Strengthening Transparency in Regulatory Science
            (Part  30 - Transparency in Regulatory Decision Making)

                        Response to Public Comments on

 Proposed Rule [83 FR 18768, April 30, 2018; 85 FR 15396, March 18, 2020]

                                 Dexember 2020

Comments, letters, and transcripts of the public hearings are also available electronically through http://www.regulations.gov by searching Docket ID EPA-HQ-OA-2018-0259

FOREWORD
This document provides the EPA's responses to public comments on the EPA's Proposed Strengthening Transparency in Regulatory Science. The EPA published a Notice of Proposed Rulemaking (NPRM) in the Federal Register on April 30, 2018, at 83 FR 18768. In addition to the NPRM, the EPA published a Supplemental Notice of Proposed Rulemaking (SNPRM) on this action in the Federal Register on March 18, 2020. The EPA received comments on the NPRM and SNPRM via mail, e-mail, facsimile, and a public hearing held in Washington, DC on July 17, 2018. Copies of all comments and transcripts for the public hearing are available at the EPA Docket Center Public Reading Room. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room was closed to public visitors on March 31, 2020, to reduce the risk of transmitting COVID-19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform while the EPA Docket Center and Reading Room are closed. Comments and transcripts of the public hearing are also available electronically through http://www.regulations.gov by searching Docket ID EPA-HQ-OA-2018-0259. For further information and updates on EPA Docket Center services and the current status, please visit us online at https://www.epa.gov/dockets.
Just over 950,000 public comments were received on the NPRM and SNPRM. The EPA Docket Center consolidated mass mail campaigns and petitions into single document control numbers (DCNs), resulting in over 22,000 unique comments. Each of these comments was reviewed and significant comments relevant to this action and submitted within the comment period have been summarized and included in this document.
It is possible some responses in the Response to Comments Document may not reflect the language in the preamble and final rule in every respect. Where the response conflicts with the preamble or the final rule, the language in the final preamble and rule controls and should be used for purposes of understanding the scope, requirements, and basis of the final rule. The responses presented in this document are intended to augment the responses to comments that appear in the preamble to the final rule or to address comments not discussed in that preamble. Although portions of the preamble to the final rule are paraphrased in this document where useful to add clarity to responses, the preamble itself remains the definitive statement of the rationale for the revisions adopted in the final rule. In many instances, responses presented in the Response to Comments Document include cross references to responses on related issues that are located either in the preamble or elsewhere in the Response to Comments Document. Accordingly, the Response to Comments Document, together with the preamble and final rule, and the rest of the administrative record should be considered collectively as the Agency's response to all the significant comments submitted on the proposed rule.

Table of Contents
Chapter 1: Legal Authority	1
1.1 General Comments	2
1.1.1 General Legal Authority (Notice of Proposed Rulemaking (NPRM) Comments)	2
1.1.2 General Legal Authority (Supplemental Notice of Proposed Rulemaking (SPNRM) Comments)	24
1.2 Housekeeping Statue	64
1.3 Specific Environmental Statues	152
1.3.1 Clean Air Act (CAA) (NPRM and SNPRM Comments).	152
1.3.2 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (NPRM and SNPRM Comments).	252
1.3.3 Safe Drinking Water Act (SDWA) (NPRM and SNPRM Comments).	282
1.3.4 Toxic Substances and Control Act (TSCA) (NPRM and SNPRM Comments)	315
1.3.5 Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)/ Resource Conservation and Recovery Act (RCRA) (NPRM and SNPRM Comments).	365
1.3.6 Emergency Planning and Community Right-to-Know Act (EPCRA) (NPRM and SNPRM Comments).	398
1.3.7 Clean Water Act (CWA) (NPRM and SNPRM comments).	407
1.3.8 National Environmental Policy Act (NEPA) (SNPRM Comments)	436
1.3.9 Other Environmental Statutes (NPRM Comments)	438
1.4 Evidence Act (SNPRM Comments)	469
1.5 Consistency with the Peer Review Processes Required Under Environmental Statue (NPRM Comments)	470
1.6 Administrative Procedures Act (APA)	482
1.6.1 APA (NPRM and SNPRM Comments).	482
1.7 Other Authorities (NPRM Comments)	622
1.8 Trying to Achieve Administratively What Could Not be Done Legislatively	645
1.9 Other Comments (NPRM Comments)	652
Chapter 2: Purpose and Effects	663
2.1 Purpose and Effects (NPRM Comments)	664
2.1.1 Change in Culture	664
2.1.2 What Problem is the Agency Intending to Fix?	668
2.1.3 Proposed Rule is Biased	703
2.1.4 Environmental and Health Protections Would be Decreased	748
2.1.5 EPA Would be at Odds with Other Parts of the Federal Government	755
2.1.6 EPA Would be at Odds with Other National and International Bodies	763
2.1.7 Proposed Rule is Flawed and Needs to Be Withdrawn/Redone with Feedback from the Scientific Community/Stakeholders	766
2.1.8 Other Effects/Impacts	831
2.2 Purpose/Basis and Effects (SNPRM Comments)	848
2.2.1 Purpose/Basis for Rule	848
2.2.2 Effects	878
Chapter 3: Capable of Being Substantially Reproduced, Independent Validation, and Reanalyze	994
3.1 NPRM Replicability, Reproducibility and Reanalysis	995
3.1.1 Proposed Rule Requirement to Make Available Information Necessary for the Public to Replicate Findings (30.5)	995
3.1.2 Clarification of the Meaning of Terms Used in the Proposal	998
3.1.3 Replication versus Reproducible versus Reanalysis	1002
3.1.4 Whether the Ability to Reanalyze, Replicate and Reproduce a Study Should Determine the Quality of the Study	1005
3.1.5 Replication-Specific Comments	1011
3.1.6 Reproducibility  -  Specific Comments	1018
3.1.7 Replication (or Reproduction) Crisis	1030
3.1.8 Reanalysis  -  Specific Comments	1042
3.1.9 Recommends Further Consultation to Develop New Rule Addressing Reproducibility and Replicability Concerns	1047
3.2 SNPRM Capable of Being Substantially Reproduced; Replication and Reproduction	1047
3.2.1 Capable of Being Substantially Reproduced; Replication and Reproduction	1047
3.2.2 Reanalyze	1072
3.2.3 Independent Validation	1088
Chapter 4: Data and Models	1098
4.1 NPRM Data and Models  -  Related Comments	1100
4.1.1 Data and Models; Dose response data and models (§30.2), requirements to the use of dose response data and models underlying pivotal regulatory science (§30.5), and additional requirements (§30.6)	1100
4.1.2 Definitions of Research Data (§30.2) and Data	1282
4.2 SNPRM Models, Variability/Uncertainty, and Assumptions/Defaults	1285
4.2.1 Modeling Definitions	1285
4.2.2 Models (General) and Best Science Practices	1286
4.2.3 Public Availability of Models/Data	1289
4.2.4 Weighting of Models	1291
4.2.5 Scope of Models Included	1293
4.2.6 Assumptions/Defaults-Variability/Uncertainty	1294
4.2.7 Impacts on Older/Existing Models	1297
4.2.8 Linear vs Nonlinear Modeling	1300
4.2.9 Impacts on Specific Models	1301
4.3 SNPRM Data, Variability/Uncertainty, and Assumptions/Defaults	1303
4.3.1. Clarity of Proposed Definitions	1303
4.3.2 Application of the Rule in Respect to Data	1314
Chapter 5: Influential Scientific Information; Expansion of Proposal; Determining and Weighting ISI (Supplemental Notice of Proposed Rulemaking (SNPRM))	1329
5.1 Definition of Influential Scientific Information	1330
5.1.1 General Support/Dissent for Definition	1330
5.1.2 What is Covered by the Definition of Influential Scientific Information	1331
5.2 Expansion of Scope to Include Influential Scientific Information	1334
5.2.1 General Support/Dissent for Expansion	1334
5.2.2 Justification/Necessity for Expanding Scope	1336
5.2.3 Application Guidance for EPA Programs	1337
5.2.4 Public Comment on Expanded Scope	1338
5.3 Determining What Constitutes Influential Scientific Information	1339
5.3.1 Limits to EPA's Application of the Rule	1345
Chapter 6: Pivotal Science	1346
6.1 NPRM Pivotal Regulatory Science	1347
6.1.1 How Should the Proposed Rule Apply to Dose Response Data and Models Underlying Pivotal Regulatory Science Developed Prior to the Effective Date?	1347
6.1.2 Could Prospective or Retrospective Application Introduce Bias Regarding the Timeliness and Quality of Scientific Information Available?	1350
6.1.3 How Does What this Rule Would Require Compare to Requirements of Environmental Statutes?	1371
6.1.4 Recommended Changes to the Definition of Pivotal Regulatory Science at §30.2	1374
6.2 SNPRM Pivotal Science	1387
6.2.1 Need for Additional Clarity/Specificity	1387
6.2.2 Scope of Pivotal Science	1390
Chapter 7: Publicly Available	1392
7.1 Publicly Available, Tiered Access	1393
7.1.1 40 CFR 30.2 Definition of Publicly Available	1393
7.1.2 40 CFR 30.5: Broad Issues	1403
7.1.3 40 CFR 30.5: Option 1	1450
7.1.4 40 CFR 30.5: Option 2	1505
7.1.5 Ensure Over Time More Availability of Data	1528
Chapter 8: Research Data	1536
8.1 Uniform Administrative Requirements	1536
8.2 Applicability of the Rule to Research Laboratory Samples.	1538
Chapter 9: Science That Serves as the Basis for Informing a Final Significant Regulatory Actions	1539
9.1 NPRM Regulatory Science (Section 30.2)	1540
9.1.1 Ensure that the Regulatory Science is Publicly Available in a Manner Sufficient for Independent Validation (§30.1)	1540
9.2 Regulatory Science Means Scientific Information that Provides the Basis for EPA Final Significant Regulatory Decisions (§30.2)	1589
9.3 EPA's Regulatory Science Should Be Consistent with the OMB's Final Information Quality Bulletin for Peer Review (83 FR 18770)	1592
9.4 EPA's Proposed Regulatory Science Requirements Consistency with OMB's Guidelines for Ensuring and Maximizing Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies (OMB Guidelines)	1592
9.5 Regulatory Science that Cannot Meet the Requirements of §§30.5 and 30.6	1596
9.6 How Should EPA Address a Circumstance in which EPA Has a Statutory Requirement to Make a Determination for Which Scientific Information Publicly Available Sufficient for Independent Validation Does Not Exist?	1598
9.7 How Does What this Rule Would Require Compare to Requirements of Environmental Statutes? (Relates to Chapter 1)	1600
9.7.1 Best Available Science	1600
9.7.2 Data Quality Act	1604
9.7.3 Other	1606
Chapter 10: Applicability of the Rule	1608
10.1 Limiting Requirements to "Significant Regulatory Actions"	1609
10.2 Expanding the Scope of Applicability of the Rule	1611
10.2.1 Application of the Rule to Other Regulatory Actions	1612
10.2.2 Application of the Rule to Agency Guidance	1614
10.2.3 Application of the Rule to Proposed Rules, Advanced Notice of Proposed Rulemaking and All Aspects of the Rulemaking Process	1615
10.2.4 Individual Party Adjudications, Enforcement Activities, or Permit Proceedings	1619
10.2.5 Application of the Rule to Actions Relying on Records from Previous Reviews	1624
10.2.6 Application of the Rule to Specific EPA Programs	1631
10.2.7 Application of the Rule to a Limited and Special Class of Laboratory Samples	1645
10.3 Narrowing the Scope of Applicability of the Rule	1646
10.3.1 Narrowing the Scope of the Applicability of the Rule	1646
10.3.2 Limiting to "Major" Issues Under the Congressional Review Act or "Economically Signification" Actions Under Executive Order 12866	1647
10.3.3 CAA	1648
10.3.4 Other Comments on Narrowing the Scope of Applicability of the Rule	1649
10.4 Changes in the Scope of the Science Subject to the Rule	1649
10.5 Scope  -  Phase-In	1651
10.5.1 Proposed Rule Does Not Provide for Any Phase-In Time	1651
10.5.2 Support Phasing-In of Transparency Requirements	1651
10.5.3 Conditional Phase-In Implementation Recommendations	1652
10.5.4 Implement Existing Guidance More Fully Before Considering Phasing-In of Rule	1654
10.5.5 Phase-In for Use of Past Studies Lacking in Sufficient Transparency	1655
10.5.6 States Involvement in Identifying Priorities	1655
10.5.7 Transparency Rule Should Never Be Implemented	1655
10.6 Scope  -  Effects on Individual EPA Programs and Exceptions	1656
10.6.1 Proposed Rule Would Have Effects on All/Several EPA Programs	1656
10.6.2 Evaluating Effects of Proposal on Environmental Programs and their Implementation is Unnecessary	1657
10.7 40 CFR 30.3 - How Do the Provisions of this Subpart Apply?	1657
10.7.1 Unlimited Discretion and Authority to Decide What "Any Other Type of Agency Action" is or is Not	1657
10.7.2 Applicability Covers Studies, Models and Analyses Integral to the Functioning of EPA Regulatory Programs	1658
10.7.3 Drafted Exclusions from Proposal's Prohibitions	1660
10.7.4 Applicability to Government-Funded and/or Beyond Government-Funded Scientific Research	1660
10.7.5 Data Pivotal to the Basis of a Regulatory Decision	1662
10.7.6 No Clear Information on How the Rule will Apply	1663
10.7.7 Physical Objects, Drafts and Preliminary Analyses Exclusion	1664
10.8 "Regulatory Decisions" Definition at 40 CFR 30.2	1664
10.8.1 Amend Definition to Remove Limitation of Applicability to Only Final Regulations	1665
10.8.2 Proposal is Inconsistent with Regards to What Types of Regulatory Actions Would be Covered	1665
10.8.3 Regulatory Decisions Should Also Apply to Permitting Activities	1666
10.8.4 Recommends that the Regulatory Decisions Definition Include EPA-Focused Criteria	1666
10.8.5 Basis for Regulatory Decisions	1667
Chapter 11: Availability of Data and Models	1669
11.1. NPRM Transparency and Integrity of Regulatory Decision Making vs. Availability of Raw Data	1669
11.1.1 Basis for EPA Decision-Making Regarding Use/Non-Use of Studies Not Required to be Transparent	1669
11.1.2 EPA Actions in Other Areas	1671
11.2 SNPRM Data Availability-Related Comments	1673
11.2.1 Confidential Business Information, Proprietary Data, or Personally Identifiable Information	1673
Chapter 12: Administrator's Exemptions	1701
12.1 Exemptions (40 CFR 30.9) (NPRM Comments)	1702
12.1.1 Legality of Proposed Exemption Provision in 40 CFR 30.9 of the Rule	1702
12.1.2 Case-by-Case Administrator Exemption Authority	1705
12.1.3 Criteria for Granting Case-by-Case Exemptions	1717
12.1.4 Requests for Specific Rule Exemptions	1726
12.1.5 Define "Reasonable Effort"	1727
12.1.6 Exemption Process Costs	1728
12.1.7 Notice-and-Comment Principles Should Inform EPA's Implementation of the Exemption Process	1728
12.2. Administrator Exemptions (SNPRM Comments)	1728
12.2.1 Granting of Exemptions is Subject to Bias	1729
12.2.2 Rule Would Preclude Consideration of Best Available Science	1740
12.2.3 Areas Needing Additional Clarity/Specificity	1743
12.2.4 Transparency	1743
12.2.5 Retroactivity	1746
12.2.6 Support for Exemptions	1750
12.2.7 Other Comments	1751
Chapter 13: Peer Review	1754
13.1 NPRM Peer Review-Related Comments	1755
13.1.1 Office of Management and Budget (OMB) Final Information Quality Bulletin for Peer Review	1755
13.1.2 Independent Peer Review Requirements (40 CFR 30.7)	1763
13.1.3 Comparison of the Approach in the Proposed Rule to Existing Scientific Review Processes	1804
13.2 SNPRM Independent Peer Review	1886
13.2.1 Existing Peer Review Processes and Protocols Are Sufficient	1886
13.2.2 Concerns Related to Transparency in EPA's Peer Reviews	1891
13.2.3 Supplemental Proposal Violates the Principles of the OMB Final Information Quality Bulletin for Peer Review	1893
13.2.4 Resource Burdens of Peer Review Requirements	1895
13.2.5 Considerations of Bias and Independence of Peer Reviewers	1896
Chapter 14: Implementation (Including Implementation Benefits and Costs)	1900
14.1 NPRM Implementation	1901
14.1.1 Lack of Clarity How the Rule Would be Implemented	1901
14.1.2 Incorporating Stronger Data and Model Access Requirements in Grants and Cooperative Agreements	1908
14.1.3 Building Upon Other Federal Agencies' Policies Regarding Grantee and Cooperator Requirements	1917
14.1.4 Platform for Increasing Public Access to EPA-Funded Data	1918
14.1.5 Methodologies and Technologies Designed to Provide Protected Access to Data	1924
14.1.6 Other Implementation Issues that May Require Special Consideration	1952
14.1.7 Timing of Implementation	1953
14.1.8 Impacts on other Federal Agencies, States and Tribes	1955
14.1.9 Communications	1956
14.1.10 Implementation Costs	1957
14.2 SNPRM Implementation	1983
14.2.1 Inter-organizational Efforts	1984
14.2.2 The EPA's Readiness to Implement the Rule	1985
14.2.3 Implementation Timing/Process	1985
14.2.4 Implementation Costs and Benefits	1987
14.2.5 Implementation Bias	2001
14.2.6 Rule Includes Insufficient Implementation Detail/Clarity	2002
Chapter 15: Statutory and Executive Order Reviews	2038
15.1 NPRM Executive Orders	2038
15.1.1 Executive Order 12291: Federal Regulation	2038
15.1.2 Executive Orders 12866: Regulatory Planning and Review, and 13563: Improving Regulation and Regulatory Review	2039
15.1.3 Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations	2043
15.1.4 Executive Order 13045: Protection of Children	2048
15.1.5 Executive Order 13132: Federalism	2051
15.1.6 Executive Order 13175: Consultation and Coordination with Indian Tribal Government	2051
15.1.7 Executive Order 13556: Controlled Unclassified Information	2052
15.1.8 Executive Order 13771: Reducing Regulation and Controlling Regulatory Costs	2053
15.1.9 Executive Order 13777: Enforcing the Regulatory Reform Agenda	2053
15.1.10 Executive Order 13783: Promoting Energy Independence and Economic Growth	2055
15.2 SNPRM Statutory and Executive Order Requirements	2058
15.2.1 Executive Orders	2058
15.2.2 Paperwork Reduction Act	2075
15.2.3 Additional Related Comments	2076
Chapter 16: Federal Transparency and Data Integrity Laws	2077
16.1 Federal Laws and Law-Related Policies Already Address Data Access Concerns	2078
16.2 Information Quality Act (IQA) and Implementation Guidelines	2080
16.2.1 Information Quality Act	2080
16.2.2 Proposed Rule Consistency with OMB Information Quality Guidelines	2080
16.2.3 EPA Information Quality Guidelines-Specific Comments	2082
16.3 OMB Circular A-110, Freedom of Information Act	2087
16.4 Open Data Policy	2088
Chapter 17: Consistency with Recommendations of Third-Party Organizations Who Advocated for Open Science and Policies Adopted by Major Scientific Journals	2090
17.1 Clarification of "takes into consideration the policies or recommendations"	2090
17.2 Misrepresentation of Third-Party and Major Scientific Journal Recommendations	2092
17.2.1 General Comment Positions on Misrepresentation	2092
17.2.2 Administrative Conference of the United States' Study	2093
17.2.3 National Academies of Science (NAS) Reports	2095
17.2.4 National Research Council Reports	2097
17.2.5 Health Effects Institute (HEI)	2098
17.2.6 Center for Open Science	2099
17.2.7 Risk Assessment Specialty Section of the Society of Toxicology and Dose-Response Specialty Group (DRSG) of the Society for Risk Analysis (SRA)	2101
17.2.8 Bipartisan Policy Center Report	2102
17.2.9 EPA's Proposal is inconsistent with policies adopted by major scientific journals	2104
17.2.10 Not Representative of Scientific Community Recommendations	2109
17.2.11 Cited Economist Article Does Not Support EPA's Proposal	2112
Chapter 18: Alternative Approaches to the Proposed Rule	2113
18.1 Base Policies and Requirements on Existing Guidance	2113
18.1.1 National Academy Guidance	2114
18.1.2 U.S. Commission on Evidence-Based Policymaking Recommendations	2116
18.1.3 Good Laboratory Practice	2117
18.1.4 Transparency and Openness Promotion Guidelines	2119
18.1.5 Radiation Effects Research Foundation	2120
18.1.6 Federal Data Strategy	2120
18.1.7 National Center for Health Statistics Research Data Centers	2121
18.2 Approaches Specific to EPA-Funded Research	2121
18.2.1 Enforce Existing Requirements	2121
18.2.2 Update Grant Awards/Cooperative Agreements	2122
18.2.3 Use EPA Funding to Enact Change	2122
18.3 Suggested Changes to the Rule/Approach	2123
18.3.1 Make the Rule More General	2123
18.3.2 Applicability of Science Covered by the Rule	2124
18.3.3 Additions to the Proposed Rule	2126
18.3.4 Subtractions from the Proposed Rule	2129
18.3.5 No Action Necessary	2130
18.3.6 Delay Rulemaking	2131
18.4 Alternative Policies to Increase Transparency in EPA Rulemaking without Releasing Private Data to Public	2132
18.4.1 Other Effective Ways to Vet Scientific Results that Do Not Require Public Access to Research Data	2133
18.4.2 Weight Studies According to Data Transparency	2135
18.4.3 Encourage Scientific Community-Led Efforts to Self-Improve Transparency	2136
18.4.4 Use Independent Third-Party to Evaluate Study Components, Results, Rules, Data Disclosure Issues	2137
18.4.5 Increase Financial Incentive Transparency	2140
18.4.6 Other	2141
18.5 Facilitate Data Publication/Accessibility	2145
18.5.1 Public Accessibility to Environmental Databases and Websites that are Easy to Navigate	2145
18.5.2 Improve Public Accessibility	2146
18.5.3 Make Use of Existing Data Repository (e.g., Rulemaking Docket)	2147
18.5.4 Transparency of Published Data	2148
18.6 Implement, Emulate or Work with Federal Programs	2148
18.6.1 Environmental Protection Agency Policy and Guidance	2149
18.6.2 Collaborate with Other Agencies/Departments	2151
Chapter 19: Comparison of Approach to Hazard, Exposure and Risk Assessment Guidance	2155
19.1 Science and Judgement in Risk Assessment	2155
19.2 Request for Inclusion of Discussion on How EPA Proposes to Address Exposure Assessments and Risk Characterization Data and Models in the Future	2156
19.3 Request Guidance on How to Use Human Data in Risk Assessments Under the Proposed Rule	2157
19.4 Industry Toxicology Study and Epidemiological Study Review and Acceptance Differ	2157
19.5 Public's Interest Best Served When Science is Replicable, Transparent and Explainable with Other Toxicology Information	2158
Chapter 20: Chemical/Pollutant Specific Comments	2160
20.1 Chlorpyrifos	2160
20.2 Formaldehyde	2161
20.3 Lead	2161
20.4 Particulate Matter	2162
20.5 Trichloroethylene (TCE)	2165
Chapter 21: Miscellaneous and Out of Scope Comments	2168
21.1 NPRM Miscellaneous Comments and Out of Scope Comments	2168
21.1.1 Miscellaneous Comments	2168
21.1.2 Out of Scope Comments	2172
21.2 SNPRM Miscellaneous Comments and Out of Scope Comments	2188
21.2.1 Miscellaneous Comments	2188
21.2.2 Out of Scope Comments	2237

Appendix A. Index of Commenters
Appendix B. Overview of Less-Detailed Comments
 Chapter 1: Legal Authority
In the 2018 Proposed Rule, EPA proposed to take the action under several statutes it administers, including 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. The Agency also states that the action is consistent with requirements in the Administrative Procedure Act (APA) to ensure public participation in the rulemaking process. Additionally, the notice of proposed rulemaking (NPRM) solicits comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation.
The supplemental notice of proposed rulemaking (SNPRM) maintains its authority under the statues provided in the original proposal. The Environmental Protection Agency (EPA) also notes its 2018 document extending the comment period and announcing a public hearing identifies 5 U.S.C 301 as a source of authority in addition to the statutes cited in the NPRM. In addition, the Agency clarifies that the NPRM's reference to RCRA section 7009, 42 U.S.C 6979 should be to RCRA section 8001, 42 U.S.C. 6981; the citation to CERCLA section 116, 42 U.S.C. 9616, should be to CERCLA section 115, 42 U.S.C. 9615; and includes CWA section 501, 33 U.S.C. 1361.
The Agency also states that it is authorized to promulgate this regulation under its housekeeping authority. While EPA acknowledges it is not one of the 15 "Executive Departments" listed at 5 U.S.C 101, the Agency provides that it gained housekeeping authority through the Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9,1970). According to the Agency, the proposed rule is an internal rule of agency procedure that is intended to be consistent with the statutes that EPA administers and EPA plans to implement this procedural rulemaking in accordance with all applicable statutory and regulatory requirements. While this rule is of internal agency procedure, EPA solicits comment on whether to use its housekeeping authority independently or in conjunction with the clarified environmental statutory provisions.
Several comments were received regarding the legal authority of the NPRM and SNPRM, including the applicability of the cited environmental statutes and EPA's ability to invoke housekeeping authority for the proposed rule. In this section the public comments are organized according to the following topics:
 General Comments
 Housekeeping Statute
 Specific Environmental Statutes
 Evidence Act (SNPRM Comments)
 Consistency with the Peer Review Processes Required Under Environmental Statute (NPRM Comments)
 Administrative Procedures Act (APA) (NPRM and SNPRM Comments)
 Other Authorities (NPRM Comments)
 Trying to Achieve Administratively What Could Not be Done Legislatively
 Other Comments (NPRM Comments)
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 commenter ID numbers (and specific comment excerpt IDs - indicated in brackets) for these commenters are cited throughout this section. In addition, some general comment letters also include comments related to the legality of the NPRM and SNPRM (the Proposal). These comments are summarized in Appendix B. Note that the points and issues raised in these general comment letters may also be raised by the more detailed comments summarized in this Chapter. Therefore, the responses provided in this Chapter adequately address the more general comments received regarding the legal authority and other issues related to the legality of the rule.
1.1 General Comments
1.1.1 General Legal Authority (Notice of Proposed Rulemaking (NPRM) Comments)
Comment [2772-2261]: Commenter (2787) contends that the EPA fails to cite any specific language providing authority for the rule and asks commenters where the authority may be found.
Response: In both the 2018 proposal and the 2020 supplemental proposal, EPA cited several sources of authority and requested comment on those sources or any others that commenters might think appropriate for the final rule. EPA has identified its housekeeping authority, conveyed through Reorganization Plan No. 3 of 1970, as the legal authority for the final rule.
Comment [4531-5099]: Commenter (4541) applauds this proposed rule and find that governing statutes and Executive Orders, not to mention the basics of the scientific method, authorize the proposed Rule and, indeed, have long required it. In not following the proposed Rule in the past, EPA has been flouting governing statutes and Executive Orders, departing from the scientific method, particularly in matters of toxicology and epidemiology, and abusing its authority by ignoring and discarding valid objections to EPA adopted science and the derivative policy and regulatory actions.
Response: EPA appreciates your comment in support of the final rule but disagrees with your assertion that the agency has flouted the law and ignored or discarded valid objections to agency science. EPA uses systematic review and weight of evidence processes to evaluate scientific studies for use in its regulatory decisions and in the development of influential scientific information.
Comment [4871-354]: Commenter (4882) agrees this proposed rule has incorporated appropriate sources of statutory authority and suggest no further source of authority is required.
Response: Thank you for your comment in support of the final rule.
Comment [6106-875]: Commenter (6116) states that on April 30, 2018, EPA published a notice in the Federal Register (FR) of a proposed rule that would drastically reduce the types of scientific studies that can be used to inform EPA regulations protecting public health under the guise of improving transparency. The commenter expresses that they are troubled by this proposal, as we believe it would vastly undermine the mission of the EPA, which is to protect human health and the environment. The commenter notes that it is curious that this proposal champions "transparency" when it seems certain to serve the opposite purpose. An example of one of the reasons the commenter states that they oppose the proposed rule includes, but is not limited to the following:
      The EPA itself seems to question whether it has the authority to promulgate this rule. The FR notice asks commenters to provide information on what areas of the CAA they feel may demonstrate this type of authority. The EPA should have a solid foundation before it proposes rules and should not have to seek answers for questions about its own authority.
Response: See response to Comment 2772-2261.
Comment [6112-1489]: Commenter (6137) contends that EPA has no authority to limit what scientific information may be considered in making regulatory decisions. The commenter states that no statute authorizes the proposed rule, and EPA lacks any inherent authority to regulate absent a statutory basis. Thus, that commenter suggest that the EPA should proceed to promulgate the Proposed Rule or otherwise limit what science can be considered in regulatory decisions, it will be acting in violation of the law. See 5 U.S.C. § 706(2)(C) (requiring a reviewing court to "hold unlawful and set aside agency action . . . found to be . . . in excess of statutory jurisdiction, authority, or limitations, or short of statutory right").
The commenter states that the stated statutory provisions upon which EPA relies do not provide authority for the Proposed Rule. The commenter notes that the EPA lists a number of statutes it administers as purported authority for this rule, including "provisions providing general authority to promulgate regulations necessary to carry out the Agency's functions under these statutes and provisions specifically addressing the Agency's conducting of and reliance on scientific activity to inform those functions." See 83 Fed. Reg. 18,769. As discussed in detail below, none of the statutes cited by EPA authorizes this proposed action. EPA thus lacks authority to promulgate this rule under any statutory regime administered by the Agency, rendering the rule invalid.
Response: In both the 2018 proposal and the 2020 supplemental proposal, EPA cited several sources of authority and requested comment on those sources or any others that commenters might think appropriate for the final rule. EPA has identified its housekeeping authority, conveyed through Reorganization Plan No. 3 of 1970, as the legal authority for the final rule.
Also see response to Comment 73-410 in this Response to Comment (RTC) document Section 1.2.2.
Comment [6112-1560]: Commenter (6137) provides that in its notice extending the comment period and adding a public hearing, as an implicit admission that it has not cited sufficient authority for the Proposed Rule, EPA adds a new source of alleged authority, stating that "EPA is proposing this rule under authority of 5 U.S.C. 301, in addition to the authorities listed in the April 30th document." See 83 Fed. Reg. 24,255, 24,256 (May 25, 2018). Just like with the other statutory provisions upon which it relies, EPA is trying to fit a square peg in a round hole.
Section 301 of Title 5 provides "[t]he head of an Executive department or military department" authority to "prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property." This provision governs internal organizational and bureaucratic steps required for operations. It allows all agencies to issue regulations to preserve and use their own papers and property. This section is plainly focused on allowing executive agencies to issue rules necessary to carry out the performance of their agencies' internal workings, not to allow EPA to regulate scientific material in rulemakings.
Indeed, according to the commenter, the "purpose" of this section, "which originated in 1789 as a law `to enable General Washington to get his administration underway by spelling out the authority of Government officers to set up offices and to file Government documents'. . . is to set up merely internal guidelines for a given governmental agency" to perform its job. United States v. Lewis, No. C-CR-89-114-01, 1990 WL 11111, *5 (W.D. N.C. Feb. 5, 1990) (citation omitted). That is why it is known as the "Housekeeping Statute," to literally allow the federal government to set up and keep house. U.S. ex. Rel. O'Keefe v. McDonnell Douglas Corp., 132 F.3d 1252, 1254 (8th Cir. 1998) (citing H.R. Rep. No. 85-1461 (1958), reprinted in 1958 U.S.C.C.A.N. 3352). The Act was amended in 1966 as "codifying the general and permanent laws relating to the organization of the Government of the United States and to its civilian officers and employees." Pub. L. No. 89-554, 80 Stat. 378 (Sept. 6, 1966).
In Chrysler Corp. v. Brown, 441 U.S. 281, 310 (1979), the Supreme Court evaluated the Housekeeping Statute and held that it does not provide statutory authority for substantive regulations. After a brief historical analysis of the provision, the Court wrote:
Given this long and relatively uncontroversial history, and the terms of the statute itself, it seems to be simply a grant of authority to the agency to regulate its own affairs. . . It is indeed a "housekeeping statute," authorizing what the APA terms "rules of agency organization procedure or practice" as opposed to "substantive rules."
Id. at 309 - 10. Multiple courts have agreed and limited rulemaking under this provision to non-substantive rules. See, e.g., McDonnell Douglas Corp., 132 F.3d at 1256 (citing examples).
Based on this long line of authority, EPA's reliance on this authority is sorely misplaced. EPA's attempt to "construe [this provision] as something more" is a "misuse" that "twist[s]" the statute beyond its intended purpose; EPA may not "twist this simple administrative statute into an authorization for the promulgation of substantive rules." Id. at 1255 (citing and quoting Chrysler Corp., 441 U.S. at 310 n.41 (quoting H.R. Rep. No. 85 - 1461 at 7 (1958)).
The Proposed Rule does not relate to the organization of EPA or how it preserves its papers or keeps house. EPA's exclusion of critical health studies is such a far cry from being necessary to "set up offices" and to "file Government documents," that reliance on this provision hardly passes the laugh test. As discussed extensively in these Comments, the Proposed Rule is by no means necessary for EPA to perform its job but rather is antithetical to the very statutes it is responsible for effectuating. Accordingly, for the same reasons the general rulemaking authority provisions under all of the environmental statutes EPA cites do not authorize this rule, § 301 likewise does not permit EPA to issue a rule that undermines scientific integrity as well as all of the public health and environmental protections EPA is charged with enforcing.
The EPA's lack of statutory authority to propose this rule is fatal, as it has no inherent power to act. Indeed, it is well settled that a federal agency "literally has no power to act . . . unless and until Congress confers power upon it." La. Pub. Serv. Comm'n v. FCC, 476 U.S. 355, 374 (1986); see also Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988) ("It is axiomatic that an administrative agency's power to promulgate legislative regulations is limited to the authority delegated by Congress."); Clean Air Council v. Pruitt, 862 F.3d 1, 9 (D.C. Cir. 2017) ("[I]t is `axiomatic' that `administrative agencies may act only pursuant to authority delegated to them by Congress'" (citation omitted)); Ohio Dep't of Medicaid v. Price, 864 F.3d 469, 476 (6th Cir. 2017) ("Agencies, after all, are creatures of statutory authority." (citation and internal quotations omitted)). This is because, under the Constitution, Congress is the branch of government with lawmaking power. City of Arlington, Tex. v. FCC, 569 U.S. 290, 317 (2013) (noting that an agency has no lawmaking power unless Congress delegates that power to it). "The legislative power of the United States is vested in the Congress, and the exercise of quasi-legislative authority by governmental departments and agencies must be rooted in a grant of such power by the Congress and subject to limitations which that body imposes." Chrysler Corp., 441 U.S. at 302. Thus, EPA only has rulemaking power to the extent that Congress delegated it such power. Lyng v. Payne, 476 U.S. 926, 937 (1986) ("an agency's power is no greater than that delegated to it by Congress.")
Moreover, the fact that Congress has given EPA the authority to regulate in a certain area does not mean that it has general authority to make any rule within that area. This argument has been squarely rejected:
The [agency's] position in this case amounts to the bare suggestion that it possesses plenary authority to act within a given area simply because Congress has endowed it with some authority to act in that area. We categorically reject that suggestion. Agencies owe their capacity to act to the delegation of authority from Congress.
Am. Library Ass'n. v. FCC, 406 F.3d 689, 708 (D.C. Cir. 2005) (quoting Ry. Labor Executives' Ass'n v. Nat'l Mediation Bd., 29 F.3d 655, 670 (D.C. Cir. 1994)) (internal quotations omitted; emphasis in original); see also Liberty Mut. Ins. Co. v. Friedman, 639 F.2d 164, 169 (4th Cir. 1981) ("a court must reasonably be able to conclude that the grant of authority contemplates the regulations issued." (citation and internal quotation marks omitted)). "[T]he power to issue regulations is not the power to issue any regulations." Nat'l Mining Ass'n v. U.S. Dep't of the Interior, 105 F.3d 691, 694 (D.C. Cir. 1997). In light of the statutory limitation on EPA's authority to restrict science in the way it proposes to do (see infra, Section IV of the commenters' comment letter), any general rulemaking authority on which it might otherwise try to rely does not authorize the Proposed Rule. See, e.g., Nat. Res. Def. Council, Inc. v. Reilly, 976 F.2d 36, 40-41 (D.C. Cir. 1992) (refusing to allow EPA to rely on general rulemaking authority to trump specific limitations on its authority because a vague "open-ended power" does not "trump the specific provisions of the [Clean Air] Act"; and "EPA's construction of the statute is condemned by the general rule that when a statute lists several specific exceptions to the general purpose, others should not be implied." (citation and internal quotation marks omitted).
Accordingly, EPA has no general or inherent authority permitting it to lawfully adopt the Proposed Rule or otherwise limit what science may be considered in the rulemaking process. It, therefore, must be acting pursuant to some grant of authority by Congress for the Proposed Rule to be lawful. Yet none of the stated authorities upon which EPA relies provides the necessary authority to promulgate this rule. Given that EPA has no statutory authority to issue the Proposed Rule, its action is ultra vires. See, e.g., McDonnell Douglas Corp., 132 F.3d at 1257 ("An agency's promulgation of rules without valid statutory authority implicates core notions of the separation of powers, and we are required by Congress to set these regulations aside." (citing cases finding ultra vires agency action)). The Proposed Rule is therefore unlawful.
Response: See responses to Comments 31-135, 32-144 and 73-410 in RTC document Section 1.2.2.
Comment [6116-1117]: Commenter (6141) asserts that the Proposal for scientific transparency is consistent with the objectives and requirements of existing federal environmental statutes and administrative policies. Most importantly, the CAA and other major federal environmental statutes provide EPA with broad authority to establish procedures, requirements, and criteria for adopting rules, regulations, and policies for how the Agency adopts new regulations, rules, and guidance. For example, section 301(a) of the CAA provides the EPA Administrator with broad authority to establish regulations "as are necessary to carry out... the functions" under the CAA, while section 307(d) provides extensive authority on the manner in which EPA may conducting notice and comment rulemakings, including provisions for ensuring a robust rulemaking record and adequate opportunities for public participation. The other relevant federal environmental statutes also provide EPA broad authority for the establishment of procedures, requirements, and criteria for how it establishes implementing rules, regulations, and policies. The commenter supports EPA's proposal to use this authority to establish new rules for ensuring the transparency and public availability of the underlying scientific data and other important supporting documentation used by EPA in its regulatory actions.
Response: Thank you for your comment in support of the rulemaking. See responses to Comments 31-135 and 73-410 in Section 1.2.2 of the RTC document.
Comment [6125-1849]: Commenter (6150) agrees that EPA has sufficient legal authority under existing environmental statutes to issue this rulemaking to strengthen the transparency of the science supporting regulatory activity. EPA lays out substantive legal support for this action in the Proposed Rule. Further, EPA's obligation under the Data Quality Act is to "maximiz[e] the quality, objectivity, utility, and integrity of information" and, as importantly, "establish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency." These provisions can only be met if the public has access to the data, models, and methodologies used by EPA and underlying research used by EPA to justify new and existing regulations.
Response: Thank you for your comment in support of the rulemaking.
Comment [6149-2754]: Commenter (6174) provides that there is no basis in existing bedrock environmental laws that authorizes EPA to limit science considered in rulemaking processes. EPA cites several key laws as a justification for this current proposal to limit or constrain the science it can consider. Nowhere in the cited statutes is there any basis for demanding access to raw data, nor does this relate sensibly to any definition of best available science. Rather it undermines the use of best available science as called for in numerous environmental statutes including the CAA. Further, there is no basis in the statutes for politically appointed administrators to choose which science will be considered and which may not be.
The CAA, for example, has requirements to update pollution standards that provide for an adequate margin of safety for public health. This determination can only be reliably made using the best available science. However, this proposal would prevent EPA from using the best available information to set science-based pollution standards that would provide for an adequate margin of safety. EPA should not cite the CAA as an appropriate source of statutory authority.
In sum, there is no statutory authority for EPA to rely on to censor or constrain science. Indeed, quite the opposite. Further, such an effort would only serve to undermine EPA's essential role.
Response: EPA is not relying on the substantive environmental statutes as authority for the final rule. See responses to Comments 32-144, 48-381 and 73-410 in RTC document Section 1.2.2.
Comment [6155-586]: Commenter (6125) states that EPA lists 14 statutory provisions as support for its proposal. On examination, these are all either general rulemaking authorities or general research authorities; none of them has anything to do with how to use science in decision-making. Moreover, the proposal does not expressly say--as a well-drafted and genuinely transparent proposal should-- that it will only apply to the programs under the cited statutes (although that may be implicit), much less discuss in any way the policies those programs embody or why the proposed per se rule would be a proper exercise of discretion under each statute. Indeed, the cited provisions, virtually the only statutory authority the proposal cites as support, are irrelevant to the per se issue.
Response: EPA is not relying on the substantive environmental statutes as authority for the final rule. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [6155-588]: Commenter (6125) contends that any rule must have a lawful basis. The proposal does not even attempt to show that it does. It claims "discretionary authority" for its proposed approach but identifies no source for such authority. It evades that question by purporting to list "statutes and provisions specifically addressing the agency's conducting of and reliance on scientific activity to inform those functions" FR 18769 (emphasis added). It does not explain how those provisions authorize the wholesale redefinition of science. All the provisions cited either authorize research, or general rulemaking not tied to any specific purpose.
EPA's proposal would, by operation of law, change the standards for using science in issuing covered rules under all of the listed substantive regulatory authorities. It would thereby make in advance a critical part of the regulatory decision in any covered proceeding, namely the decision how to weigh available studies to best evaluate scientific evidence. This is a decision that has previously been made by detailed case-by-case review in the rulemaking itself. Until today, such decisions have been made after considering the substantive goals of the particular statutory provision involved, guided by the attitude toward scientific evidence embodied in that provision, and striving for conformity with any applicable procedural requirement. The affected provisions are the relevant statutory authorities that EPA's proposal should have cited and discussed, in order to show its consistency with their mandates. EPA's citations to general provisions are insufficient because it is axiomatic that a "general grant of authority cannot trump specific statutory provisions". NRDC v. EPA, 749 F. 3d 1055, 1064 (D.C. Cir. 2014); API v. EPA, 52 F. 3d 1113, 1119 (D.C. Cir. 1995) (same).
The agency's failure to do this is by itself a fatal flaw in this proposal. It is EPA's duty, not EPN's, to identify and discuss these provisions. However, it is clear from even a brief look that these provisions require EPA to consider all the best available science, without authorizing, or even mentioning any of the per se restrictions based on "transparency" that EPA has proposed to use as a universal overriding rule. For these reasons, EPA must justify its proposal as a proper exercise of its authority under each of the statutory provisions whose operation it would affect - provisions that the agency does not even cite. It is the job of the proposer, not the commenters, to survey these provisions and provide the needed justification.
In several of the listed statutes Congress has explicitly told EPA how to use science in decision-making.
 SDWA 1412(b)(3)(A) addresses EPA's "use of science in decision-making" by providing that risk assessments "shall" use "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices."
 The EPCRA, 42 USC 11023(d)(2)(C) mandates that a determination whether to add a substance to list of "extremely hazardous substances" "shall be based on generally accepted scientific principles or laboratory tests or appropriately designed and conducted epidemiological or population studies available to the Administrator."
 The CWA, 33 USC 1314(a)(1) mandates that the Administrator "shall develop and publish ... criteria for water quality accurately reflecting the latest scientific knowledge" "on the kind and extent of all identifiable effects on health or welfare" in setting water quality standards;
 CAA 108(a)(2) specifies that "air quality criteria for an air pollutant shall accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air."
 The TSCA 15 USC Section 2605 (h) provides that "the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science."
These provisions all use mandatory language directing EPA to use reliable and relevant scientific information -- and further specify how to do so. They all direct that decisions regarding protection of public health be based on the full range of relevant scientific information, in some cases specifying how to identify what information to use. None of them give EPA discretion to ignore such information for any of the reasons set forth in the proposal.
Response: EPA is not relying on the substantive environmental statutes as authority for the final rule. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [6157-898]: Commenter (6127) provides that there is no legal or environmental basis for the agency to add restrictions and ignore available information about the risks of pollution.
Response: The final rule does not require EPA to ignore available information on pollution risks. Under the rule, EPA will give greater consideration to pivotal science based on an evaluation of study quality factors and data availability. See responses to Comments 32-144, 34-155 and 48-381 in RTC document Section 1.2.2.
Comment [6163-827]: Commenter (6133) states that EPA has unsurprisingly failed to cite a single statute that provides any basis for the Proposal. What statutes EPA does cite conflict with the Proposal, because they require EPA either to consider the best available science (which may be based on data that cannot be made public) or to regulate to protect public health and the environment (which cannot be done if critical science is ignored simply because the underlying data cannot be made public). Similarly, none of the other sources EPA cites provide legal or logical support for the Proposal.
Response: EPA is not relying on any of the substantive environmental statutes cited in the 2018 and 2020 proposals as authority for the final rule. See response to Comments 32-144, 48-381 and 73-410 in RTC document Section 1.2.2.
Comment [6163-1046]: Commenter (6133) asserts that it is clear from the above that the Proposal violates the law and must be withdrawn. There is no support for the Proposal in any of the statutes EPA cites, and in fact, those statutes conflict with the Proposal, as do other statutes that EPA failed to mention at all. Further, none of the other sources cited provide legal or logical support for the Proposal. The Proposal also suffers from a host of other problems: its definitions are vague; it is an unexplained reversal from prior agency policy; it handles Confidential Business Information (CBI) in a capricious manner; it treats other types of agency actions inconsistently; and it fails to analyze disproportionate impacts on communities of color, low-income communities, and children.
In the alternative, if EPA decides to move ahead with this reckless, unjustified, and unlawful effort to censor the science that EPA may consider, and must consider, to protect Americans' health and environment, the agency must first issue a supplemental proposal and actual administrative record to cover the multitude of issues, evidence, and specific regulatory text for which EPA fails to provide fair notice. The Proposal fails to provide fair notice or justifications addressing numerous issues that our comments detail -- from an absence of any statutory authority, to failures to address statutory authorities that the Proposal squarely contravenes, to failures to provide reasoned explanations, including basic justifications for EPA's numerous departures from past practices. The Proposal fails to propose specific regulatory text addressing numerous implementation elements, as well as issues that are touched upon only in passing in the preamble (e.g., non-linearity, and linear, non-threshold (LNT)). Apart from all of the significant substantive and procedural defects from which the Proposal suffers, it still manages to be a shockingly shoddy effort missing actual regulatory text and supporting legal, factual, scientific, and technical information that would provide fair notice to the public.
Response: EPA disagrees that the final rule violates the law. Further, EPA addressed many of the significant comments on the 2018 proposal in the 2020 supplemental proposal. Both notices included regulatory text and provide fair notice to facilitate public comment. Also see responses to Comments 31-135 and 73-410 in RTC document Section 1.2.2.
Comment [6163-1101]: Commenter (6133) states that the law is clear that EPA may adopt rules only if those rules are based on statutory authority delegated by Congress. EPA may not invent statutory authority where none exists, nor adopt regulations lacking statutory authority merely because EPA believes that to be better policy. See, e.g., Massachusetts v. EPA, 549 U.S. 497, 535, 127 S. Ct. 1438, 1463 (2007) ("EPA must ground its reasons for action or inaction in the statute."); La. Pub. Serv. Comm'n v. FCC, 476 U.S. 355, 374 (1986) (stating "agency power to act" is shaped by how "Congress confers power upon it"). Agencies need especially clear congressional delegations of authority to create regulatory exemptions. See New York v. U.S. EPA, 413 F.3d 3, 41 (D.C. Cir. 2005) (stating that the agency needs "clear congressional delegation" to support an exemption). EPA identifies no such delegations, certainly not the clear delegations required by law, for the Proposal.
EPA lists seven statutes as the basis for the Proposal. But none of the various statutes cited provides support for the rule's provisions, definitions, requirements, or exemptions. Rather, EPA invents statutory authority where none exists, and creates proposed regulatory text out of thin air. In most cases, EPA simply cites its general authority for rulemaking under the statutes. But that general authority alone cannot provide a basis for the rule, especially when, as explained in section V, the rule would conflict with the requirements of each of the statutes. See New York v. U.S. EPA, 413 F.3d 3, 40 - 42 (D.C. Cir. 2005). In other instances, it appears that EPA just searched the statutes for the word "research" and then cited those sections without any further analysis.
Response: EPA is not relying on any of the environmental statutes cited in the 2018 and 2020 proposals as authority for the final rule. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [6163-5113]: Commenter (6133) contends 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 Office of Management and Budget (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 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 claimed authorities that EPA lists do not mention peer review or even allude to the concept. Id. Neither the Proposal nor accompanying docket materials identify any provision of any federal statute that authorizes EPA to promulgate proposed § 30.7. Our own research revealed no provision of any federal statute that authorizes EPA to promulgate proposed § 30.7.
Response: None of the statutory provisions cited by the commenter prohibits EPA from conducting additional peer review of studies the agency evaluates as support for significant regulatory decisions and ISI. That said, the final rule provides that if EPA determines that studies have already undergone adequate peer review, EPA will not conduct de novo independent peer review. Adequate peer review is peer review that is consistent with both OMB's and EPA's peer review guidance. The intent of the rule is for EPA to go beyond current OMB/EPA guidance by recognizing that peer review that actually examined the underlying data will lead to even more confidence in the results of a peer reviewed study and that pivotal science that has had this deeper peer review will be given greater consideration in study quality weighting.
The final rule states in § 30.3 that "[i]n the event the procedures outlined in this rule conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." Additionally, EPA intends to promulgate future science transparency rules under its substantive environmental statutes that may address peer review requirements consistent with those authorities.
Comment [6428-1351]: Commenter (6450) states that the proposed rule is not merely a disastrous policy choice, given its threats to public health and the integrity of EPA decision-making, but it is plainly unlawful. EPA clearly lacks the authority to issue the proposal. EPA cites to various provisions in federal law to justify its authority but, in virtually every case, the agency refers to sections that authorize or mandate EPA to undertake research, not to impose arbitrary limitations on the scientific data that informs public health decisions. EPA also cites to statutory provisions authorizing it to promulgate rules "necessary" to achieving the goals of relevant statutes but restricting the use of sound science is neither necessary nor consistent with the statutory goals of protecting clean air, clean water, and a safe environment. Indeed, the proposed rule directly contradicts the specific mandate of numerous federal laws, such as the SDWA and the TSCA, which require EPA to use the "best available" science or all "reasonably available" science and information in its decision-making.
Response: EPA is not relying on any of the substantive environmental statutes cited in the 2018 and 2020 proposals as authority for the final rule. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [6894-3629]: Commenter (6916) notes that the APA further requires that a notice of proposed rulemaking contain "reference to the legal authority under which the rule is proposed." 5 U.S.C. § 553(b)(2). "`[T]he required specification of legal authority must be done with particularity,'" and "`must be sufficiently precise to apprise interested persons of the agency's legal authority to issue the proposed rule.'" Global Van Lines, 714 F.2d at 1298 (quoting H.R. Rep. No. 1980, at 24 (1946) and U.S. Dept. of Justice, Attorney General's Manual on the APA 29 (1947)). EPA has also failed to meet this requirement.
In both the April 30, 2018 notice of proposed rulemaking and the May 25, 2018 notice extending the comment period, EPA discusses statutory authority for the proposed rule, citing to a number of provisions, largely from statutes it implements. 83 Fed. Reg. at 18,769; 83 Fed. Reg. 24,255, 24,256 (May 25, 2018). In particular, EPA invokes the CAA, CWA, SDWA, EPCRA, FIFRA, TSCA, CERCLA, and RCRA. 83 Fed. Reg. at 18,769.
But rather than identify legal authority with particularity, the cited statutory provisions mainly set forth EPA's broader authorities to conduct research and promulgate regulations. Few of the cited provisions actually address EPA's ability to pick and choose amongst valid scientific information, studies, and techniques in its formation of environmental standards and modeling, and none authorize the wholesale preclusion of probative, relevant studies, as EPA proposes here. Tellingly, in the proposal itself, EPA requests assistance to determine "whether additional or alternative sources of authority are appropriate bases for the proposed regulation." Id. at 18,771. EPA's inability to identify specific statutory authority for its proposed action falls far short of the APA's standard for notice and comment rulemaking, as would any ultimate reliance on statutory authority EPA has failed to cite. See Global Van Lines, 714 F.2d at 1297-99.
Response: See response to Comment 25-96 in the APA Section <IP_ADDRESS> of the RTC document.
Comment [6895-3186]: Commenter (6919) contends that EPA, like all federal agencies, is a creature of statute, and "may act only pursuant to authority delegated ... by Congress." But the Proposal fails to state clearly under what authority EPA is proposing these rules, providing only a list of statutes that require the Agency affirmatively to take scientific information into account, but not explaining why they would offer the Agency authority to disregard certain relevant studies. Indeed, EPA seems unsure of its authority, requesting comment on "additional or alternative sources of authority."
Nor does the EPA Administrator's authority "to prescribe such regulations...as are necessary to carry out the Agency's functions" present an opening to disregard relevant information, as EPA suggests. To the contrary, courts have held that the Administrator must take into account all relevant studies in the record. Other CAA sections, not cited by the Agency, lay out and define some of the Administrator's rulemaking "functions under the Act" as requiring for example, the use of "the latest scientific knowledge useful in indicating the kinds and extent of all identifiable effects on public health or welfare..." So, the Proposal to permit him to disregard some studies is contrary not only to his general rulemaking authority, but to his specific authority to, inter alia, set the National Ambient Air Quality Standards (NAAQS) based on the "latest scientific knowledge."
The seminal CAA air quality standard-setting provisions have twice been held not to require the release of data underlying studies relied on by the Agency, as discussed above. Indeed, in both situations, the court has described such release as "unnecessary and unjustified."
The Proposal also is inconsistent with the overall precautionary nature of the CAA. Congress did not intend EPA to limit itself to considering only `sure things' but asks the Administrator to protect the public against uncertain dangers due to exposure to air pollution. Primary NAAQS are to be set with an "adequate margin of safety," meaning that "the Administrator need not regulate only the known dangers to health but may `err' on the side of overprotection." This precautionary approach is reflected also in the various technology-forcing sections of the Act, which Senator Muskie said "may [require] that people and industries will be asked to what seems to be impossible at the present time." Under this scheme, the Administrator must consider all relevant studies placed in the record, and "may apply his expertise to draw conclusions from suspected, but not completely substantiated, relationships between facts, from theoretical projections from imperfect data, from probative preliminary data not yet certifiable as `fact' and the like," in order to protect public health as Congress intended. This context simply does not authorize the Administrator to decline to consider any studies  -  but particularly not those representing the best available science  -  because the underlying data is confidential.
Response: EPA is not relying on any of the substantive environmental statutes cited in the 2018 and 2020 proposals as authority for the final rule. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [6896-3231]: Commenter (6916) provides that the Proposal claims to be "consistent with the principles underlying the APA". But, the Proposal does not clearly identify the authority under which it is promulgated, is so vague as to undermine the ability to meaningfully comment, and in its substance contradicts the APA requirement that agencies must consider all the relevant matter presented in a rulemaking record.
As discussed above, the CAA does not authorize the Proposal, which is clearly aimed at limiting the studies EPA can rely on and consider in CAA rulemaking. Additionally, APA section 553(b)(2) requires a proposed rule to provide a "reference to the legal authority under which the rule is proposed." While the Proposal's preamble lists various statutes the Agency claims support its action, a closer look reveals that none of those sections actually authorizes EPA to disregard scientific studies. Certainly that is the case for the CAA sections listed by the Agency in the Proposal, including the general rulemaking authority under the Act which requires the evaluation of all material in the record. EPA's suggestion that it has "general authority" to make rules to comply with its obligations is similarly unavailing here, as the general authority does not exist to make rules that are outside EPA's statutory obligations, or in violation of them  -  and a rule that would enable EPA to disregard relevant studies in a CAA rulemaking record is clearly outside the Agency's authority. Nowhere does the Act permit EPA to limit its own access to relevant science.
Significant issues are presented in the Proposal only in the broadest terms, despite an APA requirement that a proposed rule includes "the terms and substance of the proposed rule or a description of the subjects and issues involved," 5 U.S.C. § 553(b)(3), and with enough specificity "to permit interested parties to comment meaningfully." As noted supra [in their comment letter], we assume (as we must, given no other information from the Agency), that the Proposal is aimed at precluding EPA's reliance on studies for which the data are not made public. That is the natural reading of the proposed regulatory language, which is the most choate information offered in the Proposal. But even that reading is not certain, given the very broad discretionary nature of the exemptions provided for in the rule text (see, e.g., 83 Fed. Reg. 18,774, proposed 40 C.F.R. § 30.9, giving the Administrator the ability to grant an exemption to the data publication requirement if that is "impracticable," which is undefined in the Proposal). As a result, it is unclear how this rule would apply to EPA decision making, and how it would be different than the Agency's current protocol for considering studies relevant to specific rulemaking proposals.
As one example, EPA alludes to "transparency" multiple times, but without defining what that concept means, or explaining why it believes existing statutes, regulations, guidelines and protocols fail to meet it. While asserting an interest in "ensur[ing] that the data and models underlying science is [sic] publicly available in a manner sufficient for validation and analysis," there is no more specific statement explaining how that would be implemented or why releasing confidential health and business information is necessary. Nor is the Agency's rationale completely clear in the Proposal. When commenters are left to guess, that is not lawfully sufficient notice of the subjects and issues involved.
Section 553(c) of the APA requires that when finalizing a proposed rule, and after taking comment, an agency must "consider[] the relevant matter presented" in the record. To the extent that the Proposal envisions authorizing EPA to ignore or disregard or not to consider some studies submitted during a rulemaking comment period, such Agency action would be taken in direct violation of this provision of the APA. Nor is there any basis in the APA for EPA to decide to exclude or prohibit the consideration of otherwise relevant matter because it is based on confidential information not available to the general public.
Response: See response to comment 25-96 in APA Section <IP_ADDRESS> of this document.
Comment [6900-3485]: Commenter (6921) contends that while EPA has sufficient legal authority across all of its environmental statutes to issue this important rulemaking, the Forum believes EPA can strengthen the foundation of the rule by including statute-specific provisions or by supplementing the rule with statute specific rulemakings. This will allow EPA to link the transparency requirements to the specific regulatory authorities in each environmental statute and to tailor the data access requirements, if necessary, to the specific rulemaking and data gathering provisions.
Response: Thank you for your comment in support of the final rule. EPA intends to promulgate future transparency rules under the substantive environmental statutes that it administers. Those rules will tailor transparency requirements as appropriate for each statute. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [8750-1430]: Commenter (9227) asserts that agencies are creatures of Congress; "an agency literally has no power to act . . . unless and until Congress confers power upon it." Louisiana Pub. Serv. Comm'n v. FCC, 476 U.S. 355, 374 (1986); see Am. Library Ass'n v. FCC, 406 F.3d 689, 691 (D.C. Cir. 2005) ("It is axiomatic that administrative agencies may issue regulations only pursuant to authority delegated to them by Congress."). EPA points to a smattering of statutes as allegedly authorizing the Proposal. None of these authorities, however, authorize EPA to promulgate a one-size-fits-all regulation governing how the agency will consider science under its various statutory authorities, which is perhaps why EPA solicits comment on whether additional authorities might exist to authorize its Proposal. The varied statutes that the Proposal cites have different requirements as to the agency's obligations when considering science. Compare CAA § 108(a) (standards must "reflect the latest scientific knowledge useful in indicating" health and welfare effects) with TSCA § 4(f) (Administrator must consider "any other information available") with SDWA § 1412(b)(1)(B)(ii)(II) (Administrator must consider "the best available public health information"). The Proposal gives no explanation of how any of the provisions it cites provide authority for the Proposal, much less how all of them authorize identical requirements.
For example, EPA cites the CAA, § 301, 42 U.S.C. § 7601, as purportedly granting authority for the Proposal. The authority granted by section 301(a), however, applies only to the CAA and, in any event, is not broad enough to encompass this Proposal. Section 301 provides that "[t]he Administrator is authorized to prescribe such regulations subject to section 307(d) as are necessary to carry out his [or her] functions under this Act." The courts have consistently "decline[d] to read ... open-ended power into section 301," and instead have required that regulations promulgated under section 301 be both necessary and appropriate. As discussed in more detail below, EPA's Proposal here is not necessary, and instead directly conflicts with several other provisions of the CAA. It is axiomatic that a "general grant of authority cannot trump specific statutory provisions."
Nor does Congressional authorization to conduct or fund research authorize EPA to ignore research in regulatory decision-making. Accordingly, provisions like TSCA § 10, which directs that the "Administrator shall ... conduct such research, development, and monitoring as is necessary to carry out the purposes of this [Act]," and CAA § 103, which authorizes the agency to conduct and support research, plainly do not authorize the Proposal.
Response: EPA is not relying on any of the substantive environmental statutes cited as authority in the 2018 and 2020 proposal. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [9066-1894]: Commenter (6188) notes that EPA cites numerous statutory provisions to support this rulemaking, but none provides authority for the agency to promulgate the Proposed Rule.
Generally, the statutory provisions EPA invokes fall into one of two categories: (1) provisions authorizing EPA to conduct research in furtherance of statutory objectives and (2) general provisions authorizing the EPA Administrator to promulgate regulations as necessary to achieve the purposes of a given statute. None of these statutory references provides the requisite authority for adoption and implementation of the Proposed Rule.
As a basis for authority to promulgate the Proposed Rule, EPA points to provisions authorizing the establishment of research and development programs pursuant to each of the federal environmental laws EPA administers. But these statutory references are unavailing. Each statute directs EPA to set up research programs and to undertake specific activities attendant to the administration of those programs, but none governs -- or even references -- the extent to which research should be used in regulatory decision-making by EPA. Further, any regulatory authority EPA may have under the referenced provisions is limited to the individual research and development programs in question and does not extend to unrelated research by outside parties. In other words, the cited provisions allow EPA to set up its own research programs, but do not create authority to place limitations on how research, whether conducted or financed by EPA or produced by an outside party, is used to set regulatory standards.
For example, EPA purports to derive authority for the Proposed Rule from CAA § 103. That provision simply authorizes EPA to establish a national research and development program for the prevention and control of air pollution and, as part of that program, to conduct and promote the coordination of research and studies relating to the causes, effects, extent, prevention, and control of air pollution. 42 U.S.C. § 7403(a)(1). The section authorizes specific activities of the Administrator in establishing such a program, none of which includes limiting the scope of reviewable data, research, or studies when undertaking regulatory action. The section has no bearing on how or to what extent EPA utilizes research in regulatory decision-making processes.
Response: EPA is not relying on any of the substantive environmental statutes cited as authority in the 2018 and 2020 proposal. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [9066-1895]: Commenter (6188) contends that the rulemaking authority provided by provisions authorizing the EPA Administrator to promulgate regulations "as necessary to carry out his functions" under various environmental statutes does not extend to actions that would undermine, rather than further, the relevant acts' directives. See 42 U.S.C. § 7601(a) (CAA); 33 U.S.C. § 1361 (CWA); 42 U.S.C. § 300j-9(a)(1) (SDWA); 42 U.S.C. § 6912(a)(1) (RCRA); 42 U.S.C. § 9615 (CERCLA); 42 U.S.C. 11048 (EPCRA); 7 U.S.C. § 136w (FIFRA). As discussed in greater detail below, both the intent and the language of the Proposed Rule are in direct opposition to the statutory requirements of these environmental statutes, which seek to protect public health and the environment.
The Proposed Rule, apparently mistakenly, also cites as authority 42 U.S.C. § 6979, a labor standards provision within the RCRA requiring certain prevailing wage standards to be met on construction projects receiving EPA grants, and 42 U.S.C. § 9616, a section of the CERCLA requiring listing and evaluation of facilities and commencement of remedial activities for listed facilities. Neither one of these sections is relevant to the Proposed Rule or to research activities more generally. Inclusion of these mistaken cites in the Proposed Rule's laundry list of "authorizing" provisions highlights the absence from that list of any statutory language that provides clear authority for a rule of this unprecedented breadth and import and the hasty nature of this rulemaking process.
In sum, EPA offers no legal authority upon which to base a rulemaking of this significance.
Response: EPA is not relying on any of the substantive environmental statutes cited as authority in the 2018 and 2020 proposal. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [9078-3508]: Commenter (6194) provides that "[I]t is `axiomatic' that `administrative agencies may act only pursuant to authority delegated to them by Congress." Clean Air Council v. EPA, 862 F.3d 1, 9 (D.C. Cir. 2017). Multiple statutes administered by EPA direct the agency to consider and utilize science. While the type of science to be considered, e.g., best science or best available science, and the process for considering science, e.g., as one of multiple, discrete factors or as part of broader balancing analyses, varies across statutes, nowhere do these statutes suggest that "best" science is limited to that for which associated raw data is available to the public. Courts have concurred. See, e.g., American Trucking Ass'n v. EPA, 283 F.3d 355, 372 (D.C. Cir. 2002) (finding that the CAA imposes no requirement for EPA to "obtain and publicize the data underlying published studies on which the Agency relies" and that "requiring agencies to obtain and publicize the data underlying all studies on which they rely `would be impractical and unnecessary.'") (internal citations omitted). The EPA may not read into a statute a requirement that makes its implementation impractical.
Nor do the statutes administered by EPA have a concept akin to the Proposal's "pivotal regulatory science." EPA is now attempting to re-interpret multiple statutes with virtually no analysis. Such reinterpretation would read new requirements into well-established statutes decades after their passage in a manner inconsistent with EPA's historic positions. If Congress had intended to create additional subcategories of regulations or science as suggested by the Proposal, it would have done so.
The Proposal's creation of a new category of regulation, "regulatory decisions," and new categories of science --  "pivotal regulatory science" and "regulatory science" -- rely on factors that Congress did not authorize or intend EPA to consider. When Congress wanted to place additional emphasis on certain types of or access to science it did so; not establishing subcategories of regulations or science tied to the availability of underlying data was a deliberate decision by Congress, not an oversight that EPA can write-in to the statutes. Hence, the Proposal would change EPA's interpretation of multiple statutes that govern the agency's consideration and use of science by creating new subcategories of science and regulations. None of the statutes referenced by EPA support the Proposal's suggestion to redefine regulations or science, much less require EPA to pursue the course it has proposed.
Response: See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [9078-3548]: Commenter (6194) contends that the Proposal would prevent EPA from relying on the best available information in discharging its duties. EPA is charged with developing regulations that provide societal benefits by reducing harm to human health and the environment from the presence of chemicals in air, soil, drinking water, food, and consumer products. The Proposal implicates research that is central to making such determinations; creating an obstacle to the consideration of such science is contrary to both primary statutory directives and requirements to conduct cost benefit analyses. Likewise, according to the commenter, the EPA fails to address how it could implement a regulation that is inconsistent with federal requirements and standards governing the use of science across agencies.
The commenter notes that the statutory requirements to develop health-based standards and conduct cost-benefit analyses EPA acknowledges that it must use the "best available science" in all of its regulatory actions.
This directive is embodied in multiple statutes implemented by EPA and is reflected in other environmental statutes, further illustrating Congress' conceptualization of "best" available science. Broadly speaking, there are three basic types of statutory requirements that the EPA and other agencies consider scientific information. First, there are requirements that the agency consider the "best available science." Second, there are requirements that the agency consider particular factors, including scientific factors. Third, there are requirements that the agency balance economic costs or technological feasibility against public health, environmental, or other benefits that must be scientifically assessed. The precise terminology regarding the required use of science may, as illustrated below, vary across statutes, but what these provisions have in common are requirements for EPA and other agencies to use scientific information that is "best," not simply adequate, and "available." The commenter provides that following examples of statutory directives regarding the use of science by the EPA and other Agencies.
 SDWA [42 U.S.C § 300g1(b)(3)(A)]: EPA must use "[t]he best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices," and "[d]ata collected by accepted methods or best available methods (if the reliability of the method and the nature of the excision justifies use of the data)."
 [42 U.S.C. § 300g1(b)(1)(b)(ii)]: EPA must use "best available public health information" in determining whether to regulate contaminants.
 CWA [33 U.S.C. § 1321(a)(27)]: Some provisions dealing with oil and hazardous substances on the Gulf Coast require "best available science."
 TSCA [15 U.S.C. § 2625(h)]: "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".
 Magnuson -  Stevens Fishery Conservation and Management Act (MSA) [16 U.S.C. § 1851(a)(2)]: "Conservation and management measures shall be based upon the best scientific information available."
 Endangered Species Act (ESA) [16 U.S.C. § 1536(a)(2)]: In consultation to ensure no jeopardy to endangered or threatened species, "each agency shall use the best scientific and commercial data available."
 [16 U.S.C. § 1536(c)(1)]: Advice that an endangered or threatened species may be present in a location should be "based on the best scientific and commercial data available."
 [16 U.S.C. § 1536(h)(2)(b)(i)16 U.S.C. § 1533(b)(1)(A)]: Permanent exceptions shall be given to prevent extinction of species "based on the best scientific and commercial data available." The Secretary must determine whether a species is a threatened or endangered based upon "the best scientific and commercial data available."
 Marine Mammal Protection Act (MMPA) [16 U.S.C. § 1371(a)(4)(C)]: "If the Secretary determines, using the best scientific information available, that certain forms of deterrence have a significant adverse effect on marine mammals, the Secretary may prohibit such deterrent methods, after notice and opportunity for public comment, through regulation under this chapter."
 [16 U.S.C. § 1371(a)(3)(A)]: The decision to waive the ban on taking must be based on the "best scientific evidence available and in consultation with the Marine Mammal Commission."
None of these statutory provisions link the concept of the "best available science" to the availability of underlying raw data, nor can such a limitation be read into the statutes. Where Congress wanted to direct EPA's decision regarding what science to consider or how -- it did so. When Congress wanted to link "best available science" to data being publicly available -- it did so. Thus, if Congress had wanted to put a blanket limitation on EPA's consideration of science for which underlying data is not publicly available, it clearly knew how to do so -- and it chose not to.
As EPA has previously explained, the agency would be unable to fulfill statutory mandates if it could not consider studies that follow federal laws and ethical standards regarding the privacy of patient and individual data:
      (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 the proprietary interests of the investigators or because of arrangements made to maintain confidentiality regarding personal health status and lifestyle information of individuals included in such data. Without provisions of confidentiality, the possibility of conducting such studies could be severely compromised.)
Examples of EPA statutory mandates that could be impeded by the Proposal include (i) the development of standards to control emissions from burning hazardous waste fuels under the RCRA "as may be necessary to protect human health and the environment," 42 U.S.C. § 6924(q)(1); and (ii) determinations of whether hazardous sites need to be placed on the CERCLA National Priorities List (NPL). With respect to the latter, CERCLA provides that, if a health assessment indicates that a release or threatened release may pose a serious threat to human health, the Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR) shall "notify the Administrator of EPA who shall promptly evaluate such release or threatened release in accordance with the hazard ranking system . . . to determine whether the site shall be placed on the National Priorities List." 42 U.S.C. § 9604 (i)(6)(H). The commenter note that health assessments provided by ATSDR to EPA on a scheduled basis are exempt from peer review as a prerequisite to submission.
The Proposal would also cut EPA off from information needed to complete the cost-benefit analysis of regulations required under certain statutes and government-wide requirements.
Not only would the Proposal impede EPA's fulfillment of its statutory duties, it would also be contrary to judicial precedent, which holds that "best available science" includes "all existing scientific evidence relevant to the [agency] decision [in question]." Ecology Ctr., Inc. v. U.S. Forest Serv., 451 F.3d 1183, 1194 n.4 (10th Cir. 2006) (quoting Heartwood, Inc. v. U.S. Forest Serv., 380 F.3d 428, 436 (8th Cir. 2004)). While agencies need not produce new evidence, they must seek out information and "`cannot ignore existing data.'" Id. (emphasis added). Even if an agency is anticipating the arrival of better evidence, it must act on the basis of the evidence it currently has. Many of the fundamental public health studies on which EPA has based key rules and standards under the statutes are studies for which the raw data was not or could not have been released. Nonetheless these studies have been examined and validated, as will future studies. Arbitrarily cutting off consideration of a category of science is inconsistent with EPA's statutory obligations.
Response: See response to Comments 32-144, 34-155, 48-381 and 73-410 in RTC document Section 1.2.2.
Comment [9217-3544]: Commenter (9225) asserts that equally problematic, the proposed rule is not authorized by any authority delegated to EPA by Congress and is contrary to a number of statutes under EPA's authority. This includes, but is not limited to, the CAA; CWA; TSCA; Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA); SDWA; FIFRA; and more. Substantively, the rule violates numerous public health and environmental provisions contained in these laws, as well as requirements to use the best available science or to consider all available information, while procedurally, it violates the APA and a number of other laws that set forth specific procedures EPA must follow during its rulemaking process. It also lacks an environmental justice analysis even though the rule will have the greatest impact on low-income and minority communities that benefit from protections based on the very studies the rule restricts from consideration when setting exposure limitations for pollution and toxic chemicals. Simply put, the proposal cannot withstand legal scrutiny.
Response: See responses to Comments 32-144, 48-381 and 73-410 in RTC document Section 1.2.2. Also see response 48-502 in the APA Section <IP_ADDRESS> of the RTC document.
Comment [6092-476]: Commenter (6102) notes that as EPA takes strides to increase transparency, it is imperative that the agency assure full compliance with all statutory requirements for the protection of privacy, the confidentiality of research participants, the protection of proprietary data and the confidentiality of business information. The EPA should continue to explore and develop protocols to code or de-identify data sets to make them available while fully protecting privacy. Given these challenges, the NAM recommends the EPA explore ways to tailor requirements on a statute-by-statute basis as appropriate.
Response: EPA intends to promulgate future transparency rules under the substantive environmental statutes that it administers. Those rules will tailor transparency requirements as appropriate for each statute. See response to Comment 73-410 in RTC document Section 1.2.2.
Comment [6894-3619]: Commenter (6915) notes that EPA asks, "whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles on the programmatic or statutory level would be appropriate as alternative or additional steps." (83 FR 18771). It is EPA's job to identify and describe these alternatives, and to explain why it has put forward its particular proposal: it may not, at this late stage, ask amorphous questions on policy design.
Response: EPA disagrees that it was inappropriate or impermissible for the agency to seek comment on alternative methods to implement this policy besides rulemaking.
Comment [6425-2389]: Commenter (6447) asserts that EPA has not identified any legitimate justification for this proposal, has failed to support the proposal with any kind of administrative record, and has failed to obtain support for the proposal from its own Science Advisory Board (SAB), rendering it arbitrary and capricious. Moreover, the proposal violates existing law. For these reasons, and because it is clear that the proposal would undermine EPA's mission and public health, we are strongly opposed. EPA should not create any new restrictions on the use of scientific information.
Response: EPA provided a rationale for the rule in the 2018 proposal and expanded and clarified its justification for the rule in the 2020 supplemental proposal. EPA also sought and received input on the rule from the SAB. The rule does not limit the studies the agency may consider in actions to satisfy its mission to protect human health and the environment.
1.1.2 General Legal Authority (Supplemental Notice of Proposed Rulemaking (SPNRM) Comments)
Comment [29-121]: Commenter (11184) writes that EPA lacks authority for the proposed rule and SNPRM.
The SNPRM changes the authority EPA claims to rely on for the proposal, however either way, the proposal remains unlawful. The text of the SNPRM proposes to rely solely on 5 U.S.C.§ 301. 85 Fed. Reg. at 15404. The preamble says EPA is taking comment on whether to use 5 U.S.C. § 301, which the SNPRM calls EPA's housekeeping authority, independently or in conjunction with statutory provisions cited in the proposed rule and corrected in the SNPRM's preamble. 85 Fed. Reg. at 15398. The fact that EPA is still considering and asking what authority it can rely on for the proposed rule, twenty-two months after the initial proposed rule, shows that EPA does not have such authority. The SNPRM's statements on authority continues EPA's pattern of making rules first and searching for a justification later (which it still has not provided for this rulemaking). As the NTAA explained in its 2018 comments: In order to protect human health and environment, EPA must have a solid foundation before it proposes rules and rulemaking as such portrays the agency's naivete in seeking answers for questions about its own authority.
First, none of the initial or corrected environmental statutes provide EPA authority for the proposed rulemaking. In most cases, EPA simply cites its general authority for rulemaking under the statutes. Still that general authority alone cannot provide a basis for the rule, especially when, as here, the rule would conflict with the requirements of each of the statutes. Courts have made clear that "EPA cannot rely on its gap-filling authority to supplement [a statute's] provisions when Congress has not left the agency a gap to fill." NRDC v. EPA, 749 F.3d 1055, 1064 (D.C. Cir. 2014); see also New York v. US EPA, 413 F.3d 3, 40-42 (D.C. Cir. 2005). EPA otherwise cites to statutes describing research programs established by the agency, with no relation to or authorization for the requirements the SNPRM seeks to create. The KBIC also disagrees with EPA's reliance on 5 U.S.C. § 301 because 1) it is questionable whether§ 301 applies to EPA as EPA is not one of the fifteen "Executive Departments" listed at 5 U.S.C. § 101, and 2) the proposed rule and SNPRM are not merely internal rules of agency procedure-they would significantly impact every aspect of EPA's scientific and regulatory work, the individuals who contribute to that work, and the Tribes and communities who rely on it.
The KBIC appreciates the SNPRM's recognition that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." 85 Fed. Reg. at 15398. This statement alone should lead EPA to withdraw the proposed rule and SNPRM; the requirements conflict with every statute EPA administers and would cause EPA to unlawfully exclude valid scientific research from its work.
Response: As discussed in the final rule preamble at Section I. C, EPA is not claiming authority under the Federal Housekeeping Statute, 5 U.S.C. § 301. Rather, EPA maintains that the Reorganization Plan No. 3 of 1970, which established EPA, transferred authority to EPA that is equivalent to Federal housekeeping authority.
This is a procedural rule because it exclusively governs EPA's internal affairs and does not regulate any person or entity outside of EPA. See Chrysler Corp. v. Brown, 441 U.S. 281, 302 (1979). EPA is not interpreting, applying, or citing as authority any of the substantive environmental statutes that it administers. EPA plans to issue subsequent rulemakings implementing this procedural rule, some of which may be substantive and therefore subject to judicial review. If implementing this procedural rule will result in a conflict with an environmental statute that EPA administers, then this procedural rule will yield under § 30.3.
Comment [48-441]: Commenter (12727) writes that as they explained in their comments on the 2018 proposal, none of the environmental statutes EPA identifies in the original proposal authorize EPA to issue the proposed rule or otherwise promulgate a one-size-fits-all regulation governing how the agency will consider science under its various statutory authorities. EPA gives no explanation of how any of the provisions it cites provide authority for the 2018 proposal and Supplemental Notice, much less how all of them authorize identical requirements despite their varied obligations for considering science. Not only is there still no authority for EPA's pan-statutory proposal, but the 2018 proposal as supplemented would force EPA to more broadly violate a diversity of obligations to consider science under the different environmental laws. While the specifics of the requirements vary, Congress has often commanded EPA to utilize the "best available science" for its policies, which necessitates consideration of the full range of available science. The proposal would restrict consideration of science and cause EPA to violate both its general statutory obligations to consider all available data when undertaking rulemakings as well as the specific requirements to consider science under the respective environmental statutes.
The Supplemental Notice multiplies this defect, broadly expanding the regulation to cover "data and models underlying pivotal regulatory science and pivotal science used to support significant regulatory decisions and influential scientific information, respectively, not simply dose-response data and dose-response models" -- effectively hamstringing the agency from considering the best available science across its full portfolio of actions to protect the environment and public health, and impeding its ability to gain a better understanding of the threats to public health and the environment. Nothing in the Supplemental Notice remedies this expansive defect or even attempts to reduce it.
Response: See response to comment 29-121.
Comment [48-479]: Commenter (12727) notes that several environmental statutes require EPA to ground its decision-making in scientific evidence. The CAA, for example, mandates that "[a]ir quality criteria . . . accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare," 42 U.S.C. § 7408(a)(2), and the Toxic Substances Control Act requires the Administrator to "make decisions . . . based on the weight of the scientific evidence," 15 U.S.C. § 2625(i)."
The originally proposed regulatory language (§§ 30.3, 30.5) violated these statutory commands by preventing EPA from relying on a study as "pivotal regulatory science . . . used to justify significant regulatory decisions" if dose-response data or models underlying the study were not publicly available, without regard to whether the study had been validated by other means. The Supplemental Notice exacerbates these violations by expanding the proposed regulation's scope (§§ 30.3, 30.5) to not just pivotal regulatory science used to justify significant regulatory decisions, but also "pivotal science supporting influential scientific information."
Response: See response to comment 29-121.
Comment [48-490]: Commenter (12727) writes that just as EPA is required to consider all available science when making its regulatory decisions, governing environmental and public health statutes likewise require EPA to consider all available science when releasing ISI, which often forms the basis for the agency's regulatory decisions. For example:
CAA section 108 instructs EPA to establish air quality criteria that "accurately reflect the latest scientific knowledge," which criteria, in turn, must inform NAAQS.
The TSCA directs that, in implementing the Act's testing requirements, manufacturing and processing notice requirements, and requirements for the prioritization, risk evaluation, and regulation of chemical substances and mixtures, EPA must make its decisions "based on the weight of the scientific evidence." Likewise, in carrying out EPA's responsibilities under TSCA, "the Administrator shall use scientific information . . . employed in a manner consistent with the best available science." Numerous other TSCA provisions emphasize EPA's obligation to consider all reasonably available scientific information when implementing TSCA's requirements.
The CWA instructs that EPA's water quality criteria must "accurately reflect[] the latest scientific knowledge" on a variety of factors.
The SDWA generally requires EPA to use "the best available, peer-reviewed science," and to use the "best available public health information" when deciding whether to regulate a particular contaminant.
A rule that prohibits EPA from considering (or that downgrades) valid, high quality scientific studies when generating ISI such as the products identified above would contravene the above- noted statutory directives regarding EPA's obligation to consider all available science.
Response: See response to comment 29-121.
Comment [48-495]: Commenter (12727) writes that there are also many circumstances under which EPA develops [ISI] with broad applicability to multiple programs or varying governmental actions that have yet to be identified. Such products include Integrated Risk Information System (IRIS) chemical reviews by EPA's Office of Research and Development (ORD) (e.g., the 2019 "IRIS Toxicological Review of Ethyl Tertiary Butyl Ether (ETBE)" and "IRIS Toxicological Review of Tert-Butyl Alcohol (TBA)"), and reports by EPA's Office of Chemical Safety and Pollution Prevention (e.g., "Continuing Development of Alternative High- Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways"). EPA's application of the proposed public disclosure regulations to such products is especially pernicious because it would likely be impossible -- or at least, immensely burdensome -- to determine at the time that the ISI is utilized in agency decision- making whether, in developing the ISI, EPA omitted from consideration (or gave lesser weight to) valid scientific studies that EPA is obligated to consider fully under the relevant statutory or regulatory provisions.
For example, the purpose of ORD's IRIS chemical reviews is to support EPA's mission of protecting public health and the environment by identifying and characterizing the health hazards of chemicals found in the environment. [...] Among other things, EPA uses this information to help set national standards under TSCA, the CAA, the SDWA, and the EPCRA, and to clean up hazardous sites under CERCLA. But none of these statutes allow EPA to ignore valid, pivotal scientific studies based solely on the fact that underlying data or models are not publicly available. If ORD is forced to exclude consideration of such studies when developing its IRIS chemical reviews, EPA's reliance on these reviews when taking actions under these statutes would be unlawful and arbitrary unless EPA combs through the report and available science to confirm that all valid studies have been considered. The need to undertake such a comprehensive review of ISI before relying upon it would fundamentally undermine the purpose of preparing ISI for general use by EPA's various programs, offices, and regions. Thus, beyond the numerous statutory violations described above.
Response: See response to comment 29-121.
Comment [48-503]: Commenter (12727) writes that EPA must withdraw the Supplemental Notice as inconsistent with its substantive obligations to use the best available science. Apparently anticipating these conflicts, EPA concedes that:
"This internal agency procedure is intended to be consistent with the statutes that EPA administers and EPA plans to implement this procedural rulemaking in accordance with all applicable statutory and regulatory requirements. . . . Nonetheless, in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control."
This rationale is vague and meaningless. As an initial matter, EPA has not explained how its rule is "intended to be consistent with" the statutes it administers, nor has it attempted to identify the areas of conflict it anticipates, which renders its promise to yield to their requirements arbitrary. Even if it had offered some indication of the conflicts it foresees, its protean response is ineffectual: to the extent that the agency seeks to inoculate its rule against legal challenges based on these statutory violations, any invalid application -- of the many that would proliferate upon implementation -- would doom the rule. EPA cannot insulate its unlawful policy from challenges by promising to yield in the future to statutory and regulatory requirements.
Nor does EPA enhance its rule with the mere suggestion that its options for considering studies in some circumstances "improve consistency" with statutes requiring use of the best available science. Aside from the inherent flaws in these approaches, discussed in greater detail occasional compliance with statutory requirements cannot render its rule lawful. To correct the numerous statutory violations documented above, EPA must conform its actions to the directives Congress imposed; partial alignment will not suffice.
Response: See response to comment 29-121. The purpose of the savings clause is to clarify the scope of the rule and how it will be implemented by EPA. Specific standards set by the various environmental statutes will be discussed as appropriate when EPA develops subsequent rulemakings implementing this final procedural rule. As explained above, EPA is not relying on the substantive environmental statutes as authority for this rule. See the final rule preamble discussion at Section I. C.
Comment [48-600]: Commenter (12727) writes that EPA's failure to characterize costs and benefits necessarily precludes the agency from assessing whether the costs are disproportionate to the benefits, a finding that could render the proposal arbitrary and capricious. As described below, this failure extends to harms that the proposal would inflict upon the public at large, vulnerable populations, the research community, and the agency. EPA does not identify any statutory authority that could justify its failure to assess the costs and benefits of the proposed rule, and it is certain that the agency could not rely on a radical use of a generally applicable statute like the Housekeeping Act in order to evade well-established requirements of administrative law.
Response: Because this final rule is internal and purely procedural, it will not impose any direct costs or benefits outside of EPA.
Comment [54-249]: Commenter (11361) writes that in addition to asserting that the EPA can introduce these changes under its housekeeping authority, the EPA also lays the groundwork in this SNPRM to subvert public comment in the future. The EPA states that it is "considering how to proceed, apart from this supplemental proposal, to establish regulations interpreting provisions of, and/or exercising substantive rulemaking authority delegated to it by programmatic statutes." Creating regulations specifically about how the EPA interprets or carries out its statutes could result in a process whereby many, perhaps all, new environmental regulations pursuant to the EPA's statutes, including the CAA and CWA, would be considered internal procedures and thus give the EPA leeway to circumvent the APA's required notice-and-comment rulemaking. The EPA has been acting with an aggressive deregulatory agenda for the last three years. This action not only shuts the public out of federal environmental decisions but could lay the groundwork for discarding all of the EPA's regulatory accountability. They firmly oppose the establishment of regulations that could allow the EPA to circumvent notice-and-comment rulemaking.
Response: Any substantive regulations issued under the environmental statutes that EPA administers will be subject to notice and comment rulemaking as required in the APA.
Comment [73-412]: Commenter (11576) writes that the environmental statutes cited in the Supplemental Notice offer no support for the proposed rule.
In its original notice, of course, the EPA made no attempt to rely on any kind of "housekeeping" power. Instead, the agency said it was "propos[ing] to take this action under authority of the statutes it administers, including provisions providing general authority to promulgate regulations necessary to carry out the Agency's functions under these statutes and provisions specifically addressing the Agency's conducting of and reliance on scientific activity to inform those functions[.]" The EPA went so far as to list the specific statutory sections that it believed its rule could rest on, 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.
None of these provisions offered any support for the proposed rule -- and many were at odds with it. As noted during the prior comment period, "restricting sound science is neither necessary nor consistent with the ... goals" of the referenced environmental statutes. A few of the citations, moreover, appeared to be entirely irrelevant.
With its supplemental notice, the EPA appears to abandon its misguided effort to rely on the laws it had previously cited, stating that it no longer "propose[s] to interpret provisions of a particular statute or statutes that it administers[.]" At the same time, however, the notice declares that the agency is still "taking comment on whether to use its housekeeping authority independently as authority or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rulemaking[.]" And it also corrects two of the citations included in the agency's earlier list, "clarifying that the citation to the Resource Conservation and Recovery Act ... section 7009, 42 U.S.C. 6979, should be to ... section 8001, 42 U.S.C. 6981[,]" and "the citation to the CERCLA ... section 116, 42 U.S.C. 9616, should be to ... section 115, 42 U.S.C. 9615[.]"
Given the EPA's inconsistent statements regarding the relevance of the statutory provisions it has cited, it is not at all clear what the public is being asked to comment on. What is clear, however, is that the agency's two new citations do nothing to support the proposed rule. As none of the environmental statutes the agency has cited provide a legal basis for the proposed action, the EPA would get nowhere in trying to use them "in conjunction" with the agency's asserted and inapposite housekeeping authority.
Response: See response to comment 29-121.
Comment [79-527]: Commenter (12427) writes that there is no statutory requirement or deadline for the proposed rule for "Strengthening Transparency in Regulatory Science" or its supplemental notice. In fact, there is no statutory mandate for this proposed rule, at all. Thus, there is no requirement or need for this rule or its supplemental notice. The proposed rule and supplemental notice should be withdrawn.
Response: EPA identified a need to standardize its internal process for considering the availability of data and models underlying pivotal science used in its significant regulatory decisions and ISI so that EPA can promulgate future regulations in a more efficient and transparent manner. EPA decided to meet that need by issuing a housekeeping regulation. As explained in the final rule preamble at Section I. C, EPA's Reorganization Plan transferred the authority to issue housekeeping regulations to EPA, and EPA is issuing this procedural rule in accordance with that authority.
Comment [81-584]: Commenter (12715) writes that the proposed rule conflicts with fundamental statutory requirements to use the best available science and citation to "housekeeping" authority cannot cure that defect.
Whether EPA is arbitrarily barring consideration of scientific studies or information with nonpublic underlying data or data that are not able to be independently validated, or arbitrarily ascribing less weight to such studies or information, neither approach constitutes "housekeeping," and neither comports with statutory requirements that EPA use the best available science. To reiterate from the 2018 Comments, EPA's obligation with respect to the use of scientific information is clear: it must base its decisions on such criteria as the latest scientific knowledge, the best available, peer-reviewed science, and/or generally accepted scientific principles or laboratory tests. To cite just a few examples, in performing its duties, EPA must rely on: "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices," SDWA of 1996, 42 U.S.C. § 300g-1(b)(3)(A)(i); the "best available science," TSCA, 15 U.S.C. § 2625(h); "the latest scientific knowledge," CWA of 1977, 33 U.S.C. § 1314(a)(1), and CAA of 1970, 42 U.S.C. § 7408(a)(2); and "generally accepted scientific principles or laboratory tests, or appropriately designed and conducted epidemiological or other population studies," EPCRA, 42 U.S.C. § 11023(d)(2). EPA has repeatedly emphasized the importance of this fundamental precept, including in its 2018-2022 strategic plan, which states that one of the agency's priorities is to "identify, assess, conduct, and apply the best available science to address current and future environmental hazards."
These statutory requirements apply to all aspects of EPA's decision-making, including its scientific evaluations, adoption of regulatory standards, and development of policies. They do not permit what EPA proposes here: to either exclude or give less weight to scientific studies or information based on criteria -- availability of the underlying data and ability to independently validate underlying data -- that are not determinative of whether the studies or information constitute the best available science. Agencies may not adopt or implement regulations that conflict with the statutes under which they are promulgated, and an agency's interpretation of those statutes must always at least be reasonable. See Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 842-44 (1984). Furthermore, neither 5 U.S.C. § 301 nor any other purported housekeeping authority allows EPA to negate these statutes' fundamental, substantive, and common-sense commands. And even assuming EPA has some inherent housekeeping authority, it cannot rely on a general grant of rulemaking authority to promulgate regulations or develop policies that are otherwise inconsistent with more specific statutory directives. Glob. Van Lines, Inc. v. Interstate Commerce Comm'n, 714 F.2d 1290, 1293-97 (5th Cir. 1983).
Finally, EPA acknowledges that the statutes it administers would control in the event of a conflict between the proposed rule and those statutes, see 85 Fed. Reg. at 15,398, but that caveat cannot save the proposed rule. First, the core principle of the proposed rule is facially invalid, i.e., there is no circumstance in which it would be acceptable for EPA to exclude or give less weight to relevant, probative scientific studies, models, or other information that have been validated through peer review, on the sole basis that the underlying data are not publicly available or are not able to be independently validated. EPA cannot save an invalid rule by including what amounts to a waiver procedure, because the "essence of waiver is the assumed validity of the general rule." Alltel Corp. v. Fed. Commc'n Comm'n, 838 F.2d 551, 561 (D.C. Cir. 1988). Second, the agency's essential duty in rulemaking is to exercise its subject matter expertise to enact rules that implement and further the purposes of the statutes Congress has assigned it to administer. Chevron, 467 U.S. at 842-44. This does not include proposing rules without first determining the source of legal authority but instead asking commenters to supply that information. Third, the agency must propose its rules with specificity and be clear as to the programs, regulations, and information to which they will apply. 5 U.S.C. § 553(b)(3); Home Box Office, Inc., supra, 567 F.2d at 35-36.
Response: See response to comment 29-121. EPA identified applicable authority in the proposal (83 FR 18768), the supplemental (85 FR 15396), and the final rule Federal Register notice. [See Docket No. EPA-HQ-OA-2018-0259].
EPA also requested public comment on whether the authority EPA identified was appropriate. Requesting public insight on a proposed path forward is part and parcel of the notice and comment process.
Comment [82-695]: Commenter (12464) writes that both alternatives are inconsistent with the statutes directing which data EPA must consider in certain contexts. As they explained in a previous comment letter, many statutes require EPA to consider science in its decision-making, without any reference to whether such science is based on studies with raw data that is publicly available. For example, under the CAA, EPA must set and review the NAAQS for six common pollutants. In setting these standards, the CAA instructs EPA to use "the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects [of air pollution] on public health or welfare." Thus, a conflict would arise between the statutory language and the reduced-weight alternative if EPA gave less weight to a study that was "the latest scientific knowledge" on a relevant question merely because the raw data from that study is not publicly available. The same conflict would exist with the proposed tiered-access system, if the "latest scientific knowledge" came from a study with raw data to which researchers have not or could not grant restricted access.
Response: See response to comment 29-121.
Comment [82-834]: Commenter (12464) writes that the Proposal is similarly substantive as it "relocates the metes and bounds" of "best available science" requirements under the multiple environmental statutes that EPA implements. Specifically, the Proposal not only changes "how" EPA performs environmental decision-making under these statutes, but it also changes "what" studies EPA must consider as "best available science" when issuing ISI and making significant regulatory decisions. Indeed, the Supplemental Notice acknowledges that the purpose of the proposed rule is "to establish an agency-wide approach to ensure that the data and models underlying EPA's significant regulatory decisions are publicly available." 85 Fed. Reg. at 15,398.
Response: See response to comment 29-121.
Comment [82-865]: Commenter (12464) writes that the Proposal is inconsistent with EPA's duties under multiple statutes and executive orders. They pointed out many of these conflicts in comments on the Initial Proposal, but the Supplemental Notice continues to make the same errors. Moreover, some changes introduced in the Supplemental Notice exacerbate the problems.
Response: See response to comment 29-121. EPA issued this rulemaking consistent with its obligations under all applicable executive orders.
Comment [84-1403]: Commenter (11390) writes that the proposed rule falls outside EPA's rulemaking authority.
Despite EPA's assertion that the amended Proposed Rule governs "internal agency procedures" and "does not regulate any entity outside the Federal government," the Proposed Rule is, in fact, a substantive regulation. It will profoundly impact how EPA interacts with regulated parties by changing how the agency performs its core functions.
"It is axiomatic that an administrative agency's power to promulgate legislative regulations is limited to the authority delegated by Congress." Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988). EPA steps far beyond that authority in the SNPRM, proposing a regulation that would change the way the agency engages in virtually any decision-making or scientific process -- outside of agency adjudications and enforcement activities -- whether or not that process ultimately leads to the adoption of regulations. EPA has revised the Proposed Rule to cite the agency's housekeeping authority as its basis to regulate. But EPA has no statutory authority to issue the Proposed Rule, either through the Housekeeping Statute or via other environmental statutes EPA has previously cited.
EPA also continues to cite to numerous provisions in environmental statutes to support this rulemaking, but none provides authority for the agency to promulgate the Proposed Rule. Generally, these provisions fall into one of two categories: (1) provisions authorizing EPA to conduct research in furtherance of statutory objectives and (2) general provisions authorizing the EPA Administrator to promulgate regulations as necessary to achieve the purposes of a given statute. None of these statutory references provides the requisite authority for adoption and implementation of the Proposed Rule.
EPA points to provisions authorizing the establishment of research and development programs pursuant to each of the federal environmental laws EPA administers. But these statutory references are unavailing. Each statute directs EPA to set up research programs and to undertake specific activities attendant to the administration of those programs, but none governs -- or even references -- the extent to which research should be used in regulatory decision-making by EPA. Further, any regulatory authority EPA may have under the referenced provisions is limited to the individual research and development programs in question and does not extend to unrelated research by outside parties. In other words, the cited provisions allow EPA to set up its own research programs, but do not create authority to place limitations on how research, whether conducted or financed by EPA or produced by an outside party, is used to set regulatory standards.
For example, EPA purports to derive authority for the Proposed Rule from CAA § 103. That provision simply authorizes EPA to establish a national research and development program for the prevention and control of air pollution and, as part of that program, to conduct and promote the coordination of research and studies relating to the causes, effects, extent, prevention, and control of air pollution. 42 U.S.C. § 7403(a)(1). The section authorizes specific activities of the Administrator in establishing such a program, none of which includes limiting the scope of reviewable data, research, or studies when undertaking regulatory action. The section has no bearing on how or to what extent EPA utilizes research in regulatory decision-making processes.
The rulemaking authority provided by provisions authorizing the EPA Administrator to promulgate regulations "as necessary to carry out his functions" under various environmental statutes does not extend to actions that would undermine, rather than further, the relevant acts' directives. See 42 U.S.C. § 7601(a) (CAA); 33 U.S.C. § 1361 (CWA); 42 U.S.C. § 300j-9(a)(1) (SDWA); 42 U.S.C. § 6912(a)(1) (RCRA); 42 U.S.C. § 9615 (CERCLA); 42 U.S.C. 11048 (EPCRA); 7 U.S.C. § 136w (FIFRA). As discussed in greater detail below, both the intent and the language of the Proposed Rule are in direct opposition to the statutory requirements of these environmental statutes, which seek to protect public health and the environment.
In sum, EPA offers no legal authority upon which it may lawfully base a rulemaking of this significance.
Response: See response to comment 29-121. As discussed in the final rule preamble at Section I. C, this is a procedural rule governing EPA's internal affairs. It does not regulate or affect the legal rights and obligations of parties outside of the agency, and therefore is not a substantive rule. An internal rule of agency procedure is not substantive merely because it may indirectly affect the voluntary behavior of parties outside of the agency. See American Hosp. Ass'n v. Bowen, 834 F.2d 1037, 1051 (D.C. Cir. 1987) ("[A]gency rules that impose `derivative,' `incidental,' or `mechanical' burdens upon regulated individuals are considered procedural, rather than substantive").
This procedural rule does not impose requirements on external scientists. Instead, this rule exclusively regulates EPA employees. It is not intended to impose burdens on external scientists who want EPA to consider their research when making significant regulatory decisions or developing ISI, particularly since the final rule does not require EPA to categorically exclude studies for which the data is not available. EPA has explained that this procedural rule has limitations on its scope in terms of conflicts with other substantive requirements and that, in situations where this rule applies, EPA will give greater consideration to those studies where the underlying data and models are available for independent validation. That means that the agency will consider all relevant studies when taking covered actions.