Commenters (5178, 8272) state that a recent example of important non-public data on a neurotoxicant is research on the pesticide chlorpyrifos. The commenters report that researchers followed a cohort of children exposed to this pesticide before the current ban on residential use and found lower IQ and working memory to be associated with higher levels of prenatal chlorpyrifos exposure. The commenters state that, in a rulemaking process regarding agricultural use of chlorpyrifos, EPA requested the underlying data from the Columbia Center for Children's Environmental Health (CCEH). The commenters state that the response from CCEH explained that because of the detailed sociodemographic and health-related elements their data set contains, they did not believe they could submit extensive individual-level data to EPA in a way that would ensure participants' confidentiality. The commenters state that such concerns are not uncommon with the kinds of longitudinal data sets that allow identification of long-term consequences of environmental exposures. Commenter (8272) states that a recent analysis of the annual costs to the U.S. economy of a set of endocrine-disrupting chemicals is $340 billion, with the majority of that due to IQ point loss and intellectual disability from in-utero exposure to polybrominated diphenyl ethers (PBDEs).
 Commenter (6195) states that the past EPA administration's decision to ban chlorpyrifos was based in part on studies showing neurological problems for kids exposed to the pesticide. The commenter states that the EPA abruptly decided to reverse this proposed ban because the study authors were unable to make their "raw data" publicly available. The commenter states that the proposed rule would codify this requirement for all pollutants the EPA regulates.
 Commenter (6450) states that studies that analyze the health impacts resulting from asbestos exposure, exposure to DDT, and birth defects caused by thalidomide would also be excluded under the proposed rule because the data contain confidential patient information protected by HIPAA.
Response: In this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. This includes studies that use confidential health data. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
Intellectual Property
Comment: Commenters (1006, 4877, 6128, 9225) express concern that many studies that include intellectual property would be excluded. Commenters (4877, 6128) state that many studies contain data that is sensitive in terms of intellectual property and this data should be exempt from blanket data sharing requirements. Commenter (9225) asserts that the proposal would restrict the types of science the Agency may use in regulatory decision making, including studies that rely on intellectual property.
Response: In this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. This includes studies contain data that are intellectual property. The EPA further clarifies that this rule does not impose blanket data sharing requirements; this rule exclusively pertains to the internal practices of the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the federal government. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available due to technological feasibility or cannot be made available in a secure environment that still allows for independent analysis. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
<IP_ADDRESS>.12 Studies Controlled by Third Parties
Comment: Commenter (6125) states that, while the proposal acknowledges that data may be "controlled by third parties," the explanation of what this may mean is a vague promise that "EPA shall work with those parties to endeavor to make the data available in a manner that complies with this section." The commenter adds that the ambiguous wording never specifies what actually might qualify, nor what interactions would be required before third party studies such as the Medicare study might be given an exemption from the requirement of public availability. The commenter states that this language does not begin to address the variety of complexities involved with data controlled by a wide variety of third parties each with different policies of access, making it nearly impossible for commenters to know whether third party studies can ever be used without some type of interactive process between the study authors and EPA. The commenter contends that, even if EPA does not intend to apply this provision to categorically bar the use of third-party studies, its failure to point this out, or otherwise explain this provision makes the rule too vague to implement.
Response: This language has been removed from the final rule. 40 CFR 30.5(g) now reads: "The provisions of this section apply to dose-response data underlying studies that are pivotal science, regardless of who funded or conducted the studies. The Agency shall make all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making such data available before it concludes that doing so in a manner consistent with law and protection of privacy, confidentiality, national security is not possible."
Comment: Commenter (6191) expresses concern that data resulting from research funded through sources other than EPA may be "best available" science and per EPA's current directives, should form the basis of new regulations. The commenter states that this research would not be subject to federal data access and sharing requirements and it is unreasonable to expect that anyone doing research that may one day be important for regulatory science would anticipate the importance for this future use. The commenter states that these researchers would not be subject to current public access plans and may be unable to prepare their data in a way that it could be made publicly available, whether because their agreements with human subjects do not permit this or because a lack of funding would prevent them from taking the steps necessary to enable the data to be made public.
Response: This is a rule of internal procedure that does not impose requirements on any party other than the EPA. It therefore does not establish any requirements or expectations for third party researchers to make the dose-response data underlying their research publicly available, or accessible through a secure data enclave. Furthermore, under this rule the EPA will continue to consider and evaluate all relevant and appropriate science in its significant regulatory actions and influential scientific information. EPA further notes that this internal procedural rule does not interpret or apply any statutory requirement to use "best available science" or any variation thereof. The EPA will undertake such efforts in forthcoming statute-specific transparency or programmatic regulations.
9.2 Regulatory Science Means Scientific Information that Provides the Basis for EPA Final Significant Regulatory Decisions (§30.2)
Comment: Commenters (0567, 4932, 6180, 6356) express concerns regarding the proposed definition of "regulatory science" and provided several suggested changes to the definition for the EPA to consider.
Commenter (0567) recommends a slight revision of EPA's definition by deleting the words "significant" and "final". The commenter states that a generalized definition as recommended by the Institute for Regulatory Science is:
      Regulatory science consists of applied versions of various scientific disciplines used in different regulatory processes.
Commenter (0567) adds that a simplified, generally applicable definition is:
      Regulatory science consists of the scientific segment of the regulatory process.
Commenter (0567) also notes that other federal agencies have also promoted definitions of regulatory science:
 FDA: Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products.
 NIH: Regulatory science fosters the development, evaluation and availability of new or improved tools, methods, standards, and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.
Commenter (4932) suggests that EPA alter the definition of "regulatory science" by striking the word "final" from the proposed definition to make the Proposal fully consistent with Executive Order 12866. The commenter states that implication of including the word "final" in those definitions is that the transparency objective (i.e., the disclosure of pivotal regulatory science) does not apply to advanced notices of proposed rulemaking or proposed rulemaking. The commenter states that the public must have access to pivotal regulatory science at these earlier steps in the rulemaking process in order to assess effectively the merit of the Agency's regulatory science.
Commenter (6356) suggests EPA remove the word "significant" from the proposed definition of "Regulatory Science".
Commenter (6180) suggests "regulatory science" means scientific information, including assessments, models, criteria documents (including narrative criteria translators), and regulatory impact analyses, that provide the basis for EPA final significant regulatory decisions.
Response: The EPA agrees with commenters that the term "regulatory science" may be confusing because it suggests either the term refers to a scientific discipline of regulatory decision-making (akin to FDA), or that some science the EPA considers is inherently regulatory. Neither of these interpretations reflects the Agency's intent in defining this term. The EPA considers the breadth of scientific evidence in its rulemakings; while this scientific evidence informs policy decisions, the EPA's consideration of the science does not make it "regulatory science." To reflect this fact, in the final rule the EPA is changing the proposed term "regulatory science" to "science that serves as the basis for informing a significant regulatory action."
In the 2018 proposed rule the EPA combined both general categories of scientific information, such as assessments and models, with specific examples of EPA scientific products, such as criteria documents and regulatory impact analyses in the proposed definition for "regulatory science." The EPA acknowledges that this may increase confusion and is therefore limiting the final definition to general categories. As such, the EPA is altering the definition of "science that serves as the basis for informing a significant regulatory action" in 40 CFR 30.2 to mean "studies, analyses, models, and assessments of a body of evidence that provide the basis for EPA significant regulatory actions." Examples of models include those used in regulatory impact analyses. Examples of assessments of a body of evidence include risk assessments, hazard identifications, IRIS assessments, and criteria documents.
Comment: Commenter (6143) suggests that the definition of regulatory science should include the study protocol. The commenter states that, when a study is conducted, the most important step is the careful production of a protocol which addresses all aspects of the study. The commenter states that these should at a minimum include objectives, study design, methods for collection of data, methods for handling the data, methods of analysis, and how results will be interpreted and reported. The commenter states that all the basic parameters should be documented, and include, sensitivity, specificity, variability, reproducibility, bias etc. The commenter states that the a priori definition of how results will be interpreted avoids the temptation to look at the data and perform analyses which have the potential to be biased. The commenter states that studies that are hypothesis generating should not be used as hypothesis testing studies. The commenter states that making protocols available to the public for research funded by EPA could go a long way towards improving the underlying science. The commenter states that all too often research is carried out and variables that should have been identified at the outset are considered after the study results are examined and the data reanalyzed or interpreted differently in the light of information obtained after completion of the research.
Response: The EPA disagrees with the commenter that the definition of science that serves as the basis for informing a final significant regulatory action should specifically include the study protocol. Protocols are often provided with the studies, analyses, models, and assessments of a body of evidence that constitute the definition of the term. Further, this rule does not govern how individuals outside of EPA conduct science, but rather is a rule of internal procedure.
Comment: Commenter (6133) states that the phrase "provides the basis" does nothing to illustrate the meaning of regulatory science, or to limit or particularize its scope, because it is equally vague and unexplained. The commenter adds that all science, data, and information considered by EPA, and relied upon by EPA, "provides the basis" for final EPA regulatory decisions, insofar as EPA includes those materials in its administrative record, certifies that record for judicial review, and may cite and rely upon that information in explaining and defending its final regulatory decisions. The commenter states that, accordingly, the proposed "regulatory science" definition is capacious and unbounded. The commenter states that, alternatively, the phrase "provides the basis" in the proposed "regulatory science" (§30.2) definition could mean that science was one of many studies considered, that it was the bedrock study upon which regulation was grounded, that EPA relied on the study, or that the study was critical to EPA's determination. The commenter asserts that the term "regulatory science" lacks statutory authority, is vague, inconsistent, unexplained, and otherwise arbitrary and capricious.
Commenter (6137) states that EPA's Proposed Rule lacks the requisite standards and principles that are the hallmark of lawful agency decision-making. The commenter states that the vague definitions proposed in §30.2 invite limitless agency discretion to decide when the Rule's requirements apply. The commenter states that the Proposed Rule's definition of "regulatory science" lacks any discernible meaning. The commenter states that there is no standard or definition for determining when scientific information does or does not "provide the basis" for a regulatory decision, nor are there any standards or definitions for what subset of "regulatory decisions" should be deemed "significant."
Response: The EPA agrees with the commenters that the use of "provides the basis" in the definition indicates an expansive scope, and clarifies in the final rule that the scope of science that serves as the basis for informing a significant regulatory action is equivalent to the science included in the public docket as part of a rulemaking, but not all of that body of science would typically be considered "pivotal science." The EPA disagrees that the definition lacks any discernible meaning, as the Agency's procedure for making available science that provides the basis for a regulation in the administrative record is a well-established practice.
9.3 EPA's Regulatory Science Should Be Consistent with the OMB's Final Information Quality Bulletin for Peer Review (83 FR 18770)
Comment: Commenter (6125) states that, while the proposed rule cross-references the OMB Information Quality Bulletin for Peer Review, it is not clear what the proposed rule is intended to add to the Information Quality Bulletin with which EPA already complies or how in fact it would operate. The commenter adds that, while the Bulletin recognizes that an agency need not conduct peer review of studies which already have been adequately peer reviewed (70 FR at 2671), it is not clear if EPA is aware of this. Lastly, the commenter notes that problems may be raised by cross-referencing a document (Information Quality Bulletin for Peer Review) that can be amended.
Response: The EPA finds merit in this comment, in part. However, in this rule, the EPA is not changing the pre-existing requirements of the OMB Final Information Quality Bulletin for Peer Review. The preamble to the Bulletin states that "the intensity of peer review is highly variable across journals" and "prior peer review and publication is not by itself sufficient grounds for determining that no further review is necessary." Peer review does not typically include reanalysis of the underlying data (i.e., the proper stage of data where the data that are ready to be analyzed to extract relevant information) and, thus, peer review is not considered a replacement for the data availability requirements of this rule.
9.4 EPA's Proposed Regulatory Science Requirements Consistency with OMB's Guidelines for Ensuring and Maximizing Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies (OMB Guidelines)
Comment: Commenter (0555) contends that the proposed requirements are not a radical departure from existing guidelines, including 2004 OMB guidance and the 2011 Executive Order 13563.
Conversely, commenters (6137, 6916, 9227) state that the Proposed Rule contravenes the OMB requirements, as it will prevent EPA from considering all relevant information by precluding consideration of certain data.
Commenter (6137) states that, according to EPA's IQG, EPA uses a "weight-of-evidence" approach that "considers all relevant information and its quality, consistent with the level of effort and complexity of detail appropriate to a particular risk assessment." The commenter notes that, pursuant to EPA's guidelines, EPA must ensure that the information it disseminates "is accurate, reliable and unbiased." The commenter states that, to do so, it uses the best available science and supporting studies conducted in accordance with sound and objective scientific practices, including, when available, peer reviewed science and supporting studies; and data collected by accepted methods or best available methods.
Commenter (6916) asserts that the provisions in the proposed rule that would preclude the use of proprietary or confidential data in regulatory actions are inconsistent with OMB Guidelines that indicate that transparency "does not override other compelling interests such as privacy, trade secrets, intellectual property, and other confidentiality protections," that direct agencies to conduct robustness checks when data cannot be released, or that encourage agencies "to address ethical, feasibility, and confidentiality issues with care." The EPA does not explain either (a) why it considers the proposed rule to be consistent with the OMB Guidelines, or if it is, why (b) the regulations it now proposes are necessary in light of the OMB Guidelines' directives.
Commenter (9227) asserts that the discussion in the proposed rule relating data availability to data quality are inconsistent with provisions in the OMB Guidelines that indicate high quality science can be judged by many factors and that controls be implemented "flexibly, and in a manner appropriate to the nature . . . of the information to be disseminated." The commenter also asserts that provisions in the rule requiring public availability of data are inconsistent with provisions in the OMB Guidelines that provide for differential treatment of data due to privacy and confidentiality concerns, that indicate that not all data should be held to a reproducibility requirement, that "the objectivity standard does not override other compelling interests such as privacy, trade secrets, intellectual property, and other confidentiality protections, and that direct agencies to apply robustness checks where public access to data and methods cannot occur.
Commenter (9227) asserts that, 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 commenter adds that 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.
Commenter (6916) states that the OMB Guidelines also establish and reflect a presumption of objectivity and favored status for peer-reviewed science, which the EPA Proposal flips on its head. The commenter states that this presumption of objectivity and favor for externally peer-reviewed studies is also an element of the EPA Data Quality Act Guidelines, which also reflect the overall principle that "[a]gencies should adopt a common sense approach that build on existing processes and procedures[, and] ... do not impose unnecessary administrative burdens or inhibit agencies from disseminating quality information to the public." The commenter states that adding a mandatory agency-conducted `independent' peer review process (as this Proposal does) for all "pivotal regulatory science" used in making "regulatory decisions" does not comport at all with the EPA or OMB Guidelines implementing the Data Quality Act, EPA's statements in the Proposal notwithstanding.
Response: This final rule makes incremental steps towards increasing data transparency by codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation and thereby improving the public's access to 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. This rule is designed to build upon OMB M-19-15, which highlights the need to characterize the sensitivity of an agency's conclusions to analytic assumptions, as well as other federal guidance documents that require greater data transparency. The EPA's attention to 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 previous influential scientific information assessments and regulatory actions.[,][,][,][,] The EPA's continued progress toward maximizing transparency is vital to building and maintaining trust with the public and credibility in the Agency's decisions.
The EPA further clarifies that in this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available or not available in a manner sufficient for independent validation. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
Finally, the EPA disagrees with the commenter that this final rule undervalues the role of peer review. 40 CFR 30.6 states: "The EPA shall conduct independent peer review consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review and the exemptions described therein. The EPA will evaluate whether or not to conduct additional peer review of individual studies identified as pivotal science if the studies have already undergone peer review. Because transparency in pivotal science includes addressing issues associated with assumptions used in analyzing dose-response data, the EPA shall ask peer reviewers to articulate the strengths and weaknesses of the justification for the assumptions applied and the implications of those assumptions for the results." Adequate peer review remains an essential factor to pivotal science in the EPA's final regulatory actions and influential scientific information.
9.5 Regulatory Science that Cannot Meet the Requirements of §§30.5 and 30.6
Comment: Commenter (6924) states that the rule's requirements for specific types of defaults, test methods, dose-response models and/ or analyses are not supported by current science. The commenter refers to the proposed rule which states that "EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments." The commenter states that it is not appropriate to require use of standardized test methods (guideline studies) and good laboratory practices (GLP) studies, as described below.
      Guideline and GLP studies  -  mostly sponsored by industry to meet regulatory requirements - don't necessarily use modern methods for evaluating chemicals and are not designed to address issues with evaluated health effects from low-dose exposures, complex and systemic endocrine effects, behavioral or learning effects, metabolic perturbations, or upstream effects like reduced sperm count or reduced anogenital distance which are predictors of infertility. Furthermore, GLP and Guideline studies are not consistently associated with higher quality research, proper study design or correct statistical analysis., Much of the research available in the scientific literature is hypothesis driven-- for example, exploring mechanisms to explain how a detrimental health impact occurs. These experimental protocols are tailored to address the question being asked and generally there are no standardized test methods that could be followed. Yet, these experimental findings are critically important contributions to the body of scientific evidence. For the highest quality scientific assessment, a systematic review approach which considers all relevant scientific evidence and evaluates study quality according to established criteria should be used, as recommended by the NAS. Inappropriately using GLP as a measure of study quality would lower the overall quality of the assessment because other studies which are higher quality and/ or more directly relevant to the study question would be downgraded or excluded.
Commenter (6872) states that it is important that EPA have the ability to consider data that do not precisely fulfill the proposed rule's criteria if the data are informative and of high quality. The commenter states that, for example, requiring GLP sounds "good" but, in practice, many academic research laboratories conduct stellar research but may not meet all GLP criteria. The commenter states that data from such laboratories should be considered and weighed on its merits and should not be excluded from EPA consideration by rule. The commenter states that data from new and improved, but non-standard test methods, should be available for EPA to evaluate on their merits and use as appropriate.
Response: The EPA clarifies that in this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. In addition, this rule does not apply to dose-response models. Further, this final rule does not establish requirements that the EPA only consider standardized test methods (guideline studies) and GLP studies. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available or not available in a manner sufficient for independent validation. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
Comment: Commenter (6935) states that a final rule should not disqualify a study from consideration as pivotal regulatory science if it addresses most key factors in §§30.5 and 30.6 and can be independently assessed and verified. The commenter states that the Proposed Regulation generally would increase transparency with respect to dose response data and models. The commenter states that, in a final rule, EPA also should balance strict adherence to new transparency requirements against the need for regulatory certainty and efficiency. The commenter states that EPA should consider that only the rare past study, from inside or outside the Agency, has addressed all these factors. The commenter states that it is a worthwhile goal that future studies, especially those within the Agency, should meet as many of the requirements as possible from proposed provisions 30.5 and 30.6.
Response: The EPA clarifies that in this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. See 40 CFR 30.5 for a description of the factors the EPA will consider when determining the consideration to afford to pivotal science when the underlying dose-response data are not available in a manner sufficient for independent validation. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available or not available in a manner sufficient for independent validation. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
9.6 How Should EPA Address a Circumstance in which EPA Has a Statutory Requirement to Make a Determination for Which Scientific Information Publicly Available Sufficient for Independent Validation Does Not Exist?
Comment: Commenters (6120, 6895) notes that in the proposed rule, the EPA requested comments on how to address circumstances in which the EPA has a statutory requirement to make a determination when scientific information publicly available in a manner sufficient for independent validation does not exist.
Commenter (6120) states that this situation highlights the importance of using all available data, including studies of accidental exposures to chemicals that do not follow standardized test methods and cannot be reproduced or validated, academic studies on mechanisms such as endocrine disruption, and environmental sampling. The commenter states that all new compelling peer-reviewed research published in the scientific literature should be considered in regulatory decisions. The commenter states that this also underscores the importance of a panel of independent scientists to peer review the information and consider all the evidence. The commenter also states that, in the absence of data, the EPA should make conservative assumptions protective of vulnerable populations such as children and women of childbearing age.
Commenter (6895) notes that it is likely that in such circumstances such data does exist. The commenter states that, in the very odd circumstance that such data does not exist, it behooves EPA to develop the data. The commenter states that, since EPA regulations and other actions are applicable to all of the country, the data used to make these decisions should be collected at the community and larger aggregate level.
Commenter (6375) suggests the following approach where EPA has a statutory requirement to make a determination for which scientific information publicly available in a manner sufficient for independent validation does not exist.
      EPA should solicit input from EPA Offices (such as the Office of Pesticide Programs) and other federal agencies (such as FDA) that rely heavily on proprietary studies, many of which are not published in the peer-reviewed scientific literature and for which the data have historically not been available to the public for independent validations to make a determination as required by statute. As described above, EPA's Office of Pesticide Programs relies heavily on proprietary studies/CBI and apparently has devised mechanisms that balance protection with transparency of pivotal regulatory science and the public's right to now. One mechanism is Data Evaluation Records (DERs) that summarize proprietary studies. The other is human health risk assessments that integrate findings in DERs such that stakeholders can assess the impact of a particular endpoint (e.g. health effect) in a particular study ("pivotal regulatory science") on the overall risk assessment. Both DERs and risk assessments have been made available on the docket or by other means. While this is not as transparent as making the underlying studies fully available, sufficiently detailed DERs and risk assessments are arguably as detailed and transparent as many health studies and risk assessments published in the peer-reviewed scientific literature.
Response: The EPA clarifies that in this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available or not available in a manner sufficient for independent validation. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
Further, with this final rule, the EPA is maintaining language in 40 CFR 30.3 stating that the statutes that the EPA administers, or their implementing regulations, will control in the event of any conflicts with the requirements of this rule. The Agency will continue to comply with and abide by the requirements in those statutes and implementing regulations, including regulatory deadlines.
Comment: Commenter (6362) suggests that the regulatory text in §30.4 be clarified. The commenter states that §30.4 appears to apply to EPA's use of studies (or other regulatory science) relied upon when EPA takes any final agency action. The commenter states that, in those instances, EPA should make all such studies available to the public to the "extent practicable." The commenter states that EPA should provide greater clarity regarding what it intends to do in circumstances where raw data cannot be made publicly available.
Response: The EPA has altered the final rule to increase clarity and address the commenter's concern. The EPA has removed the term "science that serves as the basis for informing a significant regulatory action" from 40 CFR 30.1, and will not require that science that serves as the basis for informing a significant regulatory action is publicly available in a manner sufficient for independent validation. Instead, in the final rule, 40 CFR 30.4 requires that the EPA clearly identify all science that serves as the basis for informing a significant regulatory action, and make all such science that serves as the basis for informing a significant regulatory action publicly available to the extent permitted by law. The EPA clarifies that this requirement is consistent with the EPA's existing practice of making science that serves as the basis for informing a significant regulatory action available in the public docket as part of the rulemaking.
9.7 How Does What this Rule Would Require Compare to Requirements of Environmental Statutes? (Relates to Chapter 1)
9.7.1 Best Available Science
Comment: Commenters (0671, 2249, 4827, 6188, 6922, 9227) assert that the Proposal would violate EPA's statutory requirement to consider the best available science. Commenter (6188) states that the rule does not explain how the EPA will be able to fulfill its statutory duties without the ability to consider the best available science, which includes robust, peer-reviewed, and cutting-edge studies that rely upon protected data that cannot legally be made publicly available.
Commenter (6922) states that numerous statutes that EPA is charged with implementing require that EPA rely on the best available science and health information. The commenter states that any final rule must ensure that EPA is able to conduct its decision-making in a manner consistent with these and similar statutory directives. The commenter states that Congress did not mention transparency or any other reason why EPA should exclude consideration of the best available science. The commenter states that, in the Proposal, EPA did not provide any reason to exclude consideration of epidemiological studies based on the quality of science or reliability of results. The commenter states that transparency concerns or any other goal declared by the Agency cannot override EPA's statutory obligation to consider the full range of peer-reviewed, sound scientific research that is available and relevant to its regulatory decisions. The commenter states that these concerns cannot interfere with the Agency's general obligations to conduct informed, reasoned decision-making. The commenter provides the following statutory citations as examples of this obligation: 33 U.S.C. § 1314(a)(1); 42 U.S.C. § 7408(a)(2); 15 U.S.C. § 2625(h); and 42 U.S.C. § 300g-1(b)(3)(A).
Commenters (2249, 4827) suggest that, if EPA does not use the best available science, it would not be carrying out the mission given to it by Congress to protect Americans and the environment. Commenter (4827) states that the proposal directly contravenes the comprehensive federal and state regulatory programs Congress envisioned when drafting the CAA of 1970. Commenter (4827) asserts that it reduces our public health legislation to mere declarations, as EPA would be severely delayed, if not rendered entirely unable, to establish future Standards using the "best available science."
Commenter (9227) asserts that EPA's statutory authorities generally require the agency to consider all available data when undertaking significant rulemakings. The commenter states that EPA's statutory authorities mandate a variety of requirements for what scientific information EPA must consider in rulemaking. The commenter states that, to take one example that appears in numerous statutes, including TSCA, CAA, SDWA, and the Endangered Species Act, Congress has often required agencies to act on the "best available science." The commenter states that, for an agency to comply with this obligation, the agency must at least consider all available scientific information. The commenter states that "best" means "of the most excellent, effective, or desirable type or quality." The commenter states that "available" means "able to be used or obtained." The commenter states that "science" means "the intellectual and practical activity encompassing the systematic study of the structure and behavior of the physical and natural world through observation and experiment." The commenter states that assessing which science is "best" requires consideration of the overall quality of the science, and the public availability of underlying data is, at best, one of many aspects that should inform that assessment of overall quality. The commenter states that EPA cannot reasonably elevate the interest in public availability of all underlying information above all other factors in assessing the "best available science." The commenter states that, textually, EPA's approach is unlawful.
Commenter (9227) asserts that an agency "cannot ignore available. . . information." The commenter states 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." The commenter states that "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.'" The commenter states that "An agency does. . . have an obligation to deal with newly acquired evidence in some reasonable fashion." The commenter states that EPA's proposal will result in EPA precluding itself from considering certain studies that are "available," thus violating the requirement that EPA rely on the best available science.
Commenter (9227) further asserts that the requirement that agencies use "best available" science or information often means that the agency must act even if the available science or information is imperfect. The commenter states that "even if the available scientific and commercial data were quite inconclusive, [the agency] may -- indeed must -- still rely on it" when the agency has a duty to act. The commenter states that "where the information is not readily available, we cannot insist on perfection." The commenter states that, just as the Courts have recognized that they cannot expect perfection, agencies cannot choose to ignore certain studies or sources of information based solely on whether the data is publicly available -- especially where the validity of those studies has been established using techniques that do not rely on public availability of underlying data.
Commenter (9227) states that, in direct violation of statutory requirements to consider, for example, "any other information available" or "the latest scientific knowledge [that is] useful" or "best available science," the Proposal would prohibit EPA from considering relevant and high quality science whenever the underlying data for a study is not publicly available. The commenter states that, through the Proposal, EPA unlawfully tries to engraft an additional statutory requirement onto each of these statutes, requiring that to be considered a study's underlying data must be publicly available. The commenter states that, for EPA's Proposal to succeed, EPA must demonstrate that a study cannot be "other information available to the Administrator" or the "latest scientific knowledge useful in indicating" health or welfare effects or the "best available science," or any of a number of other statutory formulations if the underlying data is not publicly available. The commenter states that EPA's Proposal fails to do so, and it could not do so.
Commenter (9227) states that there are many reasons that underlying study data may not be available that have no bearing on the quality or validity of the study. The commenter states that these include legal restrictions or concerns about privacy (especially with respect to studies involving human subjects), confidentiality, CBICBI, or national security. The commenter states that, if this requirement were applied retroactively to existing studies, it may no longer be possible to make underlying data and models publicly available. The commenter states that EPA acknowledges these impediments in proposed section 30.9, which provides the Administrator with discretion -- but not an obligation -- to allow the agency to consider a study for which underlying data or models are not publicly available if he determines that public disclosure is infeasible. The commenter states that, where the Administrator fails to exercise his discretion to grant an exemption pursuant to proposed section 30.9, or where data or models are unavailable for reasons that do not satisfy the infeasibility standard, proposed section 30.5 would prohibit EPA from considering such studies, regardless of whether they meet the statutory criteria for consideration.
Commenter (9227) states that the only way that this prohibition could comport with EPA's statutory obligations is if a study for which underlying data is not available cannot be, for example, "other information available" or "the latest scientific knowledge [that is] useful" or "best available science" -- i.e., if the public unavailability of a study's underlying dose response data and models makes the study ineligible to meet these criteria, regardless of whether the study has been peer reviewed, is based on rigorous methodologies, or has been published in a leading journal, and regardless of the reason for the public unavailability. The commenter states that EPA makes no such demonstration -- nor could it. The commenter states that there is simply no support for such a proposition; to the contrary, all the evidence shows that studies may be "best available science," and certainly "other information available" regardless of whether the data underlying them is publicly available.
Response: The EPA clarifies that in this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available or not available in a manner sufficient for independent validation. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
Furthermore, this final rule does not interpret or apply the provisions of any environmental statutes, nor does it modify the Agency's interpretations of "best available science." The EPA will continue to consider all peer-reviewed science, consistent with existing study quality assessment factors and corresponding statutory mandates. The EPA will then identify and consider "pivotal science in accordance with the provisions of this rule," unless the implementation of the rule conflicts with statutory requirements and associated implementing regulations. As this rule makes clear, if implementing this procedural rule would result in conflicts with existing environmental statutes, and their implementing regulations, this rule will yield to the EPA statutes and regulations.
9.7.2 Data Quality Act
Comment: Commenter (6137) asserts that EPA's Proposed Rule ignores requirements set forth in the Data Quality Act. The commenter states that, given that the Proposed Rule eliminates from consideration any scientific study where the underlying data cannot be made publicly available, it undoubtedly precludes the use of the best available science in certain situations and, thus, the Proposed Rule is inconsistent with EPA's implementation of the Data Quality Act.
Commenter (6168) states that EPA should provide an analysis of how this rule differs from the Data Quality Act and related policies and then offer a justification for this rule considering that analysis. The commenter states that it is unclear why the proposed rule is necessary given these policies or how the proposed rule would relate to them, especially given that the Data Quality Act and its associated guidelines cover much of the same ground. The commenter states that it is unclear if, or why, this proposed regulation is meant to supersede existing legislation and policies. The commenter states that EPA should provide an analysis of how this rule differs from the Data Quality Act and related policies and then offer a justification for this rule considering that analysis. The commenter states that, without clarity on these issues, the proposed rule appears to not only be an attempt to regulate where legislation has failed (i.e. the HONEST Act), but to use a regulation to supersede legislation that is already on the books.
Commenter (9227) states that, 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. The commenter states that, accordingly, EPA's proposed regulation violates the Information Quality Act (IQA) and must be withdrawn. The commenter adds that EPA's proposed rule is unlawful because it exceeds EPA's authority under Section 515(a) of the IQA. The commenter states that the IQA requires EPA promulgate data quality guidelines that are consistent with those promulgated by OMB. The commenter states that, contrary to EPA's assertion in the preamble to the proposal, the Proposed Rule is not consistent with OMB's data quality regulations.
Response: The EPA clarifies that in this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available or not available in a manner sufficient for independent validation. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
This final rule makes incremental steps towards increasing data transparency by codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation and thereby improving the public's access to 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. Therefore, this rule is consistent with the focus on transparency in OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies and OMB M-13-13. It is also consistent with OMB M-19-15, which highlights the need to characterize the sensitivity of an agency's conclusions to analytic assumptions, as well as other federal guidance documents that require greater data transparency.
Furthermore, this final rule does not interpret or apply the provisions of any environmental statutes, nor does it modify the Agency's interpretations of "best available science." It therefore cannot conflict with the Data Quality Act. The EPA will continue to consider all peer-reviewed science, consistent with existing study quality assessment factors and corresponding statutory mandates. The EPA will then identify and consider "pivotal science in accordance with the provisions of this rule," unless the implementation of the rule conflicts with statutory requirements and associated implementing regulations. As this rule makes clear, if implementing this procedural rule would result in conflicts with existing environmental statutes, and their implementing regulations, this rule will yield to the EPA statutes and regulations.
9.7.3 Other
Comment: Commenters (5165, 6125, 6925) assert that EPA suggests in footnote 3 of the proposal that it would exercise its discretionary authority to establish a policy that would exclude studies from consideration, such as the Harvard School of Public Health "Six Cities" epidemiological study. Commenters (5165, 6925) express concern that EPA would discard rigorously vetted scientific literature such as the Six Cities Study, withdrawing from its legal obligation and stated intention to rely on the best available science. Commenter (8272) states that failure to consider the Harvard Six Cities Study and the ACS study. and others like them in setting NAAQS because their data are not publicly available would conflict with the requirement that EPA set standards that protect susceptible subgroups.
Commenter (6125) states that none of the statutes cited in the proposal provide EPA with the discretionary authority to disregard such data. The commenter adds that the cases cited in the footnote involved two of the most consequential EPA regulations, namely the NAAQS for lead and for fine particles. The commenter states that the studies at issue were the Lanphear study for lead and the Harvard Six-City and ACS studies for fine particles. The commenter states that EPA is surely aware of the extensive history involving industry challenges to those studies. The commenter states that in the two cited cases, industry had challenged EPA's reliance on those studies, arguing in each case that the underlying data should have been disclosed. The commenter states that, in each case, EPA addressed the comments on their merits, finding, with support in the record, that the studies were reliable as they stood despite the criticisms. The commenter states that both courts agreed that there was no need for disclosure. The commenter states that the current proposal claims discretionary authority--for which it identifies no basis--to ignore those considered responses in favor of categorically disregarding such repeatedly examined studies.
Response: The EPA clarifies that in this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available or not available in a manner sufficient for independent validation. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
Comment: Commenter (6133) states that the Proposal would broadly prohibit EPA from considering studies, models, and analyses that are integral to the functioning of EPA regulatory programs, implementation of statutes like the CAA, and protection of public health and the environment. The commenter states that it is unlawful for EPA to refuse or fail to consider these additional studies, models, and analyses.
Response: The EPA clarifies that in this final rule the EPA is not categorically excluding any studies from consideration when promulgating final significant regulatory actions or developing influential scientific information. Rather, the Agency will continue to evaluate the quality of all relevant studies, consistent with the intended use of the information. The EPA intends to issue implementation guidance and statute-specific rulemakings that will further describe these criteria and how the EPA will identify pivotal science in its assessments and rulemakings. The EPA will also continue to rely on the highest quality, most relevant studies available in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance.
Once the EPA has identified pivotal science -- for either significant regulatory actions or influential scientific information -- the EPA will then evaluate if the underlying dose-response data are available in a manner sufficient for independent validation. The EPA will give greater consideration to pivotal science for which the underlying dose-response data are either publicly available in a manner sufficient for independent validation or, in the case of PII, CBI, or proprietary data, available through restricted access that affords privacy in a manner sufficient for independent validation. The EPA acknowledges, and agrees with commenters, that there may be pivotal science for which the underlying dose-response data are not publicly available or not available in a manner sufficient for independent validation. For example, dose-response data underlying older pivotal science may no longer be available or may not exist in a currently usable format. In these cases, the EPA may still use the pivotal science after either giving it lesser consideration or receiving an exemption from the requirements of this rule from the Administrator.
 Chapter 10: Applicability of the Rule
The proposed rule includes 40 CFR 30.3 which states:
      The provisions of this subpart apply to dose response data and models underlying pivotal regulatory science that are used to justify significant regulatory decisions regardless of the source of funding or identity of the party conducting the regulatory science. The provisions of this section do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses. Except where explicitly stated otherwise, the provisions of this subpart do not apply to any other type of agency action, including individual party adjudications, enforcement activities, or permit proceedings.
As described in the preamble, the proposal solicits comment on (1) whether and to what extent the 40 CFR 30.3 requirements should apply to other stages of the rulemaking process, including proposed rules and guidance; (2) whether a narrower scope of coverage would be appropriate and whether certain categories of regulations should be excluded from coverage, such as individual party adjudications, enforcement activities, or permit proceedings; (3) whether the Agency should apply the provisions of the proposed rule to these actions or to specific types of actions within these categories; and (4) whether other agency actions, beyond significant final regulatory actions under Executive Order 12866, should be included, such as site-specific permitting actions or nonbinding regulatory determinations.
Several comments were received regarding the extent to which the 40 CFR 30.3 requirements should apply. In this section these comments are organized according to the following topics:
       Limiting Requirements to "Significant Regulatory Actions"
       Expanding the Scope of the Applicability of the Rule
       Narrowing the Scope of the Applicability of the Rule
       Changes in the Scope of the Science Subject to the Rule
       Scope - Phase-in
       Scope - Effects on Individual EPA Programs and Exceptions
       40 CFR 30.3  -  How do the provisions of this subpart apply?
       "Regulatory Decisions" Definition at 40 CFR 30.2
The specific comments provided in this Chapter reflect the comment letters that provide arguments supported by detailed rationale, examples, and references/documentation. The Docket ID numbers for these commenters are cited throughout this Chapter. In addition, some general comment letters may also include comments related to comments included and responded to in this Chapter. These comments are summarized in Appendix B. Note that points and issues raised in these general comment letters may also be raised by the more detailed comments summarized in this Chapter. The responses provided in this Chapter adequately address these more general comments.
10.1 Limiting Requirements to "Significant Regulatory Actions"
Comment: Commenters (4882, 6102, 6141, 6149, 6175, 6179, 6362, 6363, 6373) support the proposed rule being limited to "significant regulatory actions."
Commenter (6141) states that, by limiting the application of scientific transparency to this smaller subset of EPA regulatory actions, the Proposal ensures that the enhanced requirements for science transparency will apply in cases where EPA regulatory actions having the greatest impacts on the U.S. economy and regulated industry sectors. The commenter states that enhancing public access to underlying scientific data in the case of the most important and impactful EPA rulemakings will lead to increases in the true net benefits of these EPA regulatory actions by helping to ensure that the policies and requirements established by EPA in those regulatory actions are based on valid science and not on published studies with irreproducible results.
Response: The EPA agrees that the Agency's significant regulatory actions can potentially impact American lives and livelihoods. Because of this, the American people deserve environmental decisions and policies that are based on the best information, and only through continuous improvement to its procedures, especially those focused on transparency, can the EPA truly demonstrate its commitment to the Agency's mission of protecting public health and the environment through sound policy decisions that are informed by robust scientific and technical research.
In 2020, the EPA issued an SNPRM and proposed to expand the scope of the rulemaking to include final influential scientific information. Based on a consideration of public comments on the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments.
Comment: Commenter (6102) suggests that, over time, EPA can consider expanding the scope of the types of actions covered by this rulemaking through an amendment to the rule once stronger data sharing mechanisms are in place and operational.
Response: In 2020, the EPA issued an SNPRM and proposed to expand the scope of the rulemaking to include influential scientific information. Based on a consideration of public comments on the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. By finalizing the applicability of this rulemaking to influential scientific information, the Agency has expanded the scope not only to an important category of scientific assessments but also to a wider range of EPA regulatory actions.
The EPA would like to emphasize that the final rule does not impose requirements on any entity outside of the EPA. This is a rule of internal procedures and does not direct or require any outside entity or the EPA to establish data sharing mechanisms. Further, the rule does not require the EPA to collect, store, or publicly disseminate dose-response data underlying pivotal science.
Comment: Commenter (6149) requests that the category of radiation protection be exempted from the proposed rule, or the proposed definition of "pivotal regulatory science" should be limited solely to regulatory actions that are used as a basis for "significant regulatory action" as defined by Executive Order 12866 or for implementing/modifying a "major rule" as defined by 5 U.S.C. 804, Congressional Review of Agency Rulemaking.
Commenter (6149) states that various federal and state agencies implement radiation protection standards within an interconnected regulatory framework from a common scientific basis. In addition to the EPA, federal authority for radiation protection resides with the U.S. Nuclear Regulatory Commission (USNRC), the U.S. Department of Energy (DOE), the U.S. Department of Defense (DOD), the Occupational Safety and Health Administration (OSHA), and the U.S. Food and Drug Administration (FDA). State radiation control programs exercise regulatory authority for protection from ionizing radiation as defined in the Atomic Energy Act (AEA) through federal and state statutes. Recognizing that the EPA is not the sole regulatory authority for radiation protection, the commenter contends that it is critical that any significant changes in the associated integrated regulatory framework be coordinated and harmonized to ensure regulatory certainty and consistency. The commenter states that this is supported by the guidance in Executive Order 12866 which states, "Each agency shall avoid regulations that are inconsistent, incompatible, or duplicative with its other regulations or those of other Federal agencies."
The commenter (6149) notes that the linear no-threshold (LNT) radiation dose-response relationship is the foundation for the system of radiation protection, as well as federal and state laws and regulations. According to the commenter, any changes in its application would significantly impact radiation protection guidance, medical practice, compensation programs, environmental contamination issues, advances in technology, and communication of risk with profound corresponding safety, compliance, and financial impacts to both the private and public sectors. The commenter asserts that the National Academies, National Research Council, and National Council on Radiation Protection and Measurements (NCRP) have provided effective methods for a rigorous, holistic, and consensus review of the science behind radiation protection from all stakeholders. Thus, based upon these existing processes, the commenter recommends that the category of radiation protection be exempted from the proposed rule. At a minimum, the commenter recommends that the definition of "pivotal regulatory science" be limited to regulatory actions that are used as a basis for "significant regulatory action" as defined by Executive Order 12866 or for implementing/modifying a "major rule" as defined by 5 U.S.C. 804, Congressional Review of Agency Rulemaking.
In summary, the commenter (6149) believes the radiation protection category of regulations should be exempted from the Proposed Rule on Strengthening Transparency in Regulatory Science based upon the unique nature of the extensive - interconnected radiation protection system, the limited availability of radiation epidemiological and scientific expertise, and the demonstrated ability of the Congressionally chartered scientific advisory organizations (the National Academies, National Research Council, and NCRP) to effectively develop and review the scientific bases for radiation protection regulatory actions in an open and transparent manner.
Response: In 2020, the EPA issued an SNPRM and proposed to expand the scope of the rulemaking to include influential scientific information. Based on a consideration of public comments on the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. "Significant regulatory actions" means final regulations determined to be "significant regulatory actions" by the Office of Management and Budget (OMB) pursuant to Executive Order 12866. Influential scientific information means scientific information the Agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions. This action establishes how the Environmental Protection Agency (EPA) will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. The provisions of this part do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses, and influential scientific information or pivotal science that meet one or more of the exemptions identified in Section IX of the OMB Final Information Quality Bulletin for Peer Review. In the event the procedures outlined in this part conflict with statutes the EPA administers, or their implementing regulations, the statutes and regulations will control. Except where explicitly stated otherwise, the provisions of this part do not apply to any other type of Agency action, including individual party adjudications, enforcement activities, site-specific actions, or permit proceedings. Unless specifically exempt, this final rule will apply regardless of the scientific issue considered.
10.2 Expanding the Scope of Applicability of the Rule
Comment: Commenters (4882, 5181, 6112, 6115, 6133, 6141, 6143, 6148, 6161, 6360, 6362, 6366, 6375, 6867, 6875, 6891, 6906, 6921, 6935, 9227) support applying the proposed rule requirements more broadly and offer suggestions on expanding the scope of the rule. Commenter (6891) states that limiting transparency obligations only to significant regulatory actions ignores that EPA's actions outside of the rulemaking context can often have significant impacts on those other regulatory decisions.
Commenters (6133, 9227) argue that limiting the proposal to "significant regulatory actions" would result in treating a study differently depending on whether it supports regulation or non-regulation in a particular context. Commenter (6133) asserts that it is a hallmark of the Proposal's inherent arbitrariness and capriciousness that the Proposal prohibits EPA from considering the identical regulatory science, studies, and information in some regulatory situations, while allowing EPA to consider the identical regulatory science, studies, and information in other regulatory situations -- based merely upon the type of situation, rather than any differences in availability, replicability, verifiability, or validation concerning the information.
Specific suggestions provided by commenters for expanding the scope of the rule are summarized in sections 7.2.1 through 7.2.7 of this Chapter and include: other regulatory actions; guidance; proposed rulemaking/advanced notice of proposed rulemaking; individual party adjudications, enforcement activities, permit proceedings; actions relying on records from previous reviews; specific EPA programs, and application of the rule to a limited and special class of laboratory samples.
Response: In 2020, the EPA issued an SNPRM and proposed to expand the scope of the rulemaking to include influential scientific information. Based on a consideration of public comments on the 2018 proposed rule and the 2020 SNPRM, the EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. By finalizing the applicability of this rulemaking to influential scientific information, the Agency has expanded the scope not only to an important category of scientific assessments but also to a wider range of EPA regulatory actions.
The EPA is committed to its mission of protecting human health and the environment through sound policy decisions that are informed by robust scientific and technical research. Because of the potential impact of the EPA's significant regulatory actions and influential scientific information on American lives and livelihoods, the American people deserve environmental decisions and policies that are based on the best scientific information. Only through continuous improvement to its procedures, especially those focused on transparency, can the EPA fully demonstrate that commitment.
The provisions of final rule do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses, and influential scientific information and/or pivotal science that meet one or more of the exemptions identified in Section IX of the OMB Final Information Quality Bulletin for Peer Review. In the event the procedures outlined in this part conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control. Except where explicitly stated otherwise, the provisions of this final rule do not apply to any other type of agency action, including individual party adjudications, enforcement activities, site-specific actions or permit proceedings.
Finally, because of the potential impact of the EPA's significant regulatory actions and influential scientific information on American lives and livelihoods, this rule focuses on these important Agency actions. The EPA disagrees with commenters who believe that this rule requires the Agency to treat science differently based on the situation. Rather this rule does not categorically exclude any pivotal science, but because of the potentially significant societal impact of significant regulatory actions and influential scientific information requires the Agency to consider the availability of the underlying dose-response data to better ensure the validity of the science.
10.2.1 Application of the Rule to Other Regulatory Actions
Comment: Commenters (1972, 4882, 6141, 6148, 6362, 6375) support expansion of the rule requirements beyond "significant regulatory actions" to all EPA programs and stages of rule development; scientifically or technically novel actions (2426, 6161, 6375); interpretive rules (6141); regulatory and other key agency decision-making support assessments/studies (4882, 6112, 6115, 6125, 6141, 6143, 6148, 6161, 6360, 6369, 6375, 6867, 6891, 6906, 6911); pre-rulemaking planning activities (6375); Agency policy documents (6366); and models used in studies supporting regulations/policies (4882, 6112, 6115, 6143, 6360, 6375, 6867, 6875, 6891, 6935). In general, these commenters assert that there is no reason that there should be a distinction made between the application of the proposed rules provisions to major rules and other regulatory actions regarding the consideration of the science and modeling done in the development of such actions.
Commenter (6125) contends that allowing a distinction between using studies when they confer a benefit on industry but disallowing them when used to influence public health protection would be arbitrary and invidious.
Commenter (6360) argues that, since EPA's application of science always involves judgement and since this judgement is an exercise of government authority, all EPA applications of science should have minimum transparency standards. The commenter contends that there is no objective principle to separate permits, cleanup decisions, regulations, or other uses of EPA authority to arrive at the conclusion that one community deserves the ability to understand the government's judgement and reasoning and another does not. The commenter states that EPA commonly employs fate-and-transport models, route of exposure models, cost estimation models, statistical techniques to project analytic data beyond method detection limits, and numerous other specific applications of science that involve judgement by EPA and by the application developers, and that there is no logical principle to require transparency for one application and not another. As an example, the commenter asserts that a fate and transport model could have as much economic impact as a dose-response model.
Commenter (6360) states that, when EPA introduces a new applied science tool, the requirements of this rulemaking should apply, no matter the significance level or impact of the decision. The commenter asserts that EPA generally has discretion  -  judgement  -  as to when it introduces a new scientific application. According to the commenter, if the applicability is limited only to economically significant regulatory actions or some other impact threshold, this tiering approach creates a perverse incentive to introduce new, non-transparent tools in minor regulatory actions, permits, or product approvals. The commenter suggests that, once scientific applications are established in this manner, these applications may be granted deference as EPA policy and its precedent.
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, to expand the scope of the 2018 proposed rulemaking in two ways: (1) expanding "dose-response data and models" to "data and models," and (2) including influential scientific information. As EPA noted in the 2020 SNPRM, transparency of EPA's science should not be limited to dose-response data and dose-response models, because other types of data and models can also drive the requirements and/or quantitative analysis of EPA significant regulatory actions and influential scientific information.
Based on the comments on the 2018 proposed rule and the 2020 SNPRM, including that the number of studies that would be subject to the rule might hinder rulemaking, the EPA determined that the Agency should pursue an incremental approach to maximizing transparency in the science that it relies upon by focusing the final rule requirements on dose-response data and, in particular, only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs).
The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The provisions of the final rule apply to science that serves as the basis for informing a significant regulatory action or influential scientific information, as well as to dose-response data underlying pivotal science, regardless of the source of funding or identity of the party conducting the science.
The provisions of final rule do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses, and influential scientific information and/or pivotal science that meet one or more of the exemptions identified in Section IX of the OMB Final Information Quality Bulletin for Peer Review. In the event the procedures outlined in this part conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control. Except where explicitly stated otherwise, the provisions of this final rule do not apply to any other type of agency action, including individual party adjudications, enforcement activities, site-specific actions or permit proceedings.
Further, the requirements in this final rule set the overarching structure and principles for transparency in significant regulatory actions and influential scientific information. The EPA plans to develop internal implementing guidance and promulgate either statute-specific transparency regulations or programmatic actions implementing this procedural rule, as appropriate, to clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes the EPA administers.
10.2.2 Application of the Rule to Agency Guidance
Comment: Commenters (2426, 6141, 6148, 6161, 6366, 6375, 6906, 6911, 6913) urge the Agency to apply the requirements to EPA guidance.
Commenters (2426, 6366, 6913) assert that guidance documents can have as much impact on the regulated community as the "significant regulatory actions" discussed in the proposal. Commenters (2426, 6913) state that allowing this opportunity for public involvement safeguards the larger goal of regulatory transparency, as operational guidelines and guidance documents can often be just as impactful as official regulatory actions or rules.
Commenter (6161) states that transparency principles should be applied to all science used in developing guidance. Commenter (2426) states that the proposed data transparency rule should also apply to scientifically or technically novel guidance, and the resulting guidance document should be made available for public comment.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. Except where explicitly stated otherwise, the provisions of the final rule part do not apply to any other type of agency action. By finalizing the scope to include influential scientific information, the Agency is applying the applicability of the rule to an important category of scientific assessments that influence a wide range of EPA actions.
Comment: Commenter (6906) states that, due to the vast range of Guidance that EPA produces and utilizes, it would not be practical to require the Agency to enforce that these Guidelines be met for all Guidance Documents.
Response: EPA agrees with the commenter and is not expanding the scope of the rule to cover guidance documents. The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. Except where explicitly stated otherwise, the provisions of the final rule part do not apply to any other type of agency action. By finalizing the scope rule to include influential scientific information, the Agency is applying the applicability of the rule to an important category of scientific assessments that influence a wide range of EPA actions. Except in those instances where this rule yields to an existing environmental statute, all future influential scientific information will be subject to the requirements of this rule. Though this final rule does not apply directly to guidance documents, all new guidance will benefit from this rule if those documents rely on new influential scientific information.
Comment: Commenter (5181) expresses opposition to applying the requirements of the proposed rule to promulgation of guidance. The commenter states that applying such strenuous requirements for data early in the development of a rule would restrict initial consultation with other agencies, with stakeholders, and with the public. According to the commenter, in environmental programs, guidance often supports implementation of a rule in a practical manner at the field level. The commenter states that practical, accurate, and efficient application of regulations in the field typically depends upon guidance based not only on published science, but also on professional experience and results of field testing. The commenter asserts that it would be highly impractical to make such information available to the public in the format described by the proposed rule. According to the commenter, failure to develop guidance because of lack of extensive published data would cripple implementation of necessary regulatory programs.
Response: This final rule does not apply to guidance documents. The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. Except where explicitly stated otherwise, the provisions of the final rule part do not apply to any other type of agency action. By finalizing the scope rule to include influential scientific information, the Agency is applying the applicability of the rule to an important category of scientific assessments that influence a wide range of EPA actions.
10.2.3 Application of the Rule to Proposed Rules, Advanced Notice of Proposed Rulemaking and All Aspects of the Rulemaking Process
Comment: Commenters (4932, 6143, 6148, 6151, 6177, 6360, 6366, 6375, 6867, 6906, 6913, 6921) urge the Agency to apply the requirements of the proposed rule to proposed rulemakings.
Commenter (6360) states that transparency at the proposal stage benefits EPA by helping build a robust administrative record to support its policy decisions.
Commenter (6143) recommends that requirements apply first to proposed regulations for which rulemaking is already in progress, then prospectively to proposed and final rules alike.
Commenters (4932, 6151, 6177, 6366, 6913, 6921) assert that deferring access to the science until the final rulemaking is issued will be too late for active public engagement. Commenters (6913, 6360, 6921) state that policy decisions and scientific interpretations need to be thoroughly explained in the proposed rule stage, so that the public can understand and provide an informed opinion on them, which allows EPA to benefit from transparent stakeholder input before rendering a final agency action.
Commenter (6366) states that, when impacted stakeholders and the public are provided an opportunity to comment on federal proposals, they should have all relevant data, including cost benefit data, available to ensure they fully understand the justification for the rule and that their comments are clearly in response to the selected regulatory option(s) being proposed.
Commenters (6177, 6360, 6921) suggest that additional information may become available as a result of broadening the scope to the proposed rule stage. Commenter (6177) states that broadening the scope to the proposed rule stage would allow third parties to review the scientific underpinnings early in the process and possibly provide additional data sets and studies generated that the Agency may not currently possess. Alternatively, according to the commenter, if EPA only allows access to data sets once the rule is final, interested third parties would be more limited in their options to seek redress if a substantial issue is found.
Commenter (6906) states that it would be useful for the Agency to include language that regulators "strongly consider," rather than mandate, the use of these transparency guidelines during other moments of the regulatory process (i.e. the creation of guidance). The commenter asserts that, by requesting consideration of the guidelines at earlier stages in the proposed rule process, enforcement of these provisions for Final Rulemakings should be smoother.
Response: The EPA sees no need to include the proposed rule stage of significant regulatory actions in the final regulatory text for this rulemaking because, as a practical matter, these proposed rules must comply with this final rule in order to be finalized. The EPA does not introduce the studies and analyses it relies on for a rulemaking at the final rule stage. The basis for a rulemaking is provided for public review and comment in the public docket when the proposed rule is issued or if subsequently added to the docket through a separate opportunity for public comment. The EPA expects to identify pivotal science in proposed significant regulatory actions or external review drafts of influential scientific information, which will allow the public, if they so choose, to independently validate the pivotal science and provide comment to the EPA.
Comment: Commenters (4932, 6867, 6375, 6906) recommend revisions to the regulatory text in support of their positions that the proposed rule apply to both advanced notice of proposed rulemakings and proposed rules.
Commenter (4932) recommends that EPA revise the definitions of "regulatory decisions," "pivotal regulatory science," and "regulatory science" by striking the word "final" from the proposed definitions so that the transparency objectives (i.e., the disclosure of pivotal regulatory science) apply to advanced notices of proposed rulemaking and proposed rulemakings.
Commenter (6867) states the EPA should identify all studies (or other regulatory science) it will rely upon at the time it proposes any regulation in order for the public to meaningfully comment on the proposed action. The commenter suggests that Proposed 40 CFR 30.4 be amended to state that:
      EPA shall clearly identify all studies (or other regulatory science) relied upon to support any agency action. When EPA proposes any agency action, EPA shall make all such studies (or other regulatory science) available to the public to the extent practicable.
Commenter (6906) recommends that the EPA amend 40 CFR §§ 30.4 (identification of studies), 30.5 (disclosure of data and models), 30.6 (documentation and evaluation of studies) and 30.7 (peer review) to require these steps at an interim phase prior to issuance of the final rule.
Response: The EPA sees no need to include the proposed rule stage of significant regulatory actions in the final regulatory text for this rulemaking because, as a practical matter, these proposed rules must comply with this final rule in order to be finalized. The EPA does not introduce the studies and analyses it relies on for a rulemaking at the final rule stage. The basis for a rulemaking is provided for public review and comment in the public docket when the proposed rule is issued or if subsequently added to the docket through a separate opportunity for public comment. The EPA expects to identify pivotal science in proposed significant regulatory actions or external review drafts of influential scientific information, which will allow the public, if they so choose, to independently validate the pivotal science and provide comment to the EPA.
The EPA also sees no need to include advance notices of proposed rulemakings in this final rule because advance notices of proposed rulemakings are preliminary in nature and frequently focus on soliciting initial comment on a regulatory issue or approach. Therefore, an expansion to advance notices of proposed rulemaking would be inconsistent with the purpose of this final rule.
Finally, based on a consideration of the public comments on both the 2018 proposed rule and the 2020 SNPRM, the EPA has revised many of the rules definitions (at 40 CFR 30.2), including the definitions of "regulatory decisions," "pivotal regulatory science," and "regulatory science."
Comment: As background, the commenter (5181) explains that the proposed rule language indicates that it is generally applicable prospectively to final agency actions. However, the commenter states that the proposed rule requests comments on applicability to other stages of rulemaking. The commenter states that the EPA is currently engaged in a very extended proposed modification to the definition of waters of the United States (WOTUS) and it is unclear how the proposed rule might affect current rulemaking efforts. According to the commenter, although the definition of "dose response data and models" may not apply directly to the WOTUS rule, the Federal Register notice indicates that EPA is considering expansion of the rule "to cover other types of data and information, such as for example economic and environmental impact data and models that are designed to predict the costs, benefits, market impacts and/or environmental effects of specific regulation interventions on complex economic or environmental systems." The commenter recommends that, given the in-depth scientific analysis undertaken to support development of the 2015 rule regarding WOTUS  -  based heavily on a publicly available analysis of the pertinent peer-reviewed literature, they recommend that the WOTUS rule be exempt from any application of the proposed rule regarding transparency in science and that completion of the WOTUS rule be allowed using the existing scientific analysis. The commenter asserts that applying the proposed rule to the information gathered to support a WOTUS rule is unnecessary given currently availability of the underlying science to the public.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information developed after the effective date of the final rule; therefore, the rule does not apply to the WOTUS rule. For future, significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created.
Comment: Commenters (6112, 6143, 6375) contend that these requirements should apply to all aspects and steps in the pre-rulemaking and rulemaking process. Commenter (6112, 6143) specifically suggests that the proposed rule requirements should apply to assessments (including certain retrospective assessments), models, criteria documents, and regulatory impact analyses that provide the basis for EPA's policies, procedures, guidance, and proposed and final regulatory decisions. Commenter (6375) requests that the scope be expanded to cover, at a minimum, pre-rulemaking activities (e.g., during the planning and/or assessment stages of a National Ambient Air Quality Standard (NAAQS) cycle, EPA should indicate on which studies it plans to rely).
Commenter (1972) requests that the EPA follow the proposed requirements to the fullest extent practicable for all rulemaking decisions that rely on scientific or economic information as a basis for EPA's decision.
Commenter (4882) asserts that transparency is just as important in all aspects of rule-making as it is in regulatory science.
Response: Based on a consideration of these and other similar comments, the EPA proposed, through a 2020 SNPRM, to expand the scope of the 2018 proposed rulemaking in two ways: (1) expanding "dose-response data and models" to "data and models," and (2) including influential scientific information. The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities. Based on the comments on the 2018 proposed rule and the 2020 SNPRM, including that the number of studies that would be subject to the rule might hinder rulemaking, the EPA determined that the Agency should pursue an incremental approach to maximizing transparency in the science that it relies upon by focusing the final rule requirements on dose-response data and, in particular, only those studies that are integral to characterizing dose-reponse relationships (e.g., identifying candidate PODs).
10.2.4 Individual Party Adjudications, Enforcement Activities, or Permit Proceedings
Comment: Commenters (6112, 6115, 6143, 6375) provide arguments that support application of the proposed requirements to individual party adjudications, enforcement activities, and permit proceedings. Commenter (6143) recommends that the proposed requirements apply on a case-by-case basis to individual party adjudications, enforcement activities, and permit proceedings, to the extent that such actions are based or depend on research information.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
Comment: Commenter (6935) supports proposed provision 40 CFR 30.3 which indicates that the regulation does not apply to Agency action involving individual party adjudications, enforcement activities, or permit proceedings. The commenter states that it is not clear that the proposed new regulations should be applicable to individual party adjudications, enforcement activities, or permit proceedings, unless reliance on a particular study is a central issue. The commenter explains that adjudications and enforcement activities tend to turn on questions of fact and current processes can uncover necessary details without adding a new layer of requirements, which they assert would slow down such actions, while creating uncertainty and adding unnecessary costs for both regulated parties and regulators. The commenter suggests that even if reliance on a particular study is central to a more individualized proceeding, it would be more appropriate for the Agency to conduct a more generic regulatory action to address potential deficiencies in a study -- and the resulting regulatory requirements -- than require a private party to expend its own resources to assess and validate the underlying science.
Commenter (6137) asserts that, to the extent EPA decides to apply this Proposed Rule in the context of enforcement, adjudicatory, and permit actions  -  which it should not  -  it must first issue a proposal setting out its basis for such a rule and provide opportunity for comment, separate from the April 30, 2018 proposal, under the Administrative Procedure Act (APA) and Clean Air Act (CAA) § 307(d).
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
Comment: Commenter (6191) requests that EPA define what they would consider "practical" with respect to application of the rule to individual party adjudications, enforcement activities, or permit proceedings
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
<IP_ADDRESS> Individual Party Adjudications
Comment: Commenter (6133) states that the Proposal arbitrarily and capriciously allows EPA to continue to rely on highly relevant regulatory science and other information supplied to the agency by industry during individual party adjudications, even when that information is not "publicly available in a manner sufficient for independent validation." According to the commenter, the EPA could consider non-peer reviewed, non-transparent industry science to conclude that formaldehyde or asbestos are not carcinogens, or that fine particles (PM2.5) or lead have safe exposure levels, or that carbon dioxide (CO2) does not endanger public health or welfare. The commenter states that, under the proposed 40 CFR 30.3, EPA could conclude, after considering the non-transparent, unavailable information, that the regulations should not apply in ways that would affect an entire industrial sector favorably, while harming the public meant to be protected by those regulations.
Response: The final rule does not prohibit EPA from relying on studies when the underlying dose-response data is not available for independent validation. Implementation of this rule will not undermine EPA's efforts in protecting human health and the environment. The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
Comment: Commenter (6137) states that EPA does not explain how or where its Proposed Rule could be relevant in individual party adjudications. The commenter asserts that, though the administrative penalty provisions of the CAA provide for individual party adjudications, EPA's proposed procedures bear no relevance or applicability to such adjudications.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
Comment: Commenter (6935) states that, to the extent that an individual adjudication, whether in the context of permitting or enforcement, relies on EPA's own models or those provided by intervenors, the Agency should provide complete and transparent access to these models to the private party so that it can assess and critique any outcomes.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
<IP_ADDRESS> Enforcement Activities
Comment: Commenter (6133) asserts that the proposal arbitrarily and capriciously allows EPA to continue to rely on highly relevant regulatory science and other information supplied to the agency by industry during enforcement proceedings, even when that information is not "publicly available in a manner sufficient for independent validation." The commenter provides for consideration an example where a company that receives a notice of violation from EPA meets with the agency to make the case that EPA and the Department of Justice should not file a complaint. The commenter states that a company may submit regulatory science, confidential business information (CBI) (CBI), or other non-confidential information that is not "publicly available in a manner sufficient for independent validation." The commenter asserts that the EPA could consider non-peer reviewed, non-transparent, erroneous industry science to conclude that formaldehyde or asbestos are not carcinogens, or that PM2.5 or lead have safe exposure levels, or that CO2 does not endanger public health or welfare. According to the commenter, considering this and other non-transparent information, EPA could conclude that prosecution is not warranted, or that the information represents mitigating factors for penalties or injunctive relief, notwithstanding that the non-transparent, unavailable information is scientifically erroneous and even absurd.
Response: The final rule does not prohibit EPA from relying on studies when the underlying dose-response data is not available for independent validation. The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
Comment: Commenter (6137) states that, with respect to enforcement actions, EPA has no authority to bar the courts or administrative adjudicators from considering relevant evidence merely because that evidence has not passed an arbitrary test for transparency and peer review. The commenter contends that, whether a scientific study is sufficiently transparent or has been peer reviewed provides no bearing on administrative enforcement of statutes and is wholly irrelevant to determining administrative civil penalties. The commenter provides that the CAA, for example, vests authority over judicial enforcement actions to the courts, not EPA, and EPA has no authority to dictate to the courts what evidence they can and cannot consider, or what weight to give such evidence. See Nat. Res. Def. Council v. EPA, 749 F.3d 1055, 1063-64 (D.C. Cir. 2014). The commenter asserts that courts and administrative law judges are equipped with tools to separate out credible and non-credible scientific evidence, see, e.g., Fed. R. Evid. 702; Daubert, 509 U.S. 579. According to the commenter, whether a scientific study is sufficiently transparent or has been peer reviewed provides no bearing on administrative enforcement of these statutes, which provide enforcement authority over whether there has been a violation of specified requirements and prohibitions, see, e.g., 42 U.S.C. § 7413(a)(1)-(5). The commenter argues that it is also wholly irrelevant to determining administrative civil penalties. See, e.g., id. § 7413(e). Though the CAA does allow consideration of "such other factors as justice may require" in setting civil penalties, the commenter asserts that the EPA does not and cannot explain how its transparency and peer review tests could possibly be relevant to whether "justice" requires a different penalty for violation of a prohibition or requirement. The commenter asserts that, if a defendant feels that a standard is unjust because of a lack of data transparency or peer review in supporting studies, the defendant can seek review in the Court of Appeals within 60 days of the standard's publication and that the validity of standards cannot be questioned in an enforcement proceeding. See, e.g., 42 U.S.C. § 7607(b)(2).
Response: Nothing in the final rule bars courts or administrative adjudicators from considering relevant evidence. With this final rule, the EPA is including regulatory text in 40 CFR 30.3 stating that the statutes and regulations will control in the event of any conflicts, and clarifying that the requirements in this final rule set the overarching structure and principles for science transparency in the EPA's significant regulatory actions and influential scientific information. The EPA intends to develop internal implementation guidance and promulgate either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule, which will clarify how the Agency will implement the provisions from this final rule for specific programs authorized under the statutes that the EPA administers.
The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
Comment: Commenter (6356) recommends that the rule not apply to litigation and settlement/consent or to EPA enforcement actions, consent decrees, or administrative settlements because of the prosecutorial and confidentiality of discussions in the context of litigation and settlement agreements.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA agrees with the commenter and will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
Comment: Commenter (6362) supports the application of the rule to enforcement action. The commenter states that in civil judicial enforcement programs, EPA routinely makes discretionary decisions targeting cases to pursue on the basis of scientific data on exposure of humans and ecological resources to pollutants and that the scientific data used in such cases should be publicly available to be verified and replicated.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
<IP_ADDRESS> Permit Proceedings
Comment: Commenters (6180, 6362) state that the requirements should apply to permit proceedings. Commenter (6180) states that permit proceedings (and related water quality standards and total maximum daily loads (TMDLs)) have potentially long-lasting, widespread, and costly implications for permittees and therefore should not be excluded from this rule as they meet the requirements of pivotal regulatory science. Commenter (6362) contends that it should apply to permit proceedings because, in administrative programs, EPA routinely makes discretionary decisions targeting cases to pursue on the basis of scientific data on exposure of humans and ecological resources to pollutants and that the scientific data used in such cases should be publicly available to be verified and replicated.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
Comment: Commenters (5181, 6356) oppose application of the proposed requirements to individual permit actions.
Commenter (5181) asserts that such requirements would be inconsistent with sound and timely authorizations under the section 404 dredge and fill permit program. The commenter states that regulations that subject all data to identical requirements regarding data collection, evaluation, and release would interfere with the permitting process in an unacceptable manner. According to the commenter, the exclusion of non-peer reviewed data - which is typically collected at the time of a permit application for the purpose of clarifying both the extent and limitations of adverse impacts  -  would undermine the accuracy of individual permit decisions.
Commenter (6356) recommends that the rule, if adopted, should not apply to information that forms the basis of permits under any of the statutes such as the CAA, the Clean Water Act (CWA), or the Safe Drinking Water Act (SDWA) because separate public participation requirements provide under each of the respective statutes that the permit itself, including its requirements and conditions and their respective bases, already are subject to public comment and review. The commenter states that, while it is not clear what this rule would apply to other than these provisions, it seems possible that the applicability of this transparency regulation to other information underlying an environmental permit could open the door to confidential information about manufacturing processes and other business information and also third-party technology, which would be irrelevant to the permit's requirements and conditions and otherwise not required to be in the public's purview.
Response: The EPA is finalizing the applicability of this rulemaking to significant regulatory actions and influential scientific information because of the broad impact of these actions and assessments. The EPA will not expand the applicability of this rulemaking beyond significant regulatory actions and influential scientific assessments to individual party adjudications, permit proceedings, site-specific actions, and enforcement actions because these actions are typically focused on individual regulated entities.
10.2.5 Application of the Rule to Actions Relying on Records from Previous Reviews
 <IP_ADDRESS> Support Expanding the Scope to Prior Studies
Comment: Commenters (0555, 4882, 6143, 6362, 6375, 6867) support an expansion of the scope of the Proposal to prior studies.
Commenter (0555) states that, when possible, EPA should apply the proposed new guidelines to existing regulations and the regulatory science that supports them. The commenter recognizes that this may not always be feasible, especially for regulatory science that was developed under conditions that would limit disclosure, and EPA should develop clear criteria for the types of research that would be eligible for exemptions to its transparency policy. The commenter states that EPA has an opportunity, when conducting retrospective evaluation of regulatory impacts (as required by Executive Orders 13563 and 13771), to reexamine the studies, data, models and assumptions that generated ex-ante estimates of regulatory benefits and costs in order to ensure transparency and opportunities for independent analysis.
Commenter (6143) also recommends that the proposed requirements apply on a case-by-case basis to retrospective assessment of research information.
Commenter (6362) suggests that, in cases where EPA has developed analytical tools and models in the past that incorporate dose response data, it may be valuable to apply this rule retrospectively.
Commenter (6375) requests that a standard based on pivotal regulatory science that was not made publicly available, which has ongoing or upcoming economically significant costs, be subject to this rule. The commenter states that it would be inappropriate to reaffirm an existing standard without first reaffirming the underlying science. According to the commenter, if the underlying science was based on pivotal regulatory studies which have not been made publicly available, there would be no way to know if the standard was set correctly.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information developed after the effective date of the rule; the final rule has no retrospective effect on either final significant regulatory actions or influential scientific information. For future, significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created.
<IP_ADDRESS> Oppose Expanding the Scope to Prior Studies
Commenters (1008, 1011, 1012, 1281, 2006, 2426, 2477, 2876, 3971, 4595, 4838, 4931, 5165, 5170, 5172, 5181, 6109, 6114, 6116, 6120, 6126, 6133, 6361, 6362, 6373, 6447, 6449, 6868, 6875, 6895, 6905, 6925, 6935, 9224) oppose expanding the scope of the proposal with respect to prior studies and recommend that the rule only apply prospectively. Detailed comments supporting their positions are provided below.
<IP_ADDRESS>.1 Retrospective Implementation Would Lead to Significant Delays and Costs
Comment: Commenters (1008, 5181, 6895, 6935) assert that retrospective implementation could lead to delays and significant new costs that would lead to the EPA diverting substantial resources from its mission and a delay to the process of decision making. Commenter (6935) adds that, if previously implemented regulatory determinations were invalidated by a retrospective evaluation of the transparency in underlying scientific studies, then the investments made based on those regulatory decisions would be undermined. The commenter asserts that companies and their customers already will have made the investment to comply with a regulation and may have made corollary investments (e.g., if a regulation caused plant retirements and replacement generation is needed) that cannot be undone.
Response: This final rule applies prospectively to significant regulatory actions and influential scientific information developed after the effective date of the final rule; the final rule has no retrospective effect on either final significant regulatory actions or influential scientific information. For future, significant regulatory actions and influential scientific information, the final rule applies equally to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created.
<IP_ADDRESS>.2 Retroactive Application of the Proposed Rule is Not Practical
Comment: Commenters (1011, 2426, 4595, 6126, 6447, 6895) assert that retroactive application of this proposed rule to existing rules is not practical. Commenter (2426) states that the Proposal is infeasible considering the volume of significant environmental rules already in place and the time and expertise it would take to reanalyze the technical and legal aspects of these rules while maintaining oversight of ongoing agency business. Commenter (6895) states that applying the proposed rule retroactively to health studies, potentially initiated decades ago, may be impossible.