Commenter (6126) suggests that EPA could consider severing the connection between the availability of information to support replication and the use of scientific evidence in policymaking activities. As EPA notes in the proposed rule, "EPA has not consistently followed previous EPA policy" about scientific integrity. The commenter concludes that instead of seeking culture change through a regulatory mechanism that intends to address availability and use concurrently, EPA could instead seek to better, more consistently implement the existing policy the rule critiques.
Response: The requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making. This framework provides direction that is consistent with Agency guidelines. For example, when evaluating potential links between exposure to a pollutant, contaminant, or substance and effects and the nature of the dose-response relationship, the EPA will follow best practices and rely on the highest quality, most relevant studies in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well-substantiated evidence (consistent with Agency guidelines on hazard identification and dose-response assessment) to support a relationship between exposure and effect, the EPA will identify a subset of those studies for use in characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect. This will be based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements, quantitative analyses, or both will be identified as pivotal science, and trigger the requirements of this rule outlined in 40 CFR 30.5. The incremental progress made possible by this rule provides an important step towards prioritizing transparency in particularly impactful EPA rules and assessments and will inform future statute-specific rulemakings.
18.6.2 Collaborate with Other Agencies/Departments
Comment: Commenter (1008) suggests that the EPA should continue to work in concert with other federal research funding agencies to carefully develop policies and procedures for providing access to research data, noting that the EPA's efforts and challenges in furthering transparency to research results are not unique to the agency; `going it alone' will not serve the EPA or its core mission.
Response: The EPA disagrees with the commenter that this rule requires the Agency to "go it alone," and notes that the transparency provisions in this final rule are intended to build upon existing federal government efforts and provide incremental progress toward the Agency's goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. For example, in 2002 the OMB released its Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, which includes discussion of the importance of the reproducibility of analyses underlying influential information. that "transparency is a core EPA value" and that increased availability of research data would accelerate scientific breakthroughs that support the Agency's mission and policymaking efforts. The EPA's Open Government Plan 5.0 also details the EPA's progress in implementing the tenets of the numerous data transparency initiatives in the federal government prior to 2018, including the OMB M-10-06, the Office of Science and Technology Policy Memorandum of February 22, 2013, and OMB M-13-13. In 2019, Congress passed the Foundations for Evidence-Based Policymaking Act of 2018 (or OPEN Government Data Act, Pub. L. 115-435) into law, which included requirements for federal agencies to prioritize making their data available to the public, and OMB has released additional guidance for implementing the Act.[.].
<IP_ADDRESS> Office of Science and Technology Policy
Comment: Commenter (6924) suggests that EPA should focus on implementing existing initiatives and guidelines for improving data sharing and transparency at federal agencies, including ensuring that EPA is in full compliance with the provisions of a 2013 memo from the Office of Science and Technology Policy that discusses policy principles and the development of federal agency plans to increase public access to federally funded research. The objectives were developed in consultation with the National Science and Technology Council and with input from the public. To increase public access to science funded and used by the government, EPA should ensure it is in full compliance with the provisions of this memo.
Response: EPA is in compliance with the OSTP memo directing federal research agencies to develop public access plan. The EPA's 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research noted that "transparency is a core EPA value" and that increased availability of research data would accelerate scientific breakthroughs that support the Agency's mission and policymaking efforts. While the EPA's Public Access Plan is distinct from this rulemaking, the EPA notes that the transparency provisions in this final rule are intended to build upon existing federal government efforts and provide incremental progress toward the Agency's goal of greater transparency.
<IP_ADDRESS> Department of Energy (DOE)
Comment: Commenter (6182) suggests that EPA try to emulate the best practices of DOE's "Process Rule" while avoiding the lessons learned. The commenter also recommends that common rules and procedures (perhaps coordinated by OMB) be established lest counter-productive conflicts and confusion arise in areas with overlapping jurisdictional interest. The commenter concludes that, in other words, agencies should try to coordinate Process Rule best practices through OMB.
Response: The EPA notes that it does not have authority to direct OMB to coordinate Process Rule best practices and these comments are outside the scope of this rulemaking.
The transparency provisions in this final rule are intended to build upon existing federal government efforts and provide incremental progress toward the Agency's goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. For example, in 2002 the OMB released its Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, which includes discussion of the importance of the reproducibility of analyses underlying influential information. The EPA's 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research noted that "transparency is a core EPA value" and that increased availability of research data would accelerate scientific breakthroughs that support the Agency's mission and policymaking efforts. The EPA's Open Government Plan 5.0 also details the EPA's progress in implementing the tenets of the numerous data transparency initiatives in the federal government prior to 2018, including OMB M-10-06, the Office of Science and Technology Policy Memorandum of February 22, 2013, and OMB M-13-13. In 2019, Congress passed the Foundations for Evidence-Based Policymaking Act of 2018 (or OPEN Government Data Act, Pub. L. 115-435) into law, which included requirements for federal agencies to prioritize making their data available to the public, and OMB has released additional guidance for implementing the act.[.]
<IP_ADDRESS> FDA
Comment: Commenter (5041) suggests that instead of requiring all scientific research used to make EPA policy, regulation, or guidance be based on publicly available datasets, EPA can easily adopt the long established and proven processes and procedures used by FDA. The commenter states that this ensures that privacy laws and concerns are met while having the most robust numbers of studies to ensure sound scientific policy/regulation/guidance making where the public may bear the cost or harm of said policy/regulation/guidance.
Response: The EPA disagrees with the commenter, as this final rule does not require all scientific research used to make EPA policy, regulation, or guidance be based on publicly available datasets. Instead, the purpose of this action is to increase transparency by codifying internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information.
<IP_ADDRESS> Department of Interior (DOI) Transparency and Reproducibility Standards
Comment: Commenter (6161) recommends that EPA combine implementation of transparency and reproducibility standards with re-organized Information Quality and Scientific Integrity (SI) functions modeled on the U.S. DOI example within the Office of the Science Advisor, perhaps to be called the Office of Regulatory Science. The commenter states that this is because information quality complaints submitted to EPA overwhelmingly address science-based issues (including data transparency and reproducibility) and provides the following background on the DOI decision to consolidate the functions of the two programs in a single office.
Response: The organizational changes recommended by the commenter are outside of the scope of this rulemaking.

 Chapter 19: Comparison of Approach to Hazard, Exposure and Risk Assessment Guidance
The proposed rule preamble (83 FR 18771) solicited comment on all aspects of the proposed regulation (specifically, the notice of proposed rulemaking (NPRM)) and the bases provided in the preamble. This section provides comments received on hazard, exposure and risk assessment guidance. In this section these comments are organized as follows:
       Science and Judgement in Risk Assessment
       Request for Inclusion of Discussion on How EPA Proposes to Address Exposure Assessments and Risk Characterization Data and Models in the Future
       Request Guidance on How to Use Human Data in Risk Assessments Under the Proposed Rule
       Industry Toxicology Study and Epidemiological Study Review and Acceptance Differ
       Public's Interest Best Served When Science is Replicable, Transparent and Explainable with Other Toxicology Information
The specific comments provided in this Chapter reflect the comment letters that provide arguments supported by detailed rationale, examples, and references/documentation. The Docket ID numbers for these commenters are cited throughout this Chapter. In addition, some general comment letters may also include comments related to comments included and responded to in this Chapter. These comments are summarized in Appendix B. Note that points and issues raised in these general comment letters may also be raised by the more detailed comments summarized in this Chapter. The responses provided in this Chapter adequately address these more general comments.
19.1 Science and Judgement in Risk Assessment
Comment: Commenter (6155) asserts that the Executive Summary in Science and Judgment in Risk Assessment summarizes essential aspects of identifying and communicating uncertainty when doing dose-response assessments through the risk assessment process:
 EPA should conduct formal uncertainty analyses, which can show where additional research might resolve major uncertainties and where it might not.
 EPA should consider in its risk assessments the limits of scientific knowledge, the remaining uncertainties, and the desire to identify errors of either overestimation or underestimation.
 EPA should develop guidelines for quantifying and communicating uncertainty (e.g., for models and data sets) as it occurs into each step of the risk-assessment process.
 Despite the advantages of developing consistent risk assessments between agencies by using common assumptions..., EPA should indicate other methods, if any, that might be more accurate.
 When ranking risks, EPA should consider uncertainties in each estimate, rather than ranking solely on the basis of point estimate value. Risk managers should not be given only a single number or range of numbers. Rather, they should be given risk characterizations that are as robust (i.e., complete and accurate) as can be feasibly developed.
 Communicating risk: [T]he process of assessing probabilities is difficult. Because substantial disagreement and misunderstanding concerning the reliability of single numbers or even a range of numbers can occur, the basis for the numbers should be set forth clearly and in detail.
 Risk assessment is a set of tools, not an end in itself. The limited resources available should be spent to generate information that helps risk managers to choose the best course of action among the available options.
The commenter adds that Science and Judgment in Risk Assessment also summarized the importance of recognizing uncertainty in the risk assessment process:
      The very heart of risk assessment is the responsibility to use whatever information is at hand or can be generated to produce a number, a range, a probability distribution -- whatever expresses the best present state of knowledge about the effects of some hazard in some specific setting. Simply to ignore the uncertainty in any process is almost sure to leave critical parts of the process incompletely examined, and hence to increase the probability of generating a risk estimate that is incorrect, incomplete, or misleading.
Response: The EPA agrees that identifying and communicating uncertainty is important for any scientific assessment, including dose-response assessments. Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. The final rule requires the EPA to describe critical assumptions and methods used in its dose-response assessment and characterize the variability and uncertainty of the assessment. The final rule also requires that the EPA evaluate the appropriateness of using default assumptions on a case-by-case basis and to 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.
19.2 Request for Inclusion of Discussion on How EPA Proposes to Address Exposure Assessments and Risk Characterization Data and Models in the Future
Comment: Commenter (6362) requests that EPA include a discussion in the final rule regarding how it proposes to address exposure assessments and risk characterization data and models in the future extensions of related rules on Transparency in Regulatory Science. The commenter provides specific rule language suggestions in a redline version of the proposed rule regulatory text included in Appendix A of their comment letter for EPA to consider
Response: Based on the comments on the 2018 proposed rule and the 2020 SNPRM and as described more fully in the preamble to the final rule, the EPA determined that the Agency should pursue an incremental approach to maximizing transparency in the science that it relies upon by focusing the final rule requirements on dose-response data and, in particular, only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). This rule does not apply to exposure assessments and risk characterization data and models, but future rulemakings may be more expansive as the EPA continues to make incremental progress toward maximizing transparency.
19.3 Request Guidance on How to Use Human Data in Risk Assessments Under the Proposed Rule
Comment: Commenter (6942) requests that EPA provide clarification and guidance for implementing the proposed regulation when human data are utilized for dose-response modeling and development of a chemical-specific cancer slope factor, reference dose, or reference concentration (e.g., risk assessments by the Integrated Risk Information System (IRIS)).
Response: As detailed in the preamble to the final rule, the EPA is finalizing an approach that gives greater consideration to pivotal science whose underlying dose-response data are publicly available or available through restricted access. The EPA would like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. Therefore, any guidance developed by the EPA for implementing the rule would be intended for use by EPA staff. The EPA also intends for the final rule to be implemented in a transparent manner and will identify pivotal science in proposed significant regulatory actions or external review drafts of influential scientific information, which will allow the public, if they so choose, to independently validate the pivotal science and provide comment to the EPA.
19.4 Industry Toxicology Study and Epidemiological Study Review and Acceptance Differ
Comment: Commenter (6862) asserts that there is a great discrepancy in the review of the toxicology studies that industry is required to submit in order to register their chemical products. According to the commenter, these studies follow strict protocol guidelines and are conducted under stringent good laboratory practices (GLP), quality assurance (QA) and animal ethics reviews as well as rigid reporting standards. These studies in the Office of Pesticide Programs (OPP) have multiple layers of primary and secondary review most often by contractors at a very significant expenditure of taxpayer funds and program resources. The commenter notes that studies are essentially transcribed into Data Evaluation Records (DERs) that have to state what was done and what the results were since the reviewers cannot misrepresent what the study reported. According to the commenter, the reviewers, however, can indicate study deficiencies and identify responses not already indicated by the report. The commenter states that the reviewers responsible for the reviews are clearly identified and responsible for their decisions.
In marked contrast, the commenter (6862) states that epidemiological studies appearing in the open literature (or otherwise) follow a mixed bag of study designs, GLP, QA, ethics and reporting practices. According to the commenter, these studies are most often accepted at their face value without evidence of a critical review or identification of the responsible individuals.
The commenter (6862) contends that this practice is unfair to the public and that studies used for risk assessment should have the same level of critical review no matter what their source is.
Response: The EPA agrees that data transparency is vital for individuals who have not contributed to the study to be able to verify the quality and strength of published studies and that the opportunity to independently validate the pivotal science that the EPA relies upon is important in furthering scientific understanding and the Agency's mission. As discussed in the preamble to the final rule, peer review does not typically include reanalysis of the underlying data (i.e., the proper stage of data where the data that are ready to be analyzed to extract relevant information) and, thus, peer review is not considered a replacement for the data availability requirements of this rule. Further, the EPA determined that it cannot solely rely on data availability statements made in published research because initiatives toward greater data sharing and transparency amongst scientific journals and international organizations are still being implemented, are inconsistently enforced, and the true accessibility of data in a public repository is still limited. Therefore, the rule requirements for the EPA's independent evaluation of the availability of data are necessary and critical to prioritizing data transparency in the pivotal science underlying its significant regulatory actions and influential scientific information.
19.5 Public's Interest Best Served When Science is Replicable, Transparent and Explainable with Other Toxicology Information
Comment: Commenter (6105) notes that the publication of a series of studies on a single human group from exposure to a commonly used insecticide shows an unexpected effect at extremely low exposures (apparently an outlier amongst the pattern of available data). The commenter states that this finding has not been replicated in other human studies and is in contrast to extensive animal and other limited human studies that all point to changes in a blood enzyme as sentinel, at much higher exposures. The commenter provides that, in this case, EPA scientists asked the authors of studies from this single human group for the underlying data in order to confirm the results at the lower exposure. According to the commenter, the authors refused the release of data citing confidentiality concerns. As a result of this refusal, the commenter states that the EPA was not able to conduct its own analysis of all the study data. According to the commenter, since EPA had neither confirmatory studies, nor consistent information that made sense in light of the multitude of available studies of the chemical, nor the ability to conduct its own analysis, it chose not to use the incompletely published information from this single human group.
In one sense, the commenter contends that McCarthy and McCabe (2018) are spot on: the judgment should be left to risk scientists over which epidemiology and/or toxicology data to use for risk or safety assessment purposes. The commenter notes that from our perspective as risk scientists, EPA's decision not to use studies with incomplete information is correct. The commenter adds that the public's interest is best served when science is replicable, transparent, and explainable with other toxicology information (both experimental animal and human). The commenter states that when studies cannot be replicated or when such studies are not consistent or explainable with other information, using such studies then depends on having access to the underlying data for independent analysis. When the underlying data are not provided to EPA scientists, especially those adept in the receipt and protection of confidential information, the commenter contends that it is difficult to use these studies with confidence to make a credible risk judgment for public health, much less national rulemaking.
In short, the commenter states that the public is often worried about chemical exposure, as they should be, when the chemical exposure exceeds a safety level. The commenter states that the public's interest is best served by trusting EPA's experts dedicated to public health protection and withholding scientific data from EPA's independent analysis is not in the public's best interest.
Response: The EPA agrees that scientific openness benefits both scientific and government processes. Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. Such independent reanalyses will subsequently enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or influential scientific information. Although this rulemaking is not intended to remedy a particular issue, it does provide important incremental progress toward the Agency's overarching goal of greater transparency. Implementation of this rule will more effectively share pivotal science for external consideration and increase the opportunity for the EPA or independent subject matter experts to validate pivotal science, and as data are better understood through independent reanalysis the Agency can make stronger, data-driven decisions and the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information.
The EPA would like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedures. The rule does not direct or require any outside entity or the EPA to establish data sharing mechanisms, nor does it require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science.
 Chapter 20: Chemical/Pollutant Specific Comments
As support for the proposal and need for transparency in regulatory science, several commenters provide chemical specific examples that they contend support the need for the proposal. These comments are organized as follows:
 Chlorpyrifos
 Formaldehyde
 Lead
 Particulate Matter
 Trichloroethylene
The specific comments provided in this Chapter reflect the comment letters that provide arguments supported by detailed rationale, examples, and references/documentation. The Docket ID numbers for these commenters are cited throughout this Chapter. In addition, some general comment letters may also include comments related to comments included and responded to in this Chapter. These comments are summarized in Appendix B. Note that points and issues raised in these general comment letters may also be raised by the more detailed comments summarized in this Chapter. The responses provided in this Chapter adequately address these more general comments.
20.1 Chlorpyrifos
Comment: Commenter (1974) supports the development of sound science standards in order to prevent what they believe to be "sham" science from affecting EPA rulings. As an example, the commenter cites EPA's proposal to ban chlorpyrifos. The commenter notes that due to a federal court order that EPA had not addressed the scientific bases for its action, the EPA's own science board found that the single study the Agency sought to rely on to justify a regulatory ban was "premature and possibly inappropriate."
Commenter (6137) states that pesticide manufacturers, such as Dow Chemical Company, have long opposed the use of epidemiological studies that collect human health data that must be kept confidential. For example, the commenter provides that they vigorously challenged EPA's proposal to revoke tolerances for chlorpyrifos, one of the country's most widely used pesticides, which in effect would have prohibited the use of chlorpyrifos on food crops. The commenter notes that the EPA had found that it could not conclude that exposure to this pesticide in food and drinking water was safe based on a risk assessment that included a safety factor mandated under the Food Quality Protection Act to protect the health of infants and children whose developing bodies are uniquely vulnerable to toxic pesticides. See 80 Fed. Reg. 69,079, 69,090 (Nov. 6, 2015); see also NAS, Pesticides in the Diets of Infants and Children (1993). The commenter adds that the EPA retained the safety factor over industry objections because epidemiologic studies indicate that prenatal exposure to chlorpyrifos can harm the developing nervous system. So the commenter states that industry attacked those studies, claiming they needed to see the underlying medical information, even though the studies  -  conducted by highly reputable institutions including Columbia University, University of California-Berkeley, and Mt. Sinai School of Medicine  -  were all published peer-reviewed articles in scientific journals. While the Columbia scientists who authored the study have allowed EPA scientists to analyze the data in a secure setting on Columbia's campus, the commenter notes that they have refused to make the raw data publicly available in order to protect the privacy of the mothers and children who participated in the research. Not satisfied, the commenter states that the pesticide industry is pressing EPA to exclude the study so that it can continue to sell a pesticide known to cause severe harm to children and EPA is playing along.
Response: The final rule is not intended to remedy a particular instance in which the EPA allegedly relied on a poor-quality study or a study for which the conclusions could not be independently validated. Rather, the transparency provisions of the final rule are intended to build upon existing federal government efforts and provide incremental progress toward the EPA's goal of greater transparency.
20.2 Formaldehyde
Comment: Commenters (6362, 6369) assert that the EPA's formaldehyde assessment is an example of the long-term problems where there is a lack of consistent, transparent application of modern scientific knowledge regarding chemical exposures and human health risk. Commenter (6362) asserts that, while knowledge regarding formaldehyde is much greater today, it does not appear that this new knowledge has been applied in the EPA's assessment of formaldehyde risk. The commenter notes that EPA continues to revise its assessment while not disclosing how emerging scientific evidence or modern risk assessment methods are being employed.
Response: The final rule is not intended to remedy a particular instance in which the EPA allegedly relied on a poor-quality study or a study for which the conclusions could not be independently validated. Rather, the transparency provisions of the final rule are intended to build upon existing federal government efforts and provide incremental progress toward the EPA's goal of greater transparency.
20.3 Lead
Comment: Commenter (6365) states that the experience of the lead national ambient air quality standards (NAAQS) rulemaking demonstrates the salutary purpose that transparency would serve in the regulatory process. The commenter states that, in that rule, EPA relied heavily on the Lanphear study in its analysis of the health effects of lead exposure. The commenter states that the underlying data for the Lanphear study was not available to EPA or to stakeholders for replication and validation at the time of publication and it took stakeholders years, including litigation under the FOIA, to obtain that data. The commenter states that, due to the lack of availability, there was no complete reanalysis of that data for nearly a decade and EPA relied on the study in both the 2008 and 2016 lead NAAQS reviews. The commenter states that the lack of available data has been noted in the scientific literature as preventing alternative statistical analyses to be performed, which is particularly important given that key confounding factors such as parental education, intelligence, birthweight, smoking, and race were not controlled in several of the Lanphear cohorts and may contribute to an overestimation of health effects. The commenter provides that, when the data underlying Lanphear was reanalyzed, numerous errors that were not discovered in the peer-review process and that were not previously known to EPA were uncovered and analyzed. The commenter notes that, although EPA ultimately determined that these errors did not materially affect the NAAQS review documents that relied on the Lanphear study, the Agency considered the errors and their potential impact on EPA's regulatory efforts to be sufficiently substantial so as to include a memorandum in the subsequent NAAQS rulemaking docket acknowledging those errors and considering their impact on the regulatory process.
Response: The final rule is not intended to remedy a particular instance in which the EPA allegedly relied on a poor-quality study or a study for which the conclusions could not be independently validated. Rather, the transparency provisions of the final rule are intended to build upon existing federal government efforts and provide incremental progress toward the EPA's goal of greater transparency.
20.4 Particulate Matter
Comment: In support of the EPA's proposal for strengthening transparency in regulatory science, some commenters (6124, 6945) assert that certain studies supporting NAAQS found no significant relationship between PM2.5 and total mortality. Commenter (6945) notes that their reanalysis and the extensive null evidence on PM2.5 deaths support the importance of the EPA's "Strengthening Transparency in Regulatory Science" rule, which would make possible independent reanalysis of the "pivotal regulatory science" used as the primary basis for EPA regulations.
Commenter (6124) states that the commenter's null CPS II findings basically agree with the null findings in the April 2016 EHP Thurston article, which analyzed the National Institutes of Health (NIH)-AARP Diet and Health Cohort and found no significant relationship between PM2.5 and total mortality during 2000-2009. The commenter states that, since Thurston obtained these deidentified data from NIH, he should make his analytic data set available for additional analyses. The commenter states that Science Advisory Board (SAB) should request the publicly available Medicare data that was used by Schwartz for his recent NEJM and JAMA articles on PM2.5 deaths.
Commenter (6124) states that, since repeated requests to Pope, ACS, HEI, and other CPS II investigators have been rejected, EPA formally should ask ACS to cooperate with transparent analyses of the CPS II data, such as, the analyses that the commenter has conducted and requested. The commenter states that, if ACS fully cooperates with EPA, then it might be useful to modify the EPA Transparency Rule to include a full cooperation option that does not require releasing actual data. The commenter states that, if ACS fails to cooperate with EPA and other legitimate investigators like myself, then their CPS II research results should not be used for EPA regulations.
Commenter (3134) opposes the PM2.5 regulations and asserts they are based upon secret studies. The commenter provides a brief analysis and contends that the regulations prevent a public exposure of PM2.5 equivalent to five cigarettes spread over 80 years. The commenter asserts there have been zero serious medical investigations on PM2.5 air pollution in the United States because such a study would require at a minimum:
 A biologically plausible toxicity mechanism -- how does the toxin cause death or disease, and reliable data on exposure.
 An appropriate endpoint, which could be death if it is determined to be premature (impossible to do with observational population studies).
 An adequate size association to get past the confounders in an observational population study.
Response: The final rule is not intended to remedy a particular instance in which the EPA allegedly relied on a poor-quality study or a study for which the conclusions could not be independently validated. Rather, the transparency provisions of the final rule are intended to build upon existing federal government efforts and provide incremental progress toward the EPA's goal of greater transparency.
Comment: Other commenters emphasize the strength of the data used to support the development of particulate matter NAAQS. Commenters (5178, 6153, 6874, 8272) state that EPA's 2011 policy assessment for review the particulate NAAQS noted that in addition to epidemiologic studies, toxicological and controlled human exposure studies identify potential biological pathways for cardiovascular and respiratory effects associated with particulate exposures was sufficient and that the proposed rule is unnecessary. According to commenters, there is also evidence accumulating on the effects of PM2.5 exposure on low birthweight and infant mortality.
Commenters (5178, 6125, 6153, 6446, 6874, 6939, 8272) add that some of the most recent research adds to knowledge on susceptible populations to air pollution as well, including the analysis of 2000-2012 data on 61 million Medicare beneficiaries and zip-code level information on PM2.5 and ozone pollution. The commenters state that they found increased mortality risks  --  including higher risks for black beneficiaries and those eligible for Medicaid, who are disproportionately women with low incomes  --  at pollutant levels below the current limits. Commenter (6446) notes that, because these studies rely on confidential information about each person in the cohort, the proposed rule would either require publishing data so thoroughly redacted as to be effectively useless for validation, or preclude EPA from considering these studies and others like them in the NAAQS standard-setting process.
Commenters (5178, 6153, 6874, 8272) state that Mingyu Zhang and colleagues analyzed local air pollution data as well as data from the Boston Birth Cohort, which began recruiting pregnant women in 1998 and followed their children for several years after birth. The commenters provide that the study found that the children of women who were exposed to the highest PM2.5 levels during their third trimesters had a greater risk of elevated blood pressure at ages three to nine. The commenters state that both studies involve data that can be obtained by investigators who apply to use it and are approved by the relevant institutional review board (IRB) or Privacy Board, but their data sets are not publicly available.
Response: The EPA clarified in the final rule how the Agency will evaluate scientific studies when promulgating significant regulatory actions and finalizing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions 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 personally identifiable information (PII), confidential business information (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 from the Administrator 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.
20.5 Trichloroethylene (TCE)
Comment: Commenter (1944) supports EPA's proposed rule and points to the use of the 2003 Johnson study in EPA's derivation of toxicological values for TCE as an example of why the rule is needed. The commenter asserts that, as noted in the proposed rule, both transparency and independent validation of key findings of a study (reproducibility) are necessary in EPA's scientific assessments to ensure "that the quality of published information meets the standards of the scientific and technical community." The commenter notes that, in 2011 EPA derived a reference concentration (RfC) and a reference dose RfD for TCE, based, in part, on a 2003 Johnson study. The commenter states that this assessment was subsequently adopted in the Toxic Substances Control Act (TSCA) Chemicals Work Plan Assessment for TCE. The commenter asserts that the Johnson et al. (2003) study should not be used to develop toxicological values that serve as the basis for regulation because the data records for Johnson et al. (2003) are inadequate or non-existent and Johnson et al. (2003) is not reproducible. The commenter provides detailed information regarding the TCE assessment, which is summarized below:
 Halogenated Solvents Industry Alliance (HSIA), the commenter, reports that attempts to see the raw data which formed the basis of the Johnson et al. (2003) study report have been unsuccessful. A direct appeal to Dr. Johnson failed to make the data available for public scrutiny. And a FOIA request pursuant to the Shelby Amendment was denied by the NIH.
 Information contained in Makris, et al. (2016) constitutes a transparency as well as a data quality concern sufficient to preclude Johnson et al. (2003) from being used as the basis for regulation. The transparency problem with Johnson et al. (2003) was pointed out by the peer review of the TSCA Chemicals Work Plan assessment for TCE.
 The data reported in Johnson et al. (2003), even as amended in two subsequent errata, do not allow for data analysis generally accepted as essential to interpreting outcomes of developmental toxicity study findings. The lack of data availability and clarity sufficient to construct key analyses associated with a key study should disqualify the use of that study in important decisions such as RfC/RfD derivations used for regulatory purposes.
 At least two Good Laboratory Practice (GLP)-compliant studies conducted under both EPA and Organization for Economic Coordination and Development (OECD) guidelines have been unable to reproduce the effect seen by Johnson et al. (2003). In one of these studies, Carney et al. (2006), all stages of the testing, from development of the protocol to the final report, underwent extensive peer review by scientists from three separate governmental agencies (ASTDR, EPA, and the National Toxicology Program), as well as external experts. In addition, the protocol and study report (which includes the raw data) are available to the public.
Response: The final rule is not intended to remedy a particular instance in which the EPA allegedly relied on a poor-quality study or a study for which the conclusions could not be independently validated. Rather, the transparency provisions of the final rule are intended to build upon existing federal government efforts and provide incremental progress toward the EPA's goal of greater transparency.
Comment: Commenters (4878, 9227) express concern that, under the proposal, EPA would exclude important studies regarding TCE exposure.
Commenter (4878) states that, to exclude evidence that TCE exposure is a risk factor for Parkinson's disease is illogical and does not serve the best health interests of the American public. According to the commenter, the original recommendation was based on hundreds of studies, many of which would not be considered under the proposed rule due to data confidentiality.
Commenter (9227) states that EPA has proposed two regulations regarding TCE and the scientific basis for these proposed regulations is provided in the Agency's 2014 risk assessment: TSCA Work Plan Chemical Risk Assessment, Trichloroethylene: Degreasing, Spot Cleaning and Arts & Crafts Uses which drew heavily from the 2011 EPA IRIS Toxicological Review of TCE. The commenter states that development of TCE's hazard and dose-response assessments considered the principles set forth by the various risk assessment guidelines issued by the National Research Council and the U.S. EPA. According to the commenter, EPA found the TCE IRIS assessment to be scientifically rigorous. The commenter provides that EPA made this determination without the data underlying the key, peer-reviewed studies used in the assessment being publicly available.
Response: The EPA clarified in the final rule how the Agency will evaluate scientific studies when promulgating significant regulatory actions and finalizing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions 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 from the Administrator 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.

 Chapter 21: Miscellaneous and Out of Scope Comments
In addition to the topic-specific comments included in Chapters 1 through 21 of this document, several miscellaneous and out of scope comments were received. Comments provided in this Chapter include several of those comments. These comments are organized as follows:
Section 21.1 Miscellaneous and Out of Scope Comments (NPRM)
       Miscellaneous Comments
       Out of Scope Comments
Section 21.2 Miscellaneous and Out of Scope Comments (SNPRM)
       Miscellaneous Comments
       Out of Scope Comments
The specific comments provided in this Chapter reflect the comment letters that provide arguments supported by detailed rationale, examples, and references/documentation. The Docket ID numbers for these commenters are cited throughout this Chapter. In addition, some general comment letters may also include comments related to comments included and responded to in this Chapter. These comments are summarized in Appendix B. Note that points and issues raised in these general comment letters may also be raised by the more detailed comments summarized in this Chapter. The responses provided in this Chapter adequately address these more general comments.
21.1 NPRM Miscellaneous Comments and Out of Scope Comments
Comments received that are ancillary to the Proposal, such as requests for comment period extensions/public hearings and comments that provide support for other commenters' comments; and comments received that are considered out of scope, are provided in this Chapter.
21.1.1 Miscellaneous Comments
<IP_ADDRESS> Requests for Comment Period Extension
Comment: Commenters express concern that the initial 30-day comment period was too short. Some commenters simply request additional time to comment beyond the 30-day period. Other commenters request comment period extensions to a total comment period of 60, 90, 120, or 180 days. Commenters are generally concerned that EPA is soliciting comments on many complex scientific and technical issues that require careful and in-depth analysis, but the 30-day comment period does not provide sufficient time for the broad range of stakeholders to prepare thoughtful, detailed responses. Additional reasons commenters seek an extension include the following concerns:
 EPA has provided no analysis of the potential impacts of its proposal.
 The mechanics of the proposed rule are not described, including cooperative agreements, technology platforms, and methods and technologies to protect confidential data  -  including identifiable and sensitive data such as individual health data.
 Implementation issues such as effective date, exemptions, retroactive applicability, impact on previous rulemaking records and studies are not addressed by the proposal.
Commenters (0557, 0564, 0598, 0570, 0573-0578, 0580-0583, 0585-0592, 0599, 0600, 0601, 0603, 0606, 0607, 0609-0613, 0616-0619, 0621, 0623-0626, 0628-0644, 0647, 0649-0654, 0657, 0658, 0661-0668, 0670, 0673-0678, 0681-0683, 0686, 0689, 0691, 0695-0702, 0704, 0706-0710, 0712, 0714-0716, 0778, 0780, 0781, 0786, 0788-0790, 0792-0794, 0796, 0798, 0800-0802, 0804, 0807, 0808-0811, 0993, 0995-1000, 1003, 1005, 1331, 1334, 1338, 1343, 1345, 1347, 1369, 1638, 1639-1642, 1779, 1797, 1942, 1948, 2006, 2048, 2067, 2485, 2561, 2737, 2739, 2983, 3053, 3074, 3079, 3081, 3100, 3115, 3229, 3273, 3276, 3279, 3282, 3283, 3292, 3300, 3302, 3323, 3341, 3346, 3350, 3353, 3355, 3356, 3358, 3364-3374, 3376-3381, 3564-3567, 3569, 3571, 3573, 3575, 3576, 3578, 3582-3586, 3589, 3590, 3592, 3594, 3599, 3600, 3608-3610, 3612, 3661-3668, 3675, 3679, 3682, 3685-3690, 3692-3697, 3834, 3972, 3974, 3976, 3977, 3979, 4120, 4124, 4394-4397, 4399, 4473, 4488, 4539, 4543-4545, 4770, 4867, 4868, 4875, 4980, 5129) request additional time to comment beyond the 30-day period.
Commenters (0042, 0058, 0546, 1340, 1380) request an additional 30-day extension. Commenter (0546) states that Executive Order 13563 recommends a comment period of at least 60 days to ensure adequate public participation in the regulatory process.
Commenters (0014, 0015, 0016, 0018, 0020, 0021, 0022, 0023, 0024, 0025, 0026, 0027, 0028, 0029, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0037, 0038, 0046, 0047, 0048, 0049, 0051, 0052, 0059, 0060, 0065, 0066, 0071, 0072, 0184, 0185, 0496, 0545, 0553, 0554, 0559, 0566, 0568, 0669, 1008, 1009, 1011, 1339, 1359, 1876, 2131, 3128, 3642, 3643, 4400) request an additional 60-day extension. Commenters (0026, 0051, 0545) assert that, while Executive Order 12866 indicates that a 60-day comment period is the minimum necessary to afford the public a meaningful opportunity to comment, in this proposal, where foundational and complex issues are at stake, a significantly longer comment period is appropriate.
Commenters (0565, 1948, 2014, 5009) request an additional 90-day extension.
Commenter (5009) is concerned that the proposal considers fundamental changes in policy that could affect many of EPA's rulemaking activities and about the vagueness and potentially detrimental consequences of the proposal for those activities. The commenter states that, given the extremely broad scope and impact of this proposal, the 30 days allowed for public comment in the advance notice is insufficient to give the affected public adequate opportunity to participate in the rulemaking and comment on the proposal as required by the Administrative Procedure Act. 5 U.S.C. § 553(c). The commenter states that, under section (2)(b) of Executive Order 13563, a standard comment period should be at least 60 days, but this tremendously consequential proposal calls for an even more deliberate pace given the profound potential impacts on the regulatory processes for many of the statutes EPA implements and enforces. The commenter states that a full four-month comment period would be consistent with past practice for matters of similar importance and complexity, and is necessary to provide the public and other stakeholders a meaningful opportunity to evaluate the proposal and its implications for the agency's ability to meet its obligation to protect public health and the environment under federal environmental laws.
Commenters (0057, 0063) request an additional 150-day extension.
Commenter (0063) suggests that, in developing this rule, EPA should use a process more like the one employed in 2006, when the Office of Management and Budget (OMB) under President George W. Bush asked the National Academy of Sciences (NAS) for peer review of its proposed bulletin on risk assessment and allowed six months for submission of public comments. The commenter states that a rule with such substantial implications for public health merits considerable time for input from the public and the scientific community.
Response: The EPA extended the public comment period for the 2018 proposed rule until August 16, 2018. This constituted a 108-day comment period.
<IP_ADDRESS> Requests for Public Hearing(s)
Comment: Commenters express concern that the proposal does not include a public hearing. Some commenters simply request the EPA to set at least one public hearing. Other commenters request multiple public hearings. Commenters are generally concerned that public input on this proposed rule, which could have significant consequences on the ability of EPA to adequately protect the public from the impacts of air pollution, unsafe chemicals, and other public health and environmental hazards, is of critical importance. Some commenters argue that the Clean Air Act (CAA) requires a public hearing for applicable rulemakings, and CAA rulemakings would be directly impacted by this proposal. Commenter (0046) states that among the CAA regulatory decisions subject to §307(d) that would be affected in this manner are the national ambient air quality standards (NAAQS) (§307 (d)(1)(A)), residual risk determinations for hazardous air pollutants (§307 (d) (1)(C)), standards for mobile source air toxics (§307 (d)(1)(K)), and residual risk standards for municipal solid waste combustors (§307 (d)(1)(D)).
Commenters (0020, 0023, 0025, 0026, 0031, 0033, 0034, 0037, 0038, 0046, 0051, 0059, 0557, 0598, 0568, 0570, 0574-0578, 0581-0583, 0585-0592, 0599, 0600, 0601, 0603, 0606, 0607, 0609-0613, 0616-0619, 0621, 0629-0626, 0628-0645, 0647, 0649-0654, 0656, 0657, 0658, 0661-0668, 0673-0678, 0681-0683, 0686, 0689, 0691, 0695-0702, 0704, 0706-0710, 0712, 0714-0716, 0778, 0780, 0781, 0782, 0786, 0788-0790, 0792-0794, 0796, 0798, 0800-0802, 0804, 0807, 0809-0811, 0993, 0995-1000, 1003, 1005, 1011, 2902, 2983, 3053, 3074, 3081, 3100, 3642) request a public hearing.
Commenters (0016, 0024, 0028, 0032, 0047, 0052, 0071, 0072, 2014, 3644) request multiple public hearings. Commenters (0014, 0022, 0030, 0035, 0048, 0060, 0554, 0566, 1009, 3128) request at least three public hearings. Commenters (0048, 0566) state that, because many scientists do not have experience with the rulemaking process and may not be prepared to submit written comments, EPA should supplement such comments with public hearings at locations across the country.
Commenters (3644, 6123, 8281-PH82) express concern about the inadequate opportunity for public engagement on the public hearing due to EPA's refusal to accommodate remote participation.
Commenter (3644) urges EPA to reverse its position and ensure that the public hearing provides an opportunity for testimony and other meaningful participation by all interested members of the public, including those unable to attend the hearing in person. The commenter states that EPA's refusal to allow for remote participation in the public hearing is inconsistent with the agency's recent practice. The commenter states that EPA's commitment to providing a verbatim transcript of the public hearing is an inadequate substitution for remote participation, for several reasons:
 Many people are more comfortable providing oral testimony than they are submitting written comments -- for example, because they are fluent in spoken but not written English.
 Although EPA has promised to provide a transcript, it has not committed to do so by any particular date. Unless EPA makes the transcript available several weeks before the proposed rule's comment deadline, those who submit written comments will lack the opportunity to respond to opposing viewpoints expressed at the hearing.
 Certain potential commenters who would otherwise fully participate in the public hearing, including some people with learning disabilities, may struggle to read, understand, or respond to a verbatim transcript.
Response: The EPA hosted a public hearing on the 2018 proposed rule on July 17, 2018.
<IP_ADDRESS> Support for Other Commenters' Comments
Comment: The following commenters (5179, 6112, 6115, 6369, 6907, 6908, 6911) express support for other comments:
Commenter (5179) supports the comments submitted to date on this proposed rule by the Association of American Medical Colleges, the Association of American Universities, the Association of Public and Land-Grant Universities (plus, the Council on Government Relations, by joint letter dated July 11, 2018; attached to their comment letter), and, separately, Public Responsibility in Medicine and Research (PRIM&R) (by letter dated August 1, 2018; attached to their comment letter).
Commenters (6112, 6115) support the National Stone, Sand & Gravel Association's (NSSGA) comments on the Proposal.
Commenter (6369) supports the separate comments submitted by the American Chemistry Council on the Proposal.
Commenter (6907) supports the comments provided to this docket by the American Association of Pesticide Safety Educators (AAPSE), the National Academies of Sciences, Engineering and Medicine, Physicians for Social Responsibility, the Association of State Wetland Managers, the Vice Chancellors of Research at the University of California, the Entomological Society of America (ESA), and the joint comment made by the Association of American Medical Colleges (AAMC), Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and Council on Governmental Relations (COGR).
Commenter (6908) incorporates by reference the comments submitted by CropLife America under Docket Number EPA-HQ-OA-2018-0259.
Commenter (6911) endorses the comments submitted by the NAAQS Implementation Coalition and the American Chemistry Council's Formaldehyde Panel.
Response: The EPA notes the commenters' support, and has addressed those comments elsewhere in this response document.
21.1.2 Out of Scope Comments
<IP_ADDRESS> Use of the LNT Models and Radiation Studies
<IP_ADDRESS>.1 Oppose/Support Use of the LNT Model for Radiation
Oppose Use of LNT Model for Radiation
Comment: Commenters (0039, 0050, 0062, 4357, 6148) are opposed to continued use of the linear no-threshold (LNT) model for radiation. Commenters (0039, 0050, 4537, 6148) state that the LNT is based on a flawed scientific study or non-scientific assumptions. Commenters (0050, 0062) state that the LNT model is inappropriate for setting radiation protection rules and guidelines because low doses of radiation have been shown to be beneficial yet are not considered by the LNT model.
Commenters (0039, 4537) state that the prominence of the LNT model stems from the June 29, 1956, Science paper "Genetic Effects of Atomic Radiation" authored by the NAS Committee on the Biological Effects of Atomic Radiation. The commenters continue that this paper is now widely questioned and has been seriously critiqued in many peer-reviewed publications, including two detailed 2015 papers, as summarized in a December 2, 2015, Wall Street Journal commentary.
Commenter (0039) states that in December 2015, the National Association of Scholars called upon the NAS and the American Association for the Advancement of Science to revisit the 1956 Science paper; both declined. The commenter states that there are fairly well-known serious questions about ethical improprieties that may have contributed to flawed and overstated conclusions in the Science paper. The commenter states that due to the complacency of the scientific establishment and, no doubt, the prestige of some of the scientific bodies implicated in the cover-up, no one in a position or authority until now has been willing to challenge the linear no threshold dose-response orthodoxy.
Commenter (6148) states that restrictions imposed by LNT has left the U.S. behind in developing alternative uses for otherwise useful materials, primarily due to EPA's imposition of overly conservative safety factors by using the LNT, which in turn discourages continuing U.S. research, and in turn leaves U.S. standards stagnating at status quo. The commenter concludes that the use of scientifically developed linear dose response models, where appropriate, is needed to achieve transparency because they employ actual defensible data and risks, rather than non-scientific assumptions.
Commenter (0062) states that use of the LNT model as the default model for radiation-induced cancers by the EPA and other regulatory agencies worldwide during the past several decades, in spite of accumulating evidence supporting radiation hormesis, has not served the public well because of the unjustified fear of even small amounts of radiation it has generated, and the resulting expensive and harmful defensive actions. The commenter adds that it has increased regulatory burden on the enterprises that utilize radiation without any corresponding benefit of avoided diseases and that there are many adverse effects due to the use of the LNT model.
Commenter (0050) states that the LNT model is deeply flawed and scientifically worthless, and that there are no valid data supporting it. The commenter states that while there are many scientific papers purporting to support it, careful study shows that this so-called science is based upon flawed statistics (using only one-sided statistics to show harm, with no possibility of showing benefit), inappropriate controls, and poor experimental design. According to the commenter, the LNT model of radiation damage began as purposeful lies told by the genetics community in the 1950's, as a ploy to attract increased government funding for genetics research; it has spawned many useless (and dangerous) federal and state regulatory jobs, businesses, radiation damage lawsuits, and politicians who secure votes with an antinuclear and antiradiation agenda. The commenter continues, stating that the LNT radiation model is now more of a religion than a scientific theory, and getting rid of it is difficult. The American public has been lied to for over three generations, media assume the truth of the LNT model, and despite some 3000 scientifically valid papers showing that low levels of radiation are harmless or beneficial (hormesis), the EPA radiation scientists will not budge an inch, and are grasping the dead LNT myth with bloody fingernails; their jobs and programs are at risk, and they will never change their minds.
Commenter (0050) states that low and moderately low radiation doses have been shown to be harmless or beneficial. The commenter explains that the reason is that these doses of radiation stimulate the production of enzymes involved in radiation repair; these enzymes, once stimulated, repair not only any damage caused by the radiation, but damage caused by other noxious agents, the most important of which is oxygen (the use of oxygen for energy metabolism generates damage that is qualitatively similar to the damage caused by ionizing radiation). The commenter adds that so far, over 150 genes have been identified that repair radiation and oxygen damage and the Nobel Prize in Chemistry in 2015 went to Paul Modrich, Tomas Lindahl, and Aziz Sancar "for mechanistic studies of DNA repair". The commenter states that an essential component of the LNT is that there is no such thing as radiation repair and concludes that this is absurd and fraudulent.
In support of the above comments, Commenter (0050) submitted their February 9, 2015, petition sent to Annette L. Vietti-Cook, Secretary, USNRC, Attention: Rulemakings and Adjudications Staff, U.S. Nuclear Regulatory Commission. The petition preface paragraph follows:
      I am submitting this petition for rulemaking pursuant to 10 CFR Part 2.802. The petitioner requests that the NRC amend 10 CFR Part 20, Standards for Protection Against Radiation, based on new science and evidence that contradicts the Linear No-Threshold (LNT) hypothesis, a model that has served as the basis for radiation protection regulations. I will present scientific data as reported in study after study to justify that safety regulations and policies should no longer be derived from the LNT model in order to ensure these requirements are more risk-informed. This ultra-simplistic concept assumes that all radiation absorbed doses, no matter how small, have a finite probability of causing a fatal cancer. The lower the quantity of radiation absorbed dose, the lower the probability of cancer induction, but the probability is never zero, let alone negative (i.e. beneficial or hormetic). The rate of radiation delivery is irrelevant, and all absorbed doses are additive; this is demonstrably false as evidenced by the practices of radiation oncology and of radionuclide therapy. Use of the LNT assumption enables regulators to feel justified in ratcheting down permissible worker and public radiation levels, either through actual dose limits or use of the "as low as reasonably achievable" (ALARA) principle, giving the illusion that they are making everyone safer (and creating ever-increasing workload for themselves and their licensees). There has never been scientifically valid support for this LNT hypothesis since its use was recommended by the U.S. National Academy of Sciences Committee on Biological Effects of Atomic Radiation (BEAR I)/Genetics Panel in 1956. The costs of complying with these LNT-based regulations are enormous. Prof. Dr. Gunnar Walinder has summed it up: "The LNT is the greatest scientific scandal of the 20th century."
Support Use of Linear Non-Threshold Model for Radiation
Conversely, commenters (0776, 2159, 2687, 6133, 6149, 6169, 6882, 6924, 6928) state that the NAS has repeatedly confirmed that there is no safe dose of radiation and that the LNT model is the best option for setting radiation protection standards. Commenter (6169) states that the NAS review constitutes peer-review of the LNT, and that the public was also included in the multi-year process. The commenter states that the public provided written and verbal comments and that at least two panelists were removed due to conflicts of interest that were pointed out by public comment.
Commenters (6133, 6169, 6928) elaborate that the NAS Biological Effects of Ionizing Radiation VII (BEIR VII) committee released a report in 2006 on the impact of low doses of radiation, Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR VII Phase 2, concluding that the LNT was the best model for protection against radiation. Commenters 6133 and 6149 cite the National Council on Radiation Protection and Measurements' (NCRP's) Commentary No. 27, "Implications of Recent Epidemiologic Studies for the Linear-Nonthreshold Model and Radiation Protection" (2018), which concluded that the LNT is the most practical model for implementing radiation protection for workers and the public.
Commenter (6169) states that more than 50 years of peer-reviewed, validated, and repeatable in vivo, not just laboratory studies, underlie the LNT model. The commenter adds that to its credit, despite pressure from special interests, EPA continues to recognize the model's pervasive scientific underpinnings, recently stating:
      Of all the agents demonstrated to be carcinogenic, the evidence for LNT is particularly strong for ionizing radiation...[g]iven the continuing wide consensus on the use of LNT for regulatory purposes as well as the increasing scientific confirmation of the LNT model, it would be unacceptable to the EPA to ignore the recommendations of the NAS and other authoritative sources on this issue. The EPA cannot endorse basing radiation protection on poorly supported and highly speculative proposals for dose thresholds or doubtful notions concerning protective effects from low-level ionizing radiation.
Commenter (6915) states that to "evaluate the appropriateness" of the linear, non-threshold approach for low-dose extrapolation by also considering non-linear and threshold models would provide no cognizable benefit in modeling accuracy or clarity, but instead could result in the manipulation of results, delay, and obfuscation.
Commenter (6133) provided a detailed argument for retaining the LNT model for radiation protection:
      As it does in every other instance and under every other environmental statute, EPA relies on independent, authoritative scientific bodies to provide analyses and evaluations of scientific evidence in support of its radiation standard-setting policies. EPA bases its regulatory limits and nonregulatory guidelines for population exposures to low-level ionizing radiation on the LNT dose-response model. EPA's radiation protection standards are based on the premise that any radiation dose carries some risk, and that risk increases directly with dose. This method of estimating risk is called the "linear no-threshold dose-response model (LNT)".
      This longstanding and well-supported assumption presumes that the risk of cancer due to a low dose exposure is proportional to dose, with no threshold. For over 40 years the LNT dose-response model has been commonly utilized when developing practical and prudent guidance on ways to protect workers and members of the public from the potential for harmful effects from radiation in balance with the commercially justified and optimized uses of radiation. EPA derives the LNT model from reports by authoritative scientific bodies including the NAS, the NCRP, and the International Commission on Radiological Protection (ICRP). There is strong scientific consistency by these authoritative groups that an LNT model is the best at the current time (and has been for the past half century)., Indeed, EPA noted as recently as late 2015, "[o]ver the last half century, numerous authoritative national and international bodies have convened committees of experts to examine the issue of LNT as a tool for radiation regulation and risk assessment... Again and again, these bodies have endorsed LNT as a reasonable approach to regulating exposures to low dose radiation."
                  Studies in support of the LNT dose-response model
      The NAS BEIR VII committee has studied and published its report on risk models for estimating the relationship between exposure to low levels of ionizing radiation and harmful health effects. The data used in the BEIR VII study are: atomic bomb survivor studies, medical radiation studies, occupational radiation studies, and environmental radiation studies. The committee judged that the LNT model provided the most reasonable description of the relation between low dose exposure to ionizing radiation and the incidence of solid cancers that are induced by ionizing radiation.
      The NCRP published its latest commentary on the LNT issue only months ago, in April 2018. The specific purpose of its commentary is to provide a review of recent epidemiologic data from studies with low doses or low dose rates and the Life Span Study (LSS) of atomic bomb survivors to determine whether these epidemiologic studies broadly support the LNT dose-response model as a reasonable basis for radiation protection. Epidemiologic studies of humans provide evidence that is critically important in establishing potentially causal associations of environmental factors with the disease. The studies were selected by a consensus of experts who have a broad purview of the recent radiation epidemiology literature, and they ensured that the largest and most important eligible studies were included.
      Examples of studies of radiation-exposed populations evaluated are:
 Japanese atomic-bomb survivors
            The LSS is a research program investigating life-long health effects based on epidemiologic studies. The study being conducted by the Radiation Effects Research Foundation (RERF) is used by standard-setting bodies in establishing a recommendation for radiation protection. The LSS cohort includes both a large proportion of survivors who were within 2.5 km of the hypocenters at the time of the bombings and a similar-sized sample of survivors who were between 3 and 10 km from the hypocenters whose radiation doses were negligible.
            The major objective of the study is to investigate the long-term effects of atomic-bomb radiation on causes of death and incidence of cancer. The atomic-bomb survivors of Hiroshima and Nagasaki are subject to follow-up study,  for their remaining lives, starting from 1950. The LSS cohort of atomic-bomb survivors has provided important data because it is a large cohort (~87,000 survivors of all ages) with relatively accurate dosimetry, a wide dose range over 60 years of high-quality follow-up for mortality and over 50 years of follow-up for cancer incidence, and nearly 1,000 excess solid-cancer cases, besides excess leukemias. The study provides strong indirect support for the use of an LNT model.
 Worker exposure studies
            Radiation worker studies assess risks in worker groups exposed largely to many low doses received at a low dose rate, providing direct evidence regarding the validity of the LNT model. INWORKS is an example of these studies. INWORKS is the latest international collaboration for examining the health of workers in more than one country who were exposed occupationally to ionizing radiation. INWORKS included dosimetry for 20 different nuclear sites/organizations in three countries. Dosimetry was based on individual personal dosimeter readings at the start of the workers beginning their radiation work (at earliest, between 1944 and 1952) through 2005. The U.S. cohort of INWORKS consisted of 119,195 nuclear workers at four Department of Energy nuclear weapons facilities (Hanford site, Idaho National Laboratory, Oak Ridge National Laboratory, and Savannah River site) and at the Portsmouth Naval Shipyard. This large study provides one of the strongest pieces of epidemiologic evidence that the LNT quantitative model is useful for radiation protection.
 Environmental exposure studies
            An example of environmental exposure studies for low doses and low dose rate is the Chernobyl resident cohorts.,  The 1986 accident at the Chornobyl nuclear power plant in northern Ukraine resulted in the exposure of substantial proportion of Belarus, Ukraine, and the Russian Federation to radioactive fallout. The most notable apparent health consequence of the accident has been the large increase in thyroid cancer among those exposed as children or teenagers starting 4-5 years after the accident. Studies of cohorts of children in Ukraine and Belarus who had thyroid measurements of iodine activity shortly after the Chernobyl accident and systematic thyroid screenings were conducted. The data on exposure to radioactive iodine have added considerable information relative to the dose-response relationship. The thyroid cancer experienced by children in exposed areas of the Ukraine, Belarus, and Russia conforms to the LNT model.
 Medical exposure studies
            Patients treated with lung collapse for TB in the 1930s to 1960s are one of the few medically exposed populations that provide consistent evidence for dose-response relationships. Patients on average would receive on the order of 100 chest fluoroscopies over several years.

Since the 1970s, studies of TB patients who received repeated chest x-ray fluoroscopies to monitor lung collapse have provided valuable information relevant to the LNT hypothesis. The TB fluoroscopy studies provide strong support for the LNT model for breast cancer.
      NCRP commentary in conclusion of its epidemiology studies states that, based on current epidemiologic data, the LNT model should continue to be used for radiation protection purposes, and "no alternative dose-response relationship appears more pragmatic or prudent for radiation protection purposes than the LNT model."
Response: These comments are outside the scope of this rule. This is a rule of internal agency procedure, and does not describe the Agency's position on scientific debate over the LNT model. Instead, under this rule the EPA continue to implement existing Agency practice and review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information. 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.
<IP_ADDRESS>.2 Public Transparency of National Academy of Sciences (NAS) Process and Availability of Report/References Illustrated Greater Harm to Women
Comment: Commenter (6169) notes that, although EPA instituted a peer review for radiation models by tasking the NAS to conduct a review of radiation science, including the linear, no threshold, and other models, and it supported the use of the LNT, it failed to point out the increased harm to women and children in the data. The commenter notes that this is due to its averaging of damage across genders and ages. The commenter notes that the only reason to revisit is to un-average the results and provide additional protection for women and children. The commenter provides extensive arguments in support of the use of the LNT model for radiation.
Response: This comment is unrelated to the current rulemaking and therefore out of scope. This is a rule of internal agency procedure and does not relate to peer review for radiation models.
<IP_ADDRESS>.3 EPA Should Incorporate Uncertainty and Stochastic (Random) Impacts of Radiation
Comment: Commenter (6169) notes that one major recognized category of uncertainty in radiation is the stochastic (random) impacts of radiation, including the probability that random impacts will increase with an increasingly radiologically contaminated environment. The commenter notes that any model that incorporates uncertainty must incorporate our ever-increasing probability of exposure, in addition to the non-threshold nature of stochastic cancer and non-cancer impacts.
Response: This comment is unrelated to the current rulemaking and therefore out of scope. This is a rule of internal agency procedure and does not concern radiation studies.
<IP_ADDRESS>.4 EPA Needs to Rely on Radiation Health Studies that are Independent and Scientifically Substantiated
Comment: Commenter (6169) suggests that the EPA rely on radiation health studies that are independent and scientifically substantiated; and shun those that are not applicable to radiation protection, suffer from well-known and documented pseudo-scientific assumptions, or harbor conflicts of interest. The commenter notes that even report conclusions that are generally accepted, such as those found in NAS BEIR VII, can still reference, and be influenced by, inappropriate studies. The commenter contends that this is perhaps one of the reasons why women, children and pregnancy are not afforded the protection they require.
Commenter (6169) states that improper hypothesis formation and research design have been baked into, and continue to plague, studies on radiation's impact on health. According to the commenter, this improper methodology has, unfortunately, evolved to be the only accepted way of examining health impacts. The commenter notes that this rigid study design presupposes a conclusion of no impact before any health data are actually examined, a huge scientific faux pas. The commenter explains that design does this by relying on error-ridden dose reconstruction, which almost always concludes that environmental exposure was too low to cause health impacts. Therefore, the commenter notes that even though this research often finds increase in disease, associating it with radiation exposure becomes impossible, not because radiation isn't the cause, but because it was falsely vindicated from the beginning.
Further, commenter (6169) provides that there are a number of studies regarded as reliable by international radiation committees, such as ICRP or NCRP, which find no health impact, or claim no discernable impact. According to the commenter, many of these studies were actually funded or influenced by industry and often used in court to counter claims of health damage from radiation. Worse still, the commenter notes that these studies also received funding from Federal agencies, giving them the appearance of independence. The commenter contends that studies like these skew the overall balance of radiation damage assessment when committees, such as those from NAS, try to review the literature examining radiation's impact on health.
Response: These comments are outside the scope of this rule. This is a rule of internal agency procedure and does not describe the Agency's position on which radiation health studies to rely. Instead, under this rule the EPA continue to implement existing Agency practice and review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information. 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.
<IP_ADDRESS>.5 Radiation Protections Insufficient
Comment: Commenter (6882) states that the proposed rule would apply to radioactive substances, for which Environmental Protection Agency protection is already not protective enough and that the few protections that EPA regulations do offer must remain intact, or, better yet, strengthened. Commenter (6928) states that the EPA believes the official radiation models which underestimate harm.
Commenters (0776, 2159, 2678, 6882) note that radiation protections must be more protective for sensitive females since their cancer risk from radiation exposure is higher. Commenters (0776, 2159, 6882) provide that the EPA doesn't specifically protect against non-cancer impacts of radiation exposure and should establish a hazard index for radionuclides -- something the Environmental Protection Agency already has for toxic chemicals.
Commenter (2687) expresses that radiation protections do not cover all of the various nuclides that are contaminating public and tribal water and are not strict enough considering that children and women are affected up to seven times more than the standard 35-year old white man.
Commenter (2159) adds that the EPA should also figure out how much radiation exposure is costing us, including loss of salary from impaired neural development and lower IQ, cost of treating radiation-induced cancers, and cost of accumulating radiation damage across generations.
Commenter (2159) provides that ICRP, the United Nations Scientific Committee on Effects of Atomic Radiation (UNSCEAR), the International Atomic Energy Agency (IAEA), the U.S. National Academies of Sciences, BEIR VII, and the UK National Radiological Protection Board (NRPB) are regularly quoted on radiation risk impacts on people. The commenter notes that they utilize a model of radiation risk assessment based on physics, calculating average energy impacts on a given mass or population, developed before the discovery of DNA and based on high-dose acute external irradiation by gamma rays of a large number of Japanese inhabitants of Hiroshima and Nagasaki. The commenter adds that these studies were begun 5 or more years after the atomic bombing and that the reference was to impact on a 25 year old, healthy white male. According to the commenter, left out of consideration are alpha and beta particle radiation which is not highly penetrating like gamma rays but, breathed in or ingested, become very damaging internal emitters. Also, the commenter notes that women are 45% more susceptible to radiation than men, children more than adults, girls more than boys and the younger the child, the greater the damage. Furthermore, the commenter notes that ionizing radiation is variable and individual susceptibility is as well.
Commenter (2159) provides that the European Committee on Radiation Risk (ECRR), in its 2010 Recommendations, considered methodology for evaluating radiation risk and presented the following:
      The Committee concludes that the present cancer epidemic is a consequence of exposures to global atmospheric weapons fallout in the period 1959-63 and that more recent releases of radioisotopes to the environment from the operation of the nuclear fuel cycle will result in significant increases in cancer and other types of ill health. The ECRR model predicts 61,600,000 deaths from cancer, 1,600,000 infant deaths and 1,900,000 foetal deaths. In addition, the ECRR predicts a 10% loss of life quality integrated over all diseases and conditions in those who were exposed over the period of global weapons fallout. The total maximum permissible dose to members of the public arising from all human practices should not be more than 0.1mSv, with a value of 2mSv for nuclear workers. This would severely curtail the operation of nuclear power stations and reprocessing plants, and this reflects the Committees belief that nuclear power is a costly way of producing energy when human health deficits are included in the overall assessment.
Response: These comments are out of scope, as the current rulemaking does not establish or modify radiation protections.
<IP_ADDRESS> EPA Climate Change Model Forecasting Flawed
Comment: Commenter (4541) states that EPA has tried to develop elaborate models forecasting the effect of increasing atmospheric carbon dioxide (CO2) on global temperatures 100 years into the future, but the commenter notes that those projections have already departed far from reality. According to the commenter, the models upon which EPA relies have often hidden stubborn falsehoods within their underlying structure. The commenter contends that increased model complexity has allowed modelers to hide problems where no one can find them. The commenter states that we are expected to believe the models because they are "state of the art," but even with a large amount of funding it would be impossible to test all their assumptions. The commenter contends that there needs to be a focus on simpler models with traceable and reproduceable assumptions and results. And, when the models disagree with observations (evidence), they need to be corrected.
Commenter (4541) asserts that the EPA's scientific foundation for potentially catastrophic anthropogenic global warming is based on the temperature projections of dozens of the supposedly more sophisticated global climate models. According to the commenter, those climate models are not sound science and are merely speculative scenarios about climate, none of which has been validated by the historical temperature record. The commenter states that scientific method involves testing a falsifiable hypothesis with experiments and evidence and climate model projections do not involve any such falsifiable hypothesis, so they are not an exercise of the scientific method.
Commenter (4541) notes that even the modelers themselves recognize and admit their models are not designed to produce predictions of future temperatures, only "what if" scenarios of results assuming the accuracy of unproven assumptions. The commenter provides that the Summary for Policymakers of Climate Change Reconsidered II: Physical Science states, "The science literature is replete with admissions by leading climate modelers that forcings and feedback are not sufficiently well understood, that data are insufficient or too unreliable, and that computer power is insufficient to resolve important climate processes."
Moreover, according to the commenter (4541), none of the models adequately accounts for the Pacific and Atlantic Ocean temperature cycles (PDO and AMO). The commenter notes that none takes into account solar activity cycles indicated by variations in the number and size of sunspots, variations in solar magnetic fields, or cosmic rays flux, all of which are known to significantly affect climate. The commenter states that natural cycles have produced major climate changes in the past, such as the Minoan (peak at 1300 BC), Roman (peak at 100 BC) Medieval Warm Period (about AD 950 to 1250  -  during which "global temperatures" were higher than they are today), and the early twentieth century warm period from 1915 to 1945.
Commenter (4541) states that design flaws explain why the projections of all climate models have now diverged dramatically from the actual temperatures experienced over the past two decades. The commenter provides a figure in their commenter letter (Figure 1) that illustrates that there has been no global warming for nearly 20 years. The commenter adds that projections of the models, and their increasing divergence from real-world temperature observations are illustrated in a figure in their comment letter (Figure 2). According to the commenter, the graph presented in Figure 2 was created by NASA scientist John Christy, Ph.D., who, with his colleagues at the University of Alabama in Huntsville, monitors atmospheric temperatures as computed from the data collected by U.S. satellites. The commenter further points out that Figure 2 illustrates the actual atmospheric temperatures recorded by U.S. weather satellites and weather balloons as compared to the average of the climate models, where the average projection is well above the observed real-world temperatures, with the divergence growing over time.
Commenter (4541) asserts that this growing divergence of the models from reality invalidates and falsifies them, as does:
 the inability of the models to account for the natural global temperature cycles and changes of the past century;
 the inability of the models to account for the Little Ice Age and Medieval Warm Period over the past 1,000 plus years; and
 the projection by all models of a tropical hotspot produced by CO2 that doesn't exist in the real world.
According to the commenter, what is most shocking is how weak the models are as any sort of "evidence" at all for the idea of catastrophic anthropogenic global warming.
Response: These comments are outside the scope of this rulemaking. This is a rule of internal agency procedure and does not pertain to climate change models.
<IP_ADDRESS> Particulate Matter NAAQS Supporting Information
Comment: Several commenters contend that the supporting data for particulate matter NAAQS is strong, results have been replicated, and increasing supporting information adds to the supporting data for the NAAQS.
Commenters (5178, 6874, 8272) state that the ACS Study linked air pollution data from 151 U.S. metropolitan areas to data on risk factors and mortality in 552,138 adults residing in these areas who enrolled in 1982 and were followed through 1989. The commenters state that the authors found increased mortality to be associated with sulfate and fine particulate air pollution "at levels commonly found in U.S. cities."
Commenters (1791, 5178, 6109, 6114, 6125, 6874, 6895, 6939, 8272) assert that the results of the Six Cities Study and the ACS Study have stood up to extensive subsequent analysis, including the "Reanalysis of the Harvard Six Cities Study and the American Cancer Society Study of Particulate Air Pollution and Mortality," which highlights the strength of such research.
Commenter (5015) provides a detailed synopsis of the Particle Epidemiology Reanalysis Project (which is not repeated here). The commenter states, in conclusion, the Reanalysis Team interpreted their findings to suggest that increased relative risk of "mortality may be attributed to more than one component of the complex mix of ambient air pollutants in urban areas in the United States". In the alternative analyses of the ACS Study cohort data, the commenter states that the Reanalysis Team identified relatively robust associations of mortality with fine particles, sulfate, and sulfur dioxide, and they tested these associations in nearly every possible manner within the limitations of the datasets.
Response: These comments are outside the scope of this rulemaking. In this final rule the EPA is not categorically or specifically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. This includes those studies supporting the NAAQS cited by the commenter. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
<IP_ADDRESS> National Primary Drinking Water Regulations Arsenic Standard
Comment: Commenter (6172) asserts that EPA should identify public health levels for all National Primary Drinking Water Regulations (NPDWR), including arsenic. The commenter states that levels of regulated substances that are unsafe in drinking water as referenced in the Safe Drinking Water Act (SDWA) are: an "unreasonable risk to health," section 1415 and "protective of public health," section 1412. The commenter states that, while the EPA established a standard of 10 parts per billion (ppb) for arsenic in drinking water, in 2002, EPA did not find that arsenic concentrations above their standard necessarily present an "unreasonable risk to health." The commenter states that, in their reply to a Congressional inquiry, EPA stated that it is "determining what does not pose an unreasonable risk to health with respect to arsenic, rather than address the much more complex issue of what does constitute an unreasonable risk to health."
Commenter (6172) urges EPA to release all data used to craft SDWA policy including risk assessments of inorganic arsenic. The commenter states that this would allow for further assessment and demonstrate the repeatability of conclusions and comparisons to similar studies. The commenter states that a regulation that strengthens the transparency of science utilized by EPA will result in improved federal public policy and SDWA implementation. The commenter states that, for example, a recent study could influence the current Integrated Risk Information System (IRIS) program that is developing an updated assessment of inorganic arsenic, however, the study includes some data that is available to government agencies but not to the general public.
Response: The comments are outside the scope of this rulemaking. This is a rule of internal agency procedure, and does not pertain to national primary drinking water regulations. In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers. The EPA will undertake such efforts in forthcoming actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule.
<IP_ADDRESS> Oppose EPA's Lack of Regulation of Perchlorate
Comment: Commenter (6172) states that the lack of a clear principle or interpretation of SDWA section 1412 allowed EPA to decide not to regulate perchlorate on October 10, 2008 and a subsequent affirmative EPA decision on February 11, 2011, that perchlorate meets the section 1412 criteria for regulation as a contaminant. The commenter asserts that such ambiguity in decision-making does not provide for regulatory certainty or persuasive reasoning for the local governments. The commenter notes that regulations should result in public disclosure of a clear principle for implementing the discretion provided to the Administrator for selecting new contaminants for regulations under SDWA Section 1412.
Response: The comments are outside the scope of this rulemaking. This is a rule of internal agency procedure, and does not describe the Agency's position on perchlorate. In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers.
<IP_ADDRESS> 1,2,3-Trimethylbenzene (TMB) IRIS Assessment
Comment: Commenter (6362) states that EPA's 2016 IRIS assessment of 1,2,3-Trimethylbenzene (TMBs) does not accurately represent the health effects associated with exposure to TMBs because it fails to utilize a consistent and transparent data evaluation procedure for evaluating and weighing the full body of evidence.
Response: This comment is outside the scope of this rulemaking. This is a rule of internal agency procedure and does not pertain to the TMB IRIS Assessment .
<IP_ADDRESS> Cost of Exposure to Radioactivity
Comment: Commenter (6169) suggests EPA should account for the true costs of exposure to radioactivity. The commenter states that internal costs to the nuclear industry are not the only consideration. The commenter states that allowing more radiation exposure externalizes costs to other industries, to individual members of the public, and to the population experiencing collective effects of radiation from the nuclear power and weapons industries. The commenter states that like non-cancer health impacts of radioactivity, EPA does not account for the economic impact of radiation exposures. The commenter states that any benefit to the nuclear industry of noncompliance or non-protection is a cost borne by the exposed public, other industries, and current and future inhabitants (human and non-human species and gene pools) of contaminated environments.
Response: This comment is outside the scope of this rulemaking. This is a rule of internal agency procedure and does not pertain to radioactivity.
<IP_ADDRESS> Interagency Review
Comment: Commenters (8281-PH39, 9227, 8272, 6125, 6126, 6194, 6144, 6916, 9227) questioned the Executive Order 12866 interagency review process for the proposed rule.
Response: Comments on deliberative processes, including interagency review and Executive Order 12866, are out of the scope of this rulemaking.
<IP_ADDRESS> Federal Guidelines
Comment: Commenter (6915) provided interpretations of OMB Memorandum 13-13.
Response: OMB documents are not open to public comments and are out of the scope of this rulemaking. EPA maintains that the rule is designed to build upon federal guidelines.
Comment: Commenter (6133) asserts that greater clarity is needed in the process for determining which actions are identified as "significant regulatory actions" under Executive Order 12866.
Response: The determination of significant regulatory actions under Executive Order 12866 is not open to public comments and is outside the scope of this rulemaking.
<IP_ADDRESS> Industry Should Be Required to Disclose Data
Comment: Commenter (5290) states that in the world of industrial chemicals, EPA should stop allowing corporations to self-report and start requiring them to disclose internal studies regarding the tens of thousands of existing and proposed chemicals that assault our health and ecosystem. For reference, the commenter suggests that EPA review an article discussing the discrepancy between DuPont's public statements about the safety of its Perfluorooctanoic Acid (PFOA) chemicals with the conclusions of its own confidential health studies, which included decades of evidence pointing to harm to public health (see https://www.nytimes.com/2016/01/10/magazine/the-lawyer-who-became-duponts-worst-nightmare.html)
Response: This comment relates to practices outside the scope of this rulemaking. This rule does not impose requirements on outside parties. This rule describes how the EPA will determine the consideration to afford pivotal science in its final significant regulatory actions and influential scientific information for which the conclusions are driven by the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect based on the availability of the underlying dose-response data, in addition to other factors.
21.2 SNPRM Miscellaneous Comments and Out of Scope Comments
21.2.1 Miscellaneous Comments
<IP_ADDRESS> General Opposition/Support
Comment: While several commenters provided comments that detailed specific support and/or opposition to the rule with detailed comments on specific aspects of the initial proposal and supplemental proposal, several thousand commenters (including, but not limited to 10045, 10048, 10866, 10974, 11176, 11182, 11183, 11184, 11192, 11243, 11403, 11408, 11479, 11484, 11894, 11918, 12403, 12412, 12415, 12423, 12427, 12430, 12450, 12456, 12458, 12464, 12474, 12540, 12715, 12719, 12727, 13549, 14397) provided general opposition to the proposal. Some examples of general statements of opposition include the following:
 Commenter expresses strong opposition to the criteria proposed in the Supplemental Notice of Proposed Rulemaking (SNPRM, or supplemental proposal) put forth by the EPA relative to its rule, "Strengthening Transparency in Regulatory Science." (10866)
 The main provisions of this proposed rule are either unnecessary, duplicative, burdensome, or likely to be confusing in their application. The proposed rule will not deliver significant improvements in EPA's current regulatory processes or improve the public's confidence in science. In fact, the proposed rule is likely to slow the advancement of science in the U.S. and increase political interference in the conduct of science. (11182)
 One of the stated purposes of this SNPRM is to clarify vague, inaccurate, or inconsistent language in the 2018 proposed rule. The "clarifications" offered in the SNPRM demonstrate the intention to undermine science through the façade of increasing transparency. While the EPA frames the rule as reflecting "recent innovations and policies surrounding information access," and there is indeed a widespread movement for open data and open science (which the commenter supports), this proposed rule and its modifications in the attendant SNPRM are disingenuous to that spirit. (11192)
 While the commenter supports transparency pursuant to data and information accessibility and expanding public knowledge, the proposed rule would likely restrict public knowledge by dismissing and devaluing scientific input to the EPA's decisions. Neither the 2018 proposed rule nor this SNPRM offer potentially meaningful advances in the EPA's decision-making or the public's engagement with the decision-making process. (11361)
 The Agency uses best practices that allow for a weight of the evidence approach, and this rule would not only change the process but codify it, making it much harder to reverse. Part of that codification would be to add the nonscientific criterion "data availability" to the list of assessment factors that the EPA will use to determine the quality of a study. These factors have been guiding EPA's data quality procedures since 2003 and include soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. They help the Agency to assess the context surrounding the objectiveness and integrity of scientific information and to determine how to use it in its weight of the evidence approach. (11479)
 The EPA received thousands of comments on the initial rule in 2018, did not respond to those comments, nor hold any sort of engagement with scientists, community members, nor organizations who submitted comments is reflected in the Strengthening Transparency in Regulatory Science SNPRM. In fact, the Supplemental Notice does not reflect any of the technical or legal comments submitted in 2018. (12540)
 The EPA's proposed rule and supplemental proposal attempts to implement a mechanism to shortcut its own guidance, guidance reports from the National Academy of Sciences, and guidance reports mandated by congressional actions for the implementation of national environmental statutes for the past 50 years. (12403)
 The Transparency Rule and the modifications included in the SNPRM will negatively impact important public health research and endanger public health, limiting the use of critical research that has formed the basis for improved understanding of risks, particularly risks associated with environmental exposure to toxic substances. (11918)
Conversely, there were also commenters (10973, 11358, 11388, 11899, 11915, 12612, 12692) that provided general statements of support for the initial proposal/supplemental proposal. Some examples of these statements include the following:
 Commenter supports transparency in all EPA actions (both regulatory and non-regulatory), including making the data and information used to inform EPA decision-making public in most situations. In taking steps to improve the transparency of current EPA rulemaking processes, it is important that the Agency appropriately balance three major considerations: EPA's statutory obligations, transparency of influential (pivotal) decision-making processes, and the public and business communities' rights to privacy. (10973)
 Commenter appreciates EPA's work to clarify the proposed rulemaking, as the Agency's initial proposal was too vague and missing key components, which would have made it difficult to understand and to put into practice. The commenter would like to thank the Agency for adding and clarifying many definitions for key terms within the supplemental notice. These modifications to the proposal are critical in assuring any final rule is implementable and defendable. (11358)
 Commenter supports transparency in both regulatory and non-regulatory EPA actions, including the data and information used to inform EPA decision-making; and appreciates the additional information and definitions provided in the supplemental notice, as this information is critical to understanding the scope and meaning of the rule. (11388)
 Full transparency, as proposed by EPA and in accordance with their further recommendations, would go a long way toward eliminating incompetence, fraud and politics substituting for science  -  and thereby reducing the number of costly, burdensome regulations that have severely impacted American businesses, communities and families, for few benefits. The commenter asserts that, in reality, public health and safety depend on ensuring that research and data purportedly supporting it are made public and carefully reviewed by multiple experts, to ensure accuracy, replicability and integrity. The commenter concludes that EPA will take full advantage of all available research that passes these tests. (11899)
 The rule is necessary to encourage and enforce the use of the scientific method among the investigators who are conducting research, particularly epidemiologic research, that is relevant to EPA regulatory policy. (12612)
Response: The EPA is providing response to the comments received for both the 2018 notice of proposed rulemaking and 2020 supplemental notice of proposed rulemaking as part of the submission of the final rule. The 2020 SNPRM was developed to clarify issues noted by comments on the 2018 NPRM.
The purpose of this action is to increase transparency by codifying internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. These requirements build upon open data initiatives in the federal government and scientific community and advance the EPA's mission and commitment to the public by prioritizing transparency of the underlying dose-response data in pivotal science for the most impactful of EPA's assessments and regulatory actions. Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. Such independent reanalyses will subsequently enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or influential scientific information. This could occur through standard cyclical reviews (e.g., revisions to NAAQS, risk and technology reviews, national primary drinking water regulations), ad hoc revisions, or revisions through the information quality guidelines or other petition processes. Implementation of this rule will more effectively share pivotal science for external consideration and increase the opportunity for independent validation of pivotal science by subject matter experts. As data are better understood through independent reanalysis, the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information.
The EPA considered these comments when finalizing this rulemaking, and the EPA does not agree that its approach is "unnecessary, duplicative, burdensome, or likely to be confusing." As described in the rule and preamble, the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. When characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect, the EPA will identify pivotal science and give greater consideration to pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation. Including this review of dose-response data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by independent third parties. This approach will result in significant regulatory actions and influential scientific information that are based on the highest quality, most relevant studies and ensure adequate human health and environmental protections, while maximizing transparency and maintaining consistency with the statutes the EPA administers.
<IP_ADDRESS> Cannot Make Claim That Comments Are Out of Scope
Comment: Commenters (11403, 12427) assert that EPA cannot consider comments involving the 2018 proposed rule out of scope. The reasoning includes:
Commenter (11403) states that because EPA failed to address so many of the problems with the 2018 proposed rule, the commenter has readdressed several in this comment. The commenter notes that EPA has suggested in this proposed rule that comments "that address aspects of the 2018 proposed rulemaking that are not addressed, altered, or replaced by this SNPRM will be deemed outside the scope of this supplemental action." Rather than risk EPA deeming any comment "outside the scope," the commenter reminds EPA that when reopening a rule for public comment, the rule is "challengeable anew," and therefore nothing from the 2018 Proposal may be deemed outside the scope.
Commenter (12427) provides that, although EPA is requesting comments now only on the supplemental notice, the overall effect of the SNPRM cannot be disentangled from that of the proposed rule, since one builds on the other. Thus, the commenter contends that it will be unreasonable, arbitrary, and capricious for EPA to refuse now to accept comments that pertain to the joint interactive effect of the Proposed Rule and SNPRM.
Response: Responses to comments have been provided for both the comments on the 2018 NPRM and the 2020 SNPRM. The only comments found to be out of scope are those found not to be relevant to the rule.
<IP_ADDRESS> Alternative Options for Achieving Transparency
Comment: Commenter (10039) contends that EPA may find the Administrative Conference of the United States (ACUS) Recommendation 2013-3, Science in the Administrative Process, 78 Fed. Reg. 41,357 (July 10, 2013), especially relevant to this proposed rulemaking. The commenter notes that recommendation 2013-3 highlights innovative Agency practices to "enhance the transparency of their scientific decision-making practices" and offers "proposals to bring greater congruity to the treatment of publicly and privately funded scientific research." The commenter provides that all ACUS recommendations and their accompanying reports are available online at www.acus.gov.
Response: Thank you for the recommendation. The purpose of this action is to increase transparency by codifying internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. These requirements build upon open data initiatives in the federal government and scientific community and advance the EPA's mission and commitment to the public by prioritizing transparency of the underlying dose-response data in pivotal science for the most impactful of EPA's assessments and regulatory actions. Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. Such independent reanalyses will subsequently enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or influential scientific information. This could occur through standard cyclical reviews (e.g., revisions to NAAQS, risk and technology reviews, national primary drinking water regulations), ad hoc revisions, or revisions through the information quality guidelines or other petition processes. Implementation of this rule will more effectively share pivotal science for external consideration and increase the opportunity for independent validation of pivotal science by subject matter experts. As data are better understood through independent reanalysis, the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information.
Comment: Commenter (10740) reiterates Steinzor and Wagner's proposal for transparent science in that:
   Transparent science should make publicly available
          a conflict of interest disclosure statement if the study was privately sponsored, as well as the underlying contract governing that research, in order to ensure that researchers' independence to determine study design and report results was preserved;
          a clear statement of the methods for data collection and analysis used in the study to allow for scrutiny and even replication of the study; and
          all of the underlying data, presumably in digital form (e.g., not original specimens, etc.).
   A proposal for transparent science should
          apply the same standards to all scientific research and analyses used by the Agency, particularly research that is not published and that has escaped rigorous peer review;
          require that a list of all excluded research be shared with the public as the decisions are made. Such disclosure could be accomplished by listing excluded -- or presumptively excluded -- information on a dedicated website in the course of a rulemaking or Agency decision.
          be applied to all technical analyses prepared by the Agency.
According to the commenter, this proposed rule neither conforms with the principles above nor meets the requirements of a proposal for real transparent science.
Response: The EPA disagrees with the commenter. The application of the principles discussed in their comments are a decision made by a researcher. This final rule does not regulate any entity outside the EPA. Rather, in this action, the EPA is finalizing a rule of internal agency procedures, including how the Agency will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. In doing so, the final rule provides greater transparency on the consideration the EPA will give pivotal science where the underlying dose-response data are or are not available for independent validation.
Consistent with existing Agency practice, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information. 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  -  The extent to which the scientific and technical procedures, measures, methods or models employed to generate the information are reasonable for, and consistent with, the intended application.
    Applicability and Utility  -  The extent to which the information is relevant for the Agency's intended use.
    Clarity and Completeness  -  The degree of clarity and completeness with which the data, assumptions, methods, quality assurance, sponsoring organizations and analyses employed to generate the information are documented.
    Uncertainty and Variability  -  The extent to which the variability and uncertainty (quantitative and qualitative) in the information or in the procedures, measures, methods or models are evaluated and characterized.
    Evaluation and Review  -  The extent of independent verification, validation and peer review of the information or of the procedures, measures, methods or models.
When evaluating potential links between exposure to a pollutant, contaminant, or substance and effects and the nature of the dose-response relationship, the EPA will follow best practices and rely on the highest quality, most relevant studies in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well-substantiated evidence (consistent with Agency guidelines on hazard identification and dose-response assessment) to support a relationship between exposure and effect, the EPA will identify a subset of those studies for use in characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect. This will be based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements, quantitative analyses, or both will be identified as pivotal science. Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. 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 personally identifiable information (PII), CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation.
The EPA expects to identify pivotal science, and the consideration afforded to pivotal science, in proposed significant regulatory actions and external review drafts of influential scientific information, which will allow the subject matter experts, if they so choose, to independently validate the pivotal science and provide comment to the EPA. The EPA believes that this approach will allow the public to more effectively comment, engage, and hold the EPA accountable during the future development of specific significant regulatory actions and influential scientific information.
Finally, Part 30.4 of the rule states, "The EPA shall clearly identify all science that serves as the basis for informing a significant regulatory action. The EPA shall make all such science that serves as the basis for informing a significant regulatory action publicly available to the extent permitted by law."
Comment: Commenter (10974) notes that improvements to developing health-based benchmark values used in state air toxics and permitting reviews can be made with certain data practices, but EPA would be better served supporting state efforts to make existing data easier to understand, to help better communicate research results and conclusions, and to help states develop third-party partnerships.
Response: This final rule does not regulate any entity outside the EPA. Rather, in this action, the EPA is finalizing a rule of internal agency procedures, including how the Agency will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. In doing so, the final rule provides greater transparency on the consideration the EPA will give pivotal science where the underlying dose-response data are or are not available for independent validation. 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 (11192) states that while they support transparency pursuant to data and information accessibility and expanding public knowledge, the proposed strengthening transparency in regulatory science (STRS) rule would likely restrict public knowledge by dismissing and devaluing scientific input to the EPA's decisions. The commenter asserts that it is important to note that there are several ways the EPA could actually make its regulatory decision-making more clear to the public and support public access to data, including: (1) funding researchers to de-identify data, (2) creating a user-friendly data repository with de-identified data, (3) conducting scientific assessments for all proposed regulations, and (4) providing syntheses and summaries of science assessments at multiple levels of detail to be comprehensible by various interested parties. According to the commenter, neither the 2018 Proposed Rule nor this SNPRM offer potentially meaningful advances in the EPA's decision-making or the public's engagement with the decision-making process.
Response: The EPA disagrees with the commenter, the Agency believes that this final rule 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.
This final rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to those studies for which such data are available. Hence, this rule does not impose costs on the EPA or any other party to make data available, including costs to ensure that PII and CBI are not disclosed. The Agency may opt, at its discretion, to incur the costs associated with making data available when it is in the public interest to do so, but that will be decided on a case-by-case basis and is not a requirement of the final rule.
The EPA is not categorically excluding any studies from consideration - even studies where the underlying dose-response data are not available for independent validation - when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Comment: Commenter (12427) contends that the proposed rule and SNPRM fail to address a more pressing issue, publication ethics. The commenter notes that in the context of publication ethics, "Transparency" has a different meaning. According to the commenter, transparency means that sources of funding for research or publication should always be disclosed. The commenter states that authors should disclose role of the funding source in designing the research, recruiting investigators/authors, collecting the data, analyzing the data, preparing the manuscript, or controlling the publication process; and that, in fact, many journals require this. Furthermore, the commenter provides that conflicts of interest should be disclosed by authors and evaluated by reviewers. The commenter notes such disclosures should include "information about financial (for example, patent ownership, stock ownership, consultancies, speaker's fees), personal, political, intellectual, or religious interests relevant to the area of research or discussion. According to the commenter, publication ethics include respecting confidentiality: "In the majority of cases, editors should only consider publishing information and images from individual participants/subjects or patients where the authors have obtained the individual's explicit consent.".