Commenter (12435) states that the supplemental proposal asserts that the action "does not concern an environmental health risk or safety risk." To the contrary, the commenter asserts that the proposed rule could limit the ability of the Agency to consider all relevant data and models when making decisions that could have a direct impact on environmental health or safety of children. The commenter notes that children are considered a vulnerable class under the Federal Policy for the Protection of Human Subjects or "Common Rule" and dissemination of data from studies of children are even more stringently regulated than for the general adult population. Therefore, the commenter contends that it is reasonable to expect that environmental health studies involving children would be disproportionately discounted under the proposed rule, leading to regulations that do not adequately protect this sensitive population as required by the CAA. Further, the commenter adds that the proposed rule could restrict states ability to protect public health and the environment at EPA-lead CERCLA sites if EPA fails to consider data or models that might allow a greater level of protection.
 Commenter (11393, 11407, 11895) expresses that this rule would preclude EPA from considering important and pertinent scientific health studies that contain personal medical information which cannot be publicly released. The commenter contends that the rule would create barriers to regulations and arbitrarily deny consideration of important findings, thereby restricting EPA's ability to protect human health and the environment.
 Commenter (11482) states that the proposed rule has implications for environmental health associated with the oceans, a core advocacy objective of Ocean Conservancy's mission.
 Commenter (11330) states that this proposed rule will be used to erode landmark advancements -- achievements in public health and environmental safety. For example, the commenter notes that they know the Clean Power Plan would have led to reductions in pollution that were predicted to prevent some three -- thirty-six hundred premature deaths, ninety thousand asthma attacks in children, and three hundred thousand missed school and work days each year. The commenter states that many of these health benefits were partially determined by landmark clean air studies like the Harvard Six City study. The commenter contends that this is equivalent to telling CDC they can't use health data when fighting the coronavirus.
 Commenter (11390) states that the proposed rule, if adopted, will impose serious costs to public health and safety. The commenter contends that eliminating the consideration of relevant science from the decision-making process based solely on the availability of underlying data would compromise EPA's ability to effectively carry out its mission to protect public health and the environment.
 Commenter (9455) contends that contrary to the assertion that this proposed rule has no environmental impact, it would open current regulations to dilution or even elimination and needed new regulations to dilution or failure to be promulgated. Thus, the commenter suggests that it potentially would return the country to the days of killer smogs, rivers catching fire, widespread poisoning of fetuses and young children with heavy metals, massive illegal dumping, and extinction of species from persistent pollutants.
 Commenter (12411) states that not only will this proposed rule be detrimental to the development of environmental and public health regulations, but it will also hurt businesses across all sectors by intensifying the climate crisis and impacting air, water, and wildlife.
 Commenter (12716) states that, in addition to threatening environmental harm, the rule would jeopardize critical programs (e.g., NAAQS) that protect human health in the watershed and throughout the country.
 Commenter (11576) notes that EPA has relied on well-established studies conducted before mechanisms existed for sharing data publicly in its assessments of the environmental risks of pesticides. The commenter also mentions that bioaccumulation data's inclusion in the supplemental proposal and the potential for undermining established science on the accumulation of mercury, lead, and other metals in aquatic systems and wildlife.
Conversely, commenter (11899) argues that critics claim the rules will exclude so much research that the rules will actually endanger public health. In fact, the commenter states that only studies EPA will likely not see is what researchers know will not survive robust peer review, and thus do not submit in the first place. According to the commenter, the real danger comes from research that is based on shoddy data, algorithms, models and analyses that past researchers have been able to keep secret. The commenter contends that is precisely what the rules will ferret out and correct.
Commenter (11479) states that, with the proposed rule's implementation, underserved communities are likely to face exacerbated harms from hazardous chemicals like ethylene oxide (EtO), which is known to increase the risk of certain cancers. When conducting the 2014 National Air Toxics Assessment, the commenter provides that the EPA determined that a number of communities are now exposed to EtO levels higher than the level that EPA has deemed safe. Because EPA was able to conduct this science-based assessment, the commenter states that it could pursue policy options to alleviate harm. For instance, the commenter notes that the EPA's Office of the Inspector General recently highlighted the need for EPA to take prompt action to inform and act on concerns from residents living near EtO-emitting facilities. However, the commenter states that if the proposed rule, as modified by the supplemental notice, is implemented, the EPA will lose the ability to rely on important scientific evidence for its internal risk assessments, likely resulting in less protective policies. According to the commenter, communities like St. James, Louisiana -- plagued by EtO levels up to 765 times higher than the levels EPA considers safe -- would be unaware about the risks they face and lose the ability to advocate for policy mechanisms that reduce those risks.
The commenter (11479) notes that another example concerns the aforementioned chemical class Per- and PFAS. EPA is currently developing regulations for PFAS chemicals, like proposing maximum contaminant levels for PFOA and PFOS in drinking water. But because research from the C8 Science Panel studies relied on human health data from tens of thousands of people, the commenter is concerned that this research could be excluded or down-weighted under the proposed rule. According to the commenter, this would weaken the scientific legitimacy of EPA's regulatory decisions and endanger public health. Since evidence suggests that PFAS contamination occurs far more frequently near communities of color and low-income communities, the commenter adds that the proposed rule is likely to disproportionately affect underserved communities.
In addition, commenter (11479) states that, under the proposed rule, as modified by the SNPRM, the EPA would be prevented from using much of this crucial research, because it relies on personal health information that cannot legally or ethically be disclosed in many cases. The commenter states that such restrictions on EPA's ability to rely on relevant scientific research on air pollution and health -- even research that the EPA itself funded -- will hinder the Agency's ability to enact health-protective NAAQS and other public health and environmental protections that the Agency is charged with enacting.
Commenter (11576) refers to detailed examples of influential human-health studies that necessarily relied on sensitive human data. The commenter states that such studies have led to the crucial strengthening of public-health protections by, for example, linking exposure to chemicals to the risk of disease. The commenter states that the SNPRM expands the scope of studies that might be subjected to the rule, which could greatly weaken public-health protections.
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.
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 does not agree that this rulemaking is counter to the Agency's mission or that it would weaken human health protections. 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 approach described in the final rule will result in significant regulatory actions and influential scientific information based on the highest quality, most relevant studies and ensure adequate human health and environmental protections while maximizing transparency and maintaining consistency with the statutes the EPA administers.
Comment: Commenter (12411) states that, overwhelmingly, scientists agree that a man-made climate crisis is upon us, warranting the need for strong environmental regulations now more than ever. The commenter notes that the impacts from the climate crisis, such as rising oceans and disruptions to supply chains, pose existential threats to our entire economy, indeed to human life itself. Unchecked, the commenter adds that the climate crisis will impact gross domestic product (GDP) by $44 trillion in just the next 40 years, while a study from the Brookings Institute says by 2100, climate impacts will slash global GDP by more than 20 percent. Yet, the commenter states that this proposed change would require scientific studies to make all their raw data public, including confidential medical records, or else not be considered for future environmental rulemaking processes. According to the commenter, while public statements from the EPA have deemed this a step towards transparency, it will in fact do just the opposite by limiting legitimate research that goes into creating clean water, clean air, and other vital regulations for the environment and public health because of privacy requirements. The commenter adds that this proposed rule does not make long-term business sense, as environmental and public health regulations directly affect businesses and their workers.
Similarly, the commenter (12411) expresses that the proposed rule will weaken clean water protections. The commenter provides that clean waterways are vital for sectors like breweries, the seafood industry, and the hospitality industry. The craft brewing industry contributed $76.2 billion to the U.S. economy in 2017, more than 500,000 jobs, and depends heavily on clean water to create a high-quality product for its consumers. The commenter adds that consumers spend $887 billion annually on outdoor recreation overall, and nearly $175 billion on fishing, kayaking, rafting, canoeing, scuba diving and other water sports alone  -  all of which thrives on a visibly healthy water supply. Further, the commenter states that clean water is important for the real estate industry  -  home values can erode by as much as $85,000 each on land near water with high nutrient pollution levels. Lastly, the commenter states that a clean water source allows each of these industries to provide safe products and activities for their customers to enjoy, while also reducing the cost of water treatment for each sector.
Commenter (12707) contends that both safe recreational enjoyment of the Great Lakes and water quality are threatened by EPA's proposal. The commenter provides that the availability of scientific data has been key to addressing important public health issues in the Great Lakes, such as the development of the 2012 Recreational Water Quality Criteria (RWQC), "designed to protect the public from exposure to harmful levels of pathogens in water-contact activities." The commenter states that the RWQC sets recommended concentration thresholds of known pathogens that cause gastrointestinal illness from exposure in water, such as E. Coli and enterocci. The commenter adds that these recommendations are informed by "the latest research and science, including studies that show a link between illness and fecal contamination in recreational waterways." According to the commenter, these recommendations provide essential information for determining warnings and beach closures for recreational users in the Great Lakes region.
Finally, the commenter (12707) states that with the rise of toxic harmful algal blooms (HABs) in the region safe drinking water has become a primary concern. The commenter provides that the EPA's 2015 Drinking Water Health Advisories for Two Cyanobacterial Toxins provide necessary guidance based on scientific studies that indicate the health effects of exposure to cyanotoxins, such as gastroenteritis and liver and kidney damage. The commenter notes that cyanotoxins, similar to pathogens like E. Coli and enterocci, pose serious health risks from exposure in recreational settings as well. According to the commenter, this relatively new area of concern is still being studied and access and use of the latest research as it continues to evolve is critical to protecting the safety of drinking water and recreation in the Great Lakes region.
Response: The EPA does not agree that this rulemaking is counter to the Agency's mission or that it would weaken environmental protections. As further detailed in the preamble to the final rule, the rule will not limit research. The requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making. 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.
Finally, as described in the preamble to the final rule, that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
Comment: Commenter (12430) states that the supplemental proposal would preclude U.S.EPA from researching and fully considering the health and economic impacts to disadvantaged communities. The commenter notes that this would include both the impacts of increased exposure to pollution from nearby sources and the increased rates of illness and death from heightened vulnerability to the effects of pollution. Studies related to environmental justice are often conducted at the community level. The commenter states that it would not be possible to organize the participants into larger and less identifiable groups and be able to fulfill the purpose of the studies, which is to identify the health impacts at the community level. The commenter adds that grouping in this way is costly, time consuming, and would result in a data set that would not have the same analytical power as the original study. The commenter further adds that grouping would also reduce the locational sensitivity of the data and make more local and community-based studies unusable.
The commenter (12430) states that community level studies by CalEPA agencies -- including those required under state law and important for environmental justice considerations -- would not be considered by U.S. EPA under the SNPRM, if finalized. The commenter provides that the proposal would, for example, exclude multiple studies of the effects on children of prenatal pesticide exposure.
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.
Comment: Commenter (9455) provides extensive background information in their comment letter regarding her and colleagues' research related to the examination of public health outcomes from structural stress, i.e. chronic stress that arises out of socioeconomic disempowerment that the affected individual and community can neither fight nor flee. The commenter states that structural stress such as job strain, economic insecurity, racism, and sexism gives rise to numerous health impairments such as increased coronary heart disease (Marmot et al, 1997, abstract attached), low-weight births (Geronimus, 1996, abstract attached), metabolic syndrome and diabetes (Rosmond and Bjorntorp, 1998, abstract attached; Bjorntorp, 2001), Alzheimer's Disease and other dementias (Elovainio et al, 2009; Wang et al, 2012 ), chronic obstructive pulmonary disease (Clark et al, 2015), high blood pressure (Michaels et al, 2019), disturbed sleep patterns (Johnson et al, 2016), and obesity and the consequences of obesity (Brunner et al 1997; Bjorntorp, 2001). The commenter adds that these outcomes of structural stress indicate deterioration of underlying health in the afflicted and that many outcomes are identical to those of environmental exposures and raise the probability that structural stress and environmental exposures interact to reinforce each other and increase community incidence and prevalence of health impairments well beyond what they would be if the community had to contend with only one of the two afflictions, the well-known non-linear synergistic effect. The following examples are provided:
      Example 1. Incidence of Low-Weight Births. My own work revealed that geographic and temporal patterns of low-weight births in New York City reflected the years and neighborhoods subjected to "planned shrinkage", an extra-legal mode of urban renewal (Wallace 2011, full text attached). The discovery of the temporal patterns depended on medically confidential data on individuals. Discovery of geographic patterns depended on administrative datasets that, in turn, depended on medically confidential data (birth certificates). Other researchers (examples: Laurent et al, 2016, abstract attached; Twum et al, 2016, abstract attached) have shown that exposure to air pollutants also results in raised incidence of low-weight births, findings that depended on medically confidential data. Are we, as a nation, going to experiment with babies born to women in low income communities and brutally segregated communities of color by failing to properly regulate air pollution and seeing whether these chemicals and particles interact with structural stress to produce enormous increases in incidence of low-weight births? That would be a consequence of implementing the proposed rule.
      Example 2. Lead Body Burden Interacting with Structural Stress. Another example of how the structural stress/environmental interaction plays out involves body burden of lead. The literature on the harmful effects of lead stretches back for many decades. In the latter half of the 20th Century, effects of low exposures to lead on fetuses, babies and small children formed the basis of much regulation of air-borne, water-borne, and surface-borne lead (soil and painted surfaces). These publications depended on confidential medical data. Needleman et al (1996) studied a cohort of boys in Pittsburgh to document whether lead body burden associated with impulsivity and potential for violence. To the authors' surprise, lead body burden associated with these traits only in the African-American boys. The demographic data in the paper hint at different processes and stresses within the black and white populations in the study area: the black subcohort numbers remained fairly stable during the several years of study, but white numbers dwindled rapidly. White families moved out of the study zone but black families did not. The answer to the puzzle came, not from Needleman's team but from the social psychiatrist Mindy Fullilove in her 2005 book Root Shock which described urban renewal in several US cities and its impact on the affected communities and individuals. Pittsburgh was one of those cities. Additionally, the University of Pittsburgh, in the 1980's-1990's, bought up large tracts of "slums" and evicted the residents (personal communication, Mindy Fullilove, 2008). Pittsburgh and the University degraded and destabilized the so-called slum neighborhoods. The white families could flee but the black families had to shift around, even doubling up in the remaining housing, because of housing segregation practices and because of the need for survival to maintain community ties. Thus, Needleman, unknown to himself, was dealing with an afflicted black community and a disappearing white one. The dose/response pattern of lead body burden with impulsivity and potential for violence detected only in the black subcohort reflected the synergism of community destruction and lead body burden. Carol Stack (1974) documented how poor black families rely on a dense social network of women to survive. Ida Susser (2012) documented how poor white families rely on a dense social network of women to survive. Destruction of poor neighborhoods, especially deliberate destruction by public policies such as urban renewal and planned shrinkage (the withdrawal of essential services such as fire service and sanitation) shred these vital networks but have differing impacts on black and white families because of pervasive and illegal housing segregation maintained by such practices as racial steering and refusal to sell or rent to black families and individuals. Massey and Denton (1993) documented these practices in the late 1980's-early 1990's but they persist into the present. For example: the NYS Attorney General is now investigating racial steering by realty agents on Long Island (Newsday, 2019). Housing injustice, thus, imposes a broader and deeper structural stress on black than white communities, as well as the unraveling of social networks on which families rely for survival. It is but one of the many race-based disempowering outcomes of oppressive policies that erode the underlying health of individuals and communities of color. The bodies of residents of oppressed communities reflect the chronic and acute institutionalized violence directed against them and cannot cope with environmental exposures with the same efficacy that is shown by less-oppressed individuals and communities. Present and future regulations and policies on lead must rely on confidential medical data. The proposed rule would constitute yet another avenue of chronic and acute racial oppression.
      Example 3. Traffic Fumes and Violence: Raised Incidence of Asthma. Rosalind Wright's team at Harvard studied a cohort of children in poor communities of Boston (Clougherty et al, 2007, full text attached). One important study result was that children exposed to both traffic fumes and violence had much higher incidence of asthma. Since 2007, similar studies in other venues have confirmed the Boston findings. The website Pubmed produces a long list of peer-reviewed publications when search terms are "asthma and violence". The list includes several papers documenting the greater incidence of asthma in the aftermath of the 9/11 World Trade Center attack among people exposed to the dust and suffering from PTSD. This 2007 paper is an example of one supported by consonant results from other studies.
The commenter (9455) contends that barriers to new regulations and policies imposed by the proposed rule would constitute environmental injustice by continuing unjust exposures that interact with socioeconomic factors to produce patterns of worse health and higher mortality rates in low-income communities and communities of color.
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.
As discussed more fully in the preamble of the final rule, the rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making. The EPA believes that the approach described in the final rule will result in significant regulatory actions and influential scientific information based on the highest quality, most relevant studies and ensure adequate human health and environmental protections while maximizing transparency and maintaining consistency with the statutes the EPA administers.
Comment: Commenter (10749) states that, since this proposed rule will apply to all research that the EPA uses, many studies that have found strong associations between adverse health effects and environmental hazards would also be discarded, such as evidence that links mercury from power plants to impaired brain function and lead in paint dust to behavioral disorders in children. Commenter suggests that a consequent decrease in air quality standards would lead to more air pollution across the United States, resulting in a higher prevalence of asthma, respiratory diseases, and cancer, especially among children. The commenter states that these high cost-to-treat diseases will cause more people to seek out medical attention leading to higher rates of hospitalization and a higher burden on the healthcare system and hospitals.
Commenter (10865) states that, if the EPA excludes studies or diminishes the consideration of studies because the data cannot be made public, children and their families may be exposed to real harm. The commenter states that the resulting policy decisions affecting millions of children would be based on inadequate information that fails to include well-supported studies by expert scientists.
Commenter (12430) contends the SNPRM would allow public availability of data to supersede the evaluation of scientific quality by independent expert peer reviewers, to the detriment of public health in both routine regulatory actions and crises that rely on the federal government's use of science. The commenter states that it would reduce the consideration given to many important, high-quality studies (or preclude that consideration entirely) and could even distort the practices used to conduct certain studies in the first place.
Commenter (12707) asserts that the negative effects of the SNPRM on individual EPA programs would be far reaching and would undermine the EPA's ability to protect air and water quality across the Midwest. The commenter states that foundational studies about the impact of air pollution on public health are in the bullseye of this proposal --  indeed, they have been the target of legislative efforts to restrict Agency science for years. The commenter states that these studies have been reviewed numerous times and found to be sound and appropriate. The commenter states that, under the EPA's proposed rule, however, they could be out of bounds, compromising the Agency's ability to truly assess the impacts of air pollution and to set national air health standards at a level that will protect the public health, as required by the CAA. The commenter states that less protective standards will mean even more air pollution in our communities.
Commenter (12707) contends that the elimination of these studies would skew the evaluation of costs and benefits, inappropriately minimizing the public health benefits. The commenter states that artificially suppressing the benefits will lead to less protective rules that will not be based on a true accounting of the cost to the public in terms of public health impacts.
Commenter (12720) states that the Proposal and Supplemental Proposal has clear adverse consequences for cost-benefit analyses that consider the substantial costs of health effects caused by exposure to air pollution. The commenter notes that this area of work includes efforts to address carbon dioxide (CO2) pollution and climate change, such as the Clean Power Plan. The commenter asserts that health and air quality-related monetized benefits from reducing PM2.5 pollution, a co-benefit of CO2 reductions, would be substantially reduced if EPA is unable to rely on the best available science for pollution-health impacts.
The commenter (12720) that in its proposed rule repealing the Clean Power Plan, EPA signaled this approach: the economic health benefits of PM2.5 reduction were zeroed-out by EPA after levels reached the current annual NAAQS (12 μg/m3), The commenter states that this approach of using the NAAQS or LML as a safe threshold directly contradicts the best available science, and EPA's own stance on the pollution threshold issue as recently as 2012, more than even the current EPA dose-response approach for PM2.5 exposure assumes.
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 disagrees that implementation of the rule would either eliminate key health studies or minimize public health benefits. The benefits of greater data transparency and the significance of reanalyzing and validating study results are well-documented in scientific literature. McNutt (2014) noted, "reproducibility, rigor, transparency, and independent verification are cornerstones of the scientific method." The National Academies of Sciences, Engineering, and Medicine (NAS) workshop on Reproducibility and Replicability in Science also noted that "certainly, reproducibility and replicability play an important role in achieving rigor and transparency." Munafò et al. (2017) state, "the credibility of scientific claims is rooted in the evidence supporting them, which includes the methodology applied, the data acquired, and the process of methodology implementation, data analysis and outcome interpretation. Claims become credible by the community reviewing, critiquing, extending and reproducing the supporting evidence. However, without transparency, claims only achieve credibility based on trust in the confidence or authority of the originator. Transparency is superior to trust." The 2019 NAS workshop on Reproducibility and Replicability in Science also concluded, "the scientific enterprise depends on the ability of the scientific community to scrutinize scientific claims and to gain confidence over time in results and inferences that have stood up to repeated testing."  The EPA agrees that data transparency is vital for individuals who have not contributed to the study to be able to verify the quality and strength of published studies and finds that the benefits of reanalysis are especially important for data that drive the quantitative requirements or analyses of EPA significant regulatory actions or influential scientific information. Implementation of this rule will more effectively share pivotal science for external consideration and, thus, increase the opportunity for independent subject matter experts to validate pivotal science, and as the dose-response data are better understood through independent reanalysis the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information. Further, the rule offers 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.
As described in the preamble to the final rule, 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.
As discussed more fully in the preamble of the final rule, the rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations and privacy considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making. 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.
<IP_ADDRESS> EPA Programs
<IP_ADDRESS>.1 Need for Assessment of Impact on EPA Programs and Regulations
Comment: Commenter (11395) asserts that EPA did not evaluate the impact of the proposed rule on the existing regulations and programs that have been adopted to implement those laws. The commenter provides that EPA has not provided an analysis of how the requirements in this regulation would affect key studies that support the periodically updated IRIS risk assessments, which are used to support regulations adopted pursuant to several of those statutes and that it is irresponsible to proceed with adopting this rule without such an analysis.
Commenter (11894) contends that EPA has failed to address how it can refuse to apply these new requirements to data and models used to support Pre-manufacture Notices (PMNs) given express direction from Congress to the Agency to consider data quality. The commenter provides that EPA has not addressed the issue of applicability to this program at all, or addressed the impacts on the public health or the environment if it did. Furthermore, the commenter notes that EPA has not explored the resources that would be needed to respond.
Commenter (12403) contends that the proposed rule and the SNPRM do not provide meaningful assessments of the cost of implementing the rule or of the impact of the rule on existing regulations and programs. The commenter notes that on the other hand, a 2019 SAB draft report identifies a number of costly activities that implementation would require, including establishing an office for data-sharing, funding replication studies, promulgating guidance on methods and analysis, developing tiers of public access, and conducting data reanalysis. The commenter provides that these costs should be thoroughly assessed prior to finalization of the rule.
Response: The EPA agrees that neither the 2018 proposed rule nor the 2020 SNPRM included a characterization of costs or benefits of the proposed action. As discussed in the preamble to the final rule, this is a rule of internal procedure promulgated under the EPA's housekeeping authority and imposes no enforceable duty on any state, local, or tribal governments or the private sector. Additionally, this rule does not require the EPA or other parties to disclose or host data. Hence, this rule does not impose costs on the EPA or any other party to make such data available. The EPA recognizes there will be some incremental review and administrative costs to the Agency but anticipates these will be small. In addition, the Agency may opt, at its discretion, to incur the costs associated with making data available when it is in the public interest to do so, but that will be decided on a case-by-case basis and is not a requirement of the final rule.
The main benefits of this rule spring from greater transparency in significant regulatory actions and influential scientific information. By placing greater emphasis on the availability of dose-response data underlying pivotal science, the rule will allow for greater scientific scrutiny as EPA decision makers are developing significant regulatory actions and influential scientific information and increases the likelihood that any errors will be identified and corrected. Greater transparency is also inherently valuable as a principle of good government and provides benefits to the public at large, including reducing the risk of errors in EPA analyses and in the science such analyses rely upon. The ability for independent subject matter experts to validate pivotal science will facilitate more effective comment and engagement with the public during development of future significant regulatory actions and influential scientific information.
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>.2 Superfund National Priorities List
Comment: Commenter (11894) discusses the Superfund National Priorities List (SNPL) and EPA's three-tier hierarchy to select human health toxicity values for use in risk assessments to guide those cleanups. The commenter notes that these Superfund risk assessments do not set absolute legally binding standards but rather presumptive levels. The commenter asserts that the methodology under which the assessments are conducted expressly recognize that EPA should take action to reduce public health risks using the best available science without waiting for further study to improve the certainty of the toxicity values. According to the commenter, insisting on certainty leads to delay, which has its own costs.
The commenter (11894) contends that if the final science transparency rule applies retroactively to every one of these toxicity values will have to be re-examined. The commenter states that if the human toxicity studies underlying these values fail to meet the new tests of transparency and reproducibility, the cleanup levels for air, water and soil based on these toxicity values will be discredited. Furthermore, the commenter provides that as a result, the cleanup actions underway at all 1335 Superfund sites will be undermined, as well as the cleanups completed at 424 sites that have been deleted from the SNPL. Meanwhile, the commenter notes that if the final science transparency rule applies only prospectively to new toxicity values, EPA will still need to revise the hierarchy of human health toxicity values to incorporate the new transparency and reproducibility requirements. The commenter asserts that EPA will incur significant costs and time replacing the hierarchy, the toxicity values, and the cleanup levels at many sites.
Commenter (12720) states that the expansion to "influential scientific information" would impact cleanup levels at the 1,335 sites on the SNPL. Should the human toxicity studies underlying toxicity values used at these sites be discredited due to the failure to meet the new requirements, the commenter asserts that cleanup actions at all sites will be undermined, as well as the cleanups at the 424 sites that have been deleted from the SNPL.
Response: This rule sets the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information. The final rule provides that if implementing the rule results in any conflict between this rule and the environmental statutes that the EPA administers, and their implementing regulations, this rule will yield and the statutes and regulations will be controlling. 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 is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. 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.
The EPA would also 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.
<IP_ADDRESS>.3 Safe Drinking Water Act Programs
Comment: Commenters (11894, 12720) provide that EPA's proposal will affect two major elements of EPA's SDWA program: drinking water health advisories and human health benchmarks for pesticides in drinking water. According to the commenters, neither the advisories nor the benchmarks are enforceable, but water utilities often use them when their source water is contaminated with a pollutant for which there is no federal drinking water standard. The commenters contend that if the final science transparency rule applies retroactively to influential scientific information, every one of these advisories and benchmarks will have to be re-examined. The commenters maintain that if the human and/or animal toxicity studies underlying these advisories and benchmarks fail to meet the new tests of transparency and reproducibility, the treatment provided by utilities for these pollutants will be discredited. The commenters also provide that if the final science transparency rule applies only prospectively to new advisories and benchmarks, EPA will still need to replace the current methodologies for these recommended values in order to incorporate the new transparency and reproducibility requirements. According to the commenters, EPA will incur significant costs and time replacing these methodologies and recommendations.
Response: This rule sets the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information. The final rule provides that if implementing the rule results in any conflict between this rule and the environmental statutes that the EPA administers, and their implementing regulations, this rule will yield and the statutes and regulations will be controlling. 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 is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. 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.
Comment: Commenter (6901) states that federal regulations are the basis for the actions of state drinking water programs in protecting public health. The commenter contends that the SDWA has clear statutory language that requires regulations to be based on sound science to appropriately protect public health. According to the commenter, while states may disagree at times with details of the final regulations, states are generally comfortable with the transparency of the regulatory development process as practiced by the Office of Ground Water and Drinking Water (OGWDW). The commenter does not recommend making significant changes in that process. In fact, the commenter suggests that, if other environmental programs do not currently have a robust science-based regulatory development process, the process used by OGWDW would be a good model.
Commenter (6901) states that the SDWA statutory language in §1412(b)(3) requires the use of "best peer reviewed science and supporting studies conducted in accordance with sound and objective scientific practices." Therefore, according to the commenter, a statutory requirement that the drinking water regulations have a strong scientific basis already exists. The commenter states that this section of the SDWA also outlines the way this information must be shared with the public, so the process is currently transparent. The commenter provides that the EPA has followed this statutory mandate since the 1996 SDWA Amendments and has relied not only on peer reviewed scientific studies but has also directly involved the scientific community in supporting rule development. The commenter adds that states have also been active participants in this science-based process. The commenter suggests that the rule development currently underway for perchlorate is a good example of the process at work. According to the commenter, recommendations from the SAB helped guide the methodology to develop the Maximum Contaminant Level Goal (MCLG) and the EPA has held two peer reviews to help refine the models and determine how best to apply the modeling to determine the appropriate MCLG. The commenter states that the SAB and the peer review process are all open and the recommendations are public, providing full transparency to the deliberations and decisions.
Response: This rule sets the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information. The final rule provides that if implementing the rule results in any conflict between this rule and the environmental statutes that the EPA administers, and their implementing regulations, this rule will yield and the statutes and regulations will be controlling.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 specific criteria for determining "pivotal science" may necessarily be specific to the authorizing statute, as well as the significant regulatory action or the influential scientific information. The EPA intends to explain in each significant regulatory action and for influential scientific information how the pivotal studies were identified
<IP_ADDRESS>.4 Aquatic Life Criteria
Comment: Commenter (11894) notes that aquatic life criteria have been published for 47 toxic chemicals. The commenter provides that these criteria are designed to protect plant and animal life in surface water bodies from both short and long-term exposures to pollutants. Additionally, the commenter states that human health criteria have been published for 120 toxic chemicals, two pathogen indicators, and two harmful algal bloom toxins. The commenter contends that if the final science transparency rule applies retroactively, every one of these criteria will have to be re-examined. The commenter asserts that if the studies and bioaccumulation models underlying any of these criteria fail to meet the new tests of transparency and reproducibility, the enforceability of state water quality standards will be undermined since most such standards are based on the EPA criteria. According to the commenter, if the final science transparency rule applies only prospectively to new criteria, EPA will still need to replace the current methodologies for both aquatic life and human health criteria in order to incorporate the new transparency and reproducibility requirements. The commenter states that EPA will incur significant costs and time replacing these methodologies and water quality criteria. Despite this major impact, the supplemental notice provides no estimation of the costs and benefits.
Response: As further described in the preamble to the final rule, based on public comments and other considerations, the EPA is concentrating its efforts in the final rule to increase transparency of dose-response data, as the dose-response data are discrete and the dose-response assessment is a well-defined and impactful step in the quantitative assessment of risk. The rule does not apply to dose-response models or other types of data and models, including the bioaccumulation
Further, as discussed in the preamble to the final rule, 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. Therefore, existing water quality criteria would not be impacted by this rule.
This rule sets the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information. The final rule provides that if implementing the rule results in any conflict between this rule and the environmental statutes that the EPA administers, and their implementing regulations, this rule will yield and the statutes and regulations will be controlling. 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 is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. 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.
The EPA would also 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.
<IP_ADDRESS>.5 Clean Water Act (CWA)
Comment: Commenter (12720) provides that the CWA requires each state to develop TMDLs for every waterbody the state identifies as having uses impaired because of pollution. According to the commenter, if EPA disapproves a state TMDL, EPA must develop a replacement TMDL. The commenter contends that if the final science transparency rule applies retroactively, over 65,000 TMDLs will have to be re-examined.
The commenter (12720) contends that if the model underlying a TMDL fails to meet the new tests of transparency and reproducibility, the enforceability of the state's point source permit limits and nonpoint source controls based on that TMDL will be undermined. The commenter states that if the science transparency rule applies only prospectively to new TMDLs, EPA will need to disapprove any new TMDL based on a proprietary model since such a model would not meet the new transparency and reproducibility requirements. The commenter provides that whether the science transparency rule applies retroactively or prospectively, EPA will incur significant costs and time replacing TMDLs.
Response: As further described in the preamble to the final rule, based on public comments and other considerations, the EPA is concentrating its efforts in the final rule to increase transparency of dose-response data, as the dose-response data are discrete and the dose-response assessment is a well-defined and impactful step in the quantitative assessment of risk. The rule does not apply to dose-response models or other types of data and models.
The water quality criteria that support TMDLs may be applicable to this rule if they are classified as influential scientific information. As discussed in the preamble to the final rule, 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. Therefore, existing water quality criteria would not be impacted by this rule.
This rule sets the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information. The final rule provides that if implementing the rule results in any conflict between this rule and the environmental statutes that the EPA administers, and their implementing regulations, this rule will yield and the statutes and regulations will be controlling. 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 is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. 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.
<IP_ADDRESS>.6 NAAQS
Comment: Commenter (11479) asserts that the coverage of influential scientific information would be problematic for EPA programs with reoccurring rulemakings, such as NAAQS, because it would prevent adequate implementation of the review.
Commenter (12720) contends that many scientific interpretation activities at EPA, including legally-mandated reviews of the NAAQS, are projects that build upon a growing scientific evidence base. The commenter provides that for example, the recently-completed ISA and Policy Assessment for Fine Particulate Matter rely on scientific data and models and other information previously synthesized by the Agency for prior reviews. The commenter notes that in this case, the Agency is consulting thousands of peer-reviewed studies that already meet significant requirements established by 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 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.
In addition, with this final rule, the EPA is maintaining language from the 2020 SNPRM in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict, and clarifying in this preamble that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
Comment: Commenter (12727) states that some actions EPA intends to cover with this rule, such as ISAs that inform NAAQS, are based on an assessment of overall confidence in an at-risk factor (i.e., a factor that potentially increases the risk of air-pollutant related health effects for individuals in certain subpopulations), and excluding one or more studies showing a relationship between that factor and adverse health effects could tip the balance toward, for example, recommending a change in the NAAQS. Thus, the commenter asserts that arbitrarily ignoring rigorous studies at one or multiple stages of the regulatory process could alter critical health and environmental protections and would be illegal.
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.
In addition, 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>.7 Toxic Substances Control Act Programs
Comment: Commenter (11894) states that TSCA §4 gives EPA authority to require chemical manufacturers to test their product for several reasons, one of which is that "there is insufficient information or experience to determine or predict the effects of these activities." The commenter contends that the new data availability requirement would logically imply that in assessing the "sufficiency" of effects information on a chemical, EPA will have to avoid reliance on studies without data disclosure, and instead order manufacturers to conduct new and conforming studies to replace the studies that do not meet the disclosure standards. The commenter queries whether EPA is legally obliged to apply its own view of high standards of data quality to the implementation of a statute for which Congress expressly made data quality a central implementation concern, and if not, why not?
Response: In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers. The EPA will undertake such efforts in forthcoming actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule.
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 is unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation.
In addition, the EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. 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. The provisions of the final rule also do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses, and influential scientific information and/or pivotal science that meet one or more of the exemptions identified in Section IX of the OMB Final Information Quality Bulletin for Peer Review.
<IP_ADDRESS>.8 Pesticide Restrictions and Approvals
Comment: Commenter (11576) states that the SNPRM lists environmental-fate studies and models as an example of the types of studies included in its new, broader scope. The commenter states that these data and models are critical for the EPA's assessments of the environmental risks of pesticides, for example, and the Agency has relied on well-established studies that were conducted before mechanisms existed for sharing data publicly. The commenter states that this requirement would place an uneven burden on data requirements for pesticide restrictions compared to that required for pesticide approvals, especially if implemented retroactively.
Response: Based on comments and other considerations, the EPA is concentrating its efforts in the final rule to increase transparency on dose-response data, as further described in the preamble to the final rule. The EPA is maintaining the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. 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. The provisions of the final rule also do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses, and influential scientific information and/or pivotal science that meet one or more of the exemptions identified in Section IX of the OMB Final Information Quality Bulletin for Peer Review.
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> General Delay
Comment: Commenter (11360) contends that the current COVID-19 pandemic is showing the necessity of scientific expertise in decision-making. The commenter states that the speed of the release of the virus' genetic code was unheard of, and that making that information available to other researchers who wanted to study it, unleashed a massive collaborative effort to understand the mysterious new pathogen that rapidly spread across the world. The commenter provides that if EPA's proposed transparency rule was in place at that moment, it seems like there would be a need to determine a) whether this type of information sharing would meet the rule's requirements and/or b) whether they require independent validation or a case-by case exemption from the rule's applicability before they could be used for EPA decision-making purposes. The commenter asserts that even if these and other relevant studies were ultimately deemed to be eligible for use under this rule, this proposed rule would clearly establish barriers and result in fatal delays to using the best available science to inform EPA's actions.
Response: The EPA considered this and other similar comments when developing the final rule and does not believe that the final rule will result in any meaningful delay in promulgating regulations because of the limited application of this rule to pivotal science underlying significant regulatory actions and influential scientific information. Additionally, this rule does not require the EPA to disclose or host data, but to determine if the dose-response data underlying pivotal science are available and to give greater consideration to pivotal science for which dose-response data are available in a manner sufficient for independent validation.
Comment: Commenter (11408) states that the rulemaking would likely also be costly in terms of the forgone benefits that would occur as a result of the additional regulatory delays that it would create. The commenter contends that the "cost" of one year's delay of some of the EPA's biggest CAA rules could be measured in thousands of premature deaths and tens of thousands of asthma attacks and missed school and work days. The commenter asserts that as legal scholars across the political spectrum recognize, the rulemaking process has become extraordinarily slow, due in large part to the combination of agencies' dwindling resources and the proliferation of additional procedural and analytical requirements that agencies must satisfy before issuing new rules. The commenter contends that as a result, it already can take anywhere from five to ten years for the most complex rules to complete the rulemaking process. The commenter provides that in 2012, the Government Accountability Office found that OSHA spent an average of seven years on each of its major rulemakings.
Further, the commenter (11408) contends that implementation of this rulemaking would only exacerbate this problem, leading to even more costly delays that harm public health, safety, financial security, and the environment. The commenter recommends that to better fulfill its mission of protecting public health and the environment, the EPA should be exploring opportunities to streamline its processes for issuing new safeguards  -  not making the problem of alarming delays even worse.
Commenter (11495) notes that in an era of limited EPA funding, the expanded scope of the supplement potentially would overrun the Agency's capacity to review data and the studies relevant to any review process. The commenter provides that just handling these challenges for a single Agency action, such as reviewing the Particulate Matter ("PM") NAAQS with its over 2,000 references, would be an enormous undertaking and it begs the question whether any newly adopted system hosted by the EPA can handle what it is requesting in the Supplemental Notice.
Commenter (11890) maintains that the cost of delays for EPA programs should be considered. For example, the commenter provides that it would take considerable staff time to track down data owners and obtain consent from all studies included in a typical IRIS review. The commenter questions several aspects of this process: Will all study authors need to consent? If the study was funded by a consortium, will all participating companies need to consent? What about companies that have since been purchased by others? Will the EPA be asking international and privately funded researchers to provide data access only when a specific requester submits a request or must they provide data to a data repository to comply? The commenter states that this rule will likely further deteriorate the EPA's ability to comply with statutory reassessment deadlines in a number of programs, causing delays that keep EPA from updating their assessments and meeting its mission of protecting human health and the environment.
Response: The EPA considered this and other similar comments when developing the final rule and does not believe that the final rule will result in any meaningful delay in promulgating regulations because of the limited application of this rule to pivotal science underlying significant regulatory actions and influential scientific information. Additionally, this rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to those studies for which dose-response data are available in a manner sufficient for independent validation.
Comment: Commenter (12720) highlights concerns of Senator Thomas Carper's letter to the EPA Administrator that explains that the Supplemental Proposal's "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" because it could significantly delay EPA's ability to make timely use of critical public health research. The letter notes that
      If EPA's rule was in place, before these studies could be used by EPA decision-makers there would, at minimum, be a time-consuming review needed in order to determine a) whether they meet the rule's requirements and/or b) whether they require independent validation or a case-by case exemption from the rule's applicability before they could be used for EPA decision-making purposes. Even if these and other relevant studies were ultimately deemed to be eligible for use under this rule, this rule would clearly establish barriers and delays to using available science to inform EPA's response.
Within the text of the Supplemental Proposal, the commenter (12720) provides that EPA has not explained what safeguards are in place so that new public data release requirements do not inhibit EPA's response to public health emergencies. The letter also notes that
      it is also possible 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 well before the next pandemic or other crisis occurs if this rule is finalized.
The commenter (12720) notes that the Supplemental Proposal includes a provision that gives the EPA Administrator the ultimate authority to decide which studies are exempt from new public data release requirements. As applied to the current crisis, the commenter contends that the Supplemental Proposal's requirements for public data release conflict with the Executive Branch's approach to releasing data and models within the context of the current COVID-19 response. For example, the commenter provides that a White House representative recently told reporters that the COVID-19 task force "has not publicly released the models it drew from out of respect for the confidentiality of the modelers, many of whom approached the White House unsolicited and simply want to continue their work without publicity."
The commenter (12720) contends that EPA runs the risk of discouraging researchers from working with the Agency to quickly and safely meet the challenges presented by the COVID pandemic. Additionally, the commenter states that EPA's failure to explain how the Supplemental Proposal would not obstruct the Agency in responding to emergencies is further evidence that the Supplemental Proposal is arbitrary and capricious, an abuse of discretion, and otherwise unlawful.
Response: The EPA considered this and other similar comments when developing the final rule and does not believe that the final rule will result in any meaningful delay in promulgating regulations because of the limited application of this rule to pivotal science underlying significant regulatory actions and influential scientific information. Additionally, this rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to those studies for which dose-response data are available in a manner sufficient for independent validation.
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.
Comment: Commenter (12692) contends that the independent validation of all data used in hundreds of decisions regarding permits and product approvals would be quite impracticable, bringing the daily work of the Agency to a screeching halt, and imposing unreasonable burdens on the private sector. The commenter notes that this "lack of consistency" in application is valid due to the difference in scope, number, and consequence. The commenter provides that if consistent application across all actions was sound logic, all NEPA proceedings would require full-blown environmental impact statements. According to the commenter, there would be no provision for shorter environmental assessments, much less categorical exclusions for actions an Agency has determined have no significant impact on the human environment.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the potential broad impact of these actions and assessments on American lives and livelihoods. 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. The provisions of the final rule also do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses, and influential scientific information and/or pivotal science that meet one or more of the exemptions identified in Section IX of the OMB Final Information Quality Bulletin for Peer Review.
With this final rule, the EPA is maintaining language from the 2020 SNPRM in 40 CFR 30.3 stating that statutory requirements and corresponding implementing regulations will control in the event of any conflict, and clarifying in this preamble that the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
Comment: Commenter (10045) states that, even if relevant studies were ultimately deemed to be eligible for use under this rule, this rule would clearly establish barriers and delays to using available science to inform the EPA's response. The commenter states that, if the EPA's rule were in place, before these studies could be used by EPA decision-makers there would, at minimum, be a time-consuming review needed in order to determine a) whether they meet the rule's requirements and/or b) whether they require independent validation or a case-by case exemption from the rule's applicability before they could be used for EPA decision-making purposes.
Commenter (10742) expresses concern that the EPA has not analyzed whether the additional time needed to upload information to this database would delay rulemaking, which, in turn, would allow additional pollution to continue, potentially costing years of human life.
Commenter (11408) states that having the EPA acquire a collection of raw data would be burdensome to both the Agency and study investigators, and create major delays in rulemaking.
Commenter (11576) has concerns with respect to the practicability of requiring all information to be made available, given unequivocal statutory deadlines embedded within environmental statues.
Commenter (12412) suggests that, by not using the best available science, the SNPRM may delay regulations on emerging contaminants, such as PFAS. The commenter states that, with the exclusion of the best available science, regulations like this will likely be delayed much longer, due to the need for more studies which have all data publicly available, and may not be accurate, due to the exclusion of a portion of the best available science. The commenter states that this delay in proposing regulations could harm public health in the future, especially in communities, such as tribes, which are disproportionately exposed to environmental contaminants.
Commenter (12430) asserts that, if a team of researchers investigated and published in a top medical journal, following a rigorous peer-review process, urgent information about the health effects of lead, the SNPRM could preclude or delay EPA consideration of this information. The commenter states that, if the study relied on extensive exposure analyses with county-level data on household wipe samples and vital signs in populations of concern, the SNPRM would prohibit or undermine EPA consideration of the study until the time-consuming process of redacting PII from the raw data was complete, if even possible. The commenter states that, further, another team of scientists could publish an inferior study without county-level or demographic data, albeit with underlying data made available, that does not help state and local officials identify hot-spots based on county results or populations of concern. The commenter states that, depending on the proposed alternative, the SNPRM would either favor the inferior study or prohibit EPA experts from considering the superior study. The commenter states that such an outcome would fall short of the Agency's statutory duties and would adversely affect public health.
Response: The EPA clarified 40 CFR 30.5 that it will give equal consideration to dose-response data that are publicly available or available through restricted access. As discussed in the final rule, underlying dose-response data are considered available if they can be accessed through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. Therefore, a redaction of the PII in the hypothetical example may not be necessary in order for the study to be fully considered as the EPA promulgates significant regulatory actions or develops influential scientific information. The EPA would like to emphasize that such behavior would be purely voluntary on behalf of the researchers; the rule does not regulate the rights and obligations of any party outside of the EPA let alone have legal force and effect on them.
Further, 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 is unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. Title 40 CFR 30.5(d) provides additional factors that the Agency shall use when determining the consideration to afford pivotal science with data that is unavailable for independent validation. The EPA could also give pivotal science with underlying dose-response data that is unavailable for independent validation full consideration upon receiving an exemption from the requirements of this rule from the Administrator as detailed under 40 CFR 30.7.
Further, the EPA considered this and other similar comments when developing the final rule and does not believe that the final rule will result in any meaningful delay in promulgating regulations because of the limited application of this rule to pivotal science underlying significant regulatory actions and influential scientific information. Additionally, this rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to those studies for which dose-response data are available in a manner sufficient for independent validation.
The EPA does not agree that this rulemaking is counter to the Agency's mission. The EPA believes that the approach described in the final rule will result in significant regulatory actions and influential scientific information based on the highest quality, most relevant studies and ensure adequate human health and environmental protections while maximizing transparency and maintaining consistency with the statutes the EPA administers.
Comment: Commenters (11400, 11480, 12546) express concern that the proposal could result in substantial delays as studies are subjected raw data availability, reanalyzes, and independent validations.
Commenter (11400) asserts that this rule would make the process of seeking to use well established studies onerous and lengthy, as persons are forced to re-analyze data and apply for consideration and access. The commenter states that this rule would likely result in a lengthy, bureaucratic process to use epidemiological studies. The commenter states that, following the suggested model for tiered access, researchers would have to submit a research proposal outlining the need for restricted use data. The commenter states that the government is still developing standard data repositories. The commenter states that studies would have to be reviewed for meeting the criteria; researchers would need to apply to have the study considered or exempted; interested parties would have to redact information or see if it could be reanalyzed and validated. The commenter states that these are burdensome and time-consuming requirements, that would keep scientists from evaluating and relying on relevant studies. The commenter states that this rule will impede timely actions to protect public and environmental health.
Commenter (11480) states that tactics to demand access to raw data and selective reanalysis is a key part of the strategy that corporations from the tobacco, diesel, chemical, and pharmaceutical industries, among others, have used for decades to question the science underlying regulation and other information disseminated by government agencies (regulatory and non-regulatory). The commenter states that lobbyists have attempted many legal maneuvers to formalize processes for raw data availability and reanalysis to undermining science involved in rulemaking over the decades, from the Shelby Amendment in Fiscal Year (FY) 1999 omnibus appropriations act to this SNPRM.
Commenter (12546) objects to the proposal's statement that "approaches to increasing access to data and models can often allow stakeholders to reanalyze the data and models and explore the sensitivity of the conclusions to alternative assumptions." The commenter asserts that this sets a dangerous precedent, opening the policy and rulemaking processes to potentially endless debate via "reanalysis", "alternative models", and "independent validation" by stakeholders who may have a vested financial interest (and capability) to impact or perpetually delay critical policies to protect public and environmental health.
Commenter (12715) states that, although data may technically be "available," it is likely to be difficult to obtain and often may not be received by the requestor until after the comment period ends, if at all. The commenter states that, if this is the case, it is unlikely that interested parties would be able to obtain the information in a manner timely enough to allow for their own review and comment within any timeframe designated by EPA.
Response: The EPA considered this and other similar comments when developing the final rule and does not believe that the final rule will result in any meaningful delay in promulgating regulations because of the limited application of this rule to pivotal science underlying significant regulatory actions and influential scientific information. Additionally, this rule does not require the EPA to disclose or host data, but to determine if dose-response data are available and to give greater consideration to those studies for which dose-response data are available in a manner sufficient for independent validation.
The EPA disagrees that implementation of the rule would result in a lengthy process in order to use epidemiology data. The final rule includes sufficient flexibility in terms of the allowance for restricted access, 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 to minimize such potential unintended consequences. The EPA recognizes there will be some incremental review and administrative costs to the Agency but anticipates these will be small.
<IP_ADDRESS> Research Impacts
<IP_ADDRESS>.1 Burdens on Researchers Outside EPA
Comment: Commenters (10974, 11377, 11404, 11495, 12422, 12718, 12727) assert that the rulemaking will impose substantial burdens on researchers and that the supplemental notice adds to those burdens. According to the commenters, these burdens may result in the reduction of future studies necessary for policymaking due to the perceived difficulty of adjusting study designs to meet the new requirements with constrained resources. Additional comments and responses to comments on monetary costs to researchers are included in section <IP_ADDRESS> of Chapter 14. Examples of specific comments follow:
Commenter (11377) states the expansion of scope increases the already substantial burden that this rule would place on researchers to ensure the privacy and confidentiality of research subjects by including influential information rather than only regulatory decision-making information.
Commenter (11495) takes issue with the EPA's position that the proposed policy "exclusively pertains to the internal practices of EPA." The commenter contends that if implemented, the proposed policy would impact a wide range of external stakeholders, including scientists, research volunteers who participate in environmental health studies and the general public.
The commenter (11495) states that while the specific mechanisms regarding how this rule would be carried out has not been described in either the original proposed rule or this latest supplement, it is clear that many of the burdens of this Supplemental Notice would fall to the individual investigators and their institutions. The commenter contends that at a minimum, there would be a shared responsibility between individual researchers and EPA staff to carry out the requirements of the Supplemental Notice. The commenter provides that given that the burden of these new requirements far exceeds the EPA's capacity, most of these new responsibilities imposed by the Supplemental Notice would necessarily fall on individual researchers outside of the Agency to complete.
Additionally, the commenter (11495) asserts that contrary to the EPA's assertions in the supplement, this proposed rule would dictate the conduct of scientists outside the federal government and would place burdens on individual researchers that would go beyond just the time and resources required to adhere to these new requirements. The commenter states that if promulgated, the proposed rule would place an enormous strain on researchers as they decide whether they are able to comply with the rule. The commenter provides that on one hand, if a scientist does not share the data out of concern for violating consent agreements and breaching subject privacy, then the EPA will give less weight to the study in policymaking; on the other, if a scientist inadvertently discloses information in a way that violates data use agreements or contractual obligations, they may leave themselves open to legal action, dismissal, or have restrictions placed on their ability to conduct research in the future. The commenter notes that this is not an easy decision for scientists committed to generating and disseminating knowledge useful for the public good.
Commenter (11495) states that it is possible that fewer scientific studies will be performed and made available to the scientific community due to an awareness by potential study participants or researchers that underlying data will be released to the public, potentially subjecting them to privacy intrusions or harassment by regulated industry.
Commenter (12405) asserts that, if the EPA's rule takes effect, it could introduce selection bias that may slow studies and alter results and thereby affect regulatory decisions. The commenter states that large-scale population studies rely on many people  --  often numbering in the thousands  --  to reveal sensitive or private information. The commenter states that studies may have difficulty recruiting or retaining volunteers if the researchers are required to make deidentified data publicly available as some may be more hesitant to share their information. The commenter states that those who are willing to participate may be different from others in ways that cannot currently be predicted or described, which could introduce confounding variables and biases that may question the study's results.
Commenter (12422) provides that these new strictures will be particularly burdensome to the environmental health research community, ironically imposing substantial new costs during a time of drastic proposed research funding cuts. The commenter notes that epidemiologic research will be particularly challenged. According to the commenter, epidemiology is the foundation of public health, providing essential evidence of the distribution of disease, risk factors, and vulnerable populations. The commenter contends that while it remains to be determined how this historical evidence would be considered under this proposed rule, the implications are ominous for public health measures that have improved the health of millions of Americans.
The commenter (12422) asserts that many in the scientific and regulatory communities recognize the importance of transparency and access to the data underlying important studies. The commenter states that addressing these issues can be accomplished without injuring the scientific enterprise or discouraging scientists from pursuing pressing scientific questions. The commenter provides that mechanisms to accomplish this that do not require new regulation include development of public access databases, use of the FOIA, and reanalysis by third parties. The commenter notes that certain journals, for example require authors to agree to make their data available to editors and others upon request.
Commenter (11404) states that the concepts in the SNPRM would negatively impact future studies. According to the commenter, this proposed regulation could have the unintended consequence of tainting the epidemiological research process. The commenter notes that if this proposal were adopted, epidemiological researchers may feel pressured to modify their research processes to meet the additional standards imposed by the rule, so as to secure federal funding and / or ensure the research can be used in regulatory development. The commenter notes that giving "greater consideration" to studies that are able to make their data available for independent validation, via the SNPRM's alternative approach, would promote this as well. The commenter maintains that the risk would be a less-than-ideal research plan and less robust results.
Commenter (12718) contends that the application of restrictions for data not funded by government, even when such information can be useful for decision-making, is peculiar. The commenter provides that without grant-making powers or resources to support the scientific community or the provision of incentives for shifting expectations and requirements, there is only one logical conclusion about the impact of the regulation in practice  -  instead of transparency, the rule would likely discourage evidence-based policymaking.
Response: The EPA disagrees that this rule would impose costs on third-party researchers. This procedural rule does not regulate the conduct or determine the rights or obligations of any entity outside the federal government. This is a rule of internal procedure that does not impose requirements on any party other than the EPA. This rule imposes no costs on researchers or their institutions, and the EPA will consider and evaluate all relevant and appropriate science in its significant regulatory actions and influential scientific information. The EPA recognizes that researchers and other third parties may voluntarily consider the EPA's position on data availability, as described in this rule, as they make their own decisions about how to conduct research and the extent to which they make data and models available. Researchers may choose to make more data and models available, but the EPA recognizes that these parties will weigh their own benefits and costs and make choices that they deem appropriate.
The EPA agrees with the commenter that data sharing mechanisms already exist; however the rule is not intended to develop public access databases or encourage authors to share their data, as the commenter suggests. The purpose of the rule is to increase transparency by codifying the EPA's own internal procedures for determining the consideration to afford pivotal science according to the availability of underlying dose-response data. The preamble to the rule clarifies that restricted or tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. The rule does not prescribe a particular mechanism but does require the EPA to independently verify that such a mechanism exists for dose-response data underlying pivotal science. As discussed in the preamble to the final rule, the EPA cannot rely on data access statements made by authors to journals. Instead, in order to realize the benefits of open data, the EPA must conduct an independent evaluation of the availability of the data.
Comment: Commenter (10974) states that EPA, in this SNPRM, claims that the proposed rulemaking "does not regulate any entity outside the Federal Government...", and that "the [a]gency recognizes that any entity interested in EPA's regulations may be interested in this proposal." The commenter provides that although this language has not changed from the 2018 NPRM, the commenter still finds that this claim is incorrect, appearing purposefully deceptive. The commenter provides that at the least, this rule would impact how EPA scientists and policy makers are able to consider their own research; at worst, it would impact how epidemiological (and all other) research would be conducted in the future, thereby altering the entire environmental health science and policy landscape.
Objecting to both proposed alternatives at 40 CFR § 30.5, the commenter (10974) states that the EPA Administrator is inappropriately given carte blanche authority to judge research on a case-by-case basis. The commenter notes that when promulgating new standards or rules, EPA is expected to incorporate all available research into their findings  -  even when research results are contradictory, and/or demonstrate a broad range of possible environmental or health outcomes. According to the commenter, in either proposed version of 40 CFR § 30.5, the EPA Administrator could make the decision about what research is "worthy" of use based solely on the availability of underlying data. The commenter states that this decision would undermine, even ignore, factors that are more important for determining the validity of research  -  for example, how well a study was controlled, the power in the results used to make the conclusions, or the relevance of the study variables to the question being investigated.
Furthermore, the commenter (10974) asserts that the proposed change in the criteria for scientific studies' acceptance into decision making at 40 CFR § 30.5 would change how academia, private companies, state, local, and tribal governments, and others must conduct research in order for it to be considered relevant and useable by EPA. The commenter maintains that such a change would undoubtedly also impact how study participants perceive and ultimately decide to participate, or not, in environmental health research. Additionally, the commenter states that research would have to be conducted differently, and that is not merely an internal change in EPA processes and procedures.
Response: As discussed in the preamble to the final rule, the EPA is retaining the Administrator's exemption provision with some added considerations in response to public comments. To ensure that the Administrator's decision is appropriately transparent, in the final rule the EPA has included a provision in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. This documentation would typically be provided as part of the proposed rulemaking given this will be part of the decision of what is the pivotal science for the rule. Regardless, the final rulemaking will provide clear documentation. The EPA is confident that the criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
Further, this procedural rule does not regulate the conduct or determine the rights or obligations of any entity outside the federal government. The EPA disagrees that this rule would impose costs on third-party researchers. This is a rule of internal procedure that does not impose requirements on any party other than the EPA. This rule imposes no costs on researchers or their institutions, and the EPA will consider and evaluate all relevant and appropriate science in its significant regulatory actions and influential scientific information. The EPA recognizes that researchers and other third parties may voluntarily consider the EPA's position on data availability, as described in this rule, as they make their own decisions about how to conduct research and the extent to which they make data and models available. Researchers may choose to make more data and models available, but the EPA recognizes that these parties will weigh their own benefits and costs and make choices that they deem appropriate.
Comment: Commenter (12727) asserts that the costs that this proposal would impose on the research community would likely be significant and pervasive, thoroughly impacting the scientific process. According to the commenter, these costs are even higher than those that would have been imposed under the 2018 proposal because of the wider range of studies and EPA actions encompassed by the supplemental proposal. The commenter states that EPA cannot disregard these costs by claiming that the supplemental proposal does not directly impose requirements upon the research community. The commenter contends that researchers performing public health and environmental studies have an ethical, professional, and personal stake in how their studies are utilized. The commenter provides that it is untenable for EPA to ignore the impacts that this proposal would have on the research community, as if scientists would -- or even could -- conduct their research in a vacuum, with complete indifference to whether their work would be deemed unsuitable for consideration by the nation's top environmental regulator. Some of the specific issues/concerns highlighted by the commenter follow:
Commenter (12727) asserts that attempting to satisfy the rulemaking's parameters would be costly and convoluted for researchers. The commenter notes that the recent SAB report reveals several contexts in which costs for researchers could increase, including "researchers' time to collate data and work with EPA to make these data publicly available," and likely "additional costs that occur at an institutional level (i.e., IRBs) that would be substantial." Furthermore, the commenter provides that "there are legitimate legal, ethical, professional and financial reasons why researchers may be unable or unwilling to fully share `data.'" The commenter states that individual members of the SAB have also observed that study subjects may decline to participate in studies if researchers may ultimately share their data with others, raising serious concerns that researchers who attempt to comply with the requirements of this proposal will have difficulty persuading members of the public to participate in studies, or that participation in such studies may be biased or skewed in ways that would influence the results. The commenter contends that this proposal lacks any discernible benefit, so researchers' efforts to meet EPA's arbitrary strictures would be superfluous to any measures taken to ensure scientific rigor and valid, evidence-based outcomes; such efforts would increase costs and administrative burdens but provide almost nothing in return except checking off EPA's irrational requirements.
The commenter (12727) contends that researchers unable to obtain additional funding would have two options: (1) they could continue their study without meeting EPA's requirements (assuming funders would support a study that the Agency would ignore), with the bleak awareness that its benefit for public health and the environment -- not to mention the researchers' professional advancement -- might be arbitrarily thwarted by EPA or, (2) they might drop the study entirely in order to avoid the Agency's erratic minefield of requirements, which would deprive the entire public of the benefits of their study.
The commenter (12727) states that even if some researchers obtained additional funding to meet requirements, the overall pool of research funding cannot be expected to increase commensurately. Therefore, the commenter provides that if the cost of each study increases, and the total funding remains constant, then fewer studies could be funded; impeding not only studies incompatible with the proposal's arbitrary criteria, but even those that are compatible, drastically winnowing the available body of evidence upon which to base public health protections. The commenter asserts that organizations that devote resources to meet the proposal's requirements "will have to shift funding from ongoing, vital new research to fund this activity, at the net negative cost to the nation's health." The commenter notes that aside from constraining funds available for new research, the proposal would pose unique challenges when applied retrospectively to prior research, possibly precluding the use of past studies, with distortionary impacts on Agency analyses.
Commenter (12727) contends that the introduction of the tiered access alternative in the supplemental proposal raises major additional concerns about the costs to the research community. The commenter states that the tiered access approach would likely be difficult and costly to administer, but EPA has not explained, even in general terms, how this approach would be implemented, the degree of burden it would impose, or who would bear the costs. However, the commenter points to a recent briefing with staff on the House Committee on Science, Space, and Technology, where EPA staff revealed that "key implementation responsibilities [for tiered access] will fall on the research community." The commenter provides that EPA's apparent expectation that it will impose massive new costs on the research community without acknowledging as much in the Supplemental Notice is arbitrary and a violation of notice requirements. According to the commenter, it would further privilege EPA's reliance on studies from wealthy organizations or those with a financial incentive to expend the necessary resources for EPA to consider their work.
Commenter (12727) notes that EPA's arbitrary fixation on the public availability of underlying data would impair scientific research is the deterrent effect on study participants. The commenter asserts confidentiality pledges to study participants are often essential in order to collect accurate and complete information. The commenter maintains that this concept was reinforced by a SAB member, who advised EPA that the possibility of disclosure of PII would "[c]ertainly . . . cause[] some participants to decline participation." The commenter contends that the proposal could encumber the researcher-participant relationship by introducing several unnecessary concerns into the process: (1) some subjects in public health studies may lose confidence that their data will remain confidential; even if researchers withhold the names of study participants, the increased pressure on researchers to release information could instill a reasonable fear in subjects that their data could be traced back to them; (2) if researchers committed to keeping underlying data confidential, subjects might reasonably fear that EPA would arbitrarily disregard the findings of the study, lowering their incentive to participate, EPA seems to acknowledge that study participants are motivated in part by the potential impact of a study on public health protections; (3), by imposing new requirements for data availability that have no scientific basis, EPA may create a false impression that the public release of data is an indicator of study quality, this could deter participants from participating in studies for which data will be kept confidential.
The commenter (12727) contends that as a result, scientific research would become more arduous and expensive; fewer studies could be performed, to the detriment of public health policy at EPA and other regulatory bodies. The commenter provides that EPA's failure to consider these costs is arbitrary and unlawful and notes that while these concerns also applied to the 2018 proposal, the expanded scope of the Supplemental Notice greatly exacerbates them.
Response: This procedural rule does not regulate the conduct or determine the rights or obligations of any entity outside the federal government. The EPA disagrees that this rule would impose costs on third-party researchers. This is a rule of internal procedure that does not impose requirements on any party other than the EPA. This rule imposes no costs on researchers or their institutions, and the EPA will consider and evaluate all relevant and appropriate science in its significant regulatory actions and influential scientific information. The EPA recognizes that researchers and other third parties may voluntarily consider the EPA's position on data availability, as described in this rule, as they make their own decisions about how to conduct research and the extent to which they make data and models available. Researchers may choose to make more data and models available, but the EPA recognizes that these parties will weigh their own benefits and costs and make choices that they deem appropriate. Additionally, this rule does not require the EPA or other parties to disclose or host data. Hence, this rule does not impose costs on the EPA or any other party to make such data available. Analyses of proposals that impose such requirements are, therefore, not relevant for this rule. The EPA recognizes there will be some incremental review and administrative costs to the Agency but anticipates these will be small. The analysis noted by the commenter is not applicable to this rule because the analyses were not for this rule and the assessed requirements are not part of this rule.
The EPA acknowledges that data sharing mechanisms already exist and that researchers, if they so choose, could select the mechanism that best suits their needs and effort. The preamble to the rule clarifies that restricted or tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. The rule does not prescribe a particular mechanism but does require the EPA to independently verify that such a mechanism exists for dose-response data underlying pivotal science.
Further, 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.
<IP_ADDRESS>.2 Resulting Bias in Available Research
Comment: Commenters (10974, 11479, 11491, 11576, 11920, 12430, 12464, 12546, 12720, 12727, 12731) contend that the proposed rule will result in a bias in what information EPA is able to utilize due to capabilities of certain stakeholders to abide by the rule's requirements and the ease of some studies being able to adapt comparative to others. Additional comments and responses to comments on monetary costs to researchers are included in section <IP_ADDRESS> of Chapter 14. Examples of specific comments follow:
Commenter (11479) notes that EPA's proposed rule alludes to the use of good laboratory practices (GLP) and standardized test methods, where "available and appropriate." The commenter contends that this would bias EPA's literature review toward industry-funded GLP studies, even though GLP practices are more about recordkeeping than quality of research design. The commenter provides that for example, in a study reviewing the quality of GLP literature on the chemical bisphenol A (BPA), the authors concluded that "simply meeting GLP requirements is insufficient to guarantee scientific reliability and validity." The commenter maintains that while GLP studies should not be excluded from EPA's consideration, the highest-quality assessment that EPA can conduct would be a systematic review approach that considers all relevant data and establishes criteria for evaluating study quality, as recommended by NAS.
Commenter (12720) states that the potential for dangerous bias with adverse impacts on achieving quality scientific input at EPA is large. The commenter provides that for example, it may be relatively less burdensome for small epidemiologic studies with limited numbers of study participants to meet data release requirements-- but the results of such studies are generally less reliable and include the potential for more random error and larger confidence intervals than cohort studies that span larger population groups. The commenter asserts that the proposal threatens to bias Agency decision making towards smaller studies and anecdotal case reports rather than robust scientific information provided in larger epidemiologic cohort studies.
Commenter (10974) contends these proposed changes would bias research results and thereby erode the quality, dependability, and power of research used by EPA, state, local, and tribal governments when charged to develop programs designed to protect environment and public health. As such, the commenter does not support either proposed definition at 40 CFR § 30.5, nor do they support, generally, EPA's attempts to discredit research based on data availability or model reproducibility by either the oft-referred to "subject matter experts" or the public.