Response: The EPA maintains that the Administrator is the appropriate decision maker in this context. To ensure that the Administrator's exemption decisions are appropriately transparent, in the final rule the EPA has included a provision in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. This documentation would typically be provided as part of the proposed rulemaking given this will be part of the decision of what is the pivotal science for the rule. Regardless, the final rulemaking will provide clear documentation. To assist the Administrator in determining whether to grant an exemption, the EPA program or Region responsible for the significant regulatory action or influential scientific information and public commenters can provide input when the Administrator is considering an exemption. The EPA will document the rationale for the Administrator's exemption in the significant regulatory action or influential scientific information. The EPA is confident that the above criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
<IP_ADDRESS> Granting Exemptions Reduces Transparency in Rulemaking
Comment: Commenter (9362) expresses concern about granting exemptions for studies which rely on private third-party information even if the data are not made public. Commenter argues that such data should not be used, as doing so reduces transparency.
Response: The Administrator may grant an exemption on a case-by-case basis based on criteria provided in 40 CFR 30.7, including if he or she determines that greater consideration is warranted because making the dose-response data publicly available would conflict with laws and regulations governing privacy, confidentiality, CBI, or national security.
EPA has finalized the approach that gives greater consideration to pivotal science whose underlying dose-response data are publicly available or available through restricted access. Restricted or tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism (e.g., Data Use Agreements) that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. Although the EPA is prioritizing transparency in pivotal science, the Agency also recognizes that there will be instances where the underlying dose-response data of pivotal science is unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. These additional considerations are outlined in 40 CFR 30.5(d).
<IP_ADDRESS> Oversight and Documentation
Comment: Commenters (11192, 11332, 11404, 11495, 12422, 12727, 12715) point out that the rule fails to provide mechanisms for oversight (such as panels, petitions, required record-keeping, etc.) and that the Administrator is not required to report the criteria applied in granting exemptions. Commenter (11404) adds that the current requirement to provide a short summary of the decision-making process is insufficient.
Commenters (11397, 11500, 11892, 12422, 12727) write that when an exemption is granted or rejected, EPA should be required to provide a notice to the public identifying the data or studies as well as the specific rationale and legal basis for the decision. Commenter (11892) specifies that this should include "a summary and citations of information used in decision making; entities or persons consulted if outside the agency; sources of the information, unless prohibited for national or homeland security reasons, and reasons for how/why the decision was made."
Response: To ensure that the Administrator's decision is appropriately transparent, in the final rule the EPA has included a provision in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. This documentation would typically be provided as part of the proposed rulemaking given this will be part of the decision of what is the pivotal science for the rule. Regardless, the final rulemaking will provide clear documentation.
To assist the Administrator in determining whether to grant an exemption, the EPA program or Region responsible for the significant regulatory action or influential scientific information and public commenters can provide input when the Administrator is considering an exemption. The EPA will document the rationale for the Administrator's exemption in the significant regulatory action or influential scientific information. The EPA is confident that the above criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
<IP_ADDRESS> Public Input
Comment: Commenters (10048, 11404, 11482) write that allowing the Administrator to decide exemptions hampers public involvement in decision-making. Commenter (10048) adds that the process of granting exemptions should be subject to public review and comment.
Response: To ensure that the Administrator's decision is appropriately transparent, in the final rule the EPA has included a provision in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. This documentation would typically be provided as part of the proposed rulemaking given this will be part of the decision of what is the pivotal science for the rule. Regardless, the final rulemaking will provide clear documentation.
To assist the Administrator in determining whether to grant an exemption, the EPA program or Region responsible for the significant regulatory action or influential scientific information and public commenters can provide input when the Administrator is considering an exemption. The EPA will document the rationale for the Administrator's exemption in the significant regulatory action or influential scientific information. The EPA is confident that the above criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
12.2.5 Retroactivity
 <IP_ADDRESS> Support for Retroactive Exemptions
Comment: Commenters (11919, 11490, 11491, 11499, 11919, 12402, 12431) support granting exemptions on the basis of the age of a study if the rule is promulgated and write that this exemption should be mandatory. Commenters (11490, 11491, 12727) oppose all retroactive application of the rule.
Commenter (12402) notes that it is clear that older research and data development that may ultimately be considered pivotal to the development of significant regulatory decisions and influential scientific information may not have been conducted and recorded with the intention or provisions to provide public access to underlying data. Therefore, the commenter supports the need for the Administrator to maintain authority to exempt certain pivotal older studies or data that otherwise meet EPA program standards for acceptable data quality from transparency requirements.
Response: This rulemaking applies prospectively to significant regulatory actions and influential scientific information. This rulemaking has no retrospective effect on either final significant regulatory actions or influential scientific information. For future significant regulatory actions and influential scientific information, it applies equally to all dose-response data underlying pivotal science.
The Administrator may grant an exemption for a study on a case-by-case basis based on criteria provided in 40 CFR 30.7, including if he or she determines that compliance is impracticable because the development of the dose-response data was completed or updated before the effective date of the final rule.
<IP_ADDRESS> Age of Studies/Data Should Not Be Considered When Granting Exemptions
Comment: Commenter (11381) writes that making data and models eligible for exemption because they were produced prior to the effective date of the final rule is unnecessary and undermines transparency. Commenter (12471) also opposes consideration of age on the basis that "the rule would have very little impact for several years since most rules rely on studies completed and peer reviewed several years ago (if not decades earlier)." Commenter (12699) notes that allowing exemptions for older studies is unnecessary because studies can already be exempted on the basis of genuine privacy, confidentiality, and CBI concerns, and the provision would encourage the use of old data while discouraging the use of new data. Commenter (12399) adds that exempting all research conducted before the implementation of the rule would essentially make the rest of the rule meaningless.
Response: This rulemaking applies prospectively to significant regulatory actions and influential scientific information. This rulemaking has no retrospective effect on either final significant regulatory actions or influential scientific information. For future significant regulatory actions and influential scientific information, it applies equally to all dose-response data underlying pivotal science .
The Administrator may grant an exemption for a study on a case-by-case basis based on criteria provided in 40 CFR 30.7, including if he or she determines that compliance is impracticable because the development of the dose-response data was completed or updated before the effective date of the final rule.
Comment: Commenter (11381) writes that the proposed exemption for studies completed or updated prior to the rule being promulgated violates the Information Quality Guidelines (IQGs), which do not exempt information disseminated by EPA prior to when they came into force.
Response: This rulemaking applies prospectively to significant regulatory actions and influential scientific information. This rulemaking has no retrospective effect on either final significant regulatory actions or influential scientific information. For future significant regulatory actions and influential scientific information, it applies equally to all dose-response data underlying pivotal science.
<IP_ADDRESS> Exemptions Should Only Be Available for Older Studies
Comment: Commenter (11922) writes that exemptions should only be available for studies generated prior to the promulgation of the rule to encourage compliance by current researchers.
Response: The EPA would like to clarify that this rule exclusively governs the EPA's internal process for determining the consideration to afford pivotal science with respect to certain actions. If researchers want to increase the likelihood that their studies receive greater consideration by the EPA, they may take steps to ensure that the underlying dose-response data are available to the greatest extent possible. But any such response to this final rule would be purely voluntary.
As stated in the rule, the Administrator may grant an exemption on a case-by case basis if he or she determines that greater consideration is warranted because:
       technological or other barriers render sharing of the dose-response data infeasible;
       the development of the dose-response data was completed or updated before the effective date of the final rule;
       making the dose-response data available would conflict with laws and regulations governing privacy, confidentiality, confidential business information, or national security;
       a third-party has conducted independent validation of the study's underlying dose-response data through reanalysis; or
       the factors used in determining the consideration to afford to the pivotal science indicate full consideration is justified.
This rulemaking applies prospectively to significant regulatory actions and influential scientific information. This rulemaking has no retrospective effect on either final significant regulatory actions or influential scientific information. For significant regulatory actions and influential scientific information, it applies equally to all dose-response data underlying pivotal science.
<IP_ADDRESS> Exemptions Based on the Age of a Study
Comment: Commenters (11388, 11386, 11395, 11484, 11490, 11491, 12702, 12710, 12727) provide that any information that originated prior to the finalization of the proposed rulemaking should be excluded from the requirements. Specifics include:
Commenter (11388) supports "grandfathering" completed work, models, and data that have already been used by the Agency and supports implementing this rule in stages to prevent further delay of EPA's work. The commenter recommends ensuring that during this review process, studies that have historically been used by the Agency to make regulatory decisions are not rejected from use because of this rulemaking.
Commenter (11386) provides that the rule should only apply to data and models that are generated after the effective date. According to the commenter, even if the transparency of data and ability to be reanalyzed did indicate quality of science, then this information was available to EPA when considering past rules. The commenter states that nothing about the science used to make previous rules will be changed as a result of this new rule. Thus, the commenter notes, to suddenly treat previous studies in a way different from how they were previously treated by the EPA would be arbitrary and capricious, as nothing about the studies themselves had changed. Unless new information came to light, the commenter states, then it would be quite reasonable to change how older studies are considered, but to do so due to factors that have nothing to do with the science itself would be arbitrary.
Commenter (11395) notes that the SNPRM asks whether age of data and models should be considered in determining the feasibility of making underlying data and models publicly available and whether additional factors should also be considered in this determination. The commenter supports the consideration of age of data, as well as privacy laws, technology barriers, the nature of confidentiality agreements, and other factors that may preclude data accessibility, in any feasibility determination. The commenter states that an older study should not be excluded or devalued solely because raw data are no longer available or because accessibility to those data are restricted by use agreements in place at the time the study was conducted. The commenter states that, in addition, any other factor that precludes or limits data accessibility, including, as listed in section 30.9 of the SNPRM, technological barriers and conflicts with "laws governing privacy, confidentiality, CBI, or national and homeland security," should be considered. The commenter states that the criteria should be specified in guidelines, and data availability should be considered as only one factor in weighing the quality of studies.
Commenter (11484) writes that the age of a study "has no direct bearing on the feasibility of publicly sharing the underlying data. Although it can be credibly argued that it is much harder in 2020 to access the data underlying a study published in 1970, the same argument cannot be credibly made for a study published in 2019."
Commenter (12702) states that EPA confirms that it intends to apply the requirements of the rule to only future rulemakings in the supplemental proposal. This, according to the commenter, would help avoid regulatory uncertainty or potential disruptions for entities that have complied with past rulemakings. Additionally, the commenter encourages that requirements only be applied to future data and models to avoid undermining existing science on which decades of rulemakings rely and thus support consistency in ongoing rulemakings.
Commenter (12710) states that most studies prior to the digital age would not meet the proposed requirements, leading to EPA dismissing most science conducted in the 20th century. The commenter notes that the supplemental proposal would apply the rule to data and models evaluated at the time a significant regulatory action or influential scientific information is developed, regardless of when the data and models were generated," and recommends that the rule only be applied to studies generated after the effective date of the supplemental proposal.
Commenter (12727) asserts the new language in the SNPRM confirms it applies to pre-existing data and studies unless the Administrator exercises their discretion to exempt them due to the inclusion of the exemption criterion of the age of the data. The commenter states EPA must expressly not apply the rule to data completed or updated prior to the rulemaking as technological barriers and costs would prevent a significant number of older studies from being reviewed and brought into compliance.
Response: This rulemaking applies prospectively to significant regulatory actions and influential scientific information. This rulemaking has no retrospective effect on either final significant regulatory actions or influential scientific information. For significant regulatory actions and influential scientific information, it applies equally to all dose-response data underlying pivotal science.
Although the EPA is prioritizing transparency in pivotal science, the Agency also recognizes that there will be instances where the underlying dose-response data of pivotal science is unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. These additional considerations are outlined in 40 CFR 30.5(d).
The Administrator may grant an exemption for a study on a case-by-case basis based on criteria provided in 40 CFR 30.7, including if he or she determines that greater consideration is warranted because the development of the data was completed or updated before the effective date of the final rule.
Comment: Commenter (14397) notes that all studies begun prior to the date the SNPRM is finalized should be given a nondiscretionary, mandatory exemption from the rule.
Commenter (11900) suggests that, rather than pressure researchers into sharing their data in ways that their informed consent could not have anticipated, potentially exposing them to legal liability, the EPA should exempt all research initiated prior to the effective date of the final rule from the requirements of the rule. The commenter states that, to ensure the exemption is applied without bias, it should be applied on a blanket basis to all studies initiated prior to the passage of the rule -- and not on a case-by-case basis by the administrator. The commenter states that the exemption should continue in perpetuity, and exempted research should carry equal weight to research that complies with the requirements of the final rule.
Response: This rulemaking applies prospectively to significant regulatory actions and influential scientific information. This rulemaking has no retrospective effect on either final significant regulatory actions or influential scientific information. For future significant regulatory actions and influential scientific information, it applies equally to all dose-response data underlying pivotal science. In addition, the Administrator may grant an exemption for a study on a case-by-case basis based on criteria provided in 40 CFR 30.7, including if he or she determines that greater consideration is warranted because the development of the data was completed or updated before the effecitive date of the final rule.
This rule does not require any researcher or other outside entity to provide dose-response data to the EPA. If researchers want their studies to receive greater consideration by the EPA, they may take steps to ensure that the dose-response data are available to the greatest extent possible. But any such response to this final rule would be purely voluntary. It is not required by the rule.
12.2.6 Support for Exemptions
 <IP_ADDRESS> General Support
Comment: Commenters (11499, 11500) express general support for the version of section 30.9 put forward in the supplemental notice. Commenter (11397) writes that exemptions should be granted only after exhausting all other options for enabling public access to data.
Response: 40 CFR 30.7 in the final rule is similar to the version in the SNPRM except it includes the criteria the Administrator should consider when determining whether to grant an exemption and notes that the rationale for an exemption shall be documented in the significant regulatory action and influential scientific information. This documentation would typically be provided as part of the proposed rulemaking given this will be part of the decision of what is the pivotal science for the rule. Regardless, the final rulemaking will provide clear documentation.
An exemption will only be granted for cases where all options for enabling public access to data have been exhausted.
Comment: Commenter (12402) encourages the EPA to pursue and provide public access to underlying pivotal data whenever possible, even in cases where the data were developed prior to the effective date of this rule. The commenter states that it is clear that older research and data development that may ultimately be considered pivotal to the development of significant regulatory decisions and influential scientific information may not have been conducted and recorded with the intention or provisions to provide public access to underlying data. For this reason, the commenter supports the need for the Administrator to maintain authority to exempt certain pivotal older studies or data that otherwise meet the EPA program standards for acceptable data quality from transparency requirements.
Response: This rulemaking applies prospectively to significant regulatory actions and influential scientific information. This rulemaking has no retrospective effect on either final significant regulatory actions or influential scientific information. For future significant regulatory actions and influential scientific information, it applies equally to all dose-response data underlying pivotal science.
The Administrator may grant an exemption for a study on a case-by-case basis based on criteria provided in 40 CFR 30.7, including if he or she determines that greater consideration is warranted because the development of the dose-response data was completed or updated before the effective date of the final rule.
<IP_ADDRESS> Scope
Comment: Commenters (11358, 11499) support that EPA has modified the scope for exemptions to include instances where data may not be available due to technological barriers.
Commenters (10866, 11397) support the deletion of the provision concerning the granting of exemptions based on impracticability of peer review.
Response: The Administrator may grant an exemption for a study on a case-by-case basis based on criteria provided in 40 CFR 30.7, including if he or she determines that greater consideration is warranted because technological or other barriers render sharing of the dose-response data infeasible.
Title 40 CFR 30.7 of the final rule does not include the exemption on a case-by-case basis if the Agency determined that it was not feasible to conduct independent peer review on pivotal regulatory science, which was removed in the SNPRM.
12.2.7 Other Comments
 <IP_ADDRESS> Exemptions Provision Undermines Proposed Rule
Comment: Commenter (12715) writes, "given how severely the supplemental proposal would limit the scientific evidence available for EPA's use, the proposed exemption provisions could become the basis upon which most of the science relied on by EPA in its rulemaking is admitted. The exceptions could thus largely swallow the rule, resulting in greater arbitrariness in EPA regulatory actions rather than EPA's alleged goal of greater transparency."
Response: The EPA would like to clarify that no studies are categorically excluded from consideration under the final rule. Further, as discussed in the preamble to the final rule, although the EPA is prioritizing transparency in pivotal science, the Agency also recognizes that there will be instances where the underlying dose-response data of pivotal science is unavailable for independent validation. In order to ensure that the Agency maintains a strong scientific basis for its decision-making, the availability of underlying dose-response data should be considered as long as other significant technical considerations can provide some level of certainty or confirmation of a study's conclusions, importance, and applicability, even in the absence of maximum transparency. These additional considerations are outlined in 40 CFR 30.5(d).
<IP_ADDRESS> Rule Will Reduce Trust in EPA's Regulatory Decisions
Comment: Commenters (11399, 11482, 12431) write that if this rule is promulgated, allowing the EPA Administrator sole discretion could give the public the impression that decisions are arbitrary or biased, which may result in a loss of trust in EPA's regulatory decisions.
Response: The EPA maintains that the Administrator is the appropriate decision maker in this context.
To ensure that the Administrator's decision is appropriately transparent, in the final rule the EPA has included a provision in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. This documentation would typically be provided as part of the proposed rulemaking given this will be part of the decision of what is the pivotal science for the rule. Regardless, the final rulemaking will provide clear documentation.
To assist the Administrator in determining whether to grant an exemption, the EPA program or Region responsible for the significant regulatory action or influential scientific information and public commenters can provide input when the Administrator is considering an exemption. The EPA will document the rationale for the Administrator's exemption in the significant regulatory action or influential scientific information. The EPA is confident that the above criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
<IP_ADDRESS> Exemptions Provision Demonstrates Arbitrariness of Larger Rule
Comment: Commenters (11403, 11892, 12727) write that allowing the Administrator to grant exemptions to some studies demonstrates EPA's awareness that public availability of data is not necessarily indicative of quality or validity. Commenter (11892) notes, "It is unclear why an exemption from compliance with the rule would be needed if the final rule is not excessively burdensome." Commenter (12399) also writes that because laws prevail over Agency rules, it is not necessary to state that the rule would not apply in the case of a conflict, and that doing so "appears to do nothing more than give the Administrator an excuse to waive the rule for rather arbitrary reasons."
Response: As more fully discussed in the preamble of the final rule, the Agency is retaining the Administrator's exemption provision because there are conditions under which compliance with the requirements in 40 CFR part 30 might be impracticable. For example, the underlying dose-response data for some studies, particularly older studies, may not be readily publicly available because of the technological barriers to data sharing (e.g., differences in data storage devices or data retention practices) that existed when they were developed. As a result, the EPA is finalizing the Administrator's exemption provision as proposed in the 2020 SNPRM, with additional conditions. The EPA is confident that the above criteria provide sufficient clarity and boundaries for the Administrator to consider when granting an exemption under 40 CFR 30.7.
<IP_ADDRESS> Waiver Cannot Save an Unlawful Rule
Commenter: Commenters (12715, 198105) point to Alltel Corp. v. Federal Communications Commission, in which the D.C. Circuit found that an agency "cannot save an irrational rule by tacking on a waiver procedure" because the "essence of waiver is the assumed validity of the general rule." Commenter (198105) writes that because the proposed rule is not authorized by any of the statutory authorities cited in the supplemental notice and it "actively hinders EPA's ability to effectuate the statutes that it is charged with implementing," the rule is unlawful, and thus cannot be rescued by the creation of a waiver provision.
Commenter (12731) states that the EPA's proposal to allow the Administrator to grant exemptions from the rule's disclosure requirements demonstrates the EPA's awareness that a study can be valid and worthy of consideration even if underlying data or models are not publicly available. The commenter states that, where a statute requires that the Agency consider certain information in reaching a decision, the EPA cannot promulgate a rule that prohibits the Agency from considering such information, that automatically downgrades the value placed on such information regardless of its scientific merit, or that gives the Administrator discretion to decide whether the Agency will consider such information. The commenter states that none of the SNPRM's changes to proposed section 30.9 do anything to resolve this fundamental conflict with the relevant environmental and public health statutes. The commenter states that the mere fact that the Administrator might in the future use his or her exemption authority to allow the Agency to consider a particular study does not resolve the rule's unlawfulness.
Response: EPA notes that this final rule does not categorially exclude any studies. As detailed in the preamble to the final rule, the EPA is authorized to promulgate this procedural rule under its authority to promulgate housekeeping regulations governing its internal affairs. This final rule does not interpret or apply the provisions of any environmental statutes; such efforts will occur in the subsequent rulemakings under the relevant statutes. If implementing this procedural rule would result in conflicts with existing environmental statutes, the procedural rule will yield to the EPA statutes and regulations.
 Chapter 13: Peer Review
The NPRM (40 CFR 30.7) includes the following requirement:
      EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the Office of Management and Budget (OMB) Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein.
The EPA solicited comment in the notice of proposed rulemaking (NPRM) on whether the exemptions in Chapter 9 of the OMB's Final Information Quality Bulletin for Peer Review are appropriate, and on whether there are other situations in which specific significant regulatory actions, or specific categories of significant regulatory actions should be exempted.
Under the supplemental notice of proposed rulemaking (SNPRM), the EPA clarifies that neither the proposed nor the alternative 40 CFR 30.5 changes would require that EPA, a member of the public or other entity must independently validate a study before it can be considered to be pivotal regulatory science or pivotal science. The EPA also clarifies that independent validation is not required under proposed 40 CFR 30.7 which describes the role of independent peer review.
Related, the 2018 NPRM also included a provision at 40 CFR 30.9 allowing the Administrator to grant exemptions from the rule on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to conduct independent peer review on all pivotal regulatory science. The SNPRM proposes to delete that proposed exemption language.
Several comments were received regarding the proposal's reference to and consistency with the OMB Bulletin and issues related to "independent peer review." These comments are organized according to the following topics under sections 13.1 NPRM Peer Review-Related Comments and 13.2 SNPRM Independent Peer Review:
Section 13.1: NPRM Peer Review-Related Comments
       Office of Management and Budget (OMB) Final Information Quality Bulletin for Peer Review
       Independent Peer Review Requirements (40 CFR 30.7)
       Comparison of the Approach in the Proposed Rule to Existing Scientific Review Processes
Section 13.2 SNPRM Independent Peer Review
       Existing Peer Review Processes and Protocols are Sufficient
       Concerns Related to Transparency in EPA's Peer Reviews
       Supplemental Proposal Violates the Principles of the OMB Final Information Quality Bulletin for Peer Review
       Resource Burdens of Peer Review Requirements
       Considerations of Bias and Independence of Peer Reviewers
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.
13.1 NPRM Peer Review-Related Comments
 13.1.1 Office of Management and Budget (OMB) Final Information Quality Bulletin for Peer Review
 <IP_ADDRESS> Statutory Authority to Codify the OMB Bulletin
Comment: Commenters (6133, 9227) argue that the EPA does not have the legal authority to codify the requirements of the OMB Bulletin.
Commenter (6133) states that the EPA proposes to bind itself to conduct a particular form of peer review based on an OMB Bulletin that has never been the subject of notice and comment rulemaking and is not authorized by any federal law. According to the commenter, treating the content of the OMB Bulletin as a binding regulation would violate the federal statutes the EPA implements because those statutes do not codify the Bulletin. In addition, the commenter asserts that the proposal identifies no statutory authority for EPA to conduct independent peer review for any "pivotal regulatory science" consistent with the Bulletin, nor did the proposal identify the statutory authority for the EPA to bind itself to conduct peer review only in this fashion. Further, the commenter says the proposal identifies no Congressional intent for EPA to conduct peer review consistent with the OMB Bulletin, although Congress has known about the OMB Bulletin since 2005. The commenter contends that the EPA has made up proposed § 30.7 and the putative authority for the Proposal out of whole cloth.
Commenter (9227) asserts that there is no statutory authority for EPA to "conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." The federal statutes that EPA lists as putative authority for the Proposal provide no authority for proposed § 30.7. See 83 Fed. Reg. at 18,769/2 (citing Clean Air Act (CAA) sections 103, 301(a), 42 U.S.C. 7403, 7601(a); Clean Water Act (CWA) sections 104, 501, 33 U.S.C. 1254, 1361; Safe Drinking Water Act (SDWA) sections 1442, 1450(a)(1), 42 U.S.C. 300j - 1, 300j -  9(a)(1); Resource Conservation and Recovery Act (RCRA) sections 2002(a)(1), 7009, 42 U.S.C. 6912(a)(1), 6979; Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) (as delegated to the Administrator via Executive Order 12580) sections 115, 311, 42 U.S.C. 9616, 9660; Emergency Planning and Community Right-To-Know Act (EPCRA) section 328, 42 U.S.C. 11048; Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) sections 25(a)(1), 136r(a), 7 U.S.C. 136r(a), 136w; and Toxic Substances Control Act (TSCA) as amended, section 10, 15 U.S.C. 2609, and the Administrative Procedures Act (APA)). According to the commenter, the claimed authorities that EPA lists do not mention peer review or even allude to the concept. Id. The commenter provides that neither the Proposal nor accompanying docket materials identify any provision of any federal statute that authorizes EPA to promulgate proposed § 30.7 and that their own research revealed no provision of any federal statute that authorizes EPA to promulgate proposed § 30.7. The commenter asserts that Congress writes federal statutes.
Response: The OMB Bulletin provides that "agencies are granted broad discretion to weigh the benefits and costs of using a particular peer review mechanism for a specific information product. The selection of an appropriate peer review mechanism for scientific information is left to the agency's discretion". EPA is subject to the OMB Bulletin and its provisions have been incorporated into the Agency's peer review handbook. EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will lead to consistent implementation of those procedures across the Agency.
As stated in the final rule, EPA is authorized to promulgate this procedural rule under its authority to promulgate housekeeping regulations governing its internal affairs. The final rule does not interpret or apply the provisions of any environmental statutes. If implementing this procedural rule would result in conflicts with existing EPA environmental statutes, and their implementing regulations, the procedural rule will yield to the existing statutes and regulations.
Comment: Commenter (6449) notes that the OMB Bulletin implements the Information Quality Act (IQA) (Pub L. No. 106-554, § 515, Dec. 21, 2000) and that the rule should reference the IQA along with the OMB Bulletin.
Response: EPA references the guidelines because they provide interpretations of key terms. EPA relied on these guidelines, as well as other federal guidance documents that require greater data transparency, when describing the consistency of this rule's focus on transparency, the need to characterize the sensitivity of an agency's conclusions to analytic assumptions.
<IP_ADDRESS> Existing OMB Bulletin Sufficient
Comment: Commenters (6915, 6925) assert that there is an existing and well-established framework in place governing the use of scientific information to ensure that the information informing regulatory actions is the best-available, peer-reviewed science. These commenters point to the OMB Bulletin as one of the policy/procedure documents that comprises that existing framework.
Commenter (6895) asserts that the OMB Bulletin states that pivotal research must include information so that agency reviewers can "ensure that scientific uncertainties are clearly identified and characterized." The commenter remarks that this is the task of peer reviews, and there is no need to make anything else available if scientific uncertainties can be quantified.
Response: The EPA would like to clarify that the rule requirements are 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" (Ref. 8). 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.
Comment: Commenter (9227) asserts that the EPA has not provided any information to suggest that EPA is not already following the OMB Bulletin. According to the commenter, the EPA's lack of any supporting rationale or analysis frustrates the public's ability to provide meaningful comment on the 40 CFR 30.7 provision that "EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 Fed. Reg. 2664) and the exemptions described therein," and is itself a sign that this requirement is fundamentally arbitrary.
Response: The reference to OMB Final Information Quality Bulleting for Peer Review in the final rule is to ensure that EPA will conduct any peer reviews required under the rule in accordance with this existing policy and procedures.
<IP_ADDRESS> Consistency of Proposal with the OMB Bulletin
 <IP_ADDRESS>.1 OMB Bulletin Does Not Require Re-review of Adequately Peer-Reviewed Studies
Comment: Commenters (6125, 9227) state that the EPA must clarify that studies that have already been adequately peer-reviewed by third parties do not need to be re-reviewed by the EPA, as provided for in the OMB Bulletin. Commenter (9227) also states that the EPA must clarify that prior peer reviews are not subject to the requirement in §30.7 that reviewers consider the strengths and weaknesses of EPA's justifications.
Commenter (9227) notes that proposed §30.7 expressly incorporates the OMB Bulletin, which provides that "agencies need not have further peer review conducted on information that has already been subjected to adequate peer review." The commenter also notes that the language in proposed §30.7 instructs the EPA to "ask peer reviewers to articulate the strengths and weaknesses of EPA's justifications for the assumptions applied and the implications of those assumption for the results." The commenter remarks that peer reviews conducted prior to the EPA's reliance on a study could not have involved a review of the strengths and weaknesses of EPA's justifications, and this language implies that the EPA is required to re-peer review all influential scientific information.
Commenters (4589, 6137, 9927) state that requiring a re-review of previously peer-reviewed studies would burden the EPA with unnecessary, duplicative and significant costs and would prevent the EPA from fulfilling its statutory mission of protecting public health and the environment by bringing many EPA rulemakings to a standstill.
Commenters (6125, 9227) suggest that in order to prevent stalling rulemakings, the EPA must clarify that the rule will not supersede EPA's existing authority under the OMB Bulletin to not conduct further peer review where information has already been subject to adequate peer review. Commenter (6137) states that the OMB Bulletin recognizes, "[p]ublication in a refereed scientific journal may mean that adequate peer review has been performed." Commenter (6125) specifically requests that the EPA revise the proposed rule language to clarify what is required and what is advised.
Response: The EPA would like to clarify that the rule requirements are 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. The EPA is, therefore, finalizing the language at 40 CFR 30.6 (formerly 40 CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM) to clarify that the Agency will evaluate whether or not to initiate peer review, consistent with the OMB's Bulletin for Peer Review and the EPA's Peer Review Handbook, of individual studies identified as pivotal science if the studies have already undergone journal peer review. If the Agency conducts peer review on pivotal science, the EPA shall ask peer reviewers to articulate the strengths and weaknesses of the justification for the assumptions applied in analyzing dose-response data and the implications of those assumptions for the results.
To address the public comment regarding "unnecessary duplicative and significant costs", the preamble of the final rule specifies, "given the costs of the current robust process for identifying and reviewing scientific studies and documentation that are existing Agency practice, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions and influential scientific information, the EPA anticipates that the incremental costs of this rule will be small....relative to current administrative costs for developing significant regulatory actions or influential scientific information."
<IP_ADDRESS>.2 The Proposal Will Lead to Undue Delays, Contrary to the OMB Bulletin
Comment: Commenter (6137) asserts that the provisions in the proposed rule requiring independent peer review on all pivotal regulatory science used to justify regulatory decisions is inconsistent with provisions in the OMB Bulletin that exclude time-sensitive health and safety disseminations, which encompasses most of the studies the EPA intends to review, and direct agencies to ensure peer review does not unduly delay the release of urgent findings. The commenter states that in contrast to the OMB Bulletin, the proposal appears to require another layer of peer review, which would lead to unnecessary delays. The commenter notes that there can be hundreds to thousands of studies supporting a standard, such as the national ambient air quality standards (NAAQS), and it is difficult to see how the EPA could subject all of these to an additional peer review process, which can take months for each study to be reviewed, and still complete scientific assessments in a timely manner. The commenter asserts that the EPA must clearly outline how it will ensure the additional peer review process will not lead to undue delay.
Response: EPA disagrees that the rule adds another layer of peer review that could result in unnecessary delays. EPA clarified in 40 CFR 30.6 that "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." This should ensure that no unnecessary peer reviews are conducted that could cause undue delay.
<IP_ADDRESS>.3 Independent Peer Reviewer OMB Bulletin Guidelines
Comment: Commenter (6120) urges the EPA to follow the OMB Bulletin guidelines for peer review to ensure peer reviewers are independent of industry and include academic scientists. The commenter provides that the OMB Bulletin states that "For scientific assessments relevant to specific regulations, a reviewer's financial ties to both regulated entities (e.g., businesses) and the agency should be examined" and "goes beyond financial investments and business relationships and includes work as an expert witness, consulting arrangements, honoraria and sources of grants and contracts." The commenter further provides that the OMB Bulletin also clearly states that scientists who receive government research grants are still able to offer "independent scientific advice to the agency on other projects."
Commenter (1972) requests that EPA clarify the use of peer review in proposed 40 CFR 30.7. The commenter provides that this section states that "EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." The commenter further provides that the OMB Bulletin states that, for more important work, "independent" peer review should involve "[r]reviewers" that "are generally not employed by the agency or office producing the document. As the National Academy of Sciences (NAS) has stated, `external experts often can be more open, frank, and challenging to the status quo than internal reviewers, who may feel constrained by organizational concerns.'" Citing Nuclear Regulatory Commission (NRC), Peer Review in Environmental Technology Development Programs: The Department of Energy's Office of Science and Technology, Nat'l Academy Press (1998) at 3. According to the commenter, the EPA's own Guidelines similarly note that "[f]or those work products that are intended to support the most important decisions or that have special importance in their own right, external peer review is the procedure of choice." The commenter asserts that, given the credibility bestowed by both the courts and the public upon the studies that are "peer reviewed," the EPA should also clarify the conditions/parameters under which it will use truly independent external peer reviewers.
Response: The final rule language at 40 CFR 30.6 (formerly 40 CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM) clarifies that the Agency will evaluate whether or not to initiate peer review, consistent with the OMB's Bulletin for Peer Review and the EPA's Peer Review Handbook, of individual studies identified as pivotal science if the studies have already undergone journal peer review. If the Agency conducts peer review on pivotal science, the EPA shall ask peer reviewers to articulate the strengths and weaknesses of the justification for the assumptions applied in analyzing dose-response data and the implications of those assumptions for the results.
Adequate peer review is peer review that is consistent with the requirements of the OMB Peer Review Bulletin and EPA's Peer Review Handbook. The Agency will continue conducting peer reviews according to the peer review policies and practices that were in place before the rule goes into effect. The EPA Peer Review Handbook, 4[th] Edition, describes how peer reviewers are selected by the Agency.
<IP_ADDRESS>.4 OMB Bulletin Exemption Criteria
Comment: Commenter (9227) states that the EPA must clarify that the OMB Bulletin waiver provisions will remain in effect. The commenter notes that proposed §30.9(b) provides that the Administrator may grant an exemption from the peer review requirements if he or she determines that "[it] is not feasible to conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions for reasons outlined in OMB Final Information Quality for Peer Review (70 FR 2664), Section IX." The commenter notes that only two of seven exemptions in Section IX of the OMB Bulletin relate to feasibility, and suggests that the EPA amend its Proposal to clarify that all of the exemptions in the OMB Bulletin remain in effect regardless of whether they pertain to feasibility. The commenter recommends that the EPA clarify what additional effect, if any, is intended by the exemption provision in the proposed §30.9.
Commenter (9227) requests that the EPA amend the proposed rule to confirm that the "Deferral and Waiver" provision of Section VIII of the OMB Bulletin remains in effect for EPA. The commenter contends that this provision allows an agency to waive or defer the peer review requirements of Sections II and III of the OMB Bulletin where warranted by a compelling rationale to ensure flexibility in unusual and compelling situations that are not otherwise covered by the exemptions in the OMB Bulletin. The commenter contends that without clarifications in proposed §30.9(b), it is possible that it could be read to encompass the entirety of the Administrator's ability to grant exemptions, supplanting Section VIII of the OMB Bulletin.
Commenter (6375) states that the exemptions described in the rule and under OMB's Information Quality Bulletin for Peer Review to ensure compliance with privacy and national security laws and regulations are appropriate. The commenter recommends that the EPA handle these exemptions in a similar manner to the case-by-case exceptions for studies: EPA should provide a robust and transparent explanation in the Federal Register early in the rulemaking process to explain why the provisions of this rule do not apply to the rulemaking in question (e.g. which laws would be in conflict). The commenter believes the exemption for "promptness" under OMB's Information Quality Bulletin for Peer Review is appropriate for an exemption except during the implementation after the effective date of this regulation. The commenter states that this rule will initiate a significant change in the way EPA manages pivotal regulatory science and some time will be needed to set up new processes and systems to ensure internal compliance. The commenter suggests that the EPA identify in any rule finalized during the implementation window which dose-response studies used as pivotal regulatory science have not been made publicly available and release a schedule for making those studies available. The commenter states that once those processes and systems are set up, EPA should be evaluating new dose-response studies well in advance of any rulemaking activities such that exemptions for "promptness" should not be needed.
Response: 40 CFR 30.6 in the final rule clarifies that "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."
In the 2020 SNPRM, the EPA did not incorporate the OMB Bulletin for Peer Review Section IX exemptions to peer review, including routine statistical information and financial information. Rather than modify the proposed 40 CFR 30.2 definition of "influential scientific information," the EPA is modifying 40 CFR 30.3 in the final rule to clarify the Agency's intent. As a result, the requirements in 40 CFR 30.3 apply to influential scientific information, unless the influential scientific information is exempted from peer review requirements as described in Section IX of the OMB Bulletin for Peer Review. Consistent with this approach, the EPA is finalizing the definition of "influential scientific information" as proposed in the 2020 SNPRM. The Agency will continue to follow the provisions of the OMB Bulletin for Peer Review.
The basis for all 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 the basis for its decisions in proposed significant regulatory actions or external review drafts of influential scientific information, which will allow the public, if they so choose, to provide comment to the EPA.
<IP_ADDRESS>.5 EPA Does Not Explain Whether the OMB Bulletin is or is not Consistent with the Proposal
Comment: Commenter (6133) says the regulatory text of the proposal requiring EPA to conduct peer review on pivotal regulatory science consistent with the OMB Bulletin is too vague for the reader to understand what the EPA intends and whether the EPA's regulatory science would be consistent with the OMB Bulletin. Similarly, commenter (9227) asserts that there is some vagueness as to whether the Proposal maintains, expands, or narrows the OMB Bulletin requirements. Commenter (6133) states that it appears that neither the memorandum pointed to in the proposal on the issuance of the OMB Bulletin nor the OMB Bulletin itself supports the EPA's proposal regarding peer review. The commenter notes that the OMB Bulletin does not address standardized test methods or good laboratory practices, which the EPA proposes to use. The commenter also points out that the proposal does not identify any peer-reviewed studies without publicly available data that reached incorrect conclusions, nor does it explain how the current peer review process EPA uses for disseminating information conflicts with the OMB Bulletin. Additionally, the commenter notes that EPA does not present any strategies for dealing with past studies. The commenter asserts that before the EPA adopts any final rule with this requirement, it must propose a new rule with clear regulatory text, justification for its independent peer review requirement, and supporting legal, factual, scientific and technical information.
Response: The EPA disagrees with the commenter and believes that the language at 40 CFR 30.6 in the final rule is clear. The language clarifies that "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 is peer review that is consistent with the requirements of the OMB Peer Review Bulletin and EPA's Peer Review Handbook. The Agency will continue conducting peer reviews according to the peer review policies and practices that were in place before the rule goes into effect.
<IP_ADDRESS> OMB Bulletin Implementation Costs and Benefits Must Be Considered to be Judicially Enforceable
Comment: Commenter (9227) asserts that the proposal would apparently make the requirements of the OMB Bulletin judicially enforceable, and the EPA did not analyze the costs and benefits associated with this action. The commenter notes that the OMB Bulletin requirements are not currently judicially enforceable, and the EPA may become subject to numerous legal challenges to its regulations based on compliance with the OMB Bulletin requirements. The commenter points out that there would be a financial cost related to the litigation and a cost to public health and the environment due to delays in the implementation of regulations. The commenter asserts that the EPA must evaluate the anticipated costs and benefits from these proposed requirements and explain why they are needed.
Response: 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. Therefore, as detailed in the preamble to the final rule, the incremental burden to the Agency to carry out the requirements of this rule is expected to be small given (1) the extensive scientific review the EPA already conducts regularly and (2) that the requirement is limited to pivotal science (i.e., typically a small, though highly important, subset of the studies the EPA would review).
<IP_ADDRESS> EPA Peer Review Handbook
Comment: Commenter (9227) provides that the EPA's Peer Review Handbook incorporates the provisions of OMB's Peer Review Bulletin. In the Handbook, the commenter states that the EPA confirms that it "conducts peer review of its products in accordance with the guidance in the OMB Peer Review Bulletin." However, the commenter provides that the EPA Peer Review Handbook adds details and specific procedures that are not present in the OMB Peer Review Bulletin. According to the commenter, surprisingly, EPA's proposed peer review regulations do not even mention EPA's Peer Review Handbook, let alone explain how the new proposed regulations would impact EPA's compliance with the Handbook. For example, the commenter states that the EPA's Handbook specifies "exemption criteria" in section 3.3. The commenter requests that the EPA clarify whether anything in the proposed peer review regulation would supplant instructions in the Peer Review Handbook, and if so, provide a reasoned explanation for the change. Likewise, the commenter requests that the EPA explain the role of the Peer Review Handbook going forward in administering peer review requirements.
Response: Adequate peer review is peer review that is consistent with the requirements of the OMB Peer Review Bulletin and EPA's Peer Review Handbook. The Agency will continue conducting peer reviews according to the peer review policies and practices that were in place before the rule goes into effect. If implementing this procedural rule would result in conflicts with the guidance found in the Agency's existing Peer Review Handbook, the conflicting requirements found in the Handbook will yield to this final rule.
13.1.2 Independent Peer Review Requirements (40 CFR 30.7)
 <IP_ADDRESS> EPA Shall Conduct Independent Peer Review on All Pivotal Regulatory Science Used to Justify Regulatory Decisions
 <IP_ADDRESS>.1 Support the Proposed Independent Peer Review Requirements
Comment: Commenters (0045, 4541, 6150, 6180, 6891, 8281-PH85) support the proposed independent review requirements.
Commenter (0045) states that the public good will be served by the proven discipline of peer review and reproducibility on all sources. Commenter (4541) supports the Proposed Rule and states that it can ensure EPA is protecting public health and the environment in a manner that the public can trust and understand. Commenter (6150) states that independence is important to the peer review process and suggests that the peer review process can be improved. Commenters (6180, 8281-PH85) support the use of independent expert peer reviews as an additional level of review for pivotal regulatory science.
Commenters (6180, 8281-PH85) state that they have been involved in independent peer reviews of various permitting or related activities which have concluded that the technical basis for EPA's permit limits or water quality targets were scientifically indefensible. The commenters assert that, had no peer reviews occurred, these permits or water quality targets would have imposed hundreds of millions of dollars of wastewater treatment costs to rate payers with no anticipated benefit.
In support of their position that there is a need for independent peer review, commenter (6180) describes a case study involving a Nutrient Criteria document. The commenter provides that this case study highlights the necessity and utility of an independent peer review of EPA regulatory science and raises concerns about EPA's current peer review procedures and charge questions. The commenter notes that it is disconcerting that the findings of an EPA peer review panel of "national experts through the EPA's Nutrient Scientific Technical Exchange Partnership and Support (N-STEPS) program" were entirely contradicted by an independent peer review panel only a few years later. The following is a summary of a case study described by the commenter:
      New Hampshire Department of Environmental Services (DES), with support from EPA Region 1, published the Draft 2009 Numeric Nutrient Criteria for the Great Bay Estuary document. In early 2010, the Draft 2009 Nutrient Criteria underwent review by an EPA peer review panel which validated the scientific methods and decision-making used by DES and praised the use of multiple lines of evidence to develop the criteria as a way to enhance confidence in the results. The Great Bay Municipal Coalition (GBMC) formed in 2010 to contest the 2009 Nutrient Criteria. DES and the GBMC agreed to organize a 2013 independent peer review to review the scientific basis of the 2009 Nutrient Criteria. The peer reviewers concluded that the Draft 2009 Nutrient Criteria were not scientifically defensible. As a result of the 2013 Peer Review conclusions, DES agreed to rescind the 2009 Nutrient Criteria in April 2014.
As further support for their position that there is a need for independent peer review, commenter (6180) states that, historically, more often than not, when the scientific validity of EPA's scientific rationales, methodologies, and derivations has been called into question, even by experts on the specific issue, EPA has refused commenter's requests to conduct independent peer reviews. The commenter describes three examples which are summarized below.
      In 2013, EPA issued a draft permit and fact sheet to the City of Taunton claiming that the City's nitrogen discharge caused or contributed to excessive algal growth and dissolved oxygen (DO) violations. EPA imposed a 3 mg/L (limits of technology) total nitrogen (TN) limit, based on the presumption that nitrogen was a primary factor causing low DO. EPA used a "reference station" approach, without assessing location and site differences that would cause a completely different DO regime and nutrient response to exist at that location. Multiple water quality experts informed EPA that the methodology used to determine the nitrogen limitation was not scientifically defensible. EPA acknowledged that the simplified approach had never been determined to be scientifically defensible but still refused to conduct a peer review of the methodology. Taunton challenged the scientific defensibility of the TN permit limit in multiple venues but the EPA's Environmental Appeals Board (EAB) and the First Circuit Court of Appeals upheld the permit limit derivation and imposition. Both the EAB and the First Circuit also asserted that no cause and effect relationship is required to impose a water quality-based effluent limit. The City requested that the Massachusetts Department of Environmental Protection (MassDEP) reopen the permit based on the updated post-2006 information demonstrating that 1) the assumptions underlying EPA's TN limit derivation were erroneous, and 2) extensive water quality improvements have been documented throughout Narragansett Bay, including Mount Hope Bay (MHB), which would significantly alter, if not completely eliminate, Taunton's TN permit limit. The City's requests have been denied.
      EPA has approved water quality standards for Minnesota that include biochemical oxygen demand (BOD) and DO flux as nutrient impairment indicators. Regarding BOD, Standard Methods, the developer of the test used to measure BOD, published a memorandum explaining that BOD and the BOD test could not be used as a nutrient impairment indicator. Moreover, the response to a July 31, 2014 Freedom of Information Act (FOIA) request to EPA seeking the technical basis for the assertion that DO flux alone can cause an aquatic life impairment indicated that EPA had no supporting documentation. EPA Region 5 conducted an anonymous external review (i.e., reviewers' names are redacted) of the water quality standards in which several reviewers raised serious concerns with the water quality standards and their derivations. This constitutes an inappropriate use of a peer review as 1) it lacks transparency and may incorporate bias as the reviewers remain anonymous, and 2) the concerns of the peer reviewers were not adequately addressed in revisions to the water quality standards. While these issues have been repeatedly raised with both EPA and the Minnesota Pollution Control Agency (MPCA), MPCA has continued applying these BOD and DO flux water quality standards throughout the state. The cascading effect of inappropriately listing waters as nutrient impaired can result in hundreds of millions of dollars wasted on unnecessary Publicly Owned Treatment Works (POTW) upgrades which do not have any measurable environmental benefit.
      In 2008, EPA Region 3 proposed a group of total maximum daily loads (TMDLs) that regulated total phosphorus. The TMDLs were based on reports prepared by EPA contractor Tetra Tech, Inc. in 2007 (the "Endpoint Report"). The proposed TP endpoint was then used to derive waste load allocations in the various TMDLs that would impose multi-million-dollar costs on the regulated communities. The Endpoint Report was based on a "weight of evidence" evaluation which included novel statistical evaluations. The Endpoint Report was challenged as not scientifically defensible. EPA agreed to the Science Advisory Board (SAB) review and prepared a draft guidance manual (August 17, 2009). The SAB reviewed the draft manual and provided extensive comments on revisions necessary for the guidance to be scientifically defensible (April 27, 2010). Subsequently, EPA revised the draft guidance to address the SAB comments (November 2010). EPA asked Tetra Tech, Inc. to review and revise its 2007 Endpoint Report with consideration for USEPA's new guidance. This follow-up analysis (July 18, 2012) concluded that the original evaluation was supported by the revised evaluation. It should be obvious that the original author of the Endpoint Report should not be the arbiter of a follow-up evaluation to address significant scientific deficiencies of the original report. Even if Tetra Tech, Inc. were allowed to author the revised report, an independent scientific evaluation should have been conducted to assess the scientific defensibility of the revised evaluation. In June 2017, the Southeastern Pennsylvania Nutrient Coalition submitted a request for a peer review to EPA, however, this request was also denied.
Response: EPA appreciates the comments supporting the inclusion of independent peer review in the final rule. As provided in section 30.7, 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." 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 state 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."
The Agency is not responding to comments not directly relevant to the proposed rule. Any concerns about specific projects should be directed to the appropriate EPA programmatic or regional office
<IP_ADDRESS>.2 Do Not Support the Proposed Independent Peer Review Requirements
 Independent Review as Proposed by EPA Would Cause a Delay in EPA Actions
Comment: Commenters (6119, 6133,6137, 6866) express concern regarding EPA's proposed independent peer review requirements because it would be time-consuming and would delay EPA from meeting its responsibilities under statutory deadlines and its mission to protect the public health and environment. Commenter (6137) states that the standard time taken to review scientific manuscripts in the fields of medicine, public health, and natural sciences is, on average, 12-14 weeks. Commenter (6133) states that EPA already misses an unacceptably high number of congressional deadlines in the statutes it administers, and the Proposal to apply peer review to "all pivotal regulatory science" will only exacerbate that endemic problem and the unlawfulness that it represents. Commenter (6119) states that this proposed rule has the potential to create serious technical gaps in the regulatory process and further burden a process that is already years behind in issuing new or updated science-based regulations. Commenter (6866) adds that slowing down rulemaking in ways that may be detrimental to protecting environmental and public health may invite lawsuits that would further stymie regulatory processes.
Response: EPA disagrees that the rule could result in unnecessary delays. EPA clarified in 40 CFR 30.6 that "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." This should ensure that no unnecessary peer reviews are conducted that could cause undue delay.
Independent Review as Proposed by EPA is Duplicative and/or Unnecessary
Comment: Commenters (2425, 5165, 6119, 6125, 6137, 6142, 6866, 6915) suggest that independent peer review by EPA is duplicative and unnecessary.
Commenter (2425) states that scientific studies used by EPA to make regulatory changes are already rigorously examined prior to being published in peer-reviewed scientific journals. Commenter (6915) states that EPA fails to acknowledge the rigor of existing processes in statutes, policies and federal procedures.
Commenter (6119) states that the process that proposed 40 CFR 30.7 describes is already well established. The commenter states that, for example in December 2009, EPA completed their review of the current research on particle pollution by engaging a panel of expert scientists, and the Clean Air Scientific Advisory Committee, to help EPA assess the evidence. The commenter adds that scientific studies are peer reviewed before being published. According to the commenter, rigorous review practices are already in place for dose response data models used for developing reference values for toxic substances and environmental contaminants, and that federal regulations already set out review requirements for research involving human subjects.
Commenter (6137) states that, while it is certainly a best practice to consider only science that has been independently peer reviewed when making regulatory decisions, that does not necessitate independent peer review by EPA. The commenter notes that most scientific bodies  -  including Nature, Science, the Bipartisan Policy Center, and Proceedings of the National Academies of Sciences  -  employ some of the most robust peer review practices and that they already apply to the types of studies for which the Proposed Rule will require EPA review. The commenter asserts that the additional review by EPA that is mandated under the proposed rule is duplicative, wholly unnecessary, and inconsistent with the provision in the OMB Bulletin that states that "[p]ublication in a refereed scientific journal may mean that adequate peer review has been performed."
Commenter (6866) believes that, since most EPA decisions involve evaluating sizable scientific literature on a topic  -  comparing a range of studies  -  routinely re-peer reviewing each study seems particularly duplicative.
Commenter (6125) states that it is puzzling that section 30.7 is included in the proposed rule, given that external peer review generally already occurs in the cases of significant regulatory actions. The commenter notes that it would appear that the authors of this proposed rule are either not aware of or have never bothered to read the Agency's Peer Review Handbook. The commenter adds that, if they have read it, they chose not to cite it. The commenter provides that the Handbook lays out very clearly the levels of peer review expected to be implemented, depending upon the nature and potential impact of a particular scientific product, including risk assessments. According to the commenter, there is no evidence given in the proposed rule to support that EPA is not following these policies and that this rulemaking is necessary.
Response: Adequate peer review is peer review that is consistent with the requirements of the OMB Peer Review Bulletin and EPA's Peer Review Handbook. The EPA is finalizing the language at 40 CFR 30.6 (formerly 40 CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM) to clarify that the Agency will conduct independent peer review consistent with the OMB 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 journal peer review. In this rule, the EPA is not changing the pre-existing requirements of the OMB Final Information Quality Bulletin for Peer Review. The preamble of 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. The Agency will continue conducting peer reviews according to the peer review policies and practices that were in place before the rule goes into effect. If implementing this procedural rule would result in conflicts with the guidance found in the Agency's existing Peer Review Handbook, the conflicting requirements found in the Handbook will yield to this final rule.
To address the public comment regarding "unnecessary duplicative and significant costs", the preamble of the final rule specifies, "given the costs of the current robust process for identifying and reviewing scientific studies and documentation that are existing Agency practice, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions and influential scientific information, the EPA anticipates that the incremental costs of this rule will be small....relative to current administrative costs for developing significant regulatory actions or influential scientific information."
The final rule does not interpret or apply the provisions of any environmental statutes. If implementing this procedural rule would result in conflicts with existing EPA environmental statutes, and their implementing regulations, the procedural rule will yield to the existing statutes and regulations.
Independent Review Would Result in Increased Costs
Comment: Commenters (6119, 6137, 6142, 6866, 6868, 6915) express concern that the proposed independent EPA review requirement would be costly. Commenter (6142) states that this rule proposes adding this costly step to the process for developing EPA policy without setting aside resources for its execution. Commenter (6866) asserts that EPA would be better off having its staff assess study quality as it reviews the scientific literature, as recommended in the Science for Policy Project report, rather than putting in place a blanket requirement for an additional outside peer review of all studies. Commenter (6868) states that the proposed rule seeks to create a supplemental--and likely expensive-- peer review process conducted by agency staff.
Commenter (6119) states that, in reviewing this proposal, it appears EPA will either have to spend millions of dollars to format data to make it publicly accessible for review or limit the total number of studies used to make regulatory decisions because of the costs associated with evaluating them. According to the commenter, for those interested in providing EPA with data for regulatory purposes, new administrative requirements will need to be accounted for and potentially make certain types of studies by EPA impractical. The commenter states that some researchers may choose to avoid certain types of research if it appears likely that administrative hurdles will limit their available funding sources or the application of their findings.
Commenter (6137) asserts that the proposal would lead to undue cost if EPA were to conduct its own independent peer review of the underlying data for studies that already have undergone a rigorous scientific review process, which is the case for those studies published in scientific journals or independently evaluated by a scientific body. The commenter provides, for example, that the NAAQS Integrated Science Assessment and Risk and Exposure Assessments regularly include the review of thousands of scientific studies. According to the commenter, it would be enormously inefficient and costly (if even possible) for EPA to rereview all of these studies.
Commenter (6915) asserts that any requirement for EPA to conduct additional review would entail additional significant costs, contrary to the proposal's assertion. Id. at 18,772. The practical outcome of the proposal is that EPA may end up relying on a much smaller number of studies and/or on a less robust subset of relevant available studies, thus undermining the regulatory decision-making process.
Response: The EPA is finalizing the language at 40 CFR 30.6 (formerly 40 CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM) to clarify that the Agency will evaluate whether or not to initiate peer review, consistent with the OMB Bulletin for Peer Review and the EPA's Peer Review Handbook, of individual studies identified as pivotal science if the studies have already undergone journal peer review. In this rule, the EPA is not changing the pre-existing requirements of the OMB's Final Information Quality Bulletin for Peer Review. The preamble of 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. If the Agency conducts peer review on pivotal science, the EPA shall ask peer reviewers to articulate the strengths and weaknesses of the justification for the assumptions applied in analyzing dose-response data and the implications of those assumptions for the results.
This is a rule of internal procedures and does not direct or require any outside entity or the EPA to establish data sharing mechanisms. The final rule does not require the EPA to collect, store, or publicly disseminate dose-response data and models underlying pivotal science.
To address the public comment regarding costs, the preamble of the final rule specifies, "given the costs of the current robust process for identifying and reviewing scientific studies and documentation that are existing Agency practice, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions and influential scientific information, the EPA anticipates that the incremental costs of this rule will be small....relative to current administrative costs for developing significant regulatory actions or influential scientific information."
The EPA disagrees that the practical outcome of this rule will be that EPA may end up relying on a much smaller number of studies and/or on a less robust subset of relevant available studies or that the rule will undermine the regulatory decision-making process. The final rule includes sufficient flexibility in terms of the allowance for restricted access, considerations in 40 CFR 30.5, the Administrator's exemption in 40 CFR 30.7, and the EPA's incremental approach to maximizing transparency by first focusing on dose-response data to minimize such potential unintended consequences.
Independent Review as Proposed by EPA Has No Rationale/Legal Basis
Lack of Rationale Provided for the Proposed Rule
Comment: Commenters (6137, 6142, 6866, 6868, 6915, 9227) express concern that there is no rationale/basis provided for requiring the independent peer review. Commenter (6142) states that these requirements are likely superfluous in the vast majority of cases since all studies that appear in standard scholarly journals are already peer reviewed by several independent experts prior to acceptance and publication. Commenter (6866) states that this requirement is unnecessary since there is no indication that EPA decision-making has been marred by the use of questionable studies. Commenter (6868) states that, without articulating any deficiencies in the existing scientific peer review process, the proposed rule seeks to create a supplemental peer review process conducted by agency staff. Commenter (6915) states that EPA fails to explain how its proposal would provide any added value.
Commenter (6137) states that the requirement in proposed §30.7 that EPA independently peer-review all pivotal regulatory science used to make regulatory decisions is arbitrary. The commenter adds that, as part of the Proposed Rule, EPA injects a new requirement without justification. The commenter contends that a review of the support upon which EPA relies demonstrates that this peer review obligation is contrary to current policy. The commenter states that it is also unnecessary, costly, and unrealistic. According to the commenter, it seems the only things this new peer review process would accomplish is the exclusion of reliable science, increased cost and time for effective reviews, and delay of regulatory decisions that impact public health.
Commenter (9227) states that proposed §30.7 generally appears to be designed to enshrine OMB's existing peer review requirements for "influential scientific information." The commenter asserts that the preamble to the proposed rulemaking lacks any explanation whatsoever for why EPA is proposing this new peer review requirement or what its impact might be. The commenter adds that EPA has additionally not provided any information to suggest that EPA is not already following OMB's Peer Review Bulletin. The commenter contends that EPA's lack of any supporting rationale or analysis frustrates the public's ability to provide meaningful comment on this provision, and is itself a sign that this requirement is fundamentally arbitrary.
Response: EPA disagrees that the rule adds another layer of peer review that could result in unnecessary delays. EPA clarified in 40 CFR 30.6 that "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." This should ensure that no unnecessary peer reviews are conducted that could cause undue delay.
The EPA will continue to consider all peer-reviewed science, consistent with existing study quality assessment factors and corresponding statutory mandates. Adequate peer review is peer review that is consistent with the requirements of the OMB Peer Review Bulletin and EPA's Peer Review Handbook. The Agency will continue conducting peer reviews according to the peer review policies and practices that were in place before the rule goes into effect. The EPA Peer Review Handbook, 4[th] Edition, describes how peer reviewers are selected by the Agency. As discussed in the final rule preamble, 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." If implementing this procedural rule would result in conflicts with the guidance found in the Agency's existing Peer Review Handbook, the conflicting requirements found in the Handbook will yield to this final rule.
Further, EPA is subject to the OMB Bulletin and its provisions have been incorporated into the Agency's peer review handbook (Ref. 44). EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will lead to consistent implementation of those procedures across the Agency.
Reliance on Published Studies Without Conducting Independent Analysis/Review of Underlying Data
Comment: Commenter (6119) states that the courts have spoken clearly on the degree to which independent analyses are necessary. The commenter provides that, in American Trucking Associations, Inc. v. EPA, 283 F.3d 355, 372 (D.C. Cir. 2002), the court said, "we agree with EPA that requiring agencies to obtain and publicize the data underlying all studies on which they rely "would be impractical and unnecessary." The commenter adds that the court then quoted what it called a persuasive EPA argument: "`If EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment.... [S]uch data are often the property of scientific investigators and are often not readily available because of ... proprietary interests ... or because of [confidentiality] arrangements [with study participants].'"
Commenter (6125) expresses concern that proposed §30.7 may be trying to revive the argument thoroughly rejected and debunked by the D.C. Circuit in Coalition for Responsible Regulation v. EPA, 684 F. 3d 102 (D.C. Cir. 2012) (finding that substantial evidence supported EPA's finding that emissions of enumerated greenhouse gases endanger public health and welfare and that vehicular emissions contribute to that endangerment). The commenter provides that the court stated that "EPA simply did here what it and other decision-makers often must do to make a science-based judgment: it sought out and reviewed existing scientific evidence to determine whether a particular finding was warranted. It makes no difference that much of the scientific evidence in large part consisted of `syntheses' of individual studies and research. Even individual studies and research papers often synthesize past work in an area and then build upon it; this is how science works. EPA is not required to re-prove the existence of the atom every time it approaches a scientific question." 684 F. 3d at 120. According to the commenter, the proposed §30.7 language shows signs of being designed to `re-prove the existence of the atom' by requiring re-peer review. The commenter states that there is no need for doing so and the need for doing so is not provided in the notice, and that the proposed provision appears both substantively and procedurally defective as a result.
Response: This rule does not categorically exclude any study because the underlying dose-response data are not available, either publicly or via restricted access, for independent validation. If a study is identified as pivotal science, EPA will still consider the study but may give it lesser consideration if the dose-response data are not available for independent validation. Further, the final rule does not require EPA to obtain and publish data underlying the studies it uses to support significant regulatory actions and influential scientific information. The EPA is finalizing the language at 40 CFR 30.6 (formerly 40 CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM) to clarify that the Agency will evaluate whether or not to initiate peer review, consistent with the OMB Bulletin for Peer Review and the EPA Peer Review Handbook, of individual studies identified as pivotal science if the studies have already undergone journal peer review.

It should also be noted that in this final rule, rather than considering all studies that support the assessment of the relationship of a dose or exposure of a pollutant, contaminant, or substance to the magnitude of a predicted health or environmental impact as "pivotal science," the EPA is balancing transparency and feasibility by focusing on those studies that inform the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect. Thus, "pivotal science" includes only those studies that are integral to characterizing dose-response relationships (e.g., identifying candidate PODs). These are the studies that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information. If peer review under section 30.7 is warranted, it would be conducted on "pivotal science" and not on every dose-response study considered by the Agency in developing a significant regulatory action or influential scientific information.
Lack of Statutory Authority for Proposed §30.7
Comment: Commenter (6133) states that there is no statutory authority for EPA to "conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." The commenter provides that the federal statutes that EPA lists as putative authority for the Proposal provide no authority for proposed § 30.7. See 83 Fed. Reg. at 18,769/2 (citing CAA sections 103, 301(a), 42 U.S.C. 7403, 7601(a); CWA sections 104, 501, 33 U.S.C. 1254, 1361; SDWA sections 1442, 1450(a)(1), 42 U.S.C. 300j - 1, 300j -  9(a)(1); RCRA sections 2002(a)(1), 7009, 42 U.S.C. 6912(a)(1), 6979; CERCLA (as delegated to the Administrator via Executive Order 12580) sections 115, 311, 42 U.S.C. 9616, 9660; EPCRA section 328, 42 U.S.C. 11048; FIFRA sections 25(a)(1), 136r(a), 7 U.S.C. 136r(a), 136w; and TSCA, as amended, section 10, 15 U.S.C. 2609, and the APA. The commenter states that the claimed authorities that EPA lists do not mention peer review or even allude to the concept. The commenter adds that neither the Proposal nor accompanying docket materials identify any provision of any federal statute that authorizes EPA to promulgate proposed §30.7. According to the commenter, their own research revealed no provision of any federal statute that authorizes EPA to promulgate proposed §30.7.
Commenter (6133) asserts that the Proposal is unlawful, arbitrary and capricious, and an abuse of EPA discretion. The commenter provides that under longstanding federal case law, when Congress authorizes an approach in one section of a statute using specific language but does not do the same in other sections of a statute, the courts presume that Congress acted purposefully and did not mean to address or authorize that approach in those other statutory sections. See, e.g., Dean v. United States, 556 U.S. 568 (2009) ("It is generally presumed that Congress acts intentionally when including particular language in one section of a statute but not in another." (citing Russello v. United States, 464 U.S. 16, 23 (1983)). According to the commenter, not only are there no implied grants of authority to an agency in the other statutory sections, but the congressional decisions to authorize the approach elsewhere in the statute give even greater force to the conclusion that the agency has not been given authority where Congress did not use the same or similar authorizing language.
Commenter (6133) states that the EPA approach proposed in §30.7 is even more unlawful than would be the case, independently, under this case law. The commenter notes that the proposed language of §30.7 says "EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." According to the commenter, the EPA proposes to bind itself ("shall") to conduct a particular form of peer review on "all pivotal regulatory science" based on an unenforceable, non-binding OMB Bulletin that has never been the subject of notice and comment rulemaking and that itself is not authorized by any federal law. The commenter states that treating the content of the unenforceable bulletin as a binding regulation would itself violate the federal statutes that EPA implements, because those statutes do not codify the bulletin, and EPA would be unlawfully codifying a mere policy preference.
Commenter (6133) contends that the Proposal identifies no statutory authority for EPA to bind itself, and future administrations, to conduct peer review only in this fashion, unless and until future notice-and-comment rulemaking is undertaken. The commenter adds that the Proposal identifies no suggestion in statutory language or legislative history that Congress intended EPA to conduct binding peer review consistent with this OMB Bulletin, notwithstanding that Congress has known about this Bulletin since 2005. The commenter expresses that they believe EPA has simply made up proposed §30.7 -- with its link to the OMB Bulletin, and the putative authority for the Proposal -- out of whole cloth.
Response: The OMB Bulletin provides that "agencies are granted broad discretion to weigh the benefits and costs of using a particular peer review mechanism for a specific information product. The selection of an appropriate peer review mechanism for scientific information is left to the agency's discretion." EPA is subject to the OMB Bulletin and its provisions have been incorporated into the Agency's peer review handbook. EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will lead to consistent implementation of those procedures across the Agency.
As stated in the final rule, EPA is authorized to promulgate this procedural rule under its authority to promulgate housekeeping regulations governing its internal affairs. The final rule does not interpret or apply the provisions of any environmental statutes. If implementing this procedural rule would result in conflicts with existing EPA environmental statutes, and their implementing regulations, the procedural rule will yield to the existing statutes and regulations.
Existing Federal Environmental Statutory Requirements for Peer Review
Comment: Commenter (6915) states that the EPA fails to acknowledge the rigor of existing processes in statutes, policies and federal procedures, or to explain how its proposal would provide any added value and minimize costs.
Commenter (6133) states that the Proposal's peer review provision in §30.7 is contrary to existing requirements for peer review. The commenter states that, when Congress writes federal statutes, Congress knows how to create legal authority for peer review, who shall conduct that peer review, what role, if any, that EPA or other parties will play, and how that peer review may be conducted. The commenter asserts that none of the provisions in the law authorize EPA's Proposal in §30.7. The commenter provides that the statutes require that EPA use peer-reviewed science, regardless of whether it would meet EPA's definition of the term in §30.7. The commenter notes that, in cases where the law requires EPA to conduct the review, the statutes often spell out specifically how that should happen. The commenter provides the following excerpts from differing federal environmental statutes that establish specific peer review requirements.
CAA
      §7511b. Federal ozone measures.
      (g) Ozone design value study. The Administrator shall conduct a study of whether the methodology in use by the Environmental Protection Agency as of November 15, 1990, for establishing a design value for ozone provides a reasonable indicator of the ozone air quality of ozone nonattainment areas. The Administrator shall obtain input from States, local subdivisions thereof, and others. The study shall be completed and a report submitted to Congress not later than 3 years after November 15, 1990. The results of the study shall be subject to peer and public review before submitting it to Congress.
      §7412. Hazardous air pollutants.
      (p) Mickey Leland National Urban Air Toxics Research Center.
      [...]
      (3) Scientific Advisory Panel. The Board of Directors shall be advised by a Scientific Advisory Panel, the 13 members of which shall be appointed by the Board, and to include eminent members of the scientific and medical communities. The Panel membership may include scientists with relevant experience from the National Institute of Environmental Health Sciences, the Center for Disease Control, the Environmental Protection Agency, the National Cancer Institute, and others, and the Panel shall conduct peer review and evaluate research results. The Panel shall assist the Board in developing the research agenda, reviewing proposals and applications, and advise on the awarding of research grants.
CWA
      §1321. Oil and hazardous substance liability.
      (a) Definitions. (27) the term "best available science" means science that-- (A) maximizes the quality, objectivity, and integrity of information, including statistical information; (B) uses peer-reviewed and publicly available data; and (C) clearly documents and communicates risks and uncertainties in the scientific basis for such projects.
SDWA
      §300g-1. National drinking water regulations.
      (b) Standards.
      [...]
      (3) Risk assessment, management, and communication.
      (A) Use of science in decision-making In carrying out this section, and, to the degree that an Agency action is based on science, the Administrator shall use--
      (i) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and(ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data).
      (B) Public information.
      In carrying out this section, the Administrator shall ensure that the presentation of information on public health effects is comprehensive, informative, and understandable. The Administrator shall, in a document made available to the public in support of a regulation promulgated under this section, specify, to the extent practicable--
      (i) each population addressed by any estimate of public health effects;
      (ii) the expected risk or central estimate of risk for the specific populations;
      (iii) each appropriate upper-bound or lower-bound estimate of risk;
      (iv) each significant uncertainty identified in the process of the assessment of public health effects and studies that would assist in resolving the uncertainty; and
      (v) peer-reviewed studies known to the Administrator that support, are directly relevant to, or fail to support any estimate of public health effects and the methodology used to reconcile inconsistencies in the scientific data.
      [...]
      (12) Certain contaminants.
      (B) Sulfate.
      (i) Additional study. Prior to promulgating a national primary drinking water regulation for sulfate, the Administrator and the Director of the Centers for Disease Control and Prevention shall jointly conduct an additional study to establish a reliable dose-response relationship for the adverse human health effects that may result from exposure to sulfate in drinking water, including the health effects that may be experienced by groups within the general population (including infants and travelers) that are potentially at greater risk of adverse health effects as the result of such exposure. The study shall be conducted in consultation with interested States, shall be based on the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices, and shall be completed not later than 30 months after August 6, 1996.
      §300j-2. Grants for State programs.
      (d) New York City watershed protection program.
      (1) In general. The Administrator is authorized to provide financial assistance to the State of New York for demonstration projects implemented as part of the watershed program for the protection and enhancement of the quality of source waters of the New York City water supply system, including projects that demonstrate, assess, or provide for comprehensive monitoring and surveillance and projects necessary to comply with the criteria for avoiding filtration contained in 40 C.F.R. 141.71. Demonstration projects which shall be eligible for financial assistance shall be certified to the Administrator by the State of New York as satisfying the purposes of this subsection. In certifying projects to the Administrator, the State of New York shall give priority to monitoring projects that have undergone peer review.
RCRA
      §6939a. Exposure information and health assessments.
      (b) Health assessments.
      [...]
      (2) Whenever in the judgment of the Administrator, or the State (in the case of a State with an authorized program), a landfill or a surface impoundment poses a substantial potential risk to human health, due to the existence of releases of hazardous constituents, the magnitude of contamination with hazardous constituents which may be the result of a release, or the magnitude of the population exposed to such release or contamination, the Administrator or the State (with the concurrence of the Administrator) may request the Administrator of the Agency for Toxic Substances and Disease Registry to conduct a health assessment in connection with such facility and take other appropriate action with respect to such risks as authorized by section 9604(b) and (i) of this title. If funds are provided in connection with such request the Administrator of such Agency shall conduct such health assessment.
      [...]
      (e) Periodic reports. The Administrator of such Agency shall issue periodic reports which include the results of all the assessments carried out under this section. Such assessments or other activities shall be reported after appropriate peer review.
CERCLA
      §9604. Response authorities.
      (i) Agency for Toxic Substances and Disease Registry; establishment, functions, etc.
      [...]
      Any toxicological profile or revision thereof shall reflect the Administrator of ATSDR's assessment of all relevant toxicological testing which has been peer reviewed. The profiles required to be prepared under this paragraph for those hazardous substances listed under subparagraph (A) of paragraph (2) shall be completed, at a rate of no fewer than 25 per year, within 4 years after October 17, 1986. A profile required on a substance listed pursuant to subparagraph (B) of paragraph (2) shall be completed within 3 years after addition to the list. The profiles prepared under this paragraph shall be of those substances highest on the list of priorities under paragraph (2) for which profiles have not previously been prepared. Profiles required under this paragraph shall be revised and republished as necessary, but no less often than once every 3 years. Such profiles shall be provided to the States and made available to other interested parties.
      [...]
      (7)(A) Whenever in the judgment of the Administrator of ATSDR it is appropriate on the basis of the results of a health assessment, the Administrator of ATSDR shall conduct a pilot study of health effects for selected groups of exposed individuals in order to determine the desirability of conducting full scale epidemiological or other health studies of the entire exposed population. (B) Whenever in the judgment of the Administrator of ATSDR it is appropriate on the basis of the results of such pilot study or other study or health assessment, the Administrator of ATSDR shall conduct such full scale epidemiological or other health studies as may be necessary to determine the health effects on the population exposed to hazardous substances from a release or threatened release. If a significant excess of disease in a population is identified, the letter of transmittal of such study shall include an assessment of other risk factors, other than a release, that may, in the judgment of the peer review group, be associated with such disease, if such risk factors were not taken into account in the design or conduct of the study.
      [...]
      (13) All studies and results of research conducted under this subsection (other than health assessments) shall be reported or adopted only after appropriate peer review. Such peer review shall be completed, to the maximum extent practicable, within a period of 60 days. In the case of research conducted under the National Toxicology Program, such peer review may be conducted by the Board of Scientific Counselors. In the case of other research, such peer review shall be conducted by panels consisting of no less than three nor more than seven members, who shall be disinterested scientific experts selected for such purpose by the Administrator of ATSDR or the Administrator of EPA, as appropriate, on the basis of their reputation for scientific objectivity and the lack of institutional ties with any person involved in the conduct of the study or research under review. Support services for such panels shall be provided by the Agency for Toxic Substances and Disease Registry, or by the Environmental Protection Agency, as appropriate.
FIFRA
      §136w. Authority of Administrator.
      (e) Peer review. The Administrator shall, by written procedures, provide for peer review with respect to the design, protocols, and conduct of major scientific studies conducted under this subchapter by the Environmental Protection Agency or by any other Federal agency, any State or political subdivision thereof, or any institution or individual under grant, contract, or cooperative agreement from or with the Environmental Protection Agency. In such procedures, the Administrator shall also provide for peer review, using the advisory panel established under subsection (d) of this section or appropriate experts appointed by the Administrator from a current list of nominees maintained by such panel, with respect to the results of any such scientific studies relied upon by the Administrator with respect to actions the Administrator may take relating to the change in classification, suspension, or cancellation of a pesticide. Whenever the Administrator determines that circumstances do not permit the peer review of the results of any such scientific study prior to the Administrator's exercising authority under section 136d(c) of this title to immediately suspend the registration of any pesticide to prevent an imminent hazard, the Administrator shall promptly thereafter provide for the conduct of peer review as provided in this sentence. The evaluations and relevant documentation constituting the peer review that relate to the proposed scientific studies and the results of the completed scientific studies shall be included in the submission for comment forwarded by the Administrator to the advisory panel as provided in subsection (d). As used in this subsection, the term "peer review" shall mean an independent evaluation by scientific experts, either within or outside the Environmental Protection Agency, in the appropriate disciplines.
      §136w-8. Pesticide registration service fees.
      (a) Definition of costs. In this section, the term "costs", when used with respect to review and decision-making pertaining to an application for which registration service fees are paid under this section, means-- (1) costs to the extent that -- (A) officers and employees provide direct support for the review and decision-making for covered pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses; (B) persons and organizations under contract with the Administrator engage in the review of the applications, and corresponding risk and benefits information and assessments; and (C) advisory committees and other accredited persons or organizations, on the request of the Administrator, engage in the peer review of risk or benefits information associated with covered pesticide applications; (2) costs of management of information, and the acquisition, maintenance, and repair of computer and telecommunication resources (including software), used to support review of pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses; and (3) costs of collecting registration service fees under subsections (b) and (c) and reporting, auditing, and accounting under this section.
TSCA
      §2625. Administration.
      (h) Scientific standards. In carrying out sections 2603, 2604, and 2605 of this title, to the extent that the Administrator makes a decision based on science, the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science, and shall consider as applicable-- (1) the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information; (2) the extent to which the information is relevant for the Administrator's use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and (5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models.
      §2617. Preemption.
      (b) New statutes, criminal penalties, or administrative actions creating prohibitions or other restrictions. (1) In general Except as provided in subsections (c), (d), (e), (f), and (g), beginning on the date on which the Administrator defines the scope of a risk evaluation for a chemical substance under section 2605(b)(4)(D) of this title and ending on the date on which the deadline established pursuant to section 2605(b)(4)(G) of this title for completion of the risk evaluation expires, or on the date on which the Administrator publishes the risk evaluation under section 2605(b)(4)(C) of this title, whichever is earlier, no State or political subdivision of a State may establish a statute, criminal penalty, or administrative action prohibiting or otherwise restricting the manufacture, processing, distribution in commerce, or use of such chemical substance that is a high-priority substance designated under section 2605(b)(1)(B)(i) of this title.
      [...]
      (f) Waivers.
      [...]
      (2) Required exemptions. Upon application of a State or political subdivision of a State, the Administrator shall exempt from subsection (b) a statute or administrative action of a State or political subdivision of a State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that-- (A)(i) compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; (ii) compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and (iii) the State or political subdivision of the State has a concern about the chemical substance or use of the chemical substance based in peer-reviewed science; or (B) no later than the date that is 18 months after the date on which the Administrator has initiated the prioritization process for a chemical substance under the rule promulgated pursuant to section 2605(b)(1)(A) of this title, or the date on which the Administrator publishes the scope of the risk evaluation for a chemical substance under section 2605(b)(4)(D) of this title, whichever is sooner, the State or political subdivision of the State has enacted a statute or proposed or finalized an administrative action intended to prohibit or otherwise restrict the manufacture, processing, distribution in commerce, or use of the chemical substance.
      §2605. Prioritization, risk evaluation, and regulation of chemical substances and mixtures.
      (b) Risk evaluations.
      [...]
      (E) Metals and metal compounds. In identifying priorities for risk evaluation and conducting risk evaluations of metals and metal compounds, the Administrator shall use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated March 2007, or a successor document that addresses metals risk assessment and is peer reviewed by the Science Advisory Board.
Response: The purpose of this action is to increase transparency by codifying internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. Because this is purely a procedural rule, the EPA is not relying on any substantive environmental statutes as authority. If implementing this procedural rule would result in conflicts with existing environmental statutes and their implementing regulations, the procedural rule will yield to the existing statutes and regulations. This rulemaking is not intended to 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. Further, the EPA plans to 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.
To address the public comment regarding "added value and minimize cost", the preamble of the final rule specifies, "given the costs of the current robust process for identifying and reviewing scientific studies and documentation that are existing Agency practice, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions and influential scientific information, the EPA anticipates that the incremental costs of this rule will be small relative to current administrative costs for developing significant regulatory actions or influential scientific information."
Unlawfully Vague
Comment: Commenters (4838, 6133) suggest that the Proposed §30.7 language is unlawfully vague. The commenters assert that EPA did not provide an explanation or accompanying regulatory text about what §30.7 means. Commenter (4838) states that, for example, it is unclear whether 40 CFR 30.7 requires EPA to conduct its own peer review of all pivotal regulatory science and, if so, whether EPA has the capacity or capability to perform those reviews. Commenter (6133) expresses concern that the Proposal provides no answers to the following questions:
          How will that peer review be conducted?
          By whom?
          Who will select the peer reviewers?
          How many will there be?
          Who will assure their independence and expertise?
          Will peer reviewers be subject to federal conflict of interest rules and policies?
          Will peer reviewers be anonymous?
          Where will the funds come from to conduct EPA peer reviews for "all pivotal regulatory science"?
          Has EPA estimated how many instances of "pivotal regulatory science" it anticipates conducting peer review for in one year? In prior years?
          Will the peer review be conducted openly and publicly?
          Will it be conducted in accordance with the Federal Advisory Committee Act?
          What will the duration of any peer review be?
          What purpose will that peer review serve?
          How will it affect future regulatory decisions? Or will it?
          Will there be an administrative docket?
          Will any product of the peer review be included in the administrative dockets for rulemaking?
          Will peer reviewer comments be part of the certified record for judicial review?
          Will the agency seek deference from future reviewing courts for the views expressed by peer reviewers?
          Does EPA not believe that peer review conducted by professional journals and societies is valid? Or sufficient?
          On what basis does EPA think professional peer review is invalid or insufficient, considering there is not one iota of evidence or support for that belief in the Proposal or the accompanying docket?
          What is the basic justification for proposed § 30.7?
Response: The EPA is finalizing the language at 40 CFR 30.6 (formerly 40 CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM) to clarify that the Agency will evaluate whether or not to initiate peer review, consistent with the OMB Bulletin for Peer Review and the EPA's Peer Review Handbook, of individual studies identified as pivotal science if the studies have already undergone journal peer review.
The EPA will continue to consider all peer-reviewed science, consistent with existing study quality assessment factors and corresponding statutory mandates. Adequate peer review is peer review that is consistent with the requirements of the OMB Peer Review Bulletin and EPA's Peer Review Handbook. The Agency will continue conducting peer reviews according to the peer review policies and practices that were in place before the rule goes into effect. The EPA Peer Review Handbook, 4[th] Edition, describes how peer reviewers are selected by the Agency. As discussed in the final rule preamble, 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." If implementing this procedural rule would result in conflicts with the guidance found in the Agency's existing Peer Review Handbook, the conflicting requirements found in the Handbook will yield to this final rule.
Censoring of Peer Review Studies/Research and Data
Comment: Commenter (2169) states that the pragmatic impact of rule §30.7 is straight forward: According to the commenter, the EPA proposes to set itself up as the ultimate arbiter of science and, effectively, censor all future peer review studies conducted by the specialists in a given area. The commenter asserts that the reality is that science, not subject to the suffocating and chilling overhang of governmental censorship, is far more likely to develop a robust protocol for enhancing and assessing reproducibility than is a government agency subject to the fickle influence of private industry and its paid representatives who are in the business of producing doubt with respect to any proposal that implies increased cost to, or potentially diminished market share for, the industry affected by a particular EPA proposal.
Commenter (6111) states that it is contrary to good scientific study and practice and the advancement of knowledge for EPA to arrogate to itself the determination of what constitutes useable research and data, and to grant sweeping discretion to the Administrator -- who may not even be a scientist -- to make those determinations. Commenter states that the proposed rule was announced by EPA without any meaningful consultation with the broad research community despite the fact that it addresses a complex and contentious issue that is not yet ripe for regulatory action.
Response: 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 final rule does not categorically exclude studies based on the availability of the underlying dose-response data. The EPA would also like to clarify that the final rule does not require the EPA to collect, store, or publicly disseminate data and models underlying pivotal science. The EPA would also like to clarify that the Agency 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.
The EPA is finalizing the language at 40 CFR 30.6 (formerly 40 CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM) to clarify that the Agency will evaluate whether or not to initiate peer review, consistent with the OMB Bulletin for Peer Review and the EPA's Peer Review Handbook, of individual studies identified as pivotal science if the studies have already undergone journal peer review. The EPA Peer Review Handbook, 4th Edition, describes the process for peer reviews conducted by a Federal Advisory Committee and the National Academy of Sciences. If the Agency conducts peer review on pivotal science, the EPA shall ask peer reviewers to articulate the strengths and weaknesses of the justification for the assumptions applied in analyzing dose-response data and the implications of those assumptions for the results.