While it is entirely possible that this procedural rule may influence how scientists choose to conduct their studies or present their research to EPA, that potential incidental effect does not render the rule substantive. See James A. Hurson Assocs., Inc. v. Glickman, 229 F.3d 277, 280 (D.C. Cir. 2000) (noting that a procedural rule "covers agency actions that do not themselves alter the rights or interests of parties, although it may alter the manner in which the parties present themselves or their viewpoints to the agency.") (internal quotation marks and citations omitted).
Comment [89-799]: Commenter (11403) writes that the proposed rule is not based on any valid statutory authority and is arbitrary and capricious.
EPA's 2018 version of this rule cited a hodgepodge of statutory authority, none of it valid. EPA at least corrected the obvious typographical errors from the previous version. However, those edits still do not grant EPA the authority to restrict science from all regulatory decision-making processes within the agency. EPA is attempting to use general grants of authority to create a completely novel approach to assessing science. However, as the Supreme Court has stated, "Congress . . . does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions -- it does not, one might say, hide elephants in mouseholes." EPA does not have the authority to alter the fundamental details of all of its regulatory schemes based on such vague provisions of law.
Section 103 of the CAA directs EPA to "conduct, and promote the coordination and acceleration of, research, investigations, experiments, demonstrations, surveys and studies" on air pollution. Curtailing the use of science based on arbitrary notions of transparency does the opposite of what Section 103 requires.
Section 301(a) of the CAA gives the Administrator authority to "prescribe such regulations as are necessary to carry out his functions" relating to the CAA. This catch-all provision certainly provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is "necessary" to the carrying out of functions under the CAA.
Section 1442 of the SDWA generally authorizes the Administrator to "conduct research, studies, and demonstrations relating to the causes, diagnosis, . . . and other impairments of man resulting directly or indirectly from contaminants in water, or to the provision of dependably safe supply of drinking water . . ." This section does not authorize EPA to exclude science based on a perceived lack of transparency or support any other aspect of the proposed rule.
Section 1450(a)(1) of the SDWA states, "The Administrator is authorized to prescribe such regulations as are necessary or appropriate to carry out his functions under this subchapter." This catch-all provision provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is "necessary" to carrying out the functions under the SDWA.
Section 2002(a)(1) of the RCRA authorizes the Administrator to "prescribe, in consultation with Federal, State, and regional authorities, such regulations as are necessary to carry out his functions under this chapter. . ." This catch-all provision provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is "necessary" to carrying out functions under the RCRA.
Section 8001 of the RCRA provides EPA with authority to conduct and assist with research relating to the handling of waste management and recovery. The section includes a provision stating, "the Administrator shall establish a management program or system to insure the coordination of all such activities and to facilitate the process of development of sound new technology (or other discoveries) from the research phase, through development, and into the demonstration phase." Not only does section 8001 not provide EPA with authority to promulgate this regulation, the requirement to facilitate the development of new science contradicts the proposed rule's restrictions on science. Limiting scientific research only serves to hinder development of new science, not facilitate it.
Section 115 of the CERCLA and Executive Order 12580 authorize the President to delegate duties under CERCLA and designate EPA as the statute's administrator. This delegation provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is necessary to carrying out the functions under CERCLA.
Section 311 of the CERCLA directs the Administrator in the use and development of research and training tools. The section does not mention transparency of data or give any other indication that it authorizes EPA to promulgate the proposed rule.
Section 328 of the EPCRA states, "The Administrator may prescribe such regulations as may be necessary to carry out this chapter." This catch-all provision provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is "necessary" to carrying out functions under the EPCRA.
Section 25(a)(1) of the FIFRA authorizes the Administrator "to prescribe regulations to carry out the provisions of this subchapter." This general authorization section of FIFRA differs from that of the other statutes listed because it actually does specify some considerations the Administrator must give when promulgating regulations. For example, it states, "Such regulations shall take into account the difference in concept and usage between various classes of pesticides, including public health pesticides, and differences in environmental risk and the appropriate data for evaluating such risk between agricultural, nonagricultural, and public health pesticides." Unlike the other general grants of rulemaking authority, this provision clearly intends to offer detail and guidance on the nature of the rulemaking authority that the provision grants. As it does not mention restriction of scientific data, there is no indication that EPA has authority to undertake the proposed rule under this section.
Section 136r(a) of the FIFRA directs the Administrator to conduct research to carry out the purposes of the statute. The section states, "The Administrator shall also take care to ensure that such research does not duplicate research being undertaken by any other Federal agency." The section does not state that EPA can ignore sound science if the raw data is not publicly available.
Section 10 of the TSCA grants the Administrator authority on research, development, collection, dissemination, and utilization of data. There is no mention of any type of research or data that warrants exclusion in order to carry out the purposes of the statute.
Section 501 of the CWA states, "The Administrator is authorized to prescribe such regulations as are necessary to carry out his functions under this chapter." This catch-all provision provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is "necessary" to carrying out functions under the CWA.
In short, none of the statutory provisions cited by EPA provide authority for the proposed rule. The proposed rule fails at step one under Chevron v. Natural Resources Defense Council since it is unreasonable to believe that any statutory general grant of authority or any mention of EPA's oversight of other science or research programs would enable EPA to conduct rulemaking in a way that is altogether inconsistent with the rule of law. None of the cited provisions provide the authority sought by EPA, and as such the proposed rule should be withdrawn.
Response: See response to comment 29-121.
Comment [93-854]: Commenter (11395) writes that the requirements in the proposed regulation are inconsistent with specifications in several of the environmental statues cited in the SNRPM. In addressing this issue, the SNRPM says, "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." However, there is no attempt to delineate those conflicts or to explain how an environmental statute can serve as legal authority for a regulation that conflicts with important provisions of that statute. NESCAUM also strongly disagrees with the application of the Housekeeping Statue as an authority for a regulation with significant, far-reaching implications.
Response: See response to comment 29-121.
Comment [97-900]: Commenter (11479) writes that the proposed rule, as modified in the supplemental notice, would clearly interfere with the agency's use of the best available science. For example, the policy violates laws like the TSCA and the SDWA because of the statutory requirement to use the "best available science." That requirement does not make exception for the agency to effectively ignore certain scientific information of high quality simply because the unanalyzed data cannot be made public for reasons of privacy, confidentiality, or intellectual property. According to judicial precedent, "best available science" is defined as "all existing scientific evidence relevant to the decision" and a body of evidence that "cannot ignore existing data." In addition to the "best available science" requirements, TSCA also requires EPA to take into consideration information "that is reasonably available to the Administrator." EPA's own regulations define that term as "information that EPA possesses or can reasonably generate, obtain, and synthesize . . . , whether or not that information is confidential business information, [sic] that is protected from public disclosure..." Not only would this proposed rule conflict with TSCA's mandate to consider the best available science, it would challenge the method by which EPA can review the weight of the scientific evidence, which in rulemaking for TSCA is defined by a systematic review method. These reviews consider the entire body of scientific evidence, so the exclusion of certain studies based on whether the raw data and models are publicly available would render these reviews, as mandated, impossible.
Further, the CAA has requirements to update pollution standards that provide for an "adequate margin of safety" to protect public health. This determination can only be reliably made using the best available science. This proposal would, however, prevent EPA from using the best available science to set pollution standards that would provide for an adequate margin of safety, because the proposal excludes studies where the raw data and other underlying information cannot be made public. Because of this, EPA should not cite the CAA as a source of statutory authority. Further, the CAA encourages a close partnership with the National Academy of Sciences (NAS) and other independent scientific institutions. When EPA is considering a proposal to reinterpret how it uses science in regulatory decisions, it should first and foremost consider comments from and engage with NAS and similar bodies, which, for this rule, EPA did not.
In fact, virtually all of EPA's statutory mandates require the use of the best available scientific evidence. Congress did not state in any of these laws that the agency shall only consider scientific evidence derived from studies where the underlying unanalyzed data is publicly available, nor that the evidence considered should be solely at the Administrator's discretion.
Response: See response to comment 29-121.
Comment [101-962]: Commenter (11482) writes that the proposed rule likely violates federal laws that require the EPA to use the best scientific information available to it. EPA has a duty to use the best scientific information available under several laws. For example, the TSCA requires EPA to operate "in a manner consistent with the best available science" and make regulatory decisions based on the weight of the scientific evidence. Numerous court cases have weighed in on the best available science standard in the context of numerous different federal laws. For example, courts have found that the agency must use the best science that is available to it at the time of the decision, not the best that might be available to it at some time in the future.
Importantly, the critical actor under the best available science standard is the agency  --  the standard requires the use of the best science that is available to the agency, not necessarily available to the public. Excluding science that is available to the agency but not available to the public would thus be a violation of "best available science" provisions.
Under federal law, the agency must find a way to continue using the best available scientific data and models available to it, regardless of whether those data and models are publicly available. Excluding science whose raw data are not in the public domain runs counter to the "best available science" doctrine and is thus illegal.
Response: See response to comment 29-121.
Comment [114-1002]: Commenter (11392) notes that EPA is proposing that the Agency will only use pivotal science if the data is available in a manner sufficient for independent validation, including, for studies with restricted data and models, if there is tiered access to these data and models.
EPA addresses the limitations to publishing CBI and personally identifiable information (PII) by proposing "tiered access" to the underlying data and models deemed too sensitive to publish. The SNPRM describes tiered access as "creating multiple versions of a single dataset with varying levels of specificity and protection." This proposal is vague and impracticable. If EPA expects researchers to implement this system, then the Agency is creating enormous new requirements for the research community.
First, this undermines EPA's claim that the rule "would not regulate the conduct or determine the rights of any entity outside the federal government." This would undercut the already dubious notion that this rule falls under the Agency's authority under the Federal Housekeeping Statute. Furthermore, describing such requirements simply as "multiple versions of a single dataset with varying levels of specificity and protection" is excessively vague for such a monumental overhaul of how the Agency considers science in its rulemaking. If the intent is for the researcher to determine the appropriate level of access, who would determine whether a researcher's determined access levels appropriately met the requirements of the rule? Would researchers be expected to review the applications for reanalysis in perpetuity? Has a cost analysis been done to assess the burden this rule would place on researchers and on the institutions hosting the data? What happens if a research team has since disbanded? Does EPA expect researchers in other countries to work with the Agency to manage such a data access system so their studies can be used by the United States government? If EPA intends for the scientific community to adopt  --  and potentially implement  --  these dataset and access requirements, it is not offering researchers a meaningful description of the parameters on which they can comment.
The SNPRM references a pilot project with the Centers for Disease Control (CDC) involving a secure data enclave for sensitive EPA datasets. If EPA intends to use CDC resources to implement this rule, the Agency's argument that it is merely an internal procedure matter is far more complicated than stated. Was CDC involved in writing this rule? Do they have the resources to host EPA's data and models and moderate tiered access? Will CDC be making the decision as to who can access the data and at what level? Will CDC be reviewing applications for access? The SNPRM does not address any of these questions. If EPA intends to make its arrangement with the CDC permanent, and establish the CDC as the host of a secure data enclave for studies considered in Agency rulemaking, EPA must clearly articulate its rationale for partnering with a separate federal agency rather than performing the work internally. EPA must also describe how such an unusual arrangement would be structured. It must be clear that the CDC is involved in this rulemaking.
If, instead, the Agency plans on instituting and maintaining a "tiered access" system of its own, a host of implementation questions are unanswered in the text of the supplemental. Where will such a system be housed within the Agency? EPA is not a data management agency  --  does it have the capability to manage a large amount of sensitive data? Does EPA have a robust cybersecurity strategy? The Secret Science Reform Act of 2014, a legislative precursor to this SNPRM, was estimated by the Congressional Budget Office (CBO) to cost "$250 million annually over the next few years" should it have passed into law  --  how much will this SNPRM cost, and what money will EPA use to undertake a project of this magnitude that has not been authorized by Congress? Does EPA have staff who are capable of running this system? How many people will EPA need to hire? How will members of the public apply to access the sensitive data? Who at EPA will determine external access to the data, and at what tier? Who at EPA will determine what parts of the datasets belong in each tier of the system? How will this address restrictions put on PII protected by the Health Insurance Portability and Accountability Act, the National Institutes of Health (NIH), and Institutional Review Boards (IRB), which contain no applicable "tiered access" exemptions from privacy requirements? The Agency's solicitation for public comments on this matter is insufficient given the paucity of details on this proposed solution to the publication limitations of sensitive data.
Response: This procedural rule does not require researchers to implement the tiered data access system or provide that EPA will use CDC resources to implement that system. See responses to comments 29-121 and 84-1403.
Comment [114-1427]: Commenter (11392) writes in regard to the environmental statutory provisions cited in the proposed rule and the SNPRM, they echo the point made by many commenters in response to the proposed rule: Congress has repeatedly mandated that EPA must use the best available science to inform its regulatory process. This is a legal obligation, a clear-cut directive from Congress, and that supersedes any "general authority... to carry out the Agency's functions" under the various environmental statutes.
Response: See response to comment 29-121.
Comment [123-1046]: Commenter (11491) notes that EPA has requested comment on what legal authority it should rely on for this rulemaking. As EPA acknowledges, it lacks authority to supersede the requirements of its substantive statutes. Nor does the Agency purport to amend its prior regulations interpreting its substantive authorities. While EPA cites its housekeeping authority in Reorganization Plan 3 of 1970, this authority is for internal management purposes only. Accordingly, the Supplemental Notice acknowledges that, where the Proposed Rule conflicts with law or implementing regulations, the law or implementing regulations will control. It does not appear that EPA's substantive statutes or its housekeeping authority authorize the blanket approach to scientific transparency set forth in the Proposed Rule and Supplemental Notice. Therefore, we anticipate that the Proposed Rule will cause confusion and uncertainty in application, which will in fact undermine regulatory transparency and business certainty, a purported goal of this Agency. For this reason, as well, we urge EPA not to finalize this rulemaking.
Response: See response to comments 29-121 and 84-1403.
Comment [125-1089]: Commenter (11495) writes that EPA's Supplemental Notice is at odds with provisions of multiple environmental statutes which require the Agency to consider certain high-quality scientific information. For example, the SDWA requires that the issuance of national drinking water regulations be based on the "best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices." TSCA requires the EPA Administrator to ensure that evaluation and regulation of toxic substances is "consistent with the best available science" and to use all scientific information that is "reasonably available" when making related decisions. The CWA and the CAA require that water and air quality criteria determinations be based on the "latest scientific knowledge." Lastly, EPCRA requires that some actions "be based on generally accepted scientific principles or laboratory tests, or appropriately designed and conducted epidemiological or other population studies."
Each of these provisions directs EPA to incorporate a certain quality of scientific information into its rulemaking decisions made pursuant to the statute. In particular, these requirements are designed to ensure the scientific validity of the information upon which EPA bases its actions. Mandating a high-quality scientific basis for regulatory actions is necessary to guarantee the best possible protections for public health and welfare and to minimize partisan influence in scientific decision-making.
The Supplemental Notice, however, would impermissibly prohibit the agency from considering of relevant and high-quality scientific studies whenever the data underlying the study are not publicly available -- in direct contravention of the statutory directives that mandate, for example, consideration of the "best available science." None of the provisions requires, or even suggests, that EPA only consider information that is publicly available. It strains the plain meaning of words like "best," "latest," and even "appropriate" to suggest that they permit the unscientific requirement that all data be publicly available.
EPA "cannot ignore available . . . information." Courts have held that "best available data" requirements "prohibit[] [an agency] from disregarding available scientific evidence that is in some way better than the evidence [it] relies on." Furthermore, a plaintiff may establish a violation of a "best available science" requirement by "point[ing] to any scientific evidence that the agency failed to consider." The Supplemental Notice would undoubtedly preclude EPA from considering certain studies and scientific information that is "better" or the "best available," simply because the study's underlying data is not publicly available, thereby failing to satisfy Congressional directives and undermining the quality of regulatory decisions.
Likewise, EPA cannot avoid the statutory directives to consider high-quality scientific information simply by assigning a lesser weight to such information when the underlying data are not publicly available, as the Agency alternatively proposes. The Supplemental Notice's alternative proposal is designed to have largely the same pernicious effects as flatly prohibiting consideration of studies lacking publicly available data. Just as with the primary proposal, EPA's alternative proposal would limit the agency's consideration of the best available science in making important regulatory decisions, and is, therefore, arbitrary, and capricious.
The effect of the Proposed Rule is inconsistent with EPA's view that the Supplemental Notice 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." EPA attempts to resolve this inconsistency by stating 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." However, as discussed below, EPA lacks the statutory authority to issue a rule this broad, even when it claims that it will avoid statutory conflicts.
Response: See response to comment 29-121.
Comment [125-2205]: Commenter (11495) writes that neither the environmental statutes nor the federal Housekeeping Statute suggests that EPA, in deciding how it will handle scientific information, can reject or attribute lesser weight to scientific evidence that otherwise meets those criteria solely because the underlying data are not publicly available. EPA's Proposed Rule both lacks sufficient legal authority and unlawfully contradicts the environmental statutes that the Agency is tasked with implementing.
Response: See responses to comments 29-121 and 84-1403.
Comment [127-1209]: Commenter (11497) notes that the EPA has an obligation to adhere to the fundamental mandates of its authorizing statutes, which require the agency to promulgate regulatory decisions based on the "best available science." On behalf of the 1 in 8 women who will be diagnosed in their lifetime and the 40,000 lives that are lost each year in the U.S., the EPA must ensure that the best available science informs implementation of the national laws so as to prevent this devastating disease. This proposal seriously undermines EPA's inclusion, consideration and use of the best available science and thus takes a hard step away from that goal.
Response: See response to comment 29-121.
Comment [130-1137]: Commenter (11884) writes that presumably, EPA hopes to evade the important environmental laws (including NEPA provisions) by styling the Trio as mere housekeeping provisions, but nothing in the history of the housekeeping statute suggests that Congress intended it to permit agencies to undercut statutes that enshrine important policies like CERCLA, FIFRA, NEPA, RCRA, and TSCA. Accordingly, the SNPRM and Trio are neither authorized by the Housekeeping statute nor, if they were, could be given effect if given the Trio's conflict with such important environmental laws.
Response: See responses to comments 29-121 and 84-1403.
Comment [131-1884]: Commenter (11890) writes that this rule and supplement constitute a dramatic change to the data the agency will consider as part of its science assessment and regulatory work, and as such would be inappropriate and illegal to adopt under internal housekeeping rules. We believe the proposed rule could have serious adverse impacts across the wide range of environmental laws that are critical to protecting public health.
Response: A rule is substantive if it has legal force and effect on individual rights and obligations. See Chrysler Corp. v. Brown, 441 U.S. 281, 302 (1979). 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.
A rule is not substantive solely because it is a fundamental change of agency policy. The cases so holding are distinguishable from these circumstances. In Mendoza v. Perez, 754 F.3d 1002, 1021 (D.C. Cir. 2014), plaintiffs challenged a series of letters issued by the Department of Labor (DOL) which set forth special procedures for certifying foreign agricultural workers as temporary workers under the H-2A visa program. The court stated that "[a] rule is [substantive] if it supplements a statute, adopts a new position inconsistent with existing regulations, or otherwise effects a substantive change in existing law or policy." However, that statement was in response to the defendants' claim that the letters merely interpret existing regulations. The court's point there was that the letters do much more than that.
The court also cited Shalala v. Guernsey Mem'l Hospital, 514 U.S. 87, 100 (1995) for the proposition that rules that represent a major shift in law or policy are substantive. In that case, the Supreme Court agreed with defendants that the rule at issue was an interpretive rule but acknowledged that notice and comment would have been required had the rule adopted a position inconsistent with the agency's existing regulations.
Thereafter, the court turned to defendants' alternative argument that the letters are procedural rules. As part of that discussion, the court pointed out that "[p]rocedural rules `do not themselves alter the rights or interests of parties, although [they] may alter the manner in which the parties present themselves or their viewpoints to the agency.'" Id. at 1023 (quoting Batterton v. Marshall, 648 F.2d 694, 707 (D.C. Cir. 1980) (second alteration in original). The court then observed that the letters "do not merely describe how the Department will evaluate H-2A applications, but they set the bar for what employers must do to obtain approval." The court ultimately held that in so doing, the letters substantially affect the rights of interested private parties. In other words, the court did not hold that the letters were substantive rules because they changed Departmental policy, but rather because they imposed requirements on persons outside of the agency.
The 10th Circuit stated in Rocky Mountain Helicopters, Inc. v. F.A.A., 971 F.2d 544, 547 (10th Cir. 1992), that a rule is substantive if it "changes existing law, policy, or practice" out of context. In that case, the Federal Aviation Administration (FAA) informed the plaintiff that its pilots would no longer be allowed to wear night vision goggles. However, in that case, the FAA claimed that the letter was an interpretive rule, as opposed to a substantive rule, and the court ultimately agreed on grounds that the letter did not change existing law, policy, or practice. So again, the broad statement that commenters rely on is in the context of a court determining whether a rule is interpretive, not procedural. It makes sense for courts to point out where an allegedly interpretive rule does more than simply articulate the agency's interpretation of existing regulations.
Finally, substantive rules are not the only means for agencies to effect a change in existing policy. Agencies can also issue procedural and interpretive rules that articulate a policy shift. Nevertheless, the APA clearly differentiates procedural and interpretive rules and statements of policy from substantive rules. See 5 U.S.C. § 553 (exempting procedural and interpretive rules from notice and comment procedures).
Comment [133-1160]: Commenter (11894) writes that EPA now claims authority to base its data restriction proposal not just on the provisions of specific EPA laws that we addressed in our opening comments, but also on the general federal Housekeeping Statute, 5 U.S.C. § 301. This provision, enacted by the first Congress, provides that the head of an executive department or military department may prescribe regulations for the government of his department, the conduct of his employees, the distribution and performance of its business, and the use and preservation of its records, papers, and property. As the Supreme Court has recognized, this language only authorizes rules that govern internal agency operations and cannot be used to justify a legislative rule. In an attempt to bring the proposed science restrictions within that purpose, EPA's proposal states that it does not regulate any entity outside the federal government. Rather, they claim that the proposed requirements would modify the EPA's internal procedures regarding the transparency of science underlying regulatory decisions and that this rule would not regulate the conduct or determine the rights of any entity outside the federal government. Their position is that it exclusively pertains to the internal practices of the EPA. (85 FR 15398).
EPA specifically states that its proposal does not interpret or rely on the specific regulatory provisions of the various EPA statutes, despite the flood of comments it received demonstrating that these were indisputably the governing statutory authorities. But in a backhanded acknowledgment of a possible problem, the proposal states 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, it says 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. Id.
Response: See response to comment 29-121.
Comment [133-1171]: Commenter (11894) writes that EPA's proposal does not discuss any substantive provisions of regulatory statutes. However, it attempts to insulate itself against conflict with them by providing that:
[I]n 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.
EPA provides neither substantive legal standards nor procedures for making this shell game of a determination. Rather, it is an entirely lawless and cynical ploy. It calls on EPA to "balance" between an approach to data evaluation that is illegal because it rests neither on statutory authority nor on responsible analysis and the approach the law prescribes. The next step will be to argue that because EPA has given itself authority to sometimes not do the illegal thing, its authority to do the illegal thing should be sustained.
All this shows that EPA is well aware of the probability that the authorities on which it rests its proposal do not support it, and that any rule remotely like its proposal could only rest on the substantive provisions of the various regulatory statutes describing the types of data that can be used as rulemaking support.
It also makes clear how EPA will try to defuse this issue without ever actually confronting it. If such an "in case of conflict" provision were to take effect, EPA quite predictably would use it to uphold its data bar in most cases, hoping to prevail not on the merits, but because of the presumption of regularity given to government action and lack of opposition due to the expense and uncertainty of differing with the government. In extreme cases, EPA could back down. And if it should lose in an individual case, that could always be blamed on misapplication of the "in case of conflict" provision, not on any defect in its structure. This gambit does nothing to preserve the rule's legality, failing for the same reason that the initially proposed case-by-exception fails: a subsequent promise to cure an arbitrary result does nothing to cure that illegality. See Ameren Services v FERC 880 F. 3d 571, 584 (DC Cir 2018):
We once described an agency's effort to offer future rulemaking as a response to a claim of agency illegality as an "administrative law shell game," Am. Tel. & Tel. Co. v. FCC, 978 F.2d 727, 732 (D.C. Cir. 1992), a phrase the Supreme Court thought apt. See MCI Telecomm. v. Am. Tel. & Tel. Co., 512 U.S. 218, 222, 114 S.Ct. 2223, 129 L.Ed.2d 182 (1994).
Compounding this illegality is the absence of any discussion of either the substantive criteria or the procedural mechanisms by which EPA would determine whether this censored-science rule would be inconsistent with its actual statutory authorities. An agency's empty reference to adherence to statutory factors is not reasoned decision-making. See Philadelphia Gas Works v. FERC, 989 F. 2d 1246, 1251 (D.C. Cir. 1993 ) (for FERC to utter the words 'unique facts and circumstances' and 'equity,' ... as a wand waved over an undifferentiated porridge of facts, leaves regulated parties and a reviewing court completely in the dark as to the core of FERC's reasoning and its relationship to past precedent"); Verizon Cos. v. FCC , 570 F. 3d 294, 304 (D.C. Cir. 2009) ("These conclusory statements that such factors are being considered cannot substitute for the reasoned explanation that is wanting in this decision"); American Gas Ass'n, v. FERC, 593 F. 3d 14, 19 (D.C. Cir. 2010) ("A passing reference to relevant factors, however, is not sufficient to satisfy the Commission's obligation to carry out reasoned and principled decision-making. The Commission must fully articulate the basis for its decision.")
Response: See response to comment 48-503.
Comment [133-1176]: Commenter (11894) asks, what are the legal authorities under which EPA prepares the studies that would be affected, and how do they support this step? All government actions must be authorized by law. Yet this proposal does not even mention that topic, much less discuss how the statutory language (whatever it might be) supports such restrictions on studies prepared under its authority
Response: EPA discussed its legal authority for this action in the preamble of the proposal at Section I. C and modified that authority as discussed in the preamble of the supplemental notice at Section I. B, and the preamble of the final rule at Section I. C.
Comment [141-1273]: Commenter (11911) states that there's no doubt the finalization of the Strengthening Transparency in Regulatory Science (STRS) Rule would have a substantive impact by severely impairing the EPA's ability to protect public health and the environment.
If finalized, the STRS Rule would substantively violate a number of environmental statutes. Both the ESA and, for example, call on the EPA to use the "best scientific... data available" when issuing regulations; the TSCA requires the "best available science." This mandate means the agency cannot "disregard[] available scientific evidence that is in some way better than the evidence [it] relies on." The agency must not "ignore available studies, even if it disagrees with or discredits them." In another example, NAAQS under the CAA air must be set at a level "requisite to protect public health," and must "accurately reflect the latest scientific knowledge" including "all identifiable effects [of the pollutant] on public health or welfare."

Further, under the APA, an agency must not "fail[] to consider an important aspect of the problem" or neglect to "consider[] relevant factors" when issuing regulation. If the EPA were to ignore whole categories of scientific studies in reaching a regulatory decision, the agency would surely run afoul of longstanding Supreme Court precedent. The Proposed STRS Rule and accompanying SNPRM cannot constitute an end-run around the procedural requirements of the APA or the Congressional mandate of environmental statutes.
Response: Any impacts on third parties that result from this final rule are not enough to render it substantive. See responses to comments 29-121 and 84-1403. This final rule will enhance EPA's ability to consider the pivotal science underlying its significant regulatory decisions and ISI in the most transparent way possible. As discussed at Section III. E of the final rule preamble, EPA will apply a weighting approach when considering pivotal science, not a categorical exclusion. EPA has explained that this procedural rule has limitations on its scope in terms of conflicts with other substantive requirements and that 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.
Comment [147-1315]: Commenter (12399) notes that the supplemental states that the rule would not apply when its provisions "conflict" with statutory law. Obviously, laws prevail over agency rules, so this stated exclusion is not necessary. In any case, it is not clear that any law on the books would prevent the agency from ensuring that any science it uses meets basic scientific transparency standards. And in the unlikely situation that questions arise, this issue should remain within the purview of the courts to determine whether a conflict exists. Including this provision appears to do nothing more than give the Administrator an excuse to waive the rule for rather arbitrary reasons.
Response: See response to comment 48-503. Here, the Administrator's discretion to exempt certain studies on an ad hoc basis from the final rule's requirements comes from section 30.9 of the final rule, not the savings clause. That section clearly outlines the circumstances under which the Administrator may grant exemptions, enumerates several factors that should inform that determination, and requires the Administrator to document the rationale for the exemption.
Comment [159-1404]: Commenter (12430) writes that U.S. EPA administers and enforces most of the country's foundational environmental laws, including the CAA, CWA, SDWA, RCRA, CERCLA, EPCRA, FIFRA, and TSCA. These laws include statutes that expressly require U.S. EPA to consider the best available science. If adopted, the SNPRM would violate these statutes.
Response: See response to comment 29-121.
Comment [159-1406]: Commenter (12430) writes that the SNPRM does not address or even acknowledge the statutes that affirmatively require U.S. EPA to consider the best available science. It instead invokes additional statutes that it claims provide authority for the proposed rule. It argues that the rule may be authorized by the Federal Housekeeping Statute, by certain substantive statutes, or by a combination of the two. But the statutes the SNPRM cites do not address the use of science and certainly do not allow U.S. EPA to disregard its express statutory mandates to use best available science.
Response: See response to comment 29-121.
Comment [175-1574]: Commenter (12471) writes that environmental statutes separately provide the Administrator with substantive policy-making authority to weigh information appropriately in the regulatory process. Increased transparency resulting from the Transparency Rule's procedural framework may be one of the factors that the Administrator considers when using that authority. The Transparency Rule's framework would remain purely procedural. Even when considered as part of the regulatory process specified in an environmental statute, the framework would add no new substantive requirements to that process.
Increasing transparency assessments does not diverge from the requirement that the Administrator use the best science in reaching regulatory decisions. In fact, the opposite is true. Scientific transparency is critical to reproducibility, which is, in turn, a central tenant of the scientific process. Without a common framework to increase transparency, the Administrator's process to factor transparency and reproducibility, core components of the scientific method, in the regulatory process could be arbitrary and capricious.
Response: EPA agrees that this final rule is purely procedural and directs EPA to weigh public availability of the pivotal science underlying EPA's significant regulatory decisions among other factors enumerated in the final rule. Regarding the environmental statutes that EPA administers, see response to comment 29-121.
Comment [181-1622]: Commenter (12699) writes that the EPA should rely on both the substantive environmental statutes and the housekeeping authority.
The EPA would not be implementing these statutes properly if it were using flawed science in the promulgation of its rules. To highlight one example, it is useful to reexamine the U.S. Supreme Court case Michigan v. EPA. In discussing the "appropriate and necessary" language in 112(n)(1)(A) of the CAA, the U.S. Supreme Court argued "[o]ne would not say that it is even rational, never mind "appropriate," to impose billions of dollars in economic costs in return for a few dollars in health or environmental benefits."
Similarly, it would not be rational for the EPA to use science for these very costly policies without even knowing whether the science is credible. Nor would it be rational for the agency to fail to take every possible step to ensure scientific accuracy, including making underlying information available to the public (especially since the EPA is well aware of the problems that pervade the science). Making the information available to the public is not some nice gesture to appease the public. It is a critical step to help the agency itself get necessary feedback to better assess the science.
Response: EPA has elected to rely solely on housekeeping authority equivalent to the Federal Housekeeping authority, which was transferred to EPA in EPA's Reorganization Plan. See response to comment 29-121.
EPA would like to clarify that the final rule does not require EPA or the public to make data and models publicly available. However, EPA agrees that it is important for the pivotal science underlying EPA's significant regulatory decisions and ISI to be as transparent as possible.
Comment [181-1624]: Commenter (12699) writes that there is also a practical reason for utilizing these environmental statutes as statutory authority for the rule. It should help affected parties to enforce EPA's compliance with the rule. Relying upon the housekeeping authority alone might make this regulation covering internal procedures more difficult to enforce. Regarding this enforcement concern, the EPA should learn some lessons from the Information Quality Act (IQA). It is extremely important that the rule itself have clear and objective requirements, without creating so much flexibility and discretion that there is nothing for a court to enforce. In addition, by having clear requirements, this will limit future administrations from getting around the rule.
To its credit, the EPA is undertaking this extremely important transparency initiative. It would do a disservice to the public and the agency itself if the rule has no "teeth" and is simply ignored whenever it is convenient for future administrations.
Response: See response to comment 29-121.
Comment [183-1822]: Commenter (12702) notes that while the Supplemental Notice is proposing to allow non-public data to be used when public data are unavailable, the notice makes clear that EPA would have wide discretion to determine whether and when to do so. They remain concerned that this discretion could decrease the consistency and certainty of how certain data are treated. Additionally, such treatment could conflict with requirements under existing statutes and Court decisions. This concern applies even if EPA chooses to rely upon its housekeeping authority as proposed in the supplemental notice.
Response: Section 30.9 of the final rule outlines the circumstances under which the Administrator may grant exemptions, enumerates several factors that should inform that determination, and requires the Administrator to document the rationale for the exemption. Conflict analyses will be conducted and discussed as appropriate when EPA develops subsequent rulemakings implementing this final procedural rule. See the final rule preamble discussion at Section III.G.
Comment [184-1660]: Commenter (12707) writes that the proposed structure is arbitrary and capricious and will lead to outcomes that do not fulfill the agency's statutory mandate and will, therefore, be vulnerable to legal challenge. EPA should continue to apply the rigorous standards the agency has used over many decades of issuing lifesaving standards and let stakeholders engage in the process that is full and open with regards to science.
By setting forth unnecessary and confusing restrictions on the kinds of studies it can consider in developing significant rules under critical environmental and public health laws from air pollution standards to water quality issues to chemical regulation in consumer products, EPA is undermining its ability and duty to meet statutory obligations.
Response: As discussed in the final rule preamble at Section III.D, EPA will apply a weighting approach when considering pivotal science, not any categorical exclusions. 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. Regarding EPA's obligations under the statutes it administers, see response to comment 29-121.
Comment [184-1661]: Commenter (12707) writes that the Federal Housekeeping Statute alone or in conjunction with existing bedrock environmental laws does not authorize EPA to limit science considered in rulemaking processes. EPA's supplemental proposal is a second failed attempt at justifying an effort to limit or otherwise constrain its own ability to use the best available public health studies and science from outside EPA. The effort in the initial proposal to ground so-called "transparency" in bedrock environmental laws was exposed as untenable. EPA's addition of the Federal Housekeeping Statute to the mix and recitation of new sections of several environmental laws does not strengthen EPA's case. Whether or not EPA has 301 housekeeping authority is irrelevant. The statute authorizes EPA to control its own internal documents or materials; the statute and its authorities are not applicable to the long-standing public health studies EPA has relied upon to protect public health through the notice and comment rulemaking process.
EPA's justification that this action to constrain science or leave science up to the political whims of the administrator is about internal agency procedure does not hold. This proposal is not about internal paperwork, but about whether or not EPA can fulfill its core mission consistent with bedrock environmental laws.
Response: See response to comment 29-121.
Comment [184-1662]: in addition to the Housekeeping Statute, the supplemental proposal points to specific provisions of several key laws (RCRA, CERCLA and the CWA) as a justification for limiting or constraining the science it can consider. Nowhere in the cited statutes or sections is there any basis for demanding access to raw data or otherwise disqualifying long standing studies, 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.
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 that 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. The added confusion of the supplemental proposal, including so-called tiered access or EPA's ability to consider some research over what has long been considered "best available science" based upon the availability of data, does not legitimize the proposal.
In sum, there is no statutory authority, with or without the Housekeeping Statute, for EPA to rely on to censor or constrain science. Further, finalizing this effort will only serve to undermine EPA's essential role and create confusion over which studies will be considered and how they will be valued to set standards that directly impact public health and the quality of our air and water. Many of these uncertainties are recognized in EPA's own Science Advisory Board's April 28, 2020 letter.
Response: See response to comment 29-121.
Comment [187-1701]: Commenter (12720) writes 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 either the 2018 Proposal or the Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1714]: Commenter (12720) writes that EPA attempts to paper over this arbitrary abuse of discretion by noting that the rulemaking is intended to "be consistent with the statutes that EPA Administers and ... all applicable statutory and regulatory requirements." Id. The agency goes on to note that "in the event the procedures outlined in this proposed rulemaking conflict with the statute that EPA administers, or their implementing regulations, the statutes and regulations will control." Id. While it is certainly true that a rulemaking that conflicts with statutory authority would be struck down as arbitrary and capricious, EPA's statements here do nothing to "fix" the Proposal nor render it a valid exercise by the Agency. An administrative action that is arbitrary and capricious and an abuse of discretion does not change character through this type of Agency statement  -  the EPA does not get to pick and choose the statutory authorities it chooses to follow. Rather, Congress makes laws, and those laws contain certain proscriptions and prescriptions that the Agency to whom Congress has delegated rulemaking authority must follow. Implicit in EPA's recognition of the potential for "conflict" with statutes and implementing regulations is the understanding that this rule is arbitrary, capricious, and an abuse of the Agency's discretion. Neither the substantive statutes described above, nor the housekeeping authority, authorize the rulemaking.
Response: See response to comment 48-503.
Comment [187-1717]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposed regulatory definition, "Capable of being substantially reproduced." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of commenter's letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1720]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposed regulatory definition, "Data." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of commenter's letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1721]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposed regulatory definition, "Independent validation." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1724]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposed regulatory definition, ISI. 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1725]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposed regulatory definition, "Model." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1727]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposed regulatory definition, "Pivotal science." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1729]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation for the proposed regulatory definition, "The Supplemental Proposal and original Proposal lack any specific statutory authority or other legal authority to adopt any regulation based on the proposed regulatory definition, "Publicly available." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1730]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation for the proposed regulatory definition, "The Supplemental Proposal and original Proposal lack any specific statutory authority or other legal authority to adopt any regulation based on the proposed regulatory definition, "Publicly available." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1731]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposed regulatory definition, "Reanalyze." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1733]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal to apply "the provisions of this part" to "data and models, underlying pivotal science supporting influential scientific information and/or underlying pivotal regulatory science used to justify significant regulatory decisions regardless of the source of funding or identity of the party conducting the science." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.3). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1734]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal to condition "EPA's use of data and models underlying pivotal regulatory science and pivotal science" on any of the criteria, restrictions or provisions in proposed section 30.5, Option 1. 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.5, Option 1). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal that, "[w]hen promulgating significant regulatory decisions or finalizing influential scientific information, the Agency will only use pivotal regulatory science and/or pivotal science that includes studies with restricted data and models (i.e., those that include CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects) if there is tiered access to these data and models in a manner sufficient for independent validation, and studies that do not include restricted data and models if the data and models are publicly available in a manner sufficient for independent validation." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.5, Option 1). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 -  80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal that, "Information is considered `available in a manner sufficient for independent validation' when it includes the information necessary to understand, assess, and reanalyze findings," including the six listed examples in proposed section 30.5(a) through (f). 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.5, Option 1). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal to condition "EPA's use of data and models underlying pivotal regulatory science and pivotal science" on any of the criteria, restrictions or provisions in proposed section 30.5, Option 2. 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.5, Option 2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal that, "When promulgating significant regulatory decisions or finalizing influential scientific information, the Agency will, other things equal, give greater consideration to studies where the underlying data and models are publicly available in a manner sufficient for independent validation." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.5, Option 2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal that, "[w]hen promulgating significant regulatory decisions or finalizing influential scientific information," "[t]he Agency will also give greater consideration to studies based on data and models that include confidential business information, proprietary information or PII if these data and models were available through restricted access, such as through a secure data enclave, in a manner sufficient for independent validation." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.5, Option 2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal that, "[w]hen promulgating significant regulatory decisions or finalizing influential scientific information," "the Agency will identify those studies that are given greater consideration and provide a short description of why greater consideration was given." 85 Fed. Reg. at 15,405 (proposed 40 CFR § 30.5, Option 2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal that, "Information is considered `available in a manner sufficient for independent validation' when it includes the information necessary to understand, assess, and reanalyze findings," including the 5 listed examples in proposed section 30.5(a)(1) through (5). 85 Fed. Reg. at 15,405-406 (proposed 40 CFR § 30.5, Option 2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal that "[t] he provisions of this section apply to data and models underlying pivotal regulatory science or pivotal science regardless of who funded or conducted the underlying data, models, or other regulatory science or pivotal science." 85 Fed. Reg. at 15,406 (proposed 40 CFR § 30.5, Option 2). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal that "[w]hen promulgating significant regulatory decisions or finalizing influential scientific information," and "[w]here data and models are controlled by third parties, EPA may work with those parties to endeavor to make the data and models available in a manner that complies with this section." 85 Fed. Reg. at 15,406 (proposed 40 CFR § 30.5, Option 2) (emphasis added). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1735]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal to condition "the use of data and models underlying pivotal regulatory science and pivotal science" on any of the criteria, restrictions or provisions in proposed section 30.6. 85 Fed. Reg. at 15,406 (proposed 40 CFR § 30.6). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
The Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal to "give explicit consideration to high quality studies, including but not limited to those that explore: A broad class of parametric dose-response or concentration-response models; a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the dose or exposure range; and models that investigate factors that might account for spatial heterogeneity." 85 Fed. Reg. at 15,406 (proposed 40 CFR § 30.6). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment: Comment [187-1736]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any regulation based on the proposal to "conduct independent peer review on all pivotal regulatory science used to justify significant regulatory decisions and on all pivotal science underlying influential scientific information, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review and the exemptions described therein," prior to or instead of considering that science without independent peer review. 85 Fed. Reg. at 15,406 (proposed 40 CFR § 30.7). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [187-1737]: Commenter (12720) writes that the Supplemental Proposal and original Proposal lack any statutory authority or other legal authority to adopt any of proposed part 30, including any proposal to allow the Administrator to "grant an exemption to this part on a case-by case basis if he or she determines that compliance is impracticable because technological barriers render sharing of the data or models infeasible, the development of the data or model was completed or updated before [EFFECTIVE DATE OF FINAL RULE] or making the data and models publicly available would conflict with laws governing privacy, confidentiality, CBI, or national and homeland security." 85 Fed. Reg. at 15,406 (proposed 40 CFR § 30.9). "5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98 - 80, 84 Stat. 2086" in no way provides that authority. See supra at III.I of the commenters' comment letter. Nor do any of the organic environmental statutes that EPA cites in the Proposal or Supplemental Proposal.
Response: See response to comment 29-121.
Comment [198-1907]: Commenter (3549) writes that as a baseline, whether working on "significant regulatory actions," "influential scientific information," or anything requiring the consideration of science, EPA must base its decisions on the best available science. Anything less is nonsensical, arbitrary, and in violation of the environmental laws EPA is charged with implementing. The SNPRM does not maintain this baseline, but instead provides for ways EPA would exclude and lessen consideration of the best available science. Therefore, the SNPRM, along with the proposed rule, must be withdrawn. See, e.g., 42 U.S.C. § 300g-1(b)(1)(B)(ii), (3)(A) (SDWA provisions requiring regulation of contaminants based on best available science); 15 U.S.C. § 2625(h) (TSCA provision requiring the use of best available science); see also 83 Fed. Reg. at 18,769 ("The best available science must serve as the foundation of EPA's regulatory actions.").
Response: See response to comment 29-121. The supplemental did not provide that EPA can exclude or lessen consideration of high-quality studies and this final rule provides that EPA will weigh public availability of underlying scientific data among other enumerated factors.
Comment [198-1928]: Commenter (13549) 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 naiveté 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. U.S. 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 Band 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 Band 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.
By way of example, in CAA Section 108(a)(2), Congress requires EPA to issue air quality criteria for air pollutants to "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." 42 U.S.C. § 7408(a)(2). The SNPRM does not claim that studies that have not publicly released all their underlying data, such as those linking air pollution to mortality and disease, do not 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. If EPA were to exclude such studies from consideration when issuing air quality criteria, it would be in violation of the CAA.
Response: See response to comment 29-121. EPA requested comment on the authorities it identified to solicit public input as part of the notice and comment exercise, not as a signal that the authorities identified were inapposite. Indeed, viewing requests for comment as concessions that the underlying rule is arbitrary and capricious would be contrary to the purpose of providing notice and comment. EPA also notes that EPA discusses the justification for this rule in the final rule preamble at Sections III.D and E.
Comment [200-2215]: Commenter (12412) writes that 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 they explained in their 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 naiveté 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. U.S. 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. Little Traverse Bay Bands of Odawa Indians (LTBB) 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.
LTBB 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.
By way of example, in CAA Section 108(a)(2), Congress requires EPA to issue air quality criteria for air pollutants to "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." 42 U.S.C. § 7408(a)(2). The SNPRM does not claim that studies that have not publicly released all their underlying data, such as those linking air pollution to mortality and disease, do not 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 pollutants in the ambient air. If EPA were to exclude such studies from consideration when issuing air quality criteria, it would be in violation of the CAA.
Response: See response to comment 198-1928.
Comment [201-1983]: Commenter (12474) writes that 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 they explained in their 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 naiveté 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. U.S. 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 NTAA also disagrees with EPA's reliance on 5 U.S.C. § 301 as:
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 NTAA 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.
By way of example, in CAA Section 108(a)(2), Congress requires EPA to issue air quality criteria for air pollutants to "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." 42 U.S.C. § 7408(a)(2). The SNPRM does not claim that studies that have not publicly released all their underlying data, such as those linking air pollution to mortality and disease, do not 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. If EPA were to exclude such studies from consideration when issuing air quality criteria, it would be in violation of the CAA.
Response: EPA is not relying on 5 U.S.C. § 301 for its authority. See response to comment 29-121. See also responses to comments 84-1403 and 198-1928.
Comment [205-2037]: Commenter (13788) writes that the Federal Housekeeping Statute cannot be used to authorize rules that limit the scope of EPA's responsibilities under other statutes. The Chrysler Court was clear that "[section] 301 does not authorize regulations limiting the scope of [the Trade Secrets Act]" (the statute under consideration in that case), or of any other substantive statutory authority. Similarly, the Federal Housekeeping Statute cannot authorize regulations limiting the scope of environmental statutes. If finalized, this rule would limit EPA's ability to evaluate and use the best available science to support its regulatory decisions, thereby undermining its ability to fully implement its responsibilities as mandated under environmental statutes. It therefore cannot be a valid exercise of the authority granted by the Federal Housekeeping Statute.
Neither the Federal Housekeeping Statute nor the IQA provide authority or justification for a rule that would significantly impede and disrupt EPA's ability to fulfill its statutory mandates. For example, the air quality criteria EPA is required to issue when reviewing the NAAQS under the CAA takes the form of an integrated science assessment (ISA), in which the Agency evaluates the latest science on public health and environmental effects of criteria pollutants. The ISA document is considered a highly influential scientific assessment (HISA), which is a subset of the ISI governed by the IQA guidance. Subjecting the ISA to the requirements of this rule and SNPRM would result in the exclusion of important, longstanding public health studies from consideration, because the human health data on which they are based, and which makes them of value, is not publicly available as contemplated by the proposed rule. Such a result would directly conflict with the CAA's mandate that the air quality criteria reflect the latest scientific knowledge.
The Agency claims that "[i]n the event the procedures outlined in this part conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." EPA fails, however, to explain how the Agency will define and identify such conflicts and ensure that staff do not follow the proposed rule. This is a significant question that EPA entirely fails to discuss.
Response: See response to comment 29-121. As discussed in the final rule preamble at Section I.C because this is purely a procedural rule, EPA will discuss the statutes that EPA administers in forthcoming substantive rulemakings under those statutes.
Comment [205-2038]: Commenter (13788) writes that tot one of the other environmental statutes cited as potential authority by EPA actually authorizes this rule. At most, many of the provisions cited by EPA generally allow the agency to promulgate regulations in order to implement various statutes, with many requiring that the regulations be necessary. However, EPA has not shown how this rule would further the implementation of any statute, much less how the rule is necessary to fulfill any statutory responsibilities, and the fact that the Agency has not considered such a rule necessary until now suggests the opposite. Under the CAA, the most important scientific studies and models for use in evaluating the public health effects of air pollution are those that are based on actual human health data -- much of which cannot be publicly available due to the confidentiality requirements imposed by other federal statutes and the agreements under which the data is provided to researchers. For CAA rulemaking then, any of the approaches EPA is proposing actively undermine the Agency's use of the best science in making decisions that promote and protect the public health and welfare -- the fundamental purpose of the CAA.
If Congress had intended EPA to prioritize data transparency over the quality of scientific information in its regulatory decision-making, it could have written that requirement into the statutes. In the absence of such a requirement and as required by law, EPA should prioritize quality in accordance with the various "mandates requiring that its decisions rest on various formulations of the best available science."
Response: See response to comment 29-121.
1.2 Housekeeping Statue
Comment [9-34]: Commenter (10020) writes that the Proposed Notice of Supplemental Rulemaking is new rulemaking, not a revision of any prior proposal.
As such, it simply does not fall within your agency "housekeeping authority." Moreover, your proposed new rulemaking does not meet the requirements of the APA. Your Proposed Notice of Supplemental Rulemaking recites on its face that you want to add a definition of "publicly available." This in itself is new rulemaking, not a revision of any prior proposal. As such, it simply does not fall within your agency "housekeeping authority" and is not only unauthorized but is invalid at least to that extent and for that reason. Moreover, your proposed new rulemaking is simply not authorized or valid under the requirements of the APA. In short, your proposed new definition of "publicly available" is simply unauthorized as a part of the housekeeping authority you invoke in your subject Notice of Proposed Supplementary Rulemaking. When treated as newly proposed rulemaking, your proposal is of course subject to the requirements of the APA. It does not meet them. It must be withdrawn or rejected for that reason alone.
Response: This purely internal procedural final rule is not subject to APA notice and comment requirements, including the requirement to publish a notice of proposed rulemaking and request comment on that proposed action. See 5 USC 553(b)(A). Nevertheless, EPA elected to initiate notice and comment on both the procedural rule NPRM and SNPRM. As its title implies, the SNPRM supplements the NPRM by making the changes and clarifications outlined in the SNPRM preamble at Section I.C. It is not a new rulemaking. Regardless the additional round of notice and comment provided on the SNPRM is equivalent to that which would have been available for an NPRM initiating a new rulemaking.
Comment [13-51]: Commenter (10944) strongly opposes the 2020 supplemental to the proposed rule, Strengthening Transparency in Regulatory Science. EPA housekeeping authority should not be used to unravel existing regulations that have been instrumental in promoting public health in the US.
The supplemental rule contains new definitions and changes that are dangerous to public health, adding to the already harmful original rule. EPA housekeeping authority should not be used to limit environmental science. I urge you to reconsider the changes proposed by the supplemental rule in the interest of all Americans.
Response: The rule will apply to future rulemakings. EPA intends to continue relying on the high-quality studies to support its significant regulatory decisions and ISI. 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 studies where the underlying data and models are available for independent validation.
Comment [16-182]: Commenter (10048) notes that the SNPRM seeks comment on whether to use "housekeeping" authority for the proposed rule. The proposed rule is substantive and beyond the scope of housekeeping authority. They note, the Supreme Court held, "Section 301 is a "housekeeping statute," authorizing rules of agency organization, procedure, or practice as opposed to "substantive rules." There is nothing in the legislative history to indicate that 301 is a substantive grant of legislative power to promulgate rules authorizing the release of trade secrets or confidential business information." Chrysler Corp. v. Brown, 441 U.S. 281 (1979).
Response: The final rule is a rule of agency procedure and practice. The rule applies only to EPA and does not obligate or affect the rights of any outside parties. EPA does not intend to release trade secrets or CBI when implementing the rule. The rule governs only how EPA will consider studies used to develop significant regulatory decisions and ISI.
Comment [20-75]: Commenter (10753) writes that the EPA misleadingly suggests that the Trio is a minor housekeeping matter. Nothing can be further from the truth. Indeed, even if analyzed separately, each of the three elements of the Trio is far more than a housekeeping matter. Each element is in effect a dramatic procedural change that has dire substantive impacts. Obviously, none of the elements of the Trio can be adopted as a housekeeping matter. Cf. The EPA's `Censored Science' Rule Isn't Just Bad Policy, It's Also Illegal, J. Goodwin, 11-22-2019 https://sensiblesafeguards.org/the-epas-censored-science-rule-isnt-just-bad-policy-its-also-illegal/ (attached).
By restricting sensible scientific inquiry, the EPA effectively is proposing to ignore any and all evidence that undercuts its proposals. While the editors' numerous prior comments made this clear, an example may be helpful. Dr. Frank Kline, formerly professor of the medical schools of both USC and UC Irvine, explained how the Rule will frustrate good science. See Dr. Kline's statement included at https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8817.
As an integral part of the editors' objections to each element of the Trio, they incorporate by reference every objection stated in the following comment briefs:
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-0561 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-1037 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-3132 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-3133 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-4879 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5164 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5183 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5184 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5421 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5995 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-6107 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-6113 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-6801 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8279 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8178 https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8817 (Collectively, these 16 formal comment briefs are referred to as "the Comments").
Response: EPA will not categorically exclude any studies from consideration when promulgating significant regulatory decisions or developing ISI. 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.
Comment [22-77]: Commenter (10975) writes as to "statutory authority"  -  the disingenuously-entitled "Transparency" rule is not appropriately issued under the authority of the internal agency "house-keeping" statute. Housekeeping rules issued without full rulemaking cannot have legal effect upon third parties outside the government. But the effect of this proposed rule would be to prevent scientific researchers outside of the government from meaningfully submitting their highly relevant work essential in federal initiatives to control disease and other public health necessities. In some cases, this provision will frustrate the business and contractual undertakings of non-profit scientific entities providing services to federal agencies. The preclusion, for irrational, harmful partisan purposes, of scientists' effective submission of scientific data, moreover, may violate their First Amendment right to petition the government, by pre-emptively blocking the effectiveness of such submissions without regard to their substance and merit.
Response: Nothing in this rule would prevent scientists from submitting their data and studies to EPA. Scientists can also submit their studies for consideration during the public comment period for a significant regulatory decision or during peer review of ISI. Further, the rule does not address or affect business or contractual undertakings of any outside entities. The final rule addresses how EPA will consider the relevant scientific studies when promulgating significant regulatory decisions or developing ISI subject to the rule. 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.
Comment [25-94]: Commenter (10972) writes that the APA requires that the agency in its notice refer to the legal authority under which a rule is proposed. Section 553(b)(2). This requirement cannot be hedged away by asking for comment on the issue. This SNPRM suggests that it is under the EPA's Housekeeping authority. These rules cannot fit under the housekeeping authority. They are not merely procedural as they encode a substantive value judgment and have great substantive effects on the rights and interests of parties. In the circumstances, the EPA's legal authority ought to have been identified in the applicable substantive provisions. Not only does the EPA implicitly acknowledge the great substantive effects of these proposed rules, but it also explicitly notes substantive provisions that it believes could be applicable. The provisions providing legal authority must be correctly identified as such in order to meet the APA's legal requirements.
Identifying the correct legal authority is also important because provisions for issuance of substantive regulations often carry with them requirements unique to them. Notwithstanding the desire to discuss authority under various substantive statutes, the EPA has clearly not complied with the unique rulemaking requirements of some of these statutes. Whatever the Housekeeping authority may entail, it cannot provide a means to avoid the procedural requirements of the legal provisions authorizing a proposed rule.
Seeking to operate on the housekeeping authority is particularly inappropriate in this case where genuine scientific transparency makes different substantive demands under different laws and in different sectors. The SNPRM indicates that the EPA is aware of conflict between some of the statutes it administers and the proposed rule. A claim to be acting under those statutes cannot be sustained in such circumstances. Nothing is achieved by asserting that the statutes control if there is conflict between such statutes or their regulations and the proposed regulations; that regulations cannot be contrary to applicable statutes is trite law, but it can never empower actively passing rules contrary to the statute allegedly empowering them. The Housekeeping authority cannot allow such an effect. Regulations ought to elucidate statutes and facilitate the achievement of statutory goals, not to obfuscate statutory goals.
Response: The commenter claims that the rule is not procedural because it "encodes a substantive value judgment." The D.C. Circuit held that a rule is required to undergo full notice and comment proceedings if it "also encodes a substantive value judgment or puts a stamp of approval or disapproval on a given type of behavior." American Hosp. Ass'n v. Bowen, 834 F.2d 1037, 1047 (D.C. Cir. 1987); see also Air Transport Ass'n of America v. DOT, 900 F.2d 369, 376 (D.C.Cir.1990). Even if this applies, EPA satisfied any such requirement because the agency promulgated the rule after undergoing notice and comment. Additionally, the final rule does not categorically exclude any relevant studies from consideration. EPA will evaluate and weigh studies determined to be pivotal regulatory science, using the criteria in § 30.5, which will allow all high-quality studies to be factored into the agency's development of significant regulatory decisions and ISI.
EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In this final procedural rule, EPA does not rely on, interpret, or apply provisions of a particular statute or statutes that it administers. EPA will undertake such efforts in forthcoming substantive actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule.
EPA identified potential sources of legal authority in both the NPRM and SNPRM (Refs 5-7). Therefore, EPA did in fact meet any obligation under the APA to cite a source of authority. Furthermore, this is a purely procedural rule for reasons already discussed and therefore not subject to the APA's notice and comment requirements; EPA elected to nevertheless request public comment on various aspects of the rule, including whether the sources of authority already identified were appropriate. This was not improper under the APA.
Comment [31-135]: Commenter (9493) writes that even in the absence of an unprecedented pandemic, the proposed rule would not be one that could be adequately addressed in only thirty days. This fact is evident in the reach and complexity of the EPA's significantly revised proposal:
The EPA's new proposal appears to rest on a new theory for why the agency is even authorized to promulgate such a rule. According to the notice, the EPA is now attempting to rely on a "housekeeping authority" rooted in the Federal Housekeeping Statute, Reorganization Plan No. 3, or both, maybe. While the EPA mentioned the housekeeping statute when it extended the first comment period, it now seems to be relying on a more amorphous "housekeeping authority." (83 FR 15397-98). It is also unclear whether the EPA is relying on this asserted authority exclusively, or whether it intends to include a host of environmental statutes as additional authority for the rule. As the EPA has acknowledged in its notice, reliance on this new theory of authority calls for additional consideration and comment.
Response: EPA is authorized to promulgate this procedural rule under its authority to promulgate housekeeping regulations governing its internal affairs (hereinafter, "housekeeping authority"). EPA is relying on this housekeeping authority and not the environmental statutes as authority for the final rule. Because EPA proposed this authority in the supplemental notice, no additional notice and comment is necessary.
The Federal Housekeeping Statute provides that "[t]he head of an Executive department or military department may 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." 5 U.S.C. 301. As the Supreme Court discussed in Chrysler Corp. v. Brown, the intended purpose of section 301 was to grant early Executive departments the authority "to govern internal departmental affairs." As the Supreme Court further notes, section 301 authorizes "what the [APA] terms `rules of agency organization, procedure or practice' as opposed to substantive rules."
While EPA is not one of the 15 "Executive departments" listed at 5 U.S.C. 101, EPA gained housekeeping authority equivalent to that granted to Executive departments in section 301 through the Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9, 1970), which created EPA. The Reorganization Plan established the Administrator as "head of the agency," transferred functions and authorities of various agencies and Executive departments to EPA and gave EPA the authority to promulgate regulations to carry out the transferred functions.
Section 2(a)(1)-(8) of the Reorganization Plan transferred to EPA functions previously vested in several agencies and Executive departments including the Departments of the Interior and Agriculture. Section 2(a)(9) also transferred so much of the functions of the transferor officers and agencies "as is incidental to or necessary for the performance by or under the Administrator of the functions transferred" and provided that "[t]he transfers to the Administrator made by this section shall be deemed to include the transfer of [] authority, provided by law, to prescribe regulations relating primarily to the transferred functions." The Federal Housekeeping Statute was existing law at the time the Reorganization Plan was enacted.
The Office of Legal Counsel (OLC) has opined that the Reorganization Plan "convey[s] to the [EPA] Administrator all of the housekeeping authority available to other department heads under section 301" and demonstrates that "Congress has vested the Administrator with the authority to run EPA, to exercise its functions, and to issue regulations incidental to the performance of those functions."
Courts have considered EPA to be an agency with federal housekeeping authority. The U.S. Court of Appeals for the Second Circuit, in EPA v. General Elec. Co., 197 F.3d 592, 595 (2d Cir. 1999), found that "the Federal Housekeeping Statute, 5 U.S.C. 301, authorizes government agencies such as the EPA to adopt regulations regarding `the custody, use, and preservation of [agency] records, papers, and property.'" The Fourth Circuit Court of Appeals, in Boron Oil Co. v. Downie, 873 F.2d 67, 69 (4th Cir. 1989), held that the district court exceeded its jurisdiction where it compelled testimony contrary to duly promulgated EPA regulations which EPA argued were authorized by section 301. The Second and Fourth Circuits did not directly address whether it was an "Executive department", but rather assumed that EPA has authority to issue housekeeping regulations under section 301. Indeed, if EPA did not possess such authority, whether under section 301 or otherwise, EPA would not be able to carry out its daily functions which would in turn preclude EPA from exercising its duties as a federal regulatory agency. The same would hold true for other regulatory agencies that are not listed as an Executive department under section 101.
Even if the Federal Housekeeping statute does not directly apply to EPA, the agency's Reorganization Plan provides the authority to promulgate housekeeping regulations. As indicated by the case law and the OLC Opinion, it has long been presumed that EPA has been granted the authority to promulgate housekeeping regulations, whether pursuant to section 301 or equivalent housekeeping authority.
The Reorganization Plan does not expressly state that the authority to promulgate regulations is limited to the transferred functions, but rather that it relates primarily to the transferred functions. To argue that EPA's housekeeping authority is limited to carrying out only those functions explicitly transferred in the Reorganization Plan is to accept the statutory maxim that "the explicit mention of one thing is the exclusion of another." Courts routinely reject this principle because it is based on the faulty premise that the drafters of a statute considered and rejected all possible alternative or supplemental provisions. See, e.g., National Petroleum Refiners Ass'n v. FTC, 482 F.2d 672, 676 (D.C. Cir. 1973) (noting that the maxim is "increasingly considered unreliable"); see also Am. Trucking Ass'ns v. United States, 344 U.S. 298, 309-310 (1953) (rejecting the same principle when evaluating plaintiffs claim that the Interstate Commerce Commission (ICC) did not have the authority to power, control, regulate, or affect leasing practices because that authority was not explicitly named in the ICC's authorization statute). The court in American Trucking rejected the same principle when evaluating plaintiffs claim that the ICC did not have the authority to power, control, regulate, or affect leasing practices because that authority was not explicitly named in the ICC's authorization statute.
Comment [141-1273]: Commenter (11911) writes that EPA is not authorized to promulgate the Strengthening Transparency in Regulating Science (STRS) Rule under its housekeeping authority, as the finalized Rule itself would substantively violate a number of environmental statutes. Further, EPA neglects its mandate under Executive Order 12,866 by failing to account for the social and environmental harms STRS Rule's finalization would generate.
EPA is not authorized to promulgate the STRS Rule under its housekeeping authority. The Housekeeping Act provides that "[t]he head of an Executive department... may 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 property." 5 U.S.C. 301. As the Supreme Court has made clear, the purpose of section 301 is to grant Executive departments "authority to govern internal department affairs.... as opposed to substantive rules."
Courts have repeatedly rejected agency attempts, including recent ones, "to twist [the Housekeeping Act, a] simple administrative statute[,] into an authorization for the promulgation of substantive rules."
Response: See response to Comment 31-135.
Comment [32-144]: Commenter (11182) notes that EPA is also taking comments 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 (as clarified in the SNPRM). EPA claims it is not seeking to interpret its own statutory authority and that the changes proposed in the SNPRM are authorized under its housekeeping authority. They strongly disagree. The proposed rule creates arbitrary criteria for exclusion of studies considered pivotal science on the basis of use of confidential medical data. The SNPRM significantly increases the number of studies potentially excluded from consideration or subject to down-weighting by the proposed rule, thus far exceeding simple matters of administrative discretion. That the rule is intended to apply to studies in which the potential financial impacts are anticipated to exceed $500,000,000.00 further demonstrates a level of complexity in excess of that intended to be managed through administrative housekeeping alone.
For these reasons the commenter strongly opposes both the use of the housekeeping provisions to make the changes envisioned in the SNPRM and the proposed ability of the administrator to exempt or not exempt scientific research for consideration by EPA, no matter what aspects of the research are used in the decision-making.
Response: Implementation of the final rule will not result in the categorical exclusion of any relevant studies from consideration. EPA will evaluate studies determined to be pivotal science, using the criteria in § 30.5, which will allow all high-quality studies to be factored into the agency's development of significant regulatory decisions and ISI. The criteria are based on EPA's Framework for Human Health Risk Assessment to Inform Decision Making (Ref. 69). 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. Studies identified as pivotal science where the underlying data and models are available for independent validation will be given greater consideration than pivotal science lacking data and model transparency. The EPA will document why a particular study or studies received lesser consideration. An Administrator's exemption can be requested so that pivotal science whose underlying data and models is not, or cannot be, made publicly available can be given greater consideration.
Comment [34-155]: Commenter (11192) writes that the EPA claims to have authority to make extensive changes to how the agency uses science in its decision-making through the Federal Housekeeping Statute, and dwells on this point in the SNPRM for several paragraphs. Remarkably, the EPA suggests that this rule, which ignores established processes for evaluating scientific merit and would impact every regulation under the EPA's authority, is not a "substantive rule." The EPA asserts that the proposed rule "exclusively pertains to the internal practices of the EPA" and fails to mention that the EPA relies extensively on studies conducted by other entities, and indeed, is mandated to consider outside research under both the CAA and CWA. The EPA does not address how the application of the proposed rule could impact its ability to faithfully execute its statutory responsibilities under these acts; it simply makes reference to its intention to be consistent with its other statutes. As the EPA repeatedly asserts that this proposed rule deals with internal EPA processes, the EPA invites public comment about whether to pursue this proposed rule under only its housekeeping authority, or under its housekeeping authority along with its other statutory authorities, and conspicuously does not invite comment about whether or not invocation of the housekeeping authority is appropriate at all. Let it be clear: a rule of this breadth, with impacts extending into all significant agency decisions and actions, should by no means be considered a basic agency procedure and housekeeping.
Response: The final rule describes how EPA will consider studies underlying significant regulatory actions and ISI based on data and model availability and study quality factors. Those factors are found in the agency guidance document entitled Framework for Human Health Risk Assessment to Inform Decision Making. (Ref. 69) and are already used by EPA to evaluate outside research.
Comment [38-185]: Commenter (10751) writes that as they explained their prior comments this week, the EPA has expanded its proposal to stifle good science by publishing a SNPRM. In general, the SNPRM expands the Rule so as to further hamstring good scientific inquiry. For example, the SNPRM improperly purports to hide both scientific data and models as a minor agency housekeeping matter. Obviously, the Rule, the SNPRM, and the Rule to the extent modified by the SNPRM (collectively referred to as the Trio) is far more than an internal agency housekeeping matter.
Response: Nothing in the final rule will lead to the suppression of scientific data and models. 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. Additionally, the Administrator's exemption in § 30.9 can be used to allow greater consideration for pivotal science where the underlying data and models are not publicly available.
Comment [40-193]: Commenter (10751) notes that in the SNPRM, EPA states:
      Seventh, the EPA is proposing the option of using its housekeeping authority independently as authority for taking this action or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rulemaking (as clarified in this supplemental proposal). The Agency continues to consider whether it is appropriate to rely on its authority in the above-referenced environmental statutory provisions (potentially in conjunction with its housekeeping authority). The Agency will consider comments on this issue submitted in response to the 2018 proposal and in response to this SNPRM. Section 301 authority as transferred to EPA in Reorganization Plan No. 3 of 1970 provides appropriate authority for EPA to promulgate regulations that govern internal agency procedures. This action establishes internal agency procedures governing how EPA employees will handle studies when the data and models underlying science that is pivotal to EPA's significant regulatory decisions and/or influential scientific information are or are not publicly available.
Unfortunately, neither time nor the space permitted in public comments like this one permit a full discussion of the legal errors in the SNPRM much less in the Trio. However, it is self-evident that the Trio is both legally invalid and improper.
Congress expressly provided that in the housekeeping provisions of 5 U.S. Code § 301. Departmental regulations.
      The head of an Executive department or military department may 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 section does not authorize withholding information from the public or limiting the availability of records to the public." (Pub. L. 89 - 554, Sept. 6, 1966, 80 Stat. 379.) https://www.law.cornell.edu/uscode/text/5/301
While careful analysis of the section's every clause would further demonstrate that the Trio is void ab initio, a plain reading the last sentence suffices. It states: "This section does not authorize withholding information from the public or limiting the availability of records to the public." In the present case, the Trio try to limit the availability of good scientific information of the public. Cf., e.g., Dr. Kline's statement included at https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8817.
This result directly conflicts with the express directions of Congress.
Nor is consideration of the cannons of statutory construction necessary to conclude that each element of the Trio is invalid. As the editors explained in their prior comment briefs, both NEPA and the relevant environmental statutes require that the EPA disclose good scientific information to the public. This policy of fulsome disclosure is antithetical to the Trio.
      https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-0561
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-1037
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-3132
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-3133
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-4879
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5164
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5183
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5184
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5421
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5995
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-6107
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-6113
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-6801
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8279
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8178
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8817
(Collectively, these 16 formal comment briefs are referred to as "the Comments").
Of course, detailed consideration of the canons of statutory construction also compel the conclusion that the Trio are invalid.
For example, the plain meaning of section 301 is that: "This section does not authorize withholding information from the public or limiting the availability of records to the public."
As another example, the clear legislative intent of the underlying environmental statutes is to protect both human health and the environment; the Trio, by contrast, seeks to squelch the truth and bury valid science.
Even if one were to make the absurd assumption that Congress enacted the Trio into law, it is clear that any reviewing court would necessarily conclude that it must invalidate the Trio to avoid the absurd (an unconstitutionally irrational) result of ignoring good science.
Response: The purpose of the rule is to increase transparency of the science EPA uses to support its significant regulatory decisions and ISI. Nothing in the final rule will lead to the suppression of scientific data and models or otherwise withhold information from the public or limit the availability of records to the public. As described in § 30.5, EPA will identify those studies that are given lesser consideration and provide a short description of why lesser consideration was given. The public can provide comments on that issue and can also raise additional studies that it believes the agency should have considered during the comment period on a proposed rule. Additionally, the Administrator's exemption in § 30.9 can be used to allow greater consideration for pivotal science where the underlying data and models are not publicly available.
Comment [48-375]: Commenter (12727) writes that EPA's attempt to rely on the Housekeeping Act as a source of authority directly contradicts the statute's explicit allocation of these housekeeping authorities to "Executive departments" -- which EPA is not. The statute provides that "the head of an Executive department or military department may 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." By its terms, this statute authorizes an executive department "to regulate its own affairs" through "rules of agency organization procedure or practice."
EPA is not an "Executive department" within the meaning of section 301. As EPA acknowledges in the Supplemental Notice, section 101 of Title 5 explicitly lists the fifteen entities considered "Executive departments" under section 301, and EPA is not among them. The statute instead designates EPA as an "independent establishment," under section 104. Section 104 defines an "independent establishment" as "an establishment in the executive branch . . . which is not an Executive department, military department, Government corporation, or part thereof, or part of an independent establishment." Since EPA is an "independent establishment" rather than an "Executive department," the agency cannot rely on section 301 as the source of its authority for the 2018 Proposal.
Response: See response to Comment 31-135.
Comment [48-376]: Commenter (12727) writes that EPA incorrectly asserts that EPA has gained the authorities of an "Executive department" through delegation and reorganization. In the Supplemental Notice, EPA claims that Reorganization Plan No. 3, which established EPA -- and contains no mention of the Housekeeping Act -- implicitly granted EPA this status when it transferred programs and authorities from the Departments of Interior and Health, Education, and Welfare to the newly formed EPA. Admitting that nothing in Reorganization Plan No. 3 explicitly grants this authority, EPA points to a 2008 OLC opinion, on the entirely unrelated topic of whether federal employees should be held responsible for lost or damaged federal property, which contends that section 2(a)(9) of the plan implicitly confers this authority alongside the explicit transfer of various functions.
Such a strained interpretation clearly contradicts the requirement for Congress to amend the statute, if it so wills, to recognize additional executive departments. Congress has demonstrated its capacity to grant newly created government entities the status of executive departments with housekeeping authorities when it so chooses. In 2002, Congress created the Department of Homeland Security (DHS) and, similar to EPA's Reorganization Plan No. 3, laid out the functions transferred from existing departments to the new department. In section 101 of the Homeland Security Act (HSA), Congress specifically provided that the DHS was being "established . . . as an executive department of the United States within the meaning of title 5." Congress has had decades to take equivalent action with regard to EPA, and Congress's choice to not update the "Executive department" list cannot be conveniently ignored. To this day, EPA remains an "independent establishment" under the Housekeeping Act. It defies any reasonable interpretation for EPA to be simultaneously designated as an "executive department" and an "independent establishment," when the latter is defined as an entity not listed among the former. To construe EPA as an "executive department" contradicts the plain language of the statute and congressional intent.
Response: The term "independent establishment" is not used in the Housekeeping Statute. Also see the response to Comment 31-135.
Comment [48-377]: Commenter (12727) notes that the first case EPA cites for support, EPA v. General Electric Co., concerns the judicial reviewability of EPA's refusal to comply with a third-party subpoena under the APA. The court found the refusal reviewable; it did not find that EPA's regulations, which claimed section 301 among other authorities, applied to the subpoena as issued. The court referenced EPA's potential housekeeping authority only in dicta without any further discussion or analysis.
Response: See response to Comment 31-135.