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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
published the Strengthening Transparency in Regulatory Science Supplemental Notice of Proposed Rulemaking 2020 SNPRM, Ref. 7, in which the EPA clarified some of the citations in the 2018 proposed rule Ref.
5. However, because this is purely a procedural rule, the EPA is not relying on any substantive environmental statutes as authority.
This action is a procedural rule within the scope of the EPAs housekeeping authority. As the Supreme Court explained in Chrysler Corp., rules of internal agency management are considered procedural rules as opposed to substantive rules under the APA.5 Even if there could be downstream practical effects on the voluntary behavior of outside parties and on outside parties interactions with the EPA, such impacts do not render this procedural rule substantive. See American Hosp. Assn v. Bowen, 834
F.2d 1037, 1051 D.C. Cir. 1987
Agency rules that impose derivative, incidental, or mechanical burdens upon regulated individuals are considered procedural, rather than substantive.. As the Supreme Court explained in Chrysler Corp., the central distinction among agency regulations found in the APA is that between substantive rules on the one hand and interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice on the other. 6
The Supreme Court further clarified that unlike procedural rules, substantive rules have legal force and effect on individual rights and obligations, and noted that whether a rule affects individual rights and obligations is an important touchstone for distinguishing substantive rules from other types of rules.7 This final rule does not regulate the rights and obligations of any party outside of the EPA let alone have legal force and effect on them. Any incidental impacts on voluntary behavior outside of the EPA
do not render this a substantive rule.
Some public commenters asserted that the EPA lacks the authority under the substantive environmental statutes that it administers to promulgate this rule. However, the EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In this final procedural rule, the EPA does not interpret or apply provisions of a particular statute or statutes that it administers. The EPA
will undertake such efforts in forthcoming actions, which will be 5 Chrysler
Corp., 441 U.S. 281 at 30102.
at 301 quoting 5 U.S.C. 553b, d.
7 Id. at 302.
6 Id.

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either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule. Some of these subsequent actions will be substantive rules issued under the associated environmental statutes and will be subject to judicial review. In this action, the EPA is finalizing a rule of internal agency procedures, including how the Agency will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information for independent validation.
Some public commenters nonetheless took the position that this rule is substantive because it will affect the Agencys interactions with regulated parties. First, and as discussed above, this final rule does not regulate any party outside of the EPA but rather exclusively governs the EPAs internal process for determining the consideration to afford pivotal science with respect to certain actions. This rule does not require any researcher or other outside entity to provide data or models to the EPA. Nor does the rule categorically exclude studieseven studies where the underlying doseresponse data are not available for independent validationand therefore any incidental impact on researchers who are developing science and deciding whether to make the underlying dose-response data available is negligible. Instead, it governs internal agency procedures for determining the consideration to afford various studies according to factors that include data availability. In doing so, the final rule provides greater transparency on the consideration the EPA will give pivotal science where the underlying doseresponse data are or are not available for independent validation.
Certain commenters stated that the final rule is substantive because they asserted it imposes burdens on scientists who endeavor to have their research considered by the EPA when it makes regulatory decisions or develops influential scientific information. The EPA notes, however, that procedural rules do not alter the rights or interests of parties but they may alter the manner in which the parties present themselves or their viewpoints to the agency, without thereby becoming substantive rules James A. Hurson Assocs. v. Glickman, 229 F.3d 277, 280
D.C. Cir. 2000. If researchers want to increase the likelihood that their studies receive greater consideration by the EPA, they may take steps to ensure that the underlying dose-response data are available to the greatest extent possible.
But any such response to this final rule
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would be purely voluntary. It is not required by this rule.
Some commenters also argued that this rule is not procedural because they asserted it conflicts with the substantive environmental statutes administered by the EPA. However, this final rule does not interpret or apply the provisions of any environmental statutes; such efforts will occur in the subsequent actions under the relevant statutes described above. As this rule makes clear, if implementing this procedural rule would result in conflicts with existing environmental statutes, and their implementing regulations, this rule will yield to the EPA statutes and regulations.
This is a rulemaking of agency organization, procedure, or practice.
This procedural rule would not regulate any person or entity outside the EPA
and would not affect the rights or obligations of outside parties. As a rule of Agency procedure, this rule is exempt from the notice-and-comment and delayed effective-date requirements set forth in the Administrative Procedure Act. See 5 U.S.C. 553a2, bA, d.
Nonetheless, the Agency voluntarily sought public comment on the proposed rule because it believed that the information and opinions supplied by the public would inform the Agencys views. Vt. Yankee Nuclear Power Corp.
v. Nat. Res. Def. Council, Inc., 435 U.S.
519, 524 1978 Agencies are free to grant additional procedural rights in the exercise of their discretion. In addition, even assuming arguendo that the delayed effective-date requirement of the Act applied to this action, the EPA has determined that there would be good cause, consistent with 5 U.S.C.
553d3, for making this final rule effective immediately because immediate implementation of the rule, with its goals of ensuring transparency and consistency in how the agency considers dose-response data underlying pivotal science to be used in significant regulatory decisions and influential scientific information, is crucial for ensuring confidence in EPA
decision-making. Because this is a procedural rule that only applies internally to ensure that the EPA
consistently considers data availability, the rationale for delayed effectiveness to allow reasonable time for non-EPA
regulated entities to adjust their behavior before and prepare for the effective date of the new requirements does not apply. See Omnipoint Corp. v.
Fed. Commcn Commn, 78 F.3d 620, 630 D.C. Cir. 1996; see also United States v. Gavrilovic, 551 F.2d 1099, 1104 8th Cir. 1977 quoting legislative history. For these reasons, the Agency
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