In response to this charge, in 1981, the Commission recommended that all federal agencies adopt uniform regulations concerning the protection of human research subjects. See 47 Fed. Reg. 13,272 (March 29, 1982). Accordingly, in 1991, EPA and 13 other federal departments and agencies adopted uniform regulations on this issue (the "Common Rule"), see 56 Fed. Reg. 28,003 (June 18, 1991), requiring that all research involving human subjects that is "conducted, supported or otherwise subject to regulation by any Federal department or agency" be reviewed and approved by an institutional review board ("IRB"). 40 C.F.R. § 26.101(a). In order to approve research involving human subjects, an IRB must ensure that "there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data." Id. § 26.111(a)(7).
In particular, the Common Rule prohibits EPA from relying on research that is "deficient relative to the ethical standards prevailing at the time the research was conducted in a way that placed participants at increased risk of harm . . . or impaired their informed consent." Id. §§ 26.1704(b)(2), 26.1705(b). It recognizes that the protection of private information of the subject is central to a subject's ability to provide informed consent. See generally id. § 26.116. And the protection of private information is central to the Common Rule more broadly  -  one of only two situations under which IRBs may waive the requirement to obtain written consent is if the release of the consent form risks linking the subject to the research. Id. § 26.117(c)(1).
EPA's Proposed Rule is thus antithetical to the confidentiality requirements of the Common Rule. It would ignore relevant health science absent publication of personal data that is required to be kept confidential under the Common Rule. To enable EPA to consider their studies in a relevant rulemaking, IRBs would have to make the underlying data publicly available, which would place them at risk of termination of federal funding, termination of ongoing studies, denial of approval for new studies, or disqualification of the IRB or its parent institution. 40 C.F.R. Part 26 subpart O & §§ 26.103, 26.123, 26.1123.
Response: EPA disagrees that the rule is inconsistent with the Common Rule confidentiality requirements. The final rule does not require disclosure of information subject to statutory or regulatory limitations on disclosure such as those for confidentiality, privacy, and trade secrets. EPA did not finalize the categorical exclusion of studies from the 2018 proposal. All relevant studies will be evaluated and considered by the Agency in developing significant regulatory decisions and influential scientific information.
Comment [6125-2629]: Commenter (6150) agrees that EPA has sufficient legal authority under existing environmental statutes to issue this rulemaking to strengthen the transparency of the science supporting regulatory activity. EPA lays out substantive legal support for this action in the Proposed Rule. Further, EPA's obligation under the DQA is to "maximiz[e] the quality, objectivity, utility, and integrity of information" and, as importantly, "establish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency." These provisions can only be met if the public has access to the data, models, and methodologies used by EPA and underlying research used by EPA to justify new and existing regulations.
Response: EPA agrees that the Agency has legal authority to promulgate this rule. However, EPA decided to rely on its housekeeping authority, and not on any of the substantive environmental statutes, as authority for the rule.
Comment [6156-1322]: Commenter (6126) states that the burden on researchers is unassessed, but relevant for implementation.
EPA concluded in the proposed rule that "This action does not contain any information collection activities and therefore does not impose an information collection burden under the [Paperwork Reduction Act (PRA)]." However, EPA may have failed to conduct an important prospective analysis of the proposed rule necessary for public commenters to understand the implications on data quality, burden, and privacy implications related to data uses.
The PRA provisions for developing Information Collection Requests (ICRs) and corresponding review and public comment procedures may apply to this draft regulation if EPA intends to collect data from researchers in a consistent way. A key purpose of the PRA is to assess the burden of individuals providing information to the government and to ensure public benefit of that information. PRA requirements apply for "collection of information" which is defined to include "obtaining...facts or opinions by or for an agency, regardless of form or format, calling for...(i) answers to identical questions posed to...ten or more persons..." To the extent EPA anticipates a regulatory action that would routinely encourage voluntary submission of information to EPA as a normal matter with a consistent request established by the proposed rule, the PRA could apply.
Determination about the appropriate application of the PRA is an important issue because the processes of the PRA's ICR reviews provide an assessment of the burden of government information collection. The PRA is also an important tool for transparency about confidentiality and privacy protections, because it offers additional notice and comment periods that inform the public and offer executive branch oversight of agency information collection activities.
Minimally, consideration should be given to burdens the proposed rule would impose on researchers, including those whose research objectives may not have a stated relationship to a regulation or policy issue under consideration. Such analysis of the burden imposed by the regulation could be considered as part of the PRA requirements.
Response: Nothing in the final rule requires the collection of information by EPA or obligates outside parties to take any actions, including providing information to EPA. Therefore, there are no burdens on third parties that EPA should have analyzed. See Section III.J. for a discussion of costs and benefits of the final rule. The final procedural rule describes how EPA will handle studies used to support significant regulatory decisions and influential scientific information. In determining how to weight studies determined to be pivotal science, EPA will assess the availability of dose-response data for those studies. Pivotal science where the underlying dose-response data are available for independent validation will be given greater consideration than pivotal science lacking data availability.
Comment [6156-1326]: Commenter (6126) notes that EPA specifically asked for comment about how the rule can best be implemented in "light of existing law and prior federal policies..." Further review is likely needed to determine how the law would apply in conjunction with the IQA, the Privacy Act of 1974, as amended, and numerous other statutes and policies that encourage the use of data with appropriate privacy and confidentiality protections. For example, IQA's two brief provisions collectively encourage agencies to follow OMB guidance in issuing guidelines for "maximizing the quality, objectivity, utility, and integrity of information...disseminated by the agency." However, EPA's proposed rule does not appear to reference the IQA or suggest its direct relevance, notwithstanding the implication of substantial overlap with the goals of the proposed regulation.
Response: EPA cited OMB's guidelines because it interprets terminology in the IQA that Congress left undefined. EPA also references its own information quality guidelines. EPA's implementation of the final rule will be consistent with the Agency's obligations under the statutes cited by the commenter because the final rule does not require that the Agency disseminate information that is subject to limitations on disclosure such as confidentiality and privacy.
Comment [6161-1509]: Commenter (6131) writes that it is telling that there have been attempts in Congress to enact legislation regarding the issue of data confidentiality as those legislative efforts demonstrate that the executive branch lacks the authority to undertake a rulemaking to address these issues.
Response: EPA agrees that final rule is similar to several provisions of the HONEST Act and may have be motivated by similar concerns. However, EPA disagrees that it lacks the authority to promulgate this rule in the absence of congressional action. The agency has housekeeping authority to promulgate rules that will govern the internal procedures EPA uses to evaluate the science underlying its significant regulatory actions and influential scientific information. EPA could have revised its internal guidance without notice and comment rulemaking but doing so allowed the agency to inform the public of its efforts to increase transparency of the science the agency relies upon and to help facilitate independent validation of the science.
Comment [6425-2369]: Commenter (6447) suggests that EPA impermissibly failed to notify or seek input from its SAB with regard to the proposal.
As the SAB noted in its May 12, 2018 memo, EPA staff violated the Environmental Research, Development, and Demonstration Authorization Act by failing to inform the SAB about the current proposal. According to the SAB, it only became aware of the proposal after seeing it in the Federal Register and in the news. This is a flagrant violation of law, and of reasoned decision-making. As the SAB notes, "[t]he proposed rule deals with issues of scientific practice and proposes constraints that the agency may apply to the use of scientific studies in particular contexts. As such, this rule deals with a myriad of scientific issues for which the Agency should seek expert advice from the Science Advisory Board."
The fact that EPA failed to obtain scientific support for its proposal shows that the proposal has no scientific basis, is ideologically motivated, and is arbitrary and capricious.
Response: EPA disagrees that it violated the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA). EPA did seek and obtain SAB review of aspects of the proposed rule. See https://yosemite.epa.gov/sab/sabproduct.nsf/LookupWebProjectsCurrentBOARD/2DB3986BB8390B308525855800630FCB/$File/EPA-SAB-20-005.pdf.
Comment [6895-3139]: Commenter (6916) writes that to the extent that the Proposal would require release of the underlying confidential data as a prerequisite for EPA to be able to use a federally funded study in making a rulemaking decision, it also is in conflict with the regulations implementing the FOIA. Those regulations, following the 1998 Shelby Amendment to the 1999 Supplemental Appropriations Act, provide access through FOIA to federally supported studies' "research data"  -  so long as its confidentiality is preserved. The Shelby Amendment had directed changes to OMB Circular A-110 and FOIA. The implementing rules state that:
      [i]n response to a Freedom of Information Act (FOIA) request for research data relating to published research findings produced under a Federal award that were used by the Federal government in developing an agency action that has the force and effect of law, the Federal awarding agency must request, and the non-Federal entity must provide, within a reasonable time, the research data so that they can be made available to the public through the procedures established under the FOIA.
But the same rules make clear that "research data" does not include:
      Trade secrets, commercial information, materials necessary to be held confidential by a researcher until they are published, or similar information which is protected under law; and (ii) Personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.
The reasons for this policy are clear: researchers have shown that it takes only two or three factors to permit the identification of a study participant using study data, even if most of the features are made "blind," so that the data set can be shared without exposing confidential information. First, the researchers eliminated as much information as possible from the raw data about a health study's participants, to disguise them. But in order to permit others to meaningfully use the data set, some identifying information had to be preserved. For example, geographic location (the place of death, for example), is required to study the correlation between air quality in that location and deaths. Age is a necessary criterion to account for the effects of normal aging and also the sex of the patient, to factor in any possible sex-related issues. The researchers, who included Douglas Dockery of the Six Cities team, found that even retaining this small number of identifying features meant that the patient could be identified by any researchers wishing to use that data to reproduce a study's results.
Response: Nothing in the final rule would require release of confidential data as a prerequisite for EPA to be able to use a federally funded study when promulgating significant regulatory actions or developing influential scientific information. EPA's implementation of this rule will be consistent with statutory mandates, including FOIA, regarding the disclosure of information.
Comment [8750-1470]: Commenter (9227) suggests that EPA's proposed rule would violate the IQA.
EPA's proposed rule is also unlawful because it exceeds EPA's authority under Section 515(a) of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Public Law 16-554; H.R. 5658), commonly referred to as the IQA. Specifically, the IQA requires EPA promulgate data quality guidelines that are consistent with those promulgated by the OMB. Contrary to EPA's assertion in the preamble to the proposal, the Proposed Rule is not consistent with OMB's data quality regulations.
The OMB Guidelines recognize that data availability is not necessary to high quality science, but is one among many factors. While imposing high standards of quality, objectivity, utility, and integrity of information disseminated by Federal Agencies, the Guidelines recognize the need to implement controls "flexibly, and in a manner appropriate to the nature . . . of the information to be disseminated." As part of ensuring "objectivity" these guidelines encourage agencies that disseminate influential scientific, financial, or statistical information, "to include a high degree of transparency about data and methods to facilitate the reproducibility of such information by qualified third parties." However, they emphasize the need to treat certain data differently, due to privacy and confidentiality concerns. In fact, the OMB Regulations specifically declare that "[w]ith regard to original and supporting data related thereto, agency guidelines shall not require that all disseminated data be subjected to a reproducibility requirement." Rather, the OMB Guidelines instruct that agencies "identify, in consultation with the relevant scientific and technical communities, those particular types of data that can practicable [sic] be subjected to a reproducibility requirement, given ethical, feasibility, or confidentiality constraints." The OMB Regulations further explain that while "[m]aking the data and methods publicly available will assist in determining whether analytic results are reproducible...the objectivity standard does not override other compelling interests such as privacy, trade secrets, intellectual property, and other confidentiality protections. OMB explains that "where public access to data and methods will not occur due to other compelling interests, agencies shall apply especially rigorous robustness checks to analytic results and document what checks were undertaken."
By outright prohibiting EPA from relying on a study to support a significant rulemaking if that study's underlying data and models are not publicly available, EPA's proposed rule departs from OMB's unambiguous language instructing agencies that they "shall not" require that all data and models be subject to the reproducibility requirement, and that "the objectivity standard does not override other compelling interests." The fact that EPA's proposed rule includes a discretionary "exemption" provision does not correct this problem, as that provision would not require the Administrator even to consider whether an exemption is warranted, let alone grant such an exemption under appropriate circumstances.
Because Congress expressly granted OMB the authority to set guidelines for data quality and instructed agencies like EPA to follow OMB's lead, EPA lacks statutory authority to adopt a regulation that is contrary to OMB's guidelines. Accordingly, EPA's proposed regulation violates the IQA and must be withdrawn.
Response: EPA disagrees that the final rule violates with the IQA or is inconsistent with OMB's IQA guidelines. In 2002, EPA issued its information quality guidelines in compliance with the IQA and OMB's guidelines. The final rule does not require that the Agency disseminate information that is subject to statutory limitations on disclosure such as confidentiality, privacy and trade secrets. The final rule also does not require the categorical exclusion of studies which was included in the 2018 proposal. The Agency will consider all studies relevant to the development of a significant regulatory action or influential scientific information but will give greater consideration to the studies identified as pivotal science when the underlying dose-response data are available for independent validation.
Comment [8750-1661]: Commenter (9227) contends that EPA arbitrarily failed to consider the implications of this proposal on interagency coordination.
Additionally, the commenter further contends that the EPA arbitrarily failed to consider the far-reaching implications this Proposal could have on inter-agency coordination and consultation given that other agencies normally rely on research potentially excluded by the Proposal. 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 Proposal would almost certainly 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. The Proposal arbitrarily ignores these potential impacts.
In addition to the many examples of statutorily required consultation that are identified in Appendix B of the commenter's comment letter, 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 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. Indeed, there is no evidence that these other agencies were even permitted to comment on the Proposal as part of the usual process of interagency review.
Some selected examples of other federal agency programs provided by the commenter that rely on EPA science include:
 The Food and Drug Administration (FDA) enforces tolerances established by EPA for pesticide chemical residues in human and animal foods under the Federal Insecticide, Fungicide, and Rodenticide Act, including through a comprehensive pesticide residue monitoring program that tests for approximately 700 pesticide residues in both imported and domestic commodities. To the extent the Proposal affects EPA's tolerances, the nature and effectiveness of FDA's own work to monitor for violations of those tolerances would be impacted.
 FDA also regulates contaminants in bottled water under the Federal Food, Drug and Cosmetics Act. 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 Safe Drinking Water Act, and be no less protective of public health than those standards. If the Proposal impedes EPA's work to establish drinking water standards, this may affect FDA's own ability to justify protective bottled water standards.
 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 Proposal 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.
 The Department of Housing and Urban Development (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. HUD has also developed policies to require radon testing at properties receiving federal financing, which incorporate EPA radon standards. To the extent the Proposal affects future EPA assessments of radon risks, the scope, cost and effectiveness of HUD radon programs could be affected as well.
Response: Nothing in the final rule prohibits EPA from using any relevant studies, including studies offered by other federal agencies, in promulgating significant regulatory actions or developing influential scientific information. This rule of internal agency procedures governs how EPA will handle pivotal science based on the availability of underlying dose-response data. This rule will not impact how EPA coordinates and works with other agencies in meeting statutory mandates.
Comment [8750-1765]: Commenter (9227) argues that EPA fails to comply with the PRA.
EPA and the White House OMB must scrutinize the Proposal for its information collection burden, as that concept is defined under the Paperwork Reduction Act (PRA). The only reference to the PRA in the Proposal is EPA's denial that this action "contain[s] any information collection activities" or "impose[s] an information collection burden." But if finalized, the Proposal would significantly increase that burden in the rulemakings to which it applies. EPA and OMB cannot rationally ignore such an entirely foreseeable impact when considering this Proposal.
The PRA institutes procedural safeguards to "minimize the paperwork burden for individuals, small business, educational and nonprofit institutions," and others. It requires that, prior to initiating a "collection of information," agencies must "provide 60-day notice in the Federal Register . . . to solicit comment to," inter alia, "evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency," "evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information," and "minimize the burden of the collection of the information on those who are to respond." After evaluating public comments, agencies must submit the proposed collection of information to OMB for additional review and publish a notice in the Federal Register setting forth "an estimate of the burden that shall result from the collection of information" and "notice that comments may be submitted to the agency and [OMB]." Any such collection of information is subject to OMB approval. OMB is required to determine "whether the collection of information . . . is necessary for the proper performance of the functions of the agency." A negative determination precludes the agency from initiating the collection of information.
The requirements that EPA would impose through this Proposal qualify as collections of information under the PRA. The statute defines "collection of information" to include "the obtaining [or] causing to be obtained . . . of facts or opinions by or for an agency, regardless of form or format, calling for . . . answers to identical questions posed to, or identical reporting or recordkeeping requirements imposed on, ten or more persons. . ." OMB regulations emphasize the breadth of this definition, specifying that "[a] Collection of information may be in any form or format, including . . . reporting or recordkeeping requirements; . . . policy statements; . . . rules or regulations; . . . oral communications;" and others. "Any recordkeeping, reporting, or disclosure requirement contained in a rule of general applicability is deemed to involve ten or more persons." The definition of "collection of information" is agnostic as to whether disclosure is "mandatory, voluntary, or required to obtain or retain a benefit," and to whether disclosure is to an agency or "members of the public or the public at large."
The Proposal would impose a burden that falls squarely within the definition of "collection of information." In order to use scientific research, the agency would "obtain[] or caus[e] to be obtained . . . facts." Assuming the requirements are applied consistently, the "questions posed," or "reporting or recordkeeping requirements imposed," would be "identical." As the requirements are "contained in a rule of general applicability" -- i.e., the instant Proposal -- they are "deemed to involve ten or more persons." It makes no difference whether the agency seeks the information through a questionnaire, telephone call, or some other format. Nor does it matter whether the agency directly mandates that entities provide the information, or provides that entities must "voluntary[ily]" provide the information in order for research to be eligible for consideration in important rulemakings.
While EPA has refrained from detailing the mechanics by which entities would provide the information, the agency expressly contemplates that the burden of providing such information would fall at least partly to members of the public whom the PRA exists to protect. For example, proposed regulation 40 C.F.R. § 30.5 provides that, "[w]here data is controlled by third parties, EPA shall work with those parties to endeavor to make the data available in a manner that complies with this section." Moreover, the agency specifically "solicits comment on how to incorporate stronger data and model access requirements in the terms and conditions of cooperative agreements and grants." As noted above, the PRA is implicated when collection of information is "required to obtain or retain a benefit," and OMB guidance has identified grants as a "Federal benefit" for purposes of the PRA.
EPA cannot evade the PRA requirements by narrowly asserting that "this action" imposes no information collection burden and ignoring the action's entirely foreseeable future impacts. The proposal expressly "is intended to apply prospectively," suggesting that it "prospectively" requires burdensome collections of information in future rulemakings. EPA must not ignore the PRA in this rulemaking, only to claim in future rulemakings that this rule moots or constrains the PRA's application by compelling certain collections of information.
In the alternative, if EPA genuinely believes that this Proposal would not burden the public with new collections of information, then EPA's stated basis for this rulemaking is exposed as a farce. EPA claims that the Proposal would "ensure" that certain data "are publicly available" and expresses specific concern for science "developed outside the agency." Collection of information, including from researchers employed outside of the federal government, is central to the purpose -- and essential to the implementation -- of the Proposal. Providing this information would inevitably impose a burden on researchers. If the agency does not actually intend to collect information under this Proposal, it underscores that EPA's true purpose is not to increase transparency, but rather to thwart the development and maintenance of vital public health protections on the grounds that the agency lacks the information it would need to support them.
At a minimum, EPA must acknowledge and describe the information collection burden that this Proposal would impose so that OMB and the public can conduct a proper evaluation and provide responsive comments.
Response: EPA disagrees that the PRA applies to this rule. Nothing in the final rule requires the collection of information by EPA from outside parties nor does it obligate outside parties to provide information to EPA. The final rule describes how EPA will handle studies used to support significant regulatory decisions and influential scientific information. In determining how to weight studies determined to be "pivotal science," EPA will assess the availability of dose-response data for those studies. Pivotal science where the underlying dose-response data are available for independent validation will be given greater consideration than pivotal science lacking data availability.
Comment [6895-3138]: Commenter (6916) notes that to the extent that the Proposal would require release of the underlying confidential data as a prerequisite for EPA to be able to use a federally-funded study in making a rulemaking decision, it also is in conflict with the regulations implementing the FOIA. Those regulations, following the 1998 Shelby Amendment to the 1999 Supplemental Appropriations Act, provide access through FOIA to federally supported studies' "research data"  -  so long as its confidentiality is preserved. The Shelby Amendment had directed changes to OMB Circular A-110 and FOIA. The implementing rules state that:
      [i]n response to a Freedom of Information Act (FOIA) request for research data relating to published research findings produced under a Federal award that were used by the Federal government in developing an agency action that has the force and effect of law, the Federal awarding agency must request, and the non-Federal entity must provide, within a reasonable time, the research data so that they can be made available to the public through the procedures established under the FOIA.
But the same rules make clear that "research data" does not include:
      Trade secrets, commercial information, materials necessary to be held confidential by a researcher until they are published, or similar information which is protected under law; and (ii) Personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.
The reasons for this policy are clear: researchers have shown that it takes only two or three factors to permit the identification of a study participant using study data, even if most of the features are made "blind," so that the data set can be shared without exposing confidential information. First, the researchers eliminated as much information as possible from the raw data about a health study's participants, to disguise them. But in order to permit others to meaningfully use the data set, some identifying information had to be preserved. For example, geographic location (the place of death, for example), is required to study the correlation between air quality in that location and deaths. Age is a necessary criterion to account for the effects of normal aging and also the sex of the patient, to factor in any possible sex-related issues. The researchers, who included Douglas Dockery of the Six Cities team, found that even retaining this small number of identifying features meant that the patient could be identified by any researchers wishing to use that data to reproduce a study's results.
Response: See response to Comment 6895-3139.
1.8 Trying to Achieve Administratively What Could Not be Done Legislatively
Comment [550-4263]: Commenter (1563) notes that STRS provides that "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." It codifies what was intended in the Secret Science Reform Act of 2015, and the Honest and Open New EPA Science Treatment Act of 2017 (HONEST Act), both of which passed the House but never came up for vote in the Senate.
Response: EPA agrees with the commenter that the final rule is consistent with some of the provisions of the HONEST Act.
Comment [997-3842]: Commenter (1012) writes that this rulemaking bears a remarkable similarity to highly partisan legislation that the Chairman of the Committee on Science, Space, and Technology has attempted to enact for the past three Congresses. In each of the past three Congresses, this legislation has failed to be enacted into law. Committee Chairman Lamar Smith was present and standing next to you when you signed the proposed rulemaking on April 24. During the signing ceremony for this proposed rulemaking you acknowledged that the proposed rulemaking was a "culmination of the work" of Chairman Smith's efforts. Further illustrating the notion that this rulemaking is a direct substitute for Chairman Smith's failed legislative efforts is the Chairman's press statement from April 24, when he stated:
      Earlier in this Congress, the House passed the HONEST Act with bipartisan support. The legislation requires that scientific information relied upon by EPA for regulations be publicly available for independent analysis. Administrator Pruitt's actions enable us to put the principles of this bill into practice.
Article I of the Constitution vests the power to legislate solely in the hands of the U.S. Congress. Despite the repeated efforts of Chairman Lamar Smith, Congress has never enacted a "Secret Science" bill into law. The commenter believes that the EPA's efforts to administratively implement the provisions of Chairman Smith's failed "Secret Science" bills oversteps the EPA's authority under the U.S. Constitution. For that reason, I urge you to withdraw the proposed rulemaking.
Response: EPA agrees that final rule is similar to several provisions of the HONEST Act and may have been motivated by similar concerns. However, EPA disagrees that it lacks the authority to promulgate this rule in the absence of congressional action. The agency has housekeeping authority to promulgate rules that will govern the internal procedures EPA uses to evaluate the science underlying its significant regulatory actions and influential scientific information. EPA could have revised its internal guidance without notice and comment rulemaking but doing so allowed the agency to inform the public of its efforts to increase transparency of the science the agency relies upon and to help facilitate independent validation of the science.
Comment [1370-4426]: Commenter (1385) writes that recent news reports suggest that you plan to adopt restrictions on research similar to those contained in two pieces of proposed legislation (the Secret Science Reform Act and the HONEST Act), which have both repeatedly failed to pass Congress for several years for good reason.
Response: While the final rule is similar to aspects of the legislation cited, the rule will not restrict the use of any scientific studies to support final significant regulatory decisions and influential scientific information. The final rule adopts a weighting approach to evaluating studies rather than the categorical exclusionary approach in the 2018 proposal.
Comment [1380-4438]: Commenter (1395) writes that Congressman Lamar Smith sponsored a bill, the "Honest Act" which would bar the use of data from such studies, which did not pass. This rule making is an attempt to circumvent Congress and implement such a rule anyway.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [1409-4467]: Commenter (1424) writes that the origin of this proposal is the house bill HR1430, sponsored by the anti-science republican chair of the House of Representatives Science, Space and Technology Committee, Lamar Smith. The EPA, under the troubled head, Administrator Pruitt, has transferred this failed bill to the EPA in an attempt to enact it as an agency regulation.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [1973-4610]: Commenter (1988) writes that on 24 April 2018, Administrator Scott Pruitt signed the misleadingly named "Strengthening Transparency in Regulatory Science" - a proposal to require the Environmental Protection Agency (EPA) to make the raw data underlying regulatory action publicly available in a way that allows for independent validation. Based on the Secret Science Act and the more recent HONEST Act, this rule would restrict the use of scientific research vital to informed decision-making, such as studies containing private or proprietary information including personal health records, under the guise of transparency and the desire to ensure the robustness of science.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [4579-2459]: Commenter (4590) writes that a Congressional bill similar in intent to the EPA's proposed rule  -  the HONEST Act  -  was offered and defeated last year. Members of Congress had serious and valid concerns about the negative impact the bill would have by significantly reducing the amount of scientific evidence that EPA can consider when adopting regulatory standards to protect public health and the environment. Given the requirements of the APA and federal environmental statutes, the agency cannot do by regulation what Congress declined to do through legislation.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [4870-2301]: Commenter (4881) writes that the Congress has consistently declined to adopt legislation that would add an explicit requirement to provide public access to raw data. The EPA, in its proposed rule, is attempting to delegate to itself this clearly legislative authority, with no evidence for the allegedly "secret science" raised by a small group of legislators who seek to undermine traditional EPA authority to regulate environmental hazards. That small group of legislators has had a barely concealed focus on several particular studies that have been foundational in establishing the very real connections between exposure to air pollution and adverse public health impacts.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [4883-2114]: Commenter (4894) writes that the rule's premise, which was also the premise of the Secret Science Act and the HONEST Act, cannot stand.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [5011-2654]: Commenter (5022) writes that the proposal lacks critical citations and documentation or even an adequate justification for why it was proposed. Rather than furnishing the evidentiary support required for administrative action, the agency has merely adopted a legislative initiative that failed to pass despite support from the energy, chemical, manufacturing, and other key industries. That legislation was proposed by Rep. Lamar Smith (R-TX), Chair of the House of Representatives Committee on Science, Space, and Technology, who questions the science behind climate change and the relationship between air pollution and mortality.
Response: EPA explained the justification for the rule in the preamble of the 2018 proposal.
      Enhancing the transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA's regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions. By better informing the public, the Agency in enhancing the public's ability to understand and meaningfully participate in the regulatory process." 83 Fed. Reg. 18769 (April 30, 2018).
Further, EPA cited Executive Orders, OMB memoranda and guidelines, and scientific journal articles, etc., as justification for the rule.
Comment [5153-4081]: Commenter (5164) writes that recent news reports suggest that you plan to adopt restrictions on research similar to those contained in two pieces of proposed legislation (the Secret Science Reform Act and the HONEST Act), which have both repeatedly failed to pass Congress for several years for good reason. Multiple major scientific societies repeatedly came out strongly against the legislation at the time. "We urge caution in setting laws that submerge science beneath politics," they wrote.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [6104-614]: Commenter (6114) states that the proposal is strikingly similar to both the proposed Honest and Open New EPA Science Treatment (HONEST) Act of 2017 (H.R.1430-115th Congress, 2017-2018) and the proposed Secret Science Reform Act of 2014 (H.R. 4012-113th Congress, 2013-2014) and 2015 (H.R.1030 - 114111 Congress, 2015-2016), all of which repeatedly failed to pass in the Senate despite being supported by the energy, manufacturing, and chemical industries.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [6155-2166]: Commenter (6125) writes that this initiative is clearly based on the so-called HONEST Act, legislation introduced in each of the last two Congresses to restrict EPA's ability to rely on scientific information, but never enacted into law (H.R. 1030 in 2015 and H.R. 1430 in 2017). The CBO in consultation with EPA analyzed the costs that would be imposed by these legislative proposals. The 2015 analysis assumed that EPA would reduce the number of studies it relied on by half, but would still need to expend $250 million/year initially in an effort to determine data availability, and where necessary pay for obtaining and disseminating it. Given EPA's intention to "minimize" such costs in its proposed rule, this estimate may be considered an upper bound of the direct costs.
The CBO analysis does not tell the whole story, however, because it did not assess the disbenefits to the regulatory process and to public health of being unable to base regulations on numerous influential studies for which data could not be made available. Considering only the science policy value of the information in multiple original studies that are likely to be lost (e.g. the cohort epidemiology studies noted above, which must limit access to protect privacy) it is reasonable to conclude that their loss would almost certainly outweigh the value of any information gained by subsequent re-analyses of a more limited set of studies, which rely on publicly available databases that are often inferior to those that contain more relevant
information.
In the 2017 legislative analysis, CBO estimated a cost ranging from 1 million to 100 million dollars per year, depending on the approach taken by EPA in assessing studies. They determined that meeting H.R. 1430 requirements would cost EPA an average of $10,000 per study. EPA officials told CBO that the agency would likely greatly reduce the number of studies it relied on and would not take on the cost of disseminating the underlying data.  The proposal reiterates EPA's plan to focus on a more limited number of studies. Under these assumptions, CBO suggested costs could be as low as $1 million/year, but again did not assess the potential implications for existing or future regulations. An unofficial draft response to CBO questions from unidentified EPA staff strongly disagreed with the lower cost estimates, and expressed concern that the legislation would prevent EPA from using the best available science; this response was never forwarded to CBO.
Response: The final rule will not reduce the number of scientific studies that the EPA may use in developing significant regulatory actions or influential scientific information. Further, the rule does not require the EPA to compile, store or disseminate data from outside sources. As discussed in Section III.J. of the preamble, the EPA has identified some incremental costs that the Agency may incur as a result of this rule. The EPA will continue its current practice of conducting extensive review of scientific studies during the development of final significant regulatory actions and influential scientific information. The additional procedures required by this rule only apply to pivotal science, which is a subset of the total number of studies that the EPA would evaluate. Given the costs of the extensive review and documentation and the determination of dose-response data availability is limited to pivotal science underlying final significant regulatory actions and influential scientific information, the EPA anticipates that the incremental costs of this rule related to the additional review of data availability will be small.
Comment [6161-1506]: Commenter (6131) notes that the proposal is strikingly similar to both the Honest and Open New EPA Science Treatment (HONEST) Act of 2017 (H.R. 1430  -  115th Congress, 2017-2018) and the Secret Science Reform Act of 2014 (H.R. 4012  -  113th Congress, 2013-2014) and 2015 (H.R. 1030  -  114th Congress, 2015-2016), all of which repeatedly failed to pass in the Senate despite being supported by the energy, manufacturing, and chemical industries.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [6163-589]: Commenter (6133) contends that the governing, harmful conceit of the Proposal -- to censor the best available, peer-reviewed health science that EPA may consider, in order to prevent adoption of protective health and environmental safeguards -- is a thinly disguised version of anti-science legislation that Republican members of Congress have introduced, repeatedly, but have been unable to enact into federal law, repeatedly. The commenter opposed those bills strongly, and still does. The commenter raised many of the identical objections to those bills that they raise to the Proposal in these comments. Indeed, it is striking that one of the primary EPA co-authors of the Proposal was a Committee staff person for the leading congressional co-sponsor of the legislation in question when the failed bill was being shepherded through the House of Representatives.
Members of Congress understood that new legislation was required to censor EPA consideration of high quality, peer-reviewed science, and yet EPA barreled ahead with a Proposal based on the same legislative approach while pretending, suddenly, that multiple federal laws have authorized that approach, magically, all along. For the reasons discussed in these comments, the Proposal is not authorized by any federal laws. Moreover, the Proposal violates numerous federal laws entrusted to EPA, in addition to being arbitrary and capricious and an abuse of EPA's discretion.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [6339-1797]: Commenter (6361) states that the proposal is strikingly similar to both the Honest and Open New EPA Science Treatment (HONEST) Act of 2017 (H.R. 1430  --  115th Congress, 2017-2018) and the Secret Science Reform Act of 2014 (H.R. 4012  --  113th Congress, 2013-2014) and 2015 (H.R. 1030  --  114th Congress, 2015-2016), all of which repeatedly failed to pass in the Senate despite being supported by the energy, manufacturing, and chemical industries. These nearly interchangeable bills would have required all research data used in agency actions to be made available to the public. Our nation's health privacy laws were enacted to address citizen's concerns about this type of information being made public or getting into the wrong hands.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [6857-2946]: Commenter (6879) writes that the proposed regulation is also arbitrary and capricious. This rule has its origins in a failed congressional attempt to limit the science available for use in EPA rulemaking, and Congress rightfully rejected this extreme and harmful proposal. It is therefore shocking that EPA would take this failed effort and, unsupported by facts, reason, history, or scientific evidence, put the proposed regulation on a fast-track for administrative approval and adoption.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [6894-3593]: Commenter (6915) writes that this anti-science approach has stalled in Congress and been rejected by the courts; it has no place at EPA.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [6897-1882]: Commenter (6918) writes that they support enhanced transparency in EPA rulemakings, but recognize the vital importance of privacy, confidentiality of personal and business information, and national and homeland security as limits on data access. Commenter therefore agrees with EPA's goal of making data and models underlying pivotal regulatory science available while providing a process for protecting data if their release would impair privacy, confidentiality, or security. Commenter recommends that EPA more clearly detail an objective and consistent process that would determine when release of data underlying pivotal studies would be deemed inappropriate because it would impair privacy, confidentiality, and/or national security.
Response: The EPA appreciates your comment in support of this rule. The EPA intends to develop guidance for Agency employees to ensure that the rule implemented in a consistent manner. The EPA will continue to comply with statutory restrictions on the release of dose-response data.
Comment [6907-3957]: Commenter (6928) writes that the new EPA proposal is the latest in a long-running campaign to let the public and regulated industries sift through the raw data of epidemiologists whose work could affect pollution regulations.
In the 1990s, members of Congress pressed for legislation requiring scientists to disclose their raw scientific data, partly in response to a Harvard University study finding a correlation between more air pollution and lower life expectancy. Several times in recent years, the House of Representatives passed a bill requiring public disclosure of data from any new studies used by EPA to write regulations, but the proposal never made it out of Congress.
Response: See the responses to Comments 997-3842 and 1370-4426.
Comment [9283-3588]: Commenter (8281) notes that over the last few years, the House Committee on Science, Space, and Technology has considered several iterations of legislation that have many similarities to the proposed rule. Commenter has been a vocal opponent of these bills... Commenter also wants to note that despite repeated efforts by the majority, the so-called secret science legislation has not passed both chambers. Congress has the sole constitutional authority to legislate, and this proposed rule is an administrative attempt to circumvent the legislative process. Commenter strongly urges EPA to withdraw this proposed rule. It will undermine scientific integrity, jeopardize bedrock public health and environmental standards, and endanger the EPA's ability to protect the American people, which is its mission.
Response: See the responses to Comments 997-3842 and 1370-4426.
1.9 Other Comments (NPRM Comments)
Comment [2157-145]: Commenter (2171) states that this proposed rule is counter to the current goal of Cooperative Federalism.
As an example, the MPCA manages facility air toxics emissions through modeling and risk-based assessments, with support from MDH. Specifically, we compare modeled air concentrations to inhalation health benchmarks. ln order to keep our approach systematic and non-biased, the MPCA and MDH pre-select information sources of inhalation health benchmarks in the form of a hierarchy. Approximately 40% of the inhalation health benchmarks that the MPCA uses to manage air toxics emissions are from EPA's IRlS or Provisional Peer-Reviewed Toxicity Values (PPRTV) programs. Our Understanding of this proposed rule leads us to believe that the dose-response information used to develop these values could become mired in redundant and unnecessary review, should the rule be enacted. Any delay in the review of IRlS or PPRTV data greatly compromises the MPCA's ability to assess and appropriately set permit conditions for industries, or to determine clean up requirements for site remediation projects.
Response: This procedural rule only applies to EPA and not to any other party outside of the agency. Any potential implementation issues will be addressed as appropriate in subsequent rulemakings implementing this procedural rule.
Comment [6092-471]: Commenter (6102) suggests that given the practical and legal complexities surrounding this effort, the EPA may want to supplement this rule with statute-specific rulemakings. This would allow EPA to more precisely tailor transparency requirements in the context of individual statutes while providing greater legal certainty.
Response: EPA agrees that statute-specific rulemakings are necessary. As discussed in the final rule preamble at Section III.A, statute-specific transparency regulations or programmatic regulations are forthcoming.
Comment [6119-2471]: Commenter (6144) notes that records released through a FOIA request confirm that EPA staff are aware that the agency does not need to have access to the underlying raw data, codes, etc. to promulgate regulations. In an email sent by Dr. Nancy Beck, the Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, to her colleagues during the development of this proposed rule, she shares "for awareness" that in the 2002 court decision American Trucking Association v. EPA, it became evident that EPA would not be able to use a significant amount of important scientific literature to protect public health and the environment if it had to access the raw data of peer-reviewed scientific studies. The courts, through that decision and through Coalition of Battery Recyclers Association v. EPA, have made it abundantly clear that EPA is not required to obtain or analyze raw data in order to use independent scientific studies that are published in peer-reviewed journals to regulate.
Response: This final rule does not require EPA or any entity outside of the agency to obtain, analyze, or publicize raw data in order to consider pivotal science to be used in significant regulatory decisions and influential scientific information and does not require EPA to categorically exclude any studies. Therefore, it does not conflict with those decisions.
Comment [6125-1850]: Commenter (6150) writes that increasing transparency will improve the quality of the data used to support regulatory decisions, thereby assuring that EPA relies on the best available science. EPA may want to supplement this rule at a later date with statute-specific rulemakings. This will allow EPA to be more precise in how the transparency requirements apply in the context of individual statutes while providing greater legal certainty. This suggestion should not be justification or causation for not taking steps more generally ahead of addressing any statute-specific rulemakings.
Response: See response to Comment 6092-471.
Comment [6163-5032]: Commenter (6133) notes that EPA identifies no indication under federal laws that Congress intended to create or authorize a lose-lose dynamic, in which EPA could exercise its authority either by excluding the best available, peer-reviewed science to inform health and environmental protections, or force researchers or ordinary Americans to cast aside privacy concerns, as well as legal and ethical restrictions on the sharing of sensitive data. That false choice is entirely a creation of the agency's misguided policy preferences in the Proposal. The rule is arbitrary and capricious and an abuse of EPA discretion, with its selective application of data release requirements and disregard for the quantitative complexities of epidemiologic research.
Response: The final rule does not require EPA to exclude science or to disclose protected information. Rather, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. See the final rule preamble at Section III.E for further discussion of the finalized approach and EPA's process for considering protected information.
Comment [6356-2427]: Commenter (6378) states that drawing from their experience on multiple EPA panels for CASAC, IRIS, and FIFRA, they are convinced that the proposed rule will severely limit the information that EPA can use to make decisions by requiring that studies used in the scientific reviews in support of science make their data publicly available. This will directly contradict the mandates of many Acts that require that the scientific review draw upon the best available science.
Response: As explained in Section III.E of the final rule preamble, the EPA will give greater consideration to pivotal science for which the underlying dose-response data are publicly available in a manner sufficient for independent validation, and not categorically exclude pivotal science for which the underlying dose-response data are not available. EPA has explained that this procedural rule has limitations on its scope in terms of conflicts with other substantive requirements and that, in situations where this rule applies, EPA will give greater consideration to those studies where the underlying data and models are available for independent validation. The final rule provides that if implementing the rule results in any conflict between this rule and the environmental statutes that the EPA administers, this rule will yield and the statute will control.
Comment [6357-1865]: Commenter (6379) argues that nothing in the Proposed Rule or its implementation should preclude the use of the best available science. Numerous statutes that EPA is charged with implementing require that EPA rely on the best available science and health information. For example, the Toxic Substances Control Act requires that in conducting tests and risk assessments of toxic substances, "the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science." Similarly, the Safe Water Drinking Act requires that a determination to regulate a contaminant "shall be based on the best available public health information." And, as the Proposed Rule notes, Executive Order 13563 (2011) requires that the "regulatory system" be "based on the best available science."
However, it is unclear whether it is appropriate and legally durable to restrict the use of the best available science by, as the Proposed Rule does, defining "best" to include a requirement that data be "publicly available." Such a requirement may be inconsistent with Court findings and established Federal and EPA requirements. For example, the Eighth Circuit Court of Appeals has stated in the context of other federal regulations that "it is required of the agencies...to seek out and consider all existing scientific evidence relevant to the decision at hand. [Agencies] cannot ignore existing data."
Response: See response to Comment 6356-2427.
Comment [6852-2763]: Commenter (6874) argues that EPA has failed to demonstrate that its current processes for considering science in regulation have suffered from insufficient transparency that has resulted in outcomes contrary to its statutory mandates or executive orders. Given extensive existing procedures used by EPA and the scientific community at large to assure the quality of research, EPA has failed to make a case that additional public access to data is necessary.
Response: This rulemaking is intended to build on open data initiatives in the Federal government and scientific community, and thereby improve the transparency of EPA decision-making and assessments Where underlying dose-response data in pivotal science are available, subject matter experts could independently reanalyze the data to validate original research findings, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty. Having a better understanding of the underlying data will enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or ISI. EPA further discusses the need for additional transparency in the final rule preamble at Section III.A.1.
Comment [6891-1529]: Commenter (6912) writes that EPA has not engaged in reasoned decision-making in developing this rule.
While judicial review of agency actions is usually ''exceedingly deferential," when, given the totality of the circumstances, the agency appears not to have engaged in reasoned decision-making, a rule should be invalidated.
The scope of review under the "arbitrary and capricious'' standard is narrow and a court is not to substitute its judgment for that of the agency. Nevertheless, the agency must examine the relevant data and articulate a satisfactory explanation for its action including a ''rational connection between the facts found and the choice made." In reviewing that explanation, we must "consider whether the decision was based on a consideration of the relevant factors and whether there has been a dear error of judgement.
This heightened level of scrutiny calls on a court to "intervene not merely in case of procedural inadequacies, or bypassing of the mandate in the legislative charter, but more broadly if the court becomes aware, especially from a combination of danger' signals, that the agency has not really taken a 'hard look' at the salient problems, and has not genuinely engaged in reasoned decision-making.'
In Greater Boston Television Cmp. v FCC, the biggest "danger signal" that caused the court to give an agency's actions a "hard look'' was the fact that the chair of the Federal Communications Commission (FCC) had had potentially improper contacts with an executive at one of companies competing for a broadcast license to be attributed by the agency. Other "danger signals" that courts have held to trigger heightened scrutiny of agency actions include "abrupt shifts in policy," and "where the agency has demonstrated undue bias towards particular private interests." These concerns are epidemic for this proposed rule.
As detailed in Part II A of this comment, the proposed rule is the result of a long, tobacco and fossil fuel industry-led campaign to limit the use of science in rulemaking. This campaign focused on limiting the use of public health studies that demonstrate dramatically negative health consequences of smoking and breathing polluted air. The trick was to take advantage of the private nature of underlying individual health care information (a value worth protecting), and twist that into a faux concern about "secret science."
Part II B lays out the myriad connections between Pruitt, congressional champions of this proposed rule, and the EPA political appointees who developed it, and the fossil fuel and tobacco industries who have campaigned for it for decades. This long and well-documented record is rife with the sort of "danger signals" the courts have found to warrant "hard look" review. Potentially improper contacts between regulators and regulated industries, "abrupt shifts in policy," and ''undue bias towards particular private interests" are all present in this tawdry tail of industry capture. Based on this record, no court could conclude that EPA "genuinely engaged in reasoned decision making" nor did it "articulate a satisfactory explanation for its action including a 'rational connection between the facts found and the choice made. '"
Response: EPA notes that although this is an internal procedural rule not subject to the APA's notice and comment requirements, see 5 U.S.C. § 553(b), EPA nevertheless published a proposed rule and supplemental proposed rule in the Federal Register, solicited public comment on both, and made all relevant documents available for public review. In so doing, EPA complied with the APA's notice and comment requirements even though the rule is not subject to them. Taken together, the proposal and supplemental proposal articulate a rational basis for the final rule and demonstrate that the agency engaged in reasoned decision-making, informed by the over 950,000 public comments received (over 22,400 unique comments).
Comment [6891-1530]: Commenter (6912) argues that the proposed rule is an illegal delegation of agency rulemaking authority to the industries it regulates.
Just as an agency rulemaking will be set aside if a court determines that it was arbitrary and capricious, an agency rulemaking should be invalidated if a court finds that the agency delegated its rulemaking authority to one or more private interests; because Congress "cannot delegate regulatory authority to a private entity." "Although objections to delegations are "typically presented in the context of a transfer of legislative authority from the Congress to agencies, [...] the difficulties sparked by such allocations are even more prevalent in the context of agency delegations to private individuals."
While it is clear that an agency may not explicitly delegate its rulemaking authority to private interests, an agency that implicitly delegates its rulemaking authority to private interests raises the same concerns. An agency is effectively captured by the private interests it regulates when its '"regulation is . . . directed away from the public interest and toward the interest of the regulated industry ' by 'intent and action' of industries and their allies."
As described above, the proposed rule was the product of a process that was effectively delegated to industry, with EPA serving as little more than a rubber stamp on an industry -  sought and industry-drafted proposal. The evidence is overwhelming that the proposed rule was conceived by the tobacco industry and then advanced by the tobacco and fossil fuel industries and the network of individuals and front groups they have funded for more than two decades.
Steve Milloy and Christopher Horner, two of the biggest players in industry 's "secret science" campaign, even worked for President Trump's EPA transition team, and one boasted that he was "inside the Administrator 's office" on the day the proposed rule was announced. Richard Yamada, the political appointee drafting the proposed rule, spent most of his Washington career working for Representative Lamar Smith, the primary congressional champion of the "secret science" initiative, who also happens to count the fossil fuel industry as his biggest donors. It was Smith whose meeting with Pruitt apparently triggered the drafting of the proposed rule. Brittany Bolen, Ryan Jackson, and Erik Baptist, the other political appointees involved in drafting the proposed rule, all previously worked for Senator James Inhofe, another fossil fuel industry-funded congressional champion of the rule.
The fossil fuel industry and its long-time "secret science" allies quickly took advantage of Scott Pruitt's ascendency at EPA. At least one company - Chevron - included the "secret science" initiative on its EPA wish list. The fact that Pruitt resigned in disgrace as EPA Administrator after the publication of the proposed rule does not allay these concerns. The man is gone, but his conflicts and the flawed process he oversaw lingers on.
Moreover, the capture of EPA goes deeper than just Scott Pruitt. The case for agency capture survives his departure. Numerous EPA political appointees; all of whom have their own significant ties to the fossil fuel industry, were intimately involved in this rulemaking. Intact current EPA Acting Administrator Andrew Wheeler, who will oversee the rulemaking process going forward, has his own deep ties to the fossil fuel industry.
We are not the only ones to conclude that EPA under the current ·administration has been captured. by industry. A recently published article in the American Journal of Public Health finds that EPA is exhibiting many signs of regulatory capture. The authors of this article examined EPA actions from December 2016 through June 2017 arid they interviewed 45 current and retired EPA employees. Among their findings pointing to regulatory capture:
 Appointees have deep ties with industries."
 "Significant policy changes at the EPA favor businesses and industry, while probably incurring considerable health and environmental "
 ''Pruitt has regularly championed the interests of regulated industries, while rarely affirming environmental and health "
 "Pruitt dismissed many members of the EPA's Science Advisory Board and its Board of Scientific Counselors, created a new rule preventing EPA-funded scientists from serving on those boards, and-for the first time in agency history -  allowed lobbyists on scientific advisory "
 "Pruitt's own meetings and schedule...are almost exclusively with company and trade organizations and rarely with environmental, public health, or citizen groups."
The extreme and well-documented regulatory capture of EPA has effectively delegated its authority to the industry or industries that have captured. There is no substantive difference between an agency explicitly telling a company or industry to write a rule for it, and an agency telling a company or industry that it will write whatever rule the company or industry wants. Like Scott Pruitt' s Devon Energy letter, the substance is all industry, whatever the letterhead, and the public interest is ignored.
Response: This procedural rule outlines the internal processes by which EPA will consider dose-response data underlying pivotal science to be used in its significant regulatory actions and influential scientific information. It does not apply to anyone outside of EPA, and therefore cannot be an impermissible delegation of EPA's authority to industry stakeholders.
Comment [6903-1980]: Commenter (6924) points out that despite citing policies from the NIH and the National Science Foundation (NSF), EPA does not appear to have conducted any inter-agency consultation on the rule. EPA's SAB also notes that EPA is legally mandated to make proposed regulations available for SAB review, which the Agency failed to do.
Response: The supplemental proposal underwent interagency review and the SAB reviewed aspects of the proposed rule. See https://yosemite.epa.gov/sab/sabproduct.nsf/LookupWebProjectsCurrentBOARD/2DB3986BB8390B308525855800630FCB/$File/EPA-SAB-20-005.pdf and response to Comment 6425-2369.
Comment [9078-3499]: Commenter (6194) discusses EPA's failure to address impacts under the Paperwork Reduction Act (PRA).
The PRA requires OMB to review federal rules that impose information collection requirements on "persons," including individuals and corporations. 44 U.S.C. § 3502(10). Such collection of information includes "obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public, of facts or opinions by or for an agency, regardless of form or format" through the use of "reporting or recordkeeping requirements." 44 U.S.C. § 3502(3)(A)(i). Although EPA asserts that the Proposal is not subject to the PRA, perhaps because it does not include an explicit reference to information collection, the Proposal would create new reporting requirements that would apply to multiple "persons." Specifically, for science to be considered in certain regulatory proceedings, someone (whether the person conducting the science, preparing a report, or utilizing data) would have to "clean" confidential data so that it can be made public. Such reporting and recordkeeping procedures are costly and, in some instances, inconsistent with other federal policies governing information use and dissemination. This aspect of the Proposal must be addressed by OMB as required by the PRA.
Response: This is an internal rule of agency procedure. It does not regulate any party outside of EPA. In any event, this action does not contain any information collection activities and therefore does not impose an information collection burden under the PRA.
Comment [6093-544]: Commenter (6103) notes that the U.S. Court of Appeals for the D.C. Circuit has stated in 2002 and 2010 that the EPA is not legally obligated to obtain and publicize all the data underlying its research when crafting policies and regulations.
Response: See response to Comment 6119-2471.
Comment [6103-518]: Commenter (6113) notes that before EPA approves its proposed regulation, NEPA requires that EPA prepare an EIS. That EIS must include a detailed analysis of each registered pesticide's environmental impacts. Such analysis of each pesticide should include: the quantity of the pesticide used every year, the number of applicators applying the pesticide each year, the human toxicity of the pesticide, the non-human affect of the pesticide on the flora and fauna within wind's reach of the pesticide application area, the pesticide's impact on groundwater underlying the application area. Also in light of the studies relied in the United case, it[']s clear that the EIS must also include a detailed analysis of the pesticide's impact on the family of the applicators and any other people living near the application area. United, slip op at p. 11-12 (discussing internal EPA studies). Given that there are thousands of registered deadly pesticides, EPA should begin work on the EIS immediately. P. Finegan, FIFRA Lite: A Regulatory Solution or Part of the Pesticide Problem?, 6 Pace Environmental Law Review 615, 624 (1989) (noting that there are over fifty thousand registered pesticide products with over 600 active ingredients).
Response: See response to Comment 20-1294.
Comment [6104-621]: Commenter (6114) argues that the proposed HONEST Act, the Secret Science Reform Act, and this proposed rule all directly contradict a 2002 and a 2010 ruling from the D.C. Circuit Court of Appeals which states "we agree with EPA that requiring agencies to obtain and publicize the data underlying all studies on which they rely 'would be impractical and unnecessary'".
Response: Regarding the HONEST Act and the Secret Science Reform Act, see response to Comment 1370-4426. Regarding the cited court decisions, see response to Comment 6119-2471.
Comment [6133-2172]: Commenter (6158) notes that numerous court cases have weighed in on the best available science standard in the context of numerous different federal laws. For example, courts have found that the agency must use the best science that is available to it at the time of the decision, not the best that might be available to it at some time in the future.
Response: This purely internal procedural rule does not interpret or apply the provisions of any environmental statutes that EPA administers. As discussed in the final rule preamble at Section III.A.3, if implementing this rule would result in conflicts with existing environmental statutes, and their implementing regulations, this rule will yield to the EPA statutes.
Comment [6155-592]: Commenter (6125) writes that numerous courts have indicated that a plaintiff or petitioner can establish a violation of the "best available science" requirement by "point[ing] to any scientific evidence that the agency failed to consider." Safari Club Int'l v. Salazar (In re Polar Bear Endangered Species Act Listing & Section 4(d) Rule Litig. - MDL No. 1993), 709 F.3d 1, 9 (D.C. Cir. 2013). "The best available data requirement ... prohibits [an agency] from disregarding available scientific evidence that is in some way better than the evidence [it] relies on.'" Kern Cnty. Farm Bureau v. Allen, 450 F.3d 1072, 1080 (9th Cir. 2006) (quoting Sw. Ctr. for Biological Diversity v. Babbitt, 215 F.3d 58, 60 (D.C. Cir. 2000)). "Essentially, [the agency] `cannot ignore available ... information.'" San Luis & Delta-Mendota Water Auth. v. Jewell, 747 F.3d 581, 602 (9th Cir. 2014) (quoting Kern Cnty., 450 F.3d at 1080-81 (quoting Conner v. Burford, 848 F.2d 1441, 1454 (9th Cir. 1988))."
Response: See response to Comments 6133-2172 and 6163-5032.
Comment [6172-3286]: Commenter (6182) suggests that to serve the American public's interests, EPA should:
 Codify its findings for "Increasing Consistency and Transparency in Considering Costs and Benefits in Rulemaking Process" as a binding rule in the CFR rather than mere "guidance.
 Internally enforce such a rule and ensure it is judicially enforceable.
Enforcing such a process would also serve the purpose of Executive Order (EO) 12988 to "reduce needless litigation." Enforcement would also serve to comply with stated objectives of Federal "data quality" policies that are still "on the books" from past Administrations.
DOE's Process Rule, while ostensibly well intentioned, was fatally flawed in that:
 It has been generally treated as mere guidance rather than as an enforceable rule (despite its CFR status).
 It was made immune to judicial review and enforcement by the following text:
(c) Judicial review. The procedures, interpretations, and policies stated in this Appendix are not intended to establish any new cause of action or right to judicial review.
Regulatory staffs often tend to resolve issues by promoting more regulation. This tendency should be guarded against if the public interest is to be served. EPA staff, like DOE's, may resist enforceability by arguing that it restricts their regulatory flexibility. By yielding to such arguments, EPA would jeopardize the legitimate objectives of this ANOPR.
DOE/EERE's "process rule" also contains some solid principles regarding transparency and consistency that EPA could adopt. These include:
      Use transparent and robust analytical methods. The Department seeks to use qualitative and quantitative analytical methods that are fully documented for the public and that produce results that can be explained and reproduced, so that the analytical underpinnings for policy decisions on standards are as sound and well-accepted as possible.
Unfortunately, notwithstanding the clear statement in favor of rulemaking transparency, EERE's implementation over the years directly conflicts with the above principles by putting too much emphasis upon outsourced analyses to ostensibly "independent" experts, opaque modelling processes and proprietary data sources. Through the years, such complexity has grown and served to hinder independent verification by the public. The following excerpt is but one example from DOE's Process Rule that engendered this problem:
      Identification of experts and other interested parties for peer review. DOE, in consultation with interested parties, will identify a group of independent experts and other interested parties who can provide expert review of the results of the engineering analysis and the subsequent impact analysis.
The "moral of the story" is that EPA should recognize that ambiguously stated objectives could be misused to justify entrenched or predetermined positions through biased regulatory analyses. DOE's Process Rule provides a case-in-point.
Response: The EPA has finalized the rule "Increasing Consistency in Considering Benefits and Costs in the Clean Air Act Rulemaking Process," and plans to issue similar rules for the other substantive environmental statutes that the Agency administers. These are rules of internal agency procedure and are binding to the EPA.

 Chapter 2: Purpose and Effects
The purpose of the notice of proposed rulemaking (NPRM) and supplemental notice of proposed rulemaking (SNPRM) is to establish a clear policy of transparency of the scientific information used for significant regulations. Specifically, the NPRM preamble states that the proposed rule is designed to increase transparency of the assumptions underlying dose-response models. To meet this purpose, the proposed rule directs EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation (40 CFR 30.1). The proposal states that using scientific information that can be independently validated will lead to better outcomes and strengthen public confidence in the health and environmental protections underpinning EPA's regulatory actions.
Several comments were received regarding the purpose/basis and effects of the NPRM and SNPRM, including the effects of the proposal's requirements on available science, health protections, EPA actions, and research activities under the proposal. In this section the public comments are organized according to the following topics under sections 2.1 (Purpose and Effects (NPRM Comments)) and 2.2 Purpose/Basis and Effects (SNPRM Comments):
Section 2.1: Purpose and Effects (NPRM)
 Change in Culture
 What Problem is the Agency Intending to Fix?
 Proposed Rule is Biased
 Environmental and Health Protections Would be Decreased
 EPA Would be at Odds with Other Parts of the Federal Government
 EPA Would be at Odds with Other National and International Bodies
 Proposed Rule is Flawed and Needs to Be Withdrawn/Redone with Feedback from the Scientific Community/Stakeholders
 Other Effects/Impacts
Section 2.2: Purpose/Basis and Effects (SNPRM)
 Purpose/Basis for the Rule
 Effects
The specific comments provided in this Chapter reflect the comment letters that provide arguments supported by detailed rationale, examples, and references/documentation. The Docket ID numbers for these commenters are cited throughout this Chapter. In addition, some general comment letters may also include comments related to comments included and responded to in this Chapter. These comments are summarized in Appendix B. Note that points and issues raised in these general comment letters may also be raised by the more detailed comments summarized in this Chapter. The responses provided in this Chapter adequately address these more general detailed comments on the purpose and effects of the rulemaking.
2.1 Purpose and Effects (NPRM Comments)
 2.1.1 Change in Culture
 <IP_ADDRESS> Changing Agency Culture Does Not Occur Through Rulemaking
Comment: Commenter (2171) notes that the EPA states that the proposed rule is designed to "...change agency culture and practices regarding data access so that the scientific justification for regulatory actions is truly available for validation and analysis" (83 FR 18770). The commenter suggests that changing agency culture does not occur through rulemaking, especially if few resources are given to new rule implementation. The commenter explains that agency culture and work practices are changed when agency administrators provide leadership, direction, and support of technical and career staff through adequate funding and, in the case of EPA, partnerships with the health and environmental research communities.
Response: The EPA agrees that agency culture and work practices can be changed through a variety of mechanisms. The promulgation of these internal Agency procedures in this rulemaking provides a more durable, enforceable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data and highlights the Administration's commitment to maximizing transparency in the EPA's most impactful regulatory actions and influential scientific information. The rule requirements provide a workable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data, while balancing important technical considerations in order to ensure the Agency maintains a strong scientific basis for its decision-making. The incremental progress made by this rule provides an important step towards prioritizing transparency in particularly impactful rules and assessments and will inform future statute-specific rulemakings.
<IP_ADDRESS> Need to Have "Buy-In" From Publishers and Scientists
Comment: Commenter (6449) provides that a paper cited by EPA in the Proposed Rule, Lutter and Zorn (2016) notes that only 20% of authors contacted to provide data underlying their publication actually provide it. Given this circumstance, the commenter suggests that if EPA wishes to change the culture of data access it seems that they need to receive buy-in from publishers and scientists as well as change the internal EPA culture to ensure requirements for data availability are met by EPA funded laboratory and epidemiological studies.
Response: The findings of Lutter and Zorn (2016) are consistent with findings in other published articles on the current state of data sharing. For this reason, the rule requires the EPA to independently evaluate the availability of dose-response data for pivotal science, rather than relying on publication in a journal or a data availability statement in a published article as evidence of availability. This procedural rulemaking establishes internal Agency procedures and does not intend to change the behavior of external parties, including publishers and scientists. The EPA is also working with scientists through its continued implementation of EPA's Plan to Increase Access to Results of EPA Funded Scientific Research, which seeks to ensure greater public access to the EPA's intramural and extramural research data.
<IP_ADDRESS> Changing Agency Culture is Best Addressed by Guidelines and Not a New Federal Rule
Comment: Commenter (4881) notes that, in order to meet its statutory responsibilities for protecting public health and the environment, the EPA must consider the totality of relevant, reliable, peer-reviewed scientific research. The commenter provides that the Agency's responsibility regarding public access to raw data is already the subject of a regulation requiring EPA, in response to Freedom of Information Act (FOIA) requests, to request and make public "research data relating to published research findings produced under an award" of an EPA grant, subject to privacy and other considerations. The commenter suggests that changing agency culture can be accomplished by a thorough airing of internal guidelines, without resorting to a new federal rule subject to considerable political abuse.
Response: 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.
Although these goals might be accomplished through guidelines, the promulgation of these internal Agency procedures in this rulemaking provides a more durable, enforceable framework for evaluating pivotal science in the context of the availability of its underlying dose-response data and highlights the Administration's commitment to increasing transparency in particularly impactful regulatory actions and influential scientific information. The rule will also apply to consideration of research that was not funded by an EPA grant.
<IP_ADDRESS> Political Objective Rather Than Scientific Purpose
Comment: Commenter (4839) asserts that pivotal regulatory science is presented as a cornerstone "to change agency culture and practices" an agenda that embodies a political objective rather than a scientific purpose.
Response: The EPA disagrees that this rulemaking embodies a political objective, as transparency assumes no political ideology. 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 broader 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 organizations, such as the Center for Open Science, and international initiatives like Findable, Accessible, Interoperable, and Reusable (FAIR) data principles; Facilitate Open Science Training in European Research (FOSTER); and Guidelines for Transparency and Openness Promotion (TOP) in Journal Policies and Practices that incentivize greater transparency in research.
<IP_ADDRESS> Lack of Support for Need to Change Culture
Comment: Commenter (4881) provides that footnote number 3 in the Proposal justifies the perceived need to change agency culture by noting that "EPA has not consistently observed the policies underlying this proposal, and courts have at times upheld EPA's use of non-public data in support of its regulatory actions." The commenter notes that in the two court cases highlighted in the footnote, the United States Court of Appeals for the District of Columbia Circuit found unpersuasive the petitioners' claim that the raw data in some of the referenced studies was not publicly accessible. In addition, the commenter adds that the Court dismissed each of the industry petitioners' more technical claims that EPA had imposed "arbitrary and capricious" standards without adequate research support.
Commenter (4881) provides that the stated goal of the Proposal is "to change agency culture and practices regarding data access so that the scientific justification for regulatory actions is truly available for validation and analysis." The commenter suggests that making research results available for validation and analysis is and should be the responsibility of scientists and of the peer-review process overseen by scholarly journals. The commenter notes that scientists have organized workshops to address instances where replicating reported research results has been a problem and that scientific journals have been updating their publication policies to facilitate much more detailed reporting and data archiving.,
Commenter (4848) asserts that the rule promises "to change agency culture and practices regarding data access so that the scientific justification for regulatory actions is truly available for validation and analysis;" however, the new rule in fact just creates new regulatory hurdles by discounting and precluding consideration of long-standing, established scientific practice. Rather than promote the transparency of the scientific information used to create environmental regulations, the commenter suggests that the rule will obscure the democratic process, slow the pace of science and progress, and potentially prevent important health data from being considered by EPA in outlining environmental policy.
Response: As clarified in the preamble to the final rule, 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 information. Only through continuous improvement to its procedures, especially those focused on transparency, can the EPA truly demonstrate that commitment. The EPA's attention on data transparency is also responsive to the broader interest in greater data and model 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 many of its previous influential scientific information assessments and regulatory actions.
Further, this rule exclusively governs the EPA's internal process for handling pivotal science. This rule does not require any researcher or other outside entity to provide data or models to the EPA or the public. The final rule gives greater consideration to pivotal science where the underlying dose-response data are available for independent validation rather than providing for a categorical exclusion of the scientific information. The Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information; therefore, the rule will not prevent important scientific data from being considered by EPA.
Finally, the EPA disagrees that requirements of this rule will result in any meaningful delay in promulgating regulations. While this rule does require the Agency to evaluate the availability of dose-response data underlying 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).
<IP_ADDRESS> Proposal is Counter to EPA's Mission
Comment: Commenters (1433, 2170, 5176, 5179, 6188, 6882, 6884, 6892, 6895, 6915, 8771, 9227) and others that oppose the EPA's proposal contend that the EPA's proposal is counter to the EPA's mission. Comments include:
 If EPA does not use the best available science, it will not be carrying out the mission given to it by Congress to protect Americans and the environment. (1433)
 If EPA wants to change its mission, after nearly 50 years, and advocate for a policy of taking more risks with public health in order to impose fewer costs on industry, that is a policy choice that it should articulate and take comment on. (8771)
 Americans from all walks of life depend on the EPA to create and enforce public safeguards that they trust will protect human health and the environment. The commenter notes that their trust in EPA's work is rooted in the knowledge that agency staff are diligently gathering and reviewing studies of human and environmental risks using their best professional judgement. According to the commenter, a proposal to institute a new system for assessing the validity of scientific evidence undercuts that basis for public trust in EPA and contends that the proposal runs counter to EPA's mission. (6892)
 Commenters (5176, 5179) state that, by promoting an opaque and arbitrary evidence base for policymaking, the proposed rule will erode public trust in the EPA and its regulatory processes.
 The requirements of the Proposal would lead EPA to adopt less-protective standards across many regulatory programs, which is contrary to EPA's mission to protect human health and the environment. (6915)
 This Proposal is not grounded in a genuine concern for advancing science at EPA and is, in fact, at odds with EPA's mission of protecting human health and the environment. (9227)
Response: The EPA does not agree that this rulemaking is counter to the Agency's mission. The requirements in the final rule 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. As described in the final rule, the EPA will generally use the following factors to assess the quality of studies: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. The EPA will 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 to support a relationship between exposure and effect, the EPA will identify those studies --  based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints -- that would inform a dose-response assessment for those effect endpoints. From that subset, the specific dose-response studies or analyses that drive the requirements or quantitative analyses of an EPA significant regulatory action or influential scientific information will be identified as pivotal science. In compliance with the rule, the EPA shall give greater consideration to evidence, findings, and conclusions of pivotal science where the underlying dose-response data are available in a manner sufficient for independent validation. 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 believes this approach will result in significant regulatory actions and influential scientific information based on the highest quality studies that maximize transparency, leading to human health and environmental protections consistent with the statutes the EPA administers.
2.1.2 What Problem is the Agency Intending to Fix?
 <IP_ADDRESS> Question the Purpose of the Rule
Comment: In addition to expressing concerns with the Proposal described elsewhere in this document, commenters (0057, 0569, 0611, 1333, 2171, 2548, 2907, 2909, 3132, 3133, 3644, 4588, 4591, 4594, 4595, 5011, 5021, 5164, 5165, 5170, 5172, 5173, 5176, 5178, 5179, 5420, 6046, 6110, 6111, 6120, 6121, 6122, 6123, 6125, 6127, 6130, 6133, 6135, 6145, 6153, 6155, 6158, 6163, 6166, 6169, 6171, 6185, 6194, 6358, 6373, 6378, 6450, 6872, 6876, 6880, 6881, 6893, 6896, 6898, 6899, 6904, 6907, 6915, 6920, 6924, 6928, 6940, 8272, 8275, 8276, 8281-PH48, 8317, 9225, 9227) and others request that EPA withdraw/rescind the proposed rule.
Commenters (0572, 0670, 0671, 1006, 1272, 1301, 1311, 1333, 1335, 1375, 1400, 1409, 1433, 1742, 1883, 1905, 1988, 1995, 2003, 2004, 2004, 2159, 2241, 2361, 2408, 2430, 2472, 2492, 2906, 4843, 4872, 4879, 5129, 5131, 5170, 6107, 6109, 6109, 6110, 6113, 6114, 6131, 6139, 6168, 6357, 6367, 6368, 6370, 6373, 6801, 6860, 6876, 6884, 6894, 6905, 6934, 6937, 6944, 8281-PH84, 8317) assert that the proposed rule will not improve transparency.
Commenters (0044, 0671, 1301, 1445, 1589, 2171, 2787, 3135, 4410, 4589, 4595, 4838, 4840, 4845, 4848, 5021, 5022, 5165, 5170, 6111, 6114, 6116, 6119, 6120, 6125, 6127, 6131, 6132, 6133, 6137, 6163, 6164, 6174, 6185, 6188, 6194, 6196, 6351, 6358, 6361, 6373, 6446, 6447, 6450, 6866, 6868, 6874, 6896, 6903, 6904, 6916, 6920, 6925, 6939, 6940, 6944, 8281-PH6, 8281-PH84, 8771, 8801, 8913, 9227) question the problem that the EPA is intending to fix with its proposal. Several of these commenters and other commenters note that the proposed rule is unnecessary (0671, 1445, 1973, 4595, 4844, 4845, 5012, 6110, 6111, 6125, 6132, 6174, 6194, 6196, 6351, 6358, 6446, 6447, 6450, 6696, 6772, 6868, 6872, 6876, 6882, 6895, 6896, 6916, 6920, 6925, 6940, 9227, 8801) and that there are already guidance/mechanisms/requirements (1589, 1973, 4595, 4845, 5012, 5165, 6125, 6137, 6160, 6194, 6195, 6196, 6351, 6358, 6446, 6447, 6450, 6696, 6868, 6872, 6874, 6876, 6895, 6903, 6904, 6916, 6920, 6925, 6940, 8274, 9066, 9227, 8281-PH6, 8281-PH16, 8281-PH84, 8771, 8801) in place and/or being developed to address issues related to transparency/validation and that the rule should be withdrawn. Some specific comments provided to support assertions include:
 Commenters (2171, 2787, 4838, 4848, 5165, 6114, 6116, 6119, 6127, 6131, 6132, 6133, 6137, 6163, 6174, 6194, 6373, 6447, 6866, 6920, 9227) specifically state or infer that the Proposal is a solution in search of a problem. Specific comments include:
 EPA does not explain why the Proposal is preferable to existing recommendations and methods vetted and supported by the scientific community, which endeavor to promote transparency through open science policies and secure data-sharing systems. (6194)
 EPA's Proposal would limit the science the Agency can use to inform decision-making to address an alleged lack of transparency, but there is no crisis or flaw that needs to be addressed. (6174)
 Rulemaking does not identify key gaps in federal environmental policy but rather seeks to obtain transparency in a process that already has multiple checks and balances. (6119)
 Without any significant evidence supporting it, the proposed rule is a solution in search of a problem. The commenter suggests that the Proposal fails to identify specific weaknesses in EPA's current scientific process which is grounded in peer review. The commenter provides that Wendy Wagner, author of two of the studies EPA cites to rationalize the Proposal said in response to the proposed rule: "They don't adopt any of our recommendations, and they go in a direction that's completely opposite, completely different." (2787)
 Strengthening Transparency in Regulatory Science, 83 Fed. Reg. 18768 (Apr. 30, 2018), is a solution in search of a problem. According to the commenter, instead of strengthening ways in which EPA can benefit from advances in scientific studies, the proposed rule limits EPA's access to important studies and hampers the development of regulations needed to protect the public health and welfare of the residents of the District of Columbia and the nation. The proposed rule should be withdrawn. (4838)
 EPA has not provided any evidence that its staff uses "secret science" or "junk science" in decision-making. The commenter suggests that the agenda spearheaded by Congressman Lamar Smith and then former EPA Administrator Scott Pruitt is a solution in search of a problem. For example, the commenter provides that Smith has claimed, with no evidence, that "EPA has withheld data that has been hidden from the American people," There is no evidence of this in the record for the proposal (such as it is), or anywhere else. Similarly, the commenter adds that Pruitt announced this proposal by stating that the "era of secret science is coming to an end." But, according to the commenter, there never was such an era, because "secret science" is a myth. (6447)
 This proposal states that "... EPA solicits comment on this proposal and how it can best be implemented in light of existing law and prior statements of policy that have called for increasing public access to data and influential scientific information use to inform federal regulation. EPA has not previously implemented these policies and guidance in a robust and consistent manner" but the commenters contend that the EPA provides absolutely no evidence to support this statement. The commenters suggest that this appears to be a solution in search of a problem as EPA doesn't offer any evidence that its past decision-making has been inadequate or arbitrary. (6114, 6116, 6131)
 EPA is attempting to undertake these significant changes to its process without identifying particular instances where flawed regulatory science or problems in scientific practice negatively affected EPA action in a manner that the Proposal would prevent in the future. According to the commenter, EPA has failed to cite specific examples of research considered by EPA when promulgating past regulations that were later found to be flawed in a way that the application of the Proposal would have uncovered, or instances where EPA had difficulty verifying the analysis and findings of a study. The commenter suggests that the Proposal appears to be a solution in search of a non-existent problem. The commenter adds that the Proposal does not identify, much less remedy, any flaws in current scientific practice and regulatory process. (6373)
 This rule aims to propose a solution to what some major scientific journals call a replication crisis. The commenter notes that there is no mention in the rule, or its citations, of a study that was shown to be flawed due to a lack of raw data. (6127)
 EPA fails to point to a single example of a case in which, in developing regulations, EPA relied upon a study or studies later found to be questionable or invalid. Having failed to address this foundational question, the commenter suggests that the EPA also misses the questions that would build on that -- even if EPA actually had used invalid science in some instance, EPA would still have to ask whether the underlying data for that study had been made publicly available, and if not, if the problems with the study could have been avoided through having made the data publicly available. (9227)
 The Proposal provides no information supporting the notion that the overarching processes of EPA assessment of relevant scientific studies and subsequent peer review of such assessments, as well risk and policy assessments that EPA has developed and improved over time, are in any way insufficient to address the concerns that are allegedly the main focus of the proposal. (9227)
 EPA has not adequately explained the purpose and rationale for the proposed rule. The commenter provides that the Agency suggests that both the "integrity" and "validity" of its decision making will be strengthened by requiring full public disclosure of the data and models underlying the scientific studies on which it relies. The commenter suggests that the logical implication is that EPA believes those characteristics are currently lacking. The commenter notes that the agency does not explain how it reached that conclusion, or what particular "problems" the rule is intended to solve. The commenter adds that the EPA never explains why, specifically, it believes that existing policies and tools for vetting scientific research are insufficient, why this rule (or any rule) is the best way to address those deficiencies, or why the proposal would better serve and protect the public than its existing policies and practices. (5165)
 There is no indication that EPA science suffers from the so-called "replication crisis" that the Proposal identifies as the principal reason for requiring the public disclosure of underlying data or models for studies used in EPA decisions. The commenter notes that it is telling that the sources EPA cites in support of its claims of a "replication crisis" call into question its existence and in many instances promote solutions that do not involve access to underlying data -- such as looking at cumulative evidence using a variety of methods instead of over-emphasizing the results of a single study. The commenter adds that it is even more telling that the Proposal identifies no EPA actions that have been called into question because the science underlying those actions cannot be validated or replicated. In any event, the commenter notes that the Proposal does not require replication of studies and only limits the cumulative evidence and context in which to interpret any given study -- only hampering EPA's reliance on more robust scientific findings even if such a crisis were to exist. (9227)
 Overarching concern with the Proposal is that it not clear what shortcoming it is designed to address or how EPA would measure the rule's success. While the commenter agrees with the stated objective of increasing "transparency in the preparation, identification, and use of science in policymaking," the commenter suggests that the EPA has not demonstrated that there is a problem that is best solved through a broad, prescriptive mechanism like the Proposal. (6866)
 Although EPA's argument is that there should be a regulation to ensure increased access to dose-response data and models, EPA offers no evidence of an existing problem with dose-response data transparency that needs to be addressed, nor does EPA demonstrate how independent validation outside of existing peer review processes improves upon current data transparency practices and data availability. The commenter adds that EPA offers no evidence that EPA's previous judgement, particularly in the development of dose-response functions, has been inadequate, invalid, or otherwise arbitrary. (2171)
 The EPA provides no basis for its assumption that science or studies for which data are publicly available yield more valid or reliable results than the best available, peer-reviewed, independent, credible science, for which the underlying data are not publicly available. Similarly, the commenter suggests that the Proposal arbitrarily fails to address, much less explain, why prior EPA regulatory actions that relied upon studies, data, or other information did not reflect the "best available science" or why they were otherwise unreliable, despite failing to meet the Proposal's standards. (6133)
 The Proposal represents an unworkable, ill-explained, unjustified, and thoroughly unlawful approach to address a problem that does not exist. EPA does not explain why the data sharing requirements outlined in the Proposal are suddenly so urgent. The commenter suggests that this missing argument is especially significant given the decades of peer-reviewed data and models that EPA has justifiably relied on for regulatory actions. The commenter notes that there is no "crisis in replicability" for the types of data and models that the Proposal purports to address; as an indication of this, and EPA has not cited any sources for its assumptions presented in the Proposal. (6133)
 EPA has presented no scientific reason to prevent use of human health studies simply because the underlying medical records are not available for public inspection and review. (4848)
 Proposal does not show how or why EPA's existing practices fail to adequately achieve these purposes, or how the proposed new procedures would do a better job. In reality, EPA's historic practices in adopting health and welfare standards are extraordinarily transparent, public, and accessible to interested persons. (6137)
 As written, the proposed rule would exclude scientific research if the underlying information is not publicly available in a way that allows for independent validation. However, the notice fails to indicate why such a change is necessary, particularly as the notice acknowledges the existence of laws and policies that promote transparency. While we, the undersigned societies, support transparency and openness of science, we reject the notion that data must be publicly published to be credible and have merit in decision-making. (6163)
 Proposed rule offers very little in the way of examples of non-transparent science. Instead the rule asserts "[a]s a case in point, there is growing empirical evidence of non-linearity in the concentration-response function for specific pollutants and health effects." According to the commenter, that is true, however, it has nothing to do with lack of public access of underlying research data. Instead, the commenter expresses that it calls for increased federal funding of research on non-linearity of pollution health impacts. (6920)
 There is no need for this rule. According to the commenter, in conflict with the oral comments by Steven Milloy, who they state incorrectly suggested in his public EPA testimony that the American Cancer Society (ACS) and the Six Cities Studies' researchers have not been willing to release their data for validation by others, both of these studies have actually already provided their raw data for validation by the independent and unbiased Health Effects Institute (HEI) (HEI, 2008). The commenter asserts that such independent evaluations could easily be applied to any new cases of concern for data validation, without the risks implicit in the EPA's proposed rule. Thus, the commenter states that this dangerous rule seeks to needlessly "solve" a purported problem that does not exist. (6132)
 Several commenters (6133, 6137, 6185, 6772) cite court cases that rejected the notion that the EPA must obtain and disclose underlying studies.
 EPA tries to justify the Proposed Rule as a way to ensure the Agency is not arbitrary and capricious in its conclusions. But the commenter states that the D.C. Circuit has twice rejected the notion that EPA must obtain and disclose data underlying the studies it relies on in National Ambient Air Quality Standards (NAAQS) development. (6137)
 In light of the court's holding in American Trucking Assns. v. EPA [283 F.3d 355 (D.C. Cir. 2002)] that differentiated the substantial difference and administrative hardship between reliance on peer-reviewed scientific studies cited in a rulemaking record rather than on the raw data underlying those studies, and without additional clarity from EPA, we are having difficulty identifying the problem EPA seeks to address with the Proposal. Therefore, the commenter requests that the Agency withdraw it. (6185)
 The Proposal is unnecessary because court cases have produced rulings stating that, while the EPA should be as transparent as possible, the EPA is not required, for its decision making, to obtain or analyze raw data in order to rely on studies that cannot provide access to that underlying information. (6772)
 Commenter (6109) cites Harvard's Environmental Law program's provided analysis:
                  The failure of Pruitt's proposal to meet these requirements reflects its lack of validity on the merits. While it's true the proposal reflects the longstanding practice that the EPA rely only on impeccably trustworthy science when formulating standards, performing benefit-cost analyses, and evaluating toxic substances, it fails to articulate either (i) that there is a problem with how the EPA has done its work over the past four decades or (ii) what are the requirements, methods, and practices Pruitt believes are necessary to achieve that goal beyond those long since in place at the agency. Instead, it simply asserts that making certain data available to the public in and of itself will increase the reliability of the science the agency incorporates in performing its various actions. Nowhere does it explain why or how the new data availability requirement would enhance the trustworthiness of the science the agency relies on.
                  In fact, . . . it is through the scientific peer-review process that the ostensible goals of the proposal can be, and are being, achieved. Since the EPA already relies almost exclusively on peer-reviewed science, it's essential that the proposal explain exactly what its views are as to the adequacy of peer review and how, if the EPA believes current peer-review is inadequate, the proposal specifically addresses those inadequacies."
 The main provisions of the Proposed Rule are either unnecessary, duplicative, burdensome, and likely to be confusing in their application. (4589)
 According to the commenter, the EPA provides no examples of where and how, in the agency's view, past rulemakings specifically failed to make these efforts, and how EPA would change past practice in this context. (5021)
 Commenter urges the EPA to withdraw the rule unless it can be revised to clarify its intent and purpose, and more clearly explain how it would contribute to protecting human health and the environment. (6120)
 EPA has not established a legitimate need for the proposed rule. The commenter provides that the EPA has made thousands of regulatory decisions over the last 50 years. The commenter notes that the Congressional Budget Office (CBO) estimates that EPA "relies on about 50,000 scientific studies annually to perform its mission." The commenter suggests that the proposed rule fails to identify a single regulatory action based on faulty science. According to the commenter, the rule is not needed or warranted and will do far more harm than good. (6111)
 If EPA has any doubts or concerns regarding the merits of a particular study, it must address those doubts or concerns for that particular study in the context of a given rulemaking, where agency staff, internal scientific experts, scientific advisory committees, or commenters contend that study is relevant. The commenter contends that the EPA has provided no scientific justification for ignoring an entire class of health science simply because the underlying data has not been disclosed. (6137)
 The EPA invokes "strengthening transparency" as a primary driver for the Proposal but fails to describe how a perceived lack of transparency has hampered past rulemakings. The commenter suggests that it provides no examples of where "EPA has not previously implemented these policies and guidance in a robust and consistent manner" nor what are the specific "agency culture and practices regarding data access" that require changing. (5021)
 It would be relatively simple for EPA or a chartered external review group to analyze a sample of EPA's decisions to see if there really is a problem or whether this transparency rule would have made a difference. The commenter asks why this was not done? (6139)
 Based on the lack of meaningful information and articulated or demonstrated need for the proposed rule, EPA has not made the case for a new regulation at 40 CFR Part 30. (4410)
 EPA has advanced no evidence of a crisis of falsification of underlying data on the part of the U.S. research community. (8913)
 EPA's own Science Advisory Board (SAB) voted to review the Proposal on June 1, 2018. The commenter states that this action is in addition to the vehement reaction that the Proposal has prompted from the most reputable scientists, scientific organizations, and scientific publications in the country directly challenging the need for this proposal -- there is no "secret science." (6174)
 Request that the EPA withdraw this proposed rule as the notice does not provide a clear rationale. (5170)
 There is no indication and no specifics regarding alleged deficiencies in research data relied upon by EPA. EPA seeks to apply this new regulation across the board, with no grounding in law or fact as to where and how specific studies have caused regulatory overreach to the public's detriment. Without a reasonable basis to adopt this broad, sweeping, ill-defined regulation, EPA will likely face multiple lawsuits seeking to strike down this new regulation, distracting the EPA from its true, important mission. (6116, 6131)
 Rather than addressing a legitimate problem, the commenter suggests that the Proposal is a next step in a very transparent effort to discredit and make unavailable certain seminal studies that establish the connection between exposure to air pollution and adverse public health impacts. (6174)
Response: The EPA provides more detail explaining the EPA's 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 and long-standing 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 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 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 incremental progress made by this rule provides an important step towards prioritizing transparency in particularly impactful rules and assessments and will inform future statute-specific rulemakings.
The EPA also agrees that it is important not to categorically exclude any study because the data underlying a study at the stage required by this rulemaking may not be available for independent validation. Therefore, the EPA is not finalizing the proposal that would have categorically required that for studies to be considered pivotal science the underlying data would need to be available for independent validation. 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.
Comment: Commenter (0044) states that they do not understand the purpose of this potential rule -- is the scientific acumen and/or honesty of the EPA's professional staff under question? Has there been evidence that any standards have been done using inappropriate science? The commenter (as a citizen) states that they want government scientists, who are disinterested, to be the arbiters of pollution levels, not industrial scientists who get paid by their companies. The commenter also asks whether EPA identified significant data validity problems associated with toxicity study submissions? The commenter provides, of the approximately 810 inspections performed by the EPA for Good Laboratory Practice (GLP) studies, 27 were either rejected by agencies or became the subject of consent degrees, which computes to 31/3%. Assuming that the rejections by authorities not resulting in consent decrees were due to poor quality while only the consent decrees were due to data falsification/fabrication/etc., the commenter states that the actual rate of fraudulent data is much less. According to the commenter, this does not warrant major changes in what data are acceptable for EPA submission, but rather to enhancing regulatory inspections to assure data quality.
Response: This rulemaking is not intended to address the conduct of EPA's professional staff nor to remedy a particular instance in which the EPA relied on a poor-quality study or a study for which the conclusions could not be independently validated. 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. Transparency is an important aspect of EPA's regulatory actions and assessments, and it should be an important consideration in how the Agency considers pivotal science.
Comment: Commenter (8801) states that a key point in the proposed regulation is that data from studies used in regulatory decision making be made available to third parties for conducting their own analyses. The commenter contends that this justification fails to recognize that EPA has successfully addressed this issue in the past. For example, the commenter notes that when a series of important studies done in the 1990s by the Harvard School of Public Health and the ACS on effects of fine particle air pollution on human health were questioned by opponents of air pollution regulations, a re-analysis of the data in 2000 by the reputable HEI was undertaken. The commenter states that the independent re-analysis confirmed the findings of the original studies. According to the commenter, this demonstrates that experts independent of the regulators and the regulated can already satisfy one of EPAs primary arguments for the need of the proposed regulation.
Response: Although some mechanisms are in place to allow for data sharing and reanalysis, these mechanisms are not necessarily commonplace. 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 incremental progress made by this rule provides an important step towards prioritizing transparency in particularly impactful rules and assessments and will inform future statute-specific rulemakings.
<IP_ADDRESS> Existing Mechanisms that Already Address Validity Concerns
Comment: Commenters (1335, 2119, 2908, 4589, 4590, 5170, 5178, 5977, 6111, 6119, 6125, 6137, 6157, 6158, 6160, 6194, 6351, 6373, 6446, 6447, 6872, 6874, 6920, 6924, 6925, 8801, 9227) suggest that current EPA practices are sufficient and provide examples of how existing mechanisms/policies/procedures work to ensure proper review and validation and that the proposal does nothing to improve them. Comments include:
 The EPA already has methods in place, and the proposed rule does nothing to improve upon them while creating unnecessary obstacles for EPA's consideration of the best available evidence for policy and rulemaking. (6160)
 The proposed rule does not acknowledge that the epidemiologic science community ... has been making significant efforts to make data available where possible and to develop studies based on publicly available data where appropriate. (6447)
 EPA's regulatory process already involves peer review, solicitation of expert opinion, steps to ensure data quality, and public comment periods that allow stakeholders to raise questions or concerns and present additional evidence. (5178, 6874) If it had undertaken a similarly thorough process in developing this rule, it could have asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to investigate and report on whether the current level of transparency has resulted in outcomes contrary to EPA's statutory mandates or executive orders; procedures and considerations related to transparency in the scientific community; and the potential results of applying the proposed criteria when regulating. (6874)