The petitioners in the above case complained that EPA had relied more on actual research data for the most vulnerable population sector than on generic risk assessment models that would have suggested greater uncertainty regarding the non-linearity. The petitioners ignored the general argument that models are useful only to the extent that they maintain consistency with actual research data. The issue of lack of public access to the raw underlying data was raised for only one of the four independent research studies on which EPA relied. Had EPA been required to eliminate that study from consideration, as suggested by the proposed new rule, the Agency would have had a more difficult task to convince a court that they were fulfilling their responsibility "to protect the public health with an adequate margin of safety."
Response: The EPA disagrees that the rule is biased in favor of industry. As explained in the preamble to the final rule, the EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will increase the transparency of 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 final rule also does not allow for the categorical exclusion of studies based on the availability of their underlying data.
Comment: Commenters (4840, 4884, 5019, 6132, 6137, 6144, 6171, 6351, 6868, 6876, 6912, 6955, 9227) specifically point to the tobacco industry lawyer tactic of attacking science/studies and other industry "secret assertion" tactics that did not benefit the industry as being similar to what they believe is the intent of the proposed rule. Several of these commenters provide background information to support their assertion and also note that these tactics were the basis of a failed attempt at legislation (i.e., HONEST Act) and bias in favor of the use of industry studies/industry.
Commenter (6132) notes that a past example of abuse by consultants to a vested interest resulted when the State of Georgia set up an Open Records Law. The commenter states that the RJ Reynolds Company used that law to obtain research data to attack study findings that the use of cartoon characters (such as "Joe Camel") in tobacco advertising influences children's product recognition. The commenter provides that the research was later validated in other studies, but the damage was done, and the physician involved left research for private practice. Thus, the commenter notes that this data release approach has already been tried in the past and has been shown to be too easily abused by vested interests. The commenter also points out that there is also a tobacco industry connection to the proposed rule. Just before the 1997 Open Data amendment was presented in the House, the commenter states that a December, 1996 memo from a consultant to the Tobacco industry, laid out a similar strategy to address federal agency science with respect to secondhand smoke, including a now familiar call for science "Transparency". The commenter states that the tobacco industry's past record of abuse of data they obtained under similar rules, in order to inappropriately attack researchers, makes obvious polluting industries' motive for this misguided change in EPA's handling of scientific data for decision-making.
Commenter (9227) adds that the history of the proposal's internal development indicates that certain representatives of regulated industries had a nearly exclusive role in its promulgation, and that industry concerns were given special solicitude by EPA's senior political leadership. Meanwhile, the commenter complains that the scientific community and the EPA's own SAB were neither involved in the evolution of the proposal nor notified of its initiation until after its official publication in the Federal Register.
Commenter (6351) notes that industries and their allies have been pushing to exclude studies for decades, using the same arguments found in EPA's proposal, targeting research that shows harm to public health from their products or their emissions. The commenter provides that, in 1996, attorneys working for tobacco industry giant R.J. Reynolds recommended a similar approach requiring review of documents "because, at some point in the future, EPA will most likely be ordered to re-examine ETS [Environmental Tobacco Smoke]." The commenter states that the EPA had issued its first report on ETS in 1992, concluding that secondhand smoke was responsible for approximately 3,000 deaths from lung cancer annually in nonsmoking adults. To prepare for the anticipated next report's likely conclusion of even greater harm from the products, the commenter provides that R.J. Reynolds attorneys developed a strategy to cast doubt on the studies while obscuring the company's real purpose. As they explained in the memo:
      Because there is virtually no chance of affecting change on this issue if the focus is ETS, our approach is one of addressing process as opposed to scientific substance, and global applicability to industry rather than focusing on any single industrial sector. Thus the examples of questionable science, to justify these standards. Congress must require those examples serve as the test cases.
The commenter (6351) adds that tobacco attorneys recommended expanding this approach to other industries, which quickly happened. Two of the early industry targets were landmark air pollution studies completed in the 1990s that found solid evidence that particulate matter air pollution could cause premature death., The commenter states that both studies found the particulate matter in the air was linked to increased risk of premature death. The commenter provides that the EPA incorporated these studies into their review of the research, leading to the first national standard for fine particulate matter (PM2.5) in 1997 and were challenged in the 1990s by members of Congress and their industry supporters seeking access to the confidential patient information, arguing that the raw patient data should be public since the research was federally funded. The commenter adds that other scientists argued for more investigation of whether confounding factors, insufficient years of data collection or other limitations might mean that the findings were not as powerful as they appeared to be. According to the commenter, instead of blocking the studies, as this proposal would do, EPA took a logical step and referred both studies to an independent third party, the HEI, for a deep-dive review. There, the commenter notes, autonomous reviewers examined the data and developed a report on the two studies that confirmed their original findings.
Commenters (6137, 6144, 6912, 9227) provide a historical description of tactics/bias regarding sound science/secret science and the attempted HONEST Act legislation that they contend was the basis for the proposed rule. The commenters also highlight the proposed rule's biased treatment that favors industry studies over studies conducted by independent academic researchers. Some of their comments (which include points indicated by other commenters) are provided in the following paragraphs.
Commenter (6912) asserts that attempting to require the government to use only studies with publicly accessible data in its rulemaking, and thereby eliminating the most credible science based on actual health information, is a well-documented strategy with roots in the tobacco and fossil fuel industries. The commenter notes that during the mid-1990s, the tobacco industry and its lawyers and lobbyists strategized about changing the rules governing the use of science in agency rulemaking. Christopher Horner, then a lobbyist for the law firm Bracewell and Patterson (now Bracewell), wrote a memo in 1996 to his client, R.J. Reynolds, outlining a strategy for how to head off future regulation of secondhand tobacco smoke. In this memo, the commenter states that Horner acknowledged that R.J. Reynolds has "virtually no chance" of stopping such a regulation unless the company is able to exercise "behind the scenes leadership" in "construct[ing] explicit procedural hurdles [EPA] must follow in issuing scientific reports."
The commenter (6912) expresses that Horner's recommended approach to constructing these procedural hurdles is strikingly similar to EPA's proposed rule. The commenter provides that Horner advised that R.J. Reynolds advocate for what he termed "sound science" criteria in rulemaking, requiring the data underlying any study to be publicly available and that a study's results be reproducible. Horner further recommended that such a rule be implemented via either an EPA rulemaking or new legislation.
Commenter (6912) further explains that Horner suggested that oversight hearings on EPA's rulemakings to limit fine particulate matter (PM2.5) and ozone serve as the congressional entry point for the tobacco industry 's agenda. Fine particulate matter and ozone are both principally generated by the burning of fossil fuels. The commenter adds that, by suggesting that the "sound science" initiative be launched around PM 2.5 and ozone rulemakings, Horner accomplished two goals: hiding the hand of the tobacco industry and helping broaden the coalition of industries supporting the initiative.
In fact, commenter (6912) states that the fossil fuel and electric utility industries were quite concerned about the potential for new regulations limiting PM 2.5 and ozone. The commenter provides that Citizens for a Sound Economy (CSE), a front group founded by Charles and David Koch of Koch Industries, opposed new PM 2.5 regulations. CSE was led by C. Boyden Gray, an heir to the R.J. Reynolds tobacco fortune. The commenter adds that Gray also ran another front group, the Air Quality Standards Coalition, which was created by the National Association of Manufacturers (NAM) to fight EPA air pollution regulations.
Commenter (9227) also asserts that the proposal's justifications regarding the private-sector burden of regulatory costs reiterates concerns and suggestions about EPA's policy for evaluating science that the Agency received from industry itself and cites emails to EPA leadership from May 2014, the National Association of Manufacturers ("NAM") that specifically identified dozens of EPA regulations that were "affecting its members," many of which were chemical, air, and water regulations which were based upon the types of research and studies that would be excluded under EPA's proposed rule.
In response to EPA's 2017 proposed rule, commenter (9227) provides that the Procedures for Prioritization of Chemicals for Risk Evaluations, NAM made recommendations that EPA ensure that Toxic Substances Control Act (TSCA) prioritization relied upon "the best available science" in a process that requires "a heightened level of transparency." The commenter notes that NAM also provided the EPA with materials that called for reform of EPA's "process for evaluating science to improve transparency and better involve the public." This, according to the commenter, parallels NAM's 2014 letter to the House in support of that year's version of Rep. Smith's HONEST Act. (Whom is discussed further below.)
The commenter (9227) adds that the American Petroleum Institute's (API) Senior Director of Regulatory and Scientific Affairs wrote to the EPA: "[t]he science and data used to support a regulation should be reviewed to determine if they are still valid based on scientific integrity, consistent with EPA's Principles of Scientific Integrity and Policy (2012), with meaningful disclosure of all potential areas of bias, guarding against manipulation or misinterpretation." The commenter adds that API also issued a press release on that same day, May 15, 2017, in which the organization summarized its conversations with EPA: "API today urged the EPA to adopt a regulatory system that enhances safety and protects the environment while prioritizing the production and refining of American natural gas and oil."
In contrast, the commenter (9227) states that the EPA's SAB leadership was not notified of the rulemaking activity until it was published in the Federal Register, in contravention of Agency practices for communicating major actions such as the proposed rule. The commenter adds that the EPA also failed to provide the SAB with a description of the proposal. The commenter notes that SAB leadership took note of the HONEST Act's connection to the proposal, stating the rule was "highly controversial" as indicated by the fact that "a similar legislative effort in the House has been stalled in Congress for several years."
Commenter (6912) notes that the fossil fuel industry strongly supported the tobacco industry 's so-called "sound science" initiative. By January 1997, the commenter states that Citizens for a Sound Economy (CSE) organized a protest at a Senate hearing on proposed EPA air pollution regulations. The commenter notes that protestors, dressed in white lab coats, held signs saying "Harvard , release the data!" in reference to a Harvard study demonstrating a link between PM2.5 pollution and increased mortality. The commenter describes that an October 1997 memo obtained from Philip Morris lists the API, the Electric Power Research Institute (EPRI), and the Statistical Assessment Service, a climate denier front group funded by fossil fuel dynasties such as the Kochs and the Scaifes, as three of the five organizations supporting the "sound science" initiative.
In 1998, the commenter (6912) provides that the initiative was rebranded "secret science" by Powell Tate, a lobbying firm working for the tobacco industry. The commenter notes that "secret science" is of course the very phrase Pruitt used when announcing the proposed rule, writing "[t]he era of secret science at EPA is coming to an end." The commenter adds that Powell Tate recommended identifying a ''catalyst organization" to push the initiative, and suggested NAM and the Business Roundtable as two possibilities. Both NAM and the Business Roundtable count many fossil fuel companies among their members.
During the 1990s, commenters (6912, 9227) submit that Philip Morris (today, Altria) and public relations firm APCO partnered to create a front group to support its campaign to make it more difficult for regulatory agencies to use scientific studies in rulemaking: The Advancement of Sound Science Coalition (TASSC). Commenter (6912) notes that, while a creation of big tobacco, the commenter states that TASSC 's donors also included the oil companies Amoco, Chevron, ExxonMobil, and Occidental Petroleum. As such, the commenter adds that TASSC devoted significant efforts to challenging climate science and its executive director, Steve Milloy, helped shape the "Global Climate Science Communications Plan," an API project to develop a strategy to confuse and mislead the public about climate change. Commenter (9227) provides that TASSC led a worldwide publicity campaign in the 1990s to promote "Good Epidemiological Practices" that aimed at undermining U.S. and international regulatory efforts based on epidemiologic studies of passive smoking and lung cancer.
During the same period, commenter (9227) states that Philip Morris made it a strategic priority to pursue legislation and policies to require public disclosure of epidemiological data. A May 1997 planning document advocated for using "existing political and business coalitions" that opposed clean air regulations to promote "legislative solutions to ensure that public policy is based on sound science" and "require epidemiological studies to meet a minimum set of criteria and/or require researchers to make public the underlying data before these studies can be used as a basis for regulations at the state or federal level." In 1998, the commenter adds that Powell Tate  -  a lobbying firm that represented R.J. Reynolds  -  organized a "secret science" working group focused on "requiring the disclosure of taxpayer-funded analytical data upon which federal and state rules and regulations are based, as well as the analytic data underlying health and safety studies funded by the government . . . ."
Commenter (9227) provides that, although TASSC no longer exists, its executive director, Steve Milloy, continues the organization's "sound science" rhetoric against other types of regulation through his website, JunkScience.com. In fact, the commenter adds that Milloy has personally taken credit for EPA's proposal and was one of a select few invited to Pruitt's public announcement of the proposal earlier this year. After the proposed rule was announced, Milloy told reporters, "I look at this as one of my proudest achievements. According to the commenter, the reason this is anywhere is because of Steve Milloy."
Commenter (6912) suggests that Milloy, along with Horner and a small number of lawyers and lobbyists closely tied to the tobacco and/or fossil fuel industries, drove the industries' two-decade-long push to erect "procedural hurdles" to the use of science in rulemaking under the guise of defending "sound science" and defeating "secret science." The commenter notes that after Pruitt announced the proposed rule at an event to which Milloy was invited, Milloy declared that he'd been working on furthering the "secret science" initiative "for twenty years."
Commenter (6144) asserts that the EPA's proposed rule is not a novel idea. The commenter notes that it originates from the tobacco industry, whose lawyers and lobbyists in the 1990s developed a version of this idea in an attempt to prevent the federal government from regulating second-hand smoke. The commenter provides that the goal back then, as it appears to be today, is to create "procedural hurdles" that would hamstring an agency's ability to implement policy that would protect public health. Furthermore, the commenter contends that the records obtained by the Union of Concerned Scientists through a FOIA request clearly illustrates that this proposal has never been about transparency, and definitely not about science. Under the direction of former Administrator Pruitt, the commenter states that the proposed rule was entirely driven by politics and a way to ignore the will of Congress by administratively implementing the misleadingly named HONEST Act of 2017. The commenter notes that one email sent by an EPA political appointee to his colleagues most accurately describes this proposed rule. In an email dated January 16, 2018, the staffer writes that this idea, if implemented, would result in "no regulation (going) into effect unless the scientific data is publicly available for review." It seems clear that in proposing this rule, EPA's intent is to prevent the promulgation of public health and environmental safeguards, and not increase access to information.
Commenters (6868, 6876) add that the tobacco industry lawyer who authored this 1996 document served on the Trump EPA Transition Team and that it appears that the EPA is literally adopting policy developed by the tobacco industry to undermine the public confidence in pivotal scientific studies. Following Donald Trump's election, the commenter (6912) submits that Milloy joined the EPA transition team, as did Horner. The commenter adds that Milloy celebrated EPA's proposed rule limiting science in rulemaking on Twitter, noting that he was "inside the administrator 's office:"
Commenter (6137) notes that industry lobbied Congress in an effort to gut environmental and health laws by attacking the science upon which they are based. For example, the commenter states that both the Secret Science Reform Act of 2014 and the Secret Science Reform Act of 2015 provided that EPA may not take action "unless all scientific and technical information relied on to support such covered action is . . . publicly available online in a manner that is sufficient for independent analysis and substantial reproduction of research results." Two years later, after its prior unsuccessful attempts, the commenter states that the House passed the HONEST Act in March 2017, which again would have limited EPA's ability to perform any assessment or analysis based on science if the public does not have complete access to the underlying data. When these bills did not succeed, the commenter notes that industry looked to a new audience to try put in place what Congress failed to enact: a ban on consideration of science when making regulatory decisions critical to public health and the environment if the underlying data is not made publicly available.
Commenter (6137) states that industry pitched EPA hard, and found a willing ear, complaining that air pollution limits and toxin tolerances were being set at levels that were too stringent. Given that the strong Congressional mandate expressed in numerous statutes for strict health protections would require EPA to act if the science demonstrated a risk to public health, the commenter contends that industry saw that their best bet was to knock out the science, this time through EPA itself. The commenter provides that industry groups, including the National Association of Manufacturers and American Petroleum Institute, "pitched EPA a Proposal last spring that closely resembled what became Administrator Scott Pruitt's `secret science' plan," according to EPA internal documents. This plan closely tracks the longstanding attacks on EPA science from these groups. According to the commenter, EPA was responsive to the industry pitch and met with industry groups dozens of time, while repeatedly canceling the few scheduled meetings with public health advocates.
Commenter (6137) states that after EPA published its final Risk Assessment for Environmental Tobacco Smoke (secondhand smoke) in 1992, which concluded that secondhand smoke "is a human carcinogen, responsible for approximately 3,000 lung cancer deaths annually in U.S. nonsmokers," the commenter notes that the tobacco industry went on the attack. The commenter states that the Risk Assessment had been based in part on a meta-analysis of "31 epidemiologic studies from 8 different countries" which showed a significant risk of harm. The commenter contends that recognizing that "[v]igorous denial is not a satisfactory defensive strategy" and that "the most significant [secondhand smoke] problem facing the Industry is the result of epidemiological studies which indicate" a risk from exposure, the tobacco industry decided to attack epidemiological science. The commenter adds that industry lawyers candidly noted that "there is virtually no chance of affecting change on this issue if the focus is" secondhand smoke so "our approach is one of addressing process as opposed to scientific substance, and global applicability to industry rather than focusing on any single industrial sector." Shortly thereafter, the commenter states that one of RJ Reynolds' lobbying firms organized a "Secret Science" Work Group to "[f]ocus public attention on the importance of requiring disclosure of taxpayer-funded analytical data."
The commenter (6137) asserts that the Proposed Rule is just another effort to hide evidence of the public health harm of toxic chemicals, given that there is no way to change the research results showing the deleterious effects. And this time, the commenter states that the effort is much broader, as it is not hiding evidence related to just one industry or one product. According to the commenter, EPA should not be permitted to "deliberately misle[a]d the public about the risks of" certain pollutants or other chemicals by hiding evidence of their harms. As several courts have found, the commenter concludes that the best available politics does not equate to the "best available science," so while this Proposed Rule may serve EPA's political ends, it does not meet the mandates of sound science.
Commenter (6912) notes that another key player in the push to limit science in rulemaking is Texas Congressman Lamar Smith. The commenter provides that Smith has been the chairman of the House Committee on Science, Space, and Technology since 2013. According to the commenter, the oil and gas industry is Smith's largest source of campaign donations, contributing nearly $800,000, and Smith has drawn most of his committee staff from the fossil fuel industry. In his role as chairman of the House Science Committee, the commenter suggests that Smith has embraced the "secret science" initiative championed by Milloy, Horner, and the network of tobacco and fossil fuel industry-funded front groups that employ them. According to the commenter, in a 2013 op-ed in the Wall Street Journal , Smith attacked EPA for not releasing the data underlying two important peer-reviewed studies that demonstrated the increased mortality associated with exposure to fine particulate matter. The commenter adds that, following several letters to EPA demanding the underlying data for these studies, Smith issued a subpoena to EPA, notwithstanding the fact that Harvard University and the ACS, not EPA, possessed the confidential public health data at issue.
Commenter (6912) provides that, realizing he could not force EPA to turn over documents it did not possess, Smith introduced legislation to prohibit EPA from considering scientific studies whose underlying data were not public. In 2015 the commenter states that he introduced the Secret Science Reform Act, a bill supported by ExxonMobil, Integrys Energy Group, CMS Energy, Duke Energy, the Edison Electric Institute, the U.S. Chamber of Commerce, Peabody Energy, and NAM. In 2017, Smith introduced the Honest and Open New EPA Science Treatment Act of 2017 (HONEST Act), which, like the Secret Science Reform Act before it, would prohibit EPA from considering scientific studies whose underlying data are not public. Once again, the commenter suggests that energy interests, including ExxonMobil, the U.S. Chamber of Commerce, and NAM all lobbied in support of the bill.
Similarly, commenter (9227) asserts that a close examination of the history of this Proposal confirms that its purpose is not to strengthen science at EPA, but to undermine public health and environmental protections by arbitrarily blinding the agency to vital research. The commenter adds that the proposal resembles proposals advanced by the tobacco industry for the specific purpose of suppressing public health science warnings about the dangers of tobacco smoke. The Proposal also resembles failed legislation in Congress that was similarly advanced by industry interests seeking to undermine public health and environmental protections, and criticized by scientific experts.
Commenter (9227) also provides arguments regarding how the proposal is an outgrowth of the failed HONEST Act congressional bill:
      Internal and external EPA communications illustrate that the HONEST Act served as a precursor to EPA's Proposal. The intertwined history of the HONEST Act and EPA's Proposal cast doubt on the Agency's proffered rationale.
      The HONEST Act
      The HONEST Act is a House bill introduced in 2017 by sponsor Representative Lamar Smith (R-TX), and is the latest manifestation of various bills aimed at undermining EPA regulation through limitations on the types of scientific research the Agency may use.The HONEST Act and these related bills were introduced and passed in the House three times, but each time, failed to progress in the Senate.
      Like the current Proposal, the HONEST Act was touted by its proponents as an effort to enhance the transparency and credibility of regulatory science at EPA. But the HONEST Act --  like the Proposal -- would in fact have had the effect of limiting the scope and quality of science underlying EPA actions. Indeed the HONEST Act was widely criticized and opposed by scientists, scientific organizations, medical organizations and other scientific authorities for precisely this reason. For example, eight public health and medical associations including the American Lung Association, American Public Health Association, National Medical Association, and Physicians for Social Responsibility issued an open letter to Congress in spring 2017 opposing the HONEST Act because it "would limit the kinds of scientific data EPA can use as it develops policy to protect the American public from environmental exposures and permit violation of patient confidentiality." The American Association for the Advancement of Science and twenty-two other leading scientific organizations and research universities likewise sent a letter to House Majority Whip Kevin McCarthy in March 2017 opposing the bill and warning that it could lead to a "situation where the EPA would be prevented from using the best available science and disseminating public information in a timely fashion."As we have noted elsewhere in these comments, the CBO  -  after consulting with EPA staff  -  likewise concluded that the HONEST Act would "significantly reduce the number of studies that the agency relies on when issuing or proposing covered actions."
      That the HONEST Act would suppress rather than promote good science at EPA is not surprising, given that the sponsors of the HONEST Act have a history of rejecting established climate science and strong ties to industries that would benefit from limiting the role of science in EPA rulemakings. Representative Lamar Smith is widely known as an opponent of mainstream climate science and public health and environmental safeguards. In a July 24, 2017 opinion piece, Representative Smith lauded the benefits of increased atmospheric carbon dioxide: "A higher concentration of carbon dioxide in our atmosphere would aid photosynthesis, which in turn contributes to increased plant growth." Smith and the sponsor of the Senate version, Mike Rounds, also receive substantial contributions from the same industries that will benefit from the proposal.
      Representative Smith also has ties to EPA staff who drafted the proposal, underscoring the close connection between his failed legislation and this proposed rule. Dr. Richard Yamada, former professional staff member on Smith's House Committee on Science, Space & Technology now serves as the Deputy Assistant Administrator for EPA's Office of Research and Development. At EPA, Dr. Yamada has participated in the drafting and development of the Agency's version of the proposal.
      The HONEST Act as Predecessor for the Proposal
      As this section details, it is clear that the HONEST Act is a direct predecessor of this proposed rule and that both initiatives share the same purpose: to undermine EPA's use of rigorous science in crafting health and environmental protections. The language used in the proposal shares strong similarities with the HONEST Act. Furthermore, internal and external communications from EPA leadership demonstrate the proposal's origins in the HONEST Act.
      While lengthier than the congressional HONEST Act, EPA's proposal contains parallel language to the bill. One can compare examples from the text of the 2017 HONEST Act as passed in the House, to the text of the proposal from the Final Federal Register Notice:
      The HONEST Act of 2017
      An Act: To prohibit the [EPA] from proposing, finalizing, or disseminating regulations or assessments based upon science that is not transparent or reproducible....
      The Administrator shall not proposed, finalize, or disseminate a covered action unless all scientific and technical information relied on to support such covered action is -- (A) the best available science; (B) specifically identified; and (C) publicly available online in a manner that is sufficient for independent analysis and substantial reproduction of search results....
      Strengthening Transparency in Regulatory Science Proposal: EPA shall clearly identify all studies (or other regulatory science) relied upon when it takes any final action. EPA should make all studies available to the public to the extent practicable . . . When promulgating significant regulatory actions, the Agency shall ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation.
      The best available science must serve as the foundation of EPA's regulatory actions.
      Responsive records released to the Union of Concerned Scientists ("UCS") make evident that the HONEST Act served a predecessor to the proposal. Administrator Pruitt's schedule reveals that he met with Representative Smith on January 9, 2018, less than four months before the Federal Register announcement of the proposal. Emails from Pruitt and his staff, dated just over a week after that meeting, indicate that Smith was working on a "pitch that EPA internally implement the HONEST Act." Subsequent emails sent between Pruitt's EPA staff in February 2018 demonstrate that EPA officials promptly began drafting the proposal.
      Before Smith's internal EPA `pitch,' Agency leadership commented favorably on the HONEST Act of 2017. Although EPA initially estimated that implementation of the act would cost over $250 million per year, that estimate was never reported to the CBO. As CBO's cost estimate determination indicates, EPA political leadership diverged from the earlier estimate and instead assured CBO that the bill could be implemented "with minimal funding." Several news sources have reported that the Administrator's Office of the EPA became involved in communications with CBO, and decided to respond to CBO directly with the assurance the bill could be implemented at `no cost.'
      Finally, in an exclusive interview with the Daily Caller shortly before the proposal's publication, former Administrator Pruitt promised:
      If we use a third party to engage in scientific review or inquiry, and that's the basis of rulemaking, you and every American citizen across the country deserve to know what's the data, what's the methodology that was used to reach that conclusion that was the underpinning of what  --  rules that were adopted by this agency.
      The Daily Caller directly linked the proposal to the HONEST Act, "Pruitt's pending science transparency policy mirrors Smith's HONEST Act, which passed the House in March 2017."
      Spokeswoman for Chairman Smith's House Committee on Science, Space, and Technology, Thea McDonald, also told the Daily Caller: "[t]he chairman has long worked toward a more open and transparent rule-making process at EPA, and he looks forward to any announcement from Administrator Pruitt that would achieve that goal."
Response: The EPA, the federal government, the international scientific community, and Congress have pursued efforts to increase data sharing and transparency for many years. The EPA is committed to furthering this effort with the implementation of this final rule. This rulemaking is in no way related to any industry, including the tobacco or energy industries, or an EPA review of environmental tobacco smoke. The EPA's attention to data transparency is responsive to the broader interest in greater data transparency observed in the numerous transparency initiatives in the scientific community and federal government, as well as the criticism the EPA has received from members of the public, scientific community, and Congress on the transparency of the scientific basis for EPA's decisions in previous influential scientific information assessments and regulatory actions. Although these criticisms helped shape the rulemaking, the actual text of the rulemaking was initiated and revised by EPA personnel and was not overly influenced by any particular stakeholder.
The EPA provides more detail explaining its rationale for this rule in the preamble for the final rule. In brief, the transparency provisions in this final rule are intended to build upon existing efforts and provide incremental progress toward the Agency's overarching goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a good government principle that is inherently valuable to the public. The scientific community has also embraced greater data transparency, as evidenced by data sharing and availability requirements for many high-impact journal publishers and the emergence of several international organizations and initiatives focused on increased transparency and data sharing in science. The EPA supports these efforts and believes that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation provides additional certainty and increases the transparency of the EPA's scientific analyses and resulting regulatory actions. The incremental progress made by this rule provides an important step towards prioritizing transparency in the EPA's most impactful rules and assessments and will inform future statute-specific rulemakings.
In consideration of public comments on this rulemaking, the EPA did not finalize the 2018 proposal or the 2020 SNPRM proposed option that would have categorically required that the underlying data be available for independent validation in order for studies to be considered pivotal science. However, given that transparency is a very important aspect of EPA's regulatory actions and assessments it should be an important consideration in how the Agency considers pivotal science. 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 final significant regulatory actions and finalizing 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 with commenters that requirements of this rule will result in procedural hurdles resulting in any meaningful delay in promulgating regulations. While this rule does require the Agency to evaluate the availability of underlying dose-response data for pivotal science, the incremental burden to the Agency to carry out these requirements is expected to be small given (1) the extensive scientific review EPA already conducts regularly and (2) that the requirement is limited to pivotal science (i.e., a small, though highly important, subset of all the studies EPA reviews).
Comment: Commenters (6125, 6144, 6912, 6944, 9227) suggest that the pre-proposal correspondence between senior political officials at EPA, the Deputy Assistant Administrator for Chemical Safety and Pollution Prevention and industry, and the resulting proposal infer an industry bias.
Commenter (6944) suggests that the manner in which this rule was initiated began the process by clearly indicating whose input the EPA Administration would be considering and provided a clear example of what a predetermined (or desired) outcome would be as applied under this rule and what the Administrator and his staff considered as acceptable "peers" for review purposes. The commenter notes that conducting meetings with, and accepting input from, private sector business and industry that seek to reduce the regulatory impact and authority of the EPA, while essentially shutting out various environmental parties does not provide a good example of what will be accepted by the Agency Administrator and Staff as "transparent, understandable, and reproducible scientific assessments"
In early 2018, having been unsuccessful at moving his HONEST Act through Congress, the commenter (6912) asserts that Texas Congressman Lamar Smith (Rep.Smith) took his case directly to Administrator Pruitt (as noted previously). On January 16, the commenter states that Pruitt met with Smith to discuss implementing the HONEST Act at EPA. The commenter adds that, just a few days prior to Pruitt's meeting with Smith, internal EPA emails reveal that political appointees indicated that they had identified "a path forward" on the "secret science" initiative. These emails were sent between Brittany Bolen, EPA Senior Deputy Associate Administrator for Policy and former counsel for Senator Jim Inhofe, Richard Yamada, EPA Research and Technology Policy Advisor and former aide to Congressman Lamar Smith, Erik Baptist, EPA Senior Deputy General Counsel and former senior counsel for API, and Ryan Jackson, EPA Chief of Staff and former chief of staff for Senator Inhofe.
Commenter (6144) contends that EPA also appears to be more concerned with protecting industry data and CBI than with protecting public health information. According to the commenter, this disparity is exemplified by the fact that the agency requests that commenters provide feedback on how to balance protections for copyrighted and CBI but does not seek similar advice on how to protect patient health data. Furthermore, the commenter notes that emails obtained by Union of Concerned Scientists (UCS) through a FOIA request show that top EPA officials responsible for drafting the proposed rule, including Dr. Beck and her colleague Dr. Richard Yamada, the Deputy Assistant Administrator for the Office of Research and Development (ORD), struggled with how to incorporate exemptions and limit the impact on industry data. The commenter adds that comments raised by Dr. Beck on how to protect CBI are also very similar to those in her testimony in front of a Senate Homeland Security and Government Affairs subcommittee, where she represented her former employer, the American Chemistry Council, whose membership has a significant financial interest in EPA regulatory matters.
Commenter (9227) provides that EPA documents released in response to FOIA requests relating to the Proposal show that Trump Administration appointees deliberately tailored the scope of the Proposal in order to promote industry interests. Commenter (6125, 6912) notes that emails released pursuant to FOIA requests reveal that senior political officials at EPA did not know that pesticide registrations depend on information which is protected from disclosure to the public. The commenter states that when this was pointed out to them by Nancy Beck, Deputy Assistant Administrator for Chemical Safety and Pollution Prevention and a former senior director of regulatory science policy at the American Chemistry Council raised concerns that requiring underlying data be publicly available would create a problem for the chemical industry, the draft proposal was revised so that it would not cover licensing actions like pesticide registrations and other activities providing a benefit to industry. Commenter (9227) adds that this industry considers chemical testing data to be CBI. Several commenters (6144, 6912, 9227) state that FOIA requests indicate that Yamada assured Beck that he would address her concerns, responding he "didn't know about the intricacies of CBI - ok, we will need to thread this one real tight!"
The commenter (6144) expresses that they believe the emails also show the lack of engagement with the independent scientific community, let alone EPA's own scientists. In addition, the commenter adds that the emails show that EPA not once considered the impact of this proposed rule on its ability to protect human health and the environment.
Commenter (6144) contends that the EPA is seeking an opportunity to protect data for the industries it is supposed to regulate at the expense of science-based public health safeguards. The commenter asserts that the focus on protections for industry over the public health research community illustrates that the agency is not interested in seeking actual transparency in decisionmaking through this proposed rule. The commenter asserts that the focus on protections for industry over the public health research community illustrates that the agency is not interested in seeking actual transparency in decisionmaking through this proposed rule. Commenter (9227) states that this distinction between using studies when they confer a benefit on industry but disallowing them when used to influence public health protection is not only arbitrary but insidious. Commenter (6144) states that the proposal is irremediably tainted at its inception as a result. Commenter notes that this bias is affirmed by Dr. Yamada's response to an email from Dr. Beck, where he writes that he "didn't know about the intricacies of [confidential business information]" and that the agency would have to "thread this one real tight!"
Commenter (6912) asserts that, although it would be blatantly biased to treat industry studies differently than ones conducted by independent academic researchers, EPA found a way to "thread this one tight." The commenter submits that the proposed rule allows the Administrator to waive the data availability requirement for any study if it is not feasible to make the underlying data publicly available "in a manner sufficient for independent validation, in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security." (Emphasis added.)
Response: The EPA's attention to data transparency is responsive to the broader interest in greater data transparency observed in the numerous transparency initiatives in the scientific community and federal government, as well as the criticism the EPA has received from members of the public, scientific community, and Congress on the transparency of the scientific basis for EPA's decisions in previous influential scientific information assessments and regulatory actions. Although these criticisms helped shape the rulemaking, the actual text of the rulemaking was initiated and revised by EPA personnel and was not overly influenced by any particular stakeholder. As described more fully in the preamble to the final rule, the transparency provisions are intended to build upon existing efforts and provide incremental progress toward the Agency's overarching goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a good government principle that is inherently valuable to the public. The scientific community has also embraced greater data transparency, as evidenced by data sharing and availability requirements for many high-impact journal publishers and the emergence of several international organizations and initiatives focused on increased transparency and data sharing in science. The EPA supports these efforts and believes that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation provides additional certainty and increases the transparency of the EPA's scientific analyses and resulting regulatory actions. The incremental progress made by this rule provides an important step towards prioritizing transparency in the EPA's most impactful rules and assessments and will inform future statute-specific rulemakings.
The EPA disagrees that the rulemaking was heavily influenced by or designed to benefit industry or provide preferential treatment to industry data. The EPA seeks to appropriately protect all sensitive information (i.e., PII, CBI, proprietary information) in this rule by providing equal consideration of studies with data that is publicly available or available through restricted access or, in the case of data that cannot be appropriately safeguarded, consideration of technical factors in 40 CFR 30.5(e) or an Administrator's exemption under 40 CFR 30.7 that would also allow greater consideration to be given in the absence of data availability. Further, the Agency treats all valid claims of CBI equally under the statutes that it administers, regardless of the entity that generates it. The treatment of CBI in this rule or under the statutes that the EPA administers does not give preferential treatment to industry. In both the NPRM and SNRPM the Agency asked the public to comment on all forms of confidential information, including PII and how best to protect that information while still facilitating the transparency intentions of the rule.
The EPA also wishes to clarify that public input was an important part of shaping the final rulemaking. The EPA accepted public comment on the proposed rule from April 30, 2018 to August 16, 2018, and held a public hearing on July 17, 2018. In response to public comments, the EPA released a supplemental notice of proposed rulemaking and took public comment from March 18, 2020 to May 18, 2020. All of these comments were considered in developing the final rule.
Finally, the final rule maintains language in 40 CFR 30.3 stating that the statutes and regulations will control in the event of any conflicts, and clarifies in the preamble that the requirements in this final rule set the overarching structure and principles for transparency in the EPA's final significant regulatory actions and influential scientific information. The EPA intends to develop internal implementing guidance and promulgate either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule, which will clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes that the EPA administers.
<IP_ADDRESS> Deliberate Attempt to Limit Science Used for Decision-Making
Comment: Commenters (1272, 1390, 1589, 1997, 2428, 2495, 2501, 2905, 4840, 5016, 5019, 6107, 6132, 6446, 6915, 8281-PH5, 9227) suggest that the Proposal is a deliberate/intentional attempt to limit science used for decision-making. Comments include:
 Commenter (1272) states that applying the proposed rule to decision making would decimate the amount of research policy makers had access to and would unfairly skew the information available to those parties. Commenter (1272) states that applying the proposed rule to decision making would decimate the amount of research policy makers had access to and would unfairly skew the information available to those parties.
 Commenter states that scientific methods are based upon healthy skepticism. According to the commenter, determining that scientific findings will be ignored or considered, when forming public policies, based upon conditions that exceed the criterion for peer-reviewed presentations in scientific meetings and scientific publications is not important for transparency. The commenter asserts that the EPA Administrator, EPA, and other government agencies should not be developing or considering any definitions - about what science is and is not worthy for informing public policy --- that are incongruent with the consensus of scientific community. (1390)
 According to the commenter, the entirety of the proposed rule is steeped in purposefully obtuse and misleading language and the logic of the rule is dubious and built on unfounded suppositions, misrepresented data, and spurious conclusions, within the guise of increasing "transparency." (1589)
 Commenter (1997) states that the proposed rule is designed to make it so that the EPA can't use most of the best research on human health or cognitive outcomes (e.g. test scores), since most studies of human health and cognitive outcomes use restricted data sets. (1997)
 The Proposal is nothing more than an attempt to remove valid, relevant and peer-reviewed scientific data from the rule-making process without having provided the necessary scientific input to back up this proposal and suggests that the proposal be rejected. (2428)
 Commenter asserts that they believe that the purpose of this proposal is not to achieve "transparency," but rather to remove valid and relevant scientific evidence from the rule-making process to bias the outcome. (2495)
 Commenter questions whether the EPA wants to regulate scientific research by making it available to the public is honestly for openness and transparency. Instead, the commenter suspects that the purpose is to derail science by subjecting it to scrutiny by people who don't understand or oppose it. Could the proposed regulation's intent be to someone's financial or ideological benefit? Or to slow scientific communication to a snail's pace? (2501)
 The proposed rule is designed to slow down the scientific process by requiring EPA to provide all raw data, including CONFIDENTIAL medical and business information, which would both jeopardize the studies and tie up EPA employees in a tangle of sifting, redacting, and plowing through unnecessary hurdles to providing scientific information. Rather than providing transparency, the commenter contends that it is a transparent attempt by this Administration to undermine science and sabotage the work of the EPA. (2905)
 Certainly, according to the commenter, calls for transparency and reproducibility sound reasonable, but exposing poorly conducted studies is not what this effort is about. Instead, the commenter contends that the proposal is designed to impose onerous and burdensome requirements on independent researchers, and would result in much environmental health science, particularly epidemiologic studies, being excluded from the evidence base and becoming irrelevant to efforts by EPA to protect the public and the environment. The commenter states that valuable research findings in areas like climate change, lead exposure and particulate pollution would be ignored. (4840)
 The commenter asks:
 Why would the EPA's political leadership not want to add to the studies?
 I know they are on the "drill baby drill" ilk, but why would they want to expose themselves and the public to possible adverse health effects of these new pollutants?
 Additionally, why is the EPA curtailing the activities of their staff scientists who are so experienced? (5016)
 The proposal is intentionally misleading and being sold by EPA leadership as an effort to increase "transparency." The commenter contends that the facts suggest that the real motivation is simply to sweep under the rug the scientific evidence disfavored by polluting companies. The commenter notes that the flimsy proposal was designed without adequate input from the scientific community, according to members of EPA's own SAB. The commenter adds that it was rushed through the regulatory process and was originally proposed with a gallingly short public comment period, suggesting an intention of casting less light on the rulemaking process, not more. (5019)
 Forcing EPA to ignore such private (and appropriately non-public) data, the proposed anti-environment rule is fiendishly calculated to block the EPA staff from considering the best data available. The commenter notes that this scheme has at least two devastating impacts:
 Would nonsensically bar EPA from considering the best scientific data available disabling EPA rulemaking.
 Would violate the agency's common sense and statutory duty to consider the best data. (6107)
 The abuse of research data to undermine science credibility is likely the most dangerous aspect of this proposal. (6132)
 The fact that the proposed rule is at odds with the manner in which the scientific community evaluates research -- underscored by the large number of comments submitted in opposition to the rule by scientists, scientific organizations, and scientific journals -- and also at odds with methods EPA uses and is required to use to evaluate scientific information suggests that the proposed rule's true purpose is other than to ensure that EPA relies on the "best available science." Instead, the commenter contends that the true purpose appears to be to exclude from consideration scientific research that might support a need for rigorous regulatory action. The commenter recommends that EPA continue to use of the comprehensive criteria used by the scientific community (and historically used by EPA) to evaluate scientific research. (6446)
 The EPA's failure to consult with its own internal science experts when developing the proposal is, at best, gross malfeasance and, at worst, a conscious effort to subvert the Agency's statutorily mandated practice of using the best available science. (6915)
 The proposed rule has nothing to do with transparency and is a thinly veiled campaign to limit serious and highly credible scientific research that supports critical regulatory action. The commenter inquires: Why would a science-driver public agency undertake such a radical departure from existing and widely accepted scientific standards? They note that they have yet to hear a credible answer to this question that is not rooted in favors to industry polluters. (8281-PH5)
 While the Proposal suggests that its aim is to improve transparency by increasing public availability of data, in actuality it proposes none of the steps that a proposal seriously aimed at that goal would propose, such as increasing funding for EPA grantees to undertake this effort, or proposing solutions to real concerns about patient confidentiality. Instead, the commenter contends that the heart of the proposal is a bar on considering science simply because the underlying data is not publicly available, regardless of whether the science has been peer reviewed, reproduced, or contains other hallmarks of scientific quality. The commenter adds that the agency's recent communication to the CBO that a similar Congressional proposal could be implemented at "no cost" proves the point: EPA's aim here is not to make more data available (which costs money), but to rely on less science in decisionmaking. The commenter adds that the agency's recent communication to the CBO that a similar Congressional proposal could be implemented at "no cost" proves the point: EPA's aim here is not to make more data available (which costs money), but to rely on less science in decisionmaking. That, according to the commenter, appears to be the current Administration's goal. (9227)
Response: The EPA disagrees that the intent of this rulemaking is to limit the science used for decision-making. As described more fully in the preamble to the final rule, the transparency provisions in this final rule are intended to build upon existing federal government efforts and provide incremental progress toward the Agency's goal of greater transparency. The EPA and the federal government have long encouraged open data initiatives, as the principle of transparency in regulatory decision-making and the other operations of government agencies is a fundamental behavior of good government that is inherently valuable to the public. The scientific community has also embraced greater data transparency, as evidenced by data sharing and availability requirements for many high-impact journals and the emergence of several international organizations and initiatives that incentivize greater transparency in research. The EPA supports these efforts and believes that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety. The EPA's continued progress toward maximizing transparency is vital to building and maintaining trust with the public and credibility in the Agency's decisions. The incremental progress made possible by this rule provides an important step towards prioritizing transparency in particularly impactful EPA rules and assessments.
The EPA agrees that it is important to consider the totality of relevant, quality research. Therefore, the EPA did not finalize the 2018 proposal or the 2020 SNPRM proposed option that would have categorically required that the underlying data and models be available for independent validation in order for studies to be considered pivotal science. However, given that transparency is an important aspect of EPA's regulatory actions and assessments it should be an important consideration in how the Agency considers pivotal science. 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.
Consistent with existing Agency practice, the EPA will use existing factors (including soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review) to evaluate study quality. When evaluating potential links between exposure to a pollutant, contaminant, or substance and effects and the nature of the dose-response relationship, the EPA will follow best practices and rely on the highest quality, most relevant studies in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well-substantiated evidence (consistent with Agency guidelines on hazard identification and dose-response assessment) to support a relationship between exposure and effect, the EPA will identify a subset of those studies for use in characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect. This will be based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements, quantitative analyses, or both will be identified as pivotal science. Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. In compliance with the rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or propriety information, available through restricted access in a manner sufficient for independent validation. Including this review of data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and scrutiny by independent third parties. This approach will result in final significant regulatory actions and influential scientific information that are based on the highest quality, most relevant studies and ensure adequate human health and environmental protections, while maximizing transparency and maintaining consistency with the statutes the EPA administers. When the dose-response data underlying pivotal science are not publicly available in a manner sufficient for independent validation, the EPA will give less consideration to the studies' evidence, findings, and conclusions unless the Administrator grants an exemption request.
The EPA disagrees that this final rule is biased in favor of industry. As stated in CFR 30.3, "The provisions of this part apply to science that serves as the basis for informing a final significant regulatory action or influential scientific information, as well as to dose-response data underlying pivotal science, regardless of the source of funding or identity of the party conducting the science." Further, the rule requirements direct the EPA to evaluate the availability of the underlying dose-response data for any subject matter expert, regardless of their affiliation.
The EPA also wishes to clarify that public input was an important part of shaping the final rulemaking. The EPA accepted public comment on the proposed rule from April 30, 2018 to August 16, 2018, and held a public hearing on July 17, 2018. In response to public comments, the EPA released a supplemental notice of proposed rulemaking and took public comment from March 18, 2020 to May 18, 2020. All of these comments were considered in developing the final rule.
Finally, the EPA disagrees that requirements of this rule will result in any burdensome requirements on independent researchers, a curtailing of staff scientist activities, or any meaningful delay in promulgating regulations. 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 continue to consider and evaluate all high-quality, relevant science in its significant regulatory actions and influential scientific information. While this rule does require the Agency's staff scientists to evaluate the availability of underlying dose-response data for pivotal science, the incremental burden to the Agency's staff scientists to carry out these requirements is expected to be small given (1) the extensive scientific review EPA already conducts regularly and (2) that the requirement is limited to pivotal science (i.e., a small, though highly important, subset of all the studies EPA reviews).
<IP_ADDRESS> Deliberately Prohibiting Epidemiological Studies
Comment: Commenters (1409, 1905, 2171, 2408, 4410, 4840, 6137) suggest that the Proposal appears to intentionally limit EPA's use of epidemiological health studies. Comments include:
 The requirement that data be publicly available may sound "transparent," but in fact seems to (deliberately) prohibit epidemiological studies in which the underlying data is subject to confidentiality requirements. (1409)
 Commenter contends that the rule targets long-term epidemiological studies that linked air pollution to shorter lives and were used to justify air-quality regulations. The commenter asserts that the rule could keep that and other high-quality evidence from being used to shape regulations, even if there are legitimate reasons, such as patient privacy, why some data cannot be made public. (1905)
 The proposed rule was clearly designed to undermine and disparage the important epidemiological studies that support public health protection from all pollutants, be they in the air, water, or soil. Simply stated, according to the commenters, the proposal was written with the intent to cast doubt on EPA's prior judgement of and dependence on, health research - and to create suspicion significant enough to deter future use of health-based studies in regulatory decision-making. The commenters assert that the EPA's proposal flagrantly ignores the reasons for the privacy of health data used for epidemiological studies. (2171, 4410)
 The rule as designed would help polluters avoid regulations that protect public health and would intentionally limit EPA's use of epidemiological health studies because they contain confidential medical information that cannot be shared with the public. (2408)
 Much environmental science, particularly epidemiologic studies, would be excluded from the evidence base and would become irrelevant to efforts by EPA to protect the public and the environment. (4840)
Response: The EPA disagrees that the intent of this rulemaking is to undermine or otherwise limit the EPA's use of epidemiological studies in its decision-making. The transparency provisions in this final rule are intended to build upon existing federal government efforts and provide incremental progress toward the Agency's goal of greater transparency. The EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the opportunity for the public to access the EPA's scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency's mission, and the public's health and safety.
The EPA agrees that it is important to consider the totality of relevant, quality research. Therefore, the EPA did not finalize the 2018 proposal or the 2020 SNPRM proposed option that would have categorically required that the underlying data and models be available for independent validation in order for studies to be considered pivotal science. However, given that transparency is an important aspect of EPA's regulatory actions and assessments, it should be an important consideration in how the Agency considers pivotal science. 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 final significant regulatory actions and finalizing influential scientific information. Further, the final rule only applies to dose-response data; therefore, all quality, relevant studies will continue to inform other aspects of the EPA's evaluations.
<IP_ADDRESS> Reliability of a Study Should Be Determined by Experts in the Field
Comment: Commenters (0671, 1481, 1973, 2907, 4933, 8274) assert that how studies are conducted, reproduced and used should be determined by experts in the field and not by the EPA's political appointees. Comments include:
 The decision to make data public (and which data to make public) should stay between the researcher, the IRB, and journal editors and not through waivers granted according to politically biased and often scientifically illiterate views of Administrators. (0671)
 It is unclear why an EPA Administrator rather than experts in the field should be given final authority on the reliability of the study. The commenter notes that peer reviewed publications already exist to address concerns over poor statistical analysis and scientifically unethical policies by subjecting studies to other experts in the field prior to publication. The commenter states that giving the EPA Administrator say in which of the studies did or did not meet the transparency criteria is equivalent to allowing them to discard expert accredited research at whim. The commenter contends that the proposed policy has grave potential for the capricious disregard of facts and subsequent policies which are ignorant of reality and harmful to the public at large. (1481)
 The EPA's attempt to prescribe how a scientist should assess the shape of concentration-response relationships seems designed more to tie EPA's hands and prevent it from considering studies most scientists think are relevant, rather than to serve any public health purpose. (1973)
 Commenter asserts that the country's public health protections could be hampered by allowing the agency's political leadership to select studies that benefit its agenda and ignore those that don't, opening the door to industry interests and secrecy. The commenter adds that, with limited access to the most recent scientific research, how will the EPA make the best decisions on behalf of the American people consistent with its regulations? (2907)
 While the goal of transparency in how studies are conducted and the ability to reproduce scientific results are important, the commenter notes that it can offer a politically motivated Administration a convenient excuse for eliminating or ignoring scientific studies that may go against the wishes of a powerful industry group. The commenter adds that all one has to do is demand the data sets be handed over for "further scrutiny" or demand that the study be repeated before basing a regulation on the study in question. The commenter notes that since the founding of the EPA, independent scientific research has been the foundational basis of your mission. The commenter suggests that the science be allowed to speak the truth and that the EPA should hear from all scientific studies, not just the ones the industry wants. (4933)
 It is the scientific community, with public comments, that are best able to determine a study's value to the EPA's policy making process. (8274)
Response: The EPA disagrees that the EPA's political appointees will determine how studies are conducted, reproduced, or used. As described in the preamble to the final rule, EPA staff will continue to use best practices to review and evaluate all relevant scientific studies when developing significant regulatory actions and influential scientific information. The EPA will use existing factors (including soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review) to evaluate study quality. When evaluating potential links between exposure to a pollutant, contaminant, or substance and effects and the nature of the dose-response relationship, the EPA will follow best practices and rely on the highest quality, most relevant studies in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well-substantiated evidence (consistent with Agency guidelines on hazard identification and dose-response assessment) to support a relationship between exposure and effect, the EPA will identify a subset of those studies for use in characterizing the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect. This will be based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements, quantitative analyses, or both will be identified as pivotal science. Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. In compliance with the rule, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or propriety information, available through restricted access in a manner sufficient for independent validation. Including this review of data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and scrutiny by independent third parties. This approach will result in final significant regulatory actions and influential scientific information that are based on the highest quality, most relevant studies and ensure adequate human health and environmental protections, while maximizing transparency and maintaining consistency with the statutes the EPA administers. When the dose-response data underlying pivotal science are not publicly available in a manner sufficient for independent validation, the EPA will give less consideration to the studies' evidence, findings, and conclusions, unless the Administrator grants an exemption request. The rule also provides factors for consideration that balance some of the important scientific considerations an EPA analyst may want to consider in addition to data availability and that are particularly relevant to the stage of the analysis where dose-response data are used. EPA analysts will continue to play an important role in evaluating all relevant scientific studies and determining their quality using existing guidelines.
The EPA also does not agree with commenters regarding the role of the Administrator in determining whether to grant an exemption under 40 CFR 30.9 and finds that the Administrator is the appropriate decision maker in this context. To ensure that the Administrator's decision is appropriately transparent, the EPA has included a provision in 40 CFR 30.9 of the final rule that requires the Agency to document the rationale for any exemptions granted by the Administrator in the final significant regulatory action or final influential scientific information.
The EPA agrees with commenters about the importance of data sharing and analysis by subject matter experts. When data are widely available, researchers can validate research results and help identify and correct unintended errors, as well as reanalyze the data for new and different purposes, examine novel questions, provide new scientific insights, and improve model development.
In response to public comments, the EPA clarified and modified many aspects of the proposed rule in the 2020 supplemental notice of proposed rulemaking and final rule, including that the rule requirements are now focused on dose-response data and do not apply to dose-response models. The EPA would also like to clarify that the final rule does not require any researcher or other outside entity to provide data or models to the EPA, nor does it require the EPA to disclose or host data. Instead, it governs internal agency procedures for determining the consideration to afford to pivotal science according to factors that include the availability of underlying dose-response data.
<IP_ADDRESS> History of Suppressing Science Puts the Credibility of the Goal of Transparency in Doubt
Comment: Commenter (9227) suggests that EPA, under the Trump Administration, has a history of suppressing science and transparency and purported justifications for the proposal. Similarly, commenter (6937) suggests that the current EPA upper Administration (and industry as well) is not usually a champion of transparency. Therefore, the commenter contends that the call for transparency regulation is hypocritical and lends credibility to those that doubt whether transparency and replication are the true goals of the proposal. Transparency, according to the commenter, so lauded in this regulatory proposal, has been decimated by the current Administration  -  with extensive restrictions and changes to climate change websites, extreme efforts at secrecy and avoiding public scrutiny,,, and efforts to end disclosure of chemicals used in hydraulic fracturing.
Commenter (9227) provides that a FOIA request submitted by E&E News uncovered a document emailed by former EPA official David Schnare laying out a strategy to overturn the 2009 Greenhouse Gas Endangerment Finding. In the document, the commenter notes that one of the steps contemplated as part of the reconsideration included EPA only relying "on information, data and studies where the original data upon which assessment is based is available to the public. . . . EPA would not rely on any study whose authors refuse to provide the underlying data, including computer code used to evaluate and analyze the data." This, according to the commenter, is just one example among numerous others that this proceeding is not intended to increase transparency, but rather aimed at weakening EPA standards that the current Administration disapproves of, despite their grounding in robust scientific evidence.
The commenter (9227) contends that EPA's non-transparent approach to this rulemaking, as well as other Agency actions, underscore that the proposal was not offered in good faith. The commenter provides that the Agency has removed thousands of webpages from its website, limited public and press access to Agency events, and withheld key data underlying rulemakings and proceedings. According to the commenter, these practices cast doubt on EPA's proffered justifications of transparency and accountability. The commenter cites examples related to the stay of the Oil and Natural Gas Sector: Emissions Standards for New, Reconstructed, and Modified Sources rule, and the removal and modification of climate related and Clean Power Plan materials, webpages and files. The commenter states that the Administration has also not rigorously pursued its purported goal of transparency in other contexts by limiting public and press access to Agency events and withholding key data underlying several recent rulemaking proceedings. For example, the commenter notes that, at the event where former Administrator Pruitt announced the proposal, reporters were not invited to attend. The commenter notes that documents received in response to a Sierra Club FOIA request to the EPA reveal that the Administrator had requested press access and advertisement to the public be limited for other events (and cites examples):
 For his speaking engagement at a Federalist Society event in March 2017, Pruitt's scheduling director asked that organizers not advertise to press directly and directed organized to tell media that the event "is not open to press and is off the record."
 Emails also demonstrate that the Agency worked with a public relations firm to devise a plan to promote positive comments and censor negative comments on media from the Administrator's facility visits.
According to the commenter (6125), EPA has not even applied the principles of its proposal to rulemaking when that would get in the way of its central agenda of providing relief to industry. The commenter notes that the EPA's commitment to "transparency" seems to be a recent invention that it has not followed in recent rulemaking proposals. The commenter states that just a few months before issuing this proposal, when EPA proposed to rescind the rule restricting glider trucks (trucks with old diesel engines placed in new truck chassis), the agency uncritically summarized purported emission test results of glider trucks. The commenter provides that the study it used was not peer reviewed; did not disclose its methodology (it turned out the critical observation was done by `visual observation', i.e. eyeballing!), and EPA did not examine it for any indication of reliability. See 82 FR 53444 (Nov. 16, 2017). In contrast, the commenter adds that the EPA's National Vehicle and Fuel Emissions Laboratory (NVFEL) laboratory conducted its own study using, "standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments." 83 FR 18770. The commenter notes that the EPA did not even consider the NVFEL study in its proposal. Similarly, commenter (9227) states that the EPA has failed to provide the public with access to data in key rulemakings and proceedings. For example, in EPA's rulemaking to repeal emissions requirements for glider vehicles, engines, and kits, commenced in November 2017, the Agency failed to release the underlying reports and data before the public comment period closed. At this date, EPA still has not released data used in a key study cited in the Agency's proposal. Commenter (2427) expresses concern that, given EPA's recent proposals to restrict the use of certain scientific studies in regulatory decision-making and to allow the widespread sale of "glider kit" trucks which lack modern emission controls shows the Agency's disregard for objective information and the scientific process, and its move to rely on analysis that supports particular outcomes.
Commenter (9227) adds that, in EPA's stay of the Oil and Natural Gas Sector: Emissions Standards for New, Reconstructed, and Modified Sources, EPA failed to disclose directly relevant evidence for the basis of revision of the standards consisting of industry compliance reports. Despite the fact that these compliance reports were in the agency's possession and comprised of public documents containing factual data that should have been available for public inspection, EPA has to date still not released all of the compliance reports in its possession. The commenter provides that, in August 2017, EDF received information pursuant a FOIA request revealing that more than 1,900 climate-related webpages and files on EPA's website were removed or modified. Many of the removed and modified pages were related to climate change science and impacts, such as "Climate Impact on Health Through Life Stages," "Climate Change Science," and "Methane and Black Carbon Impacts on the Arctic: Communicating the Science."
In January 2018, commenter (9227) states that the EDF received additional responsive records to another FOIA request demonstrating that former Administrator Pruitt directed the removal of many climate change science, impacts, and resources pages as well as all material related to the Clean Power Plan on EPA.gov. At the same time, the commenter states that the EPA was soliciting comments on its proposal to repeal the Clean Power Plan. The commenter suggests that the removal of webpages related to climate and Clean Power Plan topics from the EPA website restricted the public's ability to formulate informed comments throughout the rulemaking process. Thus, according to the commenter, the public lacked the same "access to data and influential scientific information used to inform federal regulation" which EPA claims to observe in its proposal.
Commenter (9227) asserts that, in the words of the proposal, EPA acted in contravention of its goals of "better informing the public," "enhancing the public's ability to understand and meaningfully participate in the regulatory process," and "ensur[ing] that its decision-making is marked by independence, transparency, clarity, and reproducibility" as it proceeded through rulemakings that "will affect the public" and where "the public is likely to bear the cost of compliance."
Response: This rule does not target specific EPA rulemakings and only applies prospectively. The purpose of this action is to increase transparency by codifying internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. These requirements build upon open data initiatives in the federal government and scientific community and advance the EPA's mission and commitment to the public by prioritizing transparency of the underlying dose-response data in pivotal science for the most impactful of EPA's assessments and regulatory actions. Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. Such independent reanalyses will subsequently enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or influential scientific information. Implementation of this rule will more effectively share pivotal science for external consideration and increase the opportunity for independent validation of pivotal science by subject matter experts. As data are better understood through independent reanalysis, the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information.
As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider the availability of underlying dose-response data when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available for independent validation. Including this review of dose-response data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and scrutiny by independent third parties. The approach in this rule will result in significant regulatory actions and influential scientific information that are based on the highest quality, most relevant studies and ensure adequate human health and environmental protections, while maximizing transparency and maintaining consistency with the statutes the EPA administers.
<IP_ADDRESS> Societal Bias
Comment: Commenter (0567) states that pivotal regulatory science as currently performed often includes societal objectives. The commenter states that some scientific assessments state that to be "protective," authors use "conservative" assumptions. The commenter states that the inclusion of societal objectives ideology, religious, or other beliefs, or any other non-scientific goal would cause damage to scientific assessment. The commenter states that to be protective is the responsibility of policy makers rather than of scientists.
Response: Recognizing that assumptions are an inherent part of scientific assessments, this rule seeks to provide greater transparency into the critical assumptions made in an assessment and the impact of those assumptions on the assessment conclusions. As stated in 40 CFR 30.5(e), "The EPA shall also describe critical assumptions and methods used in its dose-response assessment and shall characterize the variability and uncertainty of the assessment. The EPA shall evaluate the appropriateness of using default assumptions on a case-by-case basis. The EPA shall clearly explain the scientific basis for critical assumptions used in the dose-response assessment that the EPA relied on for the significant regulatory action or influential scientific information."
<IP_ADDRESS> Science and Transparency of Decision-making is the Most Unbiased Way to Collect Data
Comment: Commenter (1559) contends that science and transparency of decision-making is the most unbiased way to collect data and to analyze it in order to make decisions and to regulate so that the health of Americans is properly protected as the government is obligated to do by the Constitution's right "to life, liberty, and the pursuit of happiness."
Response: The EPA agrees that transparency is beneficial to scientific assessments and the public. 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.
2.1.4 Environmental and Health Protections Would be Decreased
Comment: Commenters (0017, 0055, 0559, 0945, 1012, 1346, 1461, 1476, 1481, 1512, 1536, 1554, 1559, 1753, 1793, 1813, 2002, 2171, 2425, 2495, 2787, 2902, 2907, 2910, 2977, 3131, 3132, 4542, 4596, 4828, 4838, 4839, 4840, 4842, 4843, 4844, 4872, 4877, 4878, 4881, 4933, 5011, 5020, 5021, 5041, 5113, 5115, 5120, 5122, 5172, 5178, 5183, 5184, 5418, 5979, 6046, 6103, 6109, 6111, 6114, 6116, 6118, 6121, 6122, 6123, 6125, 6127, 6130, 6133, 6137, 6144, 6145, 6153, 6156, 6158, 6159, 6166, 6168, 6169, 6173, 6174, 6181, 6185, 6188, 6351, 6355, 6358, 6368, 6373, 6446, 6450, 6464, 6696, 6860, 6868, 6869, 6871, 6874, 6876, 6877, 6879, 6880, 6882, 6884, 6893, 6894, 6897, 6898, 6903, 6915, 6919, 6920, 6924, 6928, 6932, 6939, 6940, 8274, 8276, 8277, 8281-PH5, 8281-PH10, 8281-PH15, 8281-PH20, 8281-PH24, 8281-PH29, 8281-PH34, 8281-PH63, 8281-PH84, 8317, 9225, 9227) express concern that the proposed rule/policy to limit the research and data that EPA can use to make informed policy decisions under major public health and environmental laws will reduce environmental and health protections. Commenter (1346) requests that EPA please rewrite this rule, to make it clear that the health and well-being of people and the environment comes first in these decisions. Several of these commenters also express concern that the negative health impacts of inadequate environmental regulation will fall disproportionately on children, the elderly, pregnant women/fetuses, and marginalized populations, particularly low-income black and Latino communities. Several of the commenters provide specific examples of health protections that could be rolled-back (e.g., water quality criteria, air toxic regulations, drinking water standards, pesticide regulations, chemical use bans/restrictions/control, criteria pollutant standards) or not be pursued or possible (e.g., fracking health exposure/effects studies, pesticide and Parkinson's disease research, greenhouse gas emissions effects on climate change and public health) as a result of the proposal and that the proposal should be withdrawn. Specific comments include:
 Commenters (2002, 6932) assert that, because the proposed rule is retroactive, it is an attempt to reverse much-needed protections. Commenter (2002) states that, since the proposed rule is retroactive, it could lead to the dismantling of many of EPA's most important and effective health protections, including the CAA, rules that set limits on lead in drinking water, and bans on some uses of neurotoxic pesticides, as they all rely on epidemiological studies.
 Commenter (6879) states that, although the proposed regulation has a particular emphasis on undermining the application of science in regulations focused on human health, it sets a dangerous precedent for ignoring and discounting legitimate and sound science in all other areas of EPA's responsibility, including the protection and restoration of natural habitats vital for wildlife conservation.
 While EPA's previous science-based regulatory process has saved countless lives, prevented chronic diseases, and improved the quality of the air pregnant women and children breathe, the water they drink, and the world in which they will grow, the proposed rule will instead prevent evidence-based policies from being enacted and will contravene EPA's mission to ensure that American pregnant women, children, and families have clean air, land and water, and we strongly urge you not to move forward with it. (2425)
 EPA's efforts to reduce lead and methylmercury exposure for women, pregnant people, and children might not have been as successful if the agency had used the overly stringent definition of transparency it now proposes. The commenter states that programs that might not exist, or exist in less-effective forms, include those to reduce lead exposure from paint, gasoline, and drinking water; limit mercury emissions; and advise pregnant people to steer away from consuming fish species that often contain high levels of methylmercury. (6893)
 Commenter (6915) asserts that the requirements of the proposed rule would lead EPA to adopt less-protective standards across many regulatory programs. The commenter states that the proposed rule would allow for the use of less protective dose response models and assumptions in human health risk assessment. The commenter states that it would also preclude consideration of scientifically valid human and animal studies reporting sensitive and relevant toxic effects based on unjustified requirements for public availability of data, and instead favor consideration of studies that do not assess the most sensitive and relevant health effects endpoints. The commenter states that, for example, while the NAAQS review process builds on the administrative record from prior rulemakings, under the proposed rule, EPA may refuse to consider these studies and others because they rely on data pertaining to the personal medical histories of participants that cannot, by the studies' terms or by law, be divulged. The commenter states that restricting the use of such studies would significantly undermine current and future NAAQS reviews.
Commenter (9227) provides that leading experts in public health, science, and environmental policy agree that the proposed rule would have far-reaching, detrimental impacts on public health. The commenter contends that, by limiting the scientific studies that EPA may consider, the proposed rule would lead to less effective environmental policies and weaker public health protections. The commenter notes that experts have said the following:
 "[The proposed rule] will threaten the lives of real people."  -  Commissioners of the Minnesota Pollution Control Agency and Department of Health.
 "If the proposed rule is approved, science will be practically eliminated from all decisionmaking processes. Regulation would then depend uniquely on opinion and whim."  -  John P. A. Ioannidis, C.F. Rehnborg Chair in Disease Prevention at Stanford University.
 "It does not strengthen policies based on scientific evidence to limit the scientific evidence that can inform them. . . . Excluding relevant studies simply because they do not meet rigid transparency standards will adversely affect decision-making processes."  -  Editors of science family of journals, Nature, Public Library of Science journals, Proceedings of the National Academic of Sciences, and Cell.
 "Without access to the restricted data, regulatory programs could become more or less stringent than they otherwise would be, with consequences for both regulatory costs and benefits. . . . [the proposed rule] could have the effect of removing legal, ethical, and peer-reviewed studies of health effects as sources to support the agency's regulatory efforts."  -  Members of the SAB.
 "[The proposed rule] would prevent the best science from informing policy decisions and result in weaker health safeguards."  -  Harold P. Wimmer, National President and CEO of the American Lung Association.
 "If [the proposed rule] had been in effect 20 years ago, the nation might have forgone programs that are preventing over 50,000 premature deaths each year."  -  Environmental Protection Network.
 "[The proposed rule] would greatly weaken EPA's ability to comprehensively consider the scientific evidence across the full array of health effects studies. This would negatively impact EPA public protections that reduce levels of lead, harmful chemicals, and fine particle pollution, among others."  -  985 scientists in a joint letter to Administrator Pruitt.
 "[The proposed rule] would severely hamstring the agency when it comes to developing and enforcing public health rules by limiting the kinds of research the EPA can use in crafting rules."  -  Union of Concerned Scientists.
 "[Administrator] Pruitt is moving to rid the EPA of the science needed for effective regulation. . . . Its potential impact goes well beyond the EPA's regulatory effectiveness to the underlying role of science in American society."  -  Dr. Bernard Goldstein, Professor Emeritus of Environmental and Occupational Health at the University of Pittsburgh and former EPA Assistant Administrator for Research and Development.
Additionally, commenter (9227) states that when the U.S. House of Representatives passed similar legislation in 2017, H.R. 1430, numerous professional organizations raised concerns about the implications of the proposed legislation. The commenter adds that the Environmental Data & Governance Institute (EDGI) found that:
      A bill that provided genuine provisions for public data access and usability, and did not focus on mandating the reproducibility of studies and on prohibiting the use of any data that could not be divulged to the general public in its entirety, would not be expected to hamper the EPA in a significant way. EDGI's analysis of H.R. 1430 shows that it does not achieve its stated goals. Instead, our research shows that H.R. 1430 would not promote transparency and that its passage would instead block the EPA from using the data it needs to fulfill its mission of protecting public health and the environment.
Commenter (6137) provides several examples where the Proposed Rule's restriction on the science could and would potentially undercut the support provided for environmental programs and resulting adverse consequences to public health protections. The commenter notes that, in a world in which EPA cannot consider critical studies demonstrating the deleterious impacts of toxic chemicals, pollutants, and pesticides when developing rules governing exposure levels, acceptable uses, and safety measures, there will be little to no available evidence to support the imposition of public health protections. Absent such evidence, according to the commenter, the EPA will be unable to implement rules that protect our air and water from harmful pollution, our farmworkers from toxic pesticides, and the public from overall exposure to chemicals, as EPA will have no science to point to as justification for such measures. Simply put, the commenter asserts that the removal of this science from consideration in the rulemaking process will cause the very foundation upon which many of our public health standards depend to crumble.
Commenter (6137) notes that not only is EPA's elimination of its use of critical human health research and studies that serve to protect and promote public health and the environment unlawful, but it is also discriminatory. The commenter asserts that the Proposed Rule has a disproportionately deleterious impact on low-income communities and minority communities  -  the overburdened populations that benefit most from the epidemiological studies used to set limits on air and water pollutants and to set safe exposure levels for pesticides and other toxics. According to the commenter, by removing this critical category of studies from consideration when setting limits on pollutant and toxic exposure as well as standards for safe air and water, EPA is turning a blind eye to accessible and illuminating evidence that provides much-needed safeguards to the vulnerable communities most impacted by the laws EPA is charged with enforcing. These communities will disproportionately suffer as a result.
Commenter (6137) provides several examples of public health studies that indicate that communities of color and economically disadvantaged populations are disproportionately impacted by pollution. The commenter provides that since the 1987 landmark report Toxic Wastes and Race in the United States, studies have confirmed again and again that communities of color and also economically disadvantaged populations are disproportionately located near toxic waste sites and other sources of pollution. And research has also found that overall air pollution exposure is more strongly concentrated in communities of color. The commenter adds that pesticide exposure likewise disproportionately impacts low-income and minority communities: farmworkers tend to be poor, and the vast majority are of Latin American origin, and they have a higher incidence of pesticide poisoning than other workers. For example, the commenter notes that in California, the counties with the greatest use of the highly toxic pesticide chlorpyrifos are the counties with the highest poverty levels and largest Latino populations. The commenter states that, in April 2014, the California Department of Public Health issued a report showing that thousands of children, disproportionately people of color, attend school in close proximity to pesticide use. Overall, according to the commenter, the disproportionate burden of environmental exposure among these low-income communities and communities of color cannot be disputed.
Commenter (6137) expresses that, fundamental to the research revealing the disproportionate impact of environmental harms on low-income and minority communities and the need to set appropriate standards is epidemiological data. The commenter states that this category of science that EPA wants to eliminate has been foundational to establishing disparate harms from a variety of toxics in air, water, pesticides, and other environmental sources. For example:
 Epidemiological studies have shown that there is a persistent disparity in the blood lead levels measured in children of color compared to white children. These studies revealed that in 2011-2012, the mean level was almost 40 percent higher in black children 1-5 years old than in white children of the same age.
 While studies have shown that the mean blood lead level in black children is much lower than it was several decades ago, epidemiological studies have shown that even low levels of lead in the blood are harmful.
 A 2011 peer-reviewed epidemiological study found that urine samples of children ages 6 to 24 months were more likely to have six organophosphate metabolites the closer the child lived to a pesticide application site.
 Longitudinal cohort epidemiologic studies have shown that even low levels of exposure to the highly toxic pesticide chlorpyrifos can disrupt brain development in prenatally exposed children, leading to developmental delays, lower IQ, learning disabilities, and ADHD-like behaviors.
 Epidemiological studies demonstrate that farmworkers have a higher rate of pesticide poisoning than any other workers.
Thus, the commenter (6137) contends that it is clear that epidemiological studies have provided a consistent source of reliable data that has been critical to demonstrating disproportionate exposure to toxic chemicals. The commenter states that these studies in turn have been pivotal to setting air, water, and pesticide standards necessary to protect low-income and minority populations from harmful levels of exposure.
The commenter (6137) asserts that the EPA's proposal to eliminate use of epidemiological studies will have a disparate impact on the most overburdened and vulnerable communities, eliminating the very source of data relied upon to provide protections crucial to their health and wellbeing. The commenter contends that this Proposed Rule will perpetuate the environmental injustices that low-income and minority communities already face, as it will remove the primary tool used to study and address the inequitable environmental harms suffered by these populations.
Commenter (6919) expresses concern that the proposed EPA rule leads to the questioning of studies that reveal negative effects of environmental exposures and allow policymakers to take protective action on behalf of those at greatest risk. The commenter notes that, by undermining existing evidence, the EPA would set back the clock on fighting environmental injustices that are taking place in Colorado. The commenter provides that, without evidence from studies like those presently being conducted, in which personal health data is gathered and protected when the data is aggregated, we cannot protect those who are at greatest risk and have lived with the burden of environmental exposures for decades while the current evidence base was built up. For example, the commenter states that a Colorado School of Public Health study shows the negative health effects of exposures on populations living close to oil and gas operations, adding that, in parts of Colorado these are some of the only affordable places to live.
Commenter (6939) asserts that the United States has a positive obligation to ensure equality of rights.
Commenters (1481, 6168) note that decreased health protections will lead to increased health costs to the public. Commenter (2907) also notes that there could also be a loss of productivity due to air pollution created illnesses, which, according to the commenter, shows the folly of focusing only on business cost savings in the energy sector when considering environmental regulation. The commenter states that all Baltimore City area employers suffer financial consequences when productive workers are absent due to illnesses caused by air pollution. The commenter adds that future generations suffer when they are under-educated due to missed days of school.
Commenter (5977) asserts that the main consideration for all EPA's regulations should be the costs on human and non-human communities in the United States and all over the planet and not the costs of compliance for businesses, real or perceived. The commenter states that the very need for EPA's regulations is caused by the negative externalities generated by businesses.
Response: The EPA does not agree that this rulemaking is counter to the Agency's mission or that the implementation of the rule would result in regulatory actions that are less protective. The EPA is committed to its mission of protecting human health and the environment through sound policy decisions that are informed by robust scientific and technical research. Because of the potential impact of the EPA's significant regulatory actions and influential scientific information on American lives and livelihoods, the American people deserve environmental decisions and policies that are based on the best scientific information. Only through continuous improvement to its procedures, especially those focused on transparency, can the EPA fully demonstrate that commitment. The EPA 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. Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. Such independent reanalyses will subsequently enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or influential scientific information. Implementation of this rule will more effectively share pivotal science for external consideration and increase the opportunity for independent validation of pivotal science by subject matter experts. As data are better understood through independent reanalysis, the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information.
The EPA agrees that it is important to consider the totality of relevant, quality research. As described in the preamble to the final rule, the EPA is not categorically excluding any studies from consideration when promulgating significant regulatory actions and developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will subsequently consider the availability of underlying dose-response data when evaluating pivotal science and give greater consideration to studies where the underlying dose-response data are available for independent validation. Because the final rule does not categorically exclude any studies, including human health studies, from EPA's consideration, the Agency will not be prevented from evaluating and considering all quality, relevant studies when promulgating final significant regulatory actions and finalizing 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. Including this review of dose-response data availability for pivotal science is critical to the EPA's progress toward increased transparency and providing increased opportunity for scientific reanalysis and review by independent third parties. This approach will result in significant regulatory actions and influential scientific information that are based on the highest quality, most relevant studies and ensure adequate human health and environmental protections, while maximizing transparency and maintaining consistency with the statutes the EPA administers.
The EPA would like to clarify that this final rule will be implemented prospectively and rules that have already been finalized will not be subject to this rule's requirements.
2.1.5 EPA Would be at Odds with Other Parts of the Federal Government
 <IP_ADDRESS> Impact on Other Agencies by Limiting the Use of Best Available Science
Comment: Commenters (1493, 2335, 2430, 2909, 5022, 6111, 6194, 6915, 9227) express concern that the proposed rule could negatively impact other federal agencies. Commenter (9227) provides that other federal agencies routinely incorporate and rely upon EPA science assessments in their own efforts to carry out their mandates to protect human health and safety. As with statutorily required consultations, the commenter asserts that the Proposal utterly fails to acknowledge or consider what impacts restricting EPA's own use of dose-response studies would have on the work of these other agencies.
Commenter (2335) states that other government agencies use studies that rely on data from individual health records to develop policy and regulations. The commenter is concerned that moving forward with this proposed rule could undermine decisions made by other federal agencies based on similar studies and could invite challenges to other federal agencies' policies.
Commenter (6915) states that, if EPA adopts a deficient standard due to the arbitrary exclusion of available scientific information, other federal agencies relying on EPA standards as a basis for action would be affected, as would be the states that interface with those federal programs.
Commenters (2430, 2909, 5022, 6194, 9227) state that EPA's scientific research policies and findings influence not only EPA's work, but also the work of other agencies charged with protecting our health and environment. The commenters further states that the National Park Service (NPS), Occupational Safety and Health Administration (OSHA), Department of Housing and Urban Development (HUD), and FDA all rely on the data and findings of the EPA to fulfill their duties. The commenters contend that these agencies cannot effectively protect our health and environment if EPA unreasonably limits the scientific record, as the proposal would. Commenter (2430) states that moving forward with this proposed rule would undermine, and invite challenges to, decisions made by other federal agencies based on similar kinds of studies.
Commenter (6194) states that, in order for OSHA to promulgate standards under OSHA, the agency is required to demonstrate the existence of significant risks to employees using "best available evidence." The commenter states that, currently, OSHA fulfills this obligation, in part, with information provided by EPA's TSCA Section 9(a) reports. The commenter expresses concern that, if the Proposal results in the exclusion of confidential data, then OSHA will likely be forced to either gather supplementary evidence or ignore the reports altogether. The commenter contends that such an outcome will not only impede OSHA in its regulatory functions but could also burden EPA with additional responsibilities.
Commenter (9227) states that HUD is required by statute to assist EPA in assessing the extent of radon contamination in the United States and developing measures to avoid and reduce radon contamination. The commenter states that HUD has also developed policies to require radon testing at properties receiving federal financing, which incorporate EPA radon standards. The commenter contends that, to the extent the proposed rule affects future EPA assessments of radon risks, the scope, cost and effectiveness of HUD radon programs could be affected as well.
Commenter (9227) states that FDA enforces tolerances established by EPA for pesticide chemical residues in human and animal foods under the FIFRA, including through a comprehensive pesticide residue monitoring program that tests for approximately 700 pesticide residues in both imported and domestic commodities. The commenter states that to the extent the proposed rule affects EPA's tolerances, the nature and effectiveness of FDA's own work to monitor for violations of those tolerances would be impacted. The commenter further states that FDA also regulates contaminants in bottled water under the Federal Food, Drug and Cosmetics Act. The commenter states that Section 410 of the Act requires that FDA regulations for bottled water be issued in coordination with the effective date of National Primary Drinking Water Regulations issued under the SDWA and be no less protective of public health than those standards. According to the commenter, if the proposed rule impedes EPA's work to establish drinking water standards, this may affect FDA's own ability to justify protective bottled water standards. The commenter states that, in certain circumstances, FDA also coordinates with EPA to provide the public with information and advice on environmental contaminants in foods, for example, in 2017 FDA and EPA released a joint advisory on mercury hazards associated with the consumption of fish and shellfish, which was based in part on EPA's assessment of the "reference dose" or level of exposure that a person can experience over a lifetime without a risk of harm. The commenter contends that the proposed rule could radically alter the science EPA would be permitted to consider in future such initiatives and frustrate the ability of FDA and other agencies to coordinate effectively with EPA to develop joint advice and information.
Response: This is a rule of internal procedure promulgated under the EPA's housekeeping authority. The rule does not impose requirements on parties external to the EPA, including state governments and other agencies within the federal government. External users of EPA scientific assessments can still use these assessments. There are also provisions in the final rule (e.g., requirements for the EPA to document critical assumptions and methods used in its dose-response assessment, studies considered pivotal science, the rationale for the level of consideration for studies in the significant regulatory action or influential scientific information, and any Administrator exemption) that will make it clear how the provisions of this rule may have impacted the significant regulatory action or influential scientific information and will help external users determine whether the product is fit for their purpose. The final rule also provides that the EPA will give greater consideration to pivotal science where the underlying dose-response data are available for independent validation, rather than providing for a categorical exclusion, so the EPA will not be limiting the scientific record. Federal agencies were  given the opportunity to provide comment on this rulemaking through the interagency review process associated with Executive Order 12866, but comments on that deliberative process are outside the scope of this rulemaking.
<IP_ADDRESS> Coordination Among Agencies
Comment: Commenters (6194, 9227) express concern that the proposed rule would compromise coordination among federal agencies.
Commenter (6194) asserts that the proposed rule would compromise coordination requirements and data sharing agreements between the EPA and the Department of Agriculture, the Food & Drug Administration, and Agency for Toxic Substances and Disease Registry (ATSDR). The commenter asserts that such a blow to inter-agency information sharing would be devastating to regulatory progress throughout the federal government.
Commenter (9227) argues that the EPA arbitrarily failed to consider the implications of this proposal on interagency coordination and consultation given that other agencies normally rely on research potentially excluded by the Proposal. The commenter states that, in the numerous environmental statutes that EPA cites, there are dozens of provisions that require EPA to coordinate or consult with other Federal entities -- especially when implementing research programs and issuing information or guidelines. The commenter contends that the proposed rule could frustrate and impair this coordination and consultation, either by forcing EPA to ignore the science provided by other agencies or by severely restricting the science that EPA itself would be able to share with other agencies in these statutorily required processes.
Commenter (9227) states that, in addition to statutorily required consultations, other federal agencies routinely incorporate and rely upon EPA science assessments in their own efforts to meet mandates to protect human health and safety. The commenter contends that, as with statutorily required consultations, the proposed rule fails to acknowledge or consider what impacts restricting EPA's own use of dose-response studies would have on the work of these other agencies.
Response: The EPA disagrees that this rule would compromise interagency coordination. This is a rule of internal procedure promulgated under the EPA's housekeeping authority. The rule does not impose requirements on parties external to the EPA, including other agencies within the federal government. External users of EPA scientific assessments can still use these assessments. There are also provisions in the final rule (e.g., requirements for the EPA to document critical assumptions and methods used in its dose-response assessment, studies considered pivotal science, the rationale for the level of consideration for studies in the significant regulatory action or influential scientific information, and any Administrator exemption) that will make it clear how the provisions of this rule may have impacted the significant regulatory action or influential scientific information and will help external users determine whether the product is fit for their purpose. The EPA also disagrees that implementation of this rule would limit the scientific record. The final rule does not categorically exclude any studies from EPA's consideration, so 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. Federal agencies were given the opportunity to provide comment on this rulemaking through the interagency review process associated with Executive Order 12866, but comments on that deliberative process are outside the scope of this rulemaking.
<IP_ADDRESS> Counter to Policies of Other Agencies
Comment: Commenters (0671, 1973, 1796, 2746, 5170, 6117, 6125, 6152, 6158, 6896) suggest that the EPA proposal runs counter to policies that are currently being implemented by other agencies.
Commenter (0671) states that no other federal agency has such a broad standard as the one proposed by EPA. The commenter states that the EPA knows that IRBs will not allow such studies' data to be made public, so to require public data from these studies will make them invisible to the rulemaking process.
Commenters (1973, 1796, 5170, 6125) state the proposal would put EPA in direct opposition to the standards currently implemented by the Department of Health and Human Services (HHS). This includes the evidence considered on the health effects of smoking, high cholesterol, etc. by the Centers for Disease Control (CDC), the studies considered for issuing guidelines generated by the NIH, and the FDA's reliance on non-publicly available studies to approve drugs for use by people. HHS has demonstrated it is possible to reconcile the principles of access to, reliability of, and reproducibility of data while respecting the confidentiality of individual patient data.
Commenters (5170, 6117, 6125, 6158) state that the NIH and numerous other federal agencies have required public access for their funded research and they promote data sharing among researchers. The commenters state that none of these agencies require full public disclosure of confidential personal data from health studies and, consequently, EPA's proposed rule would not be consistent with other agencies.
Commenters (6152, 6158) state that the proposed rule is not consistent with the principles of open science as articulated and adopted by leading U.S. scientific bodies including the NAS, NIH, and the CDC. The commenters contend that these bodies recommend that the agency implement existing, broadly accepted tools, including "systematic review methods" rather than arbitrarily excluding science based on rigid data disclosure requirements.
Commenter (2746) expresses concern that that the proposed rule would limit EPA from basing policy on the best available science even though similar data restrictions do not apply to other areas of public policy, such as diplomacy, economy, housing, etc.
Commenter (6896) states that, while each federal agency has different requirements and protocols to ensure sensitive data held under their agency is appropriately protected, the proposed rule does not address these interagency complications. Commenter states that these include data collected and provided by government agencies under specific conditions that vary by agency and dataset and are meant to ensure fair, ethical, and scientific usage. Commenter provides examples from the Bureau of Labor Statistics (BLS), OSHA, the Department of Energy (DOE), the National Institute of Occupational Safety and Health (NIOSH), and CDC's National Center for Health Statistics (NCHS)'s Research Data Center.
Commenter (6125) states that the CDC and other Federal Agencies involved in reducing lead risk, would not be subject to the restrictions on use of science imposed by the proposal, and thus would continue to use the older studies as evidence, creating an unwarranted science practice and policy schism in the federal government. The commenter provides the following examples:
 The CDC has acknowledged that no safe level of lead in blood has been identified and has identified a "reference level" to define especially high-risk populations and geographic areas most in need of primary prevention. Even some of the studies that the Federal government's most respected lead advisory group (CDC's Advisory Committee on Childhood Lead Poisoning Prevention, or ACCLPP) used to develop background justification for the reference level could be precluded from EPA use under this policy. If some of those 92 plus references and studies fail to meet this policy, EPA could not rely on them in developing regulations, and thus could issue regulations that fail adequately to address CDC's high-risk exposures. Further, the additional requirements in the proposal could require that EPA re-evaluate the appropriateness of the CDC dose-response relationship and give "explicit consideration" to other dose-response models even if, as in this case, they have been vetted and rejected by CDC and its advisory committee.