Comment: One example of the historic studies that would have difficulty meeting the "open data" criteria, several commenters (11408, 11495, 11396, 12715) point out that the researchers who originally conducted the Harvard University's seminal, peer-reviewed "Six Cities Study," completed in 1993 (and reanalyzed in 2000) would have difficulty meeting the "open data" criteria the supplemental now proposes for inclusion in EPA's decision-making, even under the proposed tiered system.
Commenter (11396) states that industries and their allies have been pushing to exclude studies for decades, using the same arguments found in EPA's proposal, targeting research that shows harm to public health from their arguments found in their emissions. The commenter highlights the history of how (outlined in their comment letter and by several comments on the 2018 proposal), in 1996, attorneys working for tobacco industry giant R.J. Reynolds recommended a similar approach requiring review of documents "because, at some point in the future, EPA will most likely be ordered to re-examine ETS [Environmental Tobacco Smoke]." The commenter adds that the tobacco attorneys recommended expanding this approach to other industries, which quickly happened. The commenter provides that two of the early industry targets were landmark air pollution studies completed in the 1990s that found solid evidence that particulate matter air pollution could cause premature death. The two long-term studies - the 1993 Harvard Six Cities Study and the 1995 ACS Study - looked at large population in multiple locations. The commenter notes that both studies found the particulate matter in the air was linked to increased risk of premature death. Instead of blocking the studies, as this proposal would do, the commenter notes that the EPA took a logical step and referred both studies to an independent third party, the HEI, for a deep-dive review. There, the commenter notes, autonomous reviewers examined the data and developed a report on the two studies that confirmed their original findings. Since these studies, the commenter notes that other research has confirmed their findings as well, including some studies that used publicly available datasets. The commenter suggests that similar third-party reviews could readily address concerns about existing or future studies as needed.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available (either publicly or through restricted access) in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. One criterion for the Administrator's consideration of an exemption is that a third-party has conducted independent validation of the study's underlying dose-response data through reanalysis.
Although independent validation by a third-party can be informative, the presence of a third-party validation is provided as a case-by-case exemption criterion instead of an automatic rule consideration in order to more fully realize the benefits of open data. As discussed in the preamble to the final rule, when data are widely available, researchers can validate research results and help identify and correct unintended errors, as well as reanalyze the data for new and different purposes, examine novel questions, provide new scientific insights, and improve model development. The EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety.
The EPA also agrees that data sharing mechanisms, such as that used by the Health Effects Institute in conducting their reanalysis study, already exist. The final rule gives equal consideration to studies with underlying dose-response data that are available publicly and studies with underlying data that are available through restricted access. The preamble to the rule clarifies that restricted access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. The rule does not prescribe a particular mechanism but does require the EPA to independently verify that such a mechanism exists for dose-response data underlying pivotal science. As discussed in the preamble to the final rule, including this review of dose-response data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by independent third parties.
Comment: Commenter (11479) contends the SNPRM and draft rule would prevent critically important research from being used to inform the EPA's decision making on public health protections. The commenter states that, for example, the EPA funded four university-based Clean Air Research Centers between 2011 and 2016 to better understand complex air quality and health issues -- research that directly informed the Agency's air pollution standards, required under the CAA. The commenter states that the four centers have generated hundreds of research publications and helped answer crucial scientific questions that inform how the EPA can best protect public health, including that of at-risk subpopulations, from ambient air pollution, with an adequate margin of safety. The commenter states that the centers' contributions include understanding of multipollutant mixtures on health outcomes; stratification of health effects across geographies and populations; characterization of air pollution measurement error; and improved measurement and characterization of traffic emissions and their health outcomes. The commenter states that Dr. Gretchen T. Goldman, Research Director at the Union of Concerned Scientists' Center for Science and Democracy, contributed to this research with several studies that informed current and past EPA decisions on air pollution standards on ozone and particulate matter.
Commenter (11403) states that, by deliberate design, the proposed rule would have the EPA ignore some of the most rigorous, long-term, peer-reviewed studies conducted by leading independent researchers. For example, the commenter provides that a recent study found that for children younger than age two even extremely short exposure to soot particles, like those created by burning fossil fuels such as coal, oil, and natural gas, increases the kinds of respiratory infections that are the leading cause of sickness and death. This is the kind of study EPA would ignore or deprioritize because HIPAA correctly makes it illegal for researchers to release the identities and health histories of the nearly 150,000 people in the study, making the data incapable of being disclosed.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations
Comment: Commenter (12442) states that together, the expansion of the rule and the tiered-access approach brings into question whether or not a study such as the 2013 report, "National Park Service Visitor Values & Perceptions of Clean Air, Scenic Views & Dark Night Skies 1988-2011" (Exhibit A in their comment letter), which followed standard scientific norms for gathering information from groups of people visiting parks, could be considered by EPA to inform internal scientific assessments or rulemakings in the future. The commenter notes that if this kind of study were to be devalued or disregarded for the protection of clean air in national parks because individuals weren't named, it would be a great loss of information that shows the clear co-benefits of the economic value that people place on clean air -- for many different reasons -- when visiting parks.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how pivotal science would be selected. As discussed in the preamble to the final rule, rather than considering all studies that support the assessment of the relationship of a dose or exposure of a pollutant, contaminant, or substance to the magnitude of a predicted health or environmental impact as "pivotal science," the EPA is balancing transparency and feasibility by focusing on those studies that inform the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect. Thus, "pivotal science" includes only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. In the context of this rule, studies informing the dose-response modeling (e.g., benchmark response selection), studies identifying data for toxicokinetic adjustments, or studies informing the selection of uncertainty factors do not drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information.
The final rule also clarifies how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
Comment: Commenter (12716) states that many of the ongoing programs and policies in place that will restore the Chesapeake Bay are based upon regulations promulgated by EPA and supported by the Agency's consideration of the best available science. In 2010, the commenter notes that the EPA issued a total maximum daily load (TMDL) for the Chesapeake Bay region. It "sets Bay watershed limits of 185.9 million pounds of nitrogen, 12.5 million pounds of phosphorous and 6.45 billion pounds of sediment per year -- a 25 percent reduction in nitrogen, 24 percent reduction in phosphorous and 20 percent reduction in sediment." In doing so, it set a cap on Nitrogen Oxides (NOx) from air deposition to 15.7 million pounds and "committed to reducing nitrogen deposition to the Bay and its surrounding waters by a total of 3.7 million pounds between 2009 and 2025, the year all practices are to be in place to meet the Bay TMDL goals." The commenter states that the Bay TMDL based these limits on years of peer-reviewed science and relied on the implementation of various federal regulations to achieve these reductions.
In addition to regulatory programs upon which the success of the Chesapeake Clean Water Blueprint relies, the commenter (12716) states that the Agency's proposed changes could also impact other CAA and CWA programs needed to meet the goals of the Chesapeake Bay Watershed Agreement and reduce the effects of climate change. The commenter provides that the restoration of the Chesapeake Bay is dependent on the implementation of numerous federal CAA and CWA programs that are based upon the best available science. The commenter contends that a narrowing of the use of science -- under the guise of transparency -- in the promulgation of rules threatens the implementation of those programs, and therefore threatens the health of the Chesapeake Bay.
Response: The EPA is finalizing the applicability of this rule to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. The EPA is not applying this rulemaking to permit proceedings, site-specific actions, or enforcement actions because these actions are typically focused on individual regulated entities.
As described in the preamble to the final rule, the requirements in the final rule set the overarching structure and principles for transparency in the EPA's significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
Comment: Commenter (12466) states that while they support greater transparency in EPA actions around the use of antibiotics in animal agriculture, they do not believe that the proposed rule actually provides the needed transparency and add that it may make it more difficult for EPA to properly take into consideration some of the limited information that is available related to use of antibiotics in vegetable and fruit production. The commenter explains that, in the realm of crop use of antibiotics, there is very limited data available and the data that is available covers mainly apples and pears not other crops such as citrus fruits. Because approvals for citrus use in the U.S. are fairly recent, the commenter states that studies on antibiotic use in citrus are primarily available from researchers in other countries, which increases the risk that the underlying data will not be available. The commenter states that the raw data from studies on impacts of worker exposure to antibiotic pesticides might not be available both due to the confidentiality of medical records and due to the need to protect workers from retaliation by crop production companies. Despite these limitations, the commenter asserts that this type of data is often the best available. Given the low number of studies related to crop use of antibiotics and the real risk that underlying data will not be available for studies published in the peer reviewed literature for the reasons described above, it is inappropriate for EPA to move forward with the proposed rule.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7.
Comment: Commenter (11386) states that, in the case of air quality, privately-owned satellites play an increasingly important role in the observation of concentrations of atmospheric constituents. The commenter states that satellites take years to develop and launch, and private companies currently dominate the field of high-resolution atmospheric observations from satellites. The commenter states that MethaneSAT, a subsidiary of the Environmental Defense Fund, may provide publicly available data at coarser resolution than those provided by satellites like GHGSat-D, complicating the estimation of methane emission rates for point emission sources such as oil and natural gas facilities. The commenter states that there may be no plans to launch a satellite that would provide publicly available methane observations at similar resolution to those produced by GHGSat's instruments. The commenter states that excluding these observations from all regulatory science, as per the expanded scope of the proposed rule, would harm the improvement of emission inventories and the resulting policy.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7.
<IP_ADDRESS>.2 Epidemiological Studies
Comment: Commenters (10040, 11182, 11359, 11360, 11400, 11403, 11404, 11492, 11497, 11576, 11890, 11911, 12405, 12422 12430, 12431, 12435, 12720, 12715) express concern that, under this rule, many epidemiological studies that are pertinent to the EPA's work could not be considered during the rulemaking process due to data confidentiality obligations.
Commenter (11359) contends that crucial epidemiological studies would be excluded from consideration under the transparency requirements. The commenter highlights the value of using epidemiological studies for chemical risk assessment as they provide human data to accurately evaluate health impacts. To that end, the commenter states that epidemiological data should be considered essential for all chemical risk assessments, with key examples of important human studies conducted on the pesticides paraquat, atrazine, glyphosate, chlorpyrifos, and other chemical substances used in industrial and agricultural applications, such as PFAS. Additionally, the commenter provides a cancer risk study that would likely be excluded from consideration to further demonstrate the value of using human health data to better protect human health.
Commenter (11360) states that data privacy laws largely prevent information from studies involving humans from being made public in the manner being considered by the EPA. As a result, the commenter asserts, if the EPA proceeds with downgrading or dismissing such science from consideration, the Agency will be excluding from their policy and rulemaking process epidemiology studies linking air pollution to serious outcomes such as death, heart attacks, and strokes; disinfection byproducts to birth outcomes; and, toxic exposure to cognitive function.
Commenter (12405) provides that human-based clinical trials or epidemiology (observational) studies form the bedrock of knowledge for determinations about the environment's impact on human health. The commenter states that exclusion of these studies stands to affect every decision made at EPA from NAAQS to chemical registration and regulation in consumer products and pesticides. In effect, the commenter asserts the rule would restrict access to science rather than make it more transparent.
Commenters (10040, 11360) state that this proposal would result in the exclusion of epidemiology studies linking air pollution to serious outcomes such as death, heart attacks, and strokes; disinfection byproducts to birth outcomes; and toxic exposure to cognitive function in the EPA regulatory rulemaking. Commenter (11360) states that the fact that this information must be kept confidential to protect research participants does not make the data any less valid.
Commenter (11182) disagrees with the proposal to include studies containing PII in this rule. The commenter states that epidemiologic studies are the foundation of many, if not most, environmental and occupational regulations to protect workers and the public. The commenter notes the studies of asbestos-exposed insulators and lung cancer (Selikoff et al., 1979), benzene-exposed rubber workers and leukemia (Rinsky et al., 1987), and in children, low level lead exposure and brain damage (Lanphear et al., 2002) and states that these epidemiologic studies were pivotal research in the subsequent regulations that have saved many workers' lives and improved the health of millions of children. The commenter states that these studies would likely not have been considered under this supplemental proposal; the simple but profound reason is the principle of confidentiality.
Commenter (11400) contends that, under the proposed rule, large epidemiological studies like the effect of air pollution and correlation with public health in regard to respiratory, cardiac, and neurological impacts would be discounted, to the detriment of people living close to polluting sources. The commenter states that the problem is that this will exclude studies where the patient information cannot be made public, even where the study is of higher quality than studies with no PII. The commenter states that environmental and epidemiological studies often consider where people are as they are exposed to pollutants: their residence and their subsequent health issues are germane to the studies. The commenter states that residence, cause of death on death certificates, older age, are PII. The commenter states that excluding these studies because they contain PII of the patients' proximity to sources of pollution means that the most relevant studies will not be given appropriate weight.
Commenter (11403) asserts that, without these epidemiological studies, it would be impossible to put in place necessary protections to adequately protect vulnerable populations. The commenter states that studies done on animals are simply not protective of these populations. The commenter states that lab animals lack genetic heterogeneity; they live in tightly controlled environments, are fed an optimal diet, and lack any pre-existing health conditions. The commenter states that this is not reflective of the human race. The commenter states that, unlike animal studies, epidemiological studies look at human subjects, deliver results that reflect real-world exposure conditions, and are able to tease out populations that may be more vulnerable than the general population. The commenter states that these studies often have personal data associated with them that cannot be made public. The commenter states that forcing mass storage of this PII in an EPA system so that it can be released through a tiered access program is a security risk and puts members of these communities even more in danger.
Commenter (11404) expresses that the rule might greatly reduce the number and quality of health studies available to support the development of air quality standards or regulations and hinder the health protection work the EPA is entrusted to do. The commenter notes that a reduction in availability of epidemiological studies would affect not only the EPA, but also other environmental and health protection agencies - such as the Air District - via the work of our sister agencies, the California Air Resources Board (CARB) and the Office of Environmental Health Hazard Assessment (which independently establish California's ambient air quality standards and health values for toxic compounds). The commenter contends that the proposal undermines, rather than enhances the scientific studies, data and models that are needed to develop meaningful, cost-effective air quality regulations. As drafted, the commenter states that the proposal would stifle efforts to make decisions based on the best scientific information and ultimately impact our ability to protect the health of Bay Area residents.
Commenter (11492) states that the supplemental proposal assigns greater value to dose-response studies, thereby reducing the use/value of epidemiological studies. The commenter notes that EPA has acknowledged that "there is frequently a lack of dose-response data available for human subjects. When data are available, they often cover only a portion of the possible range of the dose-response relationship." As epidemiological studies form the bases of many human health exposure studies, the commenter contends that EPA must continue to use epidemiological studies; to do so otherwise is to compromise the health of all Americans.
Commenter (11497) contends that while much of the data showing a connection between chemicals and breast cancer risk comes from laboratory studies, epidemiological studies, in particular longitudinal studies, provide critical insights and important corroboration for these findings. Additionally, the commenter states epidemiological studies allow researchers to look at numerous factors in the lived experience of women to understand and parse out some of these complexities. Once such study provided by the commenter is the National Institute of Environmental Health Science's Sister Study that has and will continue to provide data on breast cancer and disease prevention. The commenter notes that most of these critical epidemiological studies, are funded by the NIH, and that their strong confidentiality policy would force EPA scientists to disregard the studies, resulting in less scientifically sound conclusions and diminished public health benefits.
Commenter (11576) states that epidemiological and public-health studies often involve confidential data related to people, and researchers must protect the privacy of study participants, rendering disclosure of the underlying data impossible and in some cases unlawful. The commenter states that the rule could have the effect of removing valid, credible, peer-reviewed studies of health effects as sources to support the Agency's regulatory efforts: "The proposed rule does not acknowledge that the epidemiologic science community, for example, has been making significant efforts to make data available where possible and to develop studies based on publicly available data where appropriate." The commenter states that excluding studies where it is not possible to make the underlying data publicly accessible would unnecessarily and irrationally exclude reliable science for no legitimate reason.
Commenter (11890) states that, if enacted, the proposal would disable the EPA's ability to use U.S. and most other countries' epidemiological studies that relied on private medical information.
Commenter (11911) states that epidemiological studies enjoy the support of the scientific community and provide the main justification -- in some cases the only possible justification -- for some of our most important environmental protections. The commenter states that these protections have significantly improved the wellbeing of the American people. The commenter states that excluding studies simply because the raw data cannot be made publicly available would result in inadequately informed regulatory decisions that could subject people to real harm.
Commenter (11911) states that many epidemiological studies that are pertinent to the EPA's work could not be considered during the rulemaking process due to data confidentiality obligations. The commenter states that, for example, in a study published in the American Journal of Respiratory and Critical Care Medicine in June 2018, researchers discovered that fine particulate matter exposure was more strongly associated with respiratory emergency hospital visits for children than for adults, while ozone exposure was more strongly associated with respiratory emergency hospital visits for adults than for children. The commenter states that the researchers concluded that in light of this finding, relying on Medicare data and other studies that restrict their analysis to populations over age sixty-five "could underestimate population respiratory health impacts of PM2.5 or ozone." The commenter states that, because the study was based on confidential emergency room visit records aggregated by state agencies to protect the patients' privacy, the proposed STRS Rule would bar the EPA from considering it.
Commenter (11911) asserts that the proposed rule is likely to have particularly harmful effects for regulations that rely on studies of low probability but high impact events, such as natural disasters, environmental catastrophes, wars, or terrorist attacks. The commenter states that some of these studies have unavailable data due to their age and changing data transparency norms. The commenter states that the data cannot be newly collected again as the disastrous event cannot be experimentally replicated. The commenter states that studies of the health effects from nuclear plant failures in Chernobyl or Fukushima, or fallout from deployment of nuclear weapons in Hiroshima and Nagasaki, likely fall in this category.
Commenter (12430) asserts the SNPRM would dramatically impede the EPA's ability to consider epidemiological studies because of the type of data collected. The commenter states that epidemiological studies rely on confidential information -- with geographical location, and birth and death dates to determine the effects of specific hazards -- to link health and lifestyle information. The commenter states that, for example, had the proposed rule been in place 25 years ago, when the Harvard Six Cities and American Cancer Society studies were first published, air pollution today would be much worse. The commenter states that these two studies laid the foundation for the 1997 PM NAAQS that set the first national standard for PM2.5. The commenter states that they also were used in all subsequent updates to the federal PM2.5 standard as well as development of the national PM10 standard. The commenter states that, in addition, these studies were integral to the development of more than two dozen different rules adopted by the EPA to implement the NAAQS since 1997. The commenter states that key rules developed using these studies to evaluate particle pollution impacts on mortality and illnesses include the Control of Emissions from Non-road Diesel Engines and the Mercury and Air Toxics Standards. The commenter provides several examples of the types of studies and models that, according to the commenter, the SNPRM would force the EPA to reject or discount including studies related to (1) fecal indicator bacteria concentrations and water-content recreation at ocean and freshwater beaches; (2) recent U.S. EPA lifetime health advisories for PFOA and Perfluorooctane Sulfonate (PFOS); and (3) studies that document adverse health impacts associated with air pollutants as part of setting NAAQS.
Commenter (12430) discusses the reliance of EPA lifetime health advisories for Perfluorooctanoic Acid and Perfluorooctane Sulfonate on epidemiological studies, for which exposure may result in several adverse health effects. The commenter also states the importance of epidemiological studies in relation to setting NAAQS, highlighting the importance of the Harvard Six Cities study and American Cancer Society study in the first national PM2.5 standard.
Commenter (12430) states that the proposed rule is likely to preclude U.S. EPA from considering high-quality CARB-funded research that provides critical findings on air pollution exposures and health impacts. The commenter notes that a significant number of the studies that CARB supports are epidemiological/cohort studies that the SNPRM is likely to preclude from U.S. EPA consideration. The commenter provides the following examples:
 The 10-year Children's Health Study (CHS): Initiated in 1993, this was the first major study to assess the impacts of long-term air pollution exposure on the respiratory health of California's children. Following 5,500 students in 12 southern California communities from fourth grade through high school, this study revealed the extent to which ozone, nitrogen dioxide, acid vapors consisting of nitric acid and hydrogen chloride, and particulate matter affect children's lung development. The results of this study are evidence for classifying children as sensitive receptors to air pollution and have influenced research since and shaped California legislation addressing children's microenvironments.
 The Los Angeles Family and Neighborhood Survey (LAFANS): This was a study of families in different neighborhoods in Los Angeles County. The researchers found that children more highly exposed to traffic pollution were 30-40 percent more likely to report wheeze symptoms.
 The East Bay Kids Study and the California Health Interview Survey (CHIS): These studies sought to determine impacts of pollution levels and greater sensitivity in low income neighborhoods on asthma, including in the CHIS study, on whether the asthma burden disparity is due to exposure to higher levels of air pollutants, greater vulnerability, or both. Findings from these studies have helped to inform policy decisions on motor vehicle emissions control and enforcement, and asthma prevention, control, and education in low socioeconomic status populations.
 Wildfire Impact: Studies currently in progress are examining the impacts of wildfire smoke on lost work days and on respiratory symptoms.
Commenter (12431) states that the proposed rule could force the EPA to exclude from its consideration epidemiologic studies that use confidential health data. The commenter states that such studies are frequently the most relevant to protecting public health as they assess outcomes in humans following real world exposures. The commenter states that the exclusion of this information may lead the EPA to increase its reliance on information from less relevant animal toxicity studies.
Commenter (12435) notes that the retroactive application could include studies on toxic substances ranging from lead to particulate matter which were properly conducted in accord with health privacy regulations, including the Harvard Six Cities and American Cancer Society Cancer Prevention Study II that serve as major references to the PM NAAQS. Additionally, the commenter states that a majority of the cost-benefit analyses for air regulations is based on these studies because they present the best epidemiological data available. According to commenter, if these studies are excluded from future regulatory action, this would also prevent their use for the EPA's cost-benefit analyses. The commenter provides that foundational studies that have gone through peer review contribute to the body of knowledge on a topic and should not be excluded.
Commenter (11497) states that a likely outcome of the proposed rule is that many epidemiological studies showing the effects of environmental exposures would be disregarded; studies which cannot now be replicated, and whose contribution to and critical role in the pool of "best available science" is undisputed.
Response: In the final rule the terms replicate and reproduce (or other forms of the word) are no longer used. The EPA is clarifying that the intent of the term in the proposed regulatory text at 40 CFR 30.5 was "reanalyze" rather than "replicate." In the 2020 SNPRM, the EPA proposed using the term "reanalyze" instead of "replicate" and proposed at 40 CFR 30.2 a definition for "reanalyze." In addition, the EPA is modifying the definition of "independent validation" in the final rule by replacing "capable of being substantially reproduced" with "produced." The EPA will not finalize the proposed 40 CFR 30.2 definition of "capable of being substantially reproduced" because the term is not used in the final rule's definition of "independent validation" or elsewhere in 40 CFR 30.
Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information, consistent with existing Agency practice. The EPA will continue to use the following, established factors to assess the quality of studies used to develop significant regulatory actions and influential scientific information: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. Only later in the process, after study quality has been assessed, the EPA will then identify those studies considered to be pivotal science. When evaluating those scientific studies considered to be pivotal science -- in either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
Although independent validation by a third-party can be informative, the presence of a third-party validation is provided as a case-by-case exemption criterion instead of an automatic rule consideration in order to more fully realize the benefits of open data. As discussed in the preamble to the final rule, when data are widely available, researchers can validate research results and help identify and correct unintended errors, as well as reanalyze the data for new and different purposes, examine novel questions, provide new scientific insights, and improve model development. The EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety.
The EPA also agrees that data sharing mechanisms, such as that used by the Health Effects Institute in conducting their reanalysis study, already exist. The final rule gives equal consideration to studies with underlying dose-response data that are available publicly and studies with underlying data that are available through restricted access. The preamble to the rule clarifies that restricted access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. The rule does not prescribe a particular mechanism but does require the EPA to independently verify that such a mechanism exists for dose-response data underlying pivotal science. As discussed in the preamble to the final rule, 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.
The EPA would like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedures and does not direct or require any outside entity or the EPA to establish data sharing mechanisms. Further, the final rule does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science.
In addition, the EPA is maintaining language from the 2020 SNPRM in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict, and clarifying in this preamble that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
Finally, the EPA would like to clarify that the final rule applies prospectively to significant regulatory actions and influential scientific information and has no retrospective effect on existing significant regulatory actions or influential scientific information.
Comment: Commenter (12720) asserts that it may not be feasible to identify and make available data in epidemiological studies and, as a result, the proposal would disallow use of an enormous body of carefully protected, de-identified health data from epidemiological studies large and small, for which IRBs have approved collection because patient privacy has been protected. The commenter states that this measure would hamstring the research community's ability to continue to produce foundational, health-protective research. The commenter states that not only would the rule destroy society's collective ability to benefit from studies of the causes of and potential cures for ill health, it also would veer dangerously toward compromised privacy during an era in which electronic data security is a nationwide crisis. The commenter states that the proposal flies in the face of decades of statutory, regulatory and institutional progress to simultaneously protect public health and privacy and should be withdrawn.
Commenter (12720) states that the supplemental proposal is even more expansive than the proposal and would seriously reduce the Agency's ability to characterize health impacts of proposed regulations in influential science products, including key regulatory impact analyses regularly produced by the Agency. For example, the commenter notes that in the last three years alone, EPA has regularly relied on a set of peer-reviewed epidemiology studies that relate long-term air pollution exposures to premature mortality risks (a list of these studies can be found in Table 1 of their comment letter). The commenter states that each of the environmental epidemiology studies identified in Table 1 of their comment letter does not meet the strict data release requirements identified in the supplemental proposal; nevertheless, EPA has identified these studies as providing robust dose-response information upon which to base regulatory impact analyses across a range of sectors.
Commenter (12720) asserts that the foundational research in air pollution epidemiology demonstrating a causal link between pollution exposures and adverse health outcomes  -- including early death, heart disease, lung cancer, stroke, and asthma exacerbations  --  is at risk of being excluded from the regulatory process - seriously undermining the efficacy of regulations on which this research has historically been based - if the Supplemental Proposal is finalized.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information, consistent with existing Agency practice. The EPA will continue to use the following, established factors to assess the quality of studies used to develop significant regulatory actions and influential scientific information: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. Only later in the process, after study quality has been assessed, the EPA will then identify those studies considered to be pivotal science. When evaluating those scientific studies considered to be pivotal science -- in either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation.
The EPA would like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedures and does not direct or require any outside entity or the EPA to establish data sharing mechanisms. Further, the final rule does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science.
Although the EPA is prioritizing transparency in pivotal science, the Agency also recognizes that there will be instances where the underlying dose-response data of pivotal science are unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, a study with underlying dose-response data that are not available should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that are unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator, as detailed under 40 CFR 30.7. One of the criteria the Administrator may use in his/her determination to grant a waiver is whether making the dose-response data available would conflict with laws and regulations governing privacy, confidentiality, CBI, or national security. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
These considerations, the Administrator's exemption, and the EPA's incremental approach to maximizing transparency by first focusing on dose-response data are intended to minimize potential unintended consequences, such as that noted by the commenter. In addition, the EPA is maintaining language from the 2020 SNPRM in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict, and clarifying in this preamble that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers. The EPA believes the rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making.
Comment: Commenter (12720) states that vinyl chloride (VC) is regulated in workplaces, and in drinking water, food, and air:
 OSHA issued workplace regulations in 1974, forcing a reduction in the allowable level of the VC monomer by 500-times, from 500 ppm to 1 ppm averaged over an 8-hour workday. Despite predictions of dire job losses, virtually all U.S. manufacturing facilities met the new standard within a few years while reducing costs, largely through better containment of the unpolymerized monomer and improved exposure monitoring.
 EPA regulates VC pollution under the SDWA (Maximum Contaminant Level (MCL)=0.02 mg/L based on increased risk of cancer), and under EPA's Ambient Water Quality Criteria (0.025 ug/L).
 FDA regulations limit vinyl chloride in food contact materials and packaging.
The commenter (12720) provides that studies that support these EPA safeguards, and particularly the identification of diseases in workers like acroosteolysis that were not identified in rodent studies, are critical to protecting human health and preventing adverse environmental impacts. The commenter adds that thanks to effective health-protective regulatory actions by EPA, OSHA and other federal agencies - regulatory actions that were based on these studies - the elevated exposure conditions suffered by industrial workers in the 1970s and earlier are no longer the industry norm. Thus, the commenter states that these studies cannot meet the standards of transparency and replicability set out in the Proposal. Because these studies cannot meet the "standards" set out in the supplemental proposal, the commenter expresses concern that they may no longer form the basis of regulatory action, seriously compromising the safeguards on which we rely to protect against exposure to VC.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
Comment: Commenter (12720) provides that Congress recognized that pesticides are designed to be poisonous, and thus requires them to be registered by EPA, under FIFRA. The commenter states that Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires that when used according to the label, a pesticide will not cause unreasonable adverse effects on the environment or human health, which is commonly referred to as FIFRA's safety standard. The commenter adds that FIFRA was amended by the Food Quality Protection Act (FQPA), which was passed by Congress unanimously in 1996.
Due to risks to children's health, the commenter (12720) states that in 2000 EPA banned household use of chlorpyrifos and most other organophosphate pesticides. The commenter notes that residential uses prior to the ban were causing very high exposures to pregnant women and young children and scientists have since learned that even much lower levels may be harmful to children.
However, according to the commenter (12720), scientists have since shown in longitudinal cohort epidemiologic studies, that even low levels of exposure -- too low to poison a pregnant mother -- can disrupt brain development in their prenatally exposed children, leading to developmental delays, lower IQ, learning disabilities, and ADHD-like behaviors.
To protect these children, in October 2015, the commenter (12720) provides that the EPA proposed to ban chlorpyrifos because Agency scientists found contamination of drinking water. A year later, the commenter states that the EPA found that chlorpyrifos residues on food, including fruits and vegetables, are unsafe for pregnant women and children; residue levels were far above their target risk level -- in some cases, by up to 140 times.
According to the commenter (12720), these epidemiologic studies can no longer be reproduced because -- thanks to FQPA and the ban on residential uses -- pregnant women and young children are no longer poisoned by indoor use of organophosphate pesticides at such high levels. Without these epidemiological studies, the commenter states that our regulators will no longer be able to use the best available science to ensure that pregnant women, fetuses, and young children receive protection from exposure to chlorpyrifos. The commenter contends that the exclusion of these studies and its corresponding impact reveals EPA's Proposal and Supplemental Proposal to be arbitrary, capricious, and an abuse of discretion.
Response: In the final rule the terms replicate and reproduce (or other forms of the word) are no longer used. The EPA is clarifying that the intent of the term in the proposed regulatory text at 40 CFR 30.5 was "reanalyze" rather than "replicate." In the 2020 SNPRM, the EPA proposed using the term "reanalyze" instead of "replicate" and proposed at 40 CFR 30.2 a definition for "reanalyze." In addition, the EPA is modifying the definition of "independent validation" in the final rule by replacing "capable of being substantially reproduced" with "produced." The EPA will not finalize the proposed 40 CFR 30.2 definition of "capable of being substantially reproduced" because the term is not used in the final rule's definition of "independent validation" or elsewhere in 40 CFR 30.
Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information, consistent with existing Agency practice. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation.
Although the EPA is prioritizing transparency in pivotal science, the Agency also recognizes that there will be instances where the underlying dose-response data of pivotal science are unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, a study with underlying dose-response data that are not available should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that are unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator, as detailed under 40 CFR 30.7. One of the criteria the Administrator may use in his/her determination to grant a waiver is whether making the dose-response data available would conflict with laws and regulations governing privacy, confidentiality, CBI, or national security. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
These considerations, the Administrator's exemption, and the EPA's incremental approach to maximizing transparency by first focusing on dose-response data are intended to minimize potential unintended consequences, such as that noted by the commenter. In addition, the EPA is maintaining language from the 2020 SNPRM in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict, and clarifying in this preamble that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers. The EPA believes the rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making.
Including this review of dose-response data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by independent third parties.
Comment: Commenter (12720) asserts that lead regulations and reduction measures resulting from the implementation of science-based EPA regulations are essential for reducing lead poisoning effects in the U.S. population. According to the commenter (12720), since 2001, life-saving EPA standards under TSCA have protected children and families from exposure to lead in paint, dust, and soil, in and around homes and childcare facilities. The commenter also notes that the EPA Lead and Copper Rule (LCR) of 1991 established drinking water protections by requiring tap water monitoring and triggering a public alert and some protective action such as corrosion prevention measures or service line replacement if lead levels exceed 15 ppb. 40 C.F.R. Part 141 Subpart I. The LCR rule applies to water utilities, and the companion Reduction of Lead in Drinking Water Act sets standards for pipes, solder, and other plumbing fittings.
The commenter (12720) provides that the lead rules are based on risk analyses conducted by EPA using epidemiology studies published in the 1990s that correlate childhood blood lead levels with impaired brain function and adverse behavioral effects. The commenter notes that many of the published studies are longitudinal cohort studies that include measurements of lead in blood from children decades ago, and then follow them out over time to observe lasting effects. The commenter states that if these studies are excluded from consideration under the Supplemental Proposal, the integrity of regulations designed to limit exposure to lead would be seriously undermined.
Further, the commenter (12720) adds that precisely because of important EPA regulations and effective lead-reduction measures in gasoline and paint, overall blood lead levels have been reduced in many people. As a result, the commenter states that it is impossible to replicate the exposure conditions at the time the original children in the study cohort had their blood lead levels measured, such as the Port Pirie cohort study population living near a lead smelter in the 1980s. The commenter contends that studies like these -- longitudinal cohort studies, particularly those that capture exposures that may no longer occur -- are not reproducible.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will evaluate the quality of scientific studies when promulgating final significant regulatory actions and finalizing influential scientific information. As described in the preamble to the final rule, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information, consistent with existing Agency practice. The EPA will subsequently consider data and model availability when evaluating pivotal science and give greater consideration to studies where the underlying data and models are available for independent validation. The EPA acknowledges that there may be pivotal science where the underlying data and/or models are not available in a manner sufficient for independent validation. In these cases, the EPA may still use these studies in final significant regulatory actions and influential scientific information after either giving lesser consideration to the study or studies or if the Administrator grants an exemption under 40 CFR 30.9.
Comment: Commenter (12720) provides that mercury is a powerful neurotoxic agent capable of adversely affecting fetus and childhood development in low concentrations. The commenter provides an extensive review of the scientific literature in their comments pertaining to health effects and costs of mercury exposure.
The commenter (12720) notes that the mercury Reference Dose (RfD) is based on recommendations of the NRC of the NAS, that conducted an extensive analysis and calculations derived from three longitudinal epidemiologic studies: the Seychelles Islands, the Faroe Islands, and the New Zealand studies. The commenter states that the studies measured neuropsychological effects in children that were exposed prenatally to methylmercury as a result of pregnant mother's consuming contaminated seafood. The commenter adds that the use of these studies to set EPA exposure limits was the result of a years-long transparent process of expert scrutiny, public engagement, inter-agency cooperation, and publication in scientific journals.
However, according to the commenter (12720), the studies can no longer be reproduced, particularly the Faroe Islands study in which the exposure to the community was a result of eating whales, a practice that has since declined due to public alerts about the hazards of eating the mercury-tainted meat particularly for children and pregnant and breastfeeding women. In addition, the commenter states that it would take decades to repeat the studies, which took decades to conduct in the first place. The commenter notes that if EPA may no longer rely on these studies under the Supplemental Proposal, the Agency will not have access to the information it needs to ensure its regulations are sufficiently protective of public health.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will evaluate the quality of scientific studies when promulgating final significant regulatory actions and finalizing influential scientific information. As described in the preamble to the final rule, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information, consistent with existing Agency practice. The EPA will subsequently consider data and model availability when evaluating pivotal science and give greater consideration to studies where the underlying data and models are available for independent validation. The EPA acknowledges that there may be pivotal science where the underlying data and/or models are not available in a manner sufficient for independent validation. In these cases, the EPA may still use these studies in final significant regulatory actions and influential scientific information after either giving lesser consideration to the study or studies or if the Administrator grants an exemption under 40 CFR 30.9.
Comment: Commenter (12431) states that excluding information that cannot be made publicly available would slow the development and implementation of alternative test methods and strategies to replace animal testing. The commenter states that such approaches can provide information of equivalent or better scientific quality and relevance for risk assessment, and their development and implementation are mandated by the TSCA. The commenter states that this potential conflict between public accessibility and continued progress in regulatory science has been recognized by EPA's Office of Pollution Prevention and Toxics (OPPT). The commenter states that, in its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program, OPPT states that public access to the datasets used to build models that predict human outcomes may not be possible in some cases, because OPPT uses CBI to update and refine its models, and these activities are critical to its mission of evaluating chemicals under TSCA. The commenter states that, under the proposed rule and SNPRM, OPPT could be limited to using only publicly accessible information and open source models. The commenter states that, in some cases, results from commercially available models can be used without the need to release proprietary code, and requiring commercial model developers to release this intellectual property would likely restrict their ability to continue developing and supporting their models. The commenter states that sponsors of new industrial chemicals and agrochemicals sometimes submit chemical and toxicological information derived from proprietary alternatives in lieu of certain animal tests. The commenter states that, under the proposed rule and SNPRM, the EPA may be unable to consider this information, resulting in animal testing that would, in the case of industrial chemicals at least, be conducted in violation of TSCA provisions to use available nonanimal test methods and strategies.
Commenter (12720) states that the epidemiologic science and associated studies that are the basis of adherence to the current EPA's radiation protection standards are likely to be expressly excluded from consideration by EPA by the terms of this Proposal. The commenter notes that the EPA relied on radiation dose-response models to develop its radiation protection reports and regulations.
The commenter (12720) provides that, for the past several decades, these models have been used when developing practical and prudent guidance on ways to protect the public from potentially harmful effects of radiation while, at the same time, balancing the beneficial, justified and optimized use of radiation. The commenter states that these models are derived from studies by authoritative scientific bodies, including the U.S. NAS, and the National Council on Radiation Protection and Measurements (NCRP). According to the commenter, the EPA's proposal, if implemented, would limit EPA's staff from basing regulatory actions on precisely these types of studies by requiring that all the underlying data be publicly shared.
The commenter (12720) states that these are profoundly important studies that have been peer-reviewed for decades and the science that has emerged from them has been validated multiple times. According to the commenter, however, these are not studies where the entirety of the public data can be shared or independently replicated. The commenter expresses that there are no other radiation epidemiologic studies of health and longevity on a large population (example: more than 120,000 individuals in the atomic-bomb survivor studies) that have continued for more than 60 years. Thus, the commenter states that the replication of the studies is impossible and unethical as this data comes from individuals exposed to significant acute and a protracted dose of radiation. The commenter contends that the implementation of the rule would effectively block the use of such key scientific studies and allow for radiation standards to be weakened.
The commenter provides examples of regulations that could be adversely impacted by this rule include:
 Cancer Risk Coefficients for Environmental Exposure to Radionuclides
 EPA Radiogenic Cancer Risk Models and Projections for the US Population (the "Blue Book")
 The Uranium Fuel Cycle (40 CFR Part 190)  -  a standard that sets generally applicable environmental limits for the entire uranium fuel cycle
 Soil cleanup levels for Superfund sites
 The concept of ALARA (As Low As Reasonably Achievable) in radiation protection
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information, consistent with existing Agency practice. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
With this final rule, the EPA is maintaining language from the 2020 SNPRM in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict, and clarifying in this preamble that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
<IP_ADDRESS>.3 Meta-Analyses
Comment: Commenters (9455, 11176, 11911, 12405, 12617, 12720) express concern that, while systematic reviews and/or meta-analyses are often extremely informative in the health and environmental sciences, the proposed rule may discount or exclude such studies.
Commenter (9455) asserts that, because only those studies with accessibility would be allowed into the highly considered level, evaluation of consonance among all high-quality, unbiased studies would not occur under this scheme. The commenter states that this is a glaring scientific gap that disallows full meta-analyses and comparison of all high-quality studies.
Commenter (11176) states that meta-analyses and systematic reviews have become important tools in evidence-based policy making. The commenter states that meta-analyses present a special challenge for data sharing because meta-analyses often do not begin with raw data, but with data that have already been "processed" to some degree (for example, the data may be from the results of primary analyses in the studies contained in the meta-analysis). The commenter states that, in such cases, the definition of raw data underlying the meta-analysis is ambiguous and the author of the meta-analysis may not have access to the underlying data in each study used in the meta-analysis. The commenter states that, even if the data were available for meta-analyses, data repositories for meta-analytic data do not currently exist. The commenter states that systematic reviews, one particular form of meta-analysis, are regularly used by EPA to bring together the many relevant studies and develop a summary weight-of-evidence recommendation. The commenter states that de-emphasizing such analyses could greatly weaken the EPA's ability to develop regulations and make them harder to defend in court challenges.
Commenter (11176) notes that researchers are developing multi-level models and privacy-preserving distributed algorithms to draw scientific conclusions based on data stored in multiple locations. The commenter states that related work is also a major focus in medical informatics for data from different hospitals (e.g., electronic health record data and biobank data) while protecting patient privacy. The commenter states that making such data available in any way would be impractical if not impossible.
Commenter (11911) states that the EPA has not addressed the impact of the proposed rule on scientific meta-analyses. The commenter states that, if researchers conclude that the rule's exclusion covers meta-analyses that incorporate some studies with underlying, unavailable, data, this would threaten the reliability of the meta-analyses themselves. The commenter states that the entire purpose of a meta-analysis is to aggregate large numbers of scientific studies, incorporating different datasets and research methods that span years. The commenter states that designating a study as having no evidentiary value simply because the underlying data cannot be made publicly available is arbitrary, and would result in a less accurate, or biased, average estimate. The commenter states that it would reduce the sample size of a meta-analysis, making it more difficult to draw legitimate statistical conclusions. The commenter states that doing so is inconsistent with the EPA's own guidance for conducting meta-analyses, which states that studies should be weighted according to their sample size or standard error.
Commenter (11911) states that the harmful effects of categorical-exclusion policies can be witnessed in the recent proposals to repeal and replace the 2015 Clean Water Rule. The commenter states that the Agency excluded studies for reasons such as study age, type of wetlands, sample size, and lack of summary statistics. The commenter states that each of those issues could be addressed by weighting the studies appropriately as part of a meta-analysis.
Commenter (12405) states that the herbicide paraquat is currently undergoing reregistration review. The commenter states that over the past few decades, studies consistently show a correlation between exposure to pesticides and Parkinson's disease, but that full breadth of data may not be reviewable by EPA under the current proposal. The commenter states that, for example, a meta-review examined 40 studies and concluded, "epidemiologic studies suggest a relatively consistent association between exposure to pesticides and an increased risk of developing [Parkinson's disease], despite differences in study design, case ascertainment and definition, control selection, and pesticide exposure assessment." The commenter states that many of these studies would be excluded from consideration under the proposed rule.
Commenter (12617) expresses concern that, while systematic reviews and meta-analyses are often extremely informative in the health and environmental sciences, it is unclear how the SNPRM applies to such studies. The commenter asks if the data access requirements apply to every study considered in a review or meta-analysis and, if so, systematic reviews and meta-analyses would be, in effect, universally ineligible for consideration at EPA.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how pivotal science would be selected. As discussed in the preamble to the final rule, rather than considering all studies that support the assessment of the relationship of a dose or exposure of a pollutant, contaminant, or substance to the magnitude of a predicted health or environmental impact as "pivotal science," the EPA is balancing transparency and feasibility by focusing on those studies that inform the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect. Thus, "pivotal science" includes only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. In some cases, there may be a large number of studies that are used to characterize a dose-response relationship (e.g., where the dose-response is based on a meta-regression of epidemiology studies); however, not all of these studies would be considered pivotal science. In the context of this rule, studies informing the dose-response modeling (e.g., benchmark response selection), studies identifying data for toxicokinetic adjustments, or studies informing the selection of uncertainty factors do not drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information.
The final rule also clarifies how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges, and agrees with commenters, that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
The EPA also clarified in the preamble to the final rule that the requirements in the final rule set the overarching structure and principles for transparency in the EPA's significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes EPA administers.
<IP_ADDRESS>.4 Coronavirus Disease 2019 (COVID-19) Implications
Comment: Commenter (12411) states that the proposed rule will limit the EPA's ability to create scientifically informed clean air regulations, which is especially reckless, right now, as the world faces COVID-19. Scientists have made the link between poor air quality and increased COVID-19 related health risks.
Commenter (12458) states that a large body of research has linked air pollution to premature death over the past several decades but in the current COVID-19 crisis, several preliminary studies have linked air pollution specifically to higher rates of COVID-19 fatality. The commenter contends that functionally excluding these kinds of public health studies would undermine public health at any time and to do so during a public health crisis is starkly at odds with the Agency's obligation to protect human health.
Commenter (12430) provides that a recent report from the Harvard T.H. Chan School of Public Health studied data from 3,000 counties and found that the presence of particulate matter in the atmosphere could increase the severity of COVID-19 cases. Specifically, it concluded:
 A small increase in long-term exposure to PM2.5 leads to a large increase in COVID-19 death rate, with the magnitude of increase 20 times that observed for PM2.5 [fine particulate] and all-cause mortality. The study results underscore the importance of continuing to enforce existing air pollution regulations to protect human health both during and after the COVID-19 crisis.
 Other studies will likely follow; indeed, U.S. EPA has already directed the Science Advisory Board to investigate "[e]nvironmental [f]actors affecting transmission and severity of COVID-19." More specifically, U.S. EPA has requested that the Science Advisory Board examine the following questions:
 Can particulate matter in the atmosphere serve as a vehicle for the transmission of SARS-CoV-2?
 Does exposure to air pollutants, including wildland fire smoke or other air pollutants (e.g. ozone, particulate matter, diesel exhaust, pollen) increase the susceptibility to respiratory viruses like SARSCoV-2? Or exacerbate existing COVID-19 infection?
 Does ambient or indoor temperature or humidity affect the transmission of SARS-CoV-2 and severity of the COVID-19 illness?
To the extent that current or future studies on these issues rely upon restricted data or models, the commenter contends that the supplemental proposal would prevent U.S. EPA from considering them. As a result, it would interfere with U.S. EPA's long-term efforts to address this virus or potential future ones.
Commenter (12692) states that, as summarized by E&E, Stanford Children's Health doctor, Lisa Patel, warned that the Rule would "bar the agency from using the latest scientific research on air pollution and disinfectants amid rapidly evolving public health crises." In other words, the commenter provides that the Transparency Rule would somehow prohibit EPA from posting and updating a list of recommended disinfectants for use against COVID-19. The commenter contends that is beyond ridiculous. The commenter states that the Transparency Rule applies only to "pivotal regulatory science" and "influential scientific information" (85 FR 15405) and that nothing in either the original proposal or the subsequent supplemental would prevent EPA from recommending the use of hydrogen peroxide or ammonium chloride (the chemical in disinfectant wipes) to kill viral pathogens on contaminated surfaces.
Commenters (10045, 11378, 11386, 11403, 14397, 12617) express concern that studies that could be usefully relied upon during a pandemic or other crisis would be systematically excluded from being used in EPA's scientific and regulatory efforts if this rule is finalized.
Commenter (10045) states that COVID-19 provides an example of the public health risks of this proposal. The commenter states that placing time-consuming barriers to the use of scientific information could in some cases be more than a mere annoyance or ministerial task; it could be fatal. The commenter states that the following are three examples of research that would seem highly applicable to EPA's responsibilities to respond to the COVID-19 pandemic:
 A March 2020 survey of existing research that describes the interaction of several coronaviruses on surfaces with biocidal agents; the EPA is responsible for recommending disinfectants for use against SARS-CoV-2 and other pathogens.
 A 2003 paper which describes a statistical correlation between SARS fatalities in China and higher exposure to air pollution, information that could be relevant to EPA air officials as new criteria pollutant standards or air quality advisories for those at risk of the most adverse effects of COVID-19 are developed.
 A 2015 paper that describes the challenges associated with the sterilization and disposal of medical waste contaminated by Ebola; the EPA worked jointly with CDC to develop disposal and sterilization guidelines and could be called on to do the same for SARSCoV-2.
Commenter (10045) states that, since the proposed rule would systematically exclude studies that do not meet the EPA's criteria for independent validation, critical studies that would otherwise inform influential scientific information will not be used or incorporated into key documents such as the Integrated Scientific Assessment for Particulate Matter. The commenter states that this document is informed by studies that show that air pollution exposure increases the risk of developing lower respiratory infection. The commenter states that an examination of Table 5-10 of this document reveals that many of these studies are epidemiological papers analyzing the numbers of hospital visits or other medical outcomes in locations all around the world on days when air pollution is high. The commenter states that it is highly likely that some or all of these studies would be presumptively excluded from being used by EPA's rule, which means that they could cease to be incorporated into updates of EPA's Integrated Scientific Assessment, and thus excluded from being used both to inform the EPA's criteria air pollutant regulatory efforts as well as to inform policymakers seeking to assess the influence of air pollution on and develop and implement measures to mitigate COVID-19 (or other future national or global challenges).
Commenter (11378) contends that confidential and proprietary geospatial data, including remotely sensed satellite imagery, location tracking of individual mobility, and georeferenced demographic and health information (which can reveal identity), play essential roles in environmental and health research. The commenter states that, for example, the U.S. response to the COVID-19 pandemic depends on temporarily restricting human mobility and tracing the spatial contacts of infected individuals in order to mitigate disease transmission, which both rely on confidential, individual-level geospatial location data for monitoring and modeling. The commenter states that the proposed rule suggests that such research could be discounted unless the underlying data, containing real-time whereabouts of individuals, be made available to the public.
Commenter (11386) states that the proposed rule discounts the use of study conclusions based on publicly unavailable data. The commenter states that an example of when this policy may be harmful is in the case of a quickly evolving health emergency such as the current COVID-19 pandemic. The commenter states that, in this case decisions may need to be made quickly based on the science that is available at the time, which may be incomplete or may not have had enough time to undergo the thorough cleaning, scrubbing, and organization that would be necessary to safely and lawfully make that data publicly available. The commenter states that, by not considering such data in these situations the EPA may respond poorly to important public health emergencies as a result of this rule.
Commenter (11403) states that the current COVID-19 pandemic has highlighted just how important it is for government agencies to be able to use health data in decision making. The commenter states that future studies on the spread and effects of the virus would be limited by the availability of the raw data, which is rightly protected by HIPAA. The commenter states that, for example, any studies drawing a comparison between instances of predisposition to respiratory illness in areas of poor air quality to cases of COVID-19 would be excluded from consideration by EPA. The commenter states that studies of this nature are of critical importance for an environmental health agency, and restricting the degree to which they may be considered is irrational.
Commenter (12617) expresses concern that the proposal places an extra burden on research that helps the world understand and fight the COVID-19 epidemic; the requirements to make all the raw data public while somehow attempting to protect people's medical information. The commenter states that one striking study showed a strong correlation between risk of death from the disease and exposure to particulate air pollution; and states that this work, at least after peer review, ought to be allowed to inform rules on particulate emissions.
Commenter (14397) states that the current coronavirus pandemic is an excellent example of a health crisis that could be exacerbated by this SNPRM. The commenter states that an article in The Independent quotes James Goodwin, senior policy analyst at the Center for Progressive Reform as saying: "A lot of the science needed to effectively respond to this pandemic would not be available if this rule existed today." The commenter states that these fears were echoed by Senator Tom Carper who stated "the ongoing COVID-19 pandemic has illustrated the importance of ensuring rapid access and response to scientific information, as well as the utilization of that information." The commenter states that it is difficult to see how the research community could, under this proposal, learn anything from this pandemic while still following the appropriate HIPAA regulations. The commenter states that those who survive this crisis can be thankful that this proposal was not in affect at the time of the initial outbreak, as virtually no medical data could be immediately shared with epidemiologists or researchers under that scenario.
Commenter (12701) asserts that the current pandemic underscores the need for decision-making of federal agencies, including the EPA, to be informed by the best available science. For example, the commenter provides that policymakers need to understand scientific evidence regarding environmental transmission of the coronavirus and how environmental factors such as air quality might impact COVID-19 outcomes. According to the commenter, the supplemental proposal would not adequately allow the EPA to prioritize the best emerging scientific studies when assembling influential scientific information necessary to inform the best policy.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how the Agency will consider the availability of underlying dose-response data of pivotal science when promulgating significant regulatory actions or developing influential scientific information. As described in the preamble to the final rule, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information, consistent with existing Agency practice. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
The EPA believes that the approach described in the final rule will result in significant regulatory actions and influential scientific information based on the highest quality, most relevant studies and ensure adequate human health and environmental protections while maximizing transparency and maintaining consistency with the statutes the EPA administers.
The EPA would like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedures and does not direct or require any outside entity or the EPA to establish data sharing mechanisms. Further, the rule does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science.
Finally, the EPA acknowledges that the COVID-19 situation is unprecedented. The EPA's most important environmental statutes provide the Agency with the authority to issue emergency orders or respond to address emergencies to protect human health and the environment. This final rule would not limit or impede the EPA's authority to undertake such responses. Moreover, the final rule includes sufficient flexibility in terms of the considerations in 40 CFR 30.5, the Administrator's exemption in 40 CFR 30.7, and the EPA's incremental approach to maximizing transparency by first focusing on dose-response data in order to minimize potential unintended consequences, such as a potential impact during a crisis situation. In addition, the EPA is maintaining language from the 2020 SNPRM in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict, and clarifying in this preamble that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers. The EPA believes the rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making.
<IP_ADDRESS>.5 Comments on Other Commenters' Science Limitation Concerns
Comment: Commenter (12692) disputed/commented on several claims regarding the limiting of science/data as a result of the proposal made by a commenter (Deborah Wallace, Ph.D. in Ecology) as follows:
      Claim: The proposal would thwart meta-analysis, or research that analyzes studies across disciplines, because many studies would be excluded.
      Comment: A meta-analysis is the use of statistics to summarize the results of other studies. Nothing in the Transparency proposal would prevent EPA analysts from conducting or reviewing meta-analyses. The new emphasis on independent validation might, however, make meta-analyses more useful by making the underlying studies more reliable.
Response: Based on a consideration of these and other similar comments, the EPA clarified in the final rule how pivotal science would be selected. As discussed in the preamble to the final rule, rather than considering all studies that support the assessment of the relationship of a dose or exposure of a pollutant, contaminant, or substance to the magnitude of a predicted health or environmental impact as "pivotal science," the EPA is balancing transparency and feasibility by focusing on those studies that inform the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect. Thus, "pivotal science" includes only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. In some cases, there may be a large number of studies that are used to characterize a dose-response relationship (e.g., where the dose-response is based on a meta-analysis); however, not all of these studies would be considered pivotal science. In the context of this rule, studies informing the dose-response modeling (e.g., benchmark response selection), studies identifying data for toxicokinetic adjustments, or studies informing the selection of uncertainty factors do not drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information.
As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
Comment: Commenter (12692) states that the Environmental Protection Network (EPN) cites an article titled "All science should inform policy and regulation" by Stanford professor John Ioannidis, the most prominent replication crisis scholar. Ioannidis warns that EPA's plan to "ban the use of scientific studies for regulatory purposes unless all their raw data are widely available in public and can be reproduced," would have dreadful consequences: "science would be practically eliminated from all decision-making processes. Regulation would then depend uniquely on opinion and whim."
In response to this, commenter (12692) states that Dr. Ioannidis' description of EPA's proposal is a caricature. The commenter notes that the EPA is not proposing to "ban" the use of studies unless the raw data are "widely available." The EPA is proposing a system of "tiered" access including the use of highly restricted "data enclaves."
The commenter (12692) provides that independent researchers seeking access to data involving PII would be subject to the same legal requirements and penalties that prevent the original researchers from publicizing confidential information. And that is only if such access is legally permissible. As noted, the commenter states that the EPA's goal is to "ensure that, over time, more of the data and models underlying the science that informs regulatory decisions . . . is available to the public for validation in a manner that honors legal and ethical obligations to reduce the risks of unauthorized disclosure and re-identification" (83 FR 18770).
Additionally, the commenter (12692) states that banning studies with inaccessible data would eliminate most science used in rulemaking precisely because of the replication crisis Dr. Ioannidis has documented and brought to national attention.
Response: As described in the preamble to the final rule, the EPA will review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information, consistent with existing Agency practice. The EPA will continue to use the following, established factors to assess the quality of studies used to develop significant regulatory actions and influential scientific information: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. Only later in the process, after study quality has been assessed, the EPA will then identify those studies considered to be pivotal science. When evaluating those scientific studies considered to be pivotal science -- in either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation.
Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
<IP_ADDRESS> Legal Validity of Ignoring Studies
Comment: Commenter (11894) states that if EPA plans to comply simply by ignoring studies that do not meet the new requirements, an assessment of the legal validity of that approach would also be required. According to the commenter, the EPA has not done this and apparently, as with many other issues, throws the burden on commenters to figure out what it meant and why.
Response: As described in the preamble to the final rule, the rule establishes how the EPA will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. The rule does not provide for categorically excluding or ignoring studies. Because the final rule does not categorically exclude any studies from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating significant regulatory actions and developing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
Further, the EPA intends for the final rule to be implemented in a transparent manner. The EPA expects to identify pivotal science, and the consideration afforded to pivotal science, in proposed significant regulatory actions and external review drafts of influential scientific information, which will allow the subject matter experts, if they so choose, to independently validate the pivotal science and provide comment to the EPA. Additionally, the final rule requires the EPA to document the rationale for exemptions granted by the Administrator to the requirements included in the final rule in the significant regulatory action or influential scientific information.
Comment: Commenter (10944) states that any use of the supplemental proposal to nullify research data used as the basis for existing regulations is in direct violation of the fourteenth amendment as the reductions in environmental regulations are more burdensome to communities of color, low income communities, and children.
Response: The EPA would like to clarify that the final rule applies prospectively to significant regulatory actions and influential scientific information; the final rule has no retrospective effect on either significant regulatory actions or influential scientific information. Further, the final rule does not violate the Fourteenth Amendment to the United States Constitution and does not deprive any person of due process or equal protection under the law. The EPA would also like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedures and does not direct or require any outside entity or the EPA to establish data sharing mechanisms. The rule also does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science.
 Moreover, as described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider underlying dose-response data availability when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. Although the EPA is prioritizing transparency in pivotal science, the EPA acknowledges that there may instances where the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7.
<IP_ADDRESS> Health and Environmental Protection Implications
Comment: Many commenters (9336, 9338, 9372, 9455, 10055, 10749, 10865, 10866, 10974, 10975, 11103, 11190, 11192, 11330, 11354, 11359, 11370, 11377, 11390, 11393,11403, 11407, 11479, 11482, 11487, 11496, 11576, 11895, 11907, 11920, 12405, 12411, 12412, 12422, 12423, 12430, 12435, 12463, 12474, 12688, 12707, 12716, 12727, 13549) express that, as a result of the rule limiting the use of science to inform regulatory and policy decisions, there will be adverse health and/or environmental protection implications. Several of these commenters also contend ￼ [See also comments and EPA's response to comments in Chapter 13, section 13.4 (Limits Use of Science When Making Policy and Regulatory Decisions).] A sample of the specific comments follow:
 Commenter (11920) states that while the original proposal was seriously flawed, the supplemental notice dramatically expands the reach and impact of this arbitrary and unlawful effort to restrict the EPA's use of valid and credible peer-reviewed science. By excluding high-quality, peer-reviewed, and validly published science from the regulatory decision-making process, the commenter contends that the proposed rule undermines the integrity of these laws and will result in under-informed and inadequate protections for vulnerable communities of people and for wildlife. According to the commenter, a plain reading of this supplemental notice reveals that through restricting the use of relevant and high-quality scientific information, the EPA is seeking to protect polluters and regulated industries, rather than carry out its statutory mandate to protect the environment and American citizens.
 Commenter (12435) states that the degradation in air quality that would surely result from this proposal would undermine public health while we are fighting a pandemic respiratory virus for which conditions such as asthma and COPD are serious risk factors.
 Commenter (12435) states that the supplemental proposal asserts that the action "does not establish an environmental health or safety standard." According to the commenter, while there are no specific standards included in the proposed rule, it has a direct impact on the data and models that can be relied on as the basis of environmental health or safety standards that demonstrably affect minority and low-income populations.