluate if the dose-response data underlying pivotal science 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.
There may be pivotal science for which 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. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
<IP_ADDRESS>.7 Revise §30.5 to Clarify How a Determination Will be Made on Information Sufficiency for the Public to Understand, Assess and Replicate Findings
Comment: Commenter (6126) states that it is not clear from the language in §30.5 on how a determination will be made on the information, or how much and what kinds of information satisfy the requirement that researchers must provide enough information for "the public to understand, assess, and replicate findings." The commenter notes that the list of types of information that may be required based on the language of §30.5 suggests an intent to be flexible, but the language needs to be clarified.
Commenter (6125) states that proposed §30.5 is so awkwardly drafted that it is not clear if it is intended as an absolute requirement or is advisory. The commenter states that the language in footnote 3, and in §30.5 suggest that it is a requirement. The commenter states that other language does not, e.g, §30.5 (information can be used if it provides the information necessary to "replicate" findings).
Response: The types of information provided in 40 CFR 30.5(f), which are necessary for the public to understand, assess, and reanalyze findings, are provided as examples. The EPA intends to issue implementation guidelines and statute-specific rulemakings that will further describe the implementation of this rule. The EPA clarifies that the procedures codified in 40 CFR 30.5 of this final rule are requirements for the Agency.
<IP_ADDRESS>.8 Revise §30.5 to Add Requirement that Information be Sufficient for Verification/Change "Computer Codes" to "Computer Algorithms"
Comment: Commenter (6362) makes the following suggested edits to §30.5 (underlined text is the suggested new text and crossed-out text is the suggested deletion):
      Section 30.5 What requirements apply to use of dose response data and models?
      When promulgating significant regulatory actions, the Agency shall ensure that the dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation, verification, and analysis. This may include:
             Data (where necessary, could be subject to access and use restrictions)
             Associated protocols
             Computer algorithmscodes and models
             Recorded factual materials
             Detailed descriptions of how to access and use such information
      But in a manner consistent with law, protects privacy, confidentiality, CBI, and is sensitive to national and homeland security. Information is "publicly available in a manner sufficient for independent evaluation" when it includes the information necessary for the public to "understand, assess, and replicate findings."
Response: The EPA is unsure what the commenter's rationale is for suggesting this change. The EPA has altered the text at 40 CFR 30.5(f)(3) to read, "Computer codes and models involved in the creation and analysis of such information."
<IP_ADDRESS>.9 Revise §30.5 to Minimize Exception to the Rule
Comment: Commenter (6867) recommends that EPA minimize exceptions to the rule and accordingly make the following suggested changes to §30.5 of the rule (crossed out regulatory text reflects the commenter's suggested deletions):
      (a) EPA should amend the second sentence of §30.5 to provide that
      Where the Agency is making data or models publicly available, it shall do so in a fashion that is consistent with law, and protects privacy, confidentiality, confidential business information, is sensitive to national and homeland security.
      (b) EPA should amend the penultimate sentence of §30.5 to provide that
      The agency shall make all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making such data available before it concludes that doing so in a manner consistent with law and protection of privacy, confidentiality, national and homeland security is not possible.
Response: The EPA disagrees with the commenter and has not made this change in the final rule. The EPA is committed to upholding legal protections for privacy, confidentiality, and CBICBI. This is a rule of internal agency procedure and does not conflict with laws governing privacy, confidentiality, CBI, or national security interests.
<IP_ADDRESS>.10 Revise §30.5 to Provide for Disclosure of Dose Response Data and Models "When Available"
Comment: Commenter (6906) states that the EPA does not address how or if it can use studies where specified dose response data and models are not available. The commenter recommends that EPA amend the text of proposed §30.5 to provide for disclosure of dose response data and models "when available."
Response: The EPA is clarifying in this final rule that 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.
<IP_ADDRESS>.11 Clarify Provisions of §30.5 to Apply at an Interim Phase Prior to Issuance of the Final Rule
Comment: Commenter (6906) suggests that EPA amend §30.5 (disclosure of data and models) to require transparency steps at an interim phase prior to issuance of the final rule.
Response: The EPA agrees with the commenter and has altered the definition of "publicly available" at 40 CFR 30.2 to include "The public must be able to access the information on the date of publication of the proposed rule (or, as appropriate, a supplemental notice of proposed rulemaking, or notice of availability) for the significant regulatory action or on the date of dissemination of the draft influential scientific information for public review and comment."
<IP_ADDRESS> Recommended Changes to and Clarifications of the Language in §30.6
<IP_ADDRESS>.1 §30.6 Does Not Provide the Necessary Details to Assure Meaningful Public Review and Comment
Comment: Commenter (6137) states that §30.6 addresses the "additional requirements" related to the use of dose response data and models underlying "pivotal regulatory science," but it is devoid of details necessary to assure meaningful public review and comment on how, when, or in what way EPA will implement this. The commenter also states that §30.6 cites no specific science and gives no indication of how or why EPA is attempting to redefine scientific information on dose response differently than it has done in the past to allow for informed consideration of why EPA is even attempting to address this issue.
Response: The EPA has removed proposed 40 CFR 30.6, and has transferred some of the requirements of that section to 40 CFR 30.5 of the final rule. However, the EPA disagrees with the commenter that there is insufficient information to review and comment. The EPA is establishing additional requirements for how it considers pivotal science because these studies are the most critical to the Agency's significant regulatory actions and influential scientific information. The EPA finds that limiting the scope of these requirements to pivotal science will still provide meaningful and impactful opportunity for reanalysis. For example, Lewandowsky et al. (2020) evaluated the cost-effectiveness of reanalysis studies under various scenarios and concluded that reanalysis studies are most cost-effective when they are focused on studies of the greatest interest to the scientific community (in this study, the number of citations was a surrogate for interest).
<IP_ADDRESS>.2 Clarify Case-by-Case Default Assumption Evaluations Under §30.6
Comment: Commenter (2169) requests that EPA clarify how it will decide, on a case-by-case basis, what default assumptions, including assumption of a linear, no-threshold dose response, are appropriate. The commenter asks:
 What if the sensitivity of the modeled results to alternative assumptions is itself not subject to scientific consensus?
 Won't any regulated industry potentially subject to a proposed regulation be able to exaggerate the impacts of assumptions based on disputed sensitivity to effectively diminish in the public mind the cost/benefit ratio of a proposed regulation?
 Will such an industry-inspired public confusion be sufficient to establish the procedural inadequacy of a proposed regulation?
Response: The EPA has removed proposed 40 CFR 30.6, and placed some of the requirements in 40 CFR 30.5(e). Of the language quoted by the commenter, "including assumptions of a linear, no threshold dose-response" has been removed. Therefore, under 40 CFR 30.5 of this final rule, the EPA shall evaluate the appropriateness of using default assumptions on a case-by-case basis used in its dose-response assessment. Further, the EPA shall clearly explain the scientific basis for critical assumptions used in the dose-response assessment that the EPA relied on for the significant regulatory action or influential scientific information. The EPA disagrees that these requirements, imposed solely on EPA, will introduce increased bias or arbitrariness, as the commenter suggests. Rather, the EPA finds that openly providing the scientific rationale for its critical assumptions used in dose-response assessments will improve the assessment's objectivity and clarity to the public.
<IP_ADDRESS>.3 Oppose §30.6 Requirement to Evaluate Appropriateness of Using Default Assumptions
Comment: Commenter (6447) states that the proposed rule, contrary to the scientific community practice, would have EPA "evaluate the appropriateness of using default assumptions, including assumptions of a linear, no-threshold dose response, on a case-by-case basis." (Proposed §30.6) According to the commenter, requiring EPA to justify default models every time it undertakes a risk assessment or rulemaking will slow the regulatory process, and increase its cost, with no benefit and the appropriate way to deal with dose-response models is to evaluate deviations from the default model on a case-by-case basis. Commenter (6133) contends that this "case-by-case" provision injects additional arbitrariness into the rule, in that it ensures that the Proposal may be applied unevenly -- for certain rulemakings the "rules" of the Proposal can be discarded or ignored where desired.
Commenter (9227) provides that the National Academies' Science and Decisions document recommends that 1) "EPA should continue and expand use of the best, most current science to support or revise its default assumptions," 2) "work toward the development of explicitly stated defaults to take place of implicit or missing defaults," and 3) that "departure [from defaults] should occur only when the evidence of the plausibility of alternatives is clearly superior to the evidence of the value of the default." According to the commenter, these recommendations underscore and reaffirm the role of defaults, and make clear that deviations from defaults are to be considered carefully, on a case-by-case basis, and only when adequately justified. The commenter also provides that this deviates from EPA's Proposal's interest and intent to move away from "default models, without consideration of alternatives or model uncertainty" which purportedly "can obscure the scientific justification for EPA actions."
Commenter (6373) suggests that limiting researchers' ability to use modeling and assumptions as they deem appropriate will have human health consequences because scientists may be tempted to use models that EPA has deemed acceptable but that are not the best fit for their research needs.
Commenter (6446) suggests that requiring justification for all default assumptions ignores establishment of defaults through prior public processes and external public peer reviews. The commenter adds that requiring EPA to justify the use of default assumptions for every toxicity health factor derivation ignores the detailed development process of those default assumptions. The commenter states that those default assumptions were developed in several EPA documents (including the 2005 Guidelines for Carcinogen Risk Assessment), which received public comment and extensive external peer-review. Requiring EPA to rejustify those default assumptions every time they are used, as the proposed rule suggests, would serve no purpose other than to add unnecessary delay to risk assessments and regulatory action.
Response: The EPA has removed proposed 40 CFR 30.6, and placed some of the requirements in 40 CFR 30.5(e). The EPA has altered the language subject to these comments to read, "the EPA shall also describe critical assumptions and methods used in its dose-response assessment and shall characterize the variability and uncertainty of the assessment. The EPA shall evaluate the appropriateness of using default assumptions on a case-by-case basis. The EPA shall clearly explain the scientific basis for critical assumptions used in the dose-response assessment that the EPA relied on for the significant regulatory action or influential scientific information." The EPA agrees with the commenters that the EPA should not be required to describe all default assumptions and methods it uses, and thus has limited this requirement to "critical assumptions and methods."
In this final rule, the EPA is only required to describe critical assumptions and methods, and anticipates that the added time and cost of this practice to EPA will be small. The EPA agrees with the commenter that, "deviations from defaults are to be considered carefully, on a case-by-case basis, and only when adequately justified." This matches the requirements of 40 CFR 30.5(e).
The EPA disagrees with the commenter that this rule will prevent researchers from using modeling and assumptions. This final rule establishes procedural requirements for the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the federal government. Further, the requirements of 40 CFR 30.5(e) do not dissuade EPA scientists from using models or assumptions, but rather requires them to provide the scientific basis for critical assumptions (not all default assumptions, as proposed).
<IP_ADDRESS>.4. Requirement to "Describe and Document Any Assumptions and Methods Used"
Comment: Commenter (6447) states that proposed §30.6 would require the Agency to "describe and document any assumptions and methods used and should describe variability and uncertainty." The commenter asserts that this is already standard Agency practice, and EPA has not provided any evidence to suggest that its staff has ever failed to follow this practice.
Response: The EPA has removed proposed 40 CFR 30.6, and placed some of the requirements in 40 CFR 30.5(e). The EPA has altered the language subject to these comments to read, "the EPA shall also describe critical assumptions and methods used in its dose-response assessment and shall characterize the variability and uncertainty of the assessment. The EPA shall evaluate the appropriateness of using default assumptions on a case-by-case basis. The EPA shall clearly explain the scientific basis for critical assumptions used in the dose-response assessment that the EPA relied on for the significant regulatory action or influential scientific information." The EPA agrees with the commenter that this is standard Agency practice and has determined to codify it in regulation.
Comment: Commenter (6449) suggests changing the regulatory text of §30.6 to read that:
      In the main text of an analysis, EPA shall describe and document any assumptions and methods used, and should clearly present, in the main text, especially any procedure used for the first time in that type of evaluation (e.g., IRIS or TSCA) as well as presenting the results of using the standard procedure.
The commenter explains that deviations from standard procedures and guidance are expected, especially in cases where more than the usual amounts and types of data are available. According to the commenter, highlighting them, providing information on how the results differ from that which would result from "standard" procedures, and requesting specific review of such changes would save reviewers from each trying to discover and evaluate this information.
Response: The EPA does not understand the commenter's suggestion that the describing and documenting assumptions and methods must occur in the main text of an analysis and has not made these changes to the regulatory text. The EPA will fulfill the requirements of this final rule in a manner that is clear and accessible to the public.
Comment: Commenter (6906) requests that the EPA amend §30.6 to require EPA make available analysis of how it weighs and/or evaluates the conclusions drawn in a study based on criteria of "best available science."
Response: In addition to following this rule, the EPA will continue to follow its guidance and guidelines in assembling dose-response assessments. Consistent with existing Agency practice, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information. As discussed in the final rule, the EPA will continue to use the following, established factors to assess the quality of studies used to develop significant regulatory actions and influential scientific information: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review., When evaluating potential links between exposure to a pollutant, contaminant, or substance and effects and the nature of the dose-response relationship, the EPA will follow best practices and rely on the highest quality, most relevant studies in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Comment: Commenter (0068) suggests that, in addition to describing and documenting any assumptions and methods used, EPA simultaneously make clear that its statutory responsibility is to protect public health, and hence in making decisions based on such evidence it will adopt the public health decision rule, "when in doubt, act to protect public health and wellbeing," as opposed to the classic decision rule used in scientific publishing, "place greatest emphasis on avoiding false positives."
Response: In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers.
<IP_ADDRESS>.5 Revise §30.6 to Clarify that it Requires Documentation of Uncertainty and Variability
Comment: Commenter (6143) requests that the EPA clarify that §30.6 sets forth a mandatory duty and requires documentation of uncertainty and variability commensurate with its requirement for other "assumptions and methods used" as described in this proposed provision. The commenter recommends that EPA replace the proposed text "and should describe variability and uncertainty . . ." with "and shall describe and thoroughly document variability and uncertainty . . ."
Response: The EPA agrees with the commenter and has revised the language (now in 40 CFR 30.5(e)) to read, "the EPA shall also describe critical assumptions and methods used in its dose-response assessment and shall characterize the variability and uncertainty of the assessment."
<IP_ADDRESS>.6 Revise §30.6 to Require, as a Default, the Application of Causal Analytics
Comment: Commenter (6143) requests that EPA require, as a default, the application of causal analytics in studies that include, but are not limited to, dose-response or concentration-response models or data, and models that investigate factors that might account for spatial heterogeneity. The commenter recommends that EPA revise the first sentence of §30.6 to read as follows:
      EPA shall describe and document any assumptions and methods used. It should describe variability, uncertainty, and treatment of missing data, exposure estimation errors, covariate estimation and classification errors, omitted explanatory variables, model specification errors and biases, data selection biases, missing data, assumptions made to support causal interpretations of dose-response or exposure-response data (e.g., unit homogeneity, no hidden confounders, etc.), and results of any tests performed to validate these assumptions and to rule out non-causal interpretations and threats to internal and external validity of causal inferences.
Response: The EPA does not understand the commenter's rationale for suggesting these revisions and has not made these changes in the final rule.
<IP_ADDRESS>.7 EPA Should Also Consider High-Quality Studies that Address Collider Biases and Latent as Well as Observed Confounders and Colliders
Comment: Commenter (6143) suggests that EPA also consider high-quality studies that address: (a) collider biases (e.g., selection, stratification, and Berkson's bias), and (b) latent as well as observed confounders and colliders.
Response: The EPA has removed proposed 40 CFR 30.6, and has removed the requirement that the EPA give explicit consideration to high quality studies that explore[...]. Instead, in 40 CFR 30.5(d) in determining the amount of consideration to grant pivotal science for which the underlying dose-response data are not available, the EPA may consider the study's consideration of a broad range of parametric dose-response or concentration-response models, a robust set of potential confounding variables, nonparametric models that incorporate fewer assumptions, various threshold models across the dose or exposure range, and models that investigate factors that might account for spatial heterogeneity. The EPA does not understand the commenter's rationale for suggesting this revision and has not made the suggested changes to the final rule.
<IP_ADDRESS>.8 Requirement to "Explain the Basis for Each Model Assumption and Present Analyses Showing the Modeled Results to Alternative Assumptions"
Commenter: Commenter (6125) asserts that the most puzzling, and perhaps costly requirement in the rule appears in the wording of §30.6 of the Proposal:
      EPA shall clearly explain the scientific basis for each model assumption used and present analyses showing the sensitivity of the modeled results to alternative assumptions.
The commenter states that this language appears to require the Agency not only to explain the basis of each model-related assumption in the original study but also to provide an analysis of the original data using alternative assumptions. The commenter asserts that the EPA provides no reasons why this should be an automatic and invariable requirement for all studies identified as "pivotal."
Response: The EPA has eliminated the language cited, and has replaced it in 40 CFR 30.5(e) with: "The EPA shall clearly explain the scientific basis for critical assumptions used in the dose-response assessment that the EPA relied on for the significant regulatory action or influential scientific information." By limiting this to critical assumptions and removing the requirement for sensitivity analysis, the EPA has addressed the commenter's concern.
Comment: Commenter (6924) states that the proposal requires that "EPA shall clearly explain the scientific basis for each model assumption used and present analyses showing the sensitivity of the modeled results to alternative assumptions. When available, EPA shall give explicit consideration to high quality studies that explore: A broad class of parametric dose-response or concentration-response models; a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the dose or exposure range; and models that investigate factors that might account for spatial heterogeneity." The commenter asserts that these mandates inappropriately dictate how scientific studies should be conducted and are not supported by current science.
Response: The EPA has removed proposed 40 CFR 30.6, and has removed the language cited by the commenter. Instead, in 40 CFR 30.5(d) in determining the amount of consideration to grant pivotal science for which the underlying dose-response data are not available, the EPA may consider the study's consideration of a broad range of parametric dose-response or concentration-response models, a robust set of potential confounding variables, nonparametric models that incorporate fewer assumptions, various threshold models across the dose or exposure range, and models that investigate factors that might account for spatial heterogeneity. This requirement will not dictate how scientific studies should be conducted and therefore addresses the commenter's concern.
Comment: Commenter (6446) states that the requirement for sensitivity analysis for all alternative-modeling assumptions does not require an evaluation of the scientific validity of those models. The commenter adds that the proposed rule's requirement that dose-response modeling include a sensitivity analysis including all alternative modeling assumptions does not make any mention of how those assumptions would be scientifically justified. The commenter suggests that this lack of scientific justification criteria would invite the submission of models that would not have biological relevance for inclusion in the sensitivity analysis. According to the commenter, this would result in a process that would make EPA risk assessment documents unwieldy, unmanageable and unreliable.
Response: The EPA has removed the requirement for sensitivity analysis for all alternative-modeling assumptions in the final rule, and therefore has addressed the commenter's concern.
<IP_ADDRESS>.9 Use of Term "Uncertainty" in §30.6 of the Proposal is Vague
Comment: Commenter (6915) states that the proposed rule would require that EPA "describe and document any assumptions and methods used . . . and uncertainty." 83 Fed. Reg. at 18,774. However, the commenter notes that uncertainty is not defined in the proposed rule, and it is unclear what type of uncertainty is implied. The commenter provides that uncertainty could mean discussion of the magnitude of the statistically-based range of model predictions. The commenter adds that there could also be uncertainties unrelated to the model, such as qualitative uncertainty about the human relevance of the animal toxicity endpoint used as the basis for the risk assessment. According to the commenter, the EPA's failure to define the type of uncertainty at issue makes the proposed rule impermissibly vague and deprives the public of a meaningful opportunity to comment on its impacts.
Response: The EPA disagrees that the term "uncertainty" is vague or that there is significant ambiguity about what should be in the scope of a characterization of uncertainty. The characterization of uncertainty is a key factor in the assessments that the EPA conducts. It is a component of various EPA guidelines (e.g., Framework for Human Health Risk Assessment to Inform Decision Making) that the EPA relies upon in conducting its assessments. The scope of the uncertainty analyses that the EPA conducts necessarily varies across assessments and actions. The intent of this regulation is not to force uncertainty analyses into a one-size-fits-all approach, as that is not practical, good policy, or good science. Thus, a regulation governing internal procedures, such as this one, does not require a regulatory definition for a term that is already a key component of current EPA practices and guidelines and EPA's assessment process.
<IP_ADDRESS>.10 Recommend that EPA Quantify the Impact of Key Uncertainties Where Possible